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 .
Status of the Claims
Claims filed 04/29/2024 has been entered. Claims 1-27, 29-55 and 57-62 are pending and under consideration.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19, 21-27, 29-47, 49-55 and 62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 and 21-27 of U.S. Patent No. 11839527 (hereinafter ‘527) as to follows (with claim dependencies shown in paratheses, e.g., 3/2/1 as claim 3 incorporating claims 1 and 2.
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The difference between the present claims and ‘527 do not identically recite each element of current claims (e.g., using substantially similar but not identical terms; different elements are in different claims; and/or different combinations of elements). However, the ‘527 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘758 claims to one of ordinary skill in the art at the time of the present invention.
For instance, although the present claims 29-55 differs from ‘527 and the claims are directed to “a method for applying negative pressure to a wound”, ‘527 recites each and every element of the current claims, i.e., negative pressure wound therapy bandage comprising a membrane, and a pump assembly comprising a pump body, a wound-side passageway, a wound-side one-way valve, an atmosphere-side passageway and an atmosphere-side one-way valve as claimed, and therefore one of skill in the art would have been motivated to modify the patented claims and provide the method as claimed for the purpose of treating a wound.
Claims 20 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11839527 in view of Wall (US 20150202354 A1)
Regarding claim 20, ‘527 claims an NPWT bandage according claim 19.
‘527 does not expressly claim wherein the pump body comprises a substantially cylindrical configuration.
In the same field of endeavor, namely a wound dressing, Wall teaches wherein the pump body comprises a substantially cylindrical configuration (figures 2 and 3, interior chamber defined by bulb head 112 having circular cross-section extend longitudinally defines substantially cylindrical configuration).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘527, to incorporate the teachings of Wall and provides the pump body as claimed, and one of skill in the art motivated to do so, for the purpose of generating desired suction that assist in drawing exudate into the dressing as taught by Wall ([0013])
Regarding claim 48, ‘527 claims a method according to claim 47.
‘527 does not expressly claim wherein the pump body comprises a substantially cylindrical configuration.
In the same field of endeavor, namely a wound dressing, Wall teaches wherein the pump body comprises a substantially cylindrical configuration (figures 2 and 3, interior chamber defined by bulb head 112 having circular cross-section extend longitudinally defines substantially cylindrical configuration).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘527, to incorporate the teachings of Wall and provides the pump body as claimed, and one of skill in the art motivated to do so, for the purpose of generating desired suction that assist in drawing exudate into the dressing as taught by Wall ([0013])
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 1-7, 12, 13, 15-21, 23, 24, 26, 27, 29-35, 40, 41, 43-52, 54, 55, 57-62 are rejected under 35 U.S.C. 103 as being unpatentable over Wall (US 20150202354 A1) in view of Locke et al (US 20180272052 A1).
Regarding claim 1, Wall substantially teaches applicant's claimed invention, and specifically discloses a device with every structural limitation (except for the limitations shown in italics and grayed-out) including:
a negative pressure wound therapy (NPWT) bandage (figure 1, 100) for applying negative pressure to a wound, said NPWT bandage comprising:
a membrane (figure 3 and [0020] cover 103 configured to be placed over a tissue site 10 and form a wound chamber underneath) configured for disposition over a wound so as to form a wound chamber between said membrane and the wound, said membrane comprising a wound-side surface (figure 3, bottom surface facing collection pad 120), an atmosphere-side surface (figure 1, opposite top surface), and an opening (figure 3 [0017], central opening ) extending through said membrane from said wound-side surface to said atmosphere-side surface; and
a pump assembly (figure 1, aspirator 110) carried by said membrane, said pump assembly comprising:
a pump body (figure 1, bulb head 112) comprising a resilient outer wall ([0013]) defining a single inner hollow chamber (figure 3, cylindrical inner hollow chamber within the bulb head );
a wound-side passageway (figure 3, portion of the hollow chamber extending through flange 114) extending through said outer wall and communicating with the wound chamber through said opening formed in said membrane;
a wound-side one-way valve disposed in said wound-side passageway, said wound-side one-way valve being configured to allow fluid to flow through said wound-side passageway from the wound chamber to said inner hollow chamber but to prevent fluid from flowing through said wound-side passageway from said inner hollow chamber to the wound chamber;
an atmosphere-side passageway (figure 3 and [0013] opening formed in the top of the bulb head 112 comprising one-way vent 116) extending through said outer wall and connecting said inner hollow chamber and the atmosphere; and
an atmosphere-side one-way valve (figure 3 and [0013 and 0118], one-way vent 116) disposed in said atmosphere-side passageway, said atmosphere-side one-way valve being configured to allow fluid to flow through said atmosphere- side passageway from said inner hollow chamber to the atmosphere but to prevent fluid from flowing through said atmosphere-side passageway from the atmosphere to said inner hollow chamber;
such that when a compressive force ([0018] manually compressing bulb head 112 purges air from the interior of bulb head 112 through vent 116) is applied to said outer wall of said pump body, fluid within said inner hollow chamber pump chamber will be forced out of said inner hollow chamber via said atmosphere-side passageway, and when the compressive force applied to said outer wall of said pump body is thereafter reduced ([0018] when released, the bulb head 112 expand back to their original shape creating the suction and causes the fluid within the wound chamber drawn into the interior of the bulb), fluid within the wound chamber will be drawn into said inner hollow chamber through said wound-side passageway.
Wall does not teach a wound-side one-way valve disposed in said wound-side passageway, said wound-side one-way valve being configured to allow fluid to flow through said wound-side passageway from the wound chamber to said inner hollow chamber but to prevent fluid from flowing through said wound-side passageway from said inner hollow chamber to the wound chamber;
In the same field of endeavor, namely a low acuity dressing with integral pump, Locke teaches a wound dressing system (figure 1, 100) comprising a wound-side one-way valve (figure 1, check valve 144) disposed in said wound-side passageway (figure 1, tube 140), said wound-side one-way valve being configured to allow fluid to flow through said wound-side passageway from the wound chamber to said inner hollow chamber but to prevent fluid from flowing through said wound-side passageway from said inner hollow chamber to the wound chamber ([0061]);
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall to incorporate the teachings of Locke and provide the one-way valve as claimed for the purpose of permitting fluid communication from the wound chamber to the single inner hollow chamber only a taught by Locke as taught by Locke ([0061]).
Regarding claim 2, Wall, as modified by Locke, teaches an NPWT bandage according to claim 1.
The combination further teaches wherein said membrane comprises a plurality of layers (Wall; figure 3, the membrane comprises at least drape 130, adhesive coating 132 and hydrophobic coating 126).
Regarding claim 3, Wall, as modified by Locke, teaches an NPWT bandage according to claim 2.
The combination further teaches wherein said membrane comprises a substantially air-impermeable layer (Wall; [0017] drape film is air impermeable) and an absorbent layer (figure 3, fluid collection pad 120), wherein said absorbent layer is disposed on the wound side of said substantially air-impermeable layer.
Regarding claim 4, Wall, as modified by Locke, teaches an NPWT bandage according to claim 3.
The combination further teaches further comprising an additional layer (figure 3, intermediate hydrophilic foam 124), wherein said absorbent layer is disposed between said substantially air-impermeable layer and said additional layer (Wall; figure 3, the collection pad 120 is disposed between drape 130 and the foam 124).
Regarding claim 5, Wall, as modified by Locke, teaches an NPWT bandage according to claim 1.
The combination further teaches wherein a portion of said pump assembly extends through said opening formed in said membrane (Wall; figure 3, the aspirator 110 extends through the central opening).
Regarding claim 6, Wall, as modified by Locke, teaches an NPWT bandage according to claim 5.
The combination further teaches wherein said pump assembly comprises a flange (Wall; figure 3, flange 114 secured to the bottom surface of drape 130 and the bulb head 112 extend through the central opening) connected to said pump body, and further wherein said flange is secured to said wound-side surface of said membrane and said pump body extends through said opening formed in said membrane.
Regarding claim 7, Wall, as modified by Locke, teaches an NPWT bandage according to claim 6.
The combination further teaches wherein said flange is formed integral with said pump body (figure 3, flange 114 integrally formed with bulb head 112).
Regarding claim 12, Wall, as modified by Locke, teaches an NPWT bandage according to claim 1.
The combination further teaches wherein said wound-side surface of said membrane comprises an adhesive (Wall; figure 3, pressure sensitive adhesive 132)
Regarding claim 13, Wall, as modified by Locke, teaches an NPWT bandage according to claim 12.
The combination further teaches wherein a release liner is disposed on said wound-side surface of said membrane atop said adhesive (Wall; [0017] figure 2, releasable backing 134)
Regarding claim 15, Wall, as modified by Locke, teaches an NPWT bandage according to claim 1.
The combination further teaches wherein, when the pressure differential between the pressure of the fluid within said inner hollow chamber and atmospheric pressure is below a predetermined threshold, said pump body of said pump assembly will assume a substantially fully expanded configuration, and when said pressure differential between the pressure of the fluid within said inner hollow chamber and atmospheric pressure is above said predetermined threshold, said pump body of said pump assembly will assume a substantially fully collapsed configuration (Wall and Locke; The combination teaches the pump body is formed of the resilient outer wall, i.e., Wall [0013], and the resiliency of the pump establishes a predetermined threshold for expansion and collapse of the pump body. When the pressure differential falls below the threshold, the restorative forces of the resilient material causes the pump body to assume its substantially fully expanded configuration or vice versa).
Regarding claim 16, Wall, as modified by Locke, teaches an NPWT bandage according to claim 15.
wherein said pump body abruptly changes state between said substantially fully expanded configuration and said substantially fully collapsed configuration, and between said substantially fully collapsed configuration and said substantially fully expanded configuration, as said pressure differential crosses said predetermined threshold so as to effectively constitute a substantially "binary state" device (Wall and Locke; the combination teaches the structure as claimed, i.e., a membrane and a pump assembly comprising a pump body comprising a resilient outer wall defining a substantially cylindrical single inner hollow chamber, a wound-side passageway with a valve, and an atmosphere-side passageway with a valve, and therefore the pump assembly abruptly changes state between the fully expanded configuration and fully collapsed configuration constituting binary state).
Regarding claim 17, Wall, as modified by Locke, teaches an NPWT bandage according to claim 15.
The combination does not expressly teach wherein said predetermined threshold is between about 60 mm Hg and about 180 mm Hg.
In the same field of endeavor, namely a low acuity dressing with integral pump, Locke teaches the therapy pressure provided by the negative pressure source is about 70 mm Hg of negative pressure ([0067]).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall, as modified by Locke, to incorporate the teachings of Locke and provide the predetermined threshold pressure as claimed for the purpose of providing desired negative pressure for therapeutic environment as taught by Locke ([0067]).
Examiner’s note, although Locke does not explicitly use the term “predetermined threshold”, Locke discloses a manual pump mechanism that generate the desired negative pressure by expanding and collapsing the pump body. Because the desired negative pressure is generated specifically during the transition, Locke inherently teaches that the pump assembly possesses a function threshold. Specifically, to achieve the disclosed pressure of 70 mm Hg, the pump body must necessarily operates at a threshold that result in said pressure.
Regarding claim 18, Wall, as modified by Locke, teaches an NPWT bandage according to claim 15.
The combination further teaches wherein said pump body is configured so as to provide an “over-the-center” deformation characteristic (Wall; figures 3 and 4, Wall’s substantially cylindrical pump body provide the over-the-center deformation characteristic between collapsed and expanded configuration).
Regarding claim 19, Wall, as modified by Locke, teaches an NPWT bandage according to claim 15.
The combination further teaches wherein said pump body comprises a substantially circular cross- section (Wall; figure 3, inner chamber within the bulb head 112 comprises a circular cross-section)
Regarding claim 20, Wall, as modified by Locke, teaches an NPWT bandage according to claim 19.
The combination further teaches wherein said pump body comprises a substantially cylindrical configuration (Wall; figures 2 and 3, inner chamber within the bulb head 112 comprises a cylindrical configuration).
Regarding claim 21, Wall, as modified by Locke, teaches an NPWT bandage according to claim 15.
The combination further teaches wherein (i) said outer wall structure of said pump body and said inner hollow chamber comprise a substantially circular cross-section when said pressure differential between the pressure of the fluid within said inner hollow chamber and atmospheric pressure is below said predetermined threshold (Wall; figure 3, the cross section of bulb head 112 is substantially circular when the pressure is above the predetermined threshold), and (ii) said outer wall structure of said pump body bows inwardly when said pressure differential between the pressure of the fluid within said inner hollow chamber and atmospheric pressure exceeds said predetermined threshold (Wall; figure 4, the cross section of bulb head 112 is inwardly bowed when the pressure is below the predetermined threshold)
Regarding claim 23, Wall, as modified by Locke, teaches an NPWT bandage according to claim 15.
The combination further teaches wherein said wound-side surface of said membrane comprises an adhesive. (Wall; figure 3, pressure sensitive adhesive 132)
Regarding claim 24, Wall, as modified by Locke, teaches an NPWT bandage according to claim 23.
The combination further teaches wherein a release liner is disposed on said wound-side surface of said membrane atop said adhesive (Wall; [0017] figure 2, releasable backing 134)
Regarding claim 26, Wall, as modified by Locke, teaches an NPWT bandage according to claim 15.
The combination further teaches wherein said pump assembly comprises a flange (Wall; figure 3, flange 114 secured to bottom surface of drape 130, and the bulb head 112 extends through the central opening of the drape) connected to said pump body, and further wherein said flange is secured to said wound-side surface of said membrane and said pump body extends through said opening formed in said membrane.
Regarding claim 27, Wall, as modified by Locke, teaches an NPWT bandage according to claim 26.
The combination further teaches wherein said flange is formed integral with said pump body (figure 3, flange 114 integrally formed with bulb head 112).
Regarding claim 29, Wall teaches a method for applying negative pressure to a wound, the method comprising:
providing a negative pressure wound therapy (NPWT) bandage (figure 1 and [0013] providing dressing 100) comprising:
a membrane (figure 3 and [0020] cover 103 configured to be placed over a tissue site 10 and form a wound chamber underneath) configured for disposition over a wound so as to form a wound chamber between said membrane and the wound, said membrane comprising a wound-side surface (figure 3, bottom surface facing collection pad 120), an atmosphere-side surface (figure 1, opposite top surface), and an opening (figure 3 [0017], central opening ) extending through said membrane from said wound-side surface to said atmosphere-side surface; and
a pump assembly (figure 1, aspirator 110) carried by said membrane, said pump assembly comprising:
a pump body (figure 1, bulb head 112) comprising a resilient outer wall ([0013]) defining a single inner hollow chamber (figure 3, cylindrical inner hollow chamber within the bulb head);
a wound-side passageway (figure 3, portion of the hollow chamber extending through flange 114) extending through said outer wall and communicating with the wound chamber through said opening formed in said membrane;
a wound-side one-way valve disposed in said wound-side passageway, said wound-side one-way valve being configured to allow fluid to flow through said wound-side passageway from the wound chamber to said inner hollow chamber but to prevent fluid from flowing through said wound-side passageway from said inner hollow chamber to the wound chamber;
an atmosphere-side passageway (figure 3 and [0013] opening formed in the top of the bulb head 112 comprising one-way vent 116) extending through said outer wall and connecting said inner hollow chamber and the atmosphere; and
an atmosphere-side one-way valve (figure 3 and [0013 and 0118], one way vent 116) disposed in said atmosphere-side passageway, said atmosphere-side one-way valve being configured to allow fluid to flow through said atmosphere- side passageway from said inner hollow chamber to the atmosphere but to prevent fluid from flowing through said atmosphere-side passageway from the atmosphere to said inner hollow chamber;
such that when a compressive force ([0018] manually compressing bulb head 112 purges air from the interior of bulb head 112 through vent 116) is applied to said outer wall of said pump body, fluid within said inner hollow chamber will be forced out of said inner hollow chamber via said atmosphere-side passageway, and when the compressive force applied to said outer wall of aid pump body is thereafter reduced ([0018] when released, the bulb head 112 expand back to their original shape creating the suction and causes the fluid within the wound chamber drawn into the interior of the bulb), fluid within the wound chamber will be drawn into said inner hollow chamber through said wound-side passageway;
positioning said negative pressure wound therapy (NPWT) bandage over the wound so as to form a wound chamber between said membrane and the wound (figure 3 and [0020] positioning 100 over a tissue site 10 and form a wound chamber underneath); and
applying a compressive force to said outer wall structure of said pump body, and thereafter reducing the compressive force applied to said outer wall of said pump body, so as to apply negative pressure to the wound ([0018]).
Wall does not teach a wound-side one-way valve disposed in said wound-side passageway, said wound-side one-way valve being configured to allow fluid to flow through said wound-side passageway from the wound chamber to said inner hollow chamber but to prevent fluid from flowing through said wound-side passageway from said inner hollow chamber to the wound chamber;
In the same field of endeavor, namely a low acuity dressing with integral pump, Locke teaches a wound dressing system (figure 1, 100) comprising a wound-side one-way valve (figure 1, check valve 144) disposed in said wound-side passageway (figure 1, tube 140), said wound-side one-way valve being configured to allow fluid to flow through said wound-side passageway from the wound chamber to said inner hollow chamber but to prevent fluid from flowing through said wound-side passageway from said inner hollow chamber to the wound chamber ([0061]);
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall to incorporate the teachings of Locke and provide the one-way valve as claimed for the purpose of permitting fluid communication from the wound chamber to the single inner hollow chamber only a taught by Locke as taught by Locke ([0061]).
Regarding claim 30, Wall, as modified by Locke, teaches a method according to claim 29.
The combination further teaches wherein said membrane comprises a plurality of layers (Wall; figure 3, the membrane comprises at least drape 130, adhesive coating 132 and hydrophobic coating 126).
Regarding claim 31, Wall, as modified by Locke, teaches a method according to claim 30.
The combination further teaches wherein said membrane comprises a substantially air-impermeable layer (Wall; [0017] drape film is air impermeable) and an absorbent layer (figure 3, fluid collection pad 120), wherein said absorbent layer is disposed on the wound side of said substantially air-impermeable layer.
Regarding claim 32, Wall, as modified by Locke, teaches a method according to claim 31.
The combination further teaches further comprising an additional layer (figure 3, intermediate hydrophilic foam 124), wherein said absorbent layer is disposed between said substantially air-impermeable layer and said additional layer (Wall; figure 3, the collection pad 120 is disposed between drape 130 and the foam 124).
Regarding claim 33, Wall, as modified by Locke, teaches a method according to claim 29.
The combination further teaches wherein a portion of said pump assembly extends through said opening formed in said membrane (Wall; figure 3, the aspirator 110 extends through the central opening).
Regarding claim 34, Wall, as modified by Locke, teaches a method according to claim 33.
The combination further teaches wherein said pump assembly comprises a flange (Wall; figure 3, flange 114 secured to the bottom surface of drape 130 and the bulb head 112 extend through the central opening) connected to said pump body, and further wherein said flange is secured to said wound-side surface of said membrane and said pump body extends through said opening formed in said membrane.
Regarding claim 35, Wall, as modified by Locke, teaches a method according to claim 34.
The combination further teaches wherein said flange is formed integral with said pump body (figure 3, flange 114 integrally formed with bulb head 112).
Regarding claim 40, Wall, as modified by Locke, teaches a method according to claim 29.
The combination further teaches wherein said wound-side surface of said membrane comprises an adhesive (Wall; figure 3, pressure sensitive adhesive 132)
Regarding claim 41, Wall, as modified by Locke, teaches an NPWT bandage according to claim 29.
The combination further teaches wherein a release liner is disposed on said wound-side surface of said membrane atop said adhesive (Wall; [0017] figure 2, releasable backing 134)
Regarding claim 43, Wall, as modified by Locke, teaches a method according to claim 29.
The combination further teaches wherein, when the pressure differential between the pressure of the fluid within said inner hollow chamber and atmospheric pressure is below a predetermined threshold, said pump body of said pump assembly will assume a substantially fully expanded configuration, and when said pressure differential between the pressure of the fluid within said inner hollow chamber and atmospheric pressure is above said predetermined threshold, said pump body of said pump assembly will assume a substantially fully collapsed configuration (Wall and Locke; The combination teaches the pump body is formed of the resilient outer wall, i.e., Wall [0013], and the resiliency of the pump establishes a predetermined threshold for expansion and collapse of the pump body. When the pressure differential falls below the threshold, the restorative forces of the resilient material causes the pump body to assume its substantially fully expanded configuration or vice versa).
Regarding claim 44, Wall, as modified by Locke, teaches a method according to claim 43.
The combination further teaches wherein said pump body abruptly changes state between said substantially fully expanded configuration and said substantially fully collapsed configuration, and between said substantially fully collapsed configuration and said substantially fully expanded configuration, as said pressure differential crosses said predetermined threshold so as to effectively constitute a substantially "binary state" device (Wall and Locke; the combination teaches the structure as claimed, i.e., a membrane and a pump assembly comprising a pump body comprising a resilient outer wall defining a substantially cylindrical single inner hollow chamber, a wound-side passageway with a valve, and an atmosphere-side passageway with a valve, and therefore the pump assembly abruptly changes state between the fully expanded configuration and fully collapsed configuration constituting binary state).
Regarding claim 45, Wall, as modified by Locke, teaches a method according to claim 43.
The combination does not expressly teach wherein said predetermined threshold is between about 60 mm Hg and about 180 mm Hg.
In the same field of endeavor, namely a low acuity dressing with integral pump, Locke teaches the therapy pressure provided by the negative pressure source is about 70 mm Hg of negative pressure ([0067]).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall, as modified by Locke, to incorporate the teachings of Locke and provide the predetermined threshold pressure as claimed for the purpose of providing desired negative pressure for therapeutic environment as taught by Locke ([0067]).
Examiner’s note, although Locke does not explicitly use the term “predetermined threshold”, Locke discloses a manual pump mechanism that generate the desired negative pressure by expansion and collapse of the pump body. Because the desired negative pressure is generated specifically during the transition, Locke inherently teaches that the pump assembly possesses a function threshold. Specifically, to achieve the disclosed pressure of 70 mm Hg, the pump body must necessarily operates at a threshold that result in said pressure.
Regarding claim 46, Wall, as modified by Locke, teaches a method according to claim 43.
The combination further teaches wherein said pump body is configured so as to provide an “over-the-center” deformation characteristic (Wall; figures 3 and 4, Wall’s substantially cylindrical pump body provide the over-the-center deformation characteristic).
Regarding claim 47, Wall, as modified by Locke, teaches a method according to claim 29.
The combination further teaches wherein said pump body comprises a substantially circular cross- section (Wall; figure 3, inner chamber within the bulb head 112 comprises a circular cross-section)
Regarding claim 48, Wall, as modified by Locke, teaches a method according to claim to claim 47.
The combination further teaches wherein said pump body comprises a substantially cylindrical configuration (Wall; figures 2 and 3, inner chamber within the bulb head 112 comprises a cylindrical configuration).
Regarding claim 49, Wall, as modified by Locke, teaches a method according to claim 43.
The combination further teaches wherein (i) said outer wall structure of said pump body and said inner hollow chamber comprise a substantially circular cross-section when said pressure differential between the pressure of the fluid within said inner hollow chamber and atmospheric pressure is below said predetermined threshold (Wall; figure 3, the cross section of bulb head 112 is substantially circular when the pressure is above the predetermined threshold), and (ii) said outer wall structure of said pump body bows inwardly when said pressure differential between the pressure of the fluid within said inner hollow chamber and atmospheric pressure exceeds said predetermined threshold (Wall; figure 4, the cross section of bulb head 112 is inwardly bowed when the pressure is below the predetermined threshold)
Regarding claim 51, Wall, as modified by Locke, teaches a method according to claim 43.
The combination further teaches wherein said wound-side surface of said membrane comprises an adhesive. (Wall; figure 3, pressure sensitive adhesive 132)
Regarding claim 52, Wall, as modified by Locke, teaches a method according to claim 51.
The combination further teaches wherein a release liner is disposed on said wound-side surface of said membrane atop said adhesive (Wall; [0017] figure 2, releasable backing 134)
Regarding claim 54, Wall, as modified by Locke, teaches a method according to claim 43.
The combination further teaches wherein said pump assembly comprises a flange (Wall; figure 3, flange 114 secured to bottom surface of drape 130, and the bulb head 112 extends through the central opening of the drape) connected to said pump body, and further wherein said flange is secured to said wound-side surface of said membrane and said pump body extends through said opening formed in said membrane.
Regarding claim 55, Wall, as modified by Locke, teaches a method according to claim 43.
The combination further teaches wherein said flange is formed integral with said pump body (Wall; figure 3, flange 114 integrally formed with bulb head 112).
Regarding claim 57, Wall, as modified by Locke, teaches an NPWT bandage according to claim 1.
The combination further teaches wherein no part of said inner hollow chamber is defined by the wound (Wall; figure 3, the hollow inner chamber defined by bulb head is not defined by the wound).
Regarding claim 58, Wall, as modified by Locke, teaches an NPWT bandage according to claim 1.
The combination further teaches wherein said pump does not apply positive pressure to the wound (Locke; [0040] pump assembly having the check valve 144 disposed in the wound side passageway prevent applying positive pressure to the wound).
Regarding claim 59, Wall, as modified by Locke, teaches an NPWT bandage according to claim 1.
The combination further teaches wherein said pump is connected to the wound chamber such that a reduction in the volume of the inner hollow chamber does not cause a change in pressure in the wound chamber (Locke; [0061] the check valve 144 disposed in the wound side passageway prevent fluid communication from the inner hollow chamber to the wound chamber such that reduction in the volume of the inner hollow chamber, i.e., collapsing, does not change a change in pressure in the wound chamber).
Regarding claim 60, Wall, as modified by Locke, teaches an NPWT bandage according to claim 1.
The combination does not teach wherein said resilient outer wall is airtight.
In the same field of endeavor, namely a low acuity dressing with integral pump, Locke teaches wherein said resilient outer wall is airtight ([0054]-[0055] film layer 132 constructed from a material that can provide a fluid seal).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall, as modified by Locke, to incorporate the teachings of Locke and provide the resilient outer wall as claimed for the purpose of fluidly isolating the inner hollow chamber from the ambient environment as taught by Locke ([0054]).
Regarding claim 61, Wall, as modified by Locke, teaches an NPWT bandage according to claim 1.
The combination further teaches wherein said inner hollow chamber is free of any solid matter (Wall; figure 3, the inner chamber is free of any solid matter).
Regarding claim 62, Wall teaches a negative pressure wound therapy (NPWT) bandage for applying negative pressure to a wound, said NPWT bandage comprising:
a membrane (figure 3 and [0020] cover 103 configured to be placed over a tissue site 10 and form a wound chamber underneath) configured for disposition over a wound so as to form a wound chamber between said membrane and the wound, said membrane comprising a wound-side surface (figure 3, bottom surface facing collection pad 120), an atmosphere-side surface (figure 3, opposite top surface), and an opening (figure 3 and [0017] central opening) extending through said membrane from said wound-side surface to said atmosphere-side surface; and
a pump assembly (figure 1, aspirator 110) carried by said membrane, said pump assembly comprising:
a pump body (figure 1 and [0013], bulb head 112) comprising a wall structure disposed about a pump chamber (figure 3, cylindrical inner hollow chamber within the bulb head), wherein at least a portion of said wall structure is resilient;
a wound-side passageway (figure 3, portion of the hollow chamber extending through flange 114) extending through said wall structure and communicating with the wound chamber through said opening formed in said membrane;
a wound-side one-way valve disposed in said wound-side passageway, said wound-side one-way valve being configured to allow fluid to flow through said wound-side passageway from the wound chamber to said pump chamber but to prevent fluid from flowing through said wound-side passageway from said pump chamber to the wound chamber;
an atmosphere-side passageway (figure 3 and [0013] opening formed in the top of the bulb head 112 comprising one-way vent 116) extending through said wall structure and connecting said pump chamber and the atmosphere; and
an atmosphere-side one-way valve (figure 3 and [0013 and 0118], one-way vent 116) disposed in said atmosphere-side passageway, said atmosphere-side one-way valve being configured to allow fluid to flow through said atmosphere- side passageway from said pump chamber to the atmosphere but to prevent fluid from flowing through said atmosphere-side passageway from the atmosphere to said pump chamber;
such that when a compressive force is applied to said wall structure of said pump body ([0018] manually compressing bulb head 112 purges air from the interior of bulb head 112 through vent 116), fluid within said pump chamber is forced out of said pump chamber via said atmosphere-side passageway, and when the compressive force applied to said wall structure of said pump body is thereafter reduced ([0018] when released, the bulb head 112 expand back to their original shape creating the suction and causes the fluid within the wound chamber drawn into the interior of the bulb), fluid within the wound chamber is drawn into said pump chamber through said wound-side passageway;
wherein the pump assembly comprises a pump flange, and further wherein the pump flange is secured to the membrane (figure 3, flange 114 secured to drape 132).
Wall does not teach a wound-side one-way valve disposed in said wound-side passageway, said wound-side one-way valve being configured to allow fluid to flow through said wound-side passageway from the wound chamber to said pump chamber but to prevent fluid from flowing through said wound-side passageway from said pump chamber to the wound chamber;
In the same field of endeavor, namely a low acuity dressing with integral pump, Locke teaches a wound dressing system (figure 1, 100) comprising a wound-side one-way valve (figure 1, check valve 144 disposed in tube 140) disposed in said wound-side passageway, said wound-side one-way valve being configured to allow fluid to flow through said wound-side passageway from the wound chamber to said pump chamber but to prevent fluid from flowing through said wound-side passageway from said pump chamber to the wound chamber ([0061]);
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall to incorporate the teachings of Locke and provide the one-way valve as claimed for the purpose of permitting fluid communication from the wound chamber to the single inner hollow chamber only a taught by Locke as taught by Locke ([0061]).
Claims 8 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Wall (US 20150202354 A1) in view of Locke et al (US 20180272052 A1), and in further view of Austin (US 3486504 A).
Regarding claim 8, Wall, as modified by Locke, teaches an NPWT bandage according to claim 7.
The combination does not tech wherein a neck is formed between said pump body and said flange, and further wherein a pair of recesses extend inwardly between said pump body and said flange.
In the same field of endeavor, namely a device for applying dressing medication and suction, Austin teaches wherein a neck (figure 1, neck between flange 12 and housing 10) is formed between said pump body and said flange, and further wherein a pair of recesses (figure 1, recesses formed in the neck) extend inwardly between said pump body and said flange.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall, as modified by Locke, to incorporate the teachings of Austin and provide the pump body as claimed, and one of skill in the art motivated to do so, for the purpose of providing effective squeezable pump body, thereby reliably generating negative pressure upon compression of the pump body. For instance, in contrast to a pump body having walls of constant width along its height, i.e., Wall’s, neck prevents unintended lifting of the flange of the pump body upon the deformation and ensures that the entire squeezing force is directed into radial compression of the pump body, producing the desired vacuum more efficiently and consistently.
Regarding claim 36, Wall, as modified by Locke, teaches a method according to claim 35.
The combination does not tech wherein a neck is formed between said pump body and said flange, and further wherein a pair of recesses extend inwardly between said pump body and said flange.
In the same field of endeavor, namely a device for applying dressing medication and suction, Austin teaches wherein a neck (figure 1, neck between flange 12 and housing 10) is formed between said pump body and said flange, and further wherein a pair of recesses (figure 1, recesses formed in the neck) extend inwardly between said pump body and said flange.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall, as modified by Locke, to incorporate the teachings of Austin and provide the pump body as claimed, and one of skill in the art motivated to do so, for the purpose of providing effective squeezable pump body, thereby reliably generating negative pressure upon compression of the pump body. For instance, in contrast to a pump body having walls of constant width along its height, i.e., Wall’s, neck prevents unintended lifting of the flange of the pump body upon the deformation and ensures that the entire squeezing force is directed into radial compression of the pump body, producing the desired vacuum more efficiently and consistently.
Claims 11, 22 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Wall (US 20150202354 A1) in view of in view of Locke et al (US 20180272052 A1), and in further view of Asfora (US 7694821 B1).
Regarding claim 11, Wall, as modified by Locke, teaches an NPWT bandage according to claim 1.
The combination does not teach wherein said pump assembly comprises a removable cap for selectively closing off said atmosphere-side passageway.
In the same field of endeavor, namely a kit for evacuating a collection of fluid, Asfora teaches wherein said pump assembly comprises a removable cap (figure 3, cap 28 removably closing opening 26) for selectively closing off said atmosphere-side passageway.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall, as modified by Locke, to incorporate the teachings of Asfora and provide the removable cap as claimed for the purpose of selectively closing the atmosphere-side passageway of the pump as taught by Asfora (col 5 lines 55-61). One of skill in the art motivated to do so for the purpose of preventing natural leakage or decline of negative pressure through the atmosphere-side passageway valve thereby maintaining desired negative pressure for the wound healing throughout therapy session.
Regarding claim 22, Wall, as modified by Locke, teaches an NPWT bandage according to claim 15.
The combination does not teach wherein said pump assembly comprises a removable cap for selectively closing off said atmosphere-side passageway.
In the same field of endeavor, namely a kit for evacuating a collection of fluid, Asfora teaches wherein said pump assembly comprises a removable cap (figure 3, cap 28 removably closing opening 26) for selectively closing off said atmosphere-side passageway.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall, as modified by Locke, to incorporate the teachings of Asfora and provide the removable cap as claimed for the purpose of selectively closing the atmosphere-side passageway of the pump as taught by Asfora (col 5 lines 55-61). One of skill in the art motivated to do so for the purpose of preventing natural leakage or decline of negative pressure through the atmosphere-side passageway valve thereby maintaining desired negative pressure for the wound healing throughout therapy session
Regarding claim 39, Wall, as modified by Locke, teaches a method according to claim 29.
The combination does not teach wherein said pump assembly comprises a removable cap for selectively closing off said atmosphere-side passageway.
In the same field of endeavor, namely a kit for evacuating a collection of fluid, Asfora teaches wherein said pump assembly comprises a removable cap (figure 3, cap 28 removably closing opening 26) for selectively closing off said atmosphere-side passageway.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall, as modified by Locke, to incorporate the teachings of Asfora and provide the removable cap as claimed for the purpose of selectively closing the atmosphere-side passageway of the pump as taught by Asfora (col 5 lines 55-61). One of skill in the art motivated to do so for the purpose of preventing natural leakage or decline of negative pressure through the atmosphere-side passageway valve thereby maintaining desired negative pressure for the wound healing.
Claim 14, 25, 42 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Wall (US 20150202354 A1) in view of Locke et al (US 20180272052 A1), and in further view of Frederiksen et al (US 20090326430 A1).
Regarding claim 14, Wall, as modified by Locke, teaches an NPWT bandage according to claim 1.
The combination does not teach wherein a removable stiffener is disposed on said atmosphere- side surface of said membrane.
In the same field of endeavor, namely a film dressing, Frederiksen teaches a flexible film (figure 1, 1) wherein a removable stiffener (figure 1, removable support layer 6 bonded to the film 1) is disposed on said atmosphere- side surface of said membrane.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall, as modified by Locke, to incorporate the teachings of Frederiksen for the purpose of facilizing the application of the flexible NPWT bandage to the wound as taught by Frederiksen ([0053]).
Regarding claim 25, Wall, as modified by Locke, teaches an NPWT bandage according to claim 15.
The combination does not teach wherein a removable stiffener is disposed on said atmosphere- side surface of said membrane.
In the same field of endeavor, namely a film dressing, Frederiksen teaches a flexible film (figure 1, 1) wherein a removable stiffener (figure 1, removable support layer 6 bonded to the film 1) is disposed on said atmosphere- side surface of said membrane.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall, as modified by Locke, to incorporate the teachings of Frederiksen for the purpose of facilizing the application of the flexible NPWT bandage to the wound as taught by Frederiksen ([0053]).
Regarding claim 42, Wall, as modified by Locke, teaches a method according to claim 29.
The combination does not teach wherein a removable stiffener is disposed on said atmosphere- side surface of said membrane.
In the same field of endeavor, namely a film dressing, Frederiksen teaches a flexible film (figure 1, 1) wherein a removable stiffener (figure 1, removable support layer 6 bonded to the film 1) is disposed on said atmosphere- side surface of said membrane.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall, as modified by Locke, to incorporate the teachings of Frederiksen for the purpose of facilizing the application of the flexible NPWT bandage to the wound as taught by Frederiksen ([0053]).
Regarding claim 53, Wall, as modified by Locke, teaches a method according to claim 43.
The combination does not teach wherein a removable stiffener is disposed on said atmosphere- side surface of said membrane.
In the same field of endeavor, namely a film dressing, Frederiksen teaches a flexible film (figure 1, 1) wherein a removable stiffener (figure 1, removable support layer 6 bonded to the film 1) is disposed on said atmosphere- side surface of said membrane.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wall, as modified by Locke, to incorporate the teachings of Frederiksen for the purpose of facilizing the application of the flexible NPWT bandage to the wound as taught by Frederiksen ([0053]).
Allowable Subject Matter
Claims 9, 10, 37 and 38 are allowable over the prior art but are rejected under double patenting rejection as discussed supra.
The following is a statement of reasons for the indication of allowable subject matter: No prior art or in combination could be found to teach (claim 9) wherein said pump assembly is mounted to said membrane by a pair of pedestals, and further wherein one of said pedestals comprises said wound-side passageway. The closest prior art Wall teaches the device as claimed (figure 3, bulb head 112 is mounted to membrane a flange 114, and the flange comprises wound-side passageway) except for the pump assembly is mounted to said membrane by a pair of pedestals. Khan (US 20080287892 A1) teaches a double pedestal structure (figure 3, flange 32 and 50), however Khan teaches the flanges is configured for providing sealant surfaces for connecting ostomy bag, therefore Khan is not relevant to the instant case. In addition, there is no motivation to add redundant pedestals to Wall, because Wall teaches the entire surface of flange is attached to the membrane which effectively secures the pump in place, and therefore additional pedestal would not provide any improvement over the prior art.
Similarly, claim 37 recites wherein said pump assembly is mounted to said membrane by a pair of pedestals, and further wherein one of said pedestals comprises said wound-side passageway, and therefore the claim is allowable over the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gross (US 5549584 A).
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/SETH HAN/Examiner, Art Unit 3781
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