DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/16/2026 has been entered.
Terminal Disclaimer
The terminal disclaimer filed on 3/13/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 10,219,973 B2 and US 11,672,725 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendments
The Amendment filed 7/10/2026 has been entered. Claims 1 and 4-5 were amended, and claims 3, 7, 14-34, and 36-37 were canceled. Thus, claims 1-2, 4-6, 8-13, 35, and 38-43 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 4, the limitation “pulling the intact skin” in lines 1-2 is confusing, as it is unclear whether this limitation is meant to be the same as or separate from “pulling the intact skin” in claim 1. For the purposes of examination, they will be interpreted as the same limitation.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 4 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weston et al. (US 2005/0203452 A1) in view of Atkinson et al. (US 2006/0287621 A1) and Knighton et al. (US 6,551,280 B1).
Regarding claim 1, Weston discloses a method for promoting perfusion at a tissue site (appliance for treating a portion of the body to treat wounds and other conditions such as lymphedema, varicose veins, venous insufficiency and status, and other infirmities via a reduced pressure treatment) (abstract; para. [0008]), the method comprising:
circumferentially disposing a dressing proximate intact skin extending over the tissue site (treatment device 311 having enclosure 320 and liner 370 over the skin of a patient’s foot, ankle, and calf; wound packing means 375 does not need to be utilized when treating conditions without skin wounds, thereby involving intact skin) (Fig. 4; abstract; paras. [0043-0044]), wherein the dressing comprises:
a comfort layer configured to be circumferentially disposed proximate the intact skin (liner 370 circumferentially disposed proximately over the intact skin of the patient’s foot) (Fig. 4; para. [0044]);
a sleeve formed from a semi-permeable material (enclosure 320 may be constructure of gas permeable material) (Fig. 4; para. [0029]) and configured to form a chamber containing the comfort layer to seal the comfort layer within the chamber between the sleeve and the intact skin (enclosure 320 forms a chamber of space containing the liner 370, and seals the liner 370 inside between the enclosure 320 and the skin of the patient’s foot) (Fig. 4; para. [0049]); and
an attachment device configured to seal the sleeve to the intact skin (enclosure 320 is sealed at portion 325 to the patient’s body portion 314, which has skin) (Fig. 4; para. [0049]);
supplying negative pressure (vacuum system 350 supplies reduced pressure to the treatment device 311) (Fig. 4; para. [0043]);
collapsing the sleeve in response to the supplied negative pressure (as the enclosure 320 can be made of flexible material, it would collapse inwards when the vacuum system 350 supplies the reduced pressure or suction force inside the enclosure 320) (Fig. 4; para. [0029]; para. [0043]);
stiffening the sleeve in response to the supplied negative pressure (the flexible enclosure 350 would be stiffer when collapsed around the patient’s limb by the reduced pressure due to the lack of air inside) (Fig. 4; para. [0029]; para. [0043]); and
pulling the intact skin radially outward in response to the supplied negative pressure (as reduced pressure is being supplied to a patient’s limb, the reduced pressure or suction would pull radially outward at the skin of the limb) (Fig. 4; para. [0043]; para. [0048]).
Weston does not disclose a manifold configured to be circumferentially disposed around and coupled to the comfort layer, the manifold formed from a porous material having flow channels for distributing negative pressure to the intact skin; the sleeve configured to cover the manifold and form a chamber containing the manifold to seal the manifold within the chamber; and the attachment device configured to seal the sleeve to the intact skin adjacent the manifold; wherein when the dressing is disposed proximate to the intact skin, the comfort layer is positioned between the intact skin and the manifold; supplying negative pressure to the manifold; pulling the intact skin radially outward in response to the supplied negative pressure by applying the supplied negative pressure to the intact skin through the flow channels of the manifold, wherein the flow channels of the manifold remain open while the manifold is compressed under the supplied negative pressure.
However, Atkinson teaches a device and method for compressing a limb (Atkinson; abstract) including a manifold coupled to the comfort layer (diffusion element 15 coupled to inner layer 11) (Atkinson; Fig. 2; paras. [0019-0020]), the manifold formed from a porous material having flow channels for distributing negative pressure to the intact skin (diffusion element 15 is an open celled foam, and thus has flow channels inside with which to diffuse the air flow from the vacuum delivered to the skin of the limb) (Atkinson; Figs. 1-2; para. [0018]; para. [0020]); the sleeve configured to cover the manifold and form a chamber containing the manifold to seal the manifold within the chamber (outer layer 13 covers the diffusion element 15 and forms a chamber with the diffusion element 15 sealed inside) (Atkinson; Figs. 1-2; paras. [0019-0020]); and the attachment device configured to seal the sleeve to the intact skin adjacent the manifold (sealed band 18 seals the outer layer 13 to the skin of the limb, and would be adjacent to the diffusion layer inside the outer layer 13) (Atkinson; Figs. 1-2; paras. [0019-0020]); supplying negative pressure to the manifold (negative pressure is supplied to the diffusion element 15 via vacuum source 20) (Atkinson; Fig. 2; para. [0018]; para. [0020]); pulling the intact skin radially outward in response to the supplied negative pressure (vacuum source 20 evacuates air from the space between the cover 12 and the limb, and so would pull outwards the skin on the limb in that space) (Atkinson; Fig. 2; paras. [0017-0018]; para. [0020]) by applying the supplied negative pressure to the intact skin through the flow channels of the manifold (vacuum source 20 evacuates air via the flow channels in the open celled foam diffusion element 15) (Atkinson; Figs. 1-2; para. [0018]; para. [0020]), wherein the flow channels of the manifold remain open while the manifold is compressed under the supplied negative pressure (the negative pressure from the vacuum source 20 applies a compressive force; there is no structure to close the cells in the open cell foam diffusion element 15, and so they would remain open while the vacuum source 20 applies the negative pressure) (Atkinson; Fig. 2; paras. [0017-0018]; para. [0020]). Furthermore, Knighton teaches a therapeutic device to provide support or pressure to tissue (Knighton; abstract) wherein a manifold is configured to be circumferentially disposed around (device 30 to treat a limb has an open cell foam in a generally cylindrical shape around the limb, where the open cell foam fluidly communicates with to vacuum/air lines) (Knighton; Fig. 3; col. 7 lines 28-36); the comfort layer is positioned between the intact skin and the manifold (the axial passage way formed by the cylindrical open cell foam can be lined with material comfortable against skin) (Knighton; Fig. 3; col. 7 lines 28-36, 45-52).
Therefore, it would have been obvious to one of ordinary skill in the art before the time of invention for the claimed invention to modify the Weston method to include providing a manifold coupled to the comfort layer, the manifold formed from a porous material having flow channels for distributing negative pressure to the intact skin; the sleeve configured to cover the manifold and form a chamber containing the manifold to seal the manifold within the chamber; and the attachment device configured to seal the sleeve to the intact skin adjacent the manifold; supplying negative pressure to the manifold; and pulling the intact skin radially outward in response to the supplied negative pressure by applying the supplied negative pressure to the intact skin through the flow channels of the manifold, wherein the flow channels of the manifold remain open while the manifold is compressed under the supplied negative pressure, as taught by Atkinson, for the purpose of helping to avoid compromising the air flow or causing pain and/or pressure sores on the limb (Atkinson; para. [0020]). Furthermore, it would have been obvious to one of ordinary skill in the art before the time of invention for the claimed invention to further modify the Weston method’s manifold to be circumferentially disposed around, and the comfort layer is positioned between the intact skin and the manifold, as taught by Knighton, for the purpose of enabling the amount of compressive force applied around a patient’s limb to be predetermined, and to thereby help to avoid discomfort and injury to the patient while also providing a comfortable material against the skin to help improve user comfort (Knighton; col. 4 lines 11-25; col. 7 lines 45-52).
With this modification, the modified Weston device would thus teach a manifold configured to be circumferentially disposed around and coupled to the comfort layer (Atkinson open celled foam diffusion element 15 modified by Knighton to be cylindrical around the limb, and so would be circumferentially around and coupled to the Weston liner 370) (Weston, Fig. 4, para. [0044]; Atkinson, Figs. 1-2, paras. [0018-0020]; Knighton, Fig. 3, col. 7 lines 28-36); wherein when the dressing is disposed proximate to the intact skin, the comfort layer is positioned between the intact skin and the manifold (Weston liner 370 is placed over the body portions 317, 319 before placement of the enclosure, and so is directly on the skin of the body portions 317, 319; Knighton teaches the axial passage way formed by the cylindrical open cell foam can be lined with material comfortable against skin, and thus the Atkinson open cell foam diffusion element 15 would be lined with the Weston liner 370, such that the Weston liner 370 is between the skin and the Atkinson diffusion element 15) (Weston, Fig. 4, para. [0051]; Atkinson, Figs. 1-2, paras. [0019-0020]; Knighton, Fig. 3, col. 7 lines 28-36, 45-52).
Regarding claim 4, as best understood, the modified Weston teaches wherein pulling the intact skin radially outward comprises pneumatically pulling the intact skin toward the sleeve after the sleeve has collapsed and the manifold has been compressed (Weston vacuum system 350 supplies the reduced pressure or suction force inside the enclosure 320, and so would pull the skin on the body portions 317, 319 radially outwards towards the enclosure 320; as the Weston enclosure 320 can be made of flexible material, it would collapse inwards when the Weston vacuum system 350 supplies the reduced pressure or suction force inside the enclosure 320 to compress against the Atkinson open cell foam diffusion element 15 underneath) (Weston, Fig. 4, para. [0029], para. [0043]; Atkinson, Fig. 2, paras. [0017-0018], para. [0020]).
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weston in view of Atkinson and Knighton as applied to claim 1 above, and further in view of Hanlon et al. (US 2008/0077176 A1).
Regarding claim 2, the modified Weston teaches the invention as previously claimed, but does not teach wherein: the dressing further comprises: a connector configured to be fluidly coupled to the manifold, the connector comprising: a housing defining an interior space having an interface aperture configured to be in fluid communication with the manifold, and a receptacle formed on the housing and having a first aperture and a second aperture, the first aperture configured to receive a conduit, the second aperture fluidly coupling the receptacle to the interior space and being smaller than the first aperture and further configured to restrict the conduit from entering the interior space; and the method further comprises fluidly communicating the negative pressure to the manifold through the connector.
However, Hanlon teaches a connector assembly for a compression therapy system (Hanlon; abstract) including a connector configured to be fluidly coupled to the manifold (connector assembly 30 used to fluidly connect a controller 2 to a compression therapy device 1 for cyclically supplying air pressure) (Hanlon; Figs. 3, 32-34; paras. [0049-0050]), the connector comprising: a housing defining an interior space having an interface aperture configured to be in fluid communication with the manifold (second connector 38 with a housing defining a hollow interior space; second connector 38 has an attachment portion 80 aperture that fluidly attaches to first tubing 32 used to supply air to compression therapy device 1 from controller 2) (Hanlon; Figs. 3, 32-34; paras. [0050-0051]; para. [0057]), and a receptacle formed on the housing and having a first aperture and a second aperture (second connector 38 has a receptacle 78 formed thereon, the receptacle 78 having apertures at both ends) (Hanlon; Fig. 3; para. [0051]; para. [0053]), the first aperture configured to receive a conduit (second connector 38 has an aperture through receptacle 78 for receiving first connector 36) (Hanlon; Fig. 3; para. [0053]), the second aperture fluidly coupling the receptacle to the interior space and being smaller than the first aperture and further configured to restrict the conduit from entering the interior space (second connector 38 has an aperture through the annular shoulder 75 inside receptacle 78 that fluidly connects the receptacle 78 to the housing of the second connector 38 interior space; the aperture through the annular shoulder 75 is smaller than the aperture used to receive the first connector 36, and prevents the first connector 36 from entering the housing space of second connector 38) (Hanlon; Fig. 3; para. [0050]; para. [0053]).
Therefore, it would have been obvious to one of ordinary skill in the art before the time of invention for the claimed invention to modify the Weston apparatus to include a connector configured to be fluidly coupled to the manifold, the connector comprising: a housing defining an interior space having an interface aperture configured to be in fluid communication with the manifold, and a receptacle formed on the housing and having a first aperture and a second aperture, the first aperture configured to receive a conduit, the second aperture fluidly coupling the receptacle to the interior space and being smaller than the first aperture and further configured to restrict the conduit from entering the interior space, as taught by Hanlon, for the purpose of enabling the treatment device to be disconnected from the pressure source while also helping to prevent erroneous or improper connections between devices when creating a fluid tight connection (Hanlon; abstract; para. [0006]).
With this modification, the modified Weston device would thus teach the method further comprises fluidly communicating the negative pressure to the manifold through the connector (Hanlon connector assembly 30 would be connecting the Weston treatment device 311 and vacuum system 350, so the vacuum system 350 can fluidly communicate the vacuum or negative pressure to the Atkinson diffusion element 15 in the Weston treatment device 311 through the Hanlon connector assembly 30) (Weston, Fig. 4, para. [0043]; Atkinson, Figs. 1-2, para. [0018], para. [0020]; Hanlon, Figs. 3, 32-34, paras. [0049-0050]).
Claims 5-6, 8, and 12-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weston in view of Atkinson and Cornet et al. (US 2007/0219585 A1).
Regarding claim 5, Weston discloses an apparatus for applying negative pressure to a tissue site of a patient (appliance for treating a portion of the body to treat wounds and other conditions via a reduced pressure treatment) (abstract; para. [0008]), the apparatus comprising: a sleeve configured to form a chamber, the sleeve further configured to seal the chamber between the sleeve and the tissue site (enclosure 320 forms a chamber of space to hold the foot, the chamber being sealed between the enclosure 320 and the foot being treated) (Fig. 4; para. [0049]).
Weston does not disclose a manifold formed from a porous material having an open cell structure and configured to be circumferentially disposed proximate to the tissue site; the sleeve configured to cover the manifold and form a chamber containing the manifold, the sleeve further configured to seal the manifold within the chamber.
However, Atkinson teaches a device and method for compressing a limb (Atkinson; abstract) including a manifold formed from a porous material having an open cell structure and configured to be circumferentially disposed proximate to the tissue site (diffusion element 15 is an open celled foam, and thus has flow channels inside with which to diffuse the air flow from the vacuum delivered to the skin of the limb being treated) (Atkinson; Figs. 1-2; para. [0018]; para. [0020]); the sleeve configured to cover the manifold and form a chamber containing the manifold, the sleeve further configured to seal the manifold within the chamber (outer layer 13 covers the diffusion element 15 and forms a chamber for the limb being treated, wherein the sealed band 18 seals the outer layer 13 such that the diffusion element 15 is sealed inside the chamber) (Atkinson; Figs. 1-2; paras. [0019-0020]).
Therefore, it would have been obvious to one of ordinary skill in the art before the time of invention for the claimed invention to modify the Weston apparatus to include a manifold formed from a porous material having an open cell structure and configured to be circumferentially disposed proximate to the tissue site; the sleeve configured to cover the manifold and form a chamber containing the manifold, the sleeve further configured to seal the manifold within the chamber, as taught by Atkinson, for the purpose of helping to avoid compromising the air flow or causing pain and/or pressure sores on the limb (Atkinson; para. [0020]).
Weston does not disclose a delivery manifold having walls surrounding one or more flow passages configured to receive a negative pressure from a negative-pressure source and deliver negative pressure to the manifold, wherein the walls include a plurality of apertures located along a length of the delivery manifold that fluidly communicate between the one or more flow passages and the manifold, and wherein the diameters of the plurality of apertures vary along the length of the delivery manifold.
However, Cornet teaches a reduced pressure delivery system (Cornet; abstract) including a delivery manifold having walls surrounding one or more flow passages configured to receive a negative pressure from a negative-pressure source and deliver negative pressure to the manifold (reduced-pressure delivery tube 241, 341 has walls surrounding a single lumen 259 or dual lumens 263, 265; reduced-pressure delivery tube 241, 341 receives reduced pressure from a reduced pressure source to be delivered to wing manifold 311 with cellular material 327) (Cornet; Figs. 1-8; para. [0081]; para. [0085]; para. [0093]; para. [0096]; para. [0099]), wherein the walls include a plurality of apertures located along a length of the delivery manifold that fluidly communicate between the one or more flow passages and the manifold (reduced-pressure delivery tube 341 has walls defining a distal orifice 343 and vent openings 251 to fluidly communicate between the single lumen 259 or dual lumens 263, 265 and the cellular material 327; the distal orifice 343 and vent openings 251 are located along a length of the reduced-pressure delivery tube 341) (Cornet; Figs. 1-8; para. [0094]), and wherein the diameters of the plurality of apertures vary along the length of the delivery manifold (the diameter of the distal orifice 343 at the end of the length of the reduced-pressure delivery tube 341 is different than the diameter of the vent openings 251 along the rest of the length of the reduced-pressure delivery tube 341) (Cornet; Figs. 5-6, 8; para. [0094]).
Therefore, it would have been obvious to one of ordinary skill in the art before the time of invention for the claimed invention to modify the modified Weston apparatus to include a delivery manifold having walls surrounding one or more flow passages configured to receive a negative pressure from a negative-pressure source and deliver negative pressure to the manifold, wherein the walls include a plurality of apertures located along a length of the delivery manifold that fluidly communicate between the one or more flow passages and the manifold, and wherein the diameters of the plurality of apertures vary along the length of the delivery manifold, as taught by Cornet, for the purpose of providing a structure with more openings to thereby increase fluid communication (Cornet; para. [0094]).
Regarding claim 6, the modified Weston teaches wherein the delivery manifold comprises a flexible material (reduced-pressure delivery manifold made of silicone, which is a flexible/elastomeric material) (Cornet; para. [0072]; para. [0079]) and is disposed between the sleeve and the manifold (Cornet reduced-pressure delivery tube 341 is at the back of the cellular material 327, and so the modified Weston would have the Cornet reduced-pressure delivery tube 341 between the Weston enclosure 320 and the Atkinson diffusion element 15/Cornet cellular material 327) (Weston, Fig. 4, para. [0049]; Atkinson, Figs. 1-2, para. [0020]; Cornet, Figs. 6-8, para. [0093]).
Regarding claim 8, the modified Weston teaches the invention as previously claimed, including further comprising a delivery tube having one or more lumens fluidly coupling the one or more flow passages of the delivery manifold to the negative-pressure source (Weston tubing member 364 of the vacuum system 350 would fluidly couple to the Cornet single lumen 259 or dual lumens 263, 265 of the reduced-pressure delivery tube 341 at the proximal orifice 355) (Weston, Fig. 4, para. [0048]; Cornet, Figs. 6-9, para. [0096]), but does not teach wherein the lumens have protrusions to prevent the lumens from collapsing under pressure.
However, Cornet further teaches wherein the lumens have protrusions to prevent the lumens from collapsing under pressure (blockage prevention member 2135, which may be projections 2137, within a manifold to prevent collapse during application of reduced pressure) (Cornet; Figs. 40-44; para. [0158]).
Therefore, it would have been obvious to one of ordinary skill in the art before the time of invention for the claimed invention to modify the modified Weston lumens to include protrusions to prevent the lumens from collapsing under pressure, as taught by Cornet, for the purpose of preventing the collapse of the manifold during the application of reduced pressure (Cornet; para. [0158]).
Regarding claim 12, the modified Weston teaches the invention as previously claimed, but does not teach further comprising a substantially rigid case enclosing the sleeve.
However, Atkinson further teaches a substantially rigid case enclosing the sleeve (sub-atmospheric compression device 10 can be used under a hard cast) (Atkinson; Figs. 1-2; para. [0023]).
Therefore, it would have been obvious to one of ordinary skill in the art before the time of invention for the claimed invention to modify Weston sleeve such that a substantially rigid case encloses the sleeve, as taught by Atkinson, for the purpose of providing additional protection and support to a patient’s injured leg.
Regarding claim 13, the modified Weston teaches the invention as previously claimed, but does not teach further comprising a flexible walking boot enclosing the sleeve.
However, Atkinson further teaches a flexible walking boot enclosing the sleeve (sub-atmospheric compression device 10 can be used under a soft cast) (Atkinson; Figs. 1-2; para. [0023]).
Therefore, it would have been obvious to one of ordinary skill in the art before the time of invention for the claimed invention to modify Weston sleeve such that a flexible walking boot enclosing the sleeve, as taught by Atkinson, for the purpose of providing additional protection and support to a patient’s injured leg.
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weston in view of Atkinson and Cornet as applied to claim 8 above, and further in view of Andresen et al. (US 2010/0324510 A1).
Regarding claim 9, the modified Weston teaches the invention as previously claimed, including wherein the delivery tube is disposed in the chamber between the sleeve and the manifold (Weston tubing member 364 of the vacuum system 350 would be in the chamber of space defined by the enclosure 320, between the enclosure 320 and the Atkinson diffusion element 15) (Weston, Fig. 4, para. [0049]; Atkinson, Figs. 1-2, para. [0020]; Cornet, Figs. 6-8), but does not teach wherein the delivery tube is elliptical in shape.
However, Andresen teaches a device for treating wounds with reduced pressure (Andresen; abstract) wherein the delivery tube is elliptical in shape (tube 3, which connects to an under pressure source, has an oval cross-section) (Andresen; Figs. 1, 17; abstract; para. [0103]).
Therefore, it would have been obvious to one of ordinary skill in the art before the time of invention for the claimed invention to modify the Weston delivery tube to be elliptical in shape, as taught by Andresen, for the purpose of providing the delivery tube with a specific suitable shape which one of ordinary skill in the art could feasibly expect to perform reasonably well to fluidly communicate with an under pressure source.
Claim 10 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weston in view of Atkinson and Cornet as applied to claim 8 above, and further in view of Sanders et al. (US 2005/0020955 A1).
Regarding claim 10, the modified Weston teaches the invention as previously claimed, including wherein the delivery manifold is formed from a soft silicone material (Cornet reduced-pressure delivery manifold made of silicone, which is a flexible/elastomeric material and so would be soft) (Cornet; para. [0072]; para. [0079]), but does not teach the delivery tube is formed from a soft silicone material
However, Sanders teaches a wound treatment device for applying negative pressure (Sanders; abstract) wherein the delivery tube is formed from a soft silicone material (fluid communication means 42 is a flexible silicone tube) (Sanders; Fig. 4G; para. [0029]).
Therefore, it would have been obvious to one of ordinary skill in the art before the time of invention for the claimed invention to modify the Weston delivery tube to be formed from a soft silicone material, as taught by Sanders, for the purpose of providing the delivery tube with a specific suitable material known in the art for a tube fluidly communicating with a negative pressure source (Sanders; para. [0029]).
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weston in view of Atkinson and Cornet as applied to claim 5 above, and further in view of Rastegar et al. (US 2003/0216672 A1).
Regarding claim 11, the modified Weston teaches the invention as previously claimed, including wherein the delivery manifold is further configured to receive airflow from a source of positive pressure and deliver the airflow to the manifold (reduced-pressure delivery tube 341 can have a second lumen 265 to supply air to the flow channels 233/cellular material 327) (Cornet; Figs. 1-8; para. [0081]; para. [0096]), but does not teach the airflow is a temperature-controlled airflow.
However, Rastegar teaches using an enclosure that alternates positive and negative pressure in a chamber to treat a patient (Rastegar; abstract) wherein the airflow is a temperature-controlled airflow (heating unit 210 provided as the inflow air stream to regulate temperature close to a set temperature) (Rastegar; Fig. 3; para. [0042]; para. [0081]).
Therefore, it would have been obvious to one of ordinary skill in the art before the time of invention for the claimed invention to modify the modified Weston airflow from a source of positive pressure such that the airflow is a temperature-controlled airflow, as taught by Rastegar, for the purpose of regulating the temperature of the air within the enclosure to keep it at a set temperature, which can thereby help a patient to maintain a normal body temperature (Rastegar; para. [0042]; para. [0081]; para. [0096]).
Claims 35 and 39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weston et al. (US 2005/0203452 A1) in view of Cazzini et al. (US 2008/0208088 A1), Kloecker (US 2002/0042585 A1), and Atkinson et al. (US 2006/0287621 A1).
Regarding claim 35, Weston discloses a dressing for applying negative pressure to a tissue site of a patient (appliance for treating a portion of the body to treat wounds and other conditions via a reduced pressure treatment) (abstract; para. [0008]), the dressing comprising:
a comfort layer configured to be disposed proximate the tissue site (liner 370 circumferentially disposed proximately over the intact skin of the patient’s foot) (Fig. 4; para. [0044]), the comfort layer comprising an occlusive material (any solid material would be occlusive; liner 370 can be made of cotton, polyester, nylon, rayon, etc.) (Fig. 4; para. [0044]);
a sealing layer comprising a sealing material and an adhesive backing material (portion 325 seals to the patient’s body portion 314; sealing means can include a combination of sealant and adhesive tape, and portion 325 is sealed) (Fig. 4; para. [0035]; para. [0043]), the sealing layer configured to cover the comfort layer and form a chamber containing the comfort layer to seal the chamber between the sealing layer and the tissue site (enclosure 320 is sealed at portion 325, over the liner 370, to form a sealed chamber with the liner 370, wherein the sealed chamber is between the portion 325 and the patient’s foot) (Fig. 4; para. [0049]); and
a fluid coupling member configured to receive negative pressure from a negative pressure source to deliver negative pressure for distribution to the tissue site (bulb connection tubing member 364 used to receive reduced pressure or vacuum from the vacuum system 350 to supply it to the treatment device 311, where it is distributed to the foot) (Fig. 4; para. [0043]; para. [0048]).
Weston does not disclose the comfort layer having a plurality of holes; wherein at least a portion of the adhesive backing material of the sealing layer is configured to extend through at least a portion of the plurality of holes of the comfort layer to secure the dressing to the patient.
However, Cazzini teaches a negative pressure compression therapy device (Cazzini; abstract) wherein the layer contacting the skin has a plurality of holes (sheet 20, which is the interior sheet and so contacts the patient’s skin, can have openings 22, 24 for ventilation) (Cazzini; Fig. 5; para. [0013]; para. [0016]; claim 10). Moreover, Kloecker teaches a compression garment (Kloecker; abstract) wherein at least a portion of the sealing layer is configured to extend through at least a portion of the plurality of holes of the comfort layer to secure the dressing to the patient (seal points can connect two layers together regardless of whether they include apertures 11 to form a pocket or chamber of the device on the patient’s limb) (Kloecker; Figs. 3-5; para. [0068]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Weston comfort layer of liner 370, which is the layer that contacts the skin, to have a plurality of holes, as taught by Cazzini, for the purpose of providing ventilation to the patient’s limb, and thereby provide a means to dissipate heat and/or coolness, provide air flow, and keep the limb dry to help avoid problems normally associated with maceration of the skin due to continuous high moisture and heat levels as well as prevent bacterial growth (Cazzini; para. [0016]). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Weston sealing layer such that wherein at least a portion of the sealing layer is configured to extend through at least a portion of the plurality of holes of the comfort layer to secure the dressing to the patient, as taught by Cazzini, for the purpose of ensuring the seal to form the pocket or chamber needed to provide the treatment can be provided regardless of any apertures (Kloecker; para. [0068]).
With this modification, the modified Weston would thus teach wherein at least a portion of the adhesive backing material of the sealing layer is configured to extend through at least a portion of the plurality of holes of the comfort layer to secure the dressing to the patient (the Weston portion 325 to create the seal of the enclosure onto the patient’s limb can be an adhesive tape and so have a backing material; the Weston liner 370 was modified by Cazzini to have holes 22, 24; as Kloecker has seal points that can connect two structures together regardless of whether they include apertures 11 to form a pocket or chamber of the device on the patient’s limb, so too can the modified Weston device’s adhesive tape portion 325 thus connect the enclosure to the limb by extending through at least a portion of the Cazzini holes 22, 24 on the Weston liner 370 to create the chamber of the Weston enclosure 320 on the limb, as taught by Kloecker) (Weston, Fig. 4, para. [0035], para. [0043], para. [0049]; Cazzini, Fig. 5, para. [0013], para. [0016], claim 10; Kloecker, Figs. 3-5, para. [0068]).
Weston does not disclose a manifold layer having an open cell structure and configured to distribute vacuum over the tissue site; the sealing layer configured to cover the manifold layer and form a chamber containing the manifold layer to seal the manifold layer within the chamber between the sealing layer and the tissue site; the fluid coupling member fluidly coupled to the manifold layer and configured to deliver negative pressure to the manifold layer for distribution to the tissue site.
However, Atkinson teaches a device and method for compressing a limb (Atkinson; abstract) including a manifold layer having an open cell structure and configured to distribute vacuum over the tissue site (diffusion element 15 is an open celled foam, and thus has flow channels inside with which to diffuse the air flow from the vacuum delivered to the skin of the limb) (Atkinson; Figs. 1-2; para. [0018]; para. [0020]); the sealing layer configured to cover the manifold layer and form a chamber containing the manifold layer to seal the manifold layer within the chamber between the sealing layer and the tissue site (sealed band 18 covers the diffusion element 15 to form a chamber inside the cover 12 containing the diffusing layer 15, thereby sealing the diffusing layer 15 inside the cover 12 chamber between the sealed band 18 and the patient’s foot) (Atkinson; Figs. 1-2; paras. [0019-0020]); the fluid coupling member fluidly coupled to the manifold layer and configured to deliver negative pressure to the manifold layer for distribution to the tissue site (connective tubing 20 fluidly coupled to the diffusion element 15 to deliver diffused vacuum flow from the vacuum source 20 to the limb) (Atkinson; Fig. 2; para. [0018]; para. [0020]).
Therefore, it would have been obvious to one of ordinary skill in the art before the time of invention for the claimed invention to modify the Weston apparatus to include a manifold layer having an open cell structure and configured to distribute vacuum over the tissue site; the sealing layer configured to cover the manifold layer and form a chamber containing the manifold layer to seal the manifold layer within the chamber between the sealing layer and the tissue site; the fluid coupling member fluidly coupled to the manifold layer and configured to deliver negative pressure to the manifold layer for distribution to the tissue site, as taught by Atkinson, for the purpose of helping to avoid compromising the air flow or causing pain and/or pressure sores on the limb (Atkinson; para. [0020]).
Regarding claim 39, the modified Weston teaches wherein the manifold layer has a perimeter (as a solid object, the diffusion element 15 has a perimeter) (Atkinson; Fig. 2; para. [0020]) and wherein the comfort layer and the sealing layer extend beyond the perimeter of the manifold layer (the Atkinson diffusion element 15 would be layered over the Weston liner 370, and so the liner 370 would be beyond the diffusion element 15 perimeter; the Atkinson diffusion element 15 would be below the Weston sealed portion 325, and so the sealed portion 325 would be beyond the diffusion element 15 perimeter) (Weston, Fig. 4, para. [0049]; Atkinson, Figs. 1-2, para. [0020]).
Claims 38 and 40-42 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weston in view of Cazzini, Kloecker, and Atkinson as applied to claim 35 above, and further in view of Kuiper et al. (US 2003/0191420 A1).
Regarding claim 38, the modified Weston teaches the invention as previously claimed, but does not teach wherein the manifold layer further comprises a series of slits.
However, Kuiper teaches a therapeutic leg covering (Kuiper; abstract) wherein the manifold layer further comprises a series of slits (notches 159 cut out from support material, which is made of foam) (Kuiper; Fig. 13; para. [0079]).
Therefore, it would have been obvious to one of ordinary skill in the art before the time of invention for the claimed invention to modify the modified Weston manifold layer to include a series of slits, as taught by Kuiper, for the purpose of improving flexibility in an area such as around the Achilles tendon (Kuiper; para. [0079]).
Regarding claim 40, the modified Weston teaches the invention as previously claimed, but does not teach wherein the dressing has a two-dimensional profile having a distal dressing portion, a proximal dressing portion, and a flexible dressing portion between the distal dressing portion and the proximal dressing portion.
However, Kuiper further teaches wherein the dressing has a two-dimensional profile having a distal dressing portion, a proximal dressing portion, and a flexible dressing portion between the distal dressing portion and the proximal dressing portion (boot 110 has a two-dimensional profile when unfastened, as best seen in Fig. 8; boot 110 has a top portion near the knee, a bottom portion near the toes, and a middle portion around the ankle that is flexible to accommodate the ankle) (Kuiper; Figs. 8-9; paras. [0070-0071]).
Therefore, it would have been obvious to one of ordinary skill in the art before the time of invention for the claimed invention to modify the Weston dressing to include layer to include a two-dimensional profile having a distal dressing portion, a proximal dressing portion, and a flexible dressing portion between the distal dressing portion and the proximal dressing portion, as taught by Kuiper, for the purpose of permitting greater flexibility through the ankle area when the covering is secured around a limb and reducing the amount of excess material that may bunch and bulge when ankle flexing occurs (Kuiper; para. [0071]).
Regarding claim 41, the modified Weston teaches wherein the flexible dressing portion has a width narrower than the distal dressing portion and the proximal dressing portion (the middle portion has a width between opposite rounded termination points 135 that is narrower than the width of the top and bottom portions) (Kuiper; Figs. 8-9).
Regarding claim 42, the modified Weston teaches wherein the distal dressing portion and the proximal dressing portion are configured to be at least partially wrapped around a limb on either side of an articulating joint with the flexible dressing portion configured to be positioned at the articulating joint (top and bottom portions of boot 110 are wrapped around the calf and foot so as to surround the ankle, which can articulate, the ankle being wrapped with the middle portion of the boot 110) (Kuiper; Figs. 8-9; paras. [0070-0071]).
Claim 43 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weston in view of Cazzini, Kloecker, and Atkinson as applied to claim 35 above, and further in view of Laghi (US 5,897,517).
Regarding claim 43, the modified Weston teaches the invention as previously claimed, but does not teach wherein the comfort layer is silicone.
However, Laghi teaches a fabric reinforced elastomer material in the medical art for applications such as brace supports and compression garments (Laghi; abstract) wherein the comfort layer is silicone (second base material 14, which forms an interface between a first base material 12 and an area of the body, can be silicone) (Laghi; Figs. 2-3, 7; col. 2 lines 42-45, 56-63).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Weston comfort layer to be silicone, as taught by Laghi, for the purpose of providing an interface between the area of the body being treated that keeps a device in place without causing discomfort to the user and helps to avoid skin reactions (Laghi; col. 3 lines 5-16).
Response to Arguments
Applicant's arguments filed 7/10/2026 have been fully considered but they are not persuasive.
On page 9 in the first paragraph of the Applicant’s remarks, the Applicant argues that Atkinson does not teach the comfort layer is positioned between the intact skin and the manifold, nor the circumferential manifold, and thus cannot be used to teach the Applicant’s claimed invention as newly amended. However, the Examiner respectfully disagrees. Atkinson is not being used to teach these limitations. Rather, the Knighton reference is used instead. Knighton teaches the comfort layer is positioned between the intact skin and the manifold (the axial passage way formed by the cylindrical open cell foam can be lined with material comfortable against skin) (Knighton; Fig. 3; col. 7 lines 28-36, 45-52) and the manifold is a circumferential manifold (device 30 to treat a limb has an open cell foam in a generally cylindrical shape around the limb, where the open cell foam fluidly communicates with to vacuum/air lines) (Knighton; Fig. 3; col. 7 lines 28-36). Thus, the current prior art of record can still be used to teach the Applicant’s invention.
On page 9 in the second paragraph of the Applicant’s remarks, the Applicant argues that Knighton does not provide a reason to transform Atkinson’s diffusion element into a circumferential manifold wherein the comfort layer is between the intact skin and manifold as claimed, and thus cannot be used to teach the Applicant’s claimed invention as newly amended. However, the Examiner respectfully disagrees. Modifying the Atkinson diffusion element to be a circumferential manifold and having the comfort layer between the intact skin and manifold, as taught by Knighton, is for the purpose of enabling the amount of compressive force applied around a patient’s limb to be predetermined, and to thereby help to avoid discomfort and injury to the patient (Knighton; col. 4 lines 11-25) while also providing a comfortable material against the skin to help improve user comfort (Knighton; col. 7 lines 45-52). Thus, the current combination of prior art of record can still be used to teach the Applicant’s invention as currently claimed.
On page 10 in the second and third paragraphs of the Applicant’s remarks, the Applicant argues that the current prior art of record, specifically Atkinson and Knighton, does not teach the newly added claim limitation of “pulling the intact skin radially outward in response to the supplied negative pressure by applying the supplied negative pressure to the intact skin through the flow channels of the manifold, wherein the flow channels of the manifold remain open while the manifold is compressed under the supplied negative pressure” as they apply pressure/compression, and thus cannot be used to teach the Applicant’s claimed invention as newly amended. However, the Examiner respectfully disagrees. Firstly, Knighton is not used to teach this claim limitation, and so these arguments against Knighton are moot. Secondly, Atkinson recites applying sub-atmospheric compression of 0.01-0.99 atm (Atkinson; paras. [0016-0017]). One of ordinary skill in the art would know that 1 atm is the commonly used standard unit of pressure to describe the normal ambient pressure at sea level. When at sea level, anything beneath 1 atm is a vacuum or ‘negative pressure’ as it is below this standard ambient environmental pressure. Therefore, the sub-atmospheric compression applied in Atkinson is still a vacuum/suction force/negative pressure that would pull at the skin in the space between the cover and the skin when evacuating air from that space (Atkinson; Fig. 2; paras. [0017-0018]; para. [0020]). Thus, the current prior art of record can still be used to teach the Applicant’s invention as currently claimed.
On page 11 in the third paragraph to page 12 in the second paragraph of the Applicant’s remarks, the Applicant argues that Cornet does not teach the claimed limitation of a plurality of apertures located along a length of the delivery manifold and of which the diameters vary as its vent openings do not have varying diameters, and thus Cornet cannot be used to teach the Applicant’s claimed invention as newly amended. However, the Examiner respectfully disagrees. Both the Cornet vent openings 251 and the distal orifice 243, 343 are used to teach the claimed plurality of apertures limitation. Although the Cornet vent openings 251 do appear to be the same size, the distal orifice 243, 343 is a different size and shape from the vent openings 251, as best seen in Cornet Fig. 5. Moreover, the vent openings 251 are at a different location along the length of the reduced-pressure delivery tube 341 than the distal orifice 243, 343 (Cornet; Figs. 1-8; para. [0094]). Thus, the Cornet reference can still be used to teach the Applicant’s invention as currently claimed.
On page 13 in the last paragraph to page 14 in the second paragraph of the Applicant’s remarks, the Applicant argues that neither the Cazzini ventilation holes in sheets of a boot nor the Kloecker apertures to allow captured air between a garment and skin to escape teach the claimed limitation of “wherein at least a portion of the adhesive backing material of the sealing layer is configured to extend through at least a portion of the plurality of holes of the comfort layer to secure the dressing to the patient”, and thus they cannot be used to teach the Applicant’s claimed invention as newly amended. However, the Examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, it is the combination of Weston, Cazzini, and Kloecker which is used to teach the claimed limitation of “wherein at least a portion of the adhesive backing material of the sealing layer is configured to extend through at least a portion of the plurality of holes of the comfort layer to secure the dressing to the patient”. Specifically, the Weston portion 325 which creates the seal of the enclosure on the patient’s limb can be an adhesive tape and so would have a backing material structure holding the adhesive. The Weston liner 370 was modified by Cazzini to have holes 22, 24 for ventilation. Kloecker teaches seal points can connect two structures together regardless of whether they include apertures 11 to form a pocket or chamber of the device on the patient’s limb. Therefore, so too can the modified Weston device’s adhesive tape portion 325 connect the enclosure to the limb by extending through at least a portion of the Cazzini holes 22, 24 on the Weston liner 370 to create the chamber of the Weston enclosure 320 on the limb as taught by Kloecker (Weston, Fig. 4, para. [0035], para. [0043], para. [0049]; Cazzini, Fig. 5, para. [0013], para. [0016], claim 10; Kloecker, Figs. 3-5, para. [0068]). Thus, the current combination of prior art of record can still be used to teach the Applicant’s invention as currently claimed.
On page 14 in the last paragraph to page 15 in the first paragraph of the Applicant’s remarks, the Applicant argues that the Atkinson reference does not teach the comfort layer holes or the adhesive backing material extending through those holes, and thus the Applicant’s claimed invention is allowable. However, the Examiner respectfully disagrees. The Examiner does not use Atkinson to teach those claim limitations. Rather, the Cazzini and Kloecker references are still used to teach them as previously discussed above. Thus, the current prior art of record can still be used to teach the Applicant’s invention as currently claimed.
Conclusion
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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