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
The Claim filed 10/10/2023 has been entered. Claims 1-17 are pending and under consideration.
Claim Objections
Claims 1, 4, 7, 8 and 11-15 are objected to because of the following informalities:
Claim 1 line 2 “the wound” which should read “a wound”
Claim 4 lines 2-3 “the drainage channel” which should read “a drainage channel”
Claim 4 line 4 “an outlet opening” which should read “the outlet opening”
Claim 4 line 4 “the surface” which should read “a surface”
Claim 7 line 3 “the front side” which should read “a front side”
Claim 8 line 4 “the front side” which should read “a front side”
Claim 11 line 4 “the sealing surface” which should read “a sealing surface”.
Claim 12 lines 4-5 “the drainage channels” which should read “drainage channels”
Claim 13 line 3 “the front side” which should read “a front side”
Claim 14 lines 3-4 “the upper side” which should read “an upper side”
Claim 15 line 6 recites “the instill outlet” which should read “the at least one instill outlet”
Appropriate correction is required.
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 15 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 15, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In an effort to compact prosecution “preferably” is being interpreted as “or”
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, 2, 5, 8, 9, 11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lockwood et al (US 20040243073 A1) in view of Locke et al (US 20190231602 A1)
Regarding claim 1, Lockwood substantially teaches applicant’s claimed invention, and specifically discloses a device with every structure limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out), including
a wound treatment system (figure 1, bandage 11) comprising a seal (figure 2 [0026], sealing film 22 adapted to be applied healthy skin surrounding the wound 12) adapted to be applied to a skin surrounding the wound and a fluid-permeable pad (figure 2 and [0030], member 19 made of plastic material, for example polyvinylchloride) disposed between the seal and a wound bed (W) made of a flat, substantially planar full plastic body penetrated by drainage passages (figure 3, through holes 60), at least one of the drainage passages having a valve.
Lockwood does not teach at least one of the drainage passage having a valve.
In the same field of endeavor, namely a dressing for treating tissue with negative pressure, Locke teaches at least one of the drainage passage having a valve (figure 5 [0056] fluid restrictions 420 may be an elastomeric valve).
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 Lockwood to incorporate the teachings of Locke and provide the drainage passages as claimed for the purpose of selectively allowing fluid flow thorough the drainage passage when pressure gradient present as taught by Locke ([0056]), which would allow one way fluid movement, i.e., such that effectively removes wound exudate from the wound and prevent the exudate flow back to the wound.
Regarding claim 2, Lockwood, as modified by Locke, teaches the wound treatment system according to claim 1.
The combination further teaches in which the drainage passages communicate with drainage channels (Lockwood; figures 2 and 3 and [0036], passageways 58 defined by channels 48 and 49 are formed on an upper surface 44 of layer 36 extend to through holes 60) which are formed on a front side of the full plastic body to be provided facing away from the wound bed (W) and are closed to a rear side to be provided opposite thereto (Lockwood; figure 3, the passageway 58 are formed on the upper surface 44 such that the channels are facing away from wound bed and closed to opposite bottom surface 42).
Regarding claim 5, Lockwood, as modified by Locke, teaches the wound treatment system according to claim 1
The combination further teaches comprising drainage channels (Lockwood; figure 3, passageway 58 delimited by upper surface 44 of layer 36, and through holes 60 recessed in the passageway) delimited by channel walls and an outlet opening recessed in the channel wall.
Examiner’s note: the channel wall is being interpreted under the broadest reasonable interpretation, i.e., at least a portion of surface of layer 36 delimiting and defining the passageway 58.
Regarding claim 8, Lockwood, as modified by Locke, teaches the wound treatment system according to claim 1.
The combination further teaches a hose connection (Lockwood; figures 2 and 3, connector 40) formed in one piece on the full plastic body (Lockwood; figures 2 and 3, connector 40 formed on layer 38 disposed on the layer 36), which is arranged on the front side of the full plastic body and projects beyond an otherwise flat surface of the full plastic body (Lockwood; figure 2, connector 40 arranged on and project beyond on the upper surface 44 of the layer 36).
The combination does not expressly teach the hose connection formed in one piece on the full plastic body.
However, 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 Lockwood, as modified by Locke, such that the hose connection formed in one piece on the full plastic body as such a modification would have been an obvious matter of design choice involving a making integral. A making integral is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04 VB). One of skill in the art motivated to do so for the purpose of preventing the hose connection being disconnected from the full plastic body during application.
Regarding claim 9, Lockwood, as modified by Locke, teaches the wound treatment system according to claim 1.
The combination further teaches an enlarged sealing surface provided adjacent to the hose connection (Lockwood; figure 2, cover 38 provided adjacent to hose connection 40)
Regarding claim 11, Lockwood, as modified by Locke, teaches the wound treatment system according to claim 1.
The combination further teaches in which a hose connection element (Lockwood, figures 2 and 3 [0034]-[0035], connector 40 connectable to layer 36 through layer 38, and positionable to layer 36 in a sealing manner) connectable to the full plastic body and positionable, in a sealing manner against the sealing surface, forms an interface for connecting a hose.
Regarding claim 17, Lockwood, as modified by Locke, teaches the wound treatment system according to claim 1.
The combination further teaches including a full plastic body (Lockwood; [0033], the member 19 is made of polyvinylchloride).
Claims 3, 4, 6 and 7 rejected under 35 U.S.C. 103 as being unpatentable over Lockwood et al (US 20040243073 A1) in view of Locke et al (US 20190231602 A1), and in further view of Greener (US 20180361039 A1).
Regarding claim 3, Lockwood, as modified by Locke teaches the wound treatment system according to claim 1.
The combination does not teach the valve forming an outlet opening which is exposed to a front side to be provided facing away from the wound bed (W) and which is surrounded by a valve channel which lies lower than the outlet opening.
In the same field of endeavor, namely a vacuum assisted wound dressing, Greener teaches the valve (figure 1, one way valve 22) forming an outlet opening (annotated figure 1, outlet formed by lips 42 and 44 exposed to upper surface of wound covering element 18 facing away the wound 10 and the lips are surrounded by valve channel lies lower than the outlet opening) which is exposed to a front side to be provided facing away from the wound bed (W) and which is surrounded by a valve channel which lies lower than the outlet opening.
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 Lockwood, as modified by Locke, to incorporate the teachings of Greener and provide the vale and valve channel as claimed for the purpose of preventing removed exudate from flowing back into the wound bed as taught by Greener ([0037]).
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Regarding claim 4, Lockwood, as modified by Locke and Greener, teaches the wound treatment system according to claim 3.
The combination further teaches the outlet opening (Greener; figure 3, valve 22 comprising outlet opening defined by lips 42 and 44 as set forth claim 3 substituting through holes 60) which opens into the drainage channel being formed in a channel wall (Lockwood; figure 3, the through holes 60 formed in a passageway 68 and extend through the layer 36) delimiting the drainage channel and which opens into the drainage channel below a surface and above a bottom of the drainage channel (figure 3, the outlet opening positioned within the passageway 68 positioned below to surface 44 and above bottom surface of the passageway 68).
Examiner’s note: the channel wall is being interpreted under the broadest reasonable interpretation, i.e., at least a portion of surface of layer 36 delimiting and defining the passageway 58.
Regarding claim 6, Lockwood, as modified by Locke, teaches the wound treatment system according to claim 5.
The combination does not expressly teach the outlet opening being formed by valve lugs extending from the channel wall.
In the same field of endeavor, namely a vacuum assisted wound dressing, Greener teaches the outlet opening being formed by valve lugs (figure 1, opening being formed by lips 42 and 44) extending from the channel wall.
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 Lockwood, as modified by Locke, to incorporate the teachings of Greener and provide the vale as claimed for the purpose of preventing removed exudate from flowing back into the wound bed as taught by Greener ([0037]).
Regarding claim 7, Lockwood, as modified by Locke and Greener, teaches the wound treatment system according to claim 6.
The combination does not expressly teach the valve lugs ending flush with a flat surface provided on a front side of the full plastic body.
However, 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, Lockwood, as modified by Locke and Greener, such that the valve lugs ending flush with a flat surface provided on a front side of the full plastic body as such a modification would have been an obvious matter of design choice involving a change in size/proportion. A change in size/proportion is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04 IV.A). One of skill in the art motivated to do so for the purpose of preventing interference between valve lug formed in the drainage channel (Lockwood; figure 3 passageway 58) and layer (Lockwood; figure 3, 38) adjacent to the front side of the full plastic body.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lockwood et al (US 20040243073 A1) in view of Locke et al (US 20190231602 A1), and in further view of Mercer et al (US 20170209641 A1)
Regarding claim 10, Lockwood, as modified by Locke, teaches the wound treatment system according to claim 8
The combination does not teach the hose connection being adapted for the connection of at least two lumens.
In the same field of endeavor, namely a combination fluid instillation and negative pressure dressing, Mercer teaches the hose connection (figure 1 and [0076] conduit interface 290 may be a multi-port interface 290a adapted for reduced-pressure connection 286 and fluid supply connection 284 ) being adapted for the connection of at least two lumens.
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 Lockwood, as modified by Locke, to incorporate the teachings of Mercer and provide the hose connection as claimed and one of skill in the art motivated to do so, for the purpose of supplying instillation fluid and negative pressure simultaneously.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lockwood et al (US 20040243073 A1) in view of Locke et al (US 20190231602 A1), and in further view of Crojzat et al (US 20110184361 A1) and Mercer et al (US 20170209641 A1)
Regarding claim 12, Lockwood, as modified by Locke, teaches the wound treatment system according to claim 1.
The combination does not teach the full plastic body having a circumferential raised outer edge and the raised outer edge deliminting a rinsing channel which communicates with the drainage channels and a rinsing hose connection which communicates with a hose with which a rinsing valve is associated for the controlled inlet of a rinsing fluid.
In the same field of endeavor, namely a connecting device for use with vacuum treatment of wounds, Crojzat teaches the full plastic body (figures 1-3c, conduit means 4) having a circumferential raised outer edge (annotated figure 3c, raised outer edge ) and the raised outer edge deliminting a rinsing channel (figure 3c and [0038], outer smaller channel 22 serve as rinsing line for supplying a rinsing medium communicate with middle vacuum channel) which communicates with the drainage channels and a rinsing hose connection which communicates with a hose ([0020], [0021], [0038] the rinsing channel communicated with a hose guide a rinsing medium)
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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 Lockwood, as modified by Locke, to incorporate the teachings of Crojzat and provide the full plastic body as claimed for the purpose of providing a one piece multi conduit that simultaneously supply rinsing fluid and vacuum simultaneously as taught by Crojzat ([0018])
Crojzat does not teach the hose provided with which a rinsing valve is associated for the controlled inlet of a rinsing fluid.
In the same field of endeavor, namely a combination fluid instillation and negative pressure dressing, Mercer teaches the hose (figure 1, fluid supply lumen 110) provided with which a rinsing valve (figure 1, valve 147) is associated for the controlled inlet of a rinsing fluid ([0030]).
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 Lockwood, as modified by Locke and Crojzat, to incorporate the teachings of Mercer and provide the hose as claimed for the purpose of controlling distribution of instillation fluid as taught by Mercer ([0030]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Lockwood et al (US 20040243073 A1) in view of Locke et al (US 20190231602 A1), and in further view of Crojzat et al (US 20110184361 A1) and Mercer et al (US 20180214315 A1, hereinafter Mercer’315)
Regarding claim 13, Lockwood, as modified by Locke, teaches the wound treatment system according to claim 1.
The combination further teaches including an adhesive layer applied to the front side of the full plastic body and which connects a film (Lockwood; figure 2, layer 38 connected to layer 36) to the full plastic body.
The combination does not teach including an adhesive layer applied to the front side of the full plastic body connect the film to the full plastic body.
In the same field of endeavor, namely a combination fluid instillation and negative pressure dressing, Mercer’315 teaches including an adhesive layer (figure 2 and [0063] attachment device 142, for example pressure-sensitive adhesive layer) applied to the front side of the full plastic body (figure 2, upper surface of cover 130) connect the film (figure 2, sealing member 128) to the full plastic body.
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 Lockwood, as modified by Locke, to incorporate the teachings of Mercer and provide the adhesive layer as claimed for the purpose of effectively attaching and sealing the film to the full plastic body as taught by Mercer ([0090]). One of skill in the art motivated to do so, for the purpose of forming a sealed passageway that enables vacuum and irrigation fluid from the port to flow through the channel to the wound
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lockwood et al (US 20040243073 A1) in view of Locke et al (US 20190231602 A1), and in further view of Mercer et al (US 20170209641 A1).
Regarding claim 15, Lockwood, as modified by Locke, teaches the wound treatment system according to claim 1.
The combination does not teach at least one instill outlet is provided on a rear side of the full plastic body to be provided facing the wound bed (W), or a plurality of instill channels open to the rear side are provided, and the full plastic body has an instill connection for an instill hose communicating with the instill outlet (108) or the instill channels.
In the same field of endeavor, namely a combination fluid instillation and negative pressure dressing, Mercer teaches at least one instill outlet (figure 1, delivery aperture 216 provided on a bottom surface of instillation assembly 182 facing tissue site 116 ) is provided on a rear side of the full plastic body to be provided facing the wound bed (W), or a plurality of instill channels open to the rear side are provided, and the full plastic body has an instill connection (figure 1, fluid hub port 220) for an instill hose (figure 1, fluid supply lumen 110 communicating with the delivery aperture 216 as shown arrows 188) communicating with the instill outlet (108) or the instill channels.
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 Lockwood, as modified by Locke, to incorporate the teachings of Mercer and provide the at least one instill outlet as claimed for the purpose of delivering the instillation fluid to tissue site as taught by Mercer ([0046]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lockwood et al (US 20040243073 A1) in view of Locke et al (US 20190231602 A1), and in further view of Pick (US 4170300 A).
Regarding claim 16, Lockwood, as modified by Locke, teaches the wound treatment system according to claim 1.
The combination does not teach further comprising a sterile package comprising a full plastic body, and a film adhered to the full plastic body.
In the same field of endeavor, namely dressing change kits, Pick teaches a sterile package (figures 1, 2, col 1 line 5-8, and col 2 line 60 – col 3 line 11, tray 10 made of any suitable plastic sheet material and cover sheet 24 adhered to tray 10) comprising a full plastic body, and a film adhered to the full plastic body.
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 Lockwood, as modified by Locke, to incorporate the teachings of Pick and provide the sterile package as claimed for the purpose of providing dressing kits in an aseptic manner as taught by Pick (col 1 lines 5-10).
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: No prior art, alone or in combination, could be found to teach (claim 14) the drainage passage being delimited by valve lugs which cooperate with a film applied to the upper side of the full plastic body in such a way that, in the event of a suction pressure acting between the film and the full plastic body, the film is applied against the valve lugs and these are thereby spread to open the valve.
The closest prior art Lockwood (US 20040243073 A1) and Greener (US 20180361039 A1), teaches the device as claimed, for example drainage passage being delimited by valve lugs (Greener; figure 1, lips 42 and 44 of valve 22) which cooperate with a film applied to the upper side of the full plastic body (Lockwood; figure 3, drainage passage 48 and through holes 60 cooperated with layer 38 applied to the upper side of layer 36), but fails to teach in the event of a suction pressure acting between the film and the full plastic body, the film is applied against the valve lugs and these are thereby spread to open the valve.
In the examiner’s view, it would have not have been obvious to modify the combination above to arrive the claimed limitation, because the valves in the combination are already actuated by a pressure gradient. Introducing the claimed film, i.e., the film is applied against the valve lugs and these are thereby spread to open the valve, would, under negative pressure, obstruct the valve openings, thereby blocking the fluid pathway for vacuum and irrigation fluid to the wound. Such a modification would render the device inoperable without providing any functional improvement.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lee et al (US 20190365962 A1) is cited as disclosing vacuum dressing comprising plurality of valves which relatively pertinent to the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SETH HAN/Examiner, Art Unit 3781