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 36, 38, 40-45 and 47-51, 53 and 54 are pending in the application and are currently rejected.
Response to Arguments
Applicant’s arguments with respect to drawing objection and specification have been fully considered and are persuasive. The objections of 04/21/2025 has been withdrawn.
Applicant’s argument with respect 35 USC 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “device that produces a negative pressure” in claim 51. Which will be interpreted as a mechanical and/or electric pump as illustrated in specification [0032].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 36, 38, 40-45 47-51, 53 and 54 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 51 recite “wherein the bulge is in an area outside of the area of the wound” and “a suction body between skin adjacent to the wound and the fixing film in the area of bulge”
It has been held that a claim directed to or including within its scope, a human being will not be considered to be patentable subject matter under 35 U.S.C. 101. For examination purpose, all claims will be considered as if such limitation involving the combination with a human were not preset, and limitations are being treated as coming after “configured to” language ., i.e., wherein the bulge is configured to be in an area outside of the area of the wound”
Claims 36, 38, 40-45, 48-49, 53 and 54 are rejected for at least being dependent of claim 51.
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 38, 40-45, 47, 50, 51 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Wild (US 20120046587 A1) in view of Zawoy et al (US 20170231823 A1) and Corey (US 20120253302 A1)
Regarding Claim 51, Wild teaches a negative pressure treatment arrangement comprising:
a multi-layered drainage film (figure 1, wound covering 2) that includes a first film layer (figure 1, first strip-like element 10, figure 2 [0032] the wound covering 2 is configured to be adjacent to a wound) configured to be adjacent to a wound and a second film layer (figure 1 and [0032], second strip-like element 20 arranged between the first film and second film) opposite the first film layer such that at least a portion of the first film layer is between the wound and the second film layer, wherein:
a drainage space (figure 1, drainage chamber 40 between strips 10 and 20) is formed between the first film layer and the second film layer;
the first film layer (figure 1, first strip-like element 10 defines at least upper boundary of drainage chamber 10) delimits the drainage space and has a plurality of channels (figure 1 and [0014], channel through perforations 16 extend in a depth direction into the chamber and toward the second layer 20) that facilitate admission of fluids or gases into the drainage space via respective first channels that extend from the first film layer in a depth direction into the drainage space towards the second film layer, wherein the depth direction is oriented perpendicularly to facing surfaces of the first and second film layers (figure 1, depth direction perpendicular to the surfaces of first and second strips), wherein a cross-sectional area of a channel of the plurality of channels is smaller at a portion of the channel that is closest to the second film layer smaller than a cross-sectional area of a portion of the channel that is furthest from the second film layer (figure 1 and [0031], "conically designed channels 16 and 26” conically designed channels 16 have smaller diameter at inner periphery 14 facing second strip like element 20 and have larger diameter on outer periphery 12 facing against the element 20);
the second film layer (figure 1, second strip-like element 20 defines at least lower boundary of drainage chamber 10) also delimits the drainage space and has a second opening arrangement (figure 1 and [0018], [0023] and [0038] negative pressure draws wound exudate through perforations 26) designed to discharge the fluids or gases from the drainage space via respective second channels; and
the multi-layered drainage film comprises at least one bulge containing the second opening arrangement (figure 2, a space formed between film 2 and occlusive foil 2 forms a bulge above the film), wherein the bulge is configured to be in an area outside of the area of the wound (figure 2, space above perimeter of the film 2 can be positioned outside the wound when the film is larger than the wound);
a fluid-tight fixing film (figure 2, occlusive foil 50 covers and secures the wound covering 2 at wound site) configured to fix the multi-layered drainage film to skin adjacent to the wound and to cover at least a portion of the second opening arrangement,
a connection arrangement (figure 2, exudate line 6) configured to connect a device ([0032] the exudate line is configured to be connected to a negative pressure source and wound area under the occlusive foil 50 and provide the negative pressure to wound covering 2) that produces a negative pressure to the second opening arrangement,
wherein at least one of the first or second plurality of channels are arranged in a grid pattern, wherein a spacing between adjacent openings of the plurality of channels in the grid pattern is 15 millimeters (mm) or less, 5 mm or less, or 3 mm or less ([0016] “a plurality of openings, arranged preferable grid-like” and “particularly in a rectangular grid, with the distance between the adjacent openings or grid points being 15 mm or less”);
wherein at least one of the first or second film layers is a perforated plastic film (figure 1 and [0030]-[0031], first and second strips comprise at least grid of perforations 16 and 26);
wherein respective apertures of channels of the first plurality of channels are arranged in a projection along the depth direction between respective apertures of channels of the second plurality of channels ([0017] “the outlets of the openings arranged in one of the strip-like elements are arranged in a projection along the depth direction between the outlets of the openings arranged at the other strip-like element”).
Wild does not expressly teach wherein a depth of the drainage space as measured in the depth direction is between 0.3 mm and 4 mm;
Though, Wild teaches depth of the drainage chamber is between 0.1 and 4 mm (Wild; [0029]).
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 the depth of the combination from 0.1 and 4 mm to 0.3 mm and 4mm as applicant appears to have placed no criticality on the claimed range ([0030]) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
Wild does not teach at least a portion of the multi-layered drainage film is formed of a transparent material;
wherein at least a portion of the fluid-tight fixing film is made of a transparent material;
wherein at least a portion of a profile of the covered wound is visible through the multi-layered drainage film and the fluid-tight fixing film during negative pressure treatment; and
a suction body is configured to be between skin adjacent to the wound and the fixing film in the area of the bulge, wherein the suction body is in fluidic connection with the drainage film and is configured to receive and store fluids from the wound.
In the same field of endeavor, namely a transparent tourniquet and bandage material system, Zawoy teaches at least a portion of the multi-layered drainage film is formed of a transparent material (figures 5a-d and [0011] transparent bandage material 20);
wherein at least a portion of the fluid-tight fixing film is made of a transparent material (figures 5a-d and [0011] transparent bandage material 20);
wherein at least a portion of a profile of the covered wound is visible through the multi-layered drainage film and the fluid-tight fixing film during negative pressure treatment (figures 5a-d and [0011] wound visible through transparent bandage material 20);
a suction body (figures 5a and 5c, foam layer 30) is configured to be positioned between skin adjacent to the wound and the fixing film in the area of the bulge (figure 5c and [0008]-[0009] and [0062], the foam layer 30 is configured to be positioned between skin surrounding the wound and the wound bandage material 20), wherein the suction body is in fluidic connection with the drainage film and is configured to receive and store fluids from the wound ([0062]).
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 Wild to incorporate the teachings of Zawoy and provide the multi-layered drainage film and the suction body as claimed for the purpose removing wound exudate away from the wound (as taught by Zawoy [0022]) while allowing continuous visualization of the wound without removing the wound dressing ([0022])
The combination is still silent as to wherein the connection arrangement includes an open-cell sponge or a flange that is configured to be placed on the second opening arrangement with a fitting configured to connect a drainage hose;
wherein the fluid-tight fixing film at least partially overlaps the connection arrangement and affixes the connection arrangement to the drainage film such that the open-cell sponge or flange of the connection arrangement is partially between, and adjacent to, both the fluid-tight fixing film and the drainage film at a periphery of the drainage film and the fluid-tight fixing film;.
However, in the same field of endeavor, namely a negative pressure wound therapy dressing, Corley teaches wherein the connection arrangement (figure 1, vacuum port 30) includes an open-cell sponge or a flange (figure 1, flange 34) that is configured to be placed on the second opening arrangement with a fitting configured to connect a drainage hose (figure 1, port 30 configured to connect hose 36);
wherein the fluid-tight fixing film at least partially overlaps the connection arrangement and affixes the connection arrangement to the drainage film (figure 1, cover layer 24 overlaps the flange 34 and the flange is partially between and adjacent to both the cove layer 24 and packing member 20 at periphery of the cover layer and packing member) such that the open-cell sponge or flange of the connection arrangement is partially between, and adjacent to, both the fluid-tight fixing film and the drainage film at a periphery of the drainage film and the fluid-tight fixing film;.
Corley teaches providing vacuum port is configured to be coupled to fluid conduit comprising flange and the flange positioned between the packing member and the cover layer in order to provide tight seal about the opening in the cover layer and facilitate connection to a vacuum source ([0008]).
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 Wild, as modified by Zawoy, to incorporate the teachings of Corley and provides the connection arrangement as claimed, and one of skill in the art motivated to do so, for the purpose of providing tight sealing about the opening of the fluid tight fixing film and facilitate connection to a negative pressure source.
Regarding Claim 38, Wild, as modified by Zawoy and Corley, teaches the negative pressure treatment arrangement of claim 51.
The combination further teaches characterized in that the depth of the drainage space ensures a capillary action on bodily fluids received in the drainage space (Wild; [0012] "the depth of which provides a capillary action in a depth direction”)
Regarding Claim 40, Wild, as modified by Zawoy and Corley, teaches the negative pressure treatment arrangement of claim 51.
The combination further teaches wherein at least one channel of the first or second plurality of channels extends over 50% or more of the depth of the drainage space in the depth direction (Wild; [0018] “at least one channel, which forms an opening in a strip-like element, extends in depth direction over 50% or more of the entire depth of the drainage chamber.”)
Regarding Claim 41, Wild, as modified by Zawoy and Corley, teaches the negative pressure treatment arrangement of claim 51.
The combination further teaches wherein the cross-sectional area of the channel at the portion of the channel that is furthest from the second film layer is 0.1 mm squared (mm2) or more, 0.5 mm2 or more, or 1 mm2 or more (Wild; [0019] "the outlet area of the individual openings facing the drainage chamber is 0.1 mm.sup.2 or more").
Regarding Claim 42, Wild, as modified by Zawoy and Corley, teaches the negative pressure treatment arrangement of claim 51.
The combination further teaches wherein the cross-section area of the channel at the portion of the channel that is closest to the second film layer is 15 mm squared (mm2) or less, 5 mm2 or less, 4 mm2 or less, or 3 mm2 or less (Wild; [0019] “the outlet area of the openings is 5 mm.sup.2”)
Regarding Claim 43, Wild, as modified by Zawoy and Corley, teaches the negative pressure treatment arrangement of claim 51.
The combination further teaches wherein at least a portion of a wall of the channel is arc shaped or a sectional plane extending parallel to the depth direction, and has a continuous transition to the boundary surface (Wild; [0030] “The channel walls of channels 16 are designed arc-shaped in a sectional plane parallel to the depth direction and smoothly proceed into the outer periphery 12 of the first strip-like element 10”).
Regarding Claim 44, Wild, as modified by Zawoy and Corley, teaches the negative pressure treatment arrangement of claim 51.
The combination further teaches wherein a surface of at least the first or second film layer includes an antimicrobial or bacteriostatic material (Wild; [0031] “strips of material 10, 20 or the drainage chamber 40 can be equipped with an antibacterial or bacteriostatic layer”).
Regarding Claim 45, Wild, as modified by Zawoy and Corley, teaches the negative pressure treatment arrangement of claim 51.
The combination further teaches wherein the first or second film layer includes an agent that counteracts a tendency of the drainage film to stick (Wild; [0026]” With respect to the prevention of the adherence propensity of wound coverings according to embodiments of the invention, at least one strip of material can comprise a hydrophilic or hydrophobic equipment”).
Regarding Claim 47, Wild, as modified by Zawoy and Corley, teaches the negative pressure treatment arrangement of claim 51.
The combination further teaches comprising the device to produce a negative pressure in the area of the wound, wherein the device to produce a negative pressure, wherein the device to produce the negative pressure is incorporated into the first film layer, the second film layer, or the fluid-tight fixing film (Wild; [0018] “wound cover is used in connection with a negative pressure source”)
Regarding Claim 50, Wild, as modified by Zawoy and Corley, teaches a negative pressure treatment kit with the negative pressure treatment of claim 51 (see claim rejection 51), and the device to produce a negative pressure (Wild; [0002] [0018] wild provide the negative pressure treatment of claim 51 and the device as a kit).
Regarding Claim 54, Wild, as modified by Zawoy and Corley, teaches the negative pressure treatment arrangement of claim 51.
The combination further teaches wherein the suction body is positioned next to the wound (Zawoy; [0062], the foam layer 30 is configured to be positioned next to the wound).
Claims 36 is rejected under 35 U.S.C. 103 as being unpatentable over Wild (US 20120046587 A1) in view of Zawoy et al (US 20170231823 A1) and Corey (US 20120253302 A1), and in further view of Chen (US 3972328 A)
Regarding Claim 36, Wild, as modified by Zawoy and Corley, teaches the negative pressure treatment arrangement of claim 51.
The combination does not teach wherein at least one side of the fluid-tight fixing film includes a polyurethane coating
In the same field of endeavor, namely a surgical bandage, Ward teaches wherein at least one side of the fluid-tight fixing film includes a polyurethane coating (col 2 lines 25-40, bandage 10 outer polymeric film coating 13 comprising elastomeric material such as flexible polyurethane ).
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 Wild, as modified by Zawoy and Corey, to incorporate the teachings of Chen and provides the fluid-tight fixing film as claimed for the purpose of maintaining adequate moisture environment for wound healing as taught by Chen (col 3 lines 50-55).
Claims 48 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Wild (US 20120046587 A1) in view of Zawoy et al (US 20170231823 A1) and Corey (US 20120253302 A1), and in further view of Locke et al (US 20180021178 A1)
Regarding Claim 48, Wild, as modified by Zawoy and Corley, teaches the negative pressure treatment arrangement of claim 51.
The combination does not teach further comprising a sensor incorporated into the first film layer, the second film layer, the fluid-tight fixing film, the flange, the fitting, the drainage hose, or the device that produces a negative pressure, wherein the sensor is configured to detect a temperature, a flow of fluid, or a fluid viscosity.
However, In the same field of endeavor, namely reduced-pressure system teaches further comprising a sensor (sensor on PCB microcontroller 760 of pump figure 9 and [0162] “Additional sensors (such as accelerometers, temperature sensors, flow sensors, etc.) can also be included to sense charging, electrical operation, and pumping performance, which can be electrically connected to the PCB microcontroller and/or circuit.”) incorporated into the first film layer, the second film layer, the fluid-tight fixing film, the flange, the fitting, the drainage hose, or the device that produces a negative pressure, wherein the sensor is configured to detect a temperature, a flow of fluid, or a fluid viscosity.
Locke provides the temperature sensor in order to monitor pumping performance and controls the pump accordance with the pumping performance ([0162]).
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 Wild, as modified by Zawoy and Corley, to incorporate the teachings of Locke and provide the at least one sensor incorporated into the device, and one of skill in the art motivates to do so, for the purpose of producing a negative pressure for the purpose of monitoring pump performance.
Regarding Claim 49, Wild, as modified by Zawoy and Corley, teaches the negative pressure treatment arrangement of claim 51.
The combination does not teach further comprising by a transmission device configured to establish a wireless connection with an external device.
However, In the same field of endeavor, namely reduced-pressure system, Locke teaches further comprising by a transmission device configured to establish a wireless connection with an external device ([0162] “A wireless communications transmitter and/or receiver can be included in the pump's electrical circuit in some embodiments, which can connect the pump controller to a remote computer or smart phone for pump monitoring”
Locke provides the wireless communications transmitter in order to remotely control the pump from external device ([0162]).
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 Wild, as modified by Zawoy and Corley, to incorporate the teachings of Locke and provide the transmission device, and one of skill in the art motivates to do so, for the purpose of establishing external remote control.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Wild (US 20120046587 A1) in view of Zawoy et al (US 20170231823 A1) and Corey (US 20120253302 A1), and in further view of Allen et al (US 20150216733 A1).
Regarding Claim 53, Wild, as modified by Zawoy and Corley, teaches the negative pressure treatment arrangement of claim 51.
The combination does not teach wherein the connection arrangement is provided in the area of the skin surrounding the wound.
However, in the same field of endeavor, namely a wound dressing and method of treatment Allen teaches wherein the connection arrangement is provided in the area of the skin surrounding the wound ([0095] “the dressing 110 is positioned so that the port 2150 is not directly overlying the wound”)
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 Wild, as modified by Zawoy and Corley, to incorporate the teachings of Allen and provide the connection arrangement is provided in the area of the skin surrounding the wound, and one of skill in the art motivated to do so, for the purpose of prevent the wound from being exposed to direct pressure from the port, which could cause damage wound granulation and disrupt wound healing.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas J Weiss can be reached at (571)270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.H./Examiner, Art Unit 3781
/NICHOLAS J. WEISS/Supervisory Patent Examiner, Art Unit 3781