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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). A certified copy of Parent Application EP 21180831.6, filed in The European Patent Office on 22 June 2021 has been received.
Claim Objections
The claims contain minor informalities.
Throughout the claims, the language “… [[characterized in that]] wherein …” should be changed for brevity.
In claim 4, the language “… wherein said first portion constitutes [[of from]] between 60% to 95% of the surface area …” should be changed for clarity.
Claim Interpretation - 35 USC § 112(f)
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.
In claims 17 and 18, the following limitations have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because they use a generic placeholder coupled with functional language without reciting sufficient structure to achieve the function. Furthermore, the generic placeholders are not preceded by a structural modifier.
Since the claim limitations invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claims 17 and 18 have been interpreted to cover the corresponding structures described in the specification that achieve the claimed functions, and equivalents thereof.
Claim and generic placeholder
Functional language
17 a remote fluid collection means fluidly connected to said negative pressure source and to said dressing.
a remote fluid collection means fluidly connected to said negative pressure source and to said dressing.
18 means to supply air to said dressing at a rate of from 2 to 7 ml/min during operation.
means to supply air to said dressing at a rate of from 2 to 7 ml/min during operation.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3-6, 8, 13, 14, 16 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gowans; John Philip et al. (US 20190015258 A1).
Regarding claim 1, Gowans discloses a negative pressure wound therapy (NPWT) dressing (¶ [0001], [0005], [0006], [0035], FIGS. 1A-B … system 10 employing a wound dressing 100; ¶ [0081] FIG. 4A … wound dressing 400; ¶ [0110] FIG. 4B … wound dressing 400);
comprising a backing layer (¶ [0038], a top or cover layer, or backing layer 220; ¶ [0083] The cover layer 430, which can be more clearly seen in FIG. 4C);
an adhesive skin contact layer (¶ [0038], wound contact layer 222; ¶ [0041] Some embodiments of the wound contact layer 222 may also act as a carrier for an optional lower and upper adhesive layer (not shown) … The lower surface of the film may be provided with a silicone pressure sensitive adhesive; ¶ [0083], wound contact layer 440 … The wound contact layer can include an adhesive on the patient facing side for securing the dressing to the surround skin); and
a wound pad arranged between said backing layer and said adhesive skin contact layer (¶ [0038], absorbent layer 221; ¶ [0083], absorbent layer 450; ¶ [0098], A spacer layer 490 can be used to provide a fluid flow path above the absorbent layer 450 preventing the blocking of the port 460);
wherein said backing layer comprises a coupling member configured to connect the dressing to a negative pressure source (¶ [0035], fluidic connector 110 … Either before, during, or after connection of the fluidic connector 110 to the dressing 100, the pump 150 is connected via the tube 190 to the coupling 160, or is connected directly to the coupling 160 or to the bridge 120);
wherein said backing layer comprises an opening in the area where the coupling member is attached (¶ [0057], In some embodiments the sealing surface 216 may comprise at least one aperture 229 therein to communicate with the wound dressing; ¶ [0096], the port 460 connects to a conduit for communication with a negative pressure source or pump);
characterized in that said wound pad comprises a first portion comprising one or more absorbent layers (¶ [0083], absorbent layer 450); and
a second portion comprising at least one transmission layer(¶ [0098], In some embodiments, the spacer layer 490 in the dressing can be provided above and below the absorbent layer; ¶ [0101], This spacer layer, or transmission layer, 490 allows transmission of fluid including liquid and gas away from a wound site into upper layers of the wound dressing);
wherein said second portion of said wound pad is arranged below said coupling member (Fig. 4C, spacer layer 490 is arranged below port 460).
This rejection cites the embodiment of Figs. 4A-4C, which comprises a transmission layer (spacer layer 490) arranged below a coupling member (port 460).
Regarding claims 3-6, 8, 13, 14, 16 and 17, Gowans discloses a NPWT dressing wherein said first portion of said wound pad comprises a superabsorbent material (¶ [0047] A layer 221 of absorbent material … which comprise a foam or non-woven natural or synthetic material, and which may optionally comprise a super-absorbent material; ¶ [0048], In some embodiments, the absorbent layer 221 may comprise a composite comprising superabsorbent powder, fibrous material such as cellulose, and bonding fibers);
wherein said second portion of said wound pad is void of a superabsorbent material (¶ [0042], The layer 226 may be formed of a material having a three dimensional structure. For example, a knitted or woven spacer fabric (for example Baltex 7970 weft knitted polyester) or a non-woven fabric could be used);
wherein said first portion constitutes of from 60% to 95% of the surface area of said wound pad (Fig. 4C, absorbent layer 450 extends across a majority of the pad except for regions where spacer layer 490 folds around the absorbent layer 450);
wherein said wound pad comprises a central portion and an edge portion surrounding said central portion, and wherein said second portion is arranged in said edge portion of said wound pad (¶ [0112], the spacer layer 490 … is positioned on the bottom surface of the absorbent layer 450, wrapped around the ends of the absorbent layer 450, and the two ends of the spacer layer 490 are folded over the top surface of the absorbent layer 450 completely or partially covering the top surface of the absorbent layer 450);
wherein said second portion of said wound pad is configured to extend across at least 60% of the cross-sectional area of said opening in said backing layer (Fig. 4C, spacer layer 490 extends across substantially all of the pad’s surface area);
wherein said transmission layer of said second portion of said wound pad comprises a spacer fabric material (¶ [0042], The layer 226 may be formed of a material having a three dimensional structure. For example, a knitted or woven spacer fabric (for example Baltex 7970 weft knitted polyester) or a non-woven fabric could be used);
wherein said transmission layer of said second portion of said wound pad is a first transmission layer (¶ [0069] As shown in FIG. 3A …The wound dressing 300 can include a second transmission layer 326b; ¶ [0080] In some embodiments, as illustrated in FIG. 3D, the second transmission layer can be a cross-shaped transmission layer … The cross-shaped transmission layer 326c can over-border the absorbent layer 321; ¶ [0098], In some embodiments, the spacer layer 490 in the dressing can be provided above and below the absorbent layer); and
wherein said dressing further comprises a second transmission layer between said adhesive skin contact layer and said wound pad (Figs. 3C, 3D and 4C show a transmission or spacer layer that extends under the pad and above the skin contact layer; ¶ [0071] In some embodiments, the first transmission layer 326a comprises a 3D polyester spacer fabric layer; ¶ [0098], In some embodiments, the spacer layer 490 in the dressing can be provided above and below the absorbent layer);
wherein said second transmission layer is arranged between said adhesive skin-contact layer and said first portion of said wound pad (Figs. 3C, 3D, 4C, a spacer layer is arranged between the wound contact layer 322 / 440 and absorbent layer 321 / 450); and
wherein said second portion of said wound pad has a thickness corresponding to the thickness of said first portion of said wound pad and said second transmission layer (Figs. 3C, 3D and 4C, each of the absorbent layer 321 / 450 and transmission layers 326a / 326b / 326c / 490 have substantially equal thicknesses);
comprising: a negative pressure wound therapy (NPWT) dressing according to claim 1 and a negative pressure source fluidly connected to said dressing (¶ [0050], A length of tubing may be coupled at a first end to the fluidic connector 110 and at a second end to a pump unit (not shown) to allow fluids to be pumped out of the dressing; ¶ [0082], The wound dressing 400 may then be connected, via the conduit 401 and/or conduit extension, to a source of negative pressure such as the pump as described with reference to FIGS. 1A-1B and 2A-2B);
wherein said system further comprises a remote fluid collection means fluidly connected to said negative pressure source and to said dressing (¶ [0035], The system 10 may include a source of negative pressure such as a pump or negative pressure unit 150 capable of supplying negative pressure. The pump may comprise a canister or other container for the storage of wound exudates and other fluids that may be removed from the wound. A canister or container may also be provided separate from the pump).
Claim Rejections - 35 USC § 103
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gowans; John Philip et al. (US 20190015258 A1) in view of Zamierowski; David S. (US 6071267 A).
Regarding claims 2 and 18, Gowans discloses first and second portions of a wound pad as discussed for claim 1 above (absorbent layer 321 / 450 and transmission layers 326a / 326b / 326c / 490).
Gowans first and second portions that form two distinct, juxtaposed portions arranged in the same plane. Gowans also lacks a means to supply air to said dressing. Zamierowski discloses a system for interfacing a vacuum-assisted fluid extraction/supply system with a patient (col. 1, lines 15-20; col. 2, lines 40-50; col. 3, lines 35-40, interface system 2);
comprising a wound pad including a first portion and a second portion, wherein said first portion and said second portion of said wound pad form two distinct, juxtaposed portions arranged in the same plane (col. 3, lines 60-70, A pair of secondary fluid transfer elements/manifolds 14.1 and 14.2 can be provided for handling evacuation and supply respectively as shown in FIG. 4b, and each can be connected to the primarily fluid transfer element 12 in the manner described); and
means to supply air to said dressing (col. 5, lines 55-60, Liquid supply operations are accomplished by inserting the catheter 38 into the primary transfer element 12. The connection can then be covered with an inlet access drape 22. Various other fluid-type connections can be utilized for introducing fluid (e.g., air, nitrogen, oxygen, etc.) into the system 2).
The air flow rate is interpreted as a result-effective variable, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The air flow rate determines how much fluid passes through the dressing through routine experimentation.
For example, Zamierowski calls for infusing therapeutic fluids into the dressing (col. 4, lines 40-50, The fluid conveyance subsystem 8 functions to extract fluids, including the patient's blood, serum, etc., from the interface system 2, and also to introduce various fluids, such as antibiotics, analgesics and growth factors into the interface system 2); and a controller that regulates fluid flow rates through the system (col. 5, lines 5-15, A fluid conveyance control system 42 includes a suitable microprocessor 42a and is connected to the vacuum source 26. The controller 42 controls pressures, flow rates, timing sequences of intermittent vacuum, and includes control features which permit the shut-down of the system 2 or its automated use).
Too low
Exudates will saturate the various layers
Optimized range
Air will displace wound exudates to make space for therapeutic fluids
Too high
Excessive air will displace both exudates and therapeutic fluids from the wound
Therefore, it would have been obvious to adjust the air flow rate in order for therapeutic fluids to stay in contact with the wound. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Zamierowski demonstrates how to partition a pad into multiple sections that infuse or remove fluid from a NPWT dressing. Zamierowski also displaces exudates away from a wound in order for therapeutic fluids to contact the wound. One would be motivated to modify Gowans with Zamierowski’s juxtaposed first and second portions and air supply means to displace exudates with therapeutic fluids and accelerate healing. Therefore, it would have been obvious to modify Gowans with Zamierowski’s adjacent first and second portions and air supply means in order to infuse therapeutic agents and displace exudates.
Regarding claim 7, Gowans discloses a dressing wherein said wound pad has a lateral (x) and a longitudinal (v) extension; and wherein said wound pad is contoured by a pair of longitudinal edges extending in parallel to each other in the lateral direction and a pair of lateral edges extending in parallel to each other in the longitudinal direction (Figs. 4A, 4B, dressing 400 has a rectangular shape with lateral and longitudinal edges).
Gowans lacks a second portion that is arranged along a longitudinal or lateral edge. Zamierowski discloses a wound pad including first and second portions (col. 3, lines 60-70, A pair of secondary fluid transfer elements/manifolds 14.1 and 14.2 can be provided for handling evacuation and supply respectively as shown in FIG. 4b);
wherein said second portion of said wound pad is arranged along one of said longitudinal edges or along one of said lateral edges of said wound pad (Fig. 4b, secondary fluid transfer elements 14.1 and 14.2 are arranged side-by-side which implies that they both extend along a longitudinal or lateral edge of the wound pad).
Zamierowski configures a NPWT dressing to displace exudates fluids with therapeutic fluids. Regarding the rationale and motivation to modify Gowans with Zamierowski’s peripherally oriented second portion, see the discussion of claims 2 and 18 above.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Gowans; John Philip et al. (US 20190015258 A1) in view of Askem; Ben Alan et al. (US 20190159938 A1).
Regarding claims 9-12, Gowans lacks a further liquid spreading layer. Askem discloses a NPWT dressing (¶ [0005], [0026], [0028], topical negative pressure (“TNP”) therapy systems; ¶ [0033], FIG. 1 … wound dressing 2100; ¶ [0036], FIGS. 3A-3C … wound dressing 1200);
comprising a backing layer (¶ [0036], moisture vapor permeable film or cover layer 1213, 1313); and
a wound pad comprising a first portion (¶ [0036], an absorbent area 1260, 1360; ¶ [0037], absorbent layer 1212, 1322); and
a second portion (¶ [0058] The electronics area 1361 of the dressing can include a plurality of layers of spacer material 1351. In some embodiments, the electronic components 1350 can be embedded within the plurality of layers of spacer material 1351);
wherein said dressing further comprises a liquid spreading layer arranged between said backing layer and said wound pad (¶ [0056], an upper spacer layer or first spacer layer 1317 that includes a continuous layer of spacer material positioned below the cover layer 1313 and above the layers of the absorbent area and the layers of the electronics area);
wherein said liquid spreading layer is configured to extend across at least 90% of the surface area of said wound pad and wherein said liquid spreading layer is void of an opening (¶ [0056], an upper spacer layer or first spacer layer 1317 that includes a continuous layer of spacer material positioned below the cover layer 1313 and above the layers of the absorbent area and the layers of the electronics area);
wherein said liquid spreading layer comprises a nonwoven (¶ [0040], The layer 1311 may be formed of a material having a three-dimensional structure. For example, a knitted or woven spacer fabric (for example Baltex 7970 weft knitted polyester) or a non-woven fabric could be used; ¶ [0042], the transmission layer 1311 comprises a 3D polyester spacer fabric layer including a top layer … which is a 84/144 textured polyester, and a bottom layer … which is a 10 denier flat polyester and a third layer … which is a region defined by a knitted polyester viscose, cellulose or the like monofilament fiber);
wherein said at least one transmission layer of said second portion is arranged in contact with said liquid spreading layer (Fig. 3C, first spacer layer 1317 is arranged in contact with electronics area and its layers of spacer material 1351).
Askem redistributes fluids across both the upper and lower sides of a NPWT dressing (¶ [0056], The continuous layer of spacer material or upper spacer layer 1317 can enable an air pathway between the two areas of the dressing). One would be motivated to modify Gowans with Askem’s liquid spreading layer since Gowans calls for distributing fluids and negative pressure (¶ [0038], This interior space or chamber may comprise additional structures that may be adapted to distribute or transmit negative pressure; ¶ [0085], Use of the cellulose fibers introduces fast wicking elements which help quickly and evenly distribute liquid taken up by the dressing). Therefore, it would have been obvious to modify Gowans with Askem’s liquid spreading layer in order to distribute fluids and negative pressure.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gowans; John Philip et al. (US 20190015258 A1) in view of Locke; Christopher Brian et al. (US 20170189236 A1).
Regarding claim 15, Gowans does not explicitly disclose a wound pad comprising first and second liquid distribution layers and a superabsorbent layer. Locke discloses a NPWT dressing (¶ [0003], [0005], [0008], [0055], FIG. 1 … system 102);
comprising a wound pad (¶ [0061], a fluid management assembly 144; ¶ [0077] The fluid management assembly 144 may be disposed in the enclosure 172);
including a first liquid distribution layer, a superabsorbent layer and a second liquid distribution layer; wherein said superabsorbent layer is arranged between said first and said second liquid distribution layers (¶ [0077], In some embodiments, the fluid management assembly 144 may include a first dressing wicking layer 176, a second dressing wicking layer 180, and an absorbent layer 184. The absorbent layer 184 may also be referred to as a dressing absorbent 184. The absorbent layer 184 may be positioned in fluid communication between the first dressing wicking layer 176 and the second dressing wicking layer 180).
Locke reduces a risk of clogging by evenly distributing fluids as they approach the absorbent layer (¶ [0077], The wicking of fluid along the first dressing wicking layer 176 and the second dressing wicking layer 180 may enhance the distribution of the fluid over a surface area of the absorbent layer 184, which may increase absorbent efficiency and resist fluid blockages). One would be motivated to modify Gowans with Locke’s liquid distribution layers and superabsorbent to absorb fluids more effectively, and since Gowans calls for a superabsorbent (¶ [0047] A layer 221 of absorbent material … which may optionally comprise a super-absorbent material). Therefore, it would have been obvious to modify Gowans with Locke’s laminated pad layers in order to distribute fluids towards a superabsorbent layer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Johnson, Royce et al. US 20020115952 A1
Joshi; Ashok V. et al. US 20070265586 A1
Bennett; John A. et al. US 20120041403 A1
Luckemeyer; James A. et al. US 20140276491 A1
Daughtery; Christopher John US 20150202353 A1
Lin; Edward D. US 20190030224 A1
Buan; John et al. US 20210052432 A1
Waite; Alexander et al. US 20220008642 A1
Locke; Christopher Brian US 20220355021 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781