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 .
Information Disclosure Statement
The information disclosure statement filed February 16, 2024 has been received and made of record. Note the acknowledged form 1449 enclosed herewith.
Claim Objections
Claims 2-30 are objected to because of the following informalities: in each of claims 2-11 and 13-20 “Claim” should read --claim--; claim 12, line 10, “the first surface” should read --the first wound facing surface--; and claim 12, line 17 “opemng” should read --opening--. 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 20 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 20 recites the broad recitation a dispersion coating, and the claim also recites a polyurethane (PU) dispersion coating which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 (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 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)(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.
Claim(s) 1, 2, 4, 5, 8, 12-14 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 2020/0268560 (hereinafter “Harrison”).
Regarding claim 1, Harrison discloses a wound dressing apparatus (wound dressing incorporating an electronics assembly 900, see Fig. 9A and para. [0137]) comprising: a cover layer (cover layer 813, see Fig. 9a and para. [0133]) configured to cover and form a seal over a wound (the cover layer can form a seal to the wound contact layer 810 at a perimeter region enclosing the absorbent layers 822 and 851 and the transmission layer 811, see para [0133]); and an electronics assembly 600/900 see para. [0111] and [0137]) comprising: an electronics unit comprising a negative pressure source (an electronics unit electronic unit 603, comprising a negative pressure source pump 605, see claim 1 and para. [0111]); wherein the negative pressure source comprises a body portion and an inlet extending from the body portion, wherein the inlet comprises a first end opposite a second end, wherein the second end is attached to the body portion (the body portion 605 has an inlet connected to inlet protection mechanism 610, see Fig. 6, para. [0111] and para. [0118]); and a housing (illustrated in Fig. 6, the housing of the electronics assembly 600 can include a plate 601 and flexible film 602 enclosing the electronics unit 603 within, see para. [0111]) comprising a plurality of flexible film layers (flexible film 602 and flexible plate 601, see para. [0113] and para. [0115] which discloses the plate can be a flexible material to allow conformability to movement or flexing of the dressing when it is applied to a wound), wherein the electronics unit is at least partially enclosed within the plurality of flexible film layers, wherein the plurality of flexible film layers comprises a first flexible film layer and a second flexible film layer, wherein the first and second flexible film layers are bonded together along a periphery of each of the first and second flexible film layers to at least partially enclose the electronics unit between the first and second flexible film layers (the flexible film 602 can be attached to the plate 601 by welding (heat welding) or adhesive bonding to form a fluid tight seal and enclosure around the electronic components; in some embodiments, the flexible film 602 can be attached to the plate at a perimeter of the plate by heat welding, adhesive bonding, ultrasonic welding, RF welding, or any other attachment or bonding technique), wherein the first flexible film layer comprises an aperture (611, see Fig. 6, para. [0117]) and configured to receive the inlet and form a hermetic seal around the inlet to prevent wound exudate from entering into the electronics unit (the flexible film 603 can include an aperture 611; the aperture 611 can allow the inlet protection mechanism 610 to be in fluid communication with the absorbent and/or transmission layers of the wound dressing; the perimeter of the aperture 611 of the flexible film 603 can be sealed or attached to the inlet protection mechanism 610 by welding (heat welding) or adhesive bonding to form a fluid tight seal and enclosure around the inlet protection mechanism 610 allowing the electronic components 603 to remain protected from fluid within the dressing), wherein the cover layer comprises an opening configured to receive the electronics assembly).
Regarding claim 2, Harrison discloses the wound dressing apparatus of claim 1, wherein the first end of the inlet comprises a first diameter and the second end of the inlet comprises a second diameter (the inlet necessarily has a first diameter on a first end, which is the portion of the inlet that connects to 605 and a second end having second diameter which is the portion attached to inlet protection mechanism 610).
Regarding claim 4, Harrison discloses a wound dressing apparatus of claim 1 , further comprising: a wound contact layer (wound contact layer 810, see Fig. 6 and para. [0136]) comprising a proximal wound-facing face and a distal face, wherein the proximal wound-facing face is configured to be positioned in contact with the wound (see Fig. 6, the proximal face is attached to wound delivery layer 846); at least one absorbent layer over the wound contact layer absorbent layers 822 and 851, see Fig. 6 and para. [0141]); wherein the cover layer is configured to cover and form a seal over the wound contact layer and the at least one absorbent layer (see para. [0133] which recites a cover layer or backing layer 813 can be positioned over the absorbent material 822; the cover layer 813 can form a seal to the wound contact layer 810 at a perimeter region enclosing the absorbent layers 822 and 851 and the transmission layer 811); and wherein the at least one absorbent layer comprises a recess configured to receive the electronics assembly (see para. [0131] which recites the first apertured absorbent layer 851 can include one or more apertures 829; in some embodiments, the aperture 829 can be sized and shaped to fit an electronics assembly and/or electronics unit therein).
Regarding claim 5, Harrison discloses the wound dressing apparatus of claim 1, wherein the electronics unit further comprises: an outlet or exhaust mechanism positioned on an outlet of the negative pressure source, the outlet or exhaust mechanism comprising a vent aperture configured to expel air exhausted from the negative pressure source; and a flexible circuit board, wherein the flexible circuit board comprises one or more of a sensor, a switch, a vent hole, and/or a light or LED indicators (see para. [0008] and claim 4, which recite the electronics unit further comprises: an outlet or exhaust mechanism positioned on an outlet of the negative pressure source, the outlet or exhaust mechanism comprising a vent aperture configured to expel air exhausted from the negative pressure source; and a flexible circuit board, wherein the flexible circuit board comprises one or more of a sensor, a switch, a vent hole, and/or a light or LED indicators).
Regarding claim 8, Harrison discloses the wound dressing apparatus of claim 1, wherein the first flexible film layer and the second flexible film layer comprise a waterproof and/or gas tight film material (see para. [0116] which recites the flexible film 602 and plate 601 can be waterproof to protect the electronics unit 603 from fluid within the dressing).
Regarding claim 12, Harrison discloses a wound dressing apparatus (wound dressing incorporating an electronics assembly 900, see Fig. 9a and para. [0137]) comprising: a cover layer (cover layer 813, see Fig. 9a and para. [0133]) configured to cover and form a seal over a wound (the cover layer can form a seal to the wound contact layer 810 at a perimeter region enclosing the absorbent layers 822 and 851 and the transmission layer 811, see para [0133]); and an electronics assembly 600/900 see para. [0111] and [0137]) comprising: an electronics unit comprising a negative pressure source (an electronics unit electronic unit 603, comprising a negative pressure source pump 605, see claim 1 and para. [0111]); and a housing (illustrated in Fig. 6, the housing of the electronics assembly 600 can include a plate 601 and flexible film 602 enclosing the electronics unit 603 within, see para. [0111]) comprising a lower flexible film layer comprising a first wound facing surface and an opposite second surface (flexible plate 601, see Fig. 6 and para. [0111]); an upper housing portion (flexible film layer 602, see para. [0111]) comprising a first wound facing surface and an opposite second surface (see Fig. 9A), the upper housing portion comprising a coating along a perimeter of the first surface of the upper housing portion (see para. [0113] which discloses the flexible film 602 can be attached to the plate 601 by welding (heat welding) or adhesive bonding to form a fluid tight seal and enclosure around the electronic components; in some embodiments, the flexible film 602 can be attached to the plate at a perimeter of the plate by heat welding, adhesive bonding, ultrasonic welding, RF welding, or any other attachment or bonding technique); wherein the electronics unit is at least partially enclosed within the flexible film layer and the upper housing portion (see Fig. 6 and 9a and para. [0113], which discloses (the flexible film 602 can be attached to the plate 601 by welding (heat welding) or adhesive bonding to form a fluid tight seal and enclosure around the electronic components); and wherein the flexible film layer is bonded to the coating of the upper housing portion along a perimeter of the flexible film layer to at least partially enclose the electronics unit between the flexible film layer and the upper housing portion; wherein the cover layer comprises an opening configured to receive the electronics assembly (Fig. 9A and see para. [0138] which discloses electronics assembly 900 is positioned within aperture 872 in the cover layer).
Regarding claim 13, Harrison discloses wound dressing apparatus of claim 12, wherein the flexible film layer is bonded to the coating of the upper housing portion through heat and/or pressure (see para. [0113] which discloses the flexible film 602 can be attached to the plate 601 by welding (heat welding) or adhesive bonding to form a fluid tight seal and enclosure around the electronic components; in some embodiments, the flexible film 602 can be attached to the plate at a perimeter of the plate by heat welding, adhesive bonding, ultrasonic welding, RF welding, or any other attachment or bonding technique).
Regarding claim 14, Harrison discloses the wound dressing apparatus of claim 12 further comprising a circuit board (circuit board 609, see Fig. 6 and para. [0111] ) comprising an exhaust hole (vent) and a first wound facing surface (an inherent wound facing surface adjacent plate 601) and an opposite second surface (adjacent pump 605, see also claim 5, which discloses the vent hole of the flexible circuit board is configured to be in fluid communication with the vent aperture of the outlet or exhaust mechanism).
Regarding claim 18, Harrison discloses the wound dressing apparatus of claim 12, wherein the negative pressure source comprises a body portion (see the body portion of pump 605 in Fig. 6) and an inlet extending from the body portion (the portion of body portion that attaches to inlet protection mechanism 610), wherein the inlet comprises a first end (which attaches to inlet protection mechanism 610) opposite a second end, wherein the second end is attached to the body portion (see Fig. 6).
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison in view of U.S. Patent No. 3,572,973 (“Le Blanc”).
Regarding claim 3, Harrison discloses the wound dressing apparatus of claim 2, except wherein the second diameter of the second end is greater than the first diameter of the first end so that the inlet tapers from the second end to the first end.
However, Le Blanc in the disclosure of an analogous pump inlet teaches it is known to decrease the diameter of a nozzle inlet in the direction toward the pump (see col. 4, lines 5-14) in order to create a pressure differential across the pump and decreasing the pressure in the space to be evacuated (col. 4, lines 27-29).
In view of Le Blanc, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have provided the inlet of the pump with first and second diameters, wherein the second diameter of the second end is greater than the first diameter of the first end so that the inlet tapers from the second end to the first end in order to create a pressure differential across the pump and decreasing the pressure in the space to be evacuated.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison in view of U.S. Patent Application Publication No. 2015/0174304 (“Askem”).
Regarding claim 6, Harrison discloses the wound dressing apparatus of claim 5, except wherein the first flexible film layer comprises a second aperture configured to be aligned with the sensor on the circuit board, wherein the sensor is configured to measure the pressure from the inlet of the negative pressure source.
With respect to the second aperture, Harrison discloses in para. [0082] an alternate embodiment wherein an electronics label (341) is configured to cover and provide communication with the one or more sensors, a switch, vent hole, and/or light or LED indicators of the flexible circuit board. The label can include the vent holes (342), indicator portions (344), and/or switch cover (343). The indicator portions (344) can include holes or transparent regions (344) for positioning over the one or more indicators or LEDs on the printed circuit board (381) below the label (341). The holes or transparent regions (344) can allow for the indicators or LEDs to be visible through the label (341). Further disclosed is the label is configured to provide communication with the one or more sensors, a switch, vent hole, and/or light or LED indicators of the flexible circuit board (see claim 7).
In light of this embodiment, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Fig. 9A by including a label having apertures aligned with the components of the circuit board, on the first flexible film layer, in order to cover and provide communication with the one or more sensors, a switch, vent hole, and/or light or LED indicators of the flexible circuit board.
With respect to the sensor, Askem in the disclosure of an analogous wound dressing apparatus teaches is it known to provide a pressure sensor in the flow pathway through a pump in order to determine the pressure through the flow pathway including the inlet (see the Abstract).
In view of Askem, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have positioned a sensor in flow pathway of a pump, including the inlet, in order to produce consistent flow rates through the pump.
Claim(s) 7, 9, 10, 11, 15-17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison.
Regarding claim 7, Harrison discloses the wound dressing apparatus of claim 6, except that the apparatus further comprises a filter configured to be positioned between the second aperture and the first sensor.
However, in an alternate embodiment, Harrison discloses that housing can include windows (404) that can be a filter (see 404). The filter can be a bacterial filter and can prevent bacterial release from the body fluids into the environment; the windows 404 can also prevent the ingress of bacteria from the environment to the wound site (see para. [0098]).
In light of this disclosure, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have provided a filter between the second aperture and the sensor in order to prevent the ingress of bacteria from the environment to the wound site.
Regarding claim 9, Harrison discloses the wound dressing apparatus of claim 1, wherein the first flexible film layer comprise a polyurethane, a thermoplastic polyurethane, polyester, ethylene-vinyl acetate, or polyethylene (see para. [0114] which recites, the flexible film 602 can be formed from a flexible or stretchable material, such as one or more of polyurethane, thermoplastic polyurethane (TPU), silicone, polycarbonate, polyethylene, methylated polyethylene, polyimide, polyamide, polyester, polyethelene tetraphthalate (PET), polybutalene tetreaphthalate (PBT), polyethylene naphthalate (PEN), polyetherimide (PEI), along with various fluropolymers (FEP) and copolymers, or another suitable material; in some embodiments, the flexible film 602 can be formed from polyurethane).
Harrison further discloses the second flexible layer (plate 601) can be a plastic polymer but fails to disclose the layer comprises a polyurethane, a thermoplastic polyurethane, polyester, ethylene-vinyl acetate, or polyethylene. However, given the fact that Harrison discloses use of plastic polymers such as a polyurethane, a thermoplastic polyurethane, polyester, or polyethylene in para. [0114], it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected one of Harrison’s disclosed plastic polymers for the purpose of cost effectiveness and since it has been held that the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960)
Regarding claim 10, Harrison discloses the wound dressing apparatus of claim 1, except wherein the first flexible film layer and the second flexible film layer comprises a material with a moisture vapor permeability configured to allow vapor to pass through the first and second flexible film layers.
However, Harrison discloses the housing can include one or more windows (404). The windows (404) can be a porous film or membrane that can allow gas to pass through (see para. [0098]). In light of this disclosure, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have constructed the housing, i.e. first flexible film layer and the second flexible layer (plate) from material with a moisture vapor permeability in order to allow gas to pass through.
Regarding claim 11, Harrison discloses the wound dressing apparatus of claim 1, except wherein the housing further comprises an upper housing portion comprising a material layer forming a label for the electronics assembly, the upper housing portion comprises a first wound facing side and an opposite second side, wherein the second flexible film layer is bonded to the first side of the upper housing portion.
However, in an alternate embodiment of the housing, Harrison discloses in para. [0096] a label as described in Figs. 3A-3C, can be a separate component attached to the top surface of plate (401). The label is configured (see para. [0008]).
In light of this disclosure, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have provided a label on an upper housing portion, namely, the top surface of the plate, of the embodiment in Fig. 9A, in order to cover and provide communication with the one or more sensors, a switch, vent hole, and/or light or LED indicators of the flexible circuit board.
Regarding claim 15, Harrison discloses the wound dressing apparatus of claim 14, wherein the coating of the upper housing portion comprises a first coating (which could be adhesive, see para. [0113]), wherein the first coating is bonded or sealed to the flexible film layer ( the flexible film 602 can be attached to the plate 601 by welding (heat welding) or adhesive bonding to form a fluid tight seal and enclosure around the electronic component). Harrison does not disclose the circuit board comprises a second coating along a perimeter of the second surface of the circuit board, and wherein the first coating is bonded or sealed to the perimeter of the flexible film layer and the second coating on the circuit board.
However, Harrison recites in para. [0119] that the flexible circuit board (409) can also include an aperture or vent aligned with the exhaust hole in the exhaust mechanism as described with reference to Figs. 2A-2B. The vent hole or apertures in the exhaust mechanism (606), casing (616), flexible circuit board (609), and plate (601) can be aligned and sealed to each other. This seal can ensure the pump exhaust is exhausted from the electronics assembly (600) through the vent in the plate (601). In other embodiments, the exhaust mechanism (606) of the electronics unit 603 can be positioned on and bonded directly to the plate (601) with an air tight seal.
In light of this disclosure, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have used adhesive on perimeter of the upper housing portion (602), the circuit board (609) and plastic plate (601) in order to seal the components to each other and prevent movement of the electrical components.
Regarding claim 16, Harrison discloses the wound dressing apparatus of claim 14, wherein the coating of the upper housing portion comprises a first coating (which could be adhesive, see para. [0113]).
Harrison fails to disclose the upper housing portion comprises a second coating on the first surface of the upper housing portion, wherein the second coating surrounds an exhaust hole in the upper housing portion, wherein the circuit board comprises a third coating on the second surface of the circuit board, the third coating surrounds the exhaust hole in the circuit board, and wherein the second coating of the upper housing portion is bonded to the third coating on the circuit board.
However, Harrison in para. [0119] recites the flexible circuit board (409) can also include an aperture or vent aligned with the exhaust hole in the exhaust mechanism as described with reference to Fig. 2A-2B. The vent hole or apertures in the exhaust mechanism (606), casing (616), flexible circuit board (609), and plate (601) can be aligned and sealed to each other. This seal can ensure the pump exhaust is exhausted from the electronics assembly (600) through the vent in the plate (601). In other embodiments, the exhaust mechanism (606) of the electronics unit (603) can be positioned on and bonded directly to the plate (601) with an air tight seal.
In light of this disclosure, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have used adhesive on perimeter of the upper housing portion (602) to obtain a first coating around the perimeter to seal the upper housing portion to plate (601), a second coating of adhesive on the upper housing to seal the exhaust hole of the circuit board (609) to the upper housing, a third coating of adhesive on a wound facing surface of the circuit board around the aperture or vent to seal the circuit board to the plastic plate (601) for the purpose of sealing the components to each other and prevent movement of the electrical components during use, as well as to create and air tight seal around the vent, aperture and hole in the apparatus.
Regarding claim 17, Harrison discloses the wound dressing apparatus of claim 14, but does not explicitly recite wherein the coating of the upper housing portion comprises a first coating, the upper housing portion comprises a second coating on the first surface of the upper housing portion, wherein the second coating surrounds an exhaust hole in the upper housing portion, wherein the circuit board comprises a third coating on the second surface of the circuit board, the third coating surrounds the exhaust hole in the circuit board, wherein the circuit board comprises a fourth coating along a perimeter of the second surface of the circuit board, and wherein the second coating of the upper housing portion is bonded to the third coating on the circuit board and the first coating is bonded to the perimeter of the flexible film layer and the fourth coating on the circuit board.
However, Harrison in para. [0119] recites the flexible circuit board (409) can also include an aperture or vent aligned with the exhaust hole in the exhaust mechanism as described with reference to Fig. 2A-2B. The vent hole or apertures in the exhaust mechanism (606), casing (616), flexible circuit board (609), and plate (601) can be aligned and sealed to each other. This seal can ensure the pump exhaust is exhausted from the electronics assembly (600) through the vent in the plate (601). In other embodiments, the exhaust mechanism (606) of the electronics unit (603) can be positioned on and bonded directly to the plate (601) with an air tight seal.
In light of this disclosure, it would have been obvious to one having ordinary skill in the art before the effective filing date of the presently claimed invention to have used adhesive on perimeter of the upper housing portion (602) to obtain a first coating around the perimeter to seal the upper housing portion to plate (601), a second coating of adhesive on the upper housing to seal the exhaust hole of the circuit board (609) to the upper housing, a third coating of adhesive on a wound facing surface of the circuit board around the aperture or vent to seal the circuit board to the plastic plate (601), and a fourth coating along a perimeter of the second surface of the circuit board to secure the circuit board to secure the circuit boards perimeter to the plate, and wherein the second coating of the upper housing portion is bonded to the third coating on the circuit board and the first coating is bonded to the perimeter of the flexible film layer and the fourth coating on the circuit board for the purpose of sealing the components to each other and prevent movement of the electrical components during use, as well as to create and air tight seal around the vent, aperture and hole in the apparatus.
Regarding claim 19, Harrison discloses the wound dressing apparatus of claim 18, wherein the flexible film layer comprises an aperture (611) configured to receive the inlet and form a hermetic seal around the inlet to prevent wound exudate from entering into the electronics unit (see Fig. 6 and para. [0117] which discloses the aperture 611 can allow the inlet protection mechanism 610 to be in fluid communication with the absorbent and/or transmission layers of the wound dressing; the perimeter of the aperture 611 of the flexible film 603 can be sealed or attached to the inlet protection mechanism 610 by welding (heat welding) or adhesive bonding to form a fluid tight seal and enclosure around the inlet protection mechanism 610 allowing the electronic components 603 to remain protected from fluid within the dressing).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison in view of U.S. Patent Application Publication No. 2021/0172114 (hereinafter “Farmer”).
Regarding claim 20, Harrison discloses the wound dressing apparatus of claim 12, except wherein the coating comprises a dispersion coating, wherein the coating comprises a polyurethane (PU) dispersion coating.
However, Farmer in the disclosure analogous coatings teaches it is known to use polyurethane dispersion coatings for adhesive bonding on bandages (see para. [0008], [0055], [0058]).
In view Farmer, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected a polyurethane dispersion for use in bonding the layers of apparatus of Harrison since they are known to have superior coatability, adhesive strength and heat resistance (see para. [0008] of Farmer).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIM M LEWIS whose telephone number is (571)272-4796. The examiner can normally be reached Monday -Friday 5:30 am -11:30 am.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571)270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIM M LEWIS/Primary Examiner, Art Unit 3786
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