DETAILED ACTION
In Applicant’s Response filed 10/27/25, Applicant has amended claim 1. Claims 2-5, 7, 9 and 26-49 have been cancelled. Currently, claims 1, 6, 8 and 10-25 are pending.
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 .
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 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.
Claims 1, 6, 8, 10-11 and 14-25 are rejected under 35 U.S.C. 103 as being unpatentable over Feng et al (EP 3078360 A1) in view of Canada et al (US 2006/0127462) and further in view of Rui (CN 107625582 A).
With respect to claim 1, Feng discloses a wound care device (3 layered wound dressing shown in fig 1; para [0009]) comprising the following sequential layers:
a first single layer of fabric having a wound contact surface (wound contact layer 1 in fig 1 which is configured to contact a wound; para [0009-0010]; formed as a fabric layer – para [0014]; as shown in fig 1, layer 1 is a single layer of fabric) and a wound fluid reservoir surface that is opposite the wound contact surface (opposite surface of layer 1 which faces and is adjacent to the middle layer 2 which is interpreted as being a wound fluid reservoir since it absorbs and retains wound fluid – para [0010]);
a first layer of hotmelt adhesive (para [0030] part 1) disposed on the wound fluid reservoir surface of the first single layer of fabric (it is inherent that the adhesive used to attach layers 1 and 2 will be provided on the surface of layer 1 which faces and is adjacent to layer 2, which is interpreted as being the “wound fluid reservoir surface” of layer 1 as discussed above); and
a second layer of nonwoven fabric (middle absorbent layer 2 in fig 1; para [0009-0010;0018-0022]; the absorbent middle layer is a nonwoven - abstract); and
wherein the wound care device is configured to transport wound fluid uni-directionally from the wound contact surface to the wound fluid reservoir surface upon exposure to a wound (wound contact layer 1 absorbs and transfers wound fluid to the middle absorbent layer 2 via almost vertical transfer whereby the fluid is absorbed and retained in layer 2; since the fluid is transferred from layer 1 to layer 2 and then retained in layer 2, the transport is interpreted as being “uni-directional” – see para [0010,0032]).
Feng does not, however, disclose that the first layer of fabric is circular jersey knit fabric.
Canada, however, teaches an analogous wound care device wherein the “fabric may be of any variety, including but not limited to, woven fabric, knitted fabric, nonwoven fabric, or combinations thereof” (para [0020]) but, preferably, is comprised of a knit construction (para [0003]) and, specifically, is a jersey knit that is a circular fabric made with a plain stitch where loops intermesh in only one direction to provide different appearances on the face/back of the fabric (para [0022]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the first layer of fabric in Feng as a jersey knit fabric as taught by Canada instead of a nonwoven fabric in order to provide a different appearance on the face as compared to the back of the fabric. Additionally, one would have been motivated to form the first layer in Feng as a jersey knit fabric as taught by Canada since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Feng also discloses that the first layer of fabric (1) contains lyocell fibers (para [0011] line 37), but does not explicitly disclose that the wound fluid reservoir surface comprises primarily the lyocell fibers while the wound contact surface is comprised primarily of hydrophobic fibers, wherein the wound fluid reservoir surface exhibits a greater affinity for aqueous fluids than the wound contact surface.
Rui, however, teaches a wound dressing which comprises a first single layer of fabric (layers are combined by needling, adhesive bonding or hot melting - see pg 4/10 of Translation; thus layers 1 and 2 are interpreted as being a single fabric layer when joined thereby forming upper/lower opposing surfaces of the single fabric layer) comprising a wound contact surface (liquid conducting layer 1) comprised primarily of hydrophobic fibers (comprises 75 wt% of polypropylene fibers; translation pg 5; polypropylene fibers are hydrophobic) and a wound fluid reservoir surface (liquid reserve/storage layer 2) that comprises primarily lyocell fibers (comprises 50 wt% lyocell fibers – translation pg 5). Additionally, it is inherent that the wound fluid reservoir surface will exhibit a greater affinity for aqueous fluids than the wound contact surface because the reservoir surface comprises primarily lyocell fibers which are highly absorbent while the contact surface is formed of primarily polypropylene fibers which are hydrophobic and will therefore repel water. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Feng in view of Canada to have a wound fluid reservoir surface that comprises primarily the lyocell fibers while the wound contact surface is comprised primarily of hydrophobic fibers, wherein the wound fluid reservoir surface exhibits a greater affinity for aqueous fluids than the wound contact surface, as taught by Rui, in order to improve moisture retention and prevent diffusion of exudates to the skin surrounding a wound (translation pg 3). Furthermore, one having ordinary skill in the art would have been motivated to make such a modification since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
With respect to claim 6, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 5) and Feng also discloses that the hydrophobic fibers are polyester fibers (para [0011] lines 40-44).
With respect to claim 8, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 5) but Feng does not disclose that the first layer of fabric further comprises an elastomeric fiber.
Canada, however, teaches an analogous wound care device wherein the device comprises a first fiber on the wound contact surface, a second fiber on the fluid reservoir surface, and, additionally, a third fiber such as an elastomeric polyurethane in order to provide elasticity to the device (para [0003]). Canada further teaches that addition of the elastomeric fiber improves conformability and provides some level of softness (para [0022]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date, to have added an elastomeric fiber as taught by Canada to the first layer of the device of Feng in view of Canada and further in view of Rui in order to provide elasticity and softness and improve conformability of the device.
With respect to claim 10, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 1) and Feng also discloses that the second layer of fabric (2) contains lyocell fibers (para [0019]).
With respect to claim 11, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 1) and Feng also discloses that the second layer of fabric (2) has a fabric construction different from the first layer of fabric (1) (the middle layer 2 has a different ratio of hydrophilic to hydrophobic fibers than the wound contact layer 1 – for middle layer 2, the ratio is specifically chosen in order to provide higher absorbency in the middle layer so that the middle layer absorbs and retains wound fluid transferred from the wound contact layer 1 – see para [0010;0018;0032]).
With respect to claim 14, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 1) and Feng also discloses that the first layer of fabric (1) is coated with a composition comprising at least one silver-containing compound (para [0027-0029]).
With respect to claim 15, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 14) and Feng also discloses that the at least one silver-containing compound is a mixture of silver ion exchange materials (para [0028]).
With respect to claim 16, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 15) and Feng also discloses that the silver ion exchange material is selected from the group consisting of silver zirconium phosphate, silver calcium phosphate, silver zeolite, and mixtures thereof (silver sodium zirconium hydrogen phosphate – para [0028]).
With respect to claim 17, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 16) and Feng also discloses that the silver ion exchange material is silver zirconium phosphate (para [0028] lines 54-55).
With respect to claims 18-19, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 14) but Feng does not disclose that the composition further comprises a binding agent wherein the binding agent is a polyurethane-based material.
Canada, however, teaches an analogous wound care device wherein silver compounds are added with a binder to the substrates (para [0030]). Canada further teaches that “When specific polyurethane-based binder materials are utilized, the antimicrobial characteristics of the treated substrate are effective with regard to the amount of surface available silver that is released to kill bacteria, without altering the color of the treated substrate” (para [0031]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have added a polyurethane-based binding agent as taught by Canada to the first layer of the device of Feng in view of Canada and further in view of Rui when adding the silver antimicrobial agents to the fabric in order to provide effective antimicrobial characteristics with regard to the amount of surface available silver that is released to kill bacteria, without altering the color of the treated fabric.
With respect to claim 20, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 14) but Feng does not disclose that the device is non-electrically conductive.
Canada, however, teaches an analogous wound care device (example 2 – para [0049]) which is non-electrically conductive (para [0092]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the device of Feng in view of Canada and further in view of Rui to be non-electrically conductive like the device of Canada in order to avoid interference with or alter the release rate of silver ions in the material.
With respect to claim 21, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 1) and Feng also discloses that a silver-containing antimicrobial agent can be added to the first layer 1 (see para [0027-0029; thus the first layer “contains” at least one silver-containing compound).
With respect to claim 22, Feng in view of Canada and further in view of Rui discloses the invention substantially as claimed (see rejection of claim 21) and also discloses that the device exhibits antimicrobial efficacy (adding antimicrobial agents such as silver renders the dressing “antimicrobial” – para [0027]; antimicrobial articles exhibit antimicrobial efficacy).
With respect to claim 23, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 1) and Feng also discloses that the device further includes a third layer of fabric (outer layer 3; fig 1).
With respect to claim 24, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 23) and Feng also discloses that the device further contains a second layer of hotmelt adhesive (the outer layer is manufactured using hot melt and adhered to the middle layer 2 based on the arrangement shown in fig 1 – see para [0024;0030]; it is inherent that the adhesive must be disposed between the second middle layer 2 and third outer layer 3 in order to adhere them to one another).
With respect to claim 25, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 24) and Feng also discloses that the second layer of hotmelt adhesive is disposed between the second layer of fabric and the third layer of fabric (it is inherent that the adhesive must be disposed between the second middle layer 2 and third outer layer 3 in order to adhere them to one another).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Feng et al (EP 3078360 A1) in view of Canada et al (US 2006/0127462) and Rui (CN 107625582 A) (with respect to claim 1) and further in view of Hanson et al (US 2017/0290945).
With respect to claim 12, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 1) but Feng does not disclose that the first hotmelt adhesive is selected from the group consisting of polyurethane hotmelt, polyolefin hotmelt, polyamide hotmelt, co-polymers of polyurethane hotmelt, co-polymers of polyolefin hotmelt, co-polymers of polyamide hotmelt, and mixtures thereof.
Hanson, however, teaches that hot melt adhesives are commonly used to bond together articles such as medical dressings (para [0002]) and, specifically, teaches a hot melt adhesive composition based on polyolefin used for constructing disposable absorbent articles (abstract) such as medical dressings and bandages (para [0043]) to provide good cohesive strength and low odor (para [0018]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used a polyolefin hotmelt adhesive as taught by Hanson as the hot melt adhesive in the device of Feng in view of Canada and further in view of Rui in order to provide good cohesive strength and low odor.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Feng et al (EP 3078360 A1) in view of Canada et al (US 2006/0127462) and Rui (CN 107625582 A) (with respect to claim 1) and further in view of Venkatasanthanam et al (US 2002/0119292).
With respect to claim 13, Feng in view of Canada and further in view of Rui discloses the invention as claimed (see rejection of claim 1) but does not disclose that the hotmelt adhesive is present on the wound fluid reservoir surface of the first layer of fabric in a substantially uniform layer.
Venkatasanthanam, however, teaches a multilayered structure formed using hot melt adhesives wherein a continuous and uniform layer of the adhesive is provided on the material layer to avoid defects in the material (para [0104]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have provided the hotmelt adhesive in the device of Feng in view of Canada and further in view of Rui as a substantially uniform layer on the wound fluid reservoir surface of the first layer of fabric, like the continuous layer of hot melt adhesive in Venkatasanthanam, in order to avoid defects in the material.
Response to Amendments/Arguments
Applicant’s arguments filed 10/27/25 have been fully considered as follows:
Regarding the objections to the claims, Applicant’s amendments to claim 1 have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on pages 5-10 have been fully considered but are not persuasive.
Specifically, the Office has noted Applicant’s arguments on pages 5-6 that the argument made by the Examiner that “appearance” of the knit fabric face differs from “appearance” of the knit fabric back is sufficient motivation to combine the references is unfounded because the wound care device of the present invention is designed for one-way movement of fluid away from a wound and the knit fabric possesses different functional aspects on the front of the fabric versus the back of the fabric when exposed to moisture so one having ordinary skill in the art would not be motivated to select the first layer of fabric as recited by the instant claims and substitute it for the nonwoven fabric of Feng for the sake of appearance and ease of manufacturing. The Office is not persuaded by these arguments, however, because the claims do not recite any functional aspects on the front of the fabric which differ from the functional aspects the back of the fabric when exposed to moisture – thus, the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, as previously argued, providing a different appearance on each face would assist in identifying the faces for correct orientation of the fabric during manufacturing. Therefore, for at least these reasons, the Office maintains that one of ordinary skill in the art would have been motivated to modify the fabric of Feng to provide a different appearance on the face as compared to the back of the fabric as taught by Canada.
The Office has also noted Applicant’s arguments on pages 6-7 that inherency is not present because no evidence has been provided that rises to the level of "explicit teaching by the reference" to support the assertions by the Examiner. Applicant further argues that Rui teaches that polypropylene can be "water-absorbing" or "hygroscopic" (water- repelling) with no guidance as to which version is ideally suited and selected for its non- woven fabric. The Office is not persuaded by these arguments, however, because Rui teaches that the fabric includes both hygroscopic and non-hygroscopic fibers blended wherein ”water-absorbing polypropylene fiber” can be used as the hygroscopic fiber and “polypropylene fiber” can be used for the non-hygroscopic fiber in the blend. Thus, even though it is true that Rui teaches use of water-absorbing polypropylene, Rui also teaches that hygroscopic polypropylene fibers are used in the fabric. Thus, based on this teaching, the Office maintains that Rui teaches use of polypropylene fibers in the dressing which are hydrophobic.
The Office has also noted Applicant’s arguments on pages 7-9 that Applicant continues to respectfully disagree with the arguments presented by the Examiner with respect to the teachings of the references because the citations provided by the Examiner fail to provide any teaching or suggestion whatsoever of a second layer of hotmelt adhesive as recited by claim 24. Applicant further argues that the Examiner has erred in interpreting the Feng reference as inherently teaching the limitations of claim 24 because Feng teaches that fibres are made with hotmelt but does not teach that layers of the dressing are adhered together with hotmelt adhesive and there is no teaching whatsoever of layers of hotmelt. The Office respectfully disagrees. Although it is true that Feng teaches that fibers are made with hotmelt, Feng also teaches that the layers are thereafter attached to one another using adhesive. This is highlighted in the citations that were reproduced on page 7 of the Response by Applicant which state the steps of “manufacturing the wound contact layer, middle layer and the outer layer separately using hot melt, needle punch or hydro entanglement methods. Then by heat lamination or needle punching or adhesive laminate the wound contact layer, middle layer and the outer layer together. Thus, the Office maintains that Feng teaches that layers are first made of hotmelt and that, thereafter, adhesive is used to attach the layers to each other wherein the adhesive must be provided between the layers in order to attach the layers together. For at least this reason, the Office maintains that that the prior art discloses a second layer of hotmelt adhesive as recited in claim 24 because it is inherent that the outer layer and middle layer are adhered to one other using adhesive, and that such adhesive must be disposed between the second middle layer 2 and third outer layer 3 in order to adhere them to one another.
The Office has also noted Applicant’s arguments on page 8 that “the Examiner has relied upon impermissible hindsight reconstruction in making the determination of obviousness”. However, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).The Office maintains that the conclusion of obviousness takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure. Therefore, the Office maintains that such a reconstruction is proper.
The Office has also noted Applicant’s arguments on pages 9-10 regarding claims 12 and 13 but for the same reasons as provided above, the Office is not persuaded by these arguments.
Therefore, for at least the reasons provided above, the Office maintains and reaffirms that the prior art of record reads on the claims substantially as recited in the present application.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 5837365 which teaches hydrophilic polypropylene membranes.
Conclusion
THIS ACTION IS MADE FINAL. 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 CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786