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 1-20 are pending.
Information Disclosure Statement
The IDS field February 24, 2025 has been considered. A signed copy is enclosed herewith.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 63/541661 and 63/586931, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim 11 recites, “wherein the wound treatment device comprises a hydration barrier between the skin substitute and the absorbent core or between the skin substitute and at least a portion of the absorbent core, wherein the hydration barrier delays passage of moisture, liquid, or vapor from a hydration of the skin substitute to the absorbent core or the at least portion of the absorbent core”. Support for the subject matter of claim 11 cannot be located in the prior-filed applications. As such, claim 11 is afforded an effective filing date of September 30, 2024.
Claim Objections
Claim 19 is objected to because of the following informalities: said claims appears to have typographical errors. The claim recites, “and first outer layer” in line 2 of the claim. It is suggested that the limitation is replaced with “a first outer layer”. At line 5, the claim recites, “removable adhered” It is suggested that the limitation is replaced with “removably adhered”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 recites, “wherein the wound treatment device comprises a hydration barrier between the skin substitute and the absorbent core or between the skin substitute and at least a portion of the absorbent core, wherein the hydration barrier delays passage of moisture, liquid, or vapor from a hydration of the skin substitute to the absorbent core or the at least portion of the absorbent core”.
The instant specification describes the hydration barrier in similar language at [0164].
While “[t]here is presumption that an adequate written description of the claimed invention is present when the application is filed”, “issues of adequate written description may arise even for original claims, for example, when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing” (MPEP 2163(I)(A)). MPEP 2163 (II)(A)(3)(a) further states, “An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that inventor was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics”. In this instance, the hydration barrier is described in terms of function, however the specification does not provide any guidance as to the structure (e.g., materials) that provide for the claimed functional characteristics.
Thus, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
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.
Claims 10 and 15-20 are 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.
Claim 10 recites the limitation "the contact film” at line 3 of the claim. A contact film is not recited previously in the claim or its parent claim 1. Thus, there is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the absorbent core” at line 3 of the claim. An absorbent core is not recited previously in independent claim 15. Thus, there is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitations, “a contact film arranged in contact with the skin substitute between the absorbent core and the skin substitute” and “a replaceable portion arranged overlaying the contact film, the replaceable portion including an absorbent core configured to absorb exudate from the wound and a top film overlaying the absorbent core, such that the absorbent core is arranged between the contact film and the top film”. The claim is indefinite because it is unclear whether “an absorbent core” in line 6 of the claim is referring the previously recited “absorbent core” in line 3 of the claim or whether “an absorbent core” is an additional absorbent core. For art purposes, the claim is being interpreted as the recited absorbent cores are one in the same.
Claim 20 recites, “the first outer layer”. Claim 20 depends from claim 18 and, ultimately, claim 15. “A first outer layer” is not recited previously recited. Thus, there is insufficient antecedent basis for this limitation in the claim.
Dependent claims 16-20 do not remedy the indefinite issues, thus, said claims suffer from the same deficiencies.
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.
Claims 1-4, 6, 7 and 14 are rejected under 35 U.S.C. 102(a)(1)as being anticipated by
Dorweiler et al. (“The marine Omega3 wound matrix for treatment of complicated wounds”, Gefässchirurgie, Aug. 1, 2018, 23 (Suppl 2), pp. S46–S55; hereafter as “Dorweiler”) as evidenced by Biatain® Silicone, Coloplast (see PTO-892) and Merriam-Webster (see PTO-892).
The claimed invention is drawn to a wound treatment device comprising: a skin substitute; an absorbent core, the skin substitute being coupled to the absorbent core, wherein the absorbent core comprises a conformable foam layer to conform to a shape of a wound bed.
Regarding instant claims 1 and 14, Dorweiler teaches treating a wound by applying a wound dressing comprising a fish skin matrix layered with a polyurethane foam dressing (Biatain® Silicone, Coloplast) (page S50, middle column, line 28 – right column, line 2; Fig. 4). Said Biatain® Silicone foam dressing is absorbable and conforms to a wound as evidenced by Biatain® Silicone, Coloplast (pages 1-2). The term “coupled” is not defined in the instant specification and, as such, is being given its broadest most reasonable interpretation which is plainly defined as “combined” as evidenced by Merriam-Webster (page 2).
Regarding instant claim 2, Dorweiler teaches the elements discussed above. Dorweiler teaches that the fish skin matrix is decellularized (page S48, left column, 1st paragraph; page S50, left column, 2nd paragraph).
Regarding instant claim 3, Dorweiler teaches the elements discussed above. Dorweiler illustrates that the fish skin matrix is in sheet form (Figure 4e).
Regarding instant claim 4, Dorweiler teaches the elements discussed above. Said Biatain® Silicone foam dressing is a soft and comfortable polyurethane foam dressing with a semi-permeable, bacteria- and waterproof top film and a soft silicone adhesive layer as evidenced by Biatain® Silicone, Coloplast (polymer contact layer integrally bonded to absorbent core; page 2). Dorweiler also teaches that the foam dressing was changed at intervals of 2–3 days while leaving the fish-skin matrix in place (removably adhered to the skin substitute) page S50, right column, lines 3-5).
Regarding instant claims 6 and 7, Dorweiler teaches the elements discussed above. Said Biatain® Silicone foam dressing is a soft and comfortable polyurethane foam dressing with a semi-permeable (porous), bacteria- and waterproof top film and a soft silicone adhesive layer as evidenced by Biatain® Silicone, Coloplast (page 2). Said Biatain® Silicone foam dressing also appears to be porous as the appearance of apertures distributed over the surface area of the polymer contact layer are evident from the images provided by Coloplast (page 1).
Thus, the teachings of Dorweiler render the instant claims anticipated.
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, 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 5 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Dorweiler et al. (“The marine Omega3 wound matrix for treatment of complicated wounds”, Gefässchirurgie, Aug. 1, 2018, 23 (Suppl 2), pp. S46–S55; hereafter as “Dorweiler”) as evidenced by Biatain® Silicone, Coloplast (see PTO-892) and Merriam-Webster (see PTO-892), as applied to claim 1 above, in view of Cotton (EP 3142615 B1, Feb. 23, 2022, hereafter as “Cotton”).
The claimed invention is described above.
Dorweiler teaches the elements discussed above. Further, the polyurethane foam dressing absorbs vertically and retains exudate as evidenced by Biatain® Silicone, Coloplast (page 2).
Dorweiler is silent to a receptacle layer (instant claim 5), wherein the receptacle layer comprises a superabsorbent polymer (instant claim 8).
Cotton teaches a wound dressing comprising an adsorbent bod, which is laminate to, or is in intimate contact with, a perforated film (abstract; [0067]). Cotton teaches that the absorbent body may comprise a foam, a gelling material, a superabsorbent material, or a combination of these components ([0069]). Cotton teaches that the foam is typically an open-celled polyurethane foam that has an open cellular structure that allows exudate from a wound to pass though it as well as be absorbed by it ([0070]). Cotton further teaches that an absorbent body comprising a layer of foam bonded to a superabsorbent layer may also be generally used as a wound dressing or as a component in a composite wound dressing ([0090]). Cotton teaches that superabsorbent materials (polymer) are useful in wound dressings for wounds that produce very high levels of exudate ([0076] and [0091]).
Both Dorweiler and Cotton are drawn to wound dressings/treatment devices, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a receptacle layer comprising a superabsorbent polymer into Dorweiler, as suggested by Cotton, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Cotton teaches that a superabsorbent polymer layer can be combined with a polyurethane foam layer and is particularly effective in wound dressings for wounds that produce very high levels of exudate.
Regarding instant claim 9, the polyurethane foam dressing described in Dorweiler absorbs vertically and retains exudate as evidenced by Biatain® Silicone, Coloplast (page 2). While Dorweiler does not explicitly teach that the absorbent core comprises microcapillaries adapted to promote vertical absorption of wound exudate, Cotton teaches that the foam is typically an open-celled polyurethane foam that has an open cellular structure that allows exudate from a wound to pass though it as well as be absorbed by it ([0070]). Cotton’s description of a polyurethane foam having an open-celled structure (microcapillaries) and both Dorweiler and Cotton teaching said polyurethane foam absorbs and retains exudate, One would reasonably conclude that the polyurethane foam of Dorweiler implicitly teaches an open-celled structure/microcapillaries.
Regarding instant claim 10, Dorweiler is silent to a backing layer arranged such that the absorbent core is arranged between the contact film and the backing layer, wherein the backing layer is liquid impermeable and vapor permeable, wherein the backing layer is adapted to create a seal about the wound bed.
Cotton further teaches that the wound dressing may comprise a backing layer 140 (upper surface of dressing that covers/adheres to foam pad 110) which forms a barrier between the wound and the surrounding atmosphere (i.e., seal; [0117] and [0141]; Fig. 3). Cotton teaches that the backing layer is generally impermeable to wound exudate and other liquids, but is preferably permeable to air and moisture vapor ([0118]). Cotton teaches that foam pad 110 is between the backing layer 140 and the skin contact layer 130 ([0141]; Fig. 3).
Both Dorweiler and Cotton are drawn to wound dressings/treatment devices, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a backing layer arranged such that the absorbent core is arranged between the contact film and the backing layer, wherein the backing layer is liquid impermeable and vapor permeable, wherein the backing layer is adapted to create a seal about the wound bed into Dorweiler, as suggested by Cotton, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Cotton teaches that a backing layer combined with a foam layer in the configuration claimed is effective in providing a liquid impermeable/vapor permeable barrier between the wound and the surrounding atmosphere.
Thus, the combined teachings of Dorweiler and Cotton render the instant claim prima facie obvious.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Dorweiler et al. (“The marine Omega3 wound matrix for treatment of complicated wounds”, Gefässchirurgie, Aug. 1, 2018, 23 (Suppl 2), pp. S46–S55; hereafter as “Dorweiler”) as evidenced by Biatain® Silicone, Coloplast (see PTO-892) and Merriam-Webster (see PTO-892), as applied to claim 1 above.
The claimed invention is drawn to a negative pressure wound therapy apparatus comprising the wound treatment device of claim 1.
Dorweiler, discussed above, teaches the wound treatment device of claim 1.
While Dorweiler teaches negative pressure wound therapy in combination with the skin fish matrix, Dorweiler does not teach the particular combination of to a negative pressure wound therapy apparatus in combination with the wound treatment device (fish skin matrix layered with a polyurethane foam dressing).
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine a negative pressure wound therapy apparatus with the wound treatment device with a reasonable expectation of success because Dorweiler teaches that both negative pressure wound therapy and the wound treatment device are effective for the same purpose, that is, treating wounds. MPEP 2144.06(I) states, “It is prima facie obvious to combine two comprising each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art."
Thus, the teachings of Dorweiler render the instant claim prima facie obvious.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Dorweiler et al. (“The marine Omega3 wound matrix for treatment of complicated wounds”, Gefässchirurgie, Aug. 1, 2018, 23 (Suppl 2), pp. S46–S55; hereafter as “Dorweiler”) as evidenced by Biatain® Silicone, Coloplast (see PTO-892) and Merriam-Webster (see PTO-892), as applied to claim 1 above, in view of Addison (USPN 5,981,822, Nov. 9, 1999, hereafter as “Addison”).
The claimed invention is drawn to a pre-packaged kit comprising the wound treatment device of claim 1, wherein the wound treatment device is provided within an aseptic packaging material.
Dorweiler, discussed above, teaches the wound treatment device of claim 1.
Dorweiler is silent to the pre-packaged kit.
Addison teaches an adsorbent wound dressing (title). Addison also teaches that the wound dressing will be packaged in conventional fashion in sterile packaging and sterilized in a conventional fashion (col. 3, lines 5-8).
Both Dorweiler and Addison are drawn to wound dressings/treatment devices, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to pre-package the wound treatment device within aseptic packaging material with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Addison teaches that it is convention to package a wound dressing in sterile packaging and then sterilized in a conventional fashion. One of ordinary skill would have reasonably expected that providing the wound treatment device in sterile or aseptic packaging would reduce the risk of infection when it is applied to patient’s wound.
Thus, the combined teachings of Dorweiler and Addison render the instant claim prima facie obvious.
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dorweiler et al. (“The marine Omega3 wound matrix for treatment of complicated wounds”, Gefässchirurgie, Aug. 1, 2018, 23 (Suppl 2), pp. S46–S55; hereafter as “Dorweiler”) as evidenced by Biatain® Silicone, Coloplast (see PTO-892) and in view of Bitain® Contact, Coloplast (see PTO-892) and YouTube (see PTO-892).
The claimed invention is drawn to wound treatment device comprising: a skin substitute configured to be placed in contact with a wound; a contact film arranged in contact with the skin substitute between the absorbent core and the skin substitute; and a replaceable portion arranged overlaying the contact film, the replaceable portion including an absorbent core configured to absorb exudate from the wound and a top film overlying the absorbent core, such that the absorbent core is arranged between the contact film and the top film, wherein the replaceable portion is separable from the contact film such that the replaceable portion may be removed from the contact film without disrupting or removing the skin substitute.
Regarding instant claims 15 and 16, Dorweiler teaches treating a wound by applying a wound dressing comprising a fish skin matrix layered with a polyurethane foam dressing (Biatain® Silicone, Coloplast) (page S50, middle column, line 28 – right column, line 2; Fig. 4). Said Biatain® Silicone foam dressing is absorbable and conforms to a wound as evidenced by Coloplast (pages 1-2). Said Biatain® Silicone foam dressing is a soft and comfortable polyurethane foam dressing with a semi-permeable, bacteria- and waterproof top film and a soft silicone adhesive layer as evidenced by Coloplast (page 2). Dorweiler also teaches that the foam dressing was changed at intervals of 2–3 days (replaceable) while leaving the fish-skin matrix in place (page S50, right column, lines 3-5).
Dorweiler is silent to a contact film such that the replaceable portion may be removed from the contact film without disrupting or removing the skin substitute.
Bitain® Contact, Coloplast and YouTube teaches that Bitain® Contact is a one-sided silicone contact layer/thin film that can be applied to a wound and in combination with a secondary absorbent dressing (Bitain® Contact, Coloplast at page 2). YouTube teaches that Bitain® Contact enables exudate transfer, protects fragile skin and against ingrowth, allows for wound assessment, and protects the tissue from direct contact with the secondary dressing (page 1, paragraphs 2-3).
Dorweiler and Bitain® Contact are both drawn to treating wounds with wound dressings, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a contact film such that the replaceable portion may be removed from the contact film without disrupting or removing the skin substitute in the invention of Dorweiler, as suggested by Bitain® Contact, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Bitain® Contact, Coloplast and YouTube teach that said contact layer can be used in combination with a secondary absorbent dressing (e.g., Biatain® Silicone) and said contact layer is effective in enabling exudate transfer, protecting fragile skin and against ingrowth, allowing for wound assessment, and protecting the tissue from direct contact with the secondary dressing.
Regarding instant claim 17, Dorweiler teaches the elements discussed above. Dorweiler teaches that the fish skin matrix is decellularized (page S48, left column, 1st paragraph; page S50, left column, 2nd paragraph).
Regarding instant claim 18, Dorweiler teaches the elements discussed above. Dorweiler illustrates that the fish skin matrix is in sheet form (Figure 4e).
Thus, the combined teachings of Dorweiler, Bitain® Contact - Coloplast and YouTube render the instant claims prima facie obvious.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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