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 .
Claim Objections
The claims contain minor informalities.
In claim 4, the language “… are provided in [[power]] powder form …” should be changed for clarity.
Claim Rejections - 35 USC § 112(b)
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 2-13 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 pre-AIA the applicant regards as the invention.
Claim 2 calls for “…wherein the exudate is absorbed by at least one of the first layer of superabsorbent polymer additive and the second layer of superabsorbent polymer additive.” This language raises the question of whether the exudate is included in the claim scope and therefore is ambiguous.
Examiner suggests to rephrase this feature in terms of the first and second layers’ capabilities, for example “… wherein [[the exudate is absorbed by]] at least one of the first layer of superabsorbent polymer additive and the second layer of superabsorbent polymer additive is configured to absorb the exudate.”
Claim 13 calls for “…hydrophilic non-woven fabric bound to at least one of the first polyurethane foam layer and the second polyurethane foam layer over the superabsorbent polymer additive.” This language is ambiguous since parent claim 1 calls for “… an absorbent layer positioned below the adhesive layer and connected to the carrier layer via the adhesive layer …” Parent claim implies that the adhesive layer contacts the absorbent layer. Interposing a nonwoven layer between the foam layers and carrier layer raises a question of how the adhesive layer connects the carrier layer and absorbent layers.
Claims 3-12 are rejected for depending on a rejected parent claim.
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 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 1, 2, 4, 8, 9, 13, 14, 17, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gowans; John Philip et al. (US 20190015258 A1).
Regarding claim 1, Gowans discloses a medical dressing (¶ [0001], [0005], [0026], apparatuses and methods of treating a wound; ¶ [0035] FIGS. 1A-B … a negative pressure wound treatment system 10 employing a wound dressing 100; ¶ [0038] FIG. 2B illustrates a cross-section through a wound dressing 100; ¶ [0069], FIG. 3A, the wound dressing 300);
comprising: a carrier layer (¶ [0053] The backing layer 220 is preferably gas impermeable, but moisture vapor permeable, and can extend across the width of the wound dressing 100. The backing layer 220, which may for example be a polyurethane film (for example, Elastollan SP9109) having a pressure sensitive adhesive on one side; ¶ [0069], FIG. 3A … backing layer 320);
an adhesive layer provided below the carrier layer closer to a user's skin when the medical dressing is in place on the user (¶ [0053], The backing layer 220, which may for example be a polyurethane film (for example, Elastollan SP9109) having a pressure sensitive adhesive on one side);
an absorbent layer positioned below the adhesive layer and connected to the carrier layer via the adhesive layer (¶ [0069], FIG. 3A … absorbent layer 321 … The wound dressing 300 can include a second transmission layer 326b);
the absorbent layer configured to absorb and retain exudate and including at least one foam layer; with superabsorbent polymer additive provided on the at least one foam layer (¶ [0047] A layer 221 of absorbent material is provided above the transmission layer 226. The absorbent material, which comprise a foam or non-woven natural or synthetic material, and which may optionally comprise a super-absorbent material, forms a reservoir for fluid, particularly liquid, removed from the wound site; ¶ [0048], The absorbent layer 221 may typically be manufactured from ALLEVYN™ foam, Freudenberg 114-224-4 and/or Chem-Posite™11C-450. In some embodiments, the absorbent layer 221 may comprise a composite comprising superabsorbent powder, fibrous material such as cellulose, and bonding fibers; ¶ [0069], A transmission layer 326a and absorbent layer 321 can be provided similar to the dressing described with reference to FIG. 2B); and
a wound contact layer positioned below the absorbent layer and configured to adhere to the user's skin; the wound contact layer including a plurality of openings through which the exudate may pass into the absorbent layer (¶ [0040] As illustrated in FIG. 2B, the wound contact layer 222 can be a polyurethane layer or polyethylene layer or other flexible layer which is perforated, for example via a hot pin process, laser ablation process, ultrasound process or in some other way or otherwise made permeable to liquid and gas … The perforations 225 preferably comprise through holes in the wound contact layer 222 which enable fluid to flow through the layer 222; ¶ [0069] As shown in FIG. 3A, the wound dressing 300 can include a wound contact layer 322. The wound contact layer can be similar to the wound contact layer 322 described with reference to FIG. 2B).
Gowans teaches the invention substantially as claimed by Applicant but not in a single embodiment. This rejection combines features from Figs. 2B, 3A and 3C of Gowans. A skilled artisan would have been able to modify the embodiment of Fig. 3C with the adhesive carrier layer, absorbent layer, super-absorbent material and perforated wound contact layer of Fig. 2B by constructing the layers in Fig. 3C from the corresponding layers of Fig. 2B. One would be motivated to combine features from Gowans’s embodiments since Gowans calls for contstructing the embodiment of Fig. 3C from the materials of other embodiments (¶ [0069], [0070]).
Regarding claim 2, Gowans discloses a medical dressing wherein the absorbent layer comprises: a first polyurethane foam layer including at least a first layer of superabsorbent polymer additive; and a second polyurethane foam layer including at least a second layer of superabsorbent polymer additive (¶ [0048], The absorbent layer 221 may typically be manufactured from ALLEVYN™ foam, Freudenberg 114-224-4 and/or Chem-Posite™11C-450. In some embodiments, the absorbent layer 221 may comprise a composite comprising superabsorbent powder, fibrous material such as cellulose, and bonding fibers; ¶ [0079], FIG. 3C also includes a second absorbent layer. The wound dressing can include multiple absorbent layers provided between the first and second transmission layers 326a, 326b);
wherein the exudate is absorbed by at least one of the first layer of superabsorbent polymer additive and the second layer of superabsorbent polymer additive (¶ [0045], the absorbent layer 221 helps lock the liquid away or itself wicks the liquid onwards towards the cover layer where it can be transpired; ¶ [0068], superabsorbent particles comprising the absorbent layer can absorb water from the input liquid).
This rejection modifies the embodiment of Fig. 3C with layers from other embodiments. Regarding the rationale and motivation to modify Gowans’s Fig. 3C by constructing it with layers from other embodiments, see the discussion of claim 1 above.
Regarding claims 4 and 14, Gowans discloses that the first layer of superabsorbent polymer additive and the second layer of superabsorbent polymer additive are provided in power form and are impregnated into the first polyurethane foam layer and the second polyurethane foam layer, respectively; and the superabsorbent polymer additive is a powder impregnated in the at least one foam layer (¶ [0085] In some embodiments, the absorbent layer is a layer of non-woven cellulose fibers having super-absorbent material in the form of dry particles dispersed throughout; ¶ [0091] Super-absorber particles/fibers may be, for example, sodium polyacrylate or carbomethoxycellulose materials or the like or any material capable of absorbing many times its own weight in liquid).
Regarding claims 8 and 9, Gowans discloses that the absorbent layer further comprises a third layer of superabsorbent polymer additive provided on at least one of the first polyurethane foam layer and the second polyurethane absorbent layer (¶ [0049] In some embodiments, the absorbent layer 221 is a layer of non-woven cellulose fibers having super-absorbent material in the form of dry particles dispersed throughout);
wherein the third layer of superabsorbent polymer additive is a powder (¶ [0085] In some embodiments, the absorbent layer is a layer of non-woven cellulose fibers having super-absorbent material in the form of dry particles dispersed throughout; ¶ [0091] Super-absorber particles/fibers may be, for example, sodium polyacrylate or carbomethoxycellulose materials or the like or any material capable of absorbing many times its own weight in liquid).
This rejection interprets the SAP present on Gowans’s foam layer surface as analogous to the claimed third SAP layer. Claim 8 calls for a third layer of SAP additive provided on one of the first or second absorbent layers. Gowans describes an absorbent layer 221 comprising non-woven cellulose fibers having super-absorbent material in the form of dry particles dispersed throughout (¶ [0049]). The absorbent layer 221 therefore also has dry SAP particles dispersed across its outer surface, which constitutes the claimed third SAP layer.
Regarding claims 13, 17, 18 and 20, Gowans further discloses a hydrophilic non-woven fabric bound to at least one of the first polyurethane foam layer and the second polyurethane foam layer over the superabsorbent polymer additive (¶ [0060] In some embodiments, the fluid passage 212 may be comprised of a wicking fabric … or a nonwoven fabric; ¶ [0070] In some embodiments, the first and second transmission layer 326a, 326b can include a 3D fabric as described herein … For example, a knitted or woven spacer fabric (for example Baltex 7970 weft knitted polyester) or a non-woven fabric could be used as described previously);
wherein the carrier layer is a polyurethane film (¶ [0053] The backing layer 220 is preferably gas impermeable, but moisture vapor permeable, and can extend across the width of the wound dressing 100. The backing layer 220, which may for example be a polyurethane film (for example, Elastollan SP9109) having a pressure sensitive adhesive on one side);
wherein the plurality of openings formed in the wound contact layer are all the same size (¶ [0040], For example, perforations formed as slits or holes having a size ranging from 0.025 mm to 1.2 mm are considered small enough to help prevent tissue ingrowth into the wound dressing while allowing wound exudate to flow into the dressing);
wherein a first area of the carrier layer and a second area of the wound contact layer are larger than a third area of the absorbent layer (Fig. 3C, backing layer 320 and wound contact layer 322 both have a larger footprint than absorbent layers 321).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gowans; John Philip et al. (US 20190015258 A1) in view of Dutkiewicz; Jacek K et al. (US 20220370268 A1).
Regarding claim 3, Gowans does not explicitly disclose a binder powder. Dutkiewicz discloses nonwoven materials for use as absorbent cores and/or acquisition distribution layers, in absorbent articles (¶ [0002], [0007], [0039]);
comprising an absorbent layer (¶ [0055] Any cellulose fibers known in the art, including cellulose fibers of any natural origin, such as those derived from wood pulp or regenerated cellulose, can be used in a cellulosic layer; ¶ [0059] Other suitable types of cellulose fiber include, but are not limited to, chemically modified cellulose fibers; ¶ [0063] In addition to the use of cellulose fibers, the presently disclosed subject matter also contemplates the use of synthetic fibers; ¶ [0071] Nonwoven materials of the present disclosure can include bicomponent fibers; ¶ [0077] Nonwoven materials of the present disclosure can include short fibers); and
a SAP additive (¶ [0090], the materials can contain superabsorbent polymer (SAP) … commercially available from a number of manufacturers, such as BASF, Dow Chemical (Midland, Mich.), Stockhausen (Greensboro, N.C.), Chemdal (Arlington Heights, Ill.), and Evonik (Essen, Germany); ¶ [0094], Optionally, the structure can further include superabsorbent polymer (SAP));
wherein the SAP additive includes a binder powder configured to hold the SAP additive on the absorbent layer (¶ [0082], the nonwoven materials described herein can include binders … liquid binders and powder binders … Non-limiting examples of binders include polyethylene powders, copolymer binders, vinylacetate ethylene binders, styrene-butadiene binders, urethanes, urethane-based binders, acrylic binders, thermoplastic binders).
Dutkiewicz demonstrates examples of other compatible binders that are suitable for anchoring a SAP additive on an absorbent layer. One would be motivated to modify Gowans with Dutkiewicz’s binder powder since Gowans calls for a binder (¶ [0048], the absorbent layer 221 may comprise a composite comprising superabsorbent powder, fibrous material such as cellulose, and bonding fibers). Therefore, it would have been obvious to modify Gowans with Dutkiewicz’s powdered binder in order to cohere the SAP and absorbent fibers with a known binder.
Claims 5-7, 10, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Gowans; John Philip et al. (US 20190015258 A1) in view of Kurata; Shuhei (US 20060094997 A1).
Regarding claims 5-7, 10, 15 and 16, Gowans does not explicitly disclose a SAP provided via an aqueous solution. Kurata discloses a wound dressing (¶ [0002], [0018], [0023], [0051] Referring to FIGS. 1(a) and 1(b), a dressing 1);
comprising an absorbent layer (¶ [0051], a second layer (absorptive layer) 20 for absorbing the exudate); and
a SAP additive layer (¶ [0096] The air-laid non-woven fabric may include super water-absorbing polymer powder (absorbent));
wherein the SAP additive layer includes superabsorbent polymer additive provided via an aqueous solution; wherein the SAP additive remains on the absorbent layer after a liquid of the aqueous solution evaporates (¶ [0100] Alternatively, the second layer 20 or the absorptive layer 20 may be a sheet-shaped composite. The sheet-shaped composite is obtained by, for example, impregnating a non-woven fabric with an acrylic acid monomer and then subjecting it to polymerization and cross- linking. Another example of the sheet-shaped composite can be obtained by pouring a dispersion liquid over a sheet-shaped support such as a non-woven fabric and then drying the dispersion liquid, the dispersion liquid being obtained by dispersing a highly hydratable fibrous substance (e.g., microfibril, etc.) and a water-swellable solid substance (e.g., any of various polysaccharides, a flocculent, a super absorbing polymer (SAP), etc.) in a mixed solvent of an organic catalyst and water).
Kurata demonstrates another way to apply SAP additive to an absorbent layer. One would be motivated to modify Gowans with Kurata’s aqueous SAP solution to distribute SAP additive through an absorbent layer since Gowans calls for dispersing SAP through the absorbent layers (¶ [0085] In some embodiments, the absorbent layer is a layer of non-woven cellulose fibers having super-absorbent material in the form of dry particles dispersed throughout). A skilled artisan would have been able to modify Gowans with Kurata’s aqueous SAP solution by applying Kurata’s aqueous SAP solution to one or more of Gowans’s absorbent layers in place of, or in addition to dry SAP. Therefore, it would have been obvious to modify Gowans with Kurata’s aqueous SAP solution in order to construct Gowans’s various absorbent layers with a known technique.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gowans; John Philip et al. (US 20190015258 A1) in view of Riesinger; Birgit (US 20100262090 A1).
Regarding claims 11 and 12, Gowans lacks a chamber sealed via ultrasonic welding. Riesinger discloses a pillow-shaped wound care article (¶ [0002], [0136] In FIG. 1a a first wound care article is represented designated with indicator 100; ¶ [0140] A wound care article 500 represented in FIG. 4; ¶ [0141] The FIG. 5 shows a further wound care article);
comprising first and second layers (¶ [0136], two internal enclosing surfaces 12.1, 12.2); and
a superabsorbent polymer additive (¶ [0138], The pad-like structure 1 contains a quantity of granular and powdery super-absorbent particles 5 (cf. FIG. 7); ¶ [0144], The fluid-absorbing structure 1 consists of fleece-like applied cellulose fibres and super-absorbent particles 5 distributed therein);
wherein respective edges of the first and second layers are sealed together to create a chamber to hold the superabsorbent polymer additive in place; wherein the respective edges are sealed via ultrasonic welding (¶ [0137] As especially shown in FIGS. 1b, 7 and 8, the enclosing surfaces 12.1, 12.2 surrounding the structure 1 as well as the external enclosing surfaces 13.1, 13.2 are each sealed with one another by a peripheral ultrasonic seam 28; ¶ [0151] The FIGS. 16, 17a and 17b show a wound care article 1000 … circulating ultrasonic seam 37).
Riesinger describes an alternative way to enclose SAP between two layers. Riesinger’s ultrasonic welding technique also permits the dressing to remain flexible while retaining SAP (¶ [0405], the seam (6) is an ultrasonic welded seam that is flexible, and remains deformable according to the pressure conditions on the wound). One would be motivated to modify Gowans with Riesinger’s ultrasonically welded chamber to both sequester SAP inside the dressing while preserving its flexibility. A skilled artisan would have been able to modify Gowans with Riesinger’s ultrasonically welded chamber by welding Gowans’s layers together according to Riesinger’s example.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gowans; John Philip et al. (US 20190015258 A1) in view of Munro; Hugh Semple (US 20190000677 A1).
Regarding claim 19, Gowans does not explicitly disclose first and second groups of openings. Munro discloses compositions and wound dressings (¶ [0001], [0009], [0069], [0133] FIG. 1 shows several embodiments (A to J) of the dressing or composition (100) described herein);
comprising a wound contact layer comprising a plurality of openings (¶ [0133], The first layer comprises a first area (101) having apertures (102) extending through the first layer … The apertures (102) are arranged in an array as shown);
PNG
media_image1.png
516
872
media_image1.png
Greyscale
wherein the plurality of openings formed in the wound contact layer include a first group of openings having a large size positioned in a center of the dressing above the wound when the dressing is on the user's skin; and a second group of openings having a small size positioned around a periphery of the dressing (Figs. 1E, 1F, 1G and 1H show patterns of apertures where the central apertures are larger than peripheral apertures).
Munro describes how to arrange openings a in a wound contact layer. One would be motivated to modify Gowans with Munro’s first and second groups of openings since Gowans calls for an apertured wound contact layer but doesn’t explain how the apertures are arranged. Therefore, it would have been obvious to modify Gowans with Munro’s first and second groups of openings in order to arrange the apertures in a known pattern.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Freeman; Frank US 5681579 A
Masaki; Kazumichi et al. US 5821179 A
Hansen, Michael R. et al. US 20030201051 A1
Cotton; Stephen US 20100159192 A1
Ehrnsperger; Bruno Johannes et al. US 20140163501 A1
Cotton; Stephen US 20140309574 A1
Luckemeyer; James A. et al. US 20150119830 A1
Carroll; Christopher Allen et al. US 20210077302 A1
Waite; Alexander et al. US 20220008642 A1
Cotton; Stephen US 20220142822 A1
Robinson; Timothy Mark et al. US 20220296425 A1
Chaut; Christophe et al. US 20230310680 A1
Hoggarth; Andrew US 20240245556 A1
Steven; Jade et al. US 20240325206 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Tel 571-272-2590
Fax 571-273-2590
Email Adam.Marcetich@uspto.gov
The Examiner can be reached 8am-4pm Mon-Fri.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application is assigned is 571-273-8300.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov.
Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Adam Marcetich/
Primary Examiner, Art Unit 3781