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 .
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group 1, claim(s) 1-4,6-12,14,16-19, drawn to a wound dressing.
Group 2, claim(s) 20,22-24, drawn to a method of making a wound dressing.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a wound dressing with a an absorbent and a gel, where the gel has a plurality of fluid channels, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Sigurjonsson US 7230154, provided in the IDS. Sigurjonsson teaches a wound dressing comprising a gel layer along the surface of an absorbent core, where the gel comprises a plurality of through extending apertures (abstract column 3, lines 53-61)
During a telephone conversation with Attorney Paige Cappelli on 03/02/2026 a provisional election was made without traverse to prosecute the invention of group 1, claims 1-4,6-12,14,16-19. Affirmation of this election must be made by applicant in replying to this Office action. Claim 20,22-24 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4,6-7,10-12,16-17,19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dagger et al. US 20230201415, hereafter Dagger provided in the IDS.
Regarding claim 1, Dagger discloses a wound dressing apparatus(figure 2C), comprising: an absorbent layer (221) having a wound-facing surface (surface pointing toward wound, “bottom”)and an opposite , non-wound facing surface (“top” , para. 0065); and a gel material adhered to the wound-facing surface of the absorbent layer (para. 0069, where the dressing of this embodiment may incorporate or comprise one or more nitric oxide generating layers as a whole component or part of a component layer (where said layers may include a nitric oxide source layer and activator layer), able to be positioned in various locations per the same citation). The examiner notes that per para. 0099, the nitric oxide source layer interpreted to be at least a part of the nitric oxide generating layers as previously described, may be a gel, mesh, or other suitable material. The activator layer, also interpreted to be part of the nitric oxide generating layers, may include a mesh, foam, gel, or any other suitable material as well (para. 0101). Therefore at least both of components of the nitric oxide generating layers may include a gel. Dagger further discloses wherein the gel material comprises a cured patterned structure defining a plurality of fluid channels extending therethrough (where the nitric oxide generating layers may include a sufficient number of pores para. 0070, and the activator layer may be a gel poured into a foam abd then cured in the foam. Therefore the layer is interpreted to be cured, and patterned, as the formation of channels is interpreted to be patterning.).
Regarding claim 2, Dagger discloses the wound dressing apparatus of Claim 1, wherein the gel material comprises acidic groups or moieties (para. 0101). The examiner notes that the activator layer, per the rejection of claim 1, is interpreted to include the gel material. Per para. 0101, the activator layer may “may include acidic groups or moieties” which “facilitate release of nitric oxide from the nitric oxide-releasing agent”.
Regarding claim 3, Dagger discloses the wound dressing apparatus of Claim 1, further comprising a cover layer positioned above the absorbent layer (figure 2C, cover layer (220), para. 0064).
Regarding claim 4, Dagger discloses the wound dressing apparatus of Claim 3, further comprising a tissue interface layer (figure 2C, wound contact layer (222)) below the gel material (per previously cited para. 0069 [claim 1 rejection] the nitic oxide delivery layers may be provided above the wound contact layer) and adhered to a peripheral portion of the cover layer (para. 0064, where cover layer 220 is sealed with wound contact layer 222). The examiner notes that the tissue interface, per the citations, is said to be perforated, and thus could be interpreted to comprise at least “a” central opening. As the interface layer is below the gel material, said central opening is below at least a portion of the gel material.
Regarding claim 6, Dagger discloses the wound dressing apparatus of Claim 3, further comprising one or more nitrite providing layers (where in the one or more nitric oxide delivery layers may include a nitric oxide source layer para. 0096-0100).
Regarding claim 7, Dagger discloses the wound dressing apparatus of Claim 6, wherein the one or more nitrite providing layers is positioned beneath the cover layer (para. 0064, where various locations for the nitric oxide delivery layers (including the source layer) are disclosed. The examiner notes that all of these locations would be beneath the cover layer).
Regarding claim 10, Dagger discloses the wound dressing apparatus of Claim 6, further comprising an acquisition distribution layer. Per para. 0064, the embodiment of figure 2c may comprise further structures adapted to “distribute or transmit negative pressure, store wound exudate and other fluids removed from the wound, and other functions”. Para. 0109 details that an acquisition distribution layer may be included in the device. Per the same citation, the acquisition distribution layer may be pressed to the activator (gel) and/or be cured into the activator layer. Therefore, as the embodiment of figure 2c may comprise structures to aid in functions such as distribution of pressure and/or fluid storage or more, and Dagger further discloses that acquisition distribution layers may be included in the dressings, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to include an acquisition distribution layer with the embodiment of figure 2c.
Regarding claim 11, Dagger discloses the wound dressing apparatus of Claim 10, wherein the acquisition distribution layer is a composite material comprising a gel material comprising acidic groups or moieties. The examiner notes that as detailed under the rejection of claim 11, the acquisition distribution layer may be made from various materials (interpreted to be a composite based on disclosure of para. 0109), and may be cured into the activator layer, where the activator layer at least includes a gel containing acidic groups or moieties, it is interpreted that the acquisition distribution layer, upon curing into the activator layer, includes a gel material.
Regarding claim 12, Dagger discloses the wound dressing apparatus of Claim 6, wherein the gel material adhered to the wound-facing surface of the absorbent layer is configured to provide acid to the one or more nitrite providing layers to release nitric oxide. (para. 0101). The examiner notes that the activator layer, per the rejection of claim 1, is interpreted to include the gel material adhered to the wound facing surface of the absorbent layer. Per para. 0101, the activator layer may “may include acidic groups or moieties” which “facilitate release of nitric oxide from the nitric oxide-releasing agent”.
Regarding claim 16, Dagger discloses the wound dressing apparatus of Claim 1, wherein the absorbent layer is perforated. As seen in figures 2C, absorbent layer comprises an opening (227) and is thus interpreted as perforated.
Regarding claim 17, Dagger discloses the wound dressing apparatus of Claim 1, wherein the gel material is at least partially saturated into the absorbent layer (para. 0044). The examiner notes that per para. 0044, Dagger discloses that the reactive compositions described in the specification (referring to the nitric oxide production) may be incorporated into any suitable absorbent layer. As such it is interpreted that the gel material (per para. 0099, where the nitric oxide source layer may be a gel) is at least partially saturated into the absorbent layer.
Regarding claim 19, Dagger discloses the wound dressing apparatus of Claim 1, wherein the cured pattern structure has a smaller outer perimeter than an outer perimeter of the absorbent layer. The examiner notes that per para. 0069, the “one or more nitric oxide generating layers may have same or substantially similar size and shape with the transmission layer 226 and/or the absorbent layer 221”. As detailed under para. 0043 “the one or more nitric oxide generating layers may have a perimeter shape that is smaller than a perimeter shape of the cover layer” and as seen in figure 5, the activator layer is suitably larger (12400) than the source layer (12600). Per MPEP Section 2144.04 IV A, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Therefore, as Dagger teaches that the size of the nitric oxide delivery layers is variable, where they may be a similar size to the absorbent layer, where the device is understood to function as intended with different sized delivery layers ( same size as and similar size to the absorbent are two different relative dimensions), it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the delivery layers of Dagger to be smaller than the outer perimeter of the absorbent.
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) 8-9,14,18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dagger.
Regarding claim 8, Dagger discloses the wound dressing apparatus of Claim 6, wherein the one or more nitrite providing layers is positioned beneath the gel material. The examiner notes that the activator layer was interpreted previously to at least incorporate “the gel material”. The examiner notes that the disclosure of para. 0069 details that any nitric oxide delivery layers as described in the specification may be suitable for inclusion in the embodiment of figure 2C. The examiner notes that figures 4-5 show a configuration of the nitric oxide delivery layers, include the activator layer (12400) and the source layer (12600), where it can be seen that the activator layer is above the source layer (see also para. 0101). As such it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to arrange the activator layer above the source layer, as Dagger teaches this configuration is suitable with the dressing of figure 2C. The examiner notes therefore that the nitric oxide providing layers are positioned beneath the gel material.
Regarding claim 9, Dagger discloses the wound dressing apparatus of Claim 6, wherein the one or more nitrite providing layers is positioned between the cover layer and the absorbent layer. The examiner notes that as detailed under the rejection of claim 1, para. 0065 details various suitable locations for the nitrite providing layers. However, between the cover an absorbent is not specifically disclosed. In another embodiment, seen in figure 3E, Dagger teaches that the dressing comprises a cover layer (501) and an absorbent layer (502) where the nitric oxide generating layers may be positioned at various locations within said dressing (para. 0089). One such location is below the cover layer. The examiner notes that therefore, as Dagger teaches that suitable location for the nitric oxide producing layers (including the providing layers) is below the cover layer, which would therefore be between the cover layer and absorbent layer, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the embodiment of figure 2C detailed under the rejection of claim 1, to place the nitrite providing layers between the cover layer and absorbent layer. Doing so would merely involve some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention and as such a prima facie case of obviousness exists.
Regarding claim 14, Dagger discloses the wound dressing apparatus of Claim 1, wherein the gel material is provided on a mesh. The examiner notes that per para. 0099, the nitric oxide source layer interpreted to be at least a part of the nitric oxide generating layers as previously described, may be a gel, mesh, or other suitable material. The activator layer, also interpreted to be part of the nitric oxide generating layers, may include a mesh, foam, gel, or any other suitable material as well (para. 0101). Per paragraph 0103, the activator layer may comprise a hydrogel that is poured into a foam and then cured in the foam. Thus the nitric oxide delivering layer may comprise a gel and a foam. Per para. 0101, both a mesh and a foam are suitable structures for the activator layer. Therefore as Dagger teaches that a construction of the activator layer may include a gel and a foam, where a foam and mesh are both suitable structures for the layer, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a gel cured into a mesh, as a mesh is a suitable structure along with a foam. Doing so would merely involve the simple substitution of one known element for another to obtain predictable results, that being creation of an activator layer, and thus a prima facie case of obviousness exists.
Regarding claim 18, Dagger discloses the wound dressing apparatus of Claim 16, wherein the perforated absorbent layer is saturated with the gel material and further comprising a second gel material adhered to the perforated absorbent layer. The examiner notes that as detailed under the rejection of claim 16, the nitric oxide source layer may be saturated into the absorbent. The examiner further notes that the nitric oxide activator layer may also comprise a gel (para. 0101, as detailed under the rejection of claim 1). Per paragraph 0105, the nitric oxide activator layer is placed in contact with the source layer to release nitric oxide. The examiner notes that as the source is at least partially saturated into the absorbent, placing the activator layer in contact with the source would be placing the activator in contact with the absorbent layer. The examiner notes that per para. 0109, the activator layer may be suitably made from a hydrogel adhesive. Therefore, as Dagger teaches that a hydrogel adhesive is a suitable construction for the activator layer, it would have been obvious to one having ordinary skill in the art to use such a material in the construction of Dagger. Doing so would merely involve the simple substitution of one known element for another to obtain predictable results, that being creation of an activator layer, and thus a prima facie case of obviousness exists. As such, the activator layer, interpreted to be a second gel layer in contact with the absorbent, is further interpreted to be adhered to the absorbent layer as said layer, per obviousness simple substitution, includes a hydrogel adhesive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781