DETAILED ACTION
This is a Final Rejection for Application 18/759,697 filed June 28, 2024. Claims 1-21 are currently 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 .
Response to Amendment
The examiner acknowledges the amendments to the claim. The claim objection indicated in the Office action filed October 2, 2025 is overcome by the amendment and hereby withdrawn. The 35 USC § 112(b) rejection indicated in the Office action filed October 2, 2025 is overcome by the amendment and hereby withdrawn.
The amendments change the scope of the claims, therefore new grounds of rejection are presented below as necessitated by the amendments.
Response to Arguments
Applicant's arguments filed December 31, 2025 have been fully considered but they are not persuasive.
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).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Brooke discloses that the secondary layer 42 forms a retention cavity (Col. 6, Lns 10-19) which is beneficial in retaining compositions in bandages. Additionally, Mohanty discloses that the intermediate layer 40 controls the rate at which a tie release active agent layer is activated by dissolving upon contact with body fluid ([0076]) which is beneficial in prevent leakage of a composition prior to the intended deployment. Both of these motivations were provided in the previous Office action in the rejection of claim 1.
In response to applicant's argument that Dizio, Brooke, and Mohanty are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Dizio, Brooke, and Mohanty are not only all drawn to bandages but both Brooke and Mohanty provide features that are pertinent to issues Dizio may face with retention of the fibrinogen powder and a timed release of the powder.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Brooke is used in the rejection of claim 1 to teach a retention cavity and modifying the carrier layer 960 of Dizio to include a secondary layer of Brooke. Attacking features of Brooke that are not relevant to the structure and function of the secondary layer 42 does not show nonobviousness.
Mohanty is used in the rejection of claim 1 to teach an intermediate layer and modifying Dizio in view of Brooke to include an intermediate layer covering the secondary layer. Attacking features of Mohanty that are not relevant to the structure and function of the intermediate layer 40 does not show nonobviousness.
Brooke and Mohanty are not being relied upon to teach all of the limitations of claim 1 and are only being relied upon to teach that the features Dizio lacks are obvious in view of the prior art.
Applicant specifically argues that Brooke fails to describe a loop defined by a continuous wall as claimed by the Applicant, which could enclose, in a sealed state, a powder format composition for direct topical release on a wound surface.
This argument is unpersuasive as the secondary layer 42 of Brooke forms a loop defined by a continuous wall and defines a recess positioned centrally on the device. Additionally, Applicant has not provided any evidence that the secondary layer of Brooke would be incapable of retaining a powder; on the contrary, since the secondary layer can retain a liquid cannabis preparation, it is expected that a powder composition may be retained.
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.
Claims 1-3, 5-6 and 9-21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0038546 (Dizio et al.) in view of US 6,328,992 (Brooke et al.) and US 2021/0322229 (Mohanty et al.).
Regarding claim 1, Dizio discloses a bandage adapted to deliver a powder composition to tissue on a body surface (Dizio discloses a wound dressing comprising a carrier layer 960, a pressure sensitive skin adhesive 920, a fibrinogen sheet 930, and a removable release liner 910. See [0115] and Fig. 9. The wound dressing is interpreted as a bandage that is capable of delivering a powder composition to tissue on a body surface. See [0054].), comprising:
a removable substrate comprising an adhesive on a first surface adapted to face the tissue (Dizio discloses a carrier layer 960 and a pressure sensitive skin adhesive 920 on a first surface configured to face the tissue. See Fig. 9.); and
a release film adapted to adhere to the first surface of the removable substrate (Dizio discloses a removable release liner 910 that is configured to adhere to the first surface of the removable substrate. See Fig. 9.).
Dizio does not disclose a loop having a thickness and defining a recess characterized by a depth, wherein the loop forms a closed wall and is positioned centrally on the first surface, and wherein the recess is positioned on said first surface; the powder composition positioned entirely within the recess; a water-soluble membrane continuously covering the loop and the recess and sealing the powder composition within the recess, wherein the water-soluble membrane covers the loop and is adapted to adhere to the first surface of the removable substrate, and wherein the water-soluble membrane is adapted to dissolve upon contact with fluid at the tissue surface to release the powder composition directly onto the tissue; and a release film adapted to cover the water-soluble membrane and adapted to adhere to the first surface of the removable substrate.
However, Dizio discloses that the dehydrated denatured fibrinogen hydrogel composition can be in various physical forms such a sheet, foam, or plurality of pieces. See [0004].
Additionally, Brooke discloses a patch with a transdermal delivery system comprising a secondary layer 42 forming a retention cavity. See Figs. 4 and 5 and Col. 6, Lns. 10-19. The secondary layer 42 is interpreted as a loop and defines a recess positioned centrally on the device.
Finally, Mohanty discloses a wound dressing comprising an intermediate layer 40 covering a time release active agent delivery layer 20. See [0076] and Fig. 4. The intermediate layer 40 is interpreted as a water-soluble membrane as it includes one or more biodegradable polymers and serves as an immediate release layer upon contact with a body fluid.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the fibrinogen sheet 930 to instead be in the form of a powder as taught by Dizio. A skilled artisan would have been motivated to do so because Dizio teaches that fibrinogen composition can be in the form of a sheet, foam, or in a plurality of pieces ([0004]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to different embodiments of the same invention.
Additionally, it would have been obvious to an artisan of ordinary skill before the effective filing date to add the secondary layer 42 of Brooke to the carrier layer 960 of Dizio as taught by Brooke. A skilled artisan would have been motivated to do so because Brooke teaches that the secondary layer forms a retention cavity for retaining a composition (Col. 6, Lns. 10-19). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to bandages comprising transdermal delivery systems.
Finally, it would have been obvious to an artisan of ordinary skill before the effective filing date to add the intermediate layer 40 of Mohanty to cover the secondary layer 42 of Brooke which contains the fibrinogen powder of Dizio as taught by Mohanty. A skilled artisan would have been motivated to do so because Mohanty teaches that the intermediate layer controls the rate at which the time release active agent layer 20 is activated by dissolving upon contact with body fluid ([0076]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to bandages comprising transdermal delivery systems.
As a result of the combinations, Dizio in view of Brooke and Mohanty discloses a loop having a thickness and defining a recess characterized by a depth (In view of Brooke, the secondary layer 42 is interpreted as a loop and has a thickness and defines a recess characterized by a depth.),
wherein the loop forms a closed wall and is positioned centrally on the first surface (In view of Brooke, the secondary layer 42 forms a closed wall and is positioned centrally on the carrier layer 960 of Dizio.), and
wherein the recess is positioned on said first surface (In view of Brooke, the secondary layer 42 is positioned centrally on the carrier layer 960 of Dizio.);
the powder composition positioned entirely within in the recess (In view of Brooke, the powdered fibrinogen of Dizio is disposed entirely within the recess of the secondary layer 42 of Brooke.);
a water-soluble membrane continuously covering the loop and the recess and sealing the powder composition within the recess (In view of Mohanty, the intermediate layer 40 of Mohanty continuously covers the recess of the secondary layer 42 of Brooke disposed on the carrier layer 960 of Dizio and containing the fibrinogen powder of Dizio. The intermediate layer 40 is interpreted as a water-soluble membrane as it includes one or more biodegradable polymers and serves as an immediate release layer upon contact with a body fluid.),
wherein the water-soluble membrane covers the loop and is adapted to adhere to the first surface of the removable substrate (In view of Mohanty, the intermediate layer 40 of Mohanty covers the secondary layer 42 of Brooke and is adapted to adhere to the first surface of the carrier layer 960 of Dizio.); and
wherein the water-soluble membrane is adapted to dissolve upon contact with fluid at the tissue surface to release the powder composition directly onto the tissue (In view of Mohanty, the intermediate layer 40 is adapted to dissolve upon contact with fluid at the tissue surface to release the powder composition directly onto the tissue. [0074] of Mohanty); and
the release film adapted to cover the water-soluble membrane (In view of Mohanty, the removable release liner 910 is adapted to cover the intermediate layer 40 of Mohanty.).
Regarding claim 2, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1, wherein the water-soluble membrane is adapted to dissolve in less than 30 seconds after removing the release film and adhering the removable substrate to the tissue (In view of Mohanty, the intermediate layer 40 starts dissolving upon contact with body fluid and is adapted to dissolve in less than 30 seconds after removing the removable release liner 910 and adhering the carrier layer 960 to the tissue. Mohanty discloses that the dissolution rate of the biodegradable polymer of the intermediate layer 40 is 3 microns per minute, and the thickness is 0.5 microns, so the intermediate layer 40 completely dissolves in 10 seconds. See [0054]-[0058].).
Regarding claim 3, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1, wherein the water-soluble membrane is adapted to dissolve in less than 10 seconds when the water-soluble membrane is in contact with at least 0.05 milliliters of a fluid (In view of Mohanty, the intermediate layer 40 starts dissolving upon contact with body fluid and is adapted to dissolve in less than 10 seconds and with at least 0.05 milliliters of fluid. Mohanty discloses that the dissolution rate of the biodegradable polymer of the intermediate layer 40 is 3 microns per minute, and the thickness is 0.5 microns, so the intermediate layer 40 completely dissolves in 10 seconds with at least 0.05 milliliters of fluid. See [0054]-[0058]. A large amount of fluid would only serve to hasten the dissolution of the intermediate layer so the intermediate layer is adapted to dissolve in at least 0.05 milliliters.).
Regarding claim 5, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1, wherein the water-soluble membrane is at least one of non-allergic, non-irritating, or non-cytotoxic (In view of Mohanty, the biodegradable polymer of the intermediate layer 40 is pullulan, which is known in the art to be non-cytotoxic. See [0055]. Evidence of Pullulan being non-cytotoxic is found in [0030] of US 2014/0148515 (Gauthier et al.)).
Regarding claim 6, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1, wherein the water-soluble membrane has a thickness between 1 µm and 500 µm (In view of Mohanty, the intermediate layer 40 has a thickness between 1 µm and 500 µm. See [0058].).
Regarding claim 9, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1 wherein the adhesive is at a pressure sensitive adhesive or an acrylic based adhesive (Dizio discloses a carrier layer 960 and a pressure sensitive skin adhesive 920 on a first surface configured to face the tissue. See Fig. 9.).
Regarding claim 10, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1, wherein the removable substrate comprises at least one of polyethylene (PE), polyphenylene ether (PPE), polyvinyl chloride (PVC), cotton, non- woven fiber, synthetic fabric, an elastic fabric, a water-proof material, or a silicone gel material (Dizio discloses that the carrier layer 960 is made of a liquid impervious, moisture vapor permeable polymeric film. See [0116]. A liquid impervious material is interpreted as a water-proof material.).
Regarding claim 11, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1, wherein the loop is of a rectangular shape, a square shape, an oval shape, or a circular shape (In view of Brooke, the secondary layer 42 is a square shape with a circular recess. See Fig. 4 of Brooke.).
Dizio in view of Brooke and Mohanty does not disclose wherein the loop comprises at least one of a silicone gel, foam, or cotton.
Brooke is silent with regards to the material of the secondary layer 42, however Dizio discloses that the carrier layer 960 may comprise foams. See [0123] of Dizio. Since the secondary layer 42 is acting as a barrier to contain the fibrinogen powder, similar to the carrier layer, it would be reasonable for the secondary layer 42 and the carrier layer to be the same material.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the secondary layer 42 of Brooke to be made of foam as taught by Dizio. A skilled artisan would have been motivated to do so because Dizio teaches that the carrier layer 960 is made of foam and is performing a similar function of containing the fibrinogen powder ([0123]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to bandages comprising transdermal delivery systems.
As a result of the modification, Dizio in view of Brooke and Mohanty discloses wherein the loop comprises at least one of a silicone gel, foam, or cotton (The secondary layer 42 of Brooke is made of foam in view of Dizio.).
Regarding claim 12, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1 wherein a first portion of the first surface comprising the adhesive does not overlap with a second portion of the first surface comprising the loop (Dizio in view of Brooke discloses that the portion of the carrier layer 960 with the adhesive 920 does not overlap with the of the carrier layer 960 with the secondary layer 42 of Brooke. This is because the adhesive 920 is disposed at peripheral regions of the carrier layer 960. See [0115] and Fig. 9.).
Regarding claim 13, Dizio in view of Brooke and Mohanty discloses the bandage of claim 12.
Dizio in view of Brooke and Mohanty does not directly disclose wherein the second portion ranges from 10% to 70% of the first surface.
However, Dizio discloses that the fibrinogen compositions can be cast into various shaped and sizes.
Additionally, Brooke discloses that the diameter of the opening in the secondary layer 42 determines the maximum volume of the preparation.
It would have been an obvious matter of design choice for the secondary layer 42 its recess to range from 10% to 70% of the surface of the carrier layer 960, since such a modification would have involved a mere change in size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Additionally, while Dizio does not directly disclose this feature, it appears that in Fig. 9, the non-adhesive portion comprises roughly half of the surface of the carrier layer 960.
As a result of the modification, Dizio in view of Brooke and Mohanty discloses wherein the second portion ranges from 10% to 70% of the first surface (The size of the secondary layers 42 and the recess within ranges from 10% to 70% of the first surface of the carrier layer 960.).
Regarding claim 14, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1, wherein the powder composition comprises granules of a size from 0.5 micron to 5 millimeters (Dizio discloses that the diameters of the particles in the fibrinogen composition are 85-180 microns. See [0055]. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05. Therefore, it would be obvious for the diameters of particles of the fibrinogen compositions to be from 0.5 micron to 5 millimeters.), and
wherein the powder composition has a moisture content between 1% and 20% (Dizio discloses that the water content of the fibrinogen composition is between 1% and 19%. See [0040]. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05. Therefore, it would be obvious for the moisture content of the fibrinogen composition to be between 1% and 20%.).
Regarding claim 15, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1.
Dizio in view of Brooke and Mohanty does not disclose wherein an amount of the powder composition positioned in the recess is between 50 milligrams (mg) and 3000 mg.
However, Dizio discloses an example where 5.1 grams of fibrinogen powder are dissolved in deionized water.
Additionally, Brooke discloses that modifying the of the secondary layer 42 determines the maximum volume of the composition able to be put into the recess. See Col. 6, Lns. 10-19. The volume is proportional to the weight of the composition.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to add between 50 mg and 3000 mg of fibrinogen powder to the recess, since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It is generally known in the art that the amount of a composition loaded into a device can be modified and Dizio discloses an amount close in scale to the claimed range. Additionally, it is generally known in the art that the size of a recess can be modified which would lead to reduced loads.
As a result of the modification, Dizio in view of Brooke and Mohanty discloses wherein an amount of the powder composition positioned in the recess is between 50 milligrams (mg) and 3000 mg (The amount of fibrinogen powder loaded into the recess of the secondary layer 42 of Brooke is between 50 mg and 3000 mg.).
Regarding claim 16, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1, wherein the powder composition comprises at least one of an anti- infective powder, an anti-fungal powder, an anesthetic powder, an analgesic powder, an anti-allergic powder, or a hemostat powder (Fibrinogen powder is known in the art to have hemostatic properties and is considered a hemostat powder by the examiner.).
Regarding claim 17, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1, wherein the release film comprises at least one of polyethylene (PE), polyester (PET), polypropylene (PP), polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), wood pulp paper, synthetic paper, or glass fiber paper (Dizio discloses that the release liner 910 is made of polyethylene. See [0108].).
Regarding claim 18, Dizio discloses a delivery system for delivery of materials to a tissue surface (Dizio discloses a wound dressing comprising a carrier layer 960, a pressure sensitive skin adhesive 920, a fibrinogen sheet 930, and a removable release liner 910. See [0115] and Fig. 9. The wound dressing is interpreted as a delivery system that is capable of delivering a powder composition to tissue on a body surface. See [0054].), comprising:
a first material continuously covering the first top surface (Dizio discloses a carrier layer 960 and a pressure sensitive skin adhesive 920 on a first surface configured to face the tissue. See Fig. 9.);
a release film (Dizio discloses a removable release liner 910 that is configured to adhere to the first surface of the removable substrate. See Fig. 9.).
Dizio does not directly disclose a loop defining a closed wall, wherein the loop has a first top surface and a second bottom surface; wherein the loop is positioned centrally on the first material; a second material continuously covering the second bottom surface, wherein the loop, the first material and the second material form an enclosure positioned centrally on the first material, and wherein the second material is a water-soluble membrane; a powder composition positioned entirely within the enclosure, wherein the second material seals the powder composition within the enclosure; and a release film adapted to cover the second material, wherein the release film is configured to be removed to place the second material in contact with a wound on the tissue surface and wherein the water-soluble membrane is adapted to dissolve upon contact with fluid at the tissue surface in order to deliver the powder composition from the enclosure to the wound.
However, Dizio discloses that the dehydrated denatured fibrinogen hydrogel composition can be in various physical forms such a sheet, foam, or plurality of pieces. See [0004].
Additionally, Brooke discloses a patch with a transdermal delivery system comprising a secondary layer 42 forming a retention cavity. See Figs. 4 and 5 and Col. 6, Lns. 10-19. The secondary layer 42 is interpreted as a loop and defines a recess positioned centrally on the device.
Finally, Mohanty discloses a wound dressing comprising an intermediate layer 40 covering a time release active agent delivery layer 20. See [0076] and Fig. 4. The intermediate layer 40 is interpreted as a water-soluble membrane as includes one or more biodegradable polymers and serves as an immediate release layer upon contact with a body fluid.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the fibrinogen sheet 930 to instead be in the form of a powder as taught by Dizio. A skilled artisan would have been motivated to do so because Dizio teaches that fibrinogen composition can be in the form of a sheet, foam, or in a plurality of pieces ([0004]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to different embodiments of the same invention.
Additionally, it would have been obvious to an artisan of ordinary skill before the effective filing date to add the secondary layer 42 of Brooke to the carrier layer 960 of Dizio as taught by Brooke. A skilled artisan would have been motivated to do so because Brooke teaches that the secondary layer forms a retention cavity for retaining a composition (Col. 6, Lns. 10-19). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to bandages comprising transdermal delivery systems.
Finally, it would have been obvious to an artisan of ordinary skill before the effective filing date to add the intermediate layer 40 of Mohanty to cover the secondary layer 42 of Brooke which contains the fibrinogen powder of Dizio as taught by Mohanty. A skilled artisan would have been motivated to do so because Mohanty teaches that the intermediate layer controls the rate at which the time release active agent layer 20 is activated by dissolving upon contact with body fluid ([0076]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to bandages comprising transdermal delivery systems.
As a result of the combinations, Dizio in view of Brooke and Mohanty discloses a loop defining a closed wall (In view of Brooke, the secondary layer 42 is interpreted as a loop defining a closed wall.),
wherein the loop has a first top surface and a second bottom surface (In view of Brooke, the secondary layer 42 has a first top surface and a second bottom surface, since it is a three-dimensional object. );
wherein the loop is positioned centrally on the first material (In view of Brooke, the secondary layer 42 forms a closed wall and is positioned centrally on the carrier layer 960 of Dizio.);
a second material continuously covering the second bottom surface (In view of Mohanty, the intermediate layer 40 is interpreted as a second material covering the second bottom surface of the secondary layer 42 of Brooke.),
wherein the loop, the first material and the second material form an enclosure positioned centrally on the first material (The secondary layer 42, the carrier layer 960, and the intermediate layer 40 form an enclosure positioned centrally on the first material.), and
wherein the second material is a water-soluble membrane (The intermediate layer 40 is interpreted as a water-soluble membrane as includes one or more biodegradable polymers and serves as an immediate release layer upon contact with a body fluid.);
a powder composition positioned entirely within the enclosure (The fibrinogen powder of Dizio is positioned entirely within the enclosure.); and
wherein the second material seals the powder composition within the enclosure (The intermediate layer 40 is interpreted as a water-soluble membrane and seals the fibrinogen powder entirely within the enclosure.);
the release film adapted to cover the second material (The removable release liner 910 is adapted to cover the intermediate layer 40 of Mohanty.),
wherein the release film is configured to be removed to place the second material in contact with a wound on the tissue surface and wherein the water-soluble membrane is adapted to dissolve upon contact with fluid at the tissue surface in order to deliver the powder composition from the enclosure to the wound (The removable release liner 910 is configured to be removed to place the second material in contact with a wound on the tissue surface and the intermediate layer 40 is adapted to dissolve in order to deliver the fibrinogen powder composition from the enclosure to the wound.).
Regarding claim 19, Dizio in view of Brooke and Mohanty discloses the delivery system of claim 18.
Dizio in view of Brooke and Mohanty does not disclose wherein the enclosure has a depth ranging from 0.1mm to 20mm.
However, Dizio discloses that the fibrinogen sheets can have a thickness of 10 microns to 2 mm. See [0103].
Additionally, Brooke discloses that the thickness of the secondary layer determines the volume of the composition contained. See Col. 6, Lns. 10-19.
Therefore, it would have been an obvious matter of design choice when combining the secondary layer 42 of Brooke with the device of Dizio for the secondary bandage to be 10 microns to 2 mm thick, since such a modification would have involved a mere change in size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955).
Additionally, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the secondary layer 42 of Brooke to be 0.1 mm to 20 mm thick, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.
As a result of the modification, Dizio in view of Brooke and Mohanty discloses wherein the enclosure has a depth ranging from 0.1mm to 20mm (The secondary layer 42 of Brooke is 0.1 mm to 20 mm thick, which makes the enclosure have a depth of the same value.).
Regarding claim 20, Dizio in view of Brooke and Mohanty discloses the delivery system of claim 18, wherein the first material comprises one or more of silicone gel, polyurethane (PU), polyethylene (PE), polyphenylene ether (PPE), polyvinyl chloride (PVC), cotton, non-woven fiber, synthetic fiber, elastic fabric, a waterproof material, or an elastic material (Dizio discloses that the carrier layer 960 is made of a liquid impervious, moisture vapor permeable polymeric film. See [0116]. A liquid impervious material is interpreted as a water-proof material.).
Dizio in view of Brooke and Mohanty does not disclose wherein the first material has a thickness ranging from 0.15 mm to 0.3 mm.
However, Dizio discloses that the carrier layer 960 has a thickness between 10 microns and 250 microns. [0118].
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the thickness of the carrier layer 960 to be from 0.15 mm to 0.3 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.
As a result of the modification, Dizio in view of Brooke and Mohanty discloses wherein the first material has a thickness ranging from 0.15 mm to 0.3 mm (The thickness of the carrier layer 960 ranges from 0.15 mm to 0.3 mm.).
Regarding claim 21, Dizio in view of Brooke and Mohanty discloses the delivery system of claim 18, wherein the loop is at least one of a circular shape, an oval shape, a rectangular shape, a square shape or a circular ring with an inner diameter of 25mm (In view of Brooke, the secondary layer 42 is a square shape with a circular recess. See Fig. 4 of Brooke.).
Dizio in view of Brooke and Mohanty does not disclose wherein the loop is formed by one or more of a silicone gel, a foam, or cotton.
Brooke is silent with regards to the material of the secondary layer 42, however Dizio discloses that the carrier layer 960 may comprise foams. See [0123] of Dizio. Since the secondary layer 42 is acting as a barrier to contain the fibrinogen powder, similar to the carrier layer, it would be reasonable for the secondary layer 42 and the carrier layer to be the same material.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the secondary layer 42 of Brooke to be made of foam as taught by Dizio. A skilled artisan would have been motivated to do so because Dizio teaches that the carrier layer 960 is made of foam and is performing a similar function of containing the fibrinogen powder ([0123]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to bandages comprising transdermal delivery systems.
As a result of the modification, Dizio in view of Brooke and Mohanty discloses wherein the loop is formed by one or more of a silicone gel, a foam, or cotton (The secondary layer 42 of Brooke is made of foam in view of Dizio.).
Claims 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0038546 (Dizio et al.) in view of US 6,328,992 (Brooke et al.) and US 2021/0322229 (Mohanty et al.), and further in view of US 3,784,390 (Hijiya et al.).
Regarding claim 4, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1.
Dizio in view of Brooke and Mohanty does not disclose wherein the water-soluble membrane has a tensile strength of at least 1N/15mm.
However, Hijiya discloses films and sheets of pullulan with a tensile strength of 7-8 kg/mm2 and a folding endurance of 800-900 cycles. See Col. 3, Lns. 13-24. a tensile strength of 7 kilograms-force per square millimeter is about 69 N/mm2.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the tensile strength of the intermediate layer 40 of Mohanty to be at least 1N/15mm2 as taught by Hijiya. A skilled artisan would have been motivated to do so because Hijiya teaches that pullulan has valuable properties in the use of films (Col. 1, Lns. 15-28). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to Pullulan films.
As a result of the modification, Dizio in view of Brooke, Mohanty and Hijiya discloses wherein the water-soluble membrane has a tensile strength of at least 1N/15mm2 (In view of Hijiya, the pullulan intermediate layer 40 of Mohanty has a tensile strength of 69 N/mm2.).
Regarding claim 8, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1.
Dizio in view of Brooke and Mohanty does not disclose wherein the water-soluble membrane has a folding endurance between 10 and 1000.
However, Hijiya discloses films and sheets of pullulan with a tensile strength of 7-8 kg/mm2 and a folding endurance of 800-900 cycles. See Col. 3, Lns. 13-24.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention for the intermediate layer 40 of Mohanty to have a folding endurance between 10 and 1000, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the folding endurance of the intermediate layer 40 of Mohanty to be between 10 and 1000 as taught by Hijiya. A skilled artisan would have been motivated to do so because Hijiya teaches that pullulan has valuable properties in the use of films (Col. 1, Lns. 15-28). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to Pullulan films.
As a result of the modification, Dizio in view of Brooke, Mohanty and Hijiya discloses wherein the water-soluble membrane has a folding endurance between 10 and 1000 (In view of Hijiya, the folding endurance of the pullulan intermediate layer 40 of Mohanty is between 10 and 1000.).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0038546 (Dizio et al.) in view of US 6,328,992 (Brooke et al.) and US 2021/0322229 (Mohanty et al.), and further in view of US 2009/0010998 (Marchitto et al.).
Regarding claim 7, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1.
Dizio in view of Brooke and Mohanty does not disclose wherein the water-soluble membrane comprises at least one of potato starch, modified starch, hydroxyethyl starch, carboxymethyl cellulose, or microcrystalline cellulose.
However, Marchitto discloses a drug-delivery patch comprising a dissolvable layer and wherein the dissolvable layer comprises modified starches.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to use a modified starch in the intermediate layer 40 of Mohanty as taught by Marchitto. A skilled artisan would have been motivated to do so because Marchitto teaches that modified starches are a preferred water soluble natural polysaccharide for use in a dissolving film ([0055]). Marchitto also discloses that pullulan is an alternative which is the same material used by Mohanty. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to dissolvable films comprising water soluble polysaccharides.
As a result of the modification, Dizio in view of Brooke, Mohanty and Marchitto discloses wherein the water-soluble membrane comprises at least one of potato starch, modified starch, hydroxyethyl starch, carboxymethyl cellulose, or microcrystalline cellulose (The intermediate layer 40 of Mohanty covering the fibrinogen powder of Dizio is made of modified starch.).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Seth Brown whose telephone number is (571)272-5642. The examiner can normally be reached 8:00 AM – 11:00 AM or 1:00 PM – 3:00 PM ET.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Rachael Bredefeld can be reached at (571)270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786