DETAILED ACTION
This is a Non-Final Rejection for Application 18/759,697 filed June 28, 2024. Claims 1-17 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 24, 2026 has been entered.
Response to Amendment
The examiner acknowledges the amendments to the claims. The amendments change the scope of the claims; therefore, new grounds of rejection are presented below.
Response to Arguments
Applicant's arguments filed June 24, 2026 have been fully considered but they are not persuasive.
Applicant argues that the individual references do not teach or suggest maintaining a localized quantity of free-flowing particulate powder within a structural recess and subsequently releasing that powder mass itself directly onto a wound surface via the explicit dissolution of an adjacent water-soluble membrane.
This argument is unpersuasive as while none of the individual references teach these limitations, the rejection is based on the combination of references. 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).
Applicant argues that converting the controlled-release matrices of Dizio or Mohanty into an open, powder-dropping cavity would entirely frustrate their intended purpose of providing slow, matrix-mediated diffusion.
This argument is unpersuasive as the main embodiment of Dizio relied upon in the rejection is the embodiment shown in Fig. 9 and described in [0115]. This embodiment does not have a controlled release mechanism, so the intended purpose is not slow, matrix-mediated diffusion. The proposed combination is to: modify the fibrinogen sheet 930 into a powder, which is supported in [0054] of Dizio, add a secondary layer 42 as taught by Brooke to retain a composition (Brooke Col. 6, Lns. 10-19), and to add an intermediate layer 40 as taught by Mohanty to dissolve upon contact with body fluid and release the active agent (Mohanty [0076]). A skilled artisan would have a reasonable expectation of success in combining these references given that all of the references are analogous and drawn to transdermal delivery systems. 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).
Applicant other arguments amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
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.
Claim(s) 1-3, 5-6, 9-17 is/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 the body surface. See [0054].), comprising:
a removable substrate comprising an adhesive on a first surface adapted to face the tissue (The carrier layer 960 is interpreted as a removable substrate that comprises pressure sensitive skin adhesive 920 on a first surface configured to face the tissue. See Fig. 9.);
a release film adapted to adhere to the first surface of the removable substrate (The removable release liner 910 is interpreted as a release film that is configured to adhere to the first surface of the carrier layer 960. 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, wherein the loop comprises a first top surface and a second bottom 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 continuously covers the first top surface of the loop and the powder composition, wherein the water-soluble membrane is adapted to adhere to the first surface of the removable substrate, wherein the removable substrate continuously covers the second bottom surface of the loop, 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 the release film adapted to cover the water-soluble membrane; wherein the loop, the water-soluble membrane, and the removable substrate form a sealed enclosure that completely surrounds the powder composition prior to removal of the release film, and wherein the powder composition is maintained as free-flowing granules within the recess prior to dissolution of the water-soluble membrane.
However, Dizio discloses that a dehydrated sheet of fibrinogen may be ground, pulverized, milled, crushed, granulated, pounded, and the like, to produce fibrinogen powder; [0054]. After granulating the fibrinogen sheet 930, the composition is interpreted as a powder composition that comprises free-flowing granules.
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 plurality of pieces ([0004]). This would increase the surface area of the fibrinogen composition which increases contact of the fibrinogen with wound exudate. 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, 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 having a thickness and defining a recess characterized by a depth, and is positioned centrally on the surface of the backing strip 41. The secondary layer 42 has a first top surface facing away from the backing strip 41 and a second bottom surface continuously covered by the backing strip 41.
Therefore, 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). This combination allows for the fibrinogen powder composition of Dizio to be positioned entirely within the recess of the secondary layer 42 of Brooke and for the powder composition to be maintained as free-flowing granules within the recess. 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, 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 that is adapted to adhere to the first surface of the adhesive layer 10 and it includes one or more biodegradable polymers to serve as an immediate release layer to dissolve upon contact with fluid at the tissue surface.
Therefore, 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]). This combination allows the intermediate layer 40 of Mohanty to continuously cover the secondary layer 42 and recess of Brooke thereby sealing the powder composition of Dizio within the recess. This combination further allows the intermediate layer 40 of Mohanty to release the powder composition of Dizio directly onto the tissue after removal of release liner 910 and dissolution of the intermediate layer 40. The secondary layer 42 of Brooke, intermediate layer 40 of Mohanty, and the carrier layer 960 of Dizio form a sealed enclosure that completely surrounds the powder composition prior to removal of the release liner 910 of Dizio, and the powder composition of Dizio is maintained within the recess of Brooke prior to dissolution of the intermediate layer 40 of Mohanty. A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to bandages comprising transdermal delivery systems.
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.
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 fibrinogen compositions can be cast into various shapes 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 and 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.
Regarding claim 14, Dizio in view of Brooke and Mohanty discloses the bandage of claim 1, wherein the free-flowing granules are of a size ranging 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 the 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 diameter 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 weight is proportional to the amount of the composition which can be modified by the volume.
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.
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].).
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.
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.
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.
Conclusion
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/SETH R. BROWN/Examiner, Art Unit 3786
/KERI J NELSON/Primary Examiner, Art Unit 3786
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