DETAILED ACTION
This application is in response to the amendment filed November 6, 2025. Claims 79, 82-90, 92 and 94 have been amended, claims 91, 93 have been cancelled. Claims 75-90, 92 and 94 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 .
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) 82 and 94 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. WO 03/097727 (Sessions) in view of U.S. Patent No. 3,969,498 (Catania).
Regarding claim 82, Sessions discloses hydrophilic foam compositions having antimicrobial properties that anticipates Applicants’ presently claimed invention. More specifically, Sessions discloses a method of treating a wound comprising placing a wound dressing comprising a loaded wound dressing layer (hydrophilic foam, see para. [0002]) comprising a flexible porous hydrophilic polymer foam or fibre matrix (see para. [0014], lines 1-2 which discloses “[t]he present invention meets the foregoing and other needs by providing an open-celled, flexible polyurethane foam composition that is hydrophilic...”) comprising two matrix faces (a side facing the wound and its opposite side, see para. [0022]) and therebetween a structural matrix framework defining a network of cells, having a cell network surface and therein a network of pores (the foam has a thickness, see para. [0070] and pores constituted by open cells which extend throughout the foam, see para. [0061]) and a powder charge comprising antimicrobial additive and/or wound dressing additive (note the disclosure of the addition of a silver metal, in particulate form, desirably provided as a powder, see para. [0041]), wherein said powder charge is comprised at said matrix face or faces and/or within said cell network or within said structural matrix framework (“the silver substantially uniformly distributed throughout the final foam material’, thus, it is provided on the faces as well as throughout) and wherein said additive is micronized (as can be read from para. [0043], “the silver particles desirably range in size up to 15,000 nanometers” (15 microns), thus the particulates are micronized, i.e., made smaller into a powder); allowing wound exudate to contact the loaded wound dressing layer before releasing at least a portion of the antimicrobial agent toward the wound, wherein the antimicrobial agent is configured to diffuse into wound exudate upon contact with wound exudate (as can be read from para. [0022], “[w]hen applied to a wound, the foam composition of the present invention will absorb and retain a high volume of aqueous liquid, i.e., wound exudate, and will release any adjuvant present therein to the wound situs”), wherein the antimicrobial release additive is activated for the release of an antimicrobial agent into the wound from the wound dressing upon contact with moist or aqueous medium(see para. [0042] which recites “[f]urther, particulate silver provides an expansive surface area relative to a providing silver in the form of a layer resident on the outer surface of a dressing. This relatively expansive surface area is believed to be significant when one considers the absorption and release properties of the foam composition. More specifically, it is believed that the silver metal will provide antimicrobial properties upon ionization of the metal. A greater concentration of ionized silver should be made available when particulate silver is used, the latter providing a relatively greater surface area per unit weight from which ions may be generated relative to a surface layer of a silver-containing compound such as silver nitrate. In addition, it is believed that the optional incorporation of a releasably carried adjuvant may assist in the distribution of silver ions into the wound. In particular, it is contemplated that the adjuvant, as it is released over time, may assist in delivering the silver ions to the wound surface by carrying them out of the foam composition and into the exudate layer adjacent the wound surface, facilitating the antimicrobial characteristics of the foam composition”); wherein the silver is a silver salt, e.g., silver nitrate (see para. [0042]).
Regarding claim 94, modified Sessions discloses the method according to claim 82, wherein the antimicrobial release additive is selected from a group consisting of silver sulfadiazine, silver zeolite, silver sulfate, silver carbonate, silver chloride, silver nitrate, silver oxide, silver phosphate, silver citrate, silver acetate, silver lactate, cadexomer iodine and combinations thereof (note the rejection of claim 82 above which discloses the silver salt is silver nitrate).
Claim 86 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sessions in view of WO 02/094443 (“Ford”).
Regarding claim 86, Sessions discloses the method according to claim 82, except wherein the antimicrobial release additive is formed by dry micronization with use of milling media selected from gaseous milling media and particulate milling media.
However, Ford in the disclosure of an analogous milling process teaches it is known use a high pressure media mill which uses high pressurized gas such as carbon dioxide in order to form dry micron or nanosize particles, which offers significant advantages over existing micronization processes, such as dry micron and nanosize particles which are difficult or impossible to generate by micronization and other existing processes (see page 4, line 1-12).
Absent a critical teaching and/or a showing of unexpected results derived from forming the antimicrobial release agent by dry micronization, the Office contends that such method of forming does not patentably distinguish Applicant’s invention.
Therefore, in view of Ford, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have formed the antimicrobial release additive particles by dry micronization with the use of gaseous milling media because it offers significant advantages over existing micronization processes, such as dry micron and nanosize particles which are difficult or impossible to generate by micronization and other existing processes.
Claim(s) 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sessions.
Regarding claim 90, Sessions discloses the method according to claim 82, wherein the adjuvant and silver are released over time (see para. [0042]). Sessions discloses fails to disclose releasing said antimicrobial release agent in an amount up to 1.8 mg/cm2 per day.
However, it has been held that optimization of results-effective variables involves only routine skill in the art and is not inventive but rather is in fact obvious to one skilled the art, and Applicants are reminded that “[w]here 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) (see MPEP §2144.05).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective time of filing, to discover through routine experimentation, that the optimum rate of releasing the antimicrobial release agent is in an amount up to 1.8 mg/cm2 per day based on the specific function of the release silver ions.
Claim(s) 92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sessions in view Patent Application Publication No. 209/0270820 (Johnson”).
Regarding claim 92, Sessions discloses the method according to claim 82, except that the method further comprises: applying negative pressure to the wound dressing.
Johnson in its analogous disclosure of a method of treating a wound teaches it is known to apply negative pressure a wound dressing loaded with an antimicrobial agent in order to distribute reduced pressure to tissue to promote healing by promoting tissue growth (see the abstract, para. [0009], and claim 21).
In view of Johnson, it would have been obvious to one having ordinary skill in the art to have applied negative pressure to the wound dressing in order to distribute negative pressure to a wound to promote healing by promoting tissue growth.
Claim(s) 87-89 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sessions in view of U.S. Patent Application Publication No. 2017/0027168 (“Heath”).
Regarding claim 87, Sessions discloses the method according to claim 82, except wherein the powder charge of antimicrobial additive further comprises a flowing agent selected from a group consisting of stearate salt, clay, silica, charcoal, graphite and a combination thereof.
However, flowing agents which aid in the delivery of agents to a wound site are known. As such, it would have been obvious to one having ordinary skill in the art to have used a flowing agent of stearate salt, clay, silica, charcoal, graphite and a combination thereof with the delivery of the antimicrobial agent in order to prevent the antimicrobial agent from clumping.
Regarding claim 88, Sessions discloses the method according to claim 87, except wherein the powder charge of antimicrobial additive further comprises a bulking agent selected from a group consisting of PEG, PVP, sodium polyacrylate, cross linked carboxymethyl cellulose (CMC or other absorbent functionalized (by carboxylation or sulfonation) cellulose derivatives), cross linked polyethylene oxide and PVA copolymer.
However, it would have been obvious to one having ordinary skill in the art to have added a bulking agent selected elected from a group consisting of PEG, PVP, sodium polyacrylate, cross linked carboxymethyl cellulose (CMC or other absorbent functionalized (by carboxylation or sulfonation) cellulose derivatives), cross linked polyethylene oxide and PVA copolymer to the powder charge material for obvious purpose of absorbing wound exudate while delivering an antimicrobial material to the wound.
Regarding claim 89, modified Sessions discloses the method according to claim 88, except wherein the antimicrobial additive is co-located with said flowing agent and/or bulking agent. However, flowing agents which aid in the delivery of agents to a wound site are known. As such, it would have been obvious to one having ordinary skill in the art to have used a flowing agent to aid in the delivery of the antimicrobial agent in order to prevent the antimicrobial agent from clumping.
Allowable Subject Matter
Claims 75-81 are allowed.
Claims 83-85 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: the prior art fails to teach or suggest to one alone or in combination, a method for dosing powder charge to an isocyante comprising: providing one or more slurry phases or solid concentrates of an antimicrobial additive in at least a part of said isocyanate phase and/or at least a part of said aqueous phase and/or in an inert carrier liquid; intimately admixing said isocyanate phase and said aqueous phase with reaction and foaming thereof; wherein said method comprises prior to, simultaneously with or subsequent to said admixing, combining said one or more slurry phases or solid concentrates with said isocyanate phase and/or said aqueous phase and/or said admixed phases, as recited in claim 75.
The prior also fails to teach or fairly suggest to one or alone or in combination, a method for manufacture of hydrophilic material comprising providing a powder charge comprising micronized antimicrobial additive and/ or micronized wound dressing additive, wherein said powder charge comprises population of particles having particle size distribution centered about a single mean and/or additionally comprises a flowing agent and/or bulking agent and/or is comprised in a slurry phase or solid concentrate in isocyanate or aqueous fluid or carrier fluid, preferably wherein said additive has loss on drying (L.O.D) less than 2%; and dosing said powder charge to said matrix and optionally directing powder charge within said matrix or dosing said slurry phase or solid concentrate to said isocyanate phase or a part thereof and/or said aqueous phase or a part thereof and/or a carrier liquid phase and/or combining said phases, thereby loading said powder charge at said matrix face or faces and/or within said cell network, or within said structural matrix framework, as recited in claim 77.
Claims 76 and 78-81 are allowable by virtue of their dependence on an allowable claim.
With respect to claim 83, the prior art of record fails to teach or fairly suggest to one alone or in combination a wound dressing comprising a powder charge of micronized antimicrobial release additive, wherein the antimicrobial release additive comprises silver salt, and wherein the antimicrobial release additive has a particle size distribution of 1 micron<D50<30 micron.
With respect to claim 84, the prior art of record fails to teach or fairly suggest to one alone or in combination a wound dressing comprising a powder charge of micronized antimicrobial release additive, wherein the antimicrobial release additive comprises silver salt, and wherein the antimicrobial release additive has a particle size distribution of 1 micron<D50<10 micron.
With respect to claim 85, the prior art of record fails to teach or fairly suggest to one alone or in combination, the method according to claim 82, wherein the antimicrobial release additive has L.O.D. (Loss on Drying) <2wt%, wherein L.O.D. is established by drying a sample thereof during 4 hours in vacuum oven at 50°C or in non-vacuum oven at 105°C.