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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 26, 2025 has been entered.
Claims 1-22, 24 and 26-32 are pending in the application. Claims 1 and 24 have been amended. Claims 7-16 and 18-22 are withdrawn. Claims 31 and 32 are newly added. Claims 1-6, 17, 24, and 26-32 will be examined.
Status of the Claims
The rejection of claims 1-6, 17, 24, and 28-30 under 35 U.S.C. 103 as being unpatentable over Dustin et al. (US 2019/0048223) in view of the Nagoba Publication (2013, Journal of Infection and Public Health, Nagoba et al.) is maintained.
The objection of claims 26 and 27 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 is maintained.
The following rejections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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.
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.
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.
Claims 1-6, 17, 24, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Dustin et al. (US 2019/0048223) in view of the Nagoba Publication (2013, Journal of Infection and Public Health, Nagoba et al.).
Applicant’s Invention
Applicant claims an antimicrobial structure comprising: (a) a discrete solid structural phase comprising a solid structural polymer, wherein said solid polymer is characterized by a glass-transition temperature from about 25°C to about 300°C; (b) a continuous transport phase that is interspersed within said discrete solid structural phase, wherein said continuous transport phase comprises a solid transport material; and (c) an antimicrobial agent contained within said continuous transport phase, wherein said antimicrobial agent is at least partially dissolved in a fluid, wherein said fluid is distinct from said antimicrobial agent and wherein said fluid is contained within said continuous transport phase, wherein said discrete solid structural phase and said continuous transport phase are separated by an average phase-separation length selected from about 100 nanometers to about 500 microns, and wherein said antimicrobial structure is characterized in that said antimicrobial agent has a diffusion coefficient from about 10-18 m2/s to about 10-9 m2/s, measured at 25˚C and 1 bar, within said continuous transport phase. Applicant claims the antimicrobial agent is selected from acids and wherein the said acids are selected from the group consisting of citric acid…hydrochloric acid and combinations thereof.
Determination of the scope of the content of the prior art
(MPEP 2141.01)
Regarding claim 1, Dustin et al. teach a multiphase polymer composition comprising a first polymer material and a second polymer material that are chemically distinct, wherein the first polymer material and said second polymer material are microphase-separated on a microphase separation length scale from about 0.1 microns to about 500 microns, wherein said multiphase polymer composition comprises first solid functional particles selective dispersed within said first polymer material, and wherein said first solid functional particles are chemically distinct from said first polymer material and said second polymer material (Abstract, page 19, claim 1). Dustin et al. teach the first solid functional particles include oxidizing agents, reducing agents, or combinations thereof (page 2, paragraphs 17-18). Dustin et al. teach that second solid functional particles may be dissolved in water or an aqueous solvent (page 8, paragraph 113). Dustin et al. teach the mass transport of first solid functional particles may be aided by a fluid (page 7, paragraph 104). Dustin et al. teach that in some embodiments the first polymer material is in liquid or dissolved form while the second polymer material is in dissolved-solid or suspended-solid form (page 14, paragraph 199).
Regarding claims 2 and 3, Dustin et al. teach phase inhomogeneity typically causes opaque coatings due to the scattering of light. Scattering of light including visible wavelengths in the bulk of a material is governed by changes in the index of refraction through the medium. The coating may be characterized by a coating transparency of less than 70% average light transmission in the wavelength range of 400 nm to 700 nm, through a 1-millimeter-thick coating sample (defined test depth) (page 11, paragraph 159).
Regarding claim 4, Dustin et al. teach combining the first polymer material, the second polymer material, and the reactive species to covalently bond the first polymer material with the second polymer material, thereby generating a multiphase polymer composition (page 3, paragraph 51).
Regarding claims 5 and 6, Dustin et al. teach the first polymer material and the second polymer material are independently selected from the group consisting of polyesters, polyethers, and polyacrylates (page 2, paragraphs 22-24; page 8, paragraph 119-121).
Regarding claim 24, Dustin et al. teach a solvent or carrier fluid is present in the fluid precursor material, the solvent or carrier fluid may include one or more compounds selected from the group consisting of water and alcohols (such as methanol, ethanol, isopropanol, or tert-butanol), and acids (such as organic acids) (page 14, paragraph 204).
Regarding claim 28, Dustin et al. teach the multiphase polymer composition may further include one or more additional components selected from the group consisting of a particulate filler, a pigment, a dye, a plasticizer, a flame retardant, and combinations thereof (page 3, paragraph 38), UV absorber, a defoamer, a viscosity modifier, a scavenger (page 11, paragraph 156).
Dustin et al. teach one of the first polymer material or the second polymer material is a continuous matrix, and the other of the first polymer material or the second polymer material is a plurality of inclusions, dispersed within the continuous matrix. Either the continuous matrix or the inclusions may be the first polymer material containing the first solid functional particles, and the continuous matrix or inclusions that do not contain the first solid functional particles optionally contain second solid functional particles (page 8, paragraph 126).
Regarding claim 29, Dustin et al. teach the material is a coating and/or is present at a surface of an object or region (page 11, paragraph 161).
Regarding claim 30, Dustin et al. teach the material could be present within a bulk region of an object or part (page 11, paragraph 161).
Dustin et al. teach a corrosion inhibitor may be introduced into one phase of a multiphase polymer composition; wherein exemplary corrosion inhibitors include benzalkonium chloride (page 12, paragraph 167-169).
Dustin et al. teach a set of corrosion inhibitors include ammonium hexafluorotitanate (AHFT) and boric acid (BA) (page 18, paragraph 256).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Dustin et al. do not specifically disclose the optical transparency is about 80% or greater or 90% or greater, as claimed in claims 2 and 3; the antimicrobial agent is selected from the acids selected from the group consisting of citric acid, acetic acid…hydrochloric acid, and combinations thereof, as claimed in claim 17, or the antimicrobial structure is characterized in that said antimicrobial agent has a diffusion coefficient from about 10-18 m2/s to about 10-9 m2/s, measured at 25°C and 1 bar, within said continuous transport phase, as claimed in claim 25. It is for this reason the Nagoba Publication is added as a secondary reference.
Nagoba et al. teach the topical use of various organic acids such as boric acid, ascorbic acid, citric acid, and acetic acid for elimination of P. aeruginosa from skin and soft tissue infections and from burn infections has been reported by various workers (page 412, col. 2, Acetic acid treatment, paragraph 1).
Finding a Prima Facie Obviousness Rationale and Motivation
(MPEP 2142-2143)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to use the teachings of Dustin et al. and the optical transparency of about 80% or greater, wherein the optical transparency is averaged across light wavelengths from 400 nm to 800 nm, through a 100-micron film of said antimicrobial structure at 25°C and 1 bar, as claimed in claim 2 or the transparency of 90% or greater, as claimed in claim 3. Dustin et al. teach a multiphase polymer composition comprising a first polymer material and a second polymer material that are chemically distinct, wherein the first polymer material and said second polymer material are microphase-separated on a microphase separation length scale from about 0.1 microns to about 500 microns, wherein said multiphase polymer composition comprises first solid functional particles selective dispersed within said first polymer material, and wherein said first solid functional particles are chemically distinct from said first polymer material and said second polymer material. Dustin et al. teach that corrosion inhibitors, such as benzalkonium chloride and boric acid are incorporated in the multiphase polymer composition. As exhibited in example 9, wherein boric acid is used in the example of preparing the multiphase polymer composition. It is known in the art that benzalkonium and boric acid are antimicrobial agents. Dustin et al. also teach a composition comprising PEG and polyurethane and benzalkonium chloride. Since the polymers and antimicrobial agents are the same as those instantly claimed, the antimicrobial structure would have the same properties, the same optical transparency of 80% or 90% or greater as claimed, without evidence to the contrary.
Likewise, regarding optical transparency, Dustin et al. teach the coating may be characterized by a coating transparency of less than 70% average light transmission in the wavelength range of 400 nm to 700 nm, through a 1-millimeter-thick coating sample. As such, one of ordinary skill in the art would have been motivated to use teachings of the prior art, experimentation and optimization to determine the optical transparency of the antimicrobial structure. The adjustment of particular conventional working conditions is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Regarding the claim limitation of the antimicrobial structure is characterized in that said antimicrobial agent has a diffusion coefficient from about 10-18 m2/s to about 10-9 m2/s, measured at 25°C and 1 bar, within said continuous transport phase, as claimed in claim 25, Dustin et al. teach a multiphase polymer composition comprising a first polymer material and a second polymer material that are chemically distinct, wherein the first polymer material and said second polymer material are microphase-separated on a microphase separation length scale from about 0.1 microns to about 500 microns, wherein said multiphase polymer composition comprises first solid functional particles selective dispersed within said first polymer material, and wherein said first solid functional particles are chemically distinct from said first polymer material and said second polymer material. Dustin et al. teach that corrosion inhibitors, such as benzalkonium chloride and boric acid are incorporated in the multiphase polymer composition. As exhibited in example 9, wherein boric acid is used in the example of preparing the multiphase polymer composition. It is known in the art that benzalkonium and boric acid are antimicrobial agents. Dustin et al. also teach compositions comprising PEG and polyurethane and benzalkonium chloride. Since the polymers and antimicrobial agents are the same as instantly claimed, the antimicrobial agent would have the same properties of the currently claimed invention would have the same diffusion coefficient, as claimed, without evidence to the contrary.
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to combine the teachings of Dustin et al. and Nagoba et al. and use citric acid or acetic acid as the antimicrobial agent. Dustin et al. teach a multiphase polymer composition comprising a first polymer material and a second polymer material that are chemically distinct, wherein the first polymer material and said second polymer material are microphase-separated on a microphase separation length scale from about 0.1 microns to about 500 microns, wherein said multiphase polymer composition comprises first solid functional particles selective dispersed within said first polymer material, and wherein said first solid functional particles are chemically distinct from said first polymer material and said second polymer material. Dustin et al. teach that corrosion inhibitors, such as benzalkonium chloride and boric acid are incorporated in the multiphase polymer composition. As exhibited in example 9, wherein boric acid is used in the example of preparing the multiphase polymer composition. It is known in the art that benzalkonium and boric acid are antimicrobial agents. It would have been obvious to one of ordinary skill in the art to substitute any of the claimed acids. Nagoba et al. teach various organic acids such as boric acid, ascorbic acid, citric acid, and acetic acid for elimination of P. aeruginosa from skin and soft tissue infections and from burn infections has been reported by various workers. Therefore, it would have been prima facie obvious to substitute one acid such as boric acid for another acid such as citric acid or acetic acid since the prior art establishes boric acid, citric acid and acetic acid are all functional equivalent antimicrobial agents.
Therefore, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant's arguments filed November 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the limitation of “wherein said antimicrobial agent is at least partially dissolved in a fluid” does not seem to be addressed in the Office Action. In response to Applicant’s argument, Dustin et al. teach the first solid functional particles include oxidizing agents, reducing agents, or combinations thereof. Dustin et al. teach that second solid functional particles may be dissolved in water or an aqueous solvent. Dustin et al. teach the mass transport of first solid functional particles may be aided by a fluid. Dustin et al. teach that in some embodiments the first polymer material is in liquid or dissolved form while the second polymer material is in dissolved-solid or suspended-solid form. Based on these teachings one of ordinary skill in the art would have found it obvious that these teachings of Dustin et al. teach that the antimicrobial agents, the functional particles, are at least partially dissolved in fluid.
Applicant argues that Dustin’s disclosure of corrosion inhibitor has nothing to do with the solvent or carrier fluid discussed by Dustin et al. Applicant also argues that Dustin et al. fail to teach the solvent or carrier fluid can be an effective fluid for at least partially dissolving the corrosion inhibitor. In response to Applicant’s argument, as indicated hereinabove, Dustin et al. teach that second solid functional particles, corrosive inhibitors, may be dissolved in water or an aqueous solvent. Water and the aqueous solvents are fluid. The limitation of “at least partially dissolved” indicates that the antimicrobial agents, corrosive inhibitors, can also be fully dissolved in water and aqueous solvents.
Applicant argues that Dustin fails to teach or suggest that the “antimicrobial structure is characterized in that said antimicrobial agent has a diffusion coefficient from about 10-18 m2/s to about 10-9 m2/s, measured at 25°C and 1 bar”. In response to Applicant’s argument, Dustin et al. teach a multiphase polymer composition comprising a first polymer material and a second polymer material that are chemically distinct, wherein the first polymer material and said second polymer material are microphase-separated on a microphase separation length scale from about 0.1 microns to about 500 microns, wherein said multiphase polymer composition comprises first solid functional particles selective dispersed within said first polymer material, and wherein said first solid functional particles are chemically distinct from said first polymer material and said second polymer material. Dustin et al. teach that corrosion inhibitors, such as benzalkonium chloride and boric acid, are incorporated in the multiphase polymer composition. As exhibited in example 9, wherein boric acid is used in the example of preparing the multiphase polymer composition. It is known in the art that benzalkonium and boric acid are antimicrobial agents. Dustin et al. also teach compositions comprising PEG and polyurethane and benzalkonium chloride. While classified as a corrosive inhibitor, benzalkonium chloride is a known antimicrobial, a quaternary ammonium molecule. As such, following the prior art teaching that if the same polymers and antimicrobial agents are taught in the prior art, one that is contained in a continuous transport phase, the skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, i.e., same diffusion coefficient, without evidence to the contrary.
Applicant argues that Dustin does not actually teach antimicrobial agents, but rather corrosion inhibitors. In response to Applicant’s argument, Dustin et al. teach a multiphase polymer composition comprising a first polymer material and a second polymer material that are chemically distinct, wherein the first polymer material and said second polymer material are microphase-separated on a microphase separation length scale from about 0.1 microns to about 500 microns, wherein said multiphase polymer composition comprises first solid functional particles selective dispersed within said first polymer material, and wherein said first solid functional particles are chemically distinct from said first polymer material and said second polymer material. Dustin et al. teach that corrosion inhibitors, such as benzalkonium chloride and boric acid, are incorporated in the multiphase polymer composition. As exhibited in example 9, wherein boric acid is used in the example of preparing the multiphase polymer composition. It is known in the art that benzalkonium and boric acid are antimicrobial agents. It would have been obvious to one of ordinary skill in the art to substitute any of the claimed acids. Nagoba et al. teach various organic acids such as boric acid, ascorbic acid, citric acid, and acetic acid for elimination of P. aeruginosa from skin and soft tissue infections and from burn infections has been reported by various workers. Therefore, it would have been prima facie obvious to substitute one acid such as boric acid for another acid such as citric acid or acetic acid since the prior art establishes boric acid, citric acid and acetic acid are all functional equivalent antimicrobial agents. Also, as indicated herein above, it is known in the art that benzalkonium and boric acid are antimicrobial agents. Dustin et al. also teach compositions comprising PEG and polyurethane and benzalkonium chloride. While classified as an anti-corrosive, benzalkonium chloride is an antimicrobial, quaternary ammonium molecule.
Allowable Subject Matter
Claims 26 and 27 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. Dustin et al. does not teach or provide a motivation to embed electrodes within the antimicrobial structure and the antimicrobial agent is electrically or electrochemically rechargeable.
Claim Rejections - 35 USC § 102
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.
Claim 31 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rubinsky Publication (2016, Biomed Microdevices, Rubinsky et al.).
Rubinsky et al. disclose a new wound dressing technology that can actively generate an inorganic germicide agent. The identity of the germicide is hypochlorous acid (HClO). The effectiveness of the Active HClO pad concept is demonstrated in a study on sterilization of E. coli in a deep wound contamination simulating gel (page 1, Abstract).
Rubinsky et al. disclose the basic technology is active production of HClO in a wound pad through a process of electrolysis. In the presence of a direct electric current between electrodes immersed in a brine solution, hydrogen gas forms at the cathode and oxygen gas, as well as chlorine gas evolve at the anode (page 3, Materials and methods, 2.1 Electrochemical concepts, col. 1)
Rubinsky et al. disclose the central design element of the active HClO pad (AHClOP) is the active production of HClO through electrolysis, in the pad itself. To this end we have designed a multilayered pad in which each flexible micron scale thick layer has a distinct function and is optimized for that function (page 3, 2.2 Active HClO pad (AHClOP) design, col. 2, paragraph 1). The schematic of the device is shown in Fig. 1, panel (a). It shows each of the various layers of the pad in the order they occur from the tissue surface (wound), outward from the body.
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Regarding claims 31, to generate the HClO, the construct was sandwiched between two layer of gel, layers A and E in Fig. 1, panel (a). The gels act as the electrolyte as well as the HClO delivery mechanism. The gel layer is made of a solution of 0.7 g UltraPure Agarose dissolved in 100 mL of distilled water with a physiological concentration of NaCl. To maintain a pH of 4 in this layer of gel, 590 µL of 1 M Citric Acid and 410 µL Sodium citrate were added to the solution (page 4, col. 2, paragraph 1). The gel facing the cathode, layer E, was also made from 0.7 UltraPure Agarose dissolved in 100 mL of distilled water with a physiological concentration of NaCl. It was cast to form a 50.8 mm diameter, 6 mm thick gel. First layer E, was cast in the Petri dish. Then the construct layers D, C, B were placed on layer E. Lastly, layer A was cast in the petri dish, over the construct (solid structural phase, continuous transport phase that is interspersed within solid structure, solid transport material, introduce an antimicrobial agent precursor). The last step caused the gel to fill the eight 2mm through holes in Layers D and C, completing the electrical connection between the cathode and anode (page 4, col. 2, paragraph 2). The gel layers A and E are continuous transport phases that contain an antimicrobial agent or precursor. This phase also contains distilled water as the transport-phase liquid. It is interspersed with the solid electrodes and with the solid wound tissue once it makes contact with the skin. The last step that causes the gel to fill the eight 2 cm through holes in Layers D and C is also an interspersion through the solid layer.
The right panels of the Fig. 1, show details on the electrochemical aspect of the production of HClO (precursor, antimicrobial agent, hypochlorous acid).
Rubinsky et al. disclose the active HClO Pad (AHClOP) was designed to overcome some of the problems. The main novel elements in this pad are that the HClO is produced in situ, with real time control over the amount produced. Furthermore, the pad is made of micron sized composite layers and is therefore flexible enough to follow the contour of the body and the wound. The production of HClO involves the input of electricity and no chemicals (page 8, col. 1, paragraphs 1 and 2).
Regarding the limitations of “wherein the solid structure phase and said continuous transport phase are separated by an average phase-separation length from about 100 nanometers to about 500 microns” of claim 1, Rubinsky et al. teach the central design element of the active HClO pad (AHClOP) is the active production of HClO through electrolysis, in the pad itself. Rubinsky et al. teach that they designed a multilayered pad in which each flexible micron scale thick layer has a distinct function and is optimized for that function. This is further supported by the schematic of the device is shown in Fig. 1, panel (a). It shows each of the various layers of the pad in the order they occur from the tissue surface (wound), outward from the body. As such, the thickness of 1 micron that separates the layers falls within the range of 100 nanometers to about 500 microns and anticipates the claim limitation.
Regarding the limitation of the glass transition temperature from about 25˚C to about 300˚C and the antimicrobial structure is characterized in that said antimicrobial agent has a diffusion coefficient from about 10-18 m2/s to about 10-9 m2/s, measured at 25˚C an 1 bar within said continuous transport phase, as claimed in claims 31 and 32, respectively, Rubinsky et al. teach the central design element of the active HClO pad (AHClOP) is the active production of HClO through electrolysis, in the pad itself. Rubinsky et al. teach that they designed a multilayered pad in which each flexible micron scale thick layer has a distinct function and is optimized for that function. Rubinsky et al. teach the construct layers D, C, B were placed on layer E. Lastly, layer A was cast in the petri dish, over the construct (solid structural phase, continuous transport phase that is interspersed within solid structure, solid transport material, introduce an antimicrobial agent precursor). The last step caused the gel to fill the eight 2mm through holes in Layers D and C, completing the electrical connection between the cathode and anode (page 4, col. 2, paragraph 2). The gel layers A and E are continuous transport phases that contain an antimicrobial agent or precursor. This phase also contains distilled water as the transport-phase liquid. It is interspersed with the solid electrodes and with the solid wound tissue once it makes contact with the skin. The last step that causes the gel to fill the eight 2 cm through holes in Layers D and C is also an interspersion through the solid layer. Therefore, the properties possessed by the composition of the instant application, the glass-transition temperature and antimicrobial agent has a diffusion coefficient from about 10-18 m2/s to about 10-9 m2/s, measured at 25˚C an 1 bar within said continuous transport phase, would be possessed by the prior art. Where the claimed and prior art product(s) are identical or substantially identical, the burden of proof is on applicant to establish that the prior art product(s) do not necessarily or inherently possess the characteristics of the instantly claimed product(s), see In re Best, 195 USPQ 430.
Rubinsky et al. meet all the limitations of the claims and thereby anticipate the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andriae M Holt whose telephone number is (571)272-9328. The examiner can normally be reached Monday-Friday, 8:00 am-4:30 pm EST.
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/ANDRIAE M HOLT/ Examiner, Art Unit 1614
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614
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