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 .
Claim Status
Claims 1-2, 4, 8, 11-20, 26, 28, 33-34, 37 and 39 are pending.
Claims 1-2, 4, 11-20, 26, 28, 37 and 39 are currently amended.
Claims 3, 5-7, 9-10, 21-25, 27, 29-32, 35-36 and 38 have been canceled.
Claims 8 and 33-34 are withdrawn.
Claims 1-2, 4, 11-20, 26, 28, 37 and 39 are currently under consideration.
Claims 1-2, 4, 11-20, 26, 28, 37 and 39 are rejected.
Acknowledgement of Receipt
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/17/2025 has been entered.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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. Applicants are 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 1-2, 4, 11-19, 28 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Sambasivam (US2018/0338945A1) herein referenced “Samba” in view of Klee (WO2009/027005A2).
Samba discloses antimicrobial compositions wherein the antimicrobial may be in the form of an adhesive, a film, a foam, or dressing (abstract, [0002], [0007]). The invention encompasses an antimicrobial adhesive composition, including at least one antimicrobial agent and at least one adhesive wherein the adhesive may be suitable to secure medical devices to mammalian body, skin , tissue, mucosal tissue ([0010]). The composition may be an antimicrobial film layer on surfaces, articles, including medical devices e.g., implant, catheter, ostomy appliance ([0055]-[0056], [0088]). Samba describes a method of applying said antimicrobial adhesive to a substrate, wherein the antimicrobial adhesive is deposited on the surface of the substrate and subsequently dried (i.e., made solid and substantially free of low boiling point solvents such as water) onto the substrate ([0051], [0087], [0137], [0185], [0217]).
Regarding the water-soluble plasticizer, glycerol (ELECTED) and claim 12 (i.e., glycerol), and claim 14 (i.e., 10 wt% to about 75 wt%), Samba teaches glycerol as a plasticizing agent ([0050]) in an amount of about 0.5 to about 20% by weight ([0050], [0066]). Samba teaches an aqueous anti-microbial composition comprising glycerol in an amount between about 0.1 to about 10% ([0245]). MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art.
Regarding the tricarboxylic acid chelator component, citric acid (ELECTED), claim 2, claim 4, and claim 13 (i.e., up to about 60 wt %), Samba teaches that the composition can include a chelating agent which may be poly(citric acid) present at 0.01-10 wt % ([0101], [0236]). Citric acid is taught as a hydrophilic additive to allow the composition to dissolve and/or gel in an aqueous medium and/or physiological fluid ([0039], [0107], [0162]); as a delivery agent ([0068], [0198]); and as a pH buffering agent in an amount ranging between approximately 0.05 to 10.0% wt % ([0200]). MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art.
Regarding the water-soluble or water-dispersible polymer, polyvinylpyrrolidone (PVP), claim 11 (i.e., polyvinylpyrrolidone), and claim 15 (i.e., 5 wt % to about 65 wt %), Samba teaches that the at least one polymer can be PVP ([0202]). The antimicrobial composition may be in the form of an antimicrobial adhesive that comprises PVP ([0011]). PVP is also taught as a thickening agent present in an amount of 0.1-50.0 wt % ([0105]). PVP and citric acid are taught as hydrophilic additives present in the range of 1.0-40.0 wt % ([0161], claim 16). MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art.
Further with respect to the range amount limitations, MPEP 2144.05 states that differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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).
Regarding (i.e., is a solution when in water) and claim 37, the hydrophilic additives (i.e., citric acid, PVP) of Samba may allow the composition to dissolve and/or disperse in aqueous medium and/or physiological fluid ([0039]). Samba discloses that the antimicrobial composition may be present in the form selected from liquids ([0234]). Samba discloses that in an aspect of the adhesive composition, the hydrophilic addition may be a liquid or solution and is suitable to lower the stiffness of the adhesive and to deliver any active which may be dissolved in the liquid phase ([0108]). Here the prior art teachings of an aqueous solution and the composition as a liquid render the limitation obvious.
Regarding claim 1, lines 7-8 and lines 16-17, Samba does not disclose plasticizer boiling point and formula weight; polymer TG. However, the invention as claimed is not structurally distinguishable from the disclosure of Samba. As such, the claimed physical properties are an inherent property of the invention taught by Samba. Applicant has the burden to provide and show any and all unobvious distinction(s) between the structural and functional characteristics of the claimed physical properties and the physical properties of the prior art.
Regarding claim 1 and claim 37, Samba does not teach a composition with a pH of 2.5-5.5 when mixed with deionized water at a 1:9 ratio.
Klee discloses a dental adhesive comprising an antimicrobial polymerizable monomers (abstract, pg. 6 last para. see Description of Embodiments). Klee teaches that by having a pH in the range of 1.5-4.5, storage stability is improved (pg. 2, line 1). The examiner notes that, upon mixing such a composition with deionized water at a 1:9 ratio, the resulting solution will have a pH that overlaps with the claimed range of 2.5-5.5.
It would have been prima facie obvious for a person of ordinary skill in the art ahead of the effective filing date of the claimed invention to combine the teachings of Samba and Klee with expected results. One would have been motivated to do so for several reasons. Regarding the limitation of being solid and solvent free, Samba teaches that drying (i.e. removing solvent from and making solid) the antimicrobial adhesive acts to effectively deposit or adhere the antimicrobial composition to a substrate. Thus, a person having ordinary skill would recognize that combining these teachings would yield the predictable results of enhancing the delivery of the antimicrobial agent, as well as the adhesion between the antimicrobial composition and substrate. It would have been prima facie obvious for a person of ordinary skill in the art to improve the composition of Samba by modifying the pH of the composition as taught by Klee. A person of ordinary skill in the art would have been motivated to do so because Klee teaches that maintaining a pH of 1.5-4.5 in an antimicrobial composition extend shelf-life (background art, paragraph 2). It is well within a skilled artisan’s purview to adjust pH buffer component taught by Samba to obtain a composition at a pH value in range taught by Klee. Such modifications would yield the predictable result of improving the stability of the composition.
Regarding claim 16 (i.e., antimicrobial) and claim 17 (i.e., fatty acid monoester), Samba teaches that the antimicrobial agent of the composition described can be selected from the group consisting of esters of glycerol and saturated and/or unsaturated fatty acids (C6-C20) and saturated and/or unsaturated alcohols (C6-C20) ([0060], [0072]).
Regarding claim 18 (i.e., less than 2 wt %), The resulting coating can be dried ([0157]
Regarding claim 19 (i.e., substrate foam), as mentioned above, Samba teaches a foam substrate ([0030]) and discloses that the antimicrobial composition may be prepared as a liquid or semi-solid, which is then coated on a substrate such as a foam ([0157], [0229]). Samba provides exemplary foam compositions ([0274], Example 3). Samba teaches frothing the polyvinyl alcohol solution with antimicrobial agent followed by crosslinking, and drying to yield a foam structure with the antimicrobial agent incorporated within the foam structure ([0092]).
Regarding claim 28 (i.e., catheter), as cited above, Samba teaches that the medical device can be a catheter ([0055]-[0056], [0088], [0229]).
Claim 20 and claim 26 are rejected under 35 U.S.C. 103 as being unpatentable over Samba in view of Klee as applied to claims 1-2, 4, 11-19, 28 and 37 above, and further in view of Bellinger (US 2019/0254966 A1, priority to 05/26/2017).
The teachings of Sambasivam and Klee above are incorporated herein.
Samba and Klee do not teach a composition wherein the active antimicrobial layer exhibits >5% transmittance of 550 µm light, nor wherein the active antimicrobial layer has a thickness between about 500-5000 µm.
Bellinger discloses a therapeutic agent delivery system to be administered to the gastrointestinal tract, wherein this composition may comprise PVP ([0129], [0157], claim 9) and an antimicrobial agent ([0016], [0264], Embodiments 22, 32). Bellinger teaches that said delivery system may further comprise a reinforcing layer, wherein the reinforcing layer is structured to provide sufficient support to the composition as a whole. Bellinger teaches that the material of the reinforcing layer may comprise PVP, and that the thickness of the reinforcing material may vary between embodiments in order to provide the necessary amount of structural support within the entire composition ([0140]). Bellinger provides embodiments wherein the reinforcing layer is between 500-1000 µm in thickness ([0136], [0141]).
Samba, Klee, and Bellinger are all directed to polymeric or polymerizable medical implants comprising one or more antimicrobial compounds. Thus, it would have been prima facie obvious to one of ordinary skill in the art as of the filing date of the instant invention to further incorporate the compositional thickness of the reinforcing layer taught by Bellinger into the antimicrobial adhesive composition described by Sambasivam, in view of Klee to yield the predictable result of an antimicrobial layer which exhibits adequate structural integrity. Neither Samba, Klee, nor Bellinger disclose the transparency of their inventions. However, the invention as claimed is not structurally distinguishable from the disclosures of Samba and Klee in view of Bellinger. The Examiner asserts that the transparency is an inherent property of the invention taught by Samba and Klee in view of Bellinger. The burden of proof is upon the Applicants to provide and show an unobvious distinction between the structural and functional characteristics of the claimed transparency and the transparency of the prior art.
Claim 39 is rejected under 35 U.S.C. § 103 as being unpatentable over Samba in view of Klee as applied to claim 37 above, further in view of Modak (US2016/0374352).
The teachings of Sambasivam and Klee above are incorporated herein.
Modak discloses antimicrobial compositions comprising essential oils, botanical extracts and synthetic antimicrobial agents which do not rely solely upon alcohol to produce anti-microbial effects; the compositions can further comprise alkanediols ([0002], [0005]). The compositions can be used in low concentrations, for example, after diluting with water ([0002]).
Modak teaches benzalkonium chloride (BAC) as microbial agent at a concentration of between about 0.01 and 30% w/w (claim 1) and from about 0.05 to 5% w/w (claim 6) and in certain embodiments BAC is at a concentration of between about 1.0 and 20% w/w, or between about 10 and 50% w/w ([0031]).
In addition, looking to Applicants’ specification, (C6-C12) 1,2-organic diol (e.g., 1,2-octanediol) is disclosed (see Spec., [0075]). Modak teaches 0.5 to 10% w/w of one or more alkanediol selected from the group consisting of octanediol where octanediol is regarded as including 1,2 octanediol ([0356], claim 6).
Modak teaches citric acid as the organic acid component of the composition embodiments ([0013]) at a concentration of between about 0.05 and about 0.5% w/w ([0026], [0076], claims 6-7). One or more organic acid at a concentration of between about 0.05 and about 0.5% w/w is selected from the group consisting of citric acid ([0026]). Modak teaches that the pH of the compositions described herein are at a pH of between about 3 and 6, or between about 3.5 and 5.5 or between about 4 and 5 ([0111]). Modak teaches wherein the water is present from 0.05% to 90 w/w ([0353]) and recites wherein the pH of the composition ranges from 3.5 to 5.5 ([0111]). Modak teaches glycerol as a solubilizing agent ([0135], claim 5), provides formulations that include water soluble polymers (e.g., U-care polymer JR-30M) ([0171]) while some embodiments are solidified (i.e., bar of soap) ([0417]). The antimicrobial efficacy of the compositions was tested at room temperature to include the temperature of 23⁰C ([0463]).
Here the prior art of Modak teaches the general conditions of claim 37 and discloses benzalkonium chloride. MPEP 2144.05 states that it is not inventive to discover the optimum or workable ranges by routine experimentation. Any differences in concentration or temperature will not support the patentability unless Applicant provides and shows evidence to indicate that such concentration or temperature is critical to the claimed invention.
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to incorporate the benzalkonium chloride taught by Modak in view of Samba and Klee with expected results. One would be motivated to do so with a reasonable expectation of success because Modak provides a composition that is suited to water-soluble polymers by teaching embodiments using them but also by stating that the concentrations of the ingredients can be adjusted to provide for concentrated formulations that can be diluted prior to use ([0041]) suggesting an ease of use for the formulator and potential extension of shelf life. Modak focuses on antimicrobial compositions which has a sufficiently low amount of alcohol to avoid the skin damage, flammability, and abuse potential of alcohol-dependent formulations (or which lacks alcohol altogether) ([0003-0004]). This comports with Samba’s attention providing antimicrobial compositions suitable for medical applications, especially those devices in direct contact with healthy and or denuded skin ([0007], [0117]). Both references disclose synergistic effects. Modak found that benzalkonium chloride and chlorhexidine synergistically enhance the activity of a botanical blend comprising alkanediol (particularly octanediol) ([0138]). Similarly, Samba teaches the employment of at least one additional antimicrobial agent with synergistic and/or enhanced antimicrobial activity to include quaternary ammonium compounds ([0158]) because the presence of at least one additional antimicrobial agent advantageously improves the spectrum of activity against various microbes and/or enhances the activity of the composition ([0158]) to suggest sustained positive clinical outcomes.
Response to Arguments
Applicant's arguments filed 06/17/2025 have been fully considered but they are not persuasive.
35 U.S.C. § 103 claims 1-2, 4, 11-19, 28 and 37
Applicants argue that Sambasivam does not suggest a single phase, i.e. solution, of the antimicrobial adhesive. Applicants argue that the new limitation that the composition forms a solution when mixed with water distinguishes the instant formulation from Sambasivam. For instance, the silicone gel taught by Sambasivam is excluded from the instant claims because it would not form a solution when mixed with water. (see Remarks, pg. 8, para. 1).
The Examiner respectfully asserts that Sambasivam teaches polyvinylpyrrolidone and silicones as being suitable adhesives in the composition of the prior art (see paragraphs [011], [0137], [0108]). Sambasivam states, “The adhesives are typically provided as a solution in organic solvents. Such solutions are coated on a carrier substrate such as films, and heat dried above the boiling point of the solvent(s) to form the adhesive.” (paragraph [0137]). As such, one of ordinary skill in the art would be able substitute the preferred silicone gel with polyvinylpyrrolidone. Alternatively, one would be motivated to do so in order to lower the overall stiffness of the adhesive and also to deliver any active, if required, which may be dispersed or dissolved in the liquid phase of the adhesive. Further, Sambasivam teaches, the antimicrobial adhesive composition can be delivered as a solution, a paste, a gel, a tape, a film, an adhesive, a layer, a non-perforated sheet, a perforated sheet, a foam, a woven material, a non-woven material, a fiber, a porous membrane, a non-porous membrane, and combinations thereof (paragraph [0030]). That the solution can be applied to a substrate (paragraphs [0084] and [0095]). Therefore, it is clear from the teaching of Sambasivam that adhesive compositions can be formulated such that they would be in solution form, including when mixed with water.
Regarding Applicants’ argument that nothing in Klee would motivate a skilled artisan to select PVP, a chelator, glycerol, Klee to show that the pH of a composition can be modified, thus by doing so, shows that the antimicrobial efficacy can be optimized. 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. There was no evidence of the criticality of the claimed range. MPEP 2144.05(II.).
35 U.S.C. § 103 – Claim 15
In response, Alcantara is no longer relied upon. Sambasivam teaches the components to meet the limitations of the claimed composition. Further, Sambasivam teaches that the antimicrobial composition can either be used on its own, incorporated into a medical device, or articles as a component or coating, or incorporated onto a surface desirable to be free of microbes or to have reduced bio-burden ([0117]). In addition, Sambasivam teaches LAE is an antimicrobial agent. As such, it would have been prima facie obvious to use an antimicrobial since the art establishes that LAE is known to be used as microbial agent as evidenced by Nerin et al. (“Ethyl Lauroyl Arginate (LAE): Antimicrobial Activity and Applications in Food Systems”, Antimicrobial Food Packing, 2016) (abstract). Thus, it would be readily envisaged by one skilled in the art to choose LAE as a microbial component.
35 U.S.C. § 103 - Claims 20 and 26
In response to Applicants’ argument regarding Berringeretal ([sic]), the cited reference, Bellinger teaches reinforcing layer may comprise PVP and exemplifies with embodiments showing a thickness to read on the claimed limitation (µm).
35 U.S.C. § 103 – Claim -39
Modak teaches the general conditions of claim 37 and discloses benzalkonium chloride. Modak found that benzalkonium chloride and chlorhexidine synergistically enhance the activity of a botanical blend comprising alkanediol (particularly octanediol) ([0138]). Sambasivam employs at least one additional antimicrobial agent with synergistic and/or enhanced antimicrobial activity to include quaternary ammonium compounds ([0158]) as the presence of at least one additional antimicrobial agent advantageously improves the spectrum of activity against various microbes and/or enhances the activity of the composition ([0158]) to suggest sustained positive clinical outcomes.
Conclusion
Claims 1-2, 4, 11-20, 26, 28, 37 and 39 are rejected; no claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 900-500 ET.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614