DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The amendment to the abstract were received on 01/09/2026. These amendments are acknowledged and accepted by the Office.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6 and 8-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ansell U.S. Patent No. (5,183,664) in view of Schonemyr et al. U.S. Publication No. (2007/0042198 A1) and evidenced by Murata et al. (JP2011205080A).
With respect to claim 1, Ansell substantially discloses a method of using a film dressing ([Col.7], lines 33-46) comprising:
securing an intravenous needle onto a patient with a medical-grade film ([Col.7], lines 33-37), at least a portion of which is coated with an adhesive formulation ([Col.3], lines 59-61, the adhesive dressings may also protect the wound or access site from mechanical trauma and can serve as a carrier for topically applied pharmacologically active agents or medicaments such as antibacterial and antimicrobial agents) and ([Col.6], lines 14-27, suitably the adhesive may contain a medicament such as an antibacterial agent. Suitable antibacterial agents include chlorhexidine and salts thereof, iodophors such as polyvinyl pyrrolidone-iodine, silver salts such as silver sulphadiazine, polymeric biguanides for example those antibacterial agents known as Vantocil (Trade mark) and metronidazole and compatible mixtures thereof).
Ansell substantially discloses the invention as claimed except the adhesive formulation comprising a silane quaternary ammonium salt mixed with an adhesive.
Schonemyr et al. teaches an antimicrobial substrate is disclosed, having adhered to at least a part of its surface an organosilicon quaternary ammonium salt compound (abstract). [0005, organosilicon quaternary ammonium salt compounds are bacteriostatic/bactericidal, fungistatic/fungicidal, sporostatic, algistatic/algicidal, and viricidal] and the application of the antimicrobial substance for use with adhesive dressings and wound compresses/cloths (for instance, for treatment of eczema and burn injuries) and [0057].
In view of the teachings of Schonemyr et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the adhesive formulation of Ansell by incorporating a silane quaternary ammonium salt mixed with an adhesive for preventing microbiological contamination by destroying (killing), inhibiting the growth or reproduction of, and/or removing an array of microorganisms, such as bacteria, fungi, yeasts, algae, and virus [0002] of Schonemyr et al.
With respect to claim 2, the combination of Ansell/ Schonemyr et al. substantially discloses the invention as claimed. Ansell further discloses (implied) before securing, coating the portion of the medical-grade film with the adhesive formulation (abstract, thin film adhesive dressings comprise a support layer having a continuous coating on one side thereof of a gel adhesive).
With respect to claim 3, the combination of Ansell/ Schonemyr et al. discloses before coating, mixing the adhesive with the silane quaternary ammonium salt to form the adhesive formulation ([Col.2], lines 52-62, the gel adhesive is cross-linked]) of Ansell. Note: cross-linking involves mixing as evidenced by Murata et al. discloses “ Cross-linking method, a method of cross-linking by mixing a low molecular weight compound having a cross-linking group represented by an acrylate group as a cross-linking agent, and exposing the lower layer to ultraviolet light to an organic solvent used for the upper layer preparation” [Page 7], 4th paragraph].
With respect to claim 4 the combination of Ansell/ Schonemyr et al. discloses the invention as claimed. Ansell further discloses: after coating, applying a release liner over the adhesive formulation coated onto the medical-grade film ([Col.6], lines 28-35).
With respect to claim 6, the combination of Ansell/ Schonemyr et al. discloses the invention as claimed. Ansell further discloses the medical grade film, i.e. transparent film, ([Col.5], lines 9-18) inherently has a first side and a second side; and coating at least a portion of the medical grade film with the adhesive formulation comprises coating the first side but not the second side (abstract, coating on one side of the film adhesive dressing).
With respect to claim 8, the combination of Ansell/ Schonemyr et al. discloses the invention as claimed. Ansell further discloses the medical-grade film is a transparent film ([Col.5], lines 14-15).
With respect to claim 9, the combination of Ansell/ Schonemyr et al. discloses the invention as claimed. Ansell further discloses the medical-grade film is a 1-mil polyurethane film ([Col.5], line 12-15); in ([Col.5], lines 27-30), the polyurethane film has a thickness of 20 to 80 µm (30 µm is 1.181 mils).
With respect to claim 10, the combination of Ansell/Schonemyr et al. discloses the invention as claimed. Schonemyr et al. further teaches the silane quaternary ammonium salt is 3-(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride [0025].
With respect to claim 11, the combination of Ansell/ Schonemyr et al. discloses the invention as claimed. Ansell further discloses the adhesive is an acrylic adhesive ([Col.8], lines 15-22).
Claim 5 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ansell/Schonemyr et al. as applied to claim 1 above, and further in view of Shah U.S. Patent No. (6,492,012).
With respect to claim 5, the combination of Ansell/Schonemyr et al. substantially discloses the invention as claimed except the coating is performed using a knife-over-roll method.
Shah however, teaches a process for producing a polymer coating on fabric materials and other porous substrates ([Col.1], lines 7-11). Shah further teaches another commonly-used method to produce thermoplastic coatings on fabrics is called "knife-over-roll” This method is also used to apply a thin sheet of elastomeric polymer onto a fabric. The knife-over-roll method melts the elastomeric polymer material. A special tool, or "knife," applies a thin layer of the melted elastomeric polymer material onto the roll and is then transferred onto the fabric. The elastomeric polymer material cools and produces a thin sheet of polymer on the fabric material ([Col.1], lines 60-38).
In view of the teachings of Shah, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of using the film dressing of Ansell/Schonemyr et al. by incorporating the technique of coating the film dressing with the adhesive formulation performed using a knife-over-roll method in order to apply a thin sheet and/or layer of the adhesive formulation to the film dressing.
Claim 7 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ansell/Schonemyr et al. as applied to claim 1 above, and further in view of Becher U.S. Patent No. (5,236,421).
With respect to claim 7, the combination of Ansell/Schonemyr et al. substantially discloses the invention as claimed except the medical-grade film has a first side and a second side; and coating at least a portion of the medical-grade film with the adhesive formulation comprises coating the first side and the second side.
Becher however, teaches a fixing system for fixing catheters, cannulas, with a skin film coated with a skin adhesion layer (abstract); wherein the skin film can be coated with an active substance on one or both sides with a bactericidal substance or the like ([Col.3], lines 12-15).
In view of the teachings of Becher, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of using the film dressing of Ansell/Schonemyr et al. by coating at least a portion of the medical-grade film with the adhesive formulation comprising coating the first side and the second side in order to prevent migration of bacteria towards the body-remote the puncture point ([Col.4], lines 41-45) of Becher.
Response to Arguments
Applicant argues the following: Applicant respectfully disagrees, because the PHOSITA would not have had a reasonable expectation of success in so modifying the film dressing of ANSELL to include the organosilicon quaternary ammonium salt of SCHONEMYR. "Where there is a reason to modify or combine the prior art to achieve the claimed invention, the claims may be rejected as prima facie obvious provided there is also a reasonable expectation of success." MPEP § 2143.02 Here, while Applicant acknowledges that ANSELL teaches mixing an antibacterial agent with an adhesive, ANSELL, col. 6, II. 14-27, the issue is whether a PHOSITA would understand from SCHONEMYR that the organosilicon quaternary ammonium salt could be substituted for ANSELL'S antibacterial agents and still retain antimicrobial activity. Applicant submits that a PHOSITA would have no such understanding, because SCHONEMYR teaches that the antimicrobial activity of the organosilicon quaternary ammonium salt compound comes from the positive surface charge that the compound imparts when surface-bound-microorganisms become electrostatically trapped on the surface.
SCHONEMYR'S method involves treating the substrate with a dilute solution to provide a surface coating: "Therefore, a common method of adhering it to a substrate surface is to add a dilute solution of TMS in methanol to water and then treat the substrate with the thus obtained solution to provide an antimicrobial coating." SCHONEMYR 1 [0008]. After treating the substrate with the dilute solution, the solvent evaporates leaving just the organosilicon quaternary ammonium salt compound adhered to the surface. Id. at 1 [0077] (describing heating at 150°C for 15 minutes after immersion); 1 [0047] (referring to "dry weight basis" confirming the final product is dry). SCHONEMYR teaches that the organosilicon quaternary ammonium salt compound binds directly to the substrate surface "either through (i) ionic bonds between O⁻ on a negatively charged surface possessing acidic hydroxyl groups and the positively charged ammonium ion, through (ii) covalent bonds between OH on a surface possessing non-acidic hydroxyl groups and the -Si-OH group, or through (iii) electrostatic attraction between the negative charge that exist on most non-hydroxylated surfaces and the positively charged ammonium ion." Id. at 1 [0009]. The intended purpose of SCHONEMYR is to provide a surface-bound quaternized organosilane that provides a positive surface charge density to increase microorganism adhesion and prevent leakage of alive microorganisms from the substrate surface. Id. at " [0029] ("[l]t is believed that the cationic polymer adhered to the substrate surface according to the invention provides an increased positive surface charge density on the substrate surface.") id.; " [0030] ("The increased positive surface charge density results in an increased microorganism adhesion, thus preventing leakage of alive microorganisms from the substrate surface."). There is no teaching or suggestion in SCHONEMYR that the compound would retain its antimicrobial properties if mixed into an adhesive rather than being surface-bound. Accordingly, a PHOSITA would not realize from SCHONEMYR that the simple substitution proposed by the Office could in fact be made-there is no reasonable expectation of success that the organosilicon quaternary ammonium salt compound would retain antimicrobial activity when mixed into an adhesive rather than being surface-bound.
This is not found to be persuasive because the teaching reference drawn to Schonemyr et al. teaches in [0057, “examples of applications (substrate) include adhesive dressings, wet wipes, liquid absorbing materials and diapers…”]. Furthermore, Schonemyr et al. teaches in [0052, “The substrate according to the invention adsorbs, and/or absorbs, and retains microbes, such as bacteria, fungi and/or virus”]; adsorb (ad-sorb) refers to particles adhering to the surface of a substance, while absorb (ab-sorb) refers to substances being taken inside or through the entire bulk of a material; since, the prior art drawn to schonemyr et al. discloses examples of application (substrate) includes adhesive dressings and liquid absorbing materials and wet wipes; the surface-bound quaternary ammonium compounds (QACs) are used in the adhesive dressings to create contact-killing antimicrobial surfaces within the polymer matrix of the dressing, allowing them to kill bacteria upon contact; the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Therefore, there is teaching or suggestion in SCHONEMYR that the compound would retain its antimicrobial properties if mixed into an adhesive rather than being surface-bound. The primary reference drawn to Ansell discloses at least a portion of which is coated with an adhesive formulation ([Col.3], lines 59-61, the adhesive dressings may also protect the wound or access site from mechanical trauma and can serve as a carrier for topically applied pharmacologically active agents or medicaments such as antibacterial and antimicrobial agents) and ([Col.6], lines 14-27). Therefore, substituting the antibacterial materials disclosed in column 6, lines 14-27 of Ansell with the silane quaternary ammonium salt, such as 3-(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride of Schonemyr et al. would not change or alter the efficacy of the antimicrobial substance in killing bacteria or microbes and therefore does not change the operating principle of the invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant further argues: dependent claim 3 recites "before coating, mixing the adhesive with the silane quaternary ammonium salt to form the adhesive formulation." As mentioned, the Office rejected claim 3 under § 103 as having been obvious over ANSELL in view of SCHONEMYR. NON-FINAL REJECTION p. 5. The Office cites ANSELL at col. 2, II. 52-62 (discussing that "the gel adhesive is cross-linked") as disclosing this limitation. Id. Applicant respectfully disagrees, for two reasons. First, the Examiner's citation is inapposite and fails to make a prima face case of obviousness. Cross-linking an adhesive is a completely different process from mixing a silane quaternary ammonium salt with the adhesive. Cross-linking refers to forming chemical bonds between polymer chains to create a gel structure-it has nothing to do with mixing a silane quaternary ammonium salt with the adhesive. Therefore, the cited passage does not teach or suggest "mixing the adhesive with the silane quaternary ammonium salt" as recited by claim 3. Second, the argument from claim 1 applies with even greater force to claim 3. Claim 3 explicitly requires "mixing the adhesive with the silane quaternary ammonium salt to form the adhesive formulation"-the very step that SCHONEMYR provides no teaching would work. As discussed above, SCHONEMYR only teaches surface treatment where the solvent evaporates leaving the compound surface-bound. There is no teaching or suggestion in SCHONEMYR that the organosilicon quaternary ammonium salt compound would retain antimicrobial activity if mixed into an adhesive.
This is not found to be persuasive as cross-linking involves mixing as evidenced by Murata et al. discloses “ Cross-linking method, a method of cross-linking by mixing a low molecular weight compound having a cross-linking group represented by an acrylate group as a cross-linking agent, and exposing the lower layer to ultraviolet light to an organic solvent used for the upper layer preparation” [Page 7], 4th paragraph].
In response to applicant’s argument “As discussed above, SCHONEMYR only teaches surface treatment where the solvent evaporates leaving the compound surface-bound. There is no teaching or suggestion in SCHONEMYR that the organosilicon quaternary ammonium salt compound would retain antimicrobial activity if mixed into an adhesive” please see above response to Schonemyr et al.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/OPHELIA A HAWTHORNE/ Primary Examiner, Art Unit 3786
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