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 .
DETAILED ACTION
Status of Claims
The amendments and arguments filed on 07/30/2025 are acknowledged and have been fully considered. Claims 1-3, 5-8, and 16-27 are now pending. Claims 4 and 9-15 are canceled; claims 1, 3, and 5 are amended; claims 8 and 16-20 are withdrawn; claims 21-27 are new.
Claims 1-3, 5-7, and 21-27 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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.
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.
Claims 1-3, 5-7, and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20110092870 A1 (Jarell, 2011; as submitted on IDS of 07/29/2022) in view of US PGPUB 20130060188 A1 (Bedwell, 2013). [emphasis added to reflect newly presented claims]
In regards to claims 1-3 and 22-23, Jarell teaches a catheter coating comprising silver oxide (i.e., a reducible form of silver) and poly(dimethylsiloxane) (i.e., a flexible polymer) (see claims 1-6 and 12). It is taught that the silver oxide is exposed to the surface of the poly(dimethylsiloxane) (see paragraph 0030). The composition comprises silver as it comprises silver oxide (see paragraph 0030, 0038; claim 3). It is also taught that the composition comprises zinc oxide (see paragraph 0038; claim 3).
In regards to the limitations of “wherein a mass of the active…surface of the polymer” in claim 1 and of “wherein the amount of the powdered mixture in the polymer …surface of the polymer”, the claim does not mention any specific amount of the active which would allow for the measuring of the electrical conduction at the surface of the polymer. As such, it would be understood by one with ordinary skill in the art using the broadest reasonable interpretation that any amount of the active would meet the limitations of the claim. It is noted that the ratio of active material to the flexible polymer in the examples of the specification can be 4:1 to 1:1 by mass (see specification as filed, page 11, lines 25-29). Jarell teaches that the amount of metal oxide precursor (which is then formed into a metal oxide (see paragraph 0062)) is used in an amount from about 50% to about 99% of the total volume of the metal oxide precursor and the polymer (see claim 1). Therefore the recitation of about 50 %-99 % would meet the limitation that it would be “sufficient to produce a measurable electrical conduction”.
The teachings of Jarell are silent on the antimicrobial coating being a paste and comprising a powdered mixture of a reducible form of silver and a metal comprising one or more of zinc and silver.
Bedwell teaches a method of forming a catheter that is comprised of poly(dimethylsiloxane) (PDMS) and a cross-linking agent (see Bedwell, paragraph 0094). The method comprises making a paste of the PDMS and curing it using heat (see Bedwell, paragraph 0094). The method also teaches that a metal oxide, such as zinc oxide, is dusted on the silicone while it is still soft and tacky (i.e., before curing) (see Bedwell, paragraph 0095). It is also taught that the metal oxide coating is in the form of a particulate (i.e., powder) (see Bedwell, paragraph 0095).
In regards to claims 1-3, 5-7, and 21-27, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to use the teachings of Jarell and Bedwell to formulate the instantly claimed composition as both references teach the use of metal oxides and PDMS to make antimicrobial catheters. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, it would be obvious to form a paste to use for the coating of the catheter as the method of Bedwell allows for the metal oxide particles to be absorbed into the PDMS (see Bedwell, paragraph 0095). One with ordinary skill in the art would be motivated to combine the composition of Jarell with the paste and particulate metal oxide of Bedwell according to the method of making antimicrobial coatings for catheters (see Jarell, paragraph 0004, 0064) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known elements to yield predictable results.
Further, in regards to the limitation of “wherein the active material is configured…bodily fluids” of claim 1 and “wherein the powdered mixture…to urine” of claim 22, as the teachings of Jarell and Bedwell would yield an identical coating composition as instantly claimed, the properties, such as the ability to induce an electrochemical/galvanic reaction, of the composition would be the same. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658. As the prior art teaches an identical chemical structure, the properties applicant discloses and/or claims are necessarily present. This is also relevant for claims 21 and 24 as the composition of Jarell and Bedwell is identical to the claimed composition, it would be understood that the active material or the powdered mixture is configured to induce the generation of hydrogen peroxide at the surface. Claims 1, 21-22, and 24 further claim a future intended use (“when exposed to an electrolyte comprising bodily fluids”, “when exposed to urine”, “configured to induce…at the surface”), however the future intended use of a product is not considered to contribute to the overall patentability of the instant invention, particularly when the product itself is claimed and that same product is taught in the prior art. It must be noted that the recitation of the intended use of the claimed invention (topical vs injectable formulation) 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. In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed.Cir. 1997) MPEP § 2111.02.
In regards to claims 5-7 and 25-27, a product-by-process claim drawn to a composition directed towards the antimicrobial coating, the patentability of a product does not depend on its method of production. The combination of Jarell and Bedwell teach the instantly claimed composition. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by- process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. The teachings of Jarell and Bedwell establish the composition as instantly claimed, thus the burden shifts to the applicant to come forward with evidence showing that the process of making the composition as instantly claimed produces a materially different product than the composition of Jarell and Bedwell.
Response to Arguments
Applicant's arguments filed 07/30/2025 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
The anticipation rejection over Jarell has been withdrawn and as such the arguments are rendered moot. However, as the reference is still used in the obviousness rejection, the relevant arguments are addressed below.
In regards to applicant’s arguments that the composition of Jarell only teaches metal oxides, not metals, it is pointed out that the claims are drawn to a reducible form of silver, which is then narrowed further to silver oxide in claim 3. Further, as silver oxide comprises silver, it would be within the understanding of one with ordinary skill in the art to say that the composition comprises silver. The same would be understood for zinc in zinc oxide. Finally, the claims are written with an open transition (i.e., comprising) and as such allow for additional components to be present in the composition, such as an oxide.
In response to applicant's argument that Bedwell only teaches metal oxides and teaches that silver is degradable, has limited efficacy, and is expensive and as such would not be used, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, silver oxide is taught to be used already with the components of titanium oxide and zinc oxide in Jarell. It would be within the purview of one with ordinary skill in the art to combine the composition of Jarell with the paste and particulate metal oxide of Bedwell according to the method of making antimicrobial coatings for catheters (see Jarell, paragraph 0004, 0064) to yield predictable results with a reasonable expectation of success as discussed above. One with ordinary skill in the art would be motivated to combine prior art elements according to known elements to yield predictable results.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611