ANTIMICROBIAL FORMULATIONS COMPRISING SILICONE

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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/08/2026 has been entered. Information Disclosure Statement The information disclosure statement (IDS) filed on 08/24/2026 has been considered here. Status of Claims The amendments and arguments filed on 09/08/2026 are acknowledged and have been fully considered. Claims 24-31 and 33-45 are now pending. Claims 1-23 and 32 are canceled; claims 24, 29, 31, and 39 are amended (though claims 29 and 31 are listed as previously presented instead of currently amended); claims 33-43 are withdrawn. Claims 24-31 and 44-45 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 Objections/Rejections Withdrawn Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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 24-31 and 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2010038040 A1 Gardner, 2010; as submitted on IDS of 12/19/2022) in view of JP 2015511969 A (‘969, 2015; machine translation from PE2E via FIT provided). In regards to claims 24-26, Gardner teaches a cationic antimicrobial peptide (CAP) which is identical to formula (I) (see Gardner, page 5, lines 14-34; pages 16-17). The formula is taught to be of the formula AA-AA-AA-X-Y-Z, wherein 2 of said AA (amino acid) moieties are cationic amino acids and 1 of said AA is an amino acid with a large lipophilic R group, the R group having 14-27 non-hydrogen atoms, wherein X is a N atom, wherein Y represents a -Ra-Ro- group, in which Ra is C, O, S, N, or F and Ro is C, and wherein Z is a group comprising 1 to 3 cyclic groups each of 5 or 6 non-hydrogen atoms (see Gardner, pages 16-17). In this case, Z would be the equivalent to the R3 group of the instant claims. Gardner also teaches that the peptide is able to be released (see Gardner, page 28, lines 10-19). It is also taught that the order of the amino acids is AA1-AA2-AA1, as claimed in claim 26 (see Gardner, page 18, lines 1-17). In regards to claim 27, the compound is taught to have a structure identical to the claimed structure (see Gardner, page 19, compound 2). In regards to claims 30-31 and 44-45, it is taught that the peptide is attached to a solid support such as a medical device, such as catheters, indwelling devices, and implants, among others (see Gardner, page 14, lines 3-25). Further, it is taught that the peptide is used in patches or wound dressings (see Gardner, page 28, lines 3-9). Gardner is silent on the peptide composition in a formulation with a silicone substrate. In regards to the silicone substrate of claim 24 and claims 28-29, 31, and 44-45, ‘969 teaches a curable silicone elastomer compound (see ‘969, abstract; page 1, technical field) that is used to make catheters, valves, antibacterial devices, and biological implants, among other medical devices (see ‘969, page 8, paragraph 8). The compound is taught to comprise an antibacterial peptide (see ‘969, paragraph bridging pages 8-9) that can be released by contact with a physiological or medical environment and can provide a transient or permanent antimicrobial effect at the contact site (see ‘969, page 9, paragraph 2). Further in regards to the hardness measurement of claim 24, it is taught that the hardness of the cured silicone rubber varies from 43-53 A (see ‘969, page 16, example 20; Table 12 of original document final column). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). It is also taught that the antimicrobial agent is introduced into the composition by soaking the elastomer in a solution of the antimicrobial agent (see ‘969, filling with activator Example 11). While the example uses silver, the antimicrobial agent is taught to be an antibacterial peptide (see ‘969, paragraph bridging pages 8-9). It would be within the purview of one with ordinary skill in the art to envisage a silicone elastomer with the antimicrobial agent being substituted with another taught in the art. In regards to claims 24-31 and 44-45, 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 combine the teachings of Gardner with ‘969 as both of the references teach using releasable peptides in implants. "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). One with ordinary skill in the art would be motivated to combine the composition of Gardner with the curable silicone substrate of ‘969 according to the known method of releasing peptides in implants (see Gardner, page 28, lines 10-19) 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 methods to yield predictable results. Response to Arguments Applicant's arguments filed 09/08/2026 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment. In regard to applicant’s argument that Gardner teaches that the compounds are covalently attached to the solid support, it is pointed out that the art teaches “The compounds of use in the present invention can be attached to solid supports by any means known in the art” (see Gardner, page 14, lines 26-27). While the same paragraph continues to teach the part that applicant has cited, it is worth noting that covalent attachment is not the only option given in the art. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). In regard to applicant’s other arguments against Gardner, it is pointed out that the rejection is not made in view of just Gardner, but in view of Gardner in view of ‘969, which does teach other methods of attachment that are known in the art and the deficiencies noted by applicant. In regard to applicant’s argument that ‘969 does not teach that the antimicrobial agent is not incorporated into the hard rubber, it is pointed out that the claims recite that the compound of formula (I) is dispersed through the silicone substrate. Reading the specification as filed that the compound of formula (I) may be considered to be dispersed through the substrate like a homogenous dispersion or it may be in just one or more zones, e.g., in the outer portions of the substrate. It is also taught that 2-100% of the silicone substrate contains the compound of formula (I) (see instant specification as filed, page 19, lines 3-9). The compound of formula (I) being dispersed in just the surface of the substrate is within the teaching the disclosure. Applicant further argues that the loading and release of the compound taught in ‘969 is a post-cure silver-ion loading experiment, not a loading and release of a substantially larger organic antimicrobial peptide, it is taught in the art that the antibacterial peptide is released from the substrate as discussed above. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). It is also taught that the antimicrobial agent is introduced into the composition by soaking the elastomer in a solution of the antimicrobial agent (see ‘969, filling with activator Example 11). While the example uses silver, the antimicrobial agent is taught to be an antibacterial peptide (see ‘969, paragraph bridging pages 8-9). It would be within the purview of one with ordinary skill in the art to envisage a silicone elastomer with the antimicrobial agent being substituted with another taught in the art. Again, the rejection is made with both references in mind, not just Gardner on its own or ‘969 on its own. As such, 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 combine the teachings of Gardner with ‘969 as both of the references teach using releasable peptides in implants. "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). One with ordinary skill in the art would be motivated to combine the composition of Gardner with the curable silicone substrate of ‘969 according to the known method of releasing peptides in implants (see Gardner, page 28, lines 10-19) 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 methods to yield predictable results. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, 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, it is pointed out that both references are drawn to using releasable peptides in implants. Although Gardner and ‘969 do not necessarily use the same substrate, they are both reasonably pertinent to the problem to be solved (i.e., releasable peptides in implants). A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. When more than one prior art reference is used as the basis of an obviousness rejection, it is not required that the references be analogous art to each other. See Sanofi-Aventis Deutschland GMbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1380, 2023 USPQ2d 552 (Fed. Cir. 2023) and Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990, 1007, 2023 USPQ2d 1202 (Fed. Cir. 2023). As such, it would be within the purview of one with ordinary skill in the art to use the teachings of Gardner and ‘969 together to formulate the composition of the instant claims with a reasonable expectation of success. Conclusion No claims allowed. 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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