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
Information Disclosure Statement
The information disclosure statement (IDS) filed on 09/17/2025 has been considered here.
Status of Claims
The amendments and arguments filed on 12/23/2025 are acknowledged and have been fully considered. Claims 24-45 are now pending. Claims 1-23 are canceled; claims 24, 29, and 31 are amended; claims 33-43 are withdrawn; claims 44-45 are new.
Claims 24-32 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Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24-32 and 44-45 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 recites the limitation "the silicone". There is insufficient antecedent basis for this limitation in the claim. For purposes of search and consideration, the claim is understood to read “the silicone substrate” instead of “the silicone”.
Claims 25-32 and 44-45 are indefinite as they depend from an indefinite claim.
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, 31-32 and 44-45, ‘969 teaches a curable silicone elastomer compound (see ‘969, abstract; page 1, technical field) that is used to make pressure sensitive adhesives, 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 is varied 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 an silicone elastomer with the antimicrobial agent being substituted with another taught in the art.
In regards to claims 24-32 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 12/23/2025 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
Applicant’s arguments with respect to references ‘494 and Cobain have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
However, it is noted that applicant argues that adhesive-type silicones are expressly excluded by the hardness limitation in the amended claim, however claim 32 still teaches that the adhesive is a pressure sensitive adhesive. It is not clear whether applicant is saying that having a pressure sensitive adhesive is not possible to be used as the silicone substrate, in which case there is an issue with enablement, or that the teaching of Cobain would not lead one with ordinary skill in the art to formulate the instant invention as it is a different type of silicone, in which case the argument is moot as Cobain is not relied upon the modified rejection as necessitated by amendment. In regards to the former point, it is noted that claim 32 is drawn to a medical device, wherein the medical device comprises a cured silicone elastomer substrate and wherein the medical device is a pressure sensitive silicone adhesive, not the substrate itself. In any event, the newly cited reference JP ‘969 teaches a curable silicone elastomer compound (see ‘969, abstract; page 1, technical field) that is used to make pressure sensitive adhesives.
Double Patenting
The terminal disclaimer filed 12/23/2025 is sufficient in overcoming the provisional nonstatutory double patenting rejection and as such, the rejection is withdrawn.
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.
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/Isis A Ghali/
Primary Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611