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 .
Status of the Claims
Acknowledgement is made of the response filed on July 15, 2025. In that response, claims 1, 3, 7, 9, 13, 18, 25, and 27 were amended; claims 2, 5, 17, and 23 were cancelled; and claims 48 and 49 were added. Claims 37, 38, 42, and 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 20, 2024.
Claims 1, 3, 7, 9, 11-13, 18, 25, 27, 29, 30, 48, and 49 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claims 12 and 30 are objected to because of the following informalities: “pm” appears to be a typo for “µm” based on the disclosure. Appropriate correction is required.
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.
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. Applicant is 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, 3, 7, 9, 11-13, 18, 25, 27, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Cichocki (US 2011/0098724) in view of Fu-Giles (US 2013/0004651).
Cichocki teaches a “medical device having … a first coating layer having an antimicrobial agent over at least part of the outer surfaces of the device”, wherein the “first coating has an outer surface”, and “a second discontinuous polymeric coating containing an antimicrobial agent, which is on top of and covering part of the outer surface of the first coating” (abstract; see title). In an embodiment a Prolene Soft MeshTM was first coated with a silver coating (Example 1, para.0043), followed by a second coating of triclosan (Example 2, para.0044). “The first coating layer will … contain a metal or metal alloy…, silver, silver alloys…” and “the first coating layer is a biocompatible polymer coating containing such metal alloys” (para.0030). Suitable biocompatible polymers include those in claim 7 (id.).
The second antimicrobial agent is preferably in a polymeric coating comprising polymers such as those in instant claim 25 as well as claim 7 (para.0032), in discrete microstructures of up 0.1 to 20 microns in diameter, e.g., 0.1 micron, which is within the range of “nanoparticles” according to Applicant (Specification, para.0043, pre-grant publication US 2022/0387304).
The first and the second coatings would have the antimicrobial agent dispersed homogeneously within the polymer because the “conventional coating processes” such as spraying, dipping, and brushing would result in a homogenous layer (paras.0030, 0037).
Cichocki does not specifically teach embodiments wherein the antimicrobial agent in the first layer is encapsulated in a nanoparticle as in claim 1, the antibiotic compounds in claims 3 and 49, or the polymers in claim 29.
Fu-Giles teaches “encapsulated antibiotics and other drugs from a polymeric coating material” on an implant (title; abstract; paras.0002, 0006-09, 0031-33, 0050-51). Suitable polymers include those in claims 7 and 29 (paras.0006, 0031, 0042; claim 9) and suitable antibiotics include those in claim 3 (para.0008).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Cichocki and Fu-Giles as recited in the instant claims and include Fu-Giles’s encapsulated antibiotics in Cichocki’s first coating layer as recited. The skilled person would have been taught to do so because both are drawn to medical devices comprising antimicrobial and polymeric coatings, and Fu-Giles teaches “drug delivery systems using nanoparticle-encapsulated antibiotics can improve antimicrobial efficacy against drug-resistant strains” (para.0003). Moreover 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.” MPEP §2144.06 (I) (citations omitted).
Regarding claims 13 and 18, Fu-Giles teaches a range of therapeutically effective amount of the antibiotics and states, “amount of antibiotic used in the nanoparticles of the present application also depends on the unit area of application” (para.0033). Regarding claims 12 and 30, Cichocki teaches the thickness of the second coating is “about 20 µm or less, although thicker coatings may be used depending upon characteristics such as the nature and type of substrate materials, the construction of the device, the type of first coating used, etc.” (para.0036). Based on these guidelines the skilled person could arrive at the optimal concentration and coating thickness range for a particular application at hand. For result-effective variables, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted). Furthermore in the absence of some recitation regarding the application of the “substrate” and the layers recited, the thickness of the coatings or the concentration of the active agent alone is not determined as overcoming prima facie obviousness over Cichocki’s teaching.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3, 7, 9, 11-13, 18, 25, 27, 29, 30, 48, and 49 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.
CONCLUSION
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 H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614