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 .
Claims Status
Claim 7 is cancelled. Examiner notes that for canceled claims the text should not be present. See MPEP 714 (c).
Claims 8-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/11/2025. It is noted that the election was made for a coating and not beads.
Applicants' arguments and amendments filed on 02/09/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application.
Claims 1-6 are under current examination to the extent of the species elections; species of: coating form and polysulfones as the matrix forming compound polymer.
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.
Claim(s) 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Claude Steven McDaniel (United States Patent Publication 20210015108) in view of Ohad et al. (United States Patent Publication 2019/0070200).
Claim 1 is directed to an antimicrobial compositing consisting essentially of lithocholic acid, zinc pyrithione, cinnamaldehyde and a polymer matrix. The instant claims are being examined directed to the species of a coating and wherein the polymer is polysulfones.
Claim interpretation: For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355. In the instant case since there is no clear indication of what constitutes consisting essentially of as this term is not defined, the claims will be construed as equivalent to comprising. (see MPEP 2111.03).
McDaniel teaches antimicrobial coating compositions where antimicrobial agents may be incorporated in a thermoplastic or applied to a surface of a thermoplastic material such as polysulfones, see paragraphs [0002] and [0079]. The composition can include zinc pyrithione (also known as zinc omadine) preservative present at 0.000000-10% by weight, see paragraph [0058]-[0059] and [0066]-[0069]. The coating can comprise a further antimicrobial, and an antioxidant see paragraphs [0059]-[0063], and [0109]. The further antimicrobial and the antioxidant can be present individually from 0.0000001-10% by weight, see paragraph [0109]. The coating can comprise from 5-1500 microns in thickness or preferable 15-150 microns, see paragraph [0103]. Cinnamaldehyde is an additive suggested to provide antimicrobial activity present at 1% by weight, see paragraphs [0454-[0455], [0460]-[0472],[0480], [0484]-[0486] and [0493].
McDaniel does not expressly teach the presence of lithocholic acid as the further antimicrobial or that lithocholic acid is present at 0.1-10% wt.
Ohad et al. teach the use of bile acids for increasing susceptibility of bacteria, see paragraph [0001] and claim 5. The bile acid includes lithocholic acid, see paragraph [0050]. The bile acid can be in an amount from 0.01-10% w/v, see paragraph [0182]. The composition can comprise water, see paragraphs [0207]. The bile acid composition can comprise an antimicrobial agents inclusive of antifungals and antibacterial agents, see paragraph [0189]. The bile acid prevents bacterial conjugation and combats infection, see paragraphs [0156]. The composition treats biofilms, se paragraphs [0018]-[0021] and entire document.
It would have been prima facie obvious to include lithocholic acid with the antimicrobial composition of McDaniel.
One of ordinary skill in the art would have been motivated to do so in order to increase susceptibility of bacteria to antimicrobials and inhibit bacterial conjugation.
There would have been a reasonable expectation of success because McDaniel teaches that further antimicrobial can be combined in the composition and per the teachings of Ohad, lithocholic acid can be combined with antimicrobials to increase susceptibility of bacteria and treat biofilms.
With regards to the zinc pyrithione, McDaniel suggests it can be present at 0.000000-10% by weight, that the cinnamaldehyde can comprise 1% and that the additional antimicrobials can be present from 0.0000001-10% by weight. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). From the teachings of Ohad, the lithocholic acid can be added to provide bacterial susceptibility at an amount from 0.01-10% w/v which is added in water so is equivalent to 0.01-10% w/w. One of ordinary skill in the art would have adjusted the concentration of the lithocholic acid to achieve the desired bacterial susceptibility.
Accordingly, the instant claims are rendered prima facie obvious by the teachings of McDaniel in view of Ohad et al.
Response to Remarks
Applicants argue that McDaniel relies on bio-based antiviral preservative of an active enzyme or peptide (paragraph 0002). Applicants argue that McDaniel requires lipolytic enzyme and peptide to mitigate activity of a virus. Applicants argue that claim 1 as amended recites a composition consisting essentially of whereas McDaniel requires the lipolytic enzyme and peptide.
Examiner respectfully submits that the argument that the instant claims reciting consisting essentially of excludes the preservative enzyme or peptide required by McDaniel is considered unpersuasive. It is noted that the phrase “consisting essentially of” is not defined in the specification and there is no indication that the composition would necessarily exclude additional components such as preservatives in view of the absence of a definition to consisting essentially of language. For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355. In the instant case since there is no clear indication of what constitutes consisting essentially of as this term is not defined, the claims will be construed as equivalent to comprising. (see MPEP 2111.03). This is distinct from “consisting of” claim language which would require the claimed elements and necessarily exclude preservatives.
Applicants argue that lithocholic acid and zinc pyrithione and cinnamaldehyde when dispersed in a matrix forming compound provided a smooth surface at a thickness of 30-40 microns and remarkable biofilm prevention. No biofilms are observed in coated hoses, see Fig.2D. As noted in paragraph [0055], reduction of bacterial colonies on stainless steel and glass was greater than 99.5% and 99%. In another example, beads of the claimed composition dispersed in poysulfone had greater than 99% removal efficacy of E. coli and E. faecalis. Applicants argue that based on the evidence presented in the specification, there is remarkable efficacy in reduction of bacterial colonies of levels at 99% which is beyond what a skilled artisan would have expected.
Examiner respectfully submits that claim 1 does not require any thickness of a coating or concentration of antimicrobial ingredients nor that the polysulfone is the matrix forming polymer. From Table 1 of the instant specification the LCA is 5%, Zn at 2% and Cinnamaldehyde at 5% by weight. Table 3 provides LCA at within 3.4-5% by weight, Zn at 3 or 3% and CN at 5 or 6% by weight. The specification at Table 3 does not demonstrate a significant difference between compositions with contain LCA-ZN and LCA-CN-Zn as the log reduction on E.coli is 3.14 versus 3.55 but the trend does not necessarily show synergy. Furthermore, from MPEP 716.02(d) whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). Here, claim 1 does not require the amounts of Zn, Cn and LCN as tested in the examples nor do the claims require a coating or any specific polymer. The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Here, one of ordinary skill the art expects good efficacy from the composition of McDaniel because McDaniel teaches compositions which impart antimicrobial synergism, see paragraphs [0035]-[0036, [0304], 38B. Furthermore, the addition of lithocholic acid as suggested by Ohad et al. is that the susceptibility of bacteria to antimicrobial treatment is enhanced, per paragraph [0156]. Thus, antimicrobial compositions which have lithocholic acid as suggested by Ohad provide enhanced susceptibility of bacteria to antimicrobial compounds. Therefore, Ohad suggests the efficacy of treating bacteria with antimicrobial is suggested to be greater with addition of lithocholic acid.
Conclusion
Currently no claims are allowed and claims 1-6 are rejected.
Applicant’s arguments/remarks are considered unpersuasive. 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619