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 .
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
Applicant has amended the preamble of claim 49 to recite that the composition is “non-antimicrobial” and “for enhancing delivery of small molecules or large molecules through the skin”. The “non-antimicrobial” recitation cannot be considered to support a conclusion of nonobviousness. The fact that the ‘627 reference teaches exemplary compositions with lower concentrations of GC does not necessarily mean that higher concentrations do not have an anti-microbial effect. Furthermore, whether a composition has a non-antimicrobial effect does not render it nonobvious. The Zakrewsky reference teaches usefulness of ionic liquids for non-antimicrobial applications. While the intended use limitation is not given patentable weight because it does not structurally limit the claim, the intended use is nevertheless suggested by Zakrewsky.
With respect to concentrations, the recitation of ranges in ‘627 is sufficient disclosure to motivate a PHOSITA to optimize concentrations. Applicant refers to the Background of ‘627 as an indication that 10% by weight ionic liquid is a disadvantage. The statement in the prior art is merely stating that the disadvantage of prior art compositions is that they require 10% by weight, not that 10% concentration is necessarily a disadvantage. The arguments regarding the Omeprazole case and solvent combinations have been previously addressed on p. 3 of the 10/01/2025 Non-Final Rejection.
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 49, 61-62, 64-65, 73 and 75 are rejected under 35 U.S.C. 103 as being unpatentable over WO2017164627A2 (hereinafter ‘627); Machine translation provided and referenced herein (page numbers refer to translation document).
‘627 teaches compositions comprising a choline cation and a geranic acid anion (see “CG” on p. 14) which are efficacious in biofilm removal. ‘627 teaches choline geranate in a molar ratio of 1:2 (see Biofilm Removal Experiment 2, p. 13) and that the 1:2 ratio is more efficacious than a 1:1 ratio (see Experimental Example 3, p. 14) ‘627 also teaches the use of a humectant and that the humectant may be used alone or in combination, for example, not lot limited to … glycerin, polyethylene glycols or propylene glycol (p. 8).
‘627 does not specifically teach: about 10% to about 40% by weight of 1:2 CG; a combination of PEG, glycerin, and propylene glycol; and 5% to 20% propylene glycol.
With respect to claim 49, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). There is no evidence that the concentration of CG taught by the prior art is critical, nor that the claimed concentration imparts any unexpected results. Additionally, the claimed range of 10% to 40% is broad enough that it would have easily been achieved during the routine optimization under the prior art conditions. Furthermore, with respect to the specific combination of glycerin, PEG and propylene glycol, the prior art teaches the use of each or the combination thereof. Furthermore, each is a common excipient in topical formulations. The skilled artisan would have arrived at the claimed combination given both the teachings of the prior art and the general knowledge available to the PHOSTIA to include each in a topical formulation. With respect to the amount of propylene glycol, ‘627 discloses the use of propylene glycol as a solvent (see claim 28 on p. 3) but does not disclose a specific concentration of propylene glycol. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See MPEP 2144.05. The skilled artisan would have been motivated to use propylene glycol as a solvent as taught by ‘627. Absent evidence of criticality, the claimed range is obvious.
With respect to claims 61-62 and 64, ‘627 teaches a specific embodiment intended for use as a toothpaste (see p. 15). It would have been obvious to include peppermint oil and/or D-limonene in a toothpaste composition in order to give the composition a pleasant scent and/or flavor, such as peppermint or citrus.
With respect to claim 65, ‘627 discloses the use of a pH adjuster “which [is] typically used in the preparation of an oral composition” and gives citric acid as an example of a pH regulator (adjuster) (see p. 8). The skilled artisan would have found it obvious to include citric acid as a pH adjuster in order to regulate pH which is routine in the art as taught by ‘627.
With respect to claim 73, the composition of ‘627 is intended as a toothpaste (see p. 15) which is formulated for topical administration.
With respect to claim 75, the glycerin taught by ‘627 is a humectant. See also response to arguments herein.
Claims 49, 61-62, 64-65, 73 and 75-76 are rejected under 35 U.S.C. 103 as being unpatentable over WO2017164627A2 in view of ZAKREWSKY MICHAEL ET AL: "Ionic liquids as a class of materials for transdermal delivery and pathogen neutralization", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, vol. 111, no. 37, 25 August 2014 2014-08-25), pages 13313-13318 (hereinafter "ZAKREWSKY" and Osborne, "Diethylene glycol monoethyl ether: an emerging solvent in topical dermatology products" 2011, Journal of Cosmetic Dermatology, 10, 324–329 (hereinafter “OSBORNE”).
With respect to claim 76, the composition of ‘627 is for use on biofilms and also discloses the presence of biofilms on skin (see p. 4), indicating that the compositions of the disclosure may be useful for application to skin. ZAKREWSKY further notes the effectiveness of ILs/choline geranate in application to skin: “choline-geranate emerged as a multipurpose IL with excellent antimicrobial activity, minimal toxicity to epithelial cells as well as skin, and effective permeation enhancement for drug delivery (see abstract p. 13313; see also whole document). It would have been obvious to modify the composition of ‘627 for topical delivery to skin given the teachings of ZAKREWSKY. OSBORNE teaches “Diethylene glycol monoethyl ether is commonly used as a solvent for topical products, with pharmaceutical formulators taking advantage of its ability to modify skin penetration and the cosmetic industry using it to alter product rub-in and feel.” It would have been obvious to use diethylene glycol monoethyl ether in a topical composition formulated for the skin in order to modify skin penetration and alter the product’s rub-in and feel as taught by OSBORNE.
In summary, the claimed composition is merely a specific, broad concentration of a known active component (CG) with a specific combination of excipients which are both suggested by the prior art and routinely used by a PHOSITA in topical formulation (glycerin, PEG, propylene glycol). Absent a showing of criticality and/or unexpected results commensurate in scope with the claimed ranges/components, the claims are obvious. See also response to arguments herein.
Conclusion
Claims 49, 61-62, 64-65, 73 and 75-76 are rejected.
Claims 78-80 are withdrawn.
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 JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/ Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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