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 .
Applicants' arguments, filed 06/09/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 103—Previous
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.
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.
1) Claims 1-14 remain rejected under 35 U.S.C. 103 as being unpatentable over Kim et al., (J, Microbiol. Biotechnol. 2002, cited in IDS) in view of Morishima et al., (JP 2005-298357, cited in IDS) and further in view of Arutchelvi et al., (J Ind Microbiol Biochemical, 2008).
Kim et al. teaches use of sophorolipid as an antimicrobial agent having “antimicrobial activity against Bacillus subtilis, Staphylococcus xylosus, Streptococcus mutans, and Propionibacteriam acne” (Abstract). “These results show potential use of sophorolipid as an active ingredient in healthcare products” (Id.).
Kim et al. recognizes “lactone-type and acidic-type sophorolipids” (Id.).
Table 2 shows an inhibitory concentration of 1ppm for Streptococcus mutans, wherein the Sophorolipid “contained 95% acid-type” (Table 2, p. 237).
Since acid-type Sophorolipid has been shown to be effective at inhibiting Streptococcus mutans, it would have been obvious to use it in a method for enhancing and/or maintaining a subject’s oral health, since streptococcus mutans is a major contributor to microbial biofilm formation in the oral cavity, i.e. dental plaque (see also Technological Background below).
Kim et al. does not teach one or more of a carrier, an additive and/or an adjuvant.
Morishima et al. teaches compositions for the oral cavity comprising a biosurfactant produced by a microorganism “capable of inhibiting the formation of pathogenic bacterial plaques” (Abstract). The compositions are effective for treating oral diseases.
The biosurfactants are selected from “a glycolipid produced by the microorganism, a polypeptide produced thereby, and a derivative thereof” (SOLUTION), specifically “viscosin, surfactin and derivatives thereof” (Claim 2). Biosurfactants also derive from “sophorolipid”, “rhamnolipid”, “cellobiolipid or the like” (para. [0011]), as per claim 3. Further, “biosurfactants may be added alone or in combination of 2 or more thereof, but the amount of the biosurfactant is preferably from 0.0001 to 5% by weight of the total composition . . . from the view point of exhibiting bactericidal activity against pathogenic bacteria” (para. [0012]).
Suitable oral composition forms include “toothpastes, mouthwashes, gingival massage creams, topical applications, troches, chewing gums, and the like” (para. [0018]). For example in a toothpaste, abrasives, binders, thickeners, surfactants, perfumes, sweeteners, various active ingredients, and the like may be blended with the biosurfactants (para. [0019]), as per claim 26. Here, these abrasives, binders, thickeners represent suitable carriers and additives for oral care compositions.
The prior art teaches a specific embodiment of a toothpaste comprising 45% aluminium hydroxide, 2% gelling silica, 25% Sorbitol (humectant), 1% carboxy methylcellulose, 1% sucrose monopalmitate (additive/flavoring/sweetener), 1% sodium lauryl sulfate, 0.05% Timor, 0.5% Surfactin (biosurfactant/lipopeptide), 1% malic acid sodium, water (carrier) (para. [0038]), Example 1).
The amount of sophorolipids would have been comparable to the amount in this embodiment. Accordingly, it would have been obvious to provide a concentration of sophorolipids falling with in the claimed range of about 0.1 to about 5%.
As a toothpaste, use of sophorolipid would apply it to teeth, gums, etc., wherein the subject is mammal or human, as per claims 2-14.
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add one or more of a carrier, an additive and/or an adjuvant to the sophorolipid of Kim et al. since sophorolipid of Kim et al. would have been useful as an oral care treatment, wherein oral care treatments include one or more of a carrier and an additive, as taught by Morishima et al.
Since the oral care compositions of Morishima et al. comprise sophorolipid, the artisan would have had a reasonable expectation of success with the combination.
The method would have implicitly whitened stained teeth; treated and/or prevented gum disease, halitosis, dental caries, inflammatory conditions, healed open sores and wounds.
The combination of Kim and Morishima et al. differs from claim 1 insofar as it does not teach mannosylerythritol. For the sake of completion, the Examiner cites Arutchelvi et al.
Arutchelvi et al. teaches a review of mannosylerythritol lipids (aka MEL), which “are surface active compounds that belong to the glycolipid class of biosurfactants” (Abstract).
Concerning the use of MEL, the reference teaches, “Both MEL-A and MEL-B show strong activity against gram positive bacteria, weak activity against gram negative bacteria and no activity against fungi” (p. 1566, left column, 1st full paragraph).
The reference also adds, “The past 60 years of research on MEL has proved that it is the most promising extracellular glycolipid ever known because of its high yield, excellent surface activity, diverse biochemical functions, biocompatibility and its wide range of applications” (p. 1567, left column, last paragraph).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add mannosylerythritol to the oral care composition of Morishima et al., like sophorolipid, for its strong activity against gram positive bacteria. Since the compositions of Morishima et al. include combinations of biosurfactants (para. [0012]), where biosurfactants include “glycolipids” (para. [0009]), it would have been obvious to select MEL insofar as it is the most promising extracellular glycolipid ever known because of its high yield, excellent surface activity, diverse biochemical functions, biocompatibility and its wide range of applications, as taught by Arutchelvi et al. The artisan would have reasonably expected success with the combination insofar as the biosurfactants of Morishima et al. are used for their bactericidal activity against pathogenic bacteria.
2) Claims 1-14 remain rejected under 35 U.S.C. 103 as being unpatentable over Price et al., (WO 2017/029175).
Price teaches compositions comprising lactams and biosurfactants, suitable for use as antimicrobial, anti-biofilm and bacteriostatic compositions” (Abstract).
“The biosurfactant preferably comprises a microbially-derived biosurfactant. Preferably it comprises a glycolipid biosurfactant moiety which may be a rhamnolipid or sophorolipid or trehalolipid or a mannosylerythritol lipid (MEL) or a combination thereof (p. 5, lines 12-14).
Accordingly, it would have been obvious for the compositions to comprise a combination of sophorolipid and/or mannosylerythritol lipid, as per claim 1.
The amount of biosurfactant depends on the amount of lactam insofar as the reference teaches “[t]he ratio of lactam to biosurfactant may, for example, be from 1: 0.5 to 1:20, preferably from 1:0.5 to 1:10, such as from 1:0.5 to 1:5” (p. 6, lines 13-14). Since the reference teaches a lactam composition range of “preferably 0.01 to 5% wt.” (p. 5, lines 8-9), at a 1:1 ratio of lactam to biosurfactant, the concentration of biosurfactant would also fall within the same concentration range, i.e. preferably 0.01 to 5% wt.
“The composition may be an oral care composition (such as a toothpaste or mouthwash and may include, for example, fluoride and/or flavourings” (p. 8, lines 20-23).
As a toothpaste, use of sophorolipid and MEL would apply them to teeth, gums, etc., wherein the subject is mammal or human, as per claims 2-14.
The prior art is not anticipatory insofar as it does not require SLP or MEL; however, it would have been obvious to select them in an oral care composition given the teaching of the prior art to add them to oral care formulations.
Technological Background
1) The prior art made of record is considered pertinent to applicant's disclosure van der Kerk et al. US 4,039,655 (cited in IDS). van der Kerk et al. is pertinent for teaching, “Streptococcus mutans (by its action on saccharose) has been identified as the only bacteria in the oral cavity which excretes the plaque forming, insoluble, high-molecular weight carbohydrate. Therefore, the suppression of the growth of Streptococcus mutans would significantly reduce caries formation by eliminating the formation of plaque” (col. 1, lines 45-51)).
2) The prior art made of record is considered pertinent to applicant's disclosure Ernenwein et al. (US 2015/0150251, cited in IDS). Ernenwein et al. is pertinent for teaching, “Generally, commercially available sophorolipids are mixtures of acid or ester open forms, with lactone forms or closed forms, deacetylated, monoacetylated or nonacetylated” (p. 1, para. [0004]).
Response to Arguments
Applicant argues, “The use of the acidic SLP, as claimed, would seem to be in direct contrast to the preferred effect of Kim, that of using at least partially lactonic SLP as the better antimicrobial agent” (p. 4) insofar as Kim et al. teaches that the lactone form of sophorolipid inhibited cell growth more effectively than acid-type for B. subtilis and P. acne. Applicant further argues, “the paragraph immediately under Table 2 indicates the sophorolipids shown no indication toward Gram-positive bacteria” (p. 5).
The Examiner disagrees.
Initially, the notion that the lactone form of sophorolipid inhibited cell growth more effectively than acid-type for B. subtilis and p. acne does not teach away from use of the acid form for antimicrobial purposes, especially since the acid-type was shown to an effective antimicrobial agent against S. mutans, which is identified as the only bacteria in the oral cavity which excretes plaque forming carbohydrates.
It is well settled, “Although a reference that teaches away is a significant factor to be considered in determining unobviousness, the nature of the teaching is highly relevant, and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
Moreover, to conclude that sophorolipids show no indication toward Gram-positive bacteria is confusing, since applicant initially argued sophorolipid is effective against B. subtilis and P. acne, which are both gram positive bacteria.
Table 2 of Kim et al., shown below, clearly shows inhibition of B. subtilis, p. acne and S. mutans, all gram positive, at a concentration of 4, 0.5, and 1ppm respectively, where the sophorolipid contained 95% acid-type. NI or not inhibited was shown for E-coli., which is gram negative.
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Morishima specifically lists sophorolipid as biosurfactant for use in its compositions from the view point of exhibiting bactericidal activity against pathogenic bacteria, and Kim et al. provided evidence that the acid type sophorolipid is capable of inhibiting main pathogenic bacteria causing dental caries, i.e., Streptococcus mutans.
Conclusion
THIS ACTION IS MADE FINAL. 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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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Webb whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/WALTER E WEBB/ Primary Examiner, Art Unit 1612
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