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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Previous Rejections
Applicant’s arguments, filed January 7, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Status
Claims 2 and 6-7 are cancelled.
Claims 18-19 are newly added.
Claims 1, 3-5, and 8-19 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Obviousness Rejections
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
1) Claims 1, 3-4, 8-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kremer (WO 2009/037270 A1; of record), in view of Koch (WO 2022/122137 A1; of record).
Kremer teaches a composition and method for the prevention and/or reduction of the presence, growth and/or activity of gram-negative bacteria using a composition comprising glycerol-based fatty acid esters and polylysine and/or salts of polylysine, wherein said glycerol-based fatty acid ester is used as antibacterial agent. The composition is useful as an antibacterial agent in various products and applications including personal-care products and food and drink products (Abstract).
For claim 3, Kremer teaches ε-polylysine comprises 30 to 50 L-lysine monomers linked by the peptide bonds between the free carboxyl groups and the e-amino groups (pg 4: 11-18).
For claim 4, Kremer teaches (pg 4: 31-36):
High synergy leading to high antibacterial activities are observed with a composition comprising polylysine and/or a salt hereof combined with fatty acid ester of glycerol and fatty acid wherein said fatty acid comprises saturated fatty acid such as for example and not limited to hexanoic (C6) acid, octanoic (C8) acid, decanoic (C10) acid, dodecanoic (C12) acid, tetradecanoic (C14) acid
For claims 6 and 7, Kremer teaches a formulation comprising e-polylysine, C8-mono/diglyceride, C10-mono/diglyceride, and NaCl (pg 14, Table 2). It is noted that C8 acid is caprylic acid and C10 acid is capric acid; both fatty acids are available from fractionation of coconut oil.
For claim 8, Kremer teaches the method is useful for prevention or reduction of bacteria in foods, beverages, and cosmetics (Abstract).
For claims 9-12, Kremer teaches the following (pg 8: 23-32):
The composition comprising glycerol fatty acid and polylysine and/or a salt hereof may be available in solid or liquid form. If the composition is in liquid form, it generally is in the form of an aqueous composition, which may be a solution or a dispersion. Such an aqueous composition generally comprises, based on total weight of the solution, from 0.0001 wt% to up to 40 wt%, more preferably from 0.1 wt% to 35 wt%, and most preferably from 1 to 25 wt% of polylysine and from 0.0001 wt% up to 45 wt%, more preferably from 1 to 40 wt%, and most preferably from 5 to 35 wt% of a glycerol fatty acid ester according to the present invention.
Therefore, Kremer teaches a range that overlaps with the amounts claimed in method claims 9-12; because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
For claims 13 and new claim 19, Kremer teaches a cosmetic composition comprising an emulsifier (pg 8: 37 to pg 9: 3) and/or a particulate such as maltodextrin or silica (pg 9: 13-14).
Kremer does not teach a preservative composition that includes a glycol compound, a polylysine, and a medium chain fatty acid 1-monoglyceride derivative.
Koch teaches the missing element of Kremer.
Koch teaches formulations such as personal hygiene products, deodorant, anti-perspirants, anti-acne products, or anti-dandruff products comprising a specific 1,2-alkanediol or a 2,3-alkanediol or a mixture of a specific 1,2-alkanediol and a specific 2,3-alkanediol (Abstract).
Koch teaches the formulations comprising the alkanediol can also comprise antimicrobial compounds such as the medium chain fatty acid monoglyceride glyceryl caprylate, as well as polylysine (pgs 42-43, [0141]). Koch teaches a preferred combination is 1,2-hexanediol and glyceryl caprylate (pg 63, [0146]).This teaching reads on claims 1 and 13.
Koch further teaches the formulations preferably comprise moisturizing substances (humectants) for treating dry skin such as alkanediols comprising 3 to 10 carbon atoms, more preferably 1,2-propylene glycol (a propanediol) and or the butanediols 1,2-butylene glycol and 1,3-butylene glycol (pgs 78-79, [0161]). Koch further teaches the compositions can contain a vitamin (pg 72, [0150]); glycerin (pg 42, [0141]); emulsifiers (pg 85, [0177]); lipids (pg 81-83, [0165]-[0171]; hydrocarbon mineral oils (pg 83, [0172]); saccharides (pg 78, 0161]); caffeine (pg 143, [0241]); and/or antioxidants (pg 91, [0191]).
Regarding claims 14-17, Kremer teaches ranges overlapping those claimed, as set forth above (pg 8: 23-32). Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
For claim 18, Kremer teaches a cosmetic composition consisting of the combination of polylysine and glyceryl caprylate, and Koch teaches a preferred antimicrobial composition comprising 1,2-hexanediol and glyceryl caprylate.
For claim 19, Kremer teaches a cosmetic composition consisting of the combination of polylysine and glyceryl caprylate, and Koch teaches a preferred antimicrobial composition comprising 1,2-hexanediol and glyceryl caprylate.
The skilled artisan would have expected success in adding Koch's propanediol and/or butanediols to the personal care product composition of Kremer because Kremer teaches the combination of polylysine and glycerol fatty acid ester unexpectedly demonstrates a synergistic effect on the antibacterial activity resulting in an antibacterial activity which is significantly higher than the sum of the activities of the individual components of the composition (Kremer, pg 2: 11-17), and Koch teaches 1,2-propylene glycol, 1,2-butylene glycol, and 1,3-butylene glycol also increased antimicrobial effects in a composition comprising polylysine and/or medium chain fatty acid monoglycerides. The skilled artisan would have found it obvious to make the substitution because ordinarily skilled artisans would have predicted that the glycol compounds would be safe and effective based on the compounds' shared activity, generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
The skilled artisan would also have expected success in adding a vitamin, glycerin, emulsifiers, lipids, a hydrocarbon mineral oil, saccharides, caffeine, and/or antioxidants, as taught by Koch, to the personal care composition of Kremer since, generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
2) Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kremer (cited above), in view of Koch (cited above), and Kinnunen (“Antibacterial and antifungal properties of propylene glycol, hexylene glycol, and 1,3-butylene glycol in vitro,” Acta Dermato-Venereologica, 71(2), 148–150).
The teachings of Kremer and Koch are discussed above.
The combination of Kremer and Koch does not teach the claim 5 limitation of “the glycol compound comprises propanediol” within the claimed range of “from about 15 wt% to about 50 wt%” as set forth in claim 1.
Kinnunen teaches the missing element of the combination of Kremer and Koch.
Kinnunen teaches that 30% propylene glycol was able to kill Candida albicans, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes A, Streptococcus mitis, and E. coli (Abstract).
The person of ordinary skill would have had a reasonable expectation of success in selecting a propylene glycol (propanediol) in an amount of 30%, which is within the claimed range, in the composition of the combination of Kremer and Koch because Koch teaches propylene glycol as a antimicrobial element and Kinnunen teaches 30% propylene glycol was able to kill microbes such as Candida albicans, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes A, Streptococcus mitis, and E. coli.
Examiner’s Reply to Attorney Arguments dated 1/7/2026
1. Rejection of claims 1, 3, 4 and 6-8 under 35 U.S.C. § 102 over Kremer
The applicant argues that this rejection has been traversed, at least in view of the present arguments and/or claim amendments.
Applicant’s arguments, with respect to the rejection under 35 U.S.C. § 102 over Kremer have been fully considered and are persuasive and this rejection has been withdrawn.
2. Rejection of claims 9-12 under 35 U.S.C. § 103 over Kremer
The applicant argues that this rejection has been traversed, at least in view of the present arguments and/or claim amendments.
Applicant’s arguments, with respect to the rejection under 35 U.S.C. § 103 over Kremer alone have been fully considered and are persuasive and this rejection has been withdrawn.
3. Rejection of claims 2, 5, and 13-17 under 35 U.S.C. § 103 over Kremer and Koch
The applicant argues that amended claim 1 is not obvious over Kremer and Koch, either alone or in combination. The applicant argues that the “field of formulations can be viewed only as a highly unpredictable art.”
The Examiner acknowledges the argument presented, but does not consider it persuasive. As best understood by the Examiner, the applicant is arguing that every formulation is highly unpredictable and therefore any and all formulation claims should be allowable. The Examiner disagrees; Kremer teaches an antimicrobial composition comprising a mixture of glyceryl caprylate and polylysine, and Koch teaches that various alkanediols enhance the antimicrobial effect of both glyceryl caprylate and polylysine. As such, while the applicant argues that “MPEP § 2143.01 III provides "The mere fact that references can be combined or modified does not render the resultant combination obvious unless the results would have been predictable to one of ordinary skill in the art," one of ordinary skill would be motivated to combine an alkanediol with the mixture of glyceryl caprylate and polylysine, as taught by Koch.
The applicant argues that Koch teaches antimicrobial diols are useful in compositions which may comprise a compound taken from a laundry list of antimicrobials including glyceryl caprylate and polylysine (pgs 10-11 of the Remarks).
The Examiner acknowledges the argument presented, but does not consider it persuasive. As set forth in MPEP 2145(IV), “One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.” In the instant case, Koch provides motivation for adding an alkanediol to the antimicrobial composition of Kremer since Koch teaches the alkanediol enhances the antimicrobial efficacy of both glyceryl caprylate and polylysine, alone and in combination.
The applicant argues that “Kremer further describes that the ester is a combination of mono-esters and di-esters of glycerol, and that the fatty acid can be C6, C8, C10, C12, C14, C16, C18 acid, or mixtures thereof,” and “Kremer is silent regarding a glycol compound comprising at least one selected from the group consisting of ethylene glycol, propanediol, butanediol, and pentanediol, hexanediol, and cyclohexanediol.” The applicant further argues:
Kremer is also silent regarding a 1-monoglyceride derivative of a medium chain fatty acid (C6-C14), or that its amount ranges from about 15 wt% to about 50 wt% of the preservative composition. Indeed, Kremer does not specify the chemical structures of the mono-esters and di-esters of glycerol, and thus one of ordinary skill in the art would have understood that the ester of Kremer is a mixture of 1-monoglyceryl-ester, 2-monoglyceryl-ester, 1,2-diglyceryl-esters, and 1,3-diglyceryl-esters. As such, the amount of the ester as taught in Kremer is irrelevant in relation to the amount of the 1-monoglyceride derivative of amended claim 1, at least because the relative abundance of the 1-mono-esters, 2-mono-esters, 1,2-di-esters, or 1,3-di-esters in the mixture of Kremer is unknown and cannot be estimated with certainty.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. Regarding the length of the fatty acid glyceride, Kremer teaches the effectiveness of mixtures of C8-glyceride and polylysine in Figure 1 (see pg 11: 24-26). Further regarding Figure 1, Kremer teaches “Synergy, independent effect, and antagonism can be visualized in a plot of Oxy versus Ox.Oy. This is exemplified in Fig. 1 - 4, wherein different plots are given of OcxG, pLys (experimentally observed relative growth rate in the presence of mixtures of a monoglyceride and polylysine) (see pg 11: 13-16). As set forth in the claims, the “fatty acid ester of glycerol is a mono- or di-ester of glycerol, or a mixture” (pg 17, claim 2). As such, one of ordinary skill may select and utilize the C-8 monoester of glycerol as the fatty acid glycerol in the antimicrobial composition based on activity or another criteria (see also pg 17, claim 3). It is also noted that one of ordinary skill in the art would recognize that the mono acylation of glycerol favors the less sterically hindered 1-position over the 2-position.
2. Applicant allegations of “Unexpected and Desirable Effects”
The applicant argues the claimed composition are “able to dramatically reduce the growth of a wide variety of microorganisms including Escherichia coli, (Gram-negative), Pseudomonas aeruginosa (Gram-negative), Staphylococcus aureus (Gram-positive), Candida albicans (fungus), and Aspergillus brasiliensis (fungus),” and further argues that the “results are highly desirable and unexpected over the applied reference, neither of which can counter such a wide variety of microorganisms.”
The Examiner acknowledges the arguments and evidence presented, but does not consider them persuasive for at least the following reasons:
1. The compositions V1, V2, and V3 each contain significant amounts various antimicrobial compounds not included in the claimed composition including natamycin, behenyl alcohol, C14-C22 alcohols, and phenoxyethanol. As such, a direct comparison with the composition reported by Kremer or Koch cannot be made. See MPEP 716.02(b).
2. The instant claims recite ranges for each of polylysine, glyceryl monocaprylate, and the glycol. As set forth in MPEP 716.02(d), unexpected results must be commensurate in scope with the claims. In the instant case, the results do not appear to be commensurate in scope with the claims since the criticality of the claimed ranges has not been demonstrated. See MPEP 716.02(d)(II).
The following is also noted: the product disclosed in the Examples as “Glyceryl Caprylate”, apparently the commercial product “GMCY”, is in fact a mixture of monoglyceryl caprylates (85%) and diglyceryl caprylates (15%), as disclosed in the fact sheet for “Lexgard® GMCY MB”, found on the internet at https://www.inolex.com/products/lexgard-gmcy-mb.
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 MICHAEL P COHEN whose telephone number is (571) 270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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