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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/14/2026 has been entered.
Status of Claims
Receipt of Remarks/Amendments filed on 07/14/2026 is acknowledged. Claims 1 and 6 are amended and claims 8-10 and 15 are canceled. Claims 4 and 16-20 remain withdrawn as being directed to a non-elected invention/species. Claims 1-3, 5-7, and 11-14 are examined on the merits herein.
Priority
The instant application filed 10/18/2023, claims benefit to U.S. Provisional Application No. 63/380,007, filed 10/18/2022.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 5-7, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Foster, S., et al. (WO 2019090105 A1, 05/09/2019, on record), hereinafter Foster, in view of Bobbert, I. (WO 2015091925 A1, 06/25/2015, IDS dated 03/05/2024), hereinafter Bobbert.
Foster discloses an antimicrobial composition comprising 3-phenylpropanol alone or in combination with an organic acid or salt thereof (abstract). Specifically, it has been found that 3-phenyl propanol is highly effective as an antimicrobial when combined with sodium benzoate ([0016]).
Regarding claim 1: Foster discloses antimicrobial compounds based on use of 3-phenyl propanol alone or in combination with other compounds having antimicrobial activity, in particular organic acids or salts thereof and/or alcohols ([0025]). Explicitly disclosed are antimicrobial composition comprising 3-phenyl propanol, which reads on the instantly claimed alkyl aryl alcohol microbial synergist, in combination with sodium benzoate, which reads on the instantly claimed carboxylic acid salt preservative, and benzyl alcohol ([0034]; [0038]; claim 12; table 1). Other organic acids (or salts thereof) are useful in combination with 3-pheny propanol including lactic acid ([0076]; claim 3).
Amounts of 3-phenyl propanol useful to achieve antimicrobial effects when used in an end-use formulation range from 0.1 wt.% to 1 .99 wt.%, based upon the total weight of the components of the end use product ([0077]). Additionally, FIG. 1-10 reflect log reduction data for colony forming units (CFU) of microbe strains exposed to 3-phenyl propanol (alone) at various concentrations ([0042]-[0051]). As seen in Figures 1-10, concentrations of 3-phenyl propanol range from 0 to 2.5% by weight, with the 2.5% concentration having the same or better log reduction in bacterial growth as a 1% concentration (FIG. 1-10).
Amounts of sodium benzoate suitable for use in combination with 3-phenyl propanol range from 0.005 wt.% to 10 wt.%, based upon the total weight of the components of the end use product ([0080]). Ranges for other organic acids (or salts thereof) in combination with 3-phenyl propanol are expected to be the same or substantially close to the ranges for sodium benzoate ([0081]).
Regarding claims 6-7: The sodium benzoate of Foster reads on a salt of benzoic acid.
Regarding claim 13: The antimicrobial compositions of Foster may be in the form of concentrated antimicrobial blends diluted with a solvent, wherein the solvent is water, ethanol, propanol, isopropyl alcohol, propylene glycol, etc. ([0084]-[0085]; claims 21-22). A specific skin lotion formulation comprises water (table 1), which reads on the instantly claimed solvent.
Regarding claim 14: A specific skin lotion formulation comprises glycerin as a humectant, xanthan gum as a rheology modifier (aka. a thickener), and mineral oil and petrolatum as emollients (table 1).
The teachings of Foster differ from that of the instantly claimed invention in that Foster does not explicitly teach a single embodiment comprising the carboxylic acid of claims 1 and 3, nor does Foster explicitly teach a single embodiment having the concentrations of claim 1. Foster also fails to explicitly teach a specific embodiment comprising an additional organic acid or preservative as recited in claims 2 and 5.
Bobbert discloses an antimicrobial disinfecting composition comprising 0.1 to 1 wt. % of a food allowed organic acid or salt thereof (abstract; claim 1), specifically lactic acid (claim 7), which reads on the carboxylic acid of claims 1 and 3. Formulation 7 comprises lactic acid, sodium benzoate, and phenoxyethanol (table 1). Lactic acid is present at 0.95% w/w, which falls within the instantly claimed range for the organic acid in claim 1 (i.e., 0.5-1.5 wt.%) (table 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to include lactic acid in the antimicrobial composition of Foster since lactic acid is a known and routine antimicrobial organic acid in the art as taught by Bobbert. One of ordinary skill in the art could have added lactic acid, as taught by both Foster and Bobbert, into the antimicrobial composition of Foster which already comprises 3-phenyl propanol and sodium benzoate, according to known methods to predictably yield a composition comprising the carboxylic acid of claims 1 and 3. Furthermore, both Foster and Bobbert teach antimicrobial compositions comprising organic acids and an alkyl aryl alcohols. “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.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding the amount of the lactic acid (i.e., carboxylic acid) and sodium benzoate (i.e., carboxylic acid salt) recited in claim 1, Foster teaches 0.005 wt.% to 10 wt.% of sodium benzoate, based upon the total weight of the end use product, and a similar range for any additional organic acids. Such a range encompasses the amounts of the instantly claimed carboxylic acid (i.e., 0.5-1.5%) and carboxylic acid salt (i.e., 1-1.5%), as defined in claim 1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Furthermore, Bobbert teaches an amount of 0.95% w/w of lactic acid when used in an antimicrobial composition also comprising sodium benzoate and an alkyl aryl alcohol. It would have been prima facie obvious to one of ordinary skill in the art to include lactic acid at an amount of 0.95% w/w in the combined composition, since such an amount is known and effective in similar antimicrobial compositions to that of Foster. Such an amount falls within the instantly claimed range of a carboxylic acid (i.e., 0.5-1.5 wt.%), as recited in claim 1.
Regarding the amount of 3-phenyl propanol, Foster teaches a range of 0.1 wt.% to 1.99 wt.%, which is very close to the claimed amount of 2 wt. %, as recited in claim 1. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05. Additionally, Foster teaches that concentrations of 3-phenyl propanol alone up to 2.5 wt.% were tested for antibacterial activity. One of ordinary skill in the art would recognize from the figures of Foster that a concentration of 2.5% was just as if not more effective than a concentration of 1%. Thus, while Foster does not explicitly teach the composition to comprise the instantly claimed amounts of phenyl propanol (i.e., 2-3 wt.%) it is well within the abilities of an ordinary artisan to optimize it’s amount in the composition depending on the desired antimicrobial effect of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed range of 2 to 3% through no more than routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, the amount of phenyl propanol directly impacts antimicrobial effect, as indicated by Figures 1-10 of Foster. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B).
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications since Foster welcomes the addition of other organic acids such as lactic acid and Bobbert teaches that lactic acid, sodium benzoate, and alkyl aryl alcohols may be used together to provide an antimicrobial effect.
Regarding claims 2 and 5, it is discussed above the Foster teaches other organic acids (or salts thereof) and alcohols as useful in combination with 3-phenol propanol. Exemplary non-limiting organic acids (and salts thereof) include: benzoic acid, dehydroacetic acid, acetic acid, citric acid, formic acid, propionic acid, fumaric acid, sorbic acid, lactic acid, sodium benzoate, potassium benzoate, potassium sorbate, sodium sorbate, sodium citrate, or sodium lactate, or mixtures thereof, all of which read on the carboxylic acid or carboxylic acid salts of claims 2 and 5. Exemplary non-limiting alcohols include: phenyl ethanol or phenoxyethanol ([0076]; claim 3), both of which read on the phenolic compounds of claim 5. As such, it would have been prima facie obvious to one of ordinary skill in the art to add in an additional carboxylic acid, carboxylic acid salt, or phenolic compound to the combined composition above since these ingredients are known and routine compounds in combination with 3-phenol propanol as taught by Foster. One of ordinary skill in the art could have incorporated any one of these compounds into the antimicrobial composition according to known methods to yield predictable results.
As such, the prior art teaches all the components of the composition as claimed with amounts within or nearing the instantly claimed ranges. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Regarding the recitation of “hand wash”, such language is classified as intended use. In the instant case, the combined composition of Foster and Bobbert is capable of functioning as a hand wash whether or not it is explicitly taught.
Claims 1-3, 5-7, and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Foster and Bobbert as applied to claims 1-3, 5-7, and 13-14 above, and further in view of Vermeulen, Y., et al. (US 20160081897 A1, 03/24/2016, IDS dated 03/05/2024), hereinafter Vermeulen.
The combined teachings of Foster and Bobbert are discussed above.
The combined teachings of Foster and Bobbert differ from that of the instantly claimed invention in that they do not explicitly teach the surfactants of claims 11 and 12.
Vermeulen discloses an antibacterial cleansing composition comprising lactic acid (abstract). Example 1 of Vermeulen discloses composition A which comprises lactic acid, sodium benzoate, and phenoxyethanol (p. 4, Ex. 1). Composition A further comprises sodium cumenesulfonate, sodium laureth sulfate, and cocamidopropyl betaine, all of which are examples of anionic or amphoteric surfactants as defined in claim 11, as evidenced by Vermeulen ([0017]) and the instant specification ([0086]; [0092]; [0114]). The sodium cumenesulfonate and sodium laureth sulfate read on the sulfate and sulfonate of (i) in claim 12, while the cocamidopropyl betaine reads on the CAPB of (iii) in claim 12. Together, these surfactants read on (iv) a combination thereof, as defined in claim 12.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to add the surfactants of Vermeulen into the combined composition of Foster and Bobbert, since such surfactants are known and routine in the art as taught by Vermeulen. One of ordinary skill in the art could have added the surfactants of Vermeulen according to known methods to predictably yield the instant invention of claims 11 and 12. As such, all of the claimed elements were known in the prior art and one skilled in the art could have combined said elements by known methods with no change in their respective functions to predictably yield the instant invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). One of ordinary skill in the art would have had a reasonable expectation of success in adding the surfactants of Vermeulen into the combined composition of Foster and Bobbert since Vermeulen teaches antimicrobial compositions comprising organic acids (or salts thereof) in combination with sodium benzoate and alky aryl alcohols.
Response to Arguments
Applicant's arguments filed 07/14/2026 have been fully considered but they are not persuasive:
(1) Applicant argues that the upper limit of 1.99 wt.% in Foster does not overlap with the instantly claimed range which recites a lower limit of 2 wt.%. Applicant asserts that Foster not only fails to disclose the claimed range but affirmatively teaches away from it. Applicant argues that Foster’s deliberate selection of 1.99 wt.% as an upper limit signals an intentional exclusion at or above 2 wt.% and that Foster’s inventive concept is directed to achieving antimicrobial efficacy at lower concentrations. As such, applicant concludes that a skilled artisan would be directed towards a lower concentration of phenyl propanol rather than the concentrations above 2 wt. % as claimed (p. 6-9 of Remarks).
As discussed in the rejection above, the 1.99 wt. % taught by Foster is extremely close to the instantly claimed amount of 2 wt.%. There is no evidence on the record that indicates a critical difference would occur when 2% versus 1.99% is used. In fact, Foster teaches that concentrations of 2.5% phenyl propanol alone had an effective antimicrobial effect. Thus, one of ordinary skill in the art could have easily derived the instantly claimed amount of phenyl propanol from the broader teachings of Foster and the natural desire to optimize a formulation through routine experimentation. There is no explicit teaching by Foster that concentrations of 2 to 3% phenyl propanol would be ineffective. Rather, Figures 1-10 indicate that higher concentrations would be just as if not more effective. Likewise, there is no teaching by Foster that higher concentrations are undesirable. Just because Foster found phenyl propanol to be effective at lower concentrations than previously disclosed, does not constitute a teaching away from the instantly claimed concentrations which are just barely higher than those taught by Foster.
(2) Applicant argues that Bobbert and Vermeulen fail to cure the deficiency of Foster in regard to the amount of phenyl propanol. Applicant asserts that since Bobbert and Vermeulen teach concentrations of an alkyl aryl alcohol of “optimally less than about 1 wt.%” and 0.9925 wt.%, respectively, that there is no motivation to increase phenyl propanol to the higher concentration of claim 1 (p. 8-9 of Remarks).
As discussed above, Foster is relied on for teaching the phenyl propanol and its amount, as well as the motivation and reasoning behind optimizing it to be within the instantly claimed range. As such, it is not required for Bobbert or Vermeulen to cure this particular “deficiency”.
(3) Applicant argues against the rationale that “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close” since Foster teaches away from the claimed range (p. 9-10 of Remarks).
As discussed above, Foster provides no explicit teaching away from the instantly claimed range. A teaching away would require a statement describing how amounts within the range of 2 to 3% are undesirable. Foster provides no such teaching. Rather, it appears from the broader teachings of Foster that the claimed concentration could have been derived through no more than routine experimentation as motivated by a desire to optimize antimicrobial effect.
(4) Applicant asserts that the synergy data from Table 9, Figures 1 and 2 of the instant specification serves as additional evidence that the specific combination of the claimed components at the claimed concentrations produces results not suggested by the prior art (p. 10-11 of Remarks).
As stated in the previous office action, Figures 1 and 2 do not indicate significant synergism in the base formulation (i.e., benzoate + lactic acid + phenyl propanol) as compared to each element alone. Generally, to claim “synergy” a greater than additive effect must be observed. See MPEP 716.02(a). In the instant case, it does not appear that the base formula results in a greater than additive effect nor does the base formulation seem significantly better than the 1% benzoate alone. For example, based on Figure 1, the additive log reduction of 1% benzoate alone, 1% lactic acid alone, and 2% phenyl propanol alone would seem to produce a total log reduction much greater than the “base formula”. As such, Applicant’s assertion of synergy is not found convincing based on the instant data. Additionally, Figures 1 and 2 only provide a comparison with the base formulation having 1.25% benzoate, 1.25 % lactic acid, and 2.5% phenyl propanol, when the claims are drawn to larger concentration ranges. As such, it is unclear if every combination across the claimed ranges would result in Applicant’s asserted synergy.
Secondly, if Applicant intends to rely on data to prove an non-obvious difference between the 1.99 wt. % phenyl propanol of Foster and the 2 wt. % phenyl propanol as claimed, a comparison should be done between compositions comprising these amounts. In addition, this comparison would need to show a non-obvious, significant difference between the two. An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. See In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). In this case, applicant has not provided a comparison to the closest prior art to sufficiently show a criticality in the claimed amount of phenyl propanol.
Conclusion
No claims allowed.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616
