Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
The Examiner acknowledges receipt of Applicant’s Response to Restriction and Election Requirements, filed 4 August 2026. Upon finalization and entry of the Restriction/Election Requirements (see below), claims 1 – 8 will be available for active consideration.
Response to Restriction/Election
The Examiner acknowledges Applicants’ election, without traverse, of the invention of Group I, claims 1 – 8, in the Response filed on 4 August 2026. The Examiner further acknowledges Applicants’ election of the species, allyl isothiocyanate, from the genus defined as composition components, for further examination.
Claims 9 – 20 are hereby withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1 - 8 are under consideration to the extent that the elected species of components is allyl thiocyanate. In this regard, the Examiner notes that claim 1 recites a limitation directed to the composition of the invention comprising two or more of the components recited in claim 1. To meet this limitation, and consistent with Applicant’s election of species, the Examiner is interpreting claim 1 as being directed to a composition comprising allyl isothiocyanate and at least one of the additional components recited in claim 1.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement (IDS) filed 14 April 2025, which is now of record in the file.
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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.
Claims 1 – 8 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 5,965,518 to Nakatsu, T., et al., published 12 October 1999, identified on the Information Disclosure Statement (IDS) filed 14 April 2025, cite no. A2 (USPAT) (“Nakatsu ‘518”), in view of US 5,436,268 to Ohama, C. and K. Kato, issued 25 July 1995, identified on the IDS filed 14 April 2025, cite no. A1 (USPAT) (“Ohama ‘268”), and Mandras, N., et al., BMC Complementary and Alternative Medicine 16: 330 (2016) (“Mandras (2016”).
The Invention As Claimed
Applicant claims a composition comprising allyl isothiocyanate and thymol, a fragrance, and (optionally) an emulsifier, wherein the effective microbial inhibitory headspace concentration is about 1 x 10-5 to about 10 µg/L of allyl isothiocyanate and thymol, wherein the composition comprises about 0.25 to about 25% wgt of allyl isothiocyanate and thymol, wherein the composition comprises about 0.25 to about 3% wgt of allyl isothiocyanate, or about 1 to about 1.5% wgt, and about 0.25 to about 3% wgt of thymol, and wherein the composition does not comprise citral.
The Teachings of the Cited Art
Nakatsu ‘518 discloses a fragrance composition having antimicrobial activity comprising between 3 and 20% phenolic compounds, and between 20 and 80% non-aromatic terpenoids, the fragrance composition further has an Odor Intensity Index of less than 100, and an Odor Evaluation Acceptability Index of greater than 50 and is suitable for use in a variety of products (see Abstract), wherein the fragrance composition achieves a Minimal Inhibitory Concentration (MIC) in media at or below normal use concentration within two days (see Col. 2, ll. 18 – 20), wherein the fragrance composition reduces the microbial number by at least 1.5 log cfu/mL within 30 minutes, at ambient temperature at or below normal use concentration (see Col. 2, ll. 21 – 24; see also, Table 9), wherein the compounds used in the fragrance compositions comprise thymol, eugenol, linalool, and/or terpinenol (see Col. Ll. 25 – 45), wherein, am exemplified embodiment, thymol is present in the composition at 7.5 - 10% wgt (see, for example, Table 3), and wherein compositions from Tables 1 – 3 all exhibited strong antimicrobial activity against Staphylococcus aureus ATCC 6538 and Staphylococcus epidermidis ATCC 12228 (see Col. 6, ll. 13 – 19). The reference does not explicitly disclose antibacterial fragrance compositions wherein the compositions comprise allyl isothiocyanate. The teachings of Ohama ‘268 and Mandras (2016) remedy that deficiency.
Ohama ‘268 discloses processes for germ-destroying air, water, and food, including a germ-destroying step using an isothiocyanic acid ester, as well as germicidal gas compositions containing an isothiocyanic acid ester (see Abstract), wherein it is known to subject food to a germ-destroying treatment using an isothiocyanate (a major component of wasabi) (see Col. 1, ll. 58 – 59), wherein the processes provide germ-free air (see Col. 2, ll. 52 – 53), wherein the germ-free air can be prepared by admixing the air with the ISOTC vapor to thereby destroy or kill harmful microorganisms contained in the air and removing the isothiocyanate from the air (see Col. 3,ll. 5 – 8; see also, Col. 7, ll. 41 – 68), wherein the preferred isothiocyanate is allyl isothiocyanate (see Col. 4, ll. 11 – 12), wherein a liquid agent for generating an isothiocyanate vapor is a solution obtained by dissolving the isothiocyanate in an oily liquid that has a vapor pressure (saturated vapor pressure) at 30° C of 2 mmHg, such as olive oil, sesame oil, safflower oil, soybean oil, tsubaki oil, corn oil, rape oil, castor oil, sunflower oil, cottonseed oil, peanut oil, cacao butter, palm oil, clove oil, coconut oil, beef tallow, fish oil, hardened oil, turtle oil, or yolk oil, among others (see Col. 4, ll. 21 – 40), and wherein the concentration of the isothiocyanate in the oil is present in an amount from 0.01 – 50% wgt (see Col. 4, ll. 50 -52).
Mandras (2016) discloses that the minimum inhibitory concentration (MIC) and the minimal fungicidal concentration (MFC) of essential oils (thyme red, fennel, clove, pine, sage, lemon balm, and lavender) and their major components were investigated by a broth microdilution method (BM) and a vapor contact assay (VC), wherein thyme red oil (MIC50-MIC90 = 0.0038% (v/v) for C.albicans and C.tropicalis, and 0.0078 - < 0.015% (v/v) for C.glabrata), were the most effective by the VC assay, with thymol showing the highest activity, and its use in the vapor phase can provide additional advantages, all without the need for direct contact, resulting in ease of environmental application (see Abstract), wherein the vapor contact assay was performed using concentrated Roswell Park Memorial Institute (RPMI) 1640 [culture medium] buffered to pH 7.0 with 0.165 M morpholinepropanesulfonic acid (MOPS), mixed with molten 3.0 % (w/v) agar in an equal ratio after which the RPMI/agar was poured into a 90-mm Petri dish and spot inoculated with 100 µL of standardized suspension of each strain tested; then a glass slide (1-cm size) was placed in the cover of the Petri dishes so that it did not directly touch the surface of the agar medium, and various amounts of pure essential oils (EO’s), or their components, were added to obtain a final concentration ranging from 1 to 0.0019% (v/v) of the air space, calculated to be 70 cm3 of air, after which sealed plates were incubated at 37° C for 48 hours, and the MIC (percentage, v/v air space) was determined by comparison with the control and was defined as the lowest concentration of EO inhibiting the visible growth (see p. 3, 1st col., last para. – 2nd col., 1st para.), wherein the MIC values obtained with vapor contact assays were lower than those in liquid medium for all the EO’s tested, with thyme oil showing the highest (MIC90 < 0.0038% (v/v) against C.albicans (see p. 3, 2nd col., last para. – p. 4, 1st col., 1st para.), wherein the MIC values showed that EO’s activity is higher than that obtained with the conventional antifungal drugs tested against C.glabrata and C.tropicalis (see p. 4, 2nd col., 2nd para.), wherein thyme red oil comprises thymol at 26.5% (v/v) (see p. 5, 1st col., 1st para.), wherein the antimicrobial activity data of EO’s depends on the methodology used, the variability of which includes
factors such as inoculum size, medium used, and use of sealants, surfactants and solvents (see p. 5, 1st col., last para. – 2nd col., 1st para.), wherein thymol, known to be lipophilic can enter between the fatty acyl chains making up membrane lipid bilayers, thus altering the fluidity and permeability of cell membranes (see p. 5, 2nd col., 3rd para.), wherein EO’s possess high antimicrobial activity in the vapor phase, and phenols, such as thymol, are among the most active natural antioxidants and antimicrobials found in EO’s (see p. 6, 1st col., 3rd para.), and wherein the data on vapor contact methods indicate that volatile screening should be employed for fumigation or active packaging purposes (see p. 6, 1st col., last para.).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare fragrance compositions having antimicrobial activity, the compositions comprising between 3 and 20% phenolic compounds, the fragrance compositions suitable for use in a variety of products, wherein the fragrance composition achieves a Minimal Inhibitory Concentration (MIC) in media at or below normal use concentration within two days, wherein the fragrance composition reduces the microbial number by at least 1.5 log cfu/mL within 30 minutes, at ambient temperature at or below normal use concentration, wherein the compounds used in the fragrance compositions comprise thymol, eugenol, linalool, and/or terpinenol, among others, wherein, in an exemplified embodiment, thymol is present in the composition at 7.5 - 10% wgt (see, for example, Table 3), and wherein compositions from Tables 1 – 3 all exhibited strong antimicrobial activity against Staphylococcus aureus ATCC 6538 and Staphylococcus epidermidis ATCC 12228, as taught by Nakatsu ‘518, wherein the compositions can also comprise germicidal gas compositions containing an isothiocyanic acid ester, wherein the compositions are used in processes to provide germ-free air, wherein germ-free air can be attained by admixing the air with isothiocyanate vapor to destroy or kill harmful microorganisms contained in the air, wherein the preferred isothiocyanate is allyl isothiocyanate, wherein a liquid agent for generating an isothiocyanate vapor is a solution obtained by dissolving the isothiocyanate in an oily liquid that has a vapor pressure (saturated vapor pressure) at 30° C of 2 mmHg, and wherein the concentration of the isothiocyanate in the oil is present in an amount from 0.01 – 50% wgt, as taught by Ohama ‘268, and wherein the minimum inhibitory concentration (MIC) and the minimal fungicidal concentration (MFC) of essential oils (thyme red, fennel, clove, pine, sage, lemon balm, and lavender) and their major components were investigated by a vapor contact assay (VC), wherein thyme red oil (MIC50-MIC90 = 0.0038% (v/v) for C.albicans and C.tropicalis, and 0.0078 - < 0.015% (v/v) for C.glabrata), were the most effective by the VC assay, with thymol showing the highest activity, wherein the vapor contact assay was performed using concentrated Roswell Park Memorial Institute (RPMI) 1640 [culture medium] buffered to pH 7.0 with 0.165 M morpholinepropanesulfonic acid (MOPS), mixed with molten 3.0 % (w/v) agar in an equal ratio, after which the RPMI/agar was poured into a 90-mm Petri dish and spot inoculated with 100 µL of standardized suspension of each strain tested; then a glass slide (1-cm size) was placed in the cover of the Petri dishes so that it did not directly touch the surface of the agar medium, and various amounts of pure essential oils (EO’s), or their components, were added to obtain a final concentration ranging from 1 to 0.0019% (v/v) of the air space, calculated to be 70 cm3 of air, after which sealed plates were incubated at 37° C for 48 hours, and the MIC (percentage, v/v air space) was determined by comparison with the control and was defined as the lowest concentration of EO inhibiting the visible growth, wherein the MIC values obtained with vapor contact assays were lower than those in liquid medium for all the EO’s tested, with thyme oil showing the highest (MIC90 < 0.0038% (v/v) against C.albicans (see p. 3, 2nd col., last para. – p. 4, 1st col., 1st para.), wherein the MIC values showed that EO’s activity is higher than that obtained with the conventional antifungal drugs tested against C.glabrata and C.tropicalis (see p. 4, 2nd col., 2nd para.), wherein thyme red oil comprises thymol at 26.5% (v/v) (see p. 5, 1st col., 1st para.), wherein the antimicrobial activity data of EO’s depends on the methodology used, the variability of which includes factors such as inoculum size, medium used, and use of sealants, surfactants and solvents, wherein EO’s possess high antimicrobial activity in the vapor phase, and phenols, such as thymol, are among the most active natural antioxidants and antimicrobials found in EO’s, and wherein the data on vapor contact methods indicate that volatile screening should be employed for fumigation or active packaging purposes, as taught by Mandras (2016). One of ordinary skill in the relevant art would be motivated to do so, with a reasonable expectation of success in so doing, by the express disclosures of Ohama ‘268 demonstrating that allyl isothiocyanates are effective in the vapor phase at producing germ-free air (see, for example, Col. 2, ll. 52 – 53), and by the teachings of Mandras (2016) to the effect that phenols, such as thymol, are among the most active natural antioxidants and antimicrobials found in essential oils (see p. 6, 1st col., 3rd para.).
The Examiner first notes that the claims are being examined solely on the basis of the identities of components and relative loadings thereof in the compositions. The claims are not being examined on the basis of the headspace concentration of the components, as recited in the preamble to claim 1, because the recitation in the preamble is merely directed to an intended use of the composition and not to a structural or compositional property of the compositions of the invention. The recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, where the claimed and prior art products are identical, or substantially identical, in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP § 2112.01 I.
In application of this principle, claim 2, directed to an effective microbial inhibitory headspace concentration, relates only to the intended use of the compositions as stated in the preamble and is, therefore, not a factor in evaluating patentabilty of the claimed invention. More specifically, and from a technical perspective, it is the Examiner’s position that what concentration of any of the composition’s components in the headspace would be effective in inhibiting microbial activity is an inherent property of the individual components and the microbe to be inhibited. Whether or not a composition can yield such a concentration is not relevant to the core question of patentability. After all, the invention is directed to a composition, and not to a method for inhibiting microbial activity in a vapor phase.
For claims 3, 4, and 7, which claims recite quantitative limitations in the form of ranges of relative concentrations of the components of the composition, the Examiner notes that the cited art does not disclose concentration ranges that are exactly congruent with the claimed ranges. However, it is the Examiner’s position that the cited art teaches a range of concentrations of these components that significantly overlap with the claimed loadings and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “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 addition, or in the alternative, it is the Examiner’s position that preparing specific concentrations of the components of the compositions that would read on the limitations in question would amount to nothing more than an optimization of a result-effective variable, the exercise of which is well with the expertise of one of ordinary skill in the appropriate art, particularly in light of specific disclosures in the cited art, such as the antimicrobial activity data of EO’s being dependent on the methodology used, the variability of which includes factors such as inoculum size, medium used, and use of sealants, surfactants and solvents (see Mandras (2016), p. 5, 1st col., last para. – 2nd col., 1st para.). Consequently, in the absence of evidence as to the criticality of such parameters, these limitations cannot support patentability. See MPEP § 2144.05 II. A.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1 - 8 would have been obvious within the meaning of 35 USC § 103.
NO CLAIM IS ALLOWED.
CONCLUSION
Any inquiry concerning this communication or any other communications from the examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The examiner can normally be reached on M-F 8:30 am - 5:30 pm.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David J Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
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