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.
Priority
It is noted that the provisional application upon which priority is claimed fails to provide adequate support under 35 U.S.C. 112 for claims 18 and 26 of this application. The treatment of an RNA virus is initially recited in the instant application. As such, the effective filing date of claims 18 and 26 of this application is 1/8/2024, the filing date of the instant application.
Previous Rejections
Applicant’s arguments, filed May 18, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 1-15 are canceled.
Claims 33-34 are newly added.
Claims 16-34 are pending.
Claims 17 and 21 are withdrawn.
Claims 16, 18-20, and 22-34 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 16, 19-20, 22, and 24-32 are rejected under 35 U.S.C. 103 as being unpatentable over Gehin-Delval (WO 2012/072488 A1; of record), in view of Noznick (US 3,628,968) and Kalemba (“Antibacterial and Antifungal Properties of Essential Oils,” Current Medicinal Chemistry, 2003, 10, 813-829).
Gehin-Delval teaches an emulsion comprising an antimicrobial essential oil, acacia gum, and water for improving the antimicrobial effect of the essential oil in an aqueous composition, and the composition can be used in a method of administering food supplements and medication for animals (Abstract; pg 10: 5-14).
Gehin-Delval teaches the method utilized an amount of essential oil of up to 0.08% essential oil (pg 11: 5-11), and further teaches the weight ratio of the essential oil versus acacia gum in the emulsions generated by the above processes is in the range from about 1:0.5 to 1:50, preferably from about 1:0.5 to 1:1 (pg 11: 20-23), overlapping the range recited in claim 16. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05(I). Gehin-Delval teaches the essential oils of oregano, cinnamon, thyme and clove (pg 9: 8-25).
For claims 19 and 27, cinnamon oil meets the limitations of the claim since it comprises mainly (E)-cinnamaldehyde, (E)-β-caryophyllene, α-terpineol, and eugenol.
Regarding claims 20 and 28, Gehin-Delval teaches thyme essential oil (pg 9: 13 and 18). Regarding claims 22 and 29, Gehin-Delval teaches the administration method may be food or beverage products, taken by the Examiner to mean food or beverages consumed by humans (pg 10: 5-12).
For claims 24 and 31, Gehin-Delval teaches a method wherein the emulsion is dosed “in an appropriate way and consistently to said final product” (pg 10: 34 to pg 11: 3). As such, it is within the skill of an ordinary practitioner to determine the effective dosing schedule, including multiple doses, with a reasonable expectation of success.
For claim 25, Gehin-Delval teaches a method of treatment of an animal or human comprising a composition comprising acacia gum, an antimicrobial essential oil, and water (pg 7: 14-18), wherein the one or more essential oils and the emulsifier are present in a ratio of about 1:0.5 to 1:1, within the claimed range.
For claim 32, Gehin-Delval teaches the essential oil can be one or more of oregano (origanum, origan), garlic, ginger, rose, mustard, cinnamon, rosemary, orange, lime, lemongrass, clove, clove leaf, vanilla, vanillin, mint, tea tree, thyme, cilantro, lime, coriander (a.k.a. cilantro), sage, eucalyptus, lavender, anise, basil, eucalyptus, aniseed, camphor, citrus, and sage (pg 9: 10-25).
Regarding the limitation in claims 16 and 25 regarding the limitation “wherein the average particle size of the essential oils in the emulsion is 25 microns or less,” Gehin-Delval teaches the emulsion formed is “an emulsion with a self-assembled structure….where such oil droplets are in a micrometer range and exhibit a nano-sized internal structurisation.” See pg 9: 27 to pg 10: 3. As such, Gehin-Delval teaches oil droplets in the micrometer range, overlapping the claimed particle size range.
Independent claim 16 recites the negative limitation “wherein the emulsifier does not comprise gum arabic,” a limitation not taught by Gehin-Delval. Furthermore, Gehin-Delval does not teach the newly added limitation “in an amount effective to provide the antiviral or antibacterial effect within the animal,” nor the newly added limitations of claims 33 and 34 reciting
Noznick and Kalemba teach the missing elements of Gehin-Delval.
Noznick teaches an emulsified food composition comprising polyglycerol partial ester of a higher fatty acid and a carbohydrate-based emulsion stabilizer from the group of starch, dextrin, gums, and sugars and/or a fat (Abstract). Noznick teaches the carbohydrate emulsion stabilizer may be cellulose ethers such as methyl cellulose, a pectin, inulin, Irish moss (carragheen), sodium alginate, gum tragacanth, gum karaya, locust bean gum, gum arabic, and larch gum arabinogalactan (col 1: 62-66; col 2: 5-17 and 40-44 (Example 1)). Noznick teaches the emulsions are homogenized in conventional fashion to achieve a particle size of 1-10 microns (col 2, 22-26), within the claimed range.
For claims 33 and 34, Noznick teaches larch gum arabinogalactan as an example of an emulsion stabilizer (col 1: 65-66).
Kalemba teaches the essential oils of thyme, oregano, cinnamon, and clove were found to possess the strongest antimicrobial properties among many essential oils tested, and further teaches that bacteria and fungi found within humans are known to be susceptible to treatment with these essential oils (Abstract). For example, Kalemba teaches the essential oils of clove and cinnamon may be effective in treating Helicobacter pylori infection in the stomach (pg 819, right column, third full paragraph):
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While Kalemba does not explicitly teach oral administration for the route of essential oil administration, one of ordinary skill would be strongly motivated to utilize oral administration for a method to treat an infection in the stomach.
The person of ordinary skill would have had a reasonable expectation of success in selecting Noznick's sodium alginate, pectin, or methyl cellulose as the carbohydrate-based emulsion stabilizer in the method of Gehin-Deval since Noznick teaches each of gum arabic, sodium alginate, pectin, methyl cellulose, or larch gum arabinogalactan as effective emulsion stabilizers. The skilled artisan would have been motivated to select sodium alginate, pectin, larch gum arabinogalactan, or methyl cellulose as an effective emulsion stabilizer in the composition of Gehin-Delval since Noznick teaches each as effective and non-toxic since they are each amenable to addition to a food product.
Additionally, the person of ordinary skill would have had a reasonable expectation of success in selecting the composition of the combination of Gehin-Deval and Noznick as effective in an animal such as a human since Kalemba teaches that it is reasonable to administer compositions comprising the essential oils of clove and cinnamon to human subjects suffering from Helicobacter pylori infection since these essential oils have been shown to be effective in inhibiting the growth of Helicobacter pylori in vitro and the compounds are safe for human consumption.
2) Claims 18, 23, 26, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Gehin-Delval (cited above), in view of Noznick (cited above), Kalemba (cited above), and Hoffman-Pennesi (“Antioxidant, Antibacterial, And Antiviral Effects Of Two Essential Oils, Their Components, and Caffeic Acid for use as Feed Additives in Poultry,” Master’s Thesis, University of Delaware 2010; of record).
The teachings of Gehin-Delval, Noznick, and Kalemba are discussed above.
The combination of Gehin-Delval, Noznick, and Kalemba does not teach a method of administration of an RNA virus with the claimed composition.
Hoffman-Pennesi teaches the missing element of the combination of Gehin-Delval, Noznick, and Kalemba.
Hoffman-Pennesi teaches that essential oils derived from aromatic medicinal plants have been reported to exhibit exceptionally good antimicrobial effects against bacteria, yeasts, filamentous fungi, and viruses (pg 79, Summary).
For claims 18, 23, 26, and 30, Hoffman-Pennesi teaches thyme oil shows a modest inhibition of Newcastle Disease Virus, at concentrations that were not toxic to chicken embryos (paragraph spanning pg 52, second full paragraph to pg 53, first partial paragraph).
The skilled artisan would have expected success in utilizing thyme oil to treat Newcastle Disease Virus, an RNA virus, method of utilizing the thyme essential oil method taught by the combination of Gehin-Delval, Noznick, and Kalemba since Hoffman-Pennesi teaches that compositions comprising thyme essential oil are useful for reducing the virus titer count in an in vivo poultry assay without harming the chicken embryos.
Examiner’s Reply to Attorney Arguments dated 5/18/2026
1. Rejection of claims 16, 19-20, 22, 24-29, 30, 31, 32 under 35 U.S.C. § 103 over Gehin-Delval
The applicant argues that Gehin-Delval relates to preventing food and beverage spoilage, not a method of providing antiviral or antibacterial effects within an animal.
The Examiner acknowledges the argument presented, but does not consider it persuasive. As discussed in the rejection above, the newly added secondary reference of Kalemba teaches the composition of Gehin-Delval, as modified by Noznick, for use in treating an animal such as a human.
The applicant argues Gehin-Delval does not teach a motivation to account for the claimed particle size.
The Examiner acknowledges the argument presented, but does not consider it persuasive since Noznick clearly teaches a range within the claimed range (“The emulsions are homogenized in conventional fashion to a particle size between >1 to 10 microns” (col 2, lines 21-22), as discussed in the rejection above.
The applicant argues that Gehin-Delval does not teach a composition that does not include gum arabic, and further argues that Gehin-Delval teaches away from any substitute for gum arabic.
The Examiner acknowledges the argument presented, but does not consider it persuasive since the newly added reference of Noznick teaches a range of substitutes for gum arabic, including species presently claimed, as set forth in the rejection above.
2. Rejection of claims 18, 23, 26, and 30 under 35 U.S.C. § 103 over Gehin-Delval and Hoffman-Pennesi
The applicant argues that Hoffman-Pennesi does not disclose essential oil emulsions at all. The applicant argues that the antiviral activity reported in Hoffman-Pennesi is limited to a specific experimental model involving Newcastle Disease Virus in chicken embryos, where test compounds are injected directly into eggs and the model does “not correspond to administering a treatment composition to an animal as recited in the claims and provides no guidance regarding formulation or delivery of an emulsion-based composition.”
The Examiner acknowledges the arguments presented, but does not consider them persuasive. The newly applied secondary art of Kalemba teaches or suggests a method of oral administration of the composition taught by the combination of Gehin-Delval and Noznick for the treatment of bacterial and viral infections. Regarding the lack of a teaching of Hoffman-Pennesi for a method of treatment of a virus utilizing an emulsion, applicant has not presented an argument regarding the lack of efficacy of an emulsion composition for treatment of a virus. As set forth in Kalemba, what is required for activity is simply exposure of the microorganism to the essential oil (Kalemba, page 818, left column, “Research Into The Mechanism Of Essential Oil Action Towards Microorganisms”).
CONCLUSION
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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