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 (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.
Priority
The instant application is a 371 of PCT/EP2022/059712 filed on 04/12/2022 and claims foreign priority to European application no. EP21179750.1 filed on 06/16/2021 and EP21168701.7 filed on 04/15/2021. The certified copies of the foreign priority applications filed on 10/11/2023 are acknowledged.
Status of the Claims
The claim amendments and remarks filed on 04/22/2026 is acknowledged. Claims 9-15 are amended. Claims 1-8 are cancelled. Claims 16-24 are newly added
Accordingly, claims 9-24 are pending and being examined on the merits herein.
Withdrawn Objections/Rejections
The objections to the specification are withdrawn because the amended Abstract is now clear and concise and does not use form and/or legal phraseology. Furthermore, the amended title is properly descriptive for the claimed invention.
The objection to claims 9-10, 13, and 15 are withdrawn because 4-hydroxy-3-methoxybenzaldhye, 2-hydroxybenzoates, and PDMN/ animal/ day have the correct spelling.
The cancellations of claim 1-8 renders the objections and rejections over these claims moot.
The 35 USC 112(b) rejection over claims 9-13 and 15 are withdrawn because all of the “preferably” exemplary terms are now removed, making it clear what the metes and bounds of the claims are. Furthermore, claim 15 now recites active steps involved in the claimed method of using.
The 35 USC 101 rejection over claim 15 is withdrawn because the claim has been amended such that it is now clear that the claim is directed toward a method of using.
The 35 USC 103 rejection over Duval in view of Losa for claims 9-15 is withdrawn because the amended claims now require a new limitation of the recited propanediol mononitrate being administered as a powderous formulation comprising a carrier material, which was not previously considered in this rejection.
The nonstatutory double patenting rejections over US’273, US’814, US’685, US’981, US’288. US’424, US’151, and US’456 are withdrawn because the amended claims now require a new limitation of the recited propanediol mononitrate being administered as a powderous formulation comprising a carrier material, which was not previously considered in these rejections.
The provisional nonstatutory double patenting rejections over co-pending application no. ‘372, ‘927, and ‘329 are withdrawn because the amended claims now require a new limitation of the recited propanediol mononitrate being administered as a powderous formulation comprising a carrier material, which was not previously considered in these rejections.
The provisional nonstatutory double patenting rejection over co-pending application no. ‘095 is withdrawn because the ‘095 application is now considered abandoned as the last office action was mailed over 6 months with no response.
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10 recites “PDMN”, which is an abbreviation for propanediol mononitrate as defined in the specification (page 2 lines 1-5). The amended claims currently do not indicate PDMN is an abbreviation for propanediol mononitrate as recited in the previous claim set. Therefore, it is suggested to change the “PDMN” to “propanediol mononitrate” to be consistent with the term usage in this claim set.
Appropriate correction is required.
The following grounds of rejection are new as necessitated by Applicant’s amendments.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 16 recites “wherein the mixture of phenolic substances are selected from the group consisting of tannic acid and compounds of formula (l)”.
Claim 16 depends from claim 9. Claim 16 fails to further limit the subject matter of the claim upon which it depends because the recited formula (l) structures would encompass phenolic compounds that were not recited in claim 9, thereby broadening the scope of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 15 recites a method of synergistically enhancing methane reducing properties of propanediol mononitrate in ruminants and/or organic matter digestibility in ruminants, comprising orally administering to the ruminant an effective amount of (a) propanediol mononitrate and (b) a mixture of phenolic substances comprising at least six of 3-hydroxyphenol, 2-methoxyphenol, 3-methylphenol, 2-(1-methylethyl)-5-methyl-phenol, 4-allyl-2-methoxyphenol, 4-hydroxy-3-methoxybenzaldehyde, 5-isopropyl-2-methylphenol, tannic acid, or 2-hydroxybenzoates, wherein the propanediol mononitrate is administered as a powderous formulation comprising a carrier material.
The instant claim recites administering a combination of propanediol mononitrate and a mixture of phenolic substances to perform the function of synergistically enhancing methane reducing properties of propanediol mononitrate in ruminants and/or organic matter digestibility in ruminants.
The disclosure, however, does not provide a structure-function relationship or a representative number of species which would allow an ordinary skilled artisan to identify which combination of the propanediol mononitrate and mixture of at least six phenolic substances are needed, what dosages of the recited combination is needed, as well as what amounts of each of the at least six phenolic substances are needed to perform the recited function of synergistically enhancing methane reducing properties of propanediol mononitrate in ruminants and/or organic matter digestibility in ruminants.
MPEP 2173.05(g) states that “A claim term is functional when it recites a feature “by what it does rather than by what it is” and that “Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph.”
Furthermore, MPEP 2163 II.A.3.(a).ii. states that “Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.”
In this case, Applicant has only demonstrated and provided one embodiment of the claimed combination of the propanediol mononitrate and mixture of phenolic substances that will synergistically reduce methane production as well as the digestibility of organic matter.
Applicant demonstrates in the Example (pages 18-19) that the combined administration of 3-NOP (propanediol mononitrate) at 80 mg/kg dry matter (DM) and CRINA (phenolic substance mixture) at 40 mg/kg DM resulted in a clear synergistic effect in methane reduction and organic matter digested as seen in Tables 1 and 2 (pages 18-19).
Furthermore, Applicant discloses that the CRINA composition comprises approx. 40 wt.-% of phenolic substance mixture and approx. 60 wt. % carrier (PAF) with the phenolic substance mixture containing 4-hydroxy-3-methoxybenzaldehyd (13%), 2-(1-methylethyl)-5-methyl-phenol (27%), 3-methylphenol (27%), 3-hydroxyphenol (4%), 2-methoxyphenol (9%), 4-allyl-2-methoxyphenol (10%), salicylates (8%), and tannic acid (4%).
Applicant has only demonstrated a specific combination of propanediol mononitrate at 80 mg/kg DM and CRINA at 40 mg/kg DM will result in a synergistic effect in methane reduction, and has not demonstrated or provided further guidance that any mixture of phenolic substances comprising at least six of 3-hydroxyphenol, 2-methoxyphenol, 3-methylphenol, 2-(1-methylethyl)-5-methyl-phenol, 4-allyl-2-methoxyphenol, 4-hydroxy-3-methoxybenzaldehyde, 5-isopropyl-2-methylphenol, tannic acid, or 2-hydroxybenzoates will result in the claimed synergistic effect. Furthermore, Applicant has not demonstrated that any amount of each of the at least six phenolic substances as well as any dosage amount of the recited combination will result in the claimed synergy.
The state of the art indicates that the substances administered to livestock will have unpredictable effects for enteric methane emissions.
For example, Gerber (Animal, 2013 in PTO-892) discloses technical options for the mitigation of direct methane and nitrous oxide emissions from livestock (Abstract).
Gerber discloses and demonstrates in Table 1 (page 222) that an effective method to reduce methane emissions from livestock include modifying their feed compositions with supplements such as lipids, nitrates, ionophores, tannins, and others (Abstract).
However, Gerber discloses that interactions among individual components of livestock production systems are very complex, and that one practice may successfully mitigate enteric methane emission, but increase fermentable substrate for increased methane emission from stored manure or N availability for increased N2O emission from land application of manure (first paragraph under section “Interactions and links with productivity” left column page 230). Gerber discloses that feed additives and dietary manipulation options targeting enteric methane emissions are mostly studied in isolation, but can have unexpected synergistic or antagonistic effects (last paragraph left column page 23). Gerber discloses that while dietary manipulation to increase nutrient digestibility is expected to decrease enteric CH4 production and would most likely decrease greenhouse gas (GHG) emissions from stored manure, Gerber discloses that increased feed quality, however, will generally result in an increased feed intake, which will in turn increase enteric methane emissions (second paragraph right column page 230). Gerber concludes that the overall effect will depend on initial conditions and strategies used to improve feed digestibility (second paragraph right column page 230).
The teachings of Gerber show that feed additives and dietary manipulation options targeting enteric methane emissions can have unexpected synergistic or antagonistic effects, and that increased feed quality may result in increased feed intake and in turn increased enteric methane emissions, which suggests that it would not be predictable to an ordinary skilled artisan to determine what combination of feed components and what amounts of these feed components will result in a synergistic effect for reducing methane emission from ruminants.
It is not evident by the disclosure or the prior art, that the Applicant was in possession of using any combination of the propanediol mononitrate and mixture of phenolic substances comprising at least six phenolic substances, any dosage amount of the recited combination, as well as any amount of each of the at least six phenolic substances to perform the recited function of synergistically enhancing methane reducing properties of propanediol mononitrate in ruminants and/or organic matter digestibility in ruminants.
Furthermore, as described above, there is no disclosed or art recognized correlation for what combination of the propanediol mononitrate and mixture of phenolic substances is needed, what dosage amount of the recited combination is needed, and what amounts of the at least six phenolic substances are need to perform the recited synergistic function, and Applicant has only demonstrated a specific combination of propanediol mononitrate at 80 mg/kg DM and CRINA at 40 mg/kg DM will result in a synergistic effect in methane reduction.
Therefore, the instant claim does not meet the written description requirement under 35 USC 112(a)
Claim Rejections - 35 USC § 103
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.
Claim(s) 9-14, 16, 18-20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025) in view of Gadient et al. (US20190343149A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025).
Duval teaches a method for reducing the production of methane emanating from the digestive activities of a ruminant and/or for improving ruminant animal performance by using, as active compound at least one organic molecule substituted at any position with at least one nitrooxy group, or a salt thereof, which is administrated to the animal together with the feed (see Abstract).
Duval teaches that the active compound can be 3-nitrooxypropanol (see Table 1, first compound on paragraph 0032), which is also referred to as propanediol mononitrate or PDMN as evidenced by the instant specification (see page 2 lines 1-5 in instant specification). Duval teaches the active compound is preferably administered from 50 mg to 500 mg per kg of feed (see paragraph 0046). Duval teaches that the active compound can be incorporated into a ruminant feed composition or feed additive (paragraph 0056), and discloses premixes as an example of animal feed additive that is a preferably uniform mixture of one or more micro-ingredients with diluents and/or carrier (paragraph 0057).
Duval teaches the preferred animal species is domestic cattle, sheep and goat (see paragraph 0043). Duval teaches the methane production in ruminants calculated in liters per kilogram of dry matter intake is reduced most preferably at least 30% (see paragraph 0044).
Duval demonstrates in Example 18 (paragraphs 00157-0164) the in vivo effect of 3-nitrooxypropanol in dairy cows, in which the cows were administered 500 mg / day or 2500 mg / day of 3-nitrooxypropanol (paragraph 0163). As seen in Table 9 (paragraph 0164), methane production and methane yield were significantly reduced by the 3-nitrooxypropanol in dairy cows, in which methane production was 93 and 90% of control values when the 500 and 2500 mg/day doses were given, respectively.
While Duval discloses an animal feed additive composition comprising the recited propanediol mononitrate compound in the same effective amounts and a carrier, Duval does not teach that the propanediol mononitrate is administered as a powderous formulation and also does not teach further including a mixture of phenolic substances comprising at least six of the recited phenolic compounds in the recited effective amounts.
Gadient teaches improved formulations of 3-nitrooxypropanol and derivatives thereof as well as production of such formulations (Abstract).
Gadient teaches that 3-nitrooxypropanol have been reported to be highly efficient in reducing the formation of methane in ruminants without affecting microbial fermentation in a way that would be detrimental to the host animal (paragraph 0003).
However, Gadient discloses that 3-nitrooxypropanol and structural analogues thereof are volatile and have been found not to be effectively retained in standard carrier systems commonly used in the feed industry under conventional storage conditions, which in turn may lead to a significant loss of the active in the final product form such as the feed product or the requirement of elaborate (i.e. tight and expensive) packaging systems (paragraph 0004).
Therefore, Gadient discloses a need to develop a product form to overcome these problems and discloses a powderous formulation comprising the 3-nitrooxypropanol and sepiolite as a carrier (paragraphs 0006-0007). Gadient discloses that sepiolite refers to a soft white clay mineral consisting of hydrous magnesium silicate, a typical chemical formula for which is Mg4Si6O15(OH)2.6H2O (paragraph 0026), which meets the limitation of silica carrier material. Gadient teaches that it was surprisingly found that 3-nitrooxypropanol is effectively retained in sepiolite as carrier under conventional storage conditions (paragraph 0006).
Losa teaches a method for reducing the production of methane emanating from the digestion of animal by using one or more essential oil compounds selected from the group consisting of limonene, eugenol, a silicylate, quinoline, vanilla, thymol and a cresol, which are administered to the animal feed (see Abstract).
Losa teaches the active essential oil compounds are suitable administrated per day in an amount preferably 0.1-20 mg/kg bodyweight of the animal (see paragraph 0008). Losa teaches that the essential oil compounds are incorporated into an animal feed composition, further teaches a feed premix contains 0.1-20% by dry weight of the essential oil compounds (see paragraph 0012) as well as the feed containing preferably 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed) (paragraph 0012). Losa discloses that the essential oils can be incorporated into animal feed, drinking water, or as a premix additive or water supplement (paragraph 0012). Losa discloses that the water supplement may contain water-soluble or water-dispersible carriers (paragraph 0016).
Losa demonstrates in Example 1 efficacy of the essential oil compounds obtainable from plants on the formation of methane and VFA in an in vitro system. Losa lists in Table 1 (paragraph 0025) specific essential oil compounds tested. Here in Table 1, resorcinol is 3-hydroxyphenol, guajacol is 2-methoxyphenol, m-cresol is 3-methylphenol, thymol is 2-(1-methylethyl)-5-methyl-phenol, eugenol is 4-allyl-2-methoxyphenol, and benzyl salicylate meets the limitation of a 2-hydroxybenzoate.
Losa demonstrates in Example 2 the effect of a blend of the essential oils disclosed in Example 1 on the production of methane and VFA in vivo on sheep, and further discloses that each sheep was fed the blend in a dosage of 110 mg per animal per day (see paragraph 0026). As seen in paragraph 0028, the methane production was lower when the diet contained the blend according their invention in comparison with a control.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the 3-nitrooxypropanol composition of Duval by using a powderous formulation further comprising sepiolite as a carrier as disclosed in Gadient and further combining this composition with the essential oil composition of Losa to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to use the powderous formulation because Gadient discloses that 3-nitrooxypropanol and structural analogues thereof are volatile and have been found not to be effectively retained in standard carrier systems commonly used in the feed industry under conventional storage conditions, which in turn may lead to a significant loss of the active in the final product form such as the feed product or the requirement of elaborate packaging systems.
One of ordinary skill in the art would have a reasonable expectation of success because Gadient discloses that their powderous formulation surprisingly retained the same 3-nitrooxypropanol compound effectively under conventional storage conditions and can be used for animal feed formulations.
One of ordinary skill in the art would have combined the 3-nitrooxypropanol composition as disclosed by the combined teachings of Duval and Gadient with the essential oil composition of Losa with a reasonable expectation of success because both Duval and Losa demonstrate that their respective compositions are useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
Furthermore, in regards to instant claim 14, Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed), rendering the recited ranges obvious. See MPEP 2144.06 I.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025) in view of Gadient et al. (US20190343149A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), as applied to claim 9 above, and further in view of Shelby et al. (US20090285931A1 in PTO-892), EFSA (EFSA Journal, 2012 in PTO-892), and as evidenced by Sinha et al. (International Journal of Food Sciences and Nutrition, 2008 in PTO-892).
The combined teachings of Duval, Gadient, and Losa are as described above and teach the method of claim 9 as discussed above.
Furthermore, Duval teaches that the compounds in their compositions in addition to reducing methane emission may also contribute to improve ruminant performance by improving the feed conversion ratio, reducing feed intake, improving weight gain, and/or improving carcass, or milk yield (paragraphs 0009-0010).
Losa discloses that their compositions include suitable growth-improving additives and lists tannin and other ingredients as examples (paragraph 0012). Losa also discloses their compositions include salicylates such as amyl salicylate and benzyl salicylate (paragraphs 0009-0010). Losa also further demonstrates in Table 1 (paragraph 0025) that the composition includes vanilla, and as evidenced by Sinha, the primary ingredient found in vanilla is vanillin (4-hydroxy-3 methoxybenzaldehyde) (second paragraph page 300 and Figure 1 on page 300).
Even though the combined teachings of Duval, Gadient, and Losa described above provide guidance of a phenolic mixture comprising 2-hydroxyphenol, 2-methoxyphenol, 3-methylphenol, 2-(1-methylethyl)-5-methyl-phenol, 4-allyl-2-methoxyphenol, 4-hydroxy-3-methoxybenzaldehyde (vanillin), tannin, and salicylates such as amyl salicylate and benzyl salicylates, the combined references do not teach that the phenolic mixture specifically includes tannic acid and isoamyl salicylate.
Shelby discloses a method for enhancing feed efficiency and reducing enteric methane production in livestock comprising a formulation of natural plants and plant extracts and chemicals (Abstract).
Shelby discloses that the plant materials are optimized to have higher levels of tannic acids, phenolic compounds, and other components (paragraph 0038). Shelby discloses these compounds with the desired activities are found in monocotyledonous flowering plants and preferred selections include sanfoin (tannic acid) and others (paragraph 0044). Shelby discloses these plant materials can be administered orally in the form of powders, sprayed into feeds, and other pelleted feed supplements, suspensions, solutions, or other suitable means for ingestion (paragraph 0045).
EFSA discloses the safety and efficacy of CRINA Poultry Plus (CPP) as a feed additive consisting of seven active substances: benzoic acid, thymol, eugenol, benzyl salicylate, piperine, isoamyl salicylate, and trans-anethole (Abstract).
EFSA discloses that the CPP is a feed additive intended to be used as an additive in complete feed for chickens for fattening with the aim to favorably affect their performance, and further discloses that the seven disclosed active ingredients are known food and feed flavorings (first two paragraphs under “Introduction” section page 7).
EFSA discloses that due to the low exposure of chickens to benzyl salicylate and isoamyl salicylate as well as their very limited retention in tissues, no safety concern was identified for the consumer (first two paragraphs under section 3.2.2.5 page 14).
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the composition as disclosed by the combined teachings of Duval, Gadient, and Losa described above plant materials that have high levels of tannic acid as disclosed in Shelby and further including isoamyl salicylates as disclosed in EFSA to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because the combined teachings of Duval, Gadient, and Losa described above provide guidance of including tannins and salicylates into the composition that are useful for reducing methane emission as well as other benefits such as improving weight gain, Shelby provides guidance of including plant materials high in tannic acid for the same purpose of reducing methane emission in livestock, and EFSA provides guidance that isoamyl salicylate and benzyl salicylates are active ingredients used in feed additive formulations for a similar purpose of weight gaining (fattening) performance.
Claim(s) 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025) in view of Gadient et al. (US20190343149A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), as applied to claims 9, 20, and 23 above, and further in view of Ruiz-Rico et al. (Food Chemistry, 2017 in PTO-892).
The combined teachings of Duval, Gadient, and Losa are as described above and teach the method of claims 9, 20, and 23 as discussed above.
Furthermore, Losa discloses that the essential oils can be incorporated into animal feed, drinking water, or as a premix additive or water supplement (paragraph 0012). Losa discloses that the water supplement may contain water-soluble or water-dispersible carriers (paragraph 0016).
Even though the combined references provide guidance of formulating the mixture of essential oil compounds with a carrier, the combined references do not disclose the carrier material comprises silica.
Ruiz-Rico discloses the enhanced antimicrobial activity of essential oil components (EOCs) immobilized on silica particles (Abstract).
Ruiz-Rico discloses that EOCs have antimicrobial activity against several food-borne microorganisms, which may help in preventing food spoilage, however essential oil components (EOCs) have limited application in the formulation of a wide range of food products due to their high volatility, powerful aroma limit, poor water solubility, and degradability (Abstract and first paragraph left column through first paragraph right column page 228). Therefore, Ruiz-Rico states there is a need for technologies, such as encapsulation or immobilization, to improve the functionality (second paragraph right column page 228).
Ruiz-Rico discloses that several materials have been developed for this purpose including silica particles and further discloses that silica particles have been widely used in animal feed and food industries (first paragraph left column page 229).
Ruiz-Rico studied the antimicrobial activity of EOCs such as carvacrol, eugenol, thymol and vanillin grafted onto the surface of three silica supports with different morphologies, textural properties, and chemical reactivities (fumed silica, amorphous silica and MCM-41) (Abstract). Ruiz-Rico discloses that sensory evaluation revealed that sensory perception of EOCs decreases after covalent immobilization. Moreover, immobilization greatly enhanced the antimicrobial activity of the essential oil components against Listeria innocua and Escherichia coli compared to free components (Abstract). Ruiz-Rico further discloses that the incorporation of EOCs immobilized on silica particles into pasteurized milk inoculated with L. innocua demonstrated their effectiveness not only for in vitro conditions, but also in a real food system (Abstract).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the essential oil composition as disclosed by the combined teachings of Duval, Gadient, and Losa described above by formulating into a silica particle composition as disclosed in Ruiz-Rico to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to formulate into a silica particle composition because Ruiz-Rico discloses that essential oil components (EOCs) have limited application in the formulation of a wide range of food products due to their high volatility, powerful aroma limit, poor water solubility, and degradability. Furthermore, Ruiz-Rico discloses an added advantage that the EOCs, which include the same compounds such as eugenol and thymol, have antimicrobial properties against several food-borne microorganisms and may be beneficial to prevent food spoilage.
One of ordinary skill in the art would have a reasonable expectation of success because Ruiz-Rico effectively demonstrates the incorporation of the silica-based EOC composition, which include several of the same compounds such as eugenol and thymol, into a real food system (pasteurized milk), and further discloses the incorporation of silica particle based compositions into animal feeds.
Response to Arguments
Applicant’s arguments filed on 04/22/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states that the claims have been amended to recite that the propanediol mononitrate is formulated or administered as a powderous formulation further comprising a carrier, and states that this feature is not taught or suggest by the present combination of references.
Applicant’s argument described above was not found persuasive because the new prior art rejection above renders obvious this feature as discussed above.
Furthermore, it is noted that Applicant has demonstrated a synergistic effect for methane reduction as well as for the digestibility of organic matter when 80 mg/kg DM 3-NOP (propanediol mononitrate) and 40 mg/kg DM CRINA (a phenolic substance mixture) was administered to together in comparison to the individual components as demonstrated in Tables 1 and 2 (pages 18-19) of the specification. Applicant discloses that the CRINA composition comprises approx. 40 wt.-% of phenolic substance mixture and approx. 60 wt. % carrier (PAF) with the phenolic substance mixture containing 4-hydroxy-3-methoxybenzaldehyd (13%), 2-(1-methylethyl)-5-methyl-phenol (27%), 3-methylphenol (27%), 3-hydroxyphenol (4%), 2-methoxyphenol (9%), 4-allyl-2-methoxyphenol (10%), salicylates (8%), and tannic acid (4%).
According to MPEP 716.02(e), the showing of an unexpected result must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness.
The closest prior arts are Duval and Losa. As described above, Duval discloses propanediol mononitrate compositions for reducing methane emission in animals, and Losa discloses an essential oil composition comprising at least six of the recited phenolic substances that is also useful for reducing methane emission in animals.
Applicant has demonstrated an unexpected synergistic effect over these closest prior arts because Applicant has compared their administered combination of propanediol mononitrate and phenolic substance mixture to the propanediol mononitrate and the phenolic substance mixture alone, which are representative of the compositions disclosed in Duval and Losa, respectively.
However, according to MPEP 716.02(d), a showing of unexpected results must be commensurate in scope with the claims which the evidence is offered to support.
Instant claim 9 recites administering an effective amount of propanediol mononitrate and a mixture of phenolic substance comprising at least six of the recited phenolic substances. Instant claim 13 recites a feed composition comprising propanediol mononitrate and a mixture of phenolic substance comprising at least six of the recited phenolic substances Furthermore, instant claims 10-11 and 14 limit the compounds to certain amounts.
As described above, Applicant has only demonstrated one specific embodiment of a combination of 80 mg/kg propanediol mononitrate and a specific mixture of phenolic substance at 40 mg/kg that resulted in a synergistic effect in reduce methane emissions, and there is no additional guidance or evidence that this synergistic effect for one specific combination would also apply for any combination of the propanediol mononitrate and mixture of any of the at least six phenolic substances, any dosages of the recited combination, as well as any amount of the at least six phenolic substances. It is also noted that the state of the art as discussed in the written description rejection above does not provide or suggest a clear trend for administering different feed components to an animal for reducing methane emissions.
Therefore, Applicant has not provided enough evidence such that an ordinary skilled artisan would be able to determine that the showing of a synergistic effect for one specific embodiment of a combination of propanediol mononitrate and a mixture of phenolic substance would also extend to the scope of the recited combinations in the instant claims.
Accordingly, Applicant’s showing of unexpected results does not rebut the prima facie case of obviousness over the current claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9-14, 16, 18-20, and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 7,763,273 (’273) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025).
Claim 1 of ‘273 recites a method for reducing the production of methane emanating from the digestive activities of an animal by using a mixture of essential oil compounds, which are administered to the animal, wherein the mixture contains: (a) 5-60% by weight of a mixture of limonene and eugenol, (b) a mixture of at least 10% by weight benzyl salicylate, at least 10% by weight quinoline, and at least 10% by weight vanilla, and (c) a mixture of thymol and cresol in an amount of 10 to 50% by weight based on the total amount of the limonene and eugenol mixture. Claim 2 of ‘273 recites wherein the mixture of essential oil compounds is administered per day in an amount of 0.01-50 mg per kg of bodyweight of the animal. Claim 3 of ‘273 recites wherein the mixture of essential oil compounds is administered via a feed composition or drinking water.
The difference between the claims of ‘273 and the claimed invention is that the claims of ‘273 do not recite a PDMN in a powderous formulation comprising a carrier and at least six phenolic substances.
The independent teachings of Duval, Gadient, and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition of the reference application by using a powderous formulation further comprising sepiolite as a carrier as disclosed in Gadient and further combining this composition with the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to use the powderous formulation because Gadient discloses that 3-nitrooxypropanol and structural analogues thereof are volatile and have been found not to be effectively retained in standard carrier systems commonly used in the feed industry under conventional storage conditions, which in turn may lead to a significant loss of the active in the final product form such as the feed product or the requirement of elaborate
One of ordinary skill in the art would have a reasonable expectation of success because Gadient discloses that their powderous formulation surprisingly retained the same 3-nitrooxypropanol compound effectively under conventional storage conditions and can be used for animal feed formulations.
One of ordinary skill in the art would have combined these compositions with a reasonable expectation of success because the reference application, Duval, and Losa all recite that their respective compositions are useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
Furthermore, in regards to instant claim 14, Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed), rendering the recited ranges obvious. See MPEP 2144.06 I.
Claim(s) 9 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 7,763,273 (’273) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), Shelby et al. (US20090285931A1 in PTO-892), EFSA (EFSA Journal, 2012 in PTO-892), and as evidenced by Sinha et al. (International Journal of Food Sciences and Nutrition, 2008 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claim 9 as discussed above.
Furthermore, as evidenced by Sinha, the primary ingredient found in vanilla is vanillin (4-hydroxy-3 methoxybenzaldehyde) (second paragraph page 300 and Figure 1 on page 300).
Even though the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of a phenolic mixture comprising 2-hydroxyphenol, 2-methoxyphenol, 3-methylphenol, 2-(1-methylethyl)-5-methyl-phenol, 4-allyl-2-methoxyphenol, 4-hydroxy-3-methoxybenzaldehyde (vanillin), tannin, and salicylates such as amyl salicylate and benzyl salicylates, the combined references do not recite that the phenolic mixture specifically includes tannic acid and isoamyl salicylate.
The independent teachings of Shelby and EFSA are described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the composition as described by the combination of the reference application, Duval, Gadient, and Losa above the plant materials that have high levels of tannic acid as disclosed in Shelby and further including isoamyl salicylates as disclosed in EFSA to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of including tannins and salicylates into the composition that are useful for reducing methane emission as well as other benefits such as improving weight gain, Shelby provides guidance of including plant materials high in tannic acid for the same purpose of reducing methane emission in livestock, and EFSA provides guidance that isoamyl salicylate and benzyl salicylates are active ingredients used in feed additive formulations for a similar purpose of weight gaining (fattening) performance.
Claim(s) 9, 20-21, and 23-24 are rejected are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 7,763,273 (’273) in view Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), and Ruiz-Rico et al. (Food Chemistry, 2017 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claims 9, 20, and 23 as discussed above.
Even though the combined references provide guidance of formulating the mixture of essential oil compounds with a carrier, the combined references do not recite the carrier material comprises silica.
The teachings of Ruiz-Rico are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the essential oil composition as disclosed by the combination of the reference application, Duval, Gadient, and Losa described above by formulating into a silica particle composition as disclosed in Ruiz-Rico to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to formulate into a silica particle composition because Ruiz-Rico discloses that essential oil components (EOCs) have limited application in the formulation of a wide range of food products due to their high volatility, powerful aroma limit, poor water solubility, and degradability. Furthermore, Ruiz-Rico discloses an added advantage that the EOCs, which include the same compounds such as eugenol and thymol, have antimicrobial properties against several food-borne microorganisms and may be beneficial to prevent food spoilage.
One of ordinary skill in the art would have a reasonable expectation of success because Ruiz-Rico effectively demonstrates the incorporation of the silica-based EOC composition, which include several of the same compounds such as eugenol and thymol, into a real food system (pasteurized milk), and further discloses the incorporation of silica particle based compositions into animal feeds.
Claims 9-14, 16, 18-20, and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,266,814 (’814) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025).
Claim 4 of ‘814 recites a method for reducing the production of methane emanating from the digestive activities of ruminants comprising orally administering to a ruminant a sufficient amount of between about 1 mg/kg of feed to about 10 g/kg of feed of 3-nitrooxy propanol, and observing a methane reduction by the ruminant by at least 10% calculated in liters per kilogram of dry matter intake when measured in a metabolic chamber.
The difference between the claims of ‘814 and the claimed invention is that the claims of ‘814 do not recite at least six phenolic substances and a powderous formulation comprising a carrier.
The independent teachings of Duval, Gadient, and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition of the reference application by using a powderous formulation further comprising sepiolite as a carrier as disclosed in Gadient and further combining this composition with the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to use the powderous formulation because Gadient discloses that 3-nitrooxypropanol and structural analogues thereof are volatile and have been found not to be effectively retained in standard carrier systems commonly used in the feed industry under conventional storage conditions, which in turn may lead to a significant loss of the active in the final product form such as the feed product or the requirement of elaborate
One of ordinary skill in the art would have a reasonable expectation of success because Gadient discloses that their powderous formulation surprisingly retained the same 3-nitrooxypropanol compound effectively under conventional storage conditions and can be used for animal feed formulations.
One of ordinary skill in the art would have combined these compositions with a reasonable expectation of success because the reference application, Duval, and Losa all recite that their respective compositions are useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
Furthermore, in regards to instant claim 14, Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed), rendering the recited ranges obvious. See MPEP 2144.06 I.
Claim(s) 9 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 9,266,814 (’814) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), Shelby et al. (US20090285931A1 in PTO-892), EFSA (EFSA Journal, 2012 in PTO-892), and as evidenced by Sinha et al. (International Journal of Food Sciences and Nutrition, 2008 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claim 9 as discussed above.
Furthermore, as evidenced by Sinha, the primary ingredient found in vanilla is vanillin (4-hydroxy-3 methoxybenzaldehyde) (second paragraph page 300 and Figure 1 on page 300).
Even though the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of a phenolic mixture comprising 2-hydroxyphenol, 2-methoxyphenol, 3-methylphenol, 2-(1-methylethyl)-5-methyl-phenol, 4-allyl-2-methoxyphenol, 4-hydroxy-3-methoxybenzaldehyde (vanillin), tannin, and salicylates such as amyl salicylate and benzyl salicylates, the combined references do not recite that the phenolic mixture specifically includes tannic acid and isoamyl salicylate.
The independent teachings of Shelby and EFSA are described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the composition as described by the combination of the reference application, Duval, Gadient, and Losa above the plant materials that have high levels of tannic acid as disclosed in Shelby and further including isoamyl salicylates as disclosed in EFSA to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of including tannins and salicylates into the composition that are useful for reducing methane emission as well as other benefits such as improving weight gain, Shelby provides guidance of including plant materials high in tannic acid for the same purpose of reducing methane emission in livestock, and EFSA provides guidance that isoamyl salicylate and benzyl salicylates are active ingredients used in feed additive formulations for a similar purpose of weight gaining (fattening) performance.
Claim(s) 9, 20-21, and 23-24 are rejected are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 9,266,814 (’814) in view Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), and Ruiz-Rico et al. (Food Chemistry, 2017 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claims 9, 20, and 23 as discussed above.
Even though the combined references provide guidance of formulating the mixture of essential oil compounds with a carrier, the combined references do not recite the carrier material comprises silica.
The teachings of Ruiz-Rico are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the essential oil composition as disclosed by the combination of the reference application, Duval, Gadient, and Losa described above by formulating into a silica particle composition as disclosed in Ruiz-Rico to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to formulate into a silica particle composition because Ruiz-Rico discloses that essential oil components (EOCs) have limited application in the formulation of a wide range of food products due to their high volatility, powerful aroma limit, poor water solubility, and degradability. Furthermore, Ruiz-Rico discloses an added advantage that the EOCs, which include the same compounds such as eugenol and thymol, have antimicrobial properties against several food-borne microorganisms and may be beneficial to prevent food spoilage.
One of ordinary skill in the art would have a reasonable expectation of success because Ruiz-Rico effectively demonstrates the incorporation of the silica-based EOC composition, which include several of the same compounds such as eugenol and thymol, into a real food system (pasteurized milk), and further discloses the incorporation of silica particle based compositions into animal feeds.
Claims 9-14, 16, 18-20, and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 9,902,685 (’685) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025).
Claim 1 of ‘685 recites a feed composition or feed additive for a ruminant comprising an amount between about 1 mg to about 10 g/kg of feed of 3-nitrooxy propanol sufficient to reduce production of methane emanating from digestive activities of a ruminant by at least 10% calculated in liters per kilogram of dry matter intake when measured in a metabolic chamber.
The difference between the claims of ‘685 and the claimed invention is that the claims of ‘685 do not recite at least six phenolic substances and a powderous formulation comprising a carrier.
The independent teachings of Duval, Gadient, and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition of the reference application by using a powderous formulation further comprising sepiolite as a carrier as disclosed in Gadient and further combining this composition with the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to use the powderous formulation because Gadient discloses that 3-nitrooxypropanol and structural analogues thereof are volatile and have been found not to be effectively retained in standard carrier systems commonly used in the feed industry under conventional storage conditions, which in turn may lead to a significant loss of the active in the final product form such as the feed product or the requirement of elaborate
One of ordinary skill in the art would have a reasonable expectation of success because Gadient discloses that their powderous formulation surprisingly retained the same 3-nitrooxypropanol compound effectively under conventional storage conditions and can be used for animal feed formulations.
One of ordinary skill in the art would have combined these compositions with a reasonable expectation of success because the reference application, Duval, and Losa all recite that their respective compositions are useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
Furthermore, in regards to instant claim 14, Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed), rendering the recited ranges obvious. See MPEP 2144.06 I.
Claim(s) 9 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 9,902,685 (’685) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), Shelby et al. (US20090285931A1 in PTO-892), EFSA (EFSA Journal, 2012 in PTO-892), and as evidenced by Sinha et al. (International Journal of Food Sciences and Nutrition, 2008 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claim 9 as discussed above.
Furthermore, as evidenced by Sinha, the primary ingredient found in vanilla is vanillin (4-hydroxy-3 methoxybenzaldehyde) (second paragraph page 300 and Figure 1 on page 300).
Even though the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of a phenolic mixture comprising 2-hydroxyphenol, 2-methoxyphenol, 3-methylphenol, 2-(1-methylethyl)-5-methyl-phenol, 4-allyl-2-methoxyphenol, 4-hydroxy-3-methoxybenzaldehyde (vanillin), tannin, and salicylates such as amyl salicylate and benzyl salicylates, the combined references do not recite that the phenolic mixture specifically includes tannic acid and isoamyl salicylate.
The independent teachings of Shelby and EFSA are described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the composition as described by the combination of the reference application, Duval, Gadient, and Losa above the plant materials that have high levels of tannic acid as disclosed in Shelby and further including isoamyl salicylates as disclosed in EFSA to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of including tannins and salicylates into the composition that are useful for reducing methane emission as well as other benefits such as improving weight gain, Shelby provides guidance of including plant materials high in tannic acid for the same purpose of reducing methane emission in livestock, and EFSA provides guidance that isoamyl salicylate and benzyl salicylates are active ingredients used in feed additive formulations for a similar purpose of weight gaining (fattening) performance.
Claim(s) 9, 20-21, and 23-24 are rejected are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 9,902,685 (’685) in view Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), and Ruiz-Rico et al. (Food Chemistry, 2017 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claims 9, 20, and 23 as discussed above.
Even though the combined references provide guidance of formulating the mixture of essential oil compounds with a carrier, the combined references do not recite the carrier material comprises silica.
The teachings of Ruiz-Rico are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the essential oil composition as disclosed by the combination of the reference application, Duval, Gadient, and Losa described above by formulating into a silica particle composition as disclosed in Ruiz-Rico to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to formulate into a silica particle composition because Ruiz-Rico discloses that essential oil components (EOCs) have limited application in the formulation of a wide range of food products due to their high volatility, powerful aroma limit, poor water solubility, and degradability. Furthermore, Ruiz-Rico discloses an added advantage that the EOCs, which include the same compounds such as eugenol and thymol, have antimicrobial properties against several food-borne microorganisms and may be beneficial to prevent food spoilage.
One of ordinary skill in the art would have a reasonable expectation of success because Ruiz-Rico effectively demonstrates the incorporation of the silica-based EOC composition, which include several of the same compounds such as eugenol and thymol, into a real food system (pasteurized milk), and further discloses the incorporation of silica particle based compositions into animal feeds.
Claims 9-14, 16, 18-20, and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,154,981 (’981) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025).
Claim 1 of ‘981 recites a feed composition or feed additive for a ruminant animal comprising: (i) at least one antibiotic, and (ii) at least one organic molecule or a salt thereof which is selected from the group consisting of 3-nitrooxypropanol, rac-4-Phenylbutane-1,2-diyl dinitrate, 2-(hydroxymethyl)-2 (nitrooxymethyl)-1,3-propanediol, N-ethyl-3-nitro-oxy-propionic sulfonyl amide, 5-nitrooxy pentanenitrile, 5-nitrooxy-pentane, 3-nitro-oxy-propyl propionate, 1,3-bis-nitrooxypropane, 1,4-bis-nitrooxybutane, 1,5-bis-nitrooxypentane, 3-nitro-oxy-propyl benzoate, 3-nitro-oxy-propyl hexanoate, 3-nitro-oxy-propyl 5-nitro-oxy-hexanoate, benzylnitrate, isosorbid-dinitrate, N-[2-(nitrooxy)ethyl]-3-pyridinecarboxamide, 3-nitrooxy propionic acid, methyl-3-nitrooxy propionate, ethyl-3-nitrooxy propionate, ethyl-4-nitrooxy butanoate, ethyl-3-nitrooxy butanoate, 5-nitrooxy pentanoic acid, ethyl-5-nitrooxy pentanoate, 6-nitrooxy hexanoic acid, ethyl-6-nitrooxy hexanoate, ethyl-4-nitrooxy-cyclohexylcarboxylate, 8-nitrooxy octanoic acid, ethyl-8-nitrooxy octanoate, 11-nitrooxy undecanoic acid, ethyl-11-nitrooxy undecanoate, 5-nitrooxy-pentanoic amide and 5-nitrooxy-N-methyl-pentanoic amide, wherein the at least one organic molecule is present in an amount sufficient to reduce formation of methane emanating from digestive activities of the ruminant animal and/or to improve performance of the ruminant animal, and wherein the at least one organic molecule and the at least one antibiotic are present in a weight ratio of the at least one organic molecule to the at least one antibiotic of between 0.05 and 50. Claim 6 of ‘981 recites wherein e organic molecule is present in an amount sufficient to reduce formation of methane emanating from digestive activities of ruminants calculated in liters per kilogram of dry matter intake by at least 10% when measured in metabolic chambers. Claim 8 of ‘981 recites wherein the amount of the at least one antibiotic is present in an amount from 0.5 to 150 mg per kg feed.
The difference between the claims of ‘981 and the claimed invention is that the claims of ‘981 do not recite at least six phenolic substances and a powderous formulation comprising a carrier.
The independent teachings of Duval, Gadient, and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition of the reference application by using a powderous formulation further comprising sepiolite as a carrier as disclosed in Gadient and further combining this composition with the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to use the powderous formulation because Gadient discloses that 3-nitrooxypropanol and structural analogues thereof are volatile and have been found not to be effectively retained in standard carrier systems commonly used in the feed industry under conventional storage conditions, which in turn may lead to a significant loss of the active in the final product form such as the feed product or the requirement of elaborate
One of ordinary skill in the art would have a reasonable expectation of success because Gadient discloses that their powderous formulation surprisingly retained the same 3-nitrooxypropanol compound effectively under conventional storage conditions and can be used for animal feed formulations.
One of ordinary skill in the art would have combined these compositions with a reasonable expectation of success because the reference application, Duval, and Losa all recite that their respective compositions are useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
Furthermore, in regards to instant claim 14, Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed), rendering the recited ranges obvious. See MPEP 2144.06 I.
Claim(s) 9 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,154,981 (’981) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), Shelby et al. (US20090285931A1 in PTO-892), EFSA (EFSA Journal, 2012 in PTO-892), and as evidenced by Sinha et al. (International Journal of Food Sciences and Nutrition, 2008 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claim 9 as discussed above.
Furthermore, as evidenced by Sinha, the primary ingredient found in vanilla is vanillin (4-hydroxy-3 methoxybenzaldehyde) (second paragraph page 300 and Figure 1 on page 300).
Even though the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of a phenolic mixture comprising 2-hydroxyphenol, 2-methoxyphenol, 3-methylphenol, 2-(1-methylethyl)-5-methyl-phenol, 4-allyl-2-methoxyphenol, 4-hydroxy-3-methoxybenzaldehyde (vanillin), tannin, and salicylates such as amyl salicylate and benzyl salicylates, the combined references do not recite that the phenolic mixture specifically includes tannic acid and isoamyl salicylate.
The independent teachings of Shelby and EFSA are described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the composition as described by the combination of the reference application, Duval, Gadient, and Losa above the plant materials that have high levels of tannic acid as disclosed in Shelby and further including isoamyl salicylates as disclosed in EFSA to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of including tannins and salicylates into the composition that are useful for reducing methane emission as well as other benefits such as improving weight gain, Shelby provides guidance of including plant materials high in tannic acid for the same purpose of reducing methane emission in livestock, and EFSA provides guidance that isoamyl salicylate and benzyl salicylates are active ingredients used in feed additive formulations for a similar purpose of weight gaining (fattening) performance.
Claim(s) 9, 20-21, and 23-24 are rejected are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,154,981 (’981) in view Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), and Ruiz-Rico et al. (Food Chemistry, 2017 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claims 9, 20, and 23 as discussed above.
Even though the combined references provide guidance of formulating the mixture of essential oil compounds with a carrier, the combined references do not recite the carrier material comprises silica.
The teachings of Ruiz-Rico are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the essential oil composition as disclosed by the combination of the reference application, Duval, Gadient, and Losa described above by formulating into a silica particle composition as disclosed in Ruiz-Rico to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to formulate into a silica particle composition because Ruiz-Rico discloses that essential oil components (EOCs) have limited application in the formulation of a wide range of food products due to their high volatility, powerful aroma limit, poor water solubility, and degradability. Furthermore, Ruiz-Rico discloses an added advantage that the EOCs, which include the same compounds such as eugenol and thymol, have antimicrobial properties against several food-borne microorganisms and may be beneficial to prevent food spoilage.
One of ordinary skill in the art would have a reasonable expectation of success because Ruiz-Rico effectively demonstrates the incorporation of the silica-based EOC composition, which include several of the same compounds such as eugenol and thymol, into a real food system (pasteurized milk), and further discloses the incorporation of silica particle based compositions into animal feeds.
Claims 9-14, 16, 18-20, and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,191,288 (’288) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025).
Claim 1 of ‘288 recites a method for reducing the production of methane emanating from the digestive activities of ruminants and/or for improving ruminant animal performance comprising orally administering to the animal a feed composition or feed additive comprising 3-nitrooxypropanol and lauric acid in a mol ratio of the 3-nitrooxypropanol to the lauric acid of between 0.0025 and 0.1 sufficient to achieve an amount of the 3-nitrooxypropanol administered to the ruminant animal of from 1 mg to 10 g per kg feed, and an amount of the lauric acid administered to the ruminant animal of from 0.1 to 20 g per kg of feed.
The difference between the claims of ‘288 and the claimed invention is that the claims of ‘288 do not recite at least six phenolic substances and a powder formulation comprising a carrier.
The independent teachings of Duval, Gadient, and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition of the reference application by using a powderous formulation further comprising sepiolite as a carrier as disclosed in Gadient and further combining this composition with the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to use the powderous formulation because Gadient discloses that 3-nitrooxypropanol and structural analogues thereof are volatile and have been found not to be effectively retained in standard carrier systems commonly used in the feed industry under conventional storage conditions, which in turn may lead to a significant loss of the active in the final product form such as the feed product or the requirement of elaborate
One of ordinary skill in the art would have a reasonable expectation of success because Gadient discloses that their powderous formulation surprisingly retained the same 3-nitrooxypropanol compound effectively under conventional storage conditions and can be used for animal feed formulations.
One of ordinary skill in the art would have combined these compositions with a reasonable expectation of success because the reference application, Duval, and Losa all recite that their respective compositions are useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
Furthermore, in regards to instant claim 14, Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed), rendering the recited ranges obvious. See MPEP 2144.06 I.
Claim(s) 9 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,191,288 (’288) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), Shelby et al. (US20090285931A1 in PTO-892), EFSA (EFSA Journal, 2012 in PTO-892), and as evidenced by Sinha et al. (International Journal of Food Sciences and Nutrition, 2008 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claim 9 as discussed above.
Furthermore, as evidenced by Sinha, the primary ingredient found in vanilla is vanillin (4-hydroxy-3 methoxybenzaldehyde) (second paragraph page 300 and Figure 1 on page 300).
Even though the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of a phenolic mixture comprising 2-hydroxyphenol, 2-methoxyphenol, 3-methylphenol, 2-(1-methylethyl)-5-methyl-phenol, 4-allyl-2-methoxyphenol, 4-hydroxy-3-methoxybenzaldehyde (vanillin), tannin, and salicylates such as amyl salicylate and benzyl salicylates, the combined references do not recite that the phenolic mixture specifically includes tannic acid and isoamyl salicylate.
The independent teachings of Shelby and EFSA are described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the composition as described by the combination of the reference application, Duval, Gadient, and Losa above the plant materials that have high levels of tannic acid as disclosed in Shelby and further including isoamyl salicylates as disclosed in EFSA to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of including tannins and salicylates into the composition that are useful for reducing methane emission as well as other benefits such as improving weight gain, Shelby provides guidance of including plant materials high in tannic acid for the same purpose of reducing methane emission in livestock, and EFSA provides guidance that isoamyl salicylate and benzyl salicylates are active ingredients used in feed additive formulations for a similar purpose of weight gaining (fattening) performance.
Claim(s) 9, 20-21, and 23-24 are rejected are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,191,288 (’288) in view Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), and Ruiz-Rico et al. (Food Chemistry, 2017 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claims 9, 20, and 23 as discussed above.
Even though the combined references provide guidance of formulating the mixture of essential oil compounds with a carrier, the combined references do not recite the carrier material comprises silica.
The teachings of Ruiz-Rico are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the essential oil composition as disclosed by the combination of the reference application, Duval, Gadient, and Losa described above by formulating into a silica particle composition as disclosed in Ruiz-Rico to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to formulate into a silica particle composition because Ruiz-Rico discloses that essential oil components (EOCs) have limited application in the formulation of a wide range of food products due to their high volatility, powerful aroma limit, poor water solubility, and degradability. Furthermore, Ruiz-Rico discloses an added advantage that the EOCs, which include the same compounds such as eugenol and thymol, have antimicrobial properties against several food-borne microorganisms and may be beneficial to prevent food spoilage.
One of ordinary skill in the art would have a reasonable expectation of success because Ruiz-Rico effectively demonstrates the incorporation of the silica-based EOC composition, which include several of the same compounds such as eugenol and thymol, into a real food system (pasteurized milk), and further discloses the incorporation of silica particle based compositions into animal feeds.
Claims 9-14, 16, 18-20, and 22-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,193,456 (’456) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025).
Claim 1 of ‘456 recites a method for reducing methane emission in adult ruminants, said method comprising administering to said ruminants an effective amount of a composition comprising 3-nitrooxypropanol (3-NOP) from birth up to an age of a maximum of 6 months.
The difference between the claims of ‘456 and the claimed invention is that the claims of ‘456 do not recite at least six phenolic substances and powderous formulation comprising a carrier.
The independent teachings of Duval, Gadient, and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition of the reference application by using a powderous formulation further comprising sepiolite as a carrier as disclosed in Gadient and further combining this composition with the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to use the powderous formulation because Gadient discloses that 3-nitrooxypropanol and structural analogues thereof are volatile and have been found not to be effectively retained in standard carrier systems commonly used in the feed industry under conventional storage conditions, which in turn may lead to a significant loss of the active in the final product form such as the feed product or the requirement of elaborate
One of ordinary skill in the art would have a reasonable expectation of success because Gadient discloses that their powderous formulation surprisingly retained the same 3-nitrooxypropanol compound effectively under conventional storage conditions and can be used for animal feed formulations.
One of ordinary skill in the art would have combined these compositions with a reasonable expectation of success because the reference application, Duval, and Losa all recite that their respective compositions are useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
Furthermore, in regards to instant claim 14, Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed), rendering the recited ranges obvious. See MPEP 2144.06 I.
Claim(s) 9 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,193,456 (’456) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), Shelby et al. (US20090285931A1 in PTO-892), EFSA (EFSA Journal, 2012 in PTO-892), and as evidenced by Sinha et al. (International Journal of Food Sciences and Nutrition, 2008 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claim 9 as discussed above.
Furthermore, as evidenced by Sinha, the primary ingredient found in vanilla is vanillin (4-hydroxy-3 methoxybenzaldehyde) (second paragraph page 300 and Figure 1 on page 300).
Even though the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of a phenolic mixture comprising 2-hydroxyphenol, 2-methoxyphenol, 3-methylphenol, 2-(1-methylethyl)-5-methyl-phenol, 4-allyl-2-methoxyphenol, 4-hydroxy-3-methoxybenzaldehyde (vanillin), tannin, and salicylates such as amyl salicylate and benzyl salicylates, the combined references do not recite that the phenolic mixture specifically includes tannic acid and isoamyl salicylate.
The independent teachings of Shelby and EFSA are described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the composition as described by the combination of the reference application, Duval, Gadient, and Losa above the plant materials that have high levels of tannic acid as disclosed in Shelby and further including isoamyl salicylates as disclosed in EFSA to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of including tannins and salicylates into the composition that are useful for reducing methane emission as well as other benefits such as improving weight gain, Shelby provides guidance of including plant materials high in tannic acid for the same purpose of reducing methane emission in livestock, and EFSA provides guidance that isoamyl salicylate and benzyl salicylates are active ingredients used in feed additive formulations for a similar purpose of weight gaining (fattening) performance.
Claim(s) 9, 20-21, and 23-24 are rejected are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,193,456 (’456) in view Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), and Ruiz-Rico et al. (Food Chemistry, 2017 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claims 9, 20, and 23 as discussed above.
Even though the combined references provide guidance of formulating the mixture of essential oil compounds with a carrier, the combined references do not recite the carrier material comprises silica.
The teachings of Ruiz-Rico are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the essential oil composition as disclosed by the combination of the reference application, Duval, Gadient, and Losa described above by formulating into a silica particle composition as disclosed in Ruiz-Rico to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to formulate into a silica particle composition because Ruiz-Rico discloses that essential oil components (EOCs) have limited application in the formulation of a wide range of food products due to their high volatility, powerful aroma limit, poor water solubility, and degradability. Furthermore, Ruiz-Rico discloses an added advantage that the EOCs, which include the same compounds such as eugenol and thymol, have antimicrobial properties against several food-borne microorganisms and may be beneficial to prevent food spoilage.
One of ordinary skill in the art would have a reasonable expectation of success because Ruiz-Rico effectively demonstrates the incorporation of the silica-based EOC composition, which include several of the same compounds such as eugenol and thymol, into a real food system (pasteurized milk), and further discloses the incorporation of silica particle based compositions into animal feeds.
Claims 9-14, 16, 18-20, and 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/954,372 (‘372) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025).
Claim 2 of ‘372 recite a feeding regime for reducing methane emissions in adult ruminants, comprising: administering a diet comprising 3-nitrooxypropanol to said ruminant in its pre-ruminant and optionally young ruminant phase followed by administering a diet which does not contain 3-nitrooxypropanol to the adult ruminant.
The difference between the claims of ‘372 and the claimed invention is that the claims of ‘372 do not recite at least six phenolic substances and a powderous formulation comprising a carrier.
The independent teachings of Duval, Gadient, and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition of the reference application by using a powderous formulation further comprising sepiolite as a carrier as disclosed in Gadient and further combining this composition with the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to use the powderous formulation because Gadient discloses that 3-nitrooxypropanol and structural analogues thereof are volatile and have been found not to be effectively retained in standard carrier systems commonly used in the feed industry under conventional storage conditions, which in turn may lead to a significant loss of the active in the final product form such as the feed product or the requirement of elaborate
One of ordinary skill in the art would have a reasonable expectation of success because Gadient discloses that their powderous formulation surprisingly retained the same 3-nitrooxypropanol compound effectively under conventional storage conditions and can be used for animal feed formulations.
One of ordinary skill in the art would have combined these compositions with a reasonable expectation of success because the reference application, Duval, and Losa all recite that their respective compositions are useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
Furthermore, in regards to instant claim 14, Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed), rendering the recited ranges obvious. See MPEP 2144.06 I.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 9 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/954,372 (‘372) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), Shelby et al. (US20090285931A1 in PTO-892), EFSA (EFSA Journal, 2012 in PTO-892), and as evidenced by Sinha et al. (International Journal of Food Sciences and Nutrition, 2008 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claim 9 as discussed above.
Furthermore, as evidenced by Sinha, the primary ingredient found in vanilla is vanillin (4-hydroxy-3 methoxybenzaldehyde) (second paragraph page 300 and Figure 1 on page 300).
Even though the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of a phenolic mixture comprising 2-hydroxyphenol, 2-methoxyphenol, 3-methylphenol, 2-(1-methylethyl)-5-methyl-phenol, 4-allyl-2-methoxyphenol, 4-hydroxy-3-methoxybenzaldehyde (vanillin), tannin, and salicylates such as amyl salicylate and benzyl salicylates, the combined references do not recite that the phenolic mixture specifically includes tannic acid and isoamyl salicylate.
The independent teachings of Shelby and EFSA are described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the composition as described by the combination of the reference application, Duval, Gadient, and Losa above the plant materials that have high levels of tannic acid as disclosed in Shelby and further including isoamyl salicylates as disclosed in EFSA to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of including tannins and salicylates into the composition that are useful for reducing methane emission as well as other benefits such as improving weight gain, Shelby provides guidance of including plant materials high in tannic acid for the same purpose of reducing methane emission in livestock, and EFSA provides guidance that isoamyl salicylate and benzyl salicylates are active ingredients used in feed additive formulations for a similar purpose of weight gaining (fattening) performance.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 9, 20-21, and 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/954,372 (‘372) in view Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), and Ruiz-Rico et al. (Food Chemistry, 2017 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claims 9, 20, and 23 as discussed above.
Even though the combined references provide guidance of formulating the mixture of essential oil compounds with a carrier, the combined references do not recite the carrier material comprises silica.
The teachings of Ruiz-Rico are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the essential oil composition as disclosed by the combination of the reference application, Duval, Gadient, and Losa described above by formulating into a silica particle composition as disclosed in Ruiz-Rico to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to formulate into a silica particle composition because Ruiz-Rico discloses that essential oil components (EOCs) have limited application in the formulation of a wide range of food products due to their high volatility, powerful aroma limit, poor water solubility, and degradability. Furthermore, Ruiz-Rico discloses an added advantage that the EOCs, which include the same compounds such as eugenol and thymol, have antimicrobial properties against several food-borne microorganisms and may be beneficial to prevent food spoilage.
One of ordinary skill in the art would have a reasonable expectation of success because Ruiz-Rico effectively demonstrates the incorporation of the silica-based EOC composition, which include several of the same compounds such as eugenol and thymol, into a real food system (pasteurized milk), and further discloses the incorporation of silica particle based compositions into animal feeds.
This is a provisional nonstatutory double patenting rejection.
Claims 9-14, 16, 18-20, and 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/554,927 (‘927) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025).
‘927 recites use of gossypol and a methane inhibitor for reducing the formation of methane emanating from the digestive activities of ruminants, wherein the methane inhibitor is administered to the ruminant in an amount selected in the range from 0.01 to 100 g methane inhibitor/animal/day and gossypol is administered to the ruminant in an amount selected in the range from 0.05 to 100 g gossypol/animal/day. ‘927 recites the methane inhibitor is selected from propanediol mononitrate and others.
The difference between the claims of ‘927 and the claimed invention is that the claims of ‘927 do not recite at least six phenolic substances and a powderous formulation comprising a carrier.
The independent teachings of Duval, Gadient, and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition of the reference application by using a powderous formulation further comprising sepiolite as a carrier as disclosed in Gadient and further combining this composition with the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to use the powderous formulation because Gadient discloses that 3-nitrooxypropanol and structural analogues thereof are volatile and have been found not to be effectively retained in standard carrier systems commonly used in the feed industry under conventional storage conditions, which in turn may lead to a significant loss of the active in the final product form such as the feed product or the requirement of elaborate
One of ordinary skill in the art would have a reasonable expectation of success because Gadient discloses that their powderous formulation surprisingly retained the same 3-nitrooxypropanol compound effectively under conventional storage conditions and can be used for animal feed formulations.
One of ordinary skill in the art would have combined these compositions with a reasonable expectation of success because the reference application, Duval, and Losa all recite that their respective compositions are useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
Furthermore, in regards to instant claim 14, Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed), rendering the recited ranges obvious. See MPEP 2144.06 I.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 9 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/554,927 (‘927) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), Shelby et al. (US20090285931A1 in PTO-892), EFSA (EFSA Journal, 2012 in PTO-892), and as evidenced by Sinha et al. (International Journal of Food Sciences and Nutrition, 2008 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claim 9 as discussed above.
Furthermore, as evidenced by Sinha, the primary ingredient found in vanilla is vanillin (4-hydroxy-3 methoxybenzaldehyde) (second paragraph page 300 and Figure 1 on page 300).
Even though the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of a phenolic mixture comprising 2-hydroxyphenol, 2-methoxyphenol, 3-methylphenol, 2-(1-methylethyl)-5-methyl-phenol, 4-allyl-2-methoxyphenol, 4-hydroxy-3-methoxybenzaldehyde (vanillin), tannin, and salicylates such as amyl salicylate and benzyl salicylates, the combined references do not recite that the phenolic mixture specifically includes tannic acid and isoamyl salicylate.
The independent teachings of Shelby and EFSA are described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the composition as described by the combination of the reference application, Duval, Gadient, and Losa above the plant materials that have high levels of tannic acid as disclosed in Shelby and further including isoamyl salicylates as disclosed in EFSA to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of including tannins and salicylates into the composition that are useful for reducing methane emission as well as other benefits such as improving weight gain, Shelby provides guidance of including plant materials high in tannic acid for the same purpose of reducing methane emission in livestock, and EFSA provides guidance that isoamyl salicylate and benzyl salicylates are active ingredients used in feed additive formulations for a similar purpose of weight gaining (fattening) performance.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 9, 20-21, and 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/554,927 (‘927) in view Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), and Ruiz-Rico et al. (Food Chemistry, 2017 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claims 9, 20, and 23 as discussed above.
Even though the combined references provide guidance of formulating the mixture of essential oil compounds with a carrier, the combined references do not recite the carrier material comprises silica.
The teachings of Ruiz-Rico are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the essential oil composition as disclosed by the combination of the reference application, Duval, Gadient, and Losa described above by formulating into a silica particle composition as disclosed in Ruiz-Rico to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to formulate into a silica particle composition because Ruiz-Rico discloses that essential oil components (EOCs) have limited application in the formulation of a wide range of food products due to their high volatility, powerful aroma limit, poor water solubility, and degradability. Furthermore, Ruiz-Rico discloses an added advantage that the EOCs, which include the same compounds such as eugenol and thymol, have antimicrobial properties against several food-borne microorganisms and may be beneficial to prevent food spoilage.
One of ordinary skill in the art would have a reasonable expectation of success because Ruiz-Rico effectively demonstrates the incorporation of the silica-based EOC composition, which include several of the same compounds such as eugenol and thymol, into a real food system (pasteurized milk), and further discloses the incorporation of silica particle based compositions into animal feeds.
This is a provisional nonstatutory double patenting rejection.
Claims 9-14, 16, 18-20, and 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/555,329 (‘329) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025).
Claim 1 of ‘329 recites use of limonene and PDMN for reducing the formation of methane emanating from the digestive activities of ruminants.
The difference between the claims of ‘329 and the claimed invention is that the claims of ‘329 do not recite at least six phenolic substances and a powderous formulation comprising a carrier.
The independent teachings of Duval, Gadient, and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition of the reference application by using a powderous formulation further comprising sepiolite as a carrier as disclosed in Gadient and further combining this composition with the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to use the powderous formulation because Gadient discloses that 3-nitrooxypropanol and structural analogues thereof are volatile and have been found not to be effectively retained in standard carrier systems commonly used in the feed industry under conventional storage conditions, which in turn may lead to a significant loss of the active in the final product form such as the feed product or the requirement of elaborate
One of ordinary skill in the art would have a reasonable expectation of success because Gadient discloses that their powderous formulation surprisingly retained the same 3-nitrooxypropanol compound effectively under conventional storage conditions and can be used for animal feed formulations.
One of ordinary skill in the art would have combined these compositions with a reasonable expectation of success because the reference application, Duval, and Losa all recite that their respective compositions are useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
Furthermore, in regards to instant claim 14, Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed), rendering the recited ranges obvious. See MPEP 2144.06 I.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 9 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/555,329 (‘329) in view of Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892), and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), Shelby et al. (US20090285931A1 in PTO-892), EFSA (EFSA Journal, 2012 in PTO-892), and as evidenced by Sinha et al. (International Journal of Food Sciences and Nutrition, 2008 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claim 9 as discussed above.
Furthermore, as evidenced by Sinha, the primary ingredient found in vanilla is vanillin (4-hydroxy-3 methoxybenzaldehyde) (second paragraph page 300 and Figure 1 on page 300).
Even though the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of a phenolic mixture comprising 2-hydroxyphenol, 2-methoxyphenol, 3-methylphenol, 2-(1-methylethyl)-5-methyl-phenol, 4-allyl-2-methoxyphenol, 4-hydroxy-3-methoxybenzaldehyde (vanillin), tannin, and salicylates such as amyl salicylate and benzyl salicylates, the combined references do not recite that the phenolic mixture specifically includes tannic acid and isoamyl salicylate.
The independent teachings of Shelby and EFSA are described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the composition as described by the combination of the reference application, Duval, Gadient, and Losa above the plant materials that have high levels of tannic acid as disclosed in Shelby and further including isoamyl salicylates as disclosed in EFSA to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because the combination of the reference application, Duval, Gadient, and Losa described above provide guidance of including tannins and salicylates into the composition that are useful for reducing methane emission as well as other benefits such as improving weight gain, Shelby provides guidance of including plant materials high in tannic acid for the same purpose of reducing methane emission in livestock, and EFSA provides guidance that isoamyl salicylate and benzyl salicylates are active ingredients used in feed additive formulations for a similar purpose of weight gaining (fattening) performance.
This is a provisional nonstatutory double patenting rejection.
Claim(s) 9, 20-21, and 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/555,329 (‘329) in view Duval et al. (US20140147529A1 in PTO-892 dated 11/26/2025), Gadient et al. (US20190343149A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892 dated 11/26/2025), and Ruiz-Rico et al. (Food Chemistry, 2017 in PTO-892).
The combination of the reference application, Duval, Gadient, and Losa are as described above and recite the method of instant claims 9, 20, and 23 as discussed above.
Even though the combined references provide guidance of formulating the mixture of essential oil compounds with a carrier, the combined references do not recite the carrier material comprises silica.
The teachings of Ruiz-Rico are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the essential oil composition as disclosed by the combination of the reference application, Duval, Gadient, and Losa described above by formulating into a silica particle composition as disclosed in Ruiz-Rico to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to formulate into a silica particle composition because Ruiz-Rico discloses that essential oil components (EOCs) have limited application in the formulation of a wide range of food products due to their high volatility, powerful aroma limit, poor water solubility, and degradability. Furthermore, Ruiz-Rico discloses an added advantage that the EOCs, which include the same compounds such as eugenol and thymol, have antimicrobial properties against several food-borne microorganisms and may be beneficial to prevent food spoilage.
One of ordinary skill in the art would have a reasonable expectation of success because Ruiz-Rico effectively demonstrates the incorporation of the silica-based EOC composition, which include several of the same compounds such as eugenol and thymol, into a real food system (pasteurized milk), and further discloses the incorporation of silica particle based compositions into animal feeds.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant requests that the nonstatutory double patenting rejections be reconsidered in view of the present amendments.
It noted that that Applicant has demonstrated a synergistic effective for methane reduction as well as for the digestibility of organic matter when 80 mg/kg DM 3-NOP (propanediol mononitrate) and 40 mg/kg DM CRINA (a phenolic substance mixture) was administered to together as described above.
However, Applicant’s showing of unexpected synergistic effect is not commensurate in scope with the claim as discussed above.
Therefore, Applicant’s showing of unexpected results does not rebut the prima facie case of obviousness over the reference applications in the nonstatutory double patenting rejections for the same reasons as discussed in response to the prior art rejections above.
Conclusion
No claim is found allowable.
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.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
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