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 .
Status of the Application
Claims 1-7, 9-10, 13-18 and 21-23 and 25 are pending. Claims 8, 11-12, 19-20 and 24 have been cancelled. The previous claim objections have been withdrawn in view of applicant’s amendments to the claims. The previous 112 rejections have been withdrawn in view of applicant’s amendments to the claims. The previous 103 rejections have been modified in view of applicant’s amendments to the claims.
Claim Interpretation
Claim 13 recites in lines 2-5: administering a composition to a subject having or susceptible to having coccidiosis and reducing a severity of coccidiosis in the subject by destruction of oocysts, reducing oocyst shedding, or reducing lesion scores.
One of ordinary skill in the art will recognize that the effects of administering the composition will be different in a subject having coccidiosis and a subject susceptible to having coccidiosis. While administering the composition to a subject with coccidiosis may reduce a severity of coccidiosis in the subject by destruction of oocysts, reducing oocyst shedding, or reducing lesion scores these effects will not occur in a subject which is merely susceptible to coccidiosis but does not actually have coccidiosis. Therefore claim 13, lines 2-5, will be interpreted as: administering a composition to a subject having or susceptible to having coccidiosis and, when the subject has coccidiosis, reducing a severity of coccidiosis in the subject by destruction of oocysts, reducing oocyst shedding, or reducing lesion scores.
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.
Claims 1-3, 7, 9-10, 13-18, 21-23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Lamb (US 2018/0125913 A1 ESSENTIAL OIL COMPOSITIONS AND APPLICATIONS UTILIZING ESSENTIAL OILS) in view of Khoo (US 2005/0112217 A1 METHOD TO REDUCE ODOR OF EXCRETA FROM COMPANION ANIMALS) as evidenced by Feed Strategy (Benefits of fiber feed additives in poultry nutrition, 2017, https://www.feedstrategy.com/animal-nutrition/poultry/article/15439457/benefits-of-fiber-feed-additives-in-poultry-nutrition).
Regarding claim 13, Lamb discloses a method of administering a composition, comprising: administering a composition to a subject (essential oil composition in broiler chicken diets [0066]). Lamb also discloses SO1 composition comprising a carrier, commercial product Larafeed solids (Larch tree arabinogalactan), and essential oil [0072]. This reads on the claim limitation “wherein the composition comprises a dietary fiber, one or more essential oils, and a carrier” because larch tree arabinogalactan (a fiber), essential oils and a carrier are present in SO1.
Lamb does not disclose the ratio of the dietary fiber to the one or more essential oils is between about 6:1 and about 20:1.
Khoo, also in the field of compositions for animals comprising essential oils and fibers, discloses a composition comprising an excreta odor reducing effective amount of zingiberaceous spice or an extract thereof [0011] where the zingiberaceous spice can include ginger [0015] and the extracts of ginger can include essential oils [0016]. Khoo further discloses an additional odor reducing agent can include fiber [0018] and the fibers can include pectin and inulin [0029]. Khoo further discloses when an extract of ginger is used it is present at 5-2000 ppm by weight of the composition [0027] and the fiber is present at about 0.1%-11% of the total weight of the composition [0029]. Khoo’s disclosed quantities of essential oil and fiber results in a fiber to essential oil ratio range of 0.9:1 to 22,000:1, which encompasses the claimed ranges of between 6:1 and 20:1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the method of administering a composition of Lamb with the essential oil and fiber proportions of Khoo in order to decrease odor from the excrements of the subject.
As to the claim limitation “a subject having or susceptible to having coccidiosis”, which is a parasitic disease of the gastrointestinal tract (spec, [0016]), it is known that all animals with gastrointestinal tracts are susceptible to having a gastrointestinal infection and/or disease caused by a pathogen. Therefore, any animal subject is considered to meet this claim limitation, including the broiler chickens of Lamb.
Regarding the claim limitation “reducing a severity of coccidiosis in the subject by destruction of oocysts, reducing oocyst shedding or reducing lesion scores,” as detailed in the claim interpretation section above, only subjects who have coccidiosis may have theses effects when the instantly claimed method is practiced. Subjects who are susceptible to coccidiosis, but who do not have coccidiosis, would have these effects when the instantly claimed method is practiced. Therefore the broiler chickens of Lamb meet the claim limitation of subjects susceptible to coccidiosis and therefore would not experience the recited effects when the method of the instant claims is practiced. Additionally, given the fact that the prior art teaches a method with all the components of the instant claims, the prior art’s method is considered to provide the same effects as the instantly claimed.
Regarding the claim limitation “a dietary fiber in an amount from about 30 mg per kg of body weight to about 50 mg per kg of body weight based on the body weight of the subject,” Lamb discloses the dietary fiber as discussed above. Lamb does not disclose the amount of dietary fiber per kg of body weight of the subject to which the composition is to be administered.
Lamb discloses the dietary fiber of the instant claim 13. As evidenced by Feed Strategy, fiber helps regulate digestive passage rate and is known to improve the development of the gastrointestinal tract (p4, 1st para). Therefore, it is known in the art that the quantity of dietary fiber is a result effective variable, when the amount of dietary fiber changes the digestive passage rate changes. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the product disclosed by the prior art by normal optimization procedures known in the art.
Regarding claim 1, Lamb discloses the essential oil composition can comprise additional components including carriers [0037] and one or more emulsifiers [0005].
Regarding claims 2 and 3, Lamb further discloses the composition may comprise larch arabinogalactan, polydextrose, chitin, psyllium, methyl-cellulose, hydrolyzed guar, guar, soy polysaccharide, oat bran, pectin, inulin, Fructooligosaccharides (FOS) and gum Arabic [0054]. Lamb refers to these materials as emulsifiers, however the instant specification lists them as dietary fibers (instant specification [0037]), therefore the larch arabinogalactan, polydextrose, chitin, psyllium, methyl-cellulose, hydrolyzed guar, guar, soy polysaccharide, oat bran, pectin, inulin, Fructooligosaccharides (FOS) and gum Arabic of Lamb meet the claim limitation of a dietary fiber.
Regarding claim 7, Lamb disclose the essential oils present in the composition can further include lavender essential oil, bay leaf essential oils, bay laurel essential oils, lemon grass essential oils, spearmint and peppermint essential oils and rosemary essential oils [0040].
Regarding claim 9, Lamb discloses the carrier can include water [0047] and limestone, diatomaceous earth and animal feed [0049].
Regarding claims 10, Lamb in view of Khoo teaches the method of claim 13, as described above. Lamb further teaches an essential oil composition can comprise one or more emulsifiers and an essential oil fraction can be combined with an emulsifier and a dry carrier, or alternatively an essential oil fraction can be combined with an emulsifier and a liquid carrier to form an emulsion [0051]. Lamb teaches tannic acid as an emulsifier [0055] and the larch arabinogalactan dietary fiber of the instant claims is also an emulsifier [0054]. Lamb further teaches that an emulsified essential oil fraction can increase the efficacy of an essential oil composition when ingested by a subject, and can make essential oil compositions more palatable to animals which consume the compositions orally [0051].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used a fiber/emulsifier, such as larch arabinogalactan, with an emulsifier of tannic acid and a liquid carrier to disperse the essential oils of instant claim 10. This combination would be motivated by the desire to increase the efficacy of an essential oil composition when ingested by a subject, and make essential oil compositions more palatable to animals which consume the compositions orally.
Regarding claim 14, Lamb further teaches wherein administering can include oral ingestion of the essential oil composition as a feed or liquid or via water or food based carriers [0061].
Regarding claim 15, Lamb teaches the composition comprises thyme essential oil and oregano essential oil (composition SO1 [0072]).
Regarding claim 16, given the prior art teaches administering a composition as claimed to a subject susceptible to coccidiosis, the composition would be effective against the pathogens as recited in claim 16. Claim 16 does not require that the subject actually be infected with one of the recited pathogens.
Regarding claim 22, Lamb discloses the essential oil composition can further comprise one or more emulsifiers and a liquid carrier [0051].
Regarding claim 23; Lamb discloses larch arabinogalactan is a suitable emulsifier [0055]. Lamb discloses the essential oil composition can comprise additional components including carriers [0037] and the carrier can be liquid water [0047].
Regarding claim 25, Lamb discloses the essential oil composition can further comprise one or more emulsifiers, such as tannic acid [0055].
Regarding claims 17-18, Lamb discloses an animal treatment composition and methods of making and using such compositions. Lamb discloses the invention provides essential oil compositions comprising oregano, thyme and cinnamon essential oils where the essential oil composition can also comprise an emulsifier [0004] and [0005]. Lamb discloses tannic acid is a suitable emulsifier [0055].
Lamb discloses the essential oil fraction can be combined with and emulsifier and a liquid carrier, which may be water [0047] and [0051]. Lamb’s water is considered to meet the claim limitation of a first carrier. Lamb’s disclosure of combining the essential oil fraction with an emulsifier and a liquid carrier is considered to meet the claim limitation of: forming or providing an essential oil composition.
Lamb discloses the essential oil fraction may first be combined with a pre-feed carrier (first carrier) followed by subsequent combination with a dry carrier (second carrier) [0049]. Lamb discloses carriers include water, diatomaceous earth, limestone and animal feed [0024].
Lamb further discloses the composition may comprise larch arabinogalactan, polydextrose, chitin, psyllium, methyl-cellulose, hydrolyzed guar, guar, soy polysaccharide, oat bran, pectin, inulin, Fructooligosaccharides (FOS) and gum Arabic [0054]. Lamb refers to these materials as emulsifiers, however the instant specification lists them as dietary fibers (instant specification [0037]), therefore the larch arabinogalactan, polydextrose, chitin, psyllium, methyl-cellulose, hydrolyzed guar, guar, soy polysaccharide, oat bran, pectin, inulin, Fructooligosaccharides (FOS) and gum Arabic of Lamb meet the claim limitation of a dietary fiber.
Lamb does not disclose adding the dietary fiber in a second step with the dry carrier. However, the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results and the selection of any order of mixing ingredients is prima facie obvious. MPEP 2144.04 IV C.
Lamb’s disclosure of tannic acid as the emulsifier and larch arabinogalactan as the dietary fiber meets the claim limitation of: wherein the dietary fiber and the emulsifier are not the same material.
Lamb discloses the emulsifier can be combined with an essential oil fraction in a ratio of about 3:1 to about 1:3 [0051].
Lamb does not disclose the ratio of dietary fiber to essential oils is between 6:1 and 20:1.
Khoo, also in the field of compositions for animals comprising essential oils and fibers, discloses a composition comprising an excreta odor reducing effective amount of zingiberaceous spice or an extract thereof [0011] where the zingiberaceous spice can include ginger [0015] and the extracts of ginger can include essential oils [0016]. Khoo further discloses an additional odor reducing agent can include fiber [0018] and the fibers can include pectin and inulin [0029]. Khoo further discloses when an extract of ginger is used it is present at 5-2000 ppm by weight of the composition [0027] and the fiber is present at about 0.1%-11% of the total weight of the composition [0029]. Khoo’s disclosed quantities of essential oil and fiber results in a fiber to essential oil ratio range of 0.9:1 to 22,000:1, which encompasses the claimed ranges of between 6:1 and 20:1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the composition of Lamb with the essential oil and fiber proportions of Khoo in order to decrease odor from the excrements of the subject.
As to the preamble recitation, “for reducing the severity of coccidiosis by destruction of oocysts, reducing oocyst shedding, or reducing lesion scores” and the claim language “for reducing the severity of coccidiosis” (line 10), given the fact that the prior art teaches a method with all the components of the instant claims, the prior art’s method is considered to provide the same effects as the instantly claimed method.
Regarding claim 21, Lamb discloses carriers include water, diatomaceous earth, limestone and animal feed [0024]. Lamb also discloses a specific example where the carrier of the SO1 essential oil composition comprises limestone and diatomaceous earth, which is also combined with RO water (also a carrier) [0072].
Lamb does not disclose which carrier is the “first carrier” and which is the “second carrier”, however, the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results and the selection of any order of mixing ingredients is prima facie obvious. MPEP 2144.04 IV C. Therefore it would be prima facie obvious to select water as the first carrier and limestone or diatomaceous earth as the second carrier.
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Lamb (US 2018/0125913 A1 ESSENTIAL OIL COMPOSITIONS AND APPLICATIONS UTILIZING ESSENTIAL OILS) in view of Khoo (US 2005/0112217 A1 METHOD TO REDUCE ODOR OF EXCRETA FROM COMPANION ANIMALS) as evidenced by Feed Strategy (Benefits of fiber feed additives in poultry nutrition, 2017, https://www.feedstrategy.com/animal-nutrition/poultry/article/15439457/benefits-of-fiber-feed-additives-in-poultry-nutrition) as applied to claims 13 and 3 above, and further in view of Phillippov (US 2013/0331354 A1).
Regarding claims 4 and 6, Lamb in view of Khoo teaches the methods of claims 13 and 3 where the arabinogalactan can be derived from larch trees (Lamb [0054])
Lamb does not disclose the presence of polyphenols from larch trees in a concentration ranging from about 1 wt% to about 4 wt%.
Phillippov, also in the field of animal feed compositions, teaches an animal feed composition including a Larch Arabinogalactan in an amount between 0.1 % and 30% of the animal feed composition, and Dihydroquercetin (taxifolin) in an amount between 0.1 % and 10% of the animal feed composition (abstract). Taxifolin is a flavonoid extracted mainly from the plan genus Larix (commonly known as larch) [0060] and flavonoids are polyphenols [0044]. Phillippov further teaches that flavonoid Dihydroquercetin (taxifolin) is one of the most effective natural antioxidant and anti-inflammatory compounds [0039].
Regarding the quantity of polyphenols of claim 6, it is known in the art that the quantity of polyphenols is a result effective variable, the more polyphenols the more antioxidant and anti-inflammatory response. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the composition disclosed by the prior art by normal optimization procedures known in the art.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lamb (US 2018/0125913 A1 ESSENTIAL OIL COMPOSITIONS AND APPLICATIONS UTILIZING ESSENTIAL OILS) in view of Khoo (US 2005/0112217 A1 METHOD TO REDUCE ODOR OF EXCRETA FROM COMPANION ANIMALS) as evidenced by Feed Strategy (Benefits of fiber feed additives in poultry nutrition, 2017, https://www.feedstrategy.com/animal-nutrition/poultry/article/15439457/benefits-of-fiber-feed-additives-in-poultry-nutrition) and Freitas (US 2014/0288021 A1 COMPOSITION COMPRISING ARABINOGALACTAN AND POLYPHENOLS FROM LARCH TREES).
Regarding claim 5, Lamb in view of Khoo teaches the methods of claims 13 and 3 above and with evidence provided by Freitas (US 2014/0288021 A1) larch arabinogalactan is known to be a highly branched polysaccharide having a molecular weight between 15000 to 60000 Daltons [0008].
Response to Arguments
Applicant's arguments filed 22 July 2025 have been fully considered. To the extent they apply to the rejections above they are not persuasive.
Applicant argues Lamb nor any of the other references do not describe reducing the severity of coccidiosis. Remarks pp7-8.
This argument is not persuasive. As detailed in the claim interpretation section and the rejection above, the instant claims require a subject having coccidiosis or a subject susceptible to having coccidiosis. One of ordinary skill in the art will recognize that the effects of administering the composition will be different in a subject having coccidiosis and a subject susceptible to having coccidiosis. While administering the composition to a subject with coccidiosis may reduce a severity of coccidiosis in the subject by destruction of oocysts, reducing oocyst shedding, or reducing lesion scores these effects will not occur in a subject which is merely susceptible to coccidiosis but does not actually have coccidiosis. Therefore claim 13, lines 2-5, will be interpreted as: administering a composition to a subject having or susceptible to having coccidiosis and, when the subject has coccidiosis, reducing a severity of coccidiosis in the subject by destruction of oocysts, reducing oocyst shedding, or reducing lesion scores.
Therefore, when the claim limitation of claim 13 is met with a subject susceptible to coccidiosis, as in Lamb, the recited effects are required since the subject does not have coccidiosis and therefore does not have any oocysts or lesions to effect.
In response to applicant's argument that Lamb and the other prior art does not contemplate a treatment of coccidiosis, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues that some materials may act as emulsifiers and dietary fibers the amounts used would be different based on the purpose of incorporation into the composition. Remarks p8.
This argument is not persuasive. Lamb further discloses the composition may comprise larch arabinogalactan, polydextrose, chitin, psyllium, methyl-cellulose, hydrolyzed guar, guar, soy polysaccharide, oat bran, pectin, inulin, Fructooligosaccharides (FOS) and gum Arabic [0054]. Lamb refers to these materials as emulsifiers, however the instant specification lists them as dietary fibers (instant specification [0037]), therefore the larch arabinogalactan, polydextrose, chitin, psyllium, methyl-cellulose, hydrolyzed guar, guar, soy polysaccharide, oat bran, pectin, inulin, Fructooligosaccharides (FOS) and gum Arabic of Lamb meet the claim limitation of a dietary fiber. As acknowledged in the specification, one of ordinary skill in the art would know these ingredients can also act as dietary fibers. As discussed above, as evidenced by Feed Strategy, fiber helps regulate digestive passage rate and is known to improve the development of the gastrointestinal tract (p4, 1st para). Therefore, it is known in the art that the quantity of dietary fiber is a result effective variable, when the amount of dietary fiber changes the digestive passage rate changes. Therefore one of ordinary skill in the art would have been motivated to adjust the amount of dietary fiber to benefit the subject.
Applicant argues one would not combine Lamb and Khoo because the inventions have different purposes and the ingredients themselves have different purposes. Remarks p8.
This argument is not persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Lamb and Khoo are both drawn to compositions for animals that include dietary fiber and essential oils. One of ordinary skill in the art wanting to make a composition with dietary fiber and essential oils would have been motivated to seek out references with the combination of the two ingredients in order to determine appropriate amounts of each for the composition.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.L.G./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793