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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 03/04/2026 has been entered.
Priority
The instant application is a 371 of PCT/US2020/040516 filed on 07/01/2020 and claims foreign priority to European application no. EP19183974.5 filed on 07/02/2019. The certified copy of the foreign priority application EP19183974.5 filed on 12/21/2021 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/04/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
The claim amendments and remarks filed on 03/04/2026 is acknowledged. Claims 10, 14, and 25 are amended. Claims 1-9, 13, and 16-24 are cancelled. Claims 26-28 are newly added
Accordingly, claims 10-12, 14-15, and 25-28 are pending and being examined on the merits herein.
Withdrawn Rejections
The 35 USC 112(a) rejection over claims 10-11, 14-15, and 25 are withdrawn because claim 10 now recites “wherein the source of glycyrrhizin comprises glycyrrhizin in an amount of from about 1% to about 30% by total weight of dry matter of the source of glycyrrhizin”, which is supported by the disclosed specification (lines 16-29 page 19).
The 35 USC 103 rejections over Park in view of Torney, Procter, and Dastagir for claims 10-11 and 15 and further in view of US’585 for claims 14 and 25 are withdrawn because claim 10 now recites new limitations which were not previously examined such as “about 0.1% to about 3.5% by weight of EPA/DHA” and “wherein the source of glycyrrhizin comprises glycyrrhizin in an amount of from about 1% to about 30% by total weight of dry matter of the source of glycyrrhizin”.
The nonstatutory double patenting rejections over US 11,419,912, US 10,441,623, and co-pending application no. 18/859,858 are withdrawn because claim 10 now recites new limitations which were not previously examined such as “about 0.1% to about 3.5% by weight of EPA/DHA” and “wherein the source of glycyrrhizin comprises glycyrrhizin in an amount of from about 1% to about 30% by total weight of dry matter of the source of glycyrrhizin”.
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) 10-12, 14-15, 25, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (WO2014149424A1 in PTO-892 dated 08/19/2025) in view of AAFCO (Pet Food Report 2015 in PTO-892), Procter et al. (US4259361A in PTO-892 dated 08/19/2025), and Dastagir et al. (Pak. J. Pharm. Sci., 2016 in PTO-892 dated 01/23/2026).
Park et al. discloses a composition containing plant materials or extracts with inhibitory effect on a 5-HT3a and/or NK-1 receptor for preventing or treating idiopathic vomiting in a companion animal (see Abstract and claim 1).
Park et al. discloses that the plant materials can be a combination of curcuma longa (turmeric) and Glycyrrhiza glabra (licorice) (see claim 3). Park et al. discloses that the term “companion animal” includes felines as well as domesticated dogs, wolves, and the like (see page 4 lines 16-21). Park et al. discloses that when the composition is administered to a companion animal in the form of a pet food composition, the plant materials or extracts are preferably administered in dosages of 0.1ppm to 75000ppm (0.00001% to 7.5% by weight) and preferably from 1ppm to 1000pm (0.0001% to 0.1% by weight) (see page 9 lines 16-21).
Park et al. discloses that their composition can be in the form of dry kibbles, wet canned, food, gravies, treats, and among other forms (see page 7 lines 19-24). Park et al. discloses that as a pet food, the dietary composition may comprise a nutritionally complete diet for the intended recipient companion animal (see page 7 lines 31-32).
Park et al. discloses the pet food composition comprises of at least a source of carbohydrate, a source of protein, and optionally a source of fat (see page 8 lines 3-5). Park et al. also discloses the pet food can comprise preferably 1-40% or preferably 5-20% by weight fat and also preferably 1-8% by weight of vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal (see page 8 lines 10-14). Park et al. discloses that their compositions may include features to reduce other causes of vomiting such as including ingredients that reduce the occurrence of hairballs, such as proteases, polyol fatty acid polyesters, laxatives, and the like as well as ingredients to promote gastrointestinal health such as prebiotics or probiotics (see page 10 lines 1-5).
Park et al. demonstrates in Fig. 40 the synergistic effects of administering a combination of turmeric (T) and licorice (L) to inhibit 5-HT3a in a 5-HT3a FLIPR cell assay.
Even though Park does not demonstrate an exemplary nutritionally complete dog food kibble comprising the recited percent by weight amounts of licorice, turmeric, and source of proteins, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared a nutritionally complete dog food kibble comprising the recited percent by weight amounts of licorice, turmeric, source of proteins, and other ingredients such as fats and vitamins based on the teachings of Park with a reasonable expectation of success because Park demonstrates the synergistic effects of administering a combination of turmeric and licorice to inhibit 5-HT3a in a 5-HT3a which may be useful for treating idiopathic vomiting in a companion animal, further discloses that these ingredients can be added in a nutritionally complete pet food composition that can comprise of a source of proteins and other ingredients including fats and vitamins, and further discloses the pet food can be in the form of kibbles as well as the pet food being intended for cats, dogs, and other domesticated animals. Furthermore, Park provides guidance that the plant materials such as turmeric and licorice can be prepared in these pet food compositions preferably from 1ppm to 1000pm (0.0001% to 0.1% by weight), which overlaps and renders obvious the recited percent by weights for the licorice and turmeric in the instant claims. See MPEP 2144.05 I.
Park, however, does not further disclose that their compositions comprise the recited percent by weight amounts of linoleic acid, EPA/DHA, the kibble having a moisture content of less than about 12% by weight, and wherein the licorice comprises glycyrrhizin in an amount of 1%-30% by weight of the licorice.
AAFCO provides nutrient profile guidelines for the practical minimum and some maximum nutrient concentrations for common ingredients used in dog and cat foods (last paragraph page 5).
AAFCO discloses in the Table on pages 7-8, for a dog food nutrient profile based on dry matter, a minimum amount of crude fat of 8.5% on a dry matter (DM) basis, and further specifies a minimum 1.3% linoleic acid and 0.05% eicosapentaenoic + docosahexaenoic acid (EPA/DHA) amount on a DM basis. AAFCO does not discloses a maximum amount for these fats. AAFCO further discloses that the CNES also did not establish maximum concentrations for fat or fatty acids and likely determined that insufficiencies in other nutrients will occur in a conventional formula before an inclusion of 33% crude fat in DM is reached (second paragraph page 12).
AAFCO discloses in the Table on pages 7-8, for a dog food nutrient profile based on dry matter, a minimum amount of 50 IU/kg of vitamin E (converts to 0.00335% by weight) and also discloses in the Table on pages 9-10, for a dog food nutrient profile based on calorie content, a minimum amount of vitamin E 12.5 IU per 1000 kcal ME (converts to 0.008375 g/Mcal). AAFCO does not disclose a maximum amount for vitamin E, and further discloses that a 2007 CNES report also does not establish a safe upper limit (SUL) for vitamin E based on there being no information on vitamin E toxicity in dogs (second paragraph page 15).
Procter et al. discloses a process for preparing dehydrate foodstuffs, feedstuffs or plant fertilizers (see Abstract).
Procter et al. discloses in claim 1 that the steps comprise of (a) subjecting raw or uncooked, or substantially raw or uncooked, protein-containing animal matter to ultra homogenization, prior to the application of heat, to yield an average particulate size of less than about three microns and to reduce any tendons, skin or connective tissues to blend with muscle tissues and to break down fibrous tissue and emulsify associated fats resulting in a smooth, creamy, liquid to semi-solid homogenate; (b) heating the resulting homogenate to form a protein agglomerate to effect gelation of said protein; (c) granulating the resulting agglomerate; (d) partially drying the granulated agglomerate; (e) kibbling the resultant partially dried and granulated agglomerate to break open case hardened protein film formed in step (d); and (f) drying the resultant kibbles.
Procter et al. discloses that their produced kibbles are dried to a moisture content of not more than 8% (claim 5). Procter et al. discloses that it is desirable that the kibble be dried to a final moisture content of less than 5% to ensure the stability of the end product on storage (see column 5 lines 8-11). Procter et al. discloses that their protein-containing meals can include other ingredients such as carbohydrates, cellulosic substances, vegetables, seasonings, and flavorings (see column 5 lines 13-20). Procter et al. discloses that their kibble food products are intended to feed animals (column 2 lines 43-46), and demonstrates in Example 11 that their food kibble was fed to domestic dogs and cats (column 8 lines 43-50).
Dastagir discloses that glycyrrhizin is the major active constituent obtained from licorice (Glycyyhiza glabra) (see Abstract). Dastagir discloses that licorice has 2-9% sweet saponin known as glycyrrhizin (see second paragraph left column page 1730).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the dog food kibble composition as disclosed by the teachings of Park described above by including and routinely optimizing the amounts of linoleic acid and DHA/EPA as well as vitamin E as sources of fats and vitamins, respectively, based on the teachings of Park and AAFCO, further modifying the moisture content of the kibble to be less than 5% as disclosed in Procter, and that the licorice in the composition would have 2-9% glycyrrhizin as disclosed in Dastagir to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements of including linoleic acid, DHA/EPA, and vitamin E according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because AAFCO establishes guidelines for including these ingredients for the nutrient profiles in dog and cat foods, and Park also discloses that their nutritionally complete pet food includes a source of fats and vitamins.
An ordinary skilled artisan would have performed routine optimization to arrive at the recited percent by weight of linoleic acid and DHA/EPA as well as the recited g/Mcal range of vitamin E because AAFCO provides guidance of providing a minimum of 1.3% linoleic acid and 0.05% EPA/DHA on a dry matter basis for the nutrient profile of dog food and further discloses that reaching 33% crude fat in DM will likely lead to insufficiencies in other nutrients in a conventional formula. AAFCO also discloses a minimum amount of 50 IU/kg of vitamin E (converts to 0.00335% by weight) and 12.5 IU per 1000 kcal ME (converts to 0.008375 g/Mcal) as well as no maximum amount for vitamin E on the basis of there being no information on vitamin E toxicity in dogs (second paragraph page 15). Furthermore, Park provides guidance of including in the pet food composition preferably 1-40% or preferably 5-20% by weight fat and also preferably 1-8% by weight of vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal. See MPEP 2144.05 II.
One of ordinary skill in the art would have been motivated to prepare the kibble to have a moisture content of less than 5% because Procter provides guidance that a moisture content of less than 5% ensures storage stability for the animal food kibble.
One of ordinary skill in the art would have a reasonable expectation of success because both Park and Procter teach animal food kibble compositions that contain similar ingredients such as proteins and fats.
Lastly, one of ordinary skill in the art would have a reasonable expectation that the licorice used in Park would have a glycyrrhizin content of 2-9% because Dastagir provides guidance that licorice contains 2% to 9% sweet saponin known as glycyrrhizin.
In regards to instant claim 15, it would have also been prima facie obvious to prepare the dog food kibble composition as disclosed by the combination of Park, AAFCO, Procter, and Dastagir described above by adding the ingredients in this food kibble composition in the homogenizing step and subsequently heating the mixture to form the kibble as disclosed in the preparation method of Procter 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 Procter provides a method of making kibble food products, which contain proteins and fats, that are intended for animals as demonstrated by their examples in which dogs and cats were fed the kibble product, and the combination of Park, AAFCO, Procter, and Dastagir described above also disclose a dog food composition that also comprises of proteins and fats, and can be in the form of a kibble product.
Claim(s) 26 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (WO2014149424A1 in PTO-892 dated 08/19/2025) in view of AAFCO (Pet Food Report 2015 in PTO-892), Procter et al. (US4259361A in PTO-892 dated 08/19/2025), and Dastagir et al. (Pak. J. Pharm. Sci., 2016 in PTO-892 dated 01/23/2026), as applied to claims 10 and 14 above, and further in view of PetMD (Article in PetMD website published on 06/08/2012 in PTO-892).
The combined teachings of Park, AAFCO, Procter, and Dastagir are as described above and teach the dog food composition of instant claims 10 and 14 as discussed above.
Furthermore, AAFCO discloses in the Table on pages 17-18 a minimum amount of either extruded or canned taurine at 0.25 g or 0.50 g, respectively, per 1000 kcal ME (0.25 g/Mcal or 0.50 g/Mcal) for the nutrient profile of cat food based on calorie content. AAFCO does not disclose a maximum amount of taurine.
Even though the combined references disclose including taurine with a minimum amount being 0.25 g/Mcal or 0.50 g/Mcal, the combined references do not disclose including taurine at the recited g/Mcal range in dog foods.
petMD discloses that the amino acid taurine plays a role in the proper development and function of the heart muscle, and that dogs do not typically have taurine deficiency so as long as they eat a diet that supplies sufficient amounts of cysteine and methionine, which can be converted in taurine, and/or intaking taurine directly (third to last paragraph page 2).
petMD further discloses certain dog breeds such as Newfoundlands and Cocker Spaniels can have altered taurine metabolism, and can developed dilated cardiomyopathy caused by taurine deficiency even when these dogs eat a diet that contain adequate amounts of cysteine, methionine, and/or taurine (third to last paragraph page 2).
Therefore, petMD suggests taurine supplementation for these dogs, and further discloses that even if it is not necessary for healthy Newfoundlands and Cocker Spaniels, taurine supplementation is relatively inexpensive and if the taurine is not needed by the dog’s body, the excess taurine is broken down and excreted as waste, which should not be harmful as long as the dog’s kidneys are functioning well (last paragraph page 2 and first paragraph page 3).
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the dog food kibble composition as disclosed by the combination of Park, AAFCO, Procter, and Dastagir described above the taurine as disclosed by AAFCO and petMD and further routinely optimize the amount of taurine as disclosed by AAFCO and petMD to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to include taurine into the dog food because petMD discloses that taurine plays a role in the proper development and function of the heart muscle and further suggesting taurine supplementation in dogs as certain dog breeds can develop diseases caused by taurine deficiencies due to an altered taurine metabolism.
One of ordinary skill in the art would have a reasonable expectation of success because the combined teachings of Park, AAFCO, Procter, and Dastagir described above provide guidance of a nutritionally complete dog food composition that can include vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal, and petMD further discloses that a dog typically has sufficient taurine levels due to their diet, and provides further guidance that excess taurine supplementation is not harmful to the dog as it is broken down and excreted as waste.
Furthermore, an ordinary skilled artisan would have performed routine optimization to arrive at the recited g/Mcal amounts for the taurine based on AAFCO disclosing a minimum 0.25 g/Mcal or 0.50 g/Mcal amount of taurine in pet foods and petMD disclosing that excess taurine does not harm the dog as it is broken down and excreted as waste. Furthermore, Park also discloses including 1-8% by weight of vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal. See MPEP 2144.05 II.
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (WO2014149424A1 in PTO-892 dated 08/19/2025) in view of AAFCO (Pet Food Report 2015 in PTO-892), Procter et al. (US4259361A in PTO-892 dated 08/19/2025), and Dastagir et al. (Pak. J. Pharm. Sci., 2016 in PTO-892 dated 01/23/2026), as applied to claims 10 and 14 above, and further in view of GRAS (GRAS notice for marigold extract published on 06/30/2016 from FDA.gov website in PTO-892).
The combined teachings of Park, AAFCO, Procter, and Dastagir are as described above and teach the dog food composition of instant claims 10 and 14 as discussed above.
The combined references, however, do not disclose including lutein at the recited g/Mcal range in dog foods.
GRAS discloses including marigold extract oleoresin into dog and cat foods as a source of lutein and not exceeding greater than 5 mg lutein per 1000 kcal ME (0.005 g/Mcal) (first paragraph page 14).
GRAS discloses that the marigold extract oleoresin contains a significant amount of lutein (first paragraph 14). GRAS discloses that lutein is a common ingredient found in dog and cat foods for many years without observed ill-effect (bullet number 10 page 5). GRAS discloses that dietary lutein has a powerful nutritional benefit to dogs and cats, including promoting healthy immune response and as an antioxidant by protecting cells form oxidative damage (first paragraph page 14).
GRAS discloses that the presumed safe intake of lutein as determined by the National Research Council of the National Academies (NRC) is 1.8 mg/kg bodyweight/day for dogs and 7.2 mg/kg bodyweight/day for cats (last paragraph page 16), and that at the maximum rate of inclusion of marigold extract of 5 mg lutein/1000 kcal ME, a 17 kg large-breed puppy will consume 0.57 mg/kg bodyweight /day while a 1.5 kg small-breed puppy will consume 1.26 mg lutein/kg bodyweight/day (first paragraph page 17). Therefore, the estimated intake of lutein (not exceeding greater than 5 mg lutein per 1000 kcal ME) from the inclusion of marigold extract is well below the presumed safe intake level as determined by the NRC (second paragraph page 17).
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the dog food kibble composition as disclosed by the combination of Park, AAFCO, Procter, and Dastagir described above the marigold extract not exceeding greater than 5 mg lutein per 1000 kcal ME (0.005 g/Mcal) as disclosed by GRAS to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to include the marigold extract, that contains lutein, into the dog food because GRAS discloses that marigold extract contains a significant amount of lutein, and that dietary lutein has a powerful nutritional benefit to dogs and cats, including promoting healthy immune response and protecting cells form oxidative damage. Furthermore, GRAS discloses including the lutein at no more than 5 mg lutein per 1000 kcal ME (0.005 g/Mcal), which overlaps and renders obvious the recited lutein g/Mcal range. See MPEP 2144.05 I.
One of ordinary skill in the art would have a reasonable expectation of success because the combined teachings of Park, AAFCO, Procter, and Dastagir described above provide guidance of a nutritionally complete dog food composition that can include vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal, and GRAS also provides guidance of including the marigold extract, which contains lutein, into dog and cat foods and treats and that lutein has been included in dog and cat foods for many years without any ill effects.
Response to Arguments
Applicant’s arguments filed on 03/04/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states in regards to the teaching of Park that Park only broadly teaches the inclusion of various plants in a dietary composition for inhibiting 5-HT3a and NK-3 receptors. Applicant states that a skilled artisan would therefore refer to the data of Park to determine an amount of a source of glycyrrhizin and curcuminoids. Applicant states that the data presented by Park shows that 100% inhibition of 5HT3A varies depending on the plant material used such as 0.01% concentration for cayenne and 0.12% for wisteria pure oils. Therefore, Applicant states that Park shows dissimilar properties within the recited range of plant material and would not invite optimization by one skilled in the art. Furthermore, Applicant refers to Fig. 29 of Park, which is a dose response curve showing that 100% inhibition of 5HT3A was seen at approximately 0.001%, which is below the range required in instant claim 10. Therefore, Applicant states that the skilled artisan would have no motivation to increase the concentration of turmeric to arrive at the claimed invention.
Applicant’s arguments described above was not found persuasive because it is first noted that routine optimization or an explicit motivation is not relied upon in the prior rejection described above to arrive at the claimed amounts of source of glycyrrhizin and curcuminoids. Rather, the claimed range for the source of glycyrrhizin and curcuminoids was rendered obvious based on Park teaching a synergy for a combination of licorice and turmeric and further disclosing an overlapping amount for including the plant materials in pet foods at 0.00001% to 7.5%, which renders the claimed percent by weight amounts obvious according to MPEP 2144.05 I, which states that “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists”.
Furthermore, MPEP 2123 II states that “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments”.
FIG. 29 only demonstrates the dose response of turmeric for inhibiting 5HT3A, and does not teach or suggest that greater amounts of the compound cannot be used. Furthermore, based on Park disclosing overlapping amounts of plant material to be included in pet food compositions as described above, the ordinary skilled artisan would have been able to arrive at the amounts of licorice and turmeric with a reasonable expectation of success.
Applicant presents argument over the teachings of Torney and US’585 (Park 2), however the prior rejections described above do not cite Torney or US’585 (Park 2), rendering the arguments over these references moot.
Applicant states that there is no motivation to combine the teachings of Park and Procter on the basis that Procter does not contemplate the instant dog food composition and Park failing to disclose a method of manufacturing.
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, Park does disclose that their pet food compositions can be provided as dried kibbles and contains proteins and fats, and Procter provides a method of making kibble food products containing proteins and fats that are intended for animals as demonstrated by their examples in which dogs and cats were fed the kibble product. Therefore, as described above, one of ordinary skill in the art would have been motivated to prepare the pet kibble of Park using the methods of Procter to have a moisture content of less than 5% because Procter provides guidance that a moisture content of less than 5% ensures storage stability for the animal food kibble. One of ordinary skill in the art would have a reasonable expectation of success because both Park and Procter teach animal food kibble compositions that contain ingredients such as proteins and fats.
Applicant states that Dastagir simply discusses the various application of glycyrrhiza or licorice and does not disclose its application as a pet food or supplement. Therefore, Applicant states that Dastgir fails to cure the deficiencies of the prior art rejection.
Applicant’s argument described above was not persuasive because Dastagir is not relied upon to provide guidance of using licorice for pet food or supplement application. Rather, Dastagir is only relied to provide guidance that the licorice, used in the pet food composition of Park, would be reasonably expected to contain 2-9% glycyrrhizin.
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 10-12, 14-15, 25, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,419,912 (referred to as ‘912) in view of Park et al. (WO2014149424A1 in PTO-892 dated 08/19/2025), AAFCO (Pet Food Report 2015 in PTO-892), Procter et al. (US4259361A in PTO-892 dated 08/19/2025), and Dastagir et al. (Pak. J. Pharm. Sci., 2016 in PTO-892 dated 01/23/2026).
Claim 1 of ‘912 recites a pet dietary composition comprising one or more plant materials or extracts thereof, wherein the plant materials or extracts thereof consist of Curcuma longa and one or more of licorice, ginger or rhubarb in amounts effective to result in a greater 5-HT3a and/or NK-1 receptor inhibition than the sum of the 5HT3a or NK-1 inhibitory effects achieved by each plant material or extract, separately. Claim 2 of ‘912 recites the composition is a pet food, and claim 3 of ‘912 recites the pet food is in the form of dry kibbles, wet canned food, gravies, or treats. Claim 5 of ‘912 recites the pet supplement comprises from 0.5% to 15% of said one of more plant materials or extracts thereof by weight.
Even though the claims of ‘912 recite a dry kibble pet food composition comprising a combination of turmeric and licorice in overlapping amounts, the claims of ‘912 do not further recite further comprising the recited amounts of linoleic acid, EPA/DHA, vitamin E, and glycyrrhizin in the licorice as well as a kibble having moisture content of less than 12% by weight, a source of proteins, and a nutritionally complete food composition.
The independent teachings of Park, AAFCO, Procter, and Dastagir are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the pet food composition as recited in the claims of ‘912 by preparing the composition as a nutritionally complete dog food kibble comprising source of proteins, fats, vitamins, and other ingredients as disclosed in Park, further including and routinely optimizing the amounts of linoleic acid and DHA/EPA as well as vitamin E as sources of fats and vitamins, respectively, based on the teachings of Park and AAFCO, further modifying the moisture content of the kibble to be less than 5% as disclosed in Procter, and that the licorice in the composition would have 2-9% glycyrrhizin as disclosed in Dastagir to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements of preparing the composition as a nutritionally complete dog food kibble according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both the claims of ‘912 and Park recite similar pet food compositions that comprise a combination of turmeric and licorice to inhibit 5HT3a or NK-1, and Park provides further guidance that this combination can be added into nutritionally complete pet foods in the form of dry kibbles and can be given to companion animals such as dogs, cats, and other domestic animals.
One of ordinary skill in the art would have combined prior art elements of including linoleic acid, DHA/EPA, and vitamin E according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because AAFCO establishes guidelines for including these ingredients for the nutrient profiles in dog and cat foods, and the combination of the claims of ‘912 and Park described above also recite a nutritionally complete pet food includes a source of fats and vitamins.
An ordinary skilled artisan would have performed routine optimization to arrive at the recited percent by weight of linoleic acid and DHA/EPA as well as the recited g/Mcal range of vitamin E because AAFCO provides guidance of providing a minimum of 1.3% linoleic acid and 0.05% EPA/DHA on a dry matter basis for the nutrient profile of dog food and further discloses that reaching 33% crude fat in DM will likely lead to insufficiencies in other nutrients in a conventional formula. AAFCO also discloses a minimum amount of 50 IU/kg of vitamin E (converts to 0.00335% by weight) and 12.5 IU per 1000 kcal ME (converts to 0.008375 g/Mcal) as well as no maximum amount for vitamin E on the basis of there being no information on vitamin E toxicity in dogs (second paragraph page 15). Furthermore, Park provides guidance of including in the pet food composition preferably 1-40% or preferably 5-20% by weight fat and also preferably 1-8% by weight of vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal. See MPEP 2144.05 II.
One of ordinary skill in the art would have been motivated to prepare the kibble to have a moisture content of less than 5% because Procter provides guidance that a moisture content of less than 5% ensures storage stability for the animal food kibble.
One of ordinary skill in the art would have a reasonable expectation of success because both the combination of the claims of ‘912 and Park described above and Procter recite animal food kibble compositions that contain similar ingredients such as proteins and fats.
Lastly, one of ordinary skill in the art would have a reasonable expectation that the licorice used in the claims of ’912 would have a glycyrrhizin content of 2-9% because Dastagir provides guidance that licorice contains 2% to 9% sweet saponin known as glycyrrhizin.
In regards to instant claim 15, it would have also been prima facie obvious to prepare the dog food kibble composition as disclosed by the combination of Park, AAFCO, Procter, and Dastagir described above by adding the ingredients in this food kibble composition in the homogenizing step and subsequently heating the mixture to form the kibble as disclosed in the preparation method of Procter 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 Procter provides a method of making kibble food products, which contain proteins and fats, that are intended for animals as demonstrated by their examples in which dogs and cats were fed the kibble product, and the combination of Park, AAFCO, Procter, and Dastagir described above also disclose a dog food composition that also comprises of proteins and fats, and can be in the form of a kibble product.
Claims 10, 14, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,419,912 (referred to as ‘912) in view of Park et al. (WO2014149424A1 in PTO-892 dated 08/19/2025), AAFCO (Pet Food Report 2015 in PTO-892), Procter et al. (US4259361A in PTO-892 dated 08/19/2025), Dastagir et al. (Pak. J. Pharm. Sci., 2016 in PTO-892 dated 01/23/2026), and PetMD (Article in PetMD website published on 06/08/2012 in PTO-892).
The combination of the claims of ‘912, Park, AAFCO, Procter, and Dastagir are as described above and recite the composition of instant claims 10 and 14 as discussed above.
The combined references, however, do not recite including taurine at the recited g/Mcal range in dog foods.
The teachings of petMD are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the dog food kibble composition as disclosed by the combination of the claims of ‘912, Park, AAFCO, Procter, and Dastagir described above the taurine as disclosed by AAFCO and petMD and further routinely optimize the amount of taurine as disclosed by AAFCO and petMD to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to include taurine into the dog food because petMD discloses that taurine plays a role in the proper development and function of the heart muscle and further suggesting taurine supplementation in dogs as certain dog breeds can develop diseases caused by taurine deficiencies due to an altered taurine metabolism.
One of ordinary skill in the art would have a reasonable expectation of success because the combination of the claims of ‘912, Park, AAFCO, Procter, and Dastagir described above provide guidance of a nutritionally complete dog food composition that can include vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal, and petMD further discloses that a dog typically has sufficient taurine levels due to their diet, and provides further guidance that excess taurine supplementation is not harmful to the dog as it is broken down and excreted as waste.
Furthermore, an ordinary skilled artisan would have performed routine optimization to arrive at the recited g/Mcal amounts for the taurine based on AAFCO disclosing a minimum 0.25 g/Mcal or 0.50 g/Mcal amount of taurine in pet foods and petMD disclosing that excess taurine does not harm the dog as it is broken down and excreted as waste. Furthermore, Park also discloses including 1-8% by weight of vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal. See MPEP 2144.05 II.
Claims 10, 14, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,419,912 (referred to as ‘912) in view of Park et al. (WO2014149424A1 in PTO-892 dated 08/19/2025), AAFCO (Pet Food Report 2015 in PTO-892), Procter et al. (US4259361A in PTO-892 dated 08/19/2025), Dastagir et al. (Pak. J. Pharm. Sci., 2016 in PTO-892 dated 01/23/2026), and GRAS (GRAS notice for marigold extract published on 06/30/2016 from FDA.gov website in PTO-892).
The combination of the claims of ‘912, Park, AAFCO, Procter, and Dastagir are as described above and recite the composition of instant claims 10 and 14 as discussed above.
The combined references, however, do not recite including lutein at the recited g/Mcal range in dog foods.
The teachings of GRAS are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the dog food kibble composition as disclosed by the combination of the claims of ‘912, Park, AAFCO, Procter, and Dastagir described above the marigold extract not exceeding greater than 5 mg lutein per 1000 kcal ME (0.005 g/Mcal) as disclosed by GRAS to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to include the marigold extract, that contains lutein, into the dog food because GRAS discloses that marigold extract contains a significant amount of lutein, and that dietary lutein has a powerful nutritional benefit to dogs and cats, including promoting healthy immune response and protecting cells form oxidative damage. Furthermore, GRAS discloses including the lutein at no more than 5 mg lutein per 1000 kcal ME (0.005 g/Mcal), which overlaps and renders obvious the recited lutein g/Mcal range. See MPEP 2144.05 I.
One of ordinary skill in the art would have a reasonable expectation of success because the combination of the claims of ‘912, Park, AAFCO, Procter, and Dastagir described above provide guidance of a nutritionally complete dog food composition that can include vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal, and GRAS also provides guidance of including the marigold extract, which contains lutein, into dog and cat foods and treats and that lutein has been included in dog and cat foods for many years without any ill effects.
Claims 10-12, 14-15, 25, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,441,623 (referred to as ‘623) in view of Park et al. (WO2014149424A1 in PTO-892 dated 08/19/2025), AAFCO (Pet Food Report 2015 in PTO-892), Procter et al. (US4259361A in PTO-892 dated 08/19/2025), and Dastagir et al. (Pak. J. Pharm. Sci., 2016 in PTO-892 dated 01/23/2026).
Claim 1 of ‘623 recites a method for treating idiopathic vomiting in a companion animal, comprising the step of orally administering to said companion animal one or more plant materials or extracts thereof in an effective amount for inhibiting a 5-hydroxytryptamine-3a serotonin (5-HT3a) receptor and/or a neurokinin-1 (NK-1) receptor, wherein the one or more plant materials or extracts thereof consists of Curcuma longa (turmeric) and licorice, ginger, rhubarb, or a combination thereof. Claim 3 of ‘623 recites wherein said dietary composition is a pet food comprising from 0.1 ppm to 75,000 ppm of said plant materials or extracts thereof, and wherein said pet food further comprises a source of carbohydrate, a source of protein, and optionally a source of fat. Claim 4 of ‘623 recites wherein said dietary composition is a pet food supplement comprising from 0.1% to 99% of said plant materials or extracts thereof by weight.
Even though the claims of ‘623 recite a pet food composition comprising a combination of turmeric and licorice in overlapping amounts, as well as source of protein and fat, the claims of ‘912 do not further recite further comprising the recited amounts of linoleic acid, EPA/DHA, vitamin E, and glycyrrhizin in the licorice as well as a kibble having moisture content of less than 12% by weight, and a nutritionally complete food composition.
The independent teachings of Park, AAFCO, Procter, and Dastagir are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the pet food composition as recited in the claims of ‘623 by preparing the composition as a nutritionally complete dog food kibble as disclosed in Park, further including and routinely optimizing the amounts of linoleic acid and DHA/EPA as well as vitamin E as sources of fats and vitamins, respectively, based on the teachings of Park and AAFCO, further modifying the moisture content of the kibble to be less than 5% as disclosed in Procter, and that the licorice in the composition would have 2-9% glycyrrhizin as disclosed in Dastagir to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements of preparing the composition as a nutritionally complete dog food kibble according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both the claims of ‘623 and Park recite similar pet food compositions that comprise a combination of turmeric and licorice to inhibit 5HT3a or NK-1, and Park provides further guidance that this combination can be added into nutritionally complete pet foods in the form of dry kibbles and can be given to companion animals such as dogs, cats, and other domestic animals.
One of ordinary skill in the art would have combined prior art elements of including linoleic acid, DHA/EPA, and vitamin E according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because AAFCO establishes guidelines for including these ingredients for the nutrient profiles in dog and cat foods, and the combination of the claims of ‘623 and Park described above also recite a nutritionally complete pet food includes a source of fats and vitamins.
An ordinary skilled artisan would have performed routine optimization to arrive at the recited percent by weight of linoleic acid and DHA/EPA as well as the recited g/Mcal range of vitamin E because AAFCO provides guidance of providing a minimum of 1.3% linoleic acid and 0.05% EPA/DHA on a dry matter basis for the nutrient profile of dog food and further discloses that reaching 33% crude fat in DM will likely lead to insufficiencies in other nutrients in a conventional formula. AAFCO also discloses a minimum amount of 50 IU/kg of vitamin E (converts to 0.00335% by weight) and 12.5 IU per 1000 kcal ME (converts to 0.008375 g/Mcal) as well as no maximum amount for vitamin E on the basis of there being no information on vitamin E toxicity in dogs (second paragraph page 15). Furthermore, Park provides guidance of including in the pet food composition preferably 1-40% or preferably 5-20% by weight fat and also preferably 1-8% by weight of vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal. See MPEP 2144.05 II.
One of ordinary skill in the art would have been motivated to prepare the kibble to have a moisture content of less than 5% because Procter provides guidance that a moisture content of less than 5% ensures storage stability for the animal food kibble.
One of ordinary skill in the art would have a reasonable expectation of success because both the claims of ‘623 and Park described above and Procter recite animal food kibble compositions that contain similar ingredients such as proteins and fats.
Lastly, one of ordinary skill in the art would have a reasonable expectation that the licorice used in the claims of ‘623 would have a glycyrrhizin content of 2-9% because Dastagir provides guidance that licorice contains 2% to 9% sweet saponin known as glycyrrhizin.
In regards to instant claim 15, it would have also been prima facie obvious to prepare the dog food kibble composition as disclosed by the combination of Park, AAFCO, Procter, and Dastagir described above by adding the ingredients in this food kibble composition in the homogenizing step and subsequently heating the mixture to form the kibble as disclosed in the preparation method of Procter 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 Procter provides a method of making kibble food products, which contain proteins and fats, that are intended for animals as demonstrated by their examples in which dogs and cats were fed the kibble product, and the combination of Park, AAFCO, Procter, and Dastagir described above also disclose a dog food composition that also comprises of proteins and fats, and can be in the form of a kibble product.
Claims 10, 14, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,441,623 (referred to as ‘623) in view of Park et al. (WO2014149424A1 in PTO-892 dated 08/19/2025), AAFCO (Pet Food Report 2015 in PTO-892), Procter et al. (US4259361A in PTO-892 dated 08/19/2025), Dastagir et al. (Pak. J. Pharm. Sci., 2016 in PTO-892 dated 01/23/2026), and PetMD (Article in PetMD website published on 06/08/2012 in PTO-892).
The combination of the claims of ‘623, Park, AAFCO, Procter, and Dastagir are as described above and recite the composition of instant claims 10 and 14 as discussed above.
The combined references, however, do not recite including taurine at the recited g/Mcal range in dog foods.
The teachings of petMD are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the dog food kibble composition as disclosed by the combination of the claims of ‘623, Park, AAFCO, Procter, and Dastagir described above the taurine as disclosed by AAFCO and petMD and further routinely optimize the amount of taurine as disclosed by AAFCO and petMD to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to include taurine into the dog food because petMD discloses that taurine plays a role in the proper development and function of the heart muscle and further suggesting taurine supplementation in dogs as certain dog breeds can develop diseases caused by taurine deficiencies due to an altered taurine metabolism.
One of ordinary skill in the art would have a reasonable expectation of success because the combination of the claims of ‘623, Park, AAFCO, Procter, and Dastagir described above provide guidance of a nutritionally complete dog food composition that can include vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal, and petMD further discloses that a dog typically has sufficient taurine levels due to their diet, and provides further guidance that excess taurine supplementation is not harmful to the dog as it is broken down and excreted as waste.
Furthermore, an ordinary skilled artisan would have performed routine optimization to arrive at the recited g/Mcal amounts for the taurine based on AAFCO disclosing a minimum 0.25 g/Mcal or 0.50 g/Mcal amount of taurine in pet foods and petMD disclosing that excess taurine does not harm the dog as it is broken down and excreted as waste. Furthermore, Park also discloses including 1-8% by weight of vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal. See MPEP 2144.05 II.
Claims 10, 14, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,441,623 (referred to as ‘623)in view of Park et al. (WO2014149424A1 in PTO-892 dated 08/19/2025), AAFCO (Pet Food Report 2015 in PTO-892), Procter et al. (US4259361A in PTO-892 dated 08/19/2025), Dastagir et al. (Pak. J. Pharm. Sci., 2016 in PTO-892 dated 01/23/2026), and GRAS (GRAS notice for marigold extract published on 06/30/2016 from FDA.gov website in PTO-892).
The combination of the claims of ‘623, Park, AAFCO, Procter, and Dastagir are as described above and recite the composition of instant claims 10 and 14 as discussed above.
The combined references, however, do not recite including lutein at the recited g/Mcal range in dog foods.
The teachings of GRAS are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the dog food kibble composition as disclosed by the combination of the claims of ‘623, Park, AAFCO, Procter, and Dastagir described above the marigold extract not exceeding greater than 5 mg lutein per 1000 kcal ME (0.005 g/Mcal) as disclosed by GRAS to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to include the marigold extract, that contains lutein, into the dog food because GRAS discloses that marigold extract contains a significant amount of lutein, and that dietary lutein has a powerful nutritional benefit to dogs and cats, including promoting healthy immune response and protecting cells form oxidative damage. Furthermore, GRAS discloses including the lutein at no more than 5 mg lutein per 1000 kcal ME (0.005 g/Mcal), which overlaps and renders obvious the recited lutein g/Mcal range. See MPEP 2144.05 I.
One of ordinary skill in the art would have a reasonable expectation of success because the combination of the claims of ‘623, Park, AAFCO, Procter, and Dastagir described above provide guidance of a nutritionally complete dog food composition that can include vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal, and GRAS also provides guidance of including the marigold extract, which contains lutein, into dog and cat foods and treats and that lutein has been included in dog and cat foods for many years without any ill effects.
Claims 10-12, 14-15, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/859,858 (‘858) in view of in view of Vondran et al. (US20170332664 in IDS filed 02/25/2022), Axelrod et al. (US20130101648 in PTO-892 dated 05/15/2025), RU2416400 C2 (in PTO-892 dated 01/23/2026, an English translation is provided and used as the basis for this rejection), and Dastagir et al. (Pak. J. Pharm. Sci., 2016 in PTO-892 dated 01/23/2026).
Claim 1 of ‘858 recites a method of treating inflammatory diseases or disorders comprising providing an animal food composition, wherein animal food composition comprises glycyrrhizin. Claim 4 of ‘858 recites the animal food composition a nutritionally complete animal food composition. Claims 5-7 of ‘858 recites the glycyrrhizin comprises a licorice root extract and the composition further comprises linoleic acid, EPA/DHA, Taurine, Lutein, Vitamin E, or a combination thereof. Claim 11 of ‘858 recites the amount of glycyrrhizin is 5-100 mg/kg (0.0005% to 0.01% weight) of the composition. Claim 19 of ‘858 recites the composition further comprises a source of proteins.
Even though the claims of ‘858 recite a nutritionally complete animal food composition comprising glycyrrhizin, linoleic acid, EPA/DHA, taurine, lutein, and vitamin E, the claims of ‘858, however, do not recite the percent weight range of a source of glycyrrhizin / curcuminoids, linoleic acid, EPA/DHA, and moisture content. Furthermore, the claims of ‘858 do not recite a method of making as recited in instant claim 15.
Vondran et al. discloses animal food kibbles having a primarily disc shape and including botanicals such as curcumin and methods to reduce oral inflammation in an animal by feeding the animal with the food kibbles (see Abstract). Vondran discloses the food kibbles has a moisture content of less than 15% by weight (paragraph 0009). Vondral et al. discloses that the oral inflammation refers to inflammation in the oral cavity of an animal and may include gingivitis, periodontitis, swelling, redness and/or ulcers that affects any part of the mouth (see paragraph 0018). Vondran discloses the animal can be domestic dogs, cats, and among others (paragraph 0012).
Vondran et al. also discloses that the amount of curcumin added to the food kibbles in Example 2 was 0.1 % wt (see Table 2, paragraph 0055 and paragraph 0056). Vondran et al. discloses that botanicals refer to food or dietary supplements extracted or derived from a plant or herbal source that can provide health benefits and/or treat/prevent diseases and exemplifies several botanicals extracted from sources such as licorice root and turmeric. (see paragraph 0013). Furthermore, Vondran et al. discloses that the food kibbles may comprise of one or more fatty acids such as linoleic acid and EPA (see paragraph 0048). Lastly, Vondran et al. discloses that the kibble dough can be prepared in any suitable means from any suitable ingredients, such as, for example, a protein source, a carbohydrate source, a fat source, and any other ingredients suitable for animal or pet nutrition (see paragraph 044). Vondran et al. also discloses a method for making food kibbles containing one or more botanicals, the method comprising (a) preconditioning by mixing wet and dry ingredients at elevated temperature to form a kibble dough, and (b) extruding the kibble dough at a high temperature and pressure through an extruder configured to form food kibbles having primarily a disc shape (see paragraph 0005). Here, the method of making described above meets the limitation of the method of making recited in instant claim 15.
Axelrod et al. discloses an animal chew comprising a base composition forming the animal chew and includes Ascophyllum nodosum (see Abstract). Axelrod et al. discloses that the animal chew is used to treat dental plaque or tartar in an animal’s mouth (see paragraph 0014). Alexrod et al. discloses that dental plaque may lead to tooth decay due to acid produced form the bacterial degradation of fermentable sugars and periodontal problems such as gingivitis and chronic periodontitis (see paragraph 0002). Furthermore, Axelrod et al. discloses that the base composition may include abrasive additives, breath sweeteners, or compounds that may be ingested for improving oral health (see paragraph 0029). Axelrod et al. discloses ingestible compounds include licorice root and turmeric that may be present in the range of 0.01%-5% by weight of the base composition (see paragraph 0029)
RU’400 disclsoes a method for the reducing the amount of pro-inflammatory substance present at an elevated level in the blood of an animal, wherein the elevated level of the pro-inflammatory substance is associated with an oral condition, comprising administering to the animal a composition containing at least one omega-3 fatty acid that reduced the amount of pro-inflammatory substance (see paragraph 0031). RU’400 discloses that oral conditions include plaque, gingivitis, and periodontitis (see paragraph 0028). RU’400 discloses the composition may be a dry food composition suitable for animals such as dogs or cats (paragraphs 0037-0038). RU’400 discloses that the omega-3 fatty acid is present in amounts 0.1%-20% (paragraph 0051). RU’400 discloses the omega-3 fatty acid are 12 and 26 carbon atoms with methylene-broken double bonds and discloses examples such as EPA, DHA, or alpha-linolenic acid (paragraph 0027).
The teachings of Dastagir are described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the animal food composition recited in the claims of ‘858 into a dog food kibble composition having a moisture content of less than 15% by weight as disclosed in Vondran, substituting the glycyrrhizin of ‘858 with licorice root in the range of 0.01%-5% by weight as disclosed in Axelrod and the licorice having 2-9% glycyrrhizin content as disclosed in Dastagir, further including turmeric in the range of 0.01%-5% by weight as disclosed in Axelrod, and preparing the linoleic acid and EPA/DHA in the amounts disclosed in RU’400 to arrive at the claimed invention.
One of ordinary skill in the art would have made these modifications with a reasonable expectation of success because the claims of ‘858 recite a method of treating an inflammatory condition by administering an animal food composition comprising glycyrrhizin, linoleic acid, EPA/DHA, taurine, lutein, and vitamin E, and Vondran, Axelrod, and RU’400 provide guidance to include these recited ingredients in overlapping amounts for similar animal food compositions useful for treating the same inflammatory condition in an animal. See MPEP 2144.05 I. Furthermore, one of ordinary skill in the art would have a reasonable expectation that the licorice as disclosed by the combination of the claims of ‘858, Vondran, Axelrod, and RU’400 described above would have a glycyrrhizin content of 2-9% because Dastagir provides guidance that licorice contains 2% to 9% sweet saponin known as glycyrrhizin.
In regards to instant claim 15, it would have also been prima facie obvious to prepare the dog food kibble composition as suggested by the combination of the claims of ‘858 and the teachings of Vondran, Axelrod, RU’400, and Dastgir described above with the preparation method disclosed in Vondran.
One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Vondran et al. discloses a process of forming animal food kibbles with animal food ingredients that are the same or similar to the animal food ingredients disclosed in the combination of the claims of ‘912 and the teachings of Vondran, Axelrod, RU’400, and Dastagir described above.
This is a provisional nonstatutory double patenting rejection.
Claims 10, 14, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/859,858 (‘858) in view of Vondran et al. (US20170332664 in IDS filed 02/25/2022), Axelrod et al. (US20130101648 in PTO-892 dated 05/15/2025), RU2416400 C2 (in PTO-892 dated 01/23/2026, an English translation is provided and used as the basis for this rejection), and Dastagir et al. (Pak. J. Pharm. Sci., 2016 in PTO-892 dated 01/23/2026), AAFCO (Pet Food Report 2015 in PTO-892), and PetMD (Article in PetMD website published on 06/08/2012 in PTO-892).
The combination of the claims of ‘858, Vondran, Axelrod, RU’400, and Dastagir are as described above and recite the composition of instant claims 10 and 14 as discussed above.
The combined references, however, do not recite including taurine at the recited g/Mcal range in dog foods.
The independent teachings of AAFCO and petMD are as described above.
An ordinary skilled artisan would have performed routine optimization to arrive at the recited g/Mcal amounts for the taurine as disclosed by the combination of the claims of ‘858, Vondran, Axelrod, RU’400, and Dastagir described above based on AAFCO disclosing a minimum 0.25 g/Mcal or 0.50 g/Mcal amount of taurine in the nutrient profiles of pet foods and petMD disclosing that excess taurine does not harm the dog as it is broken down and excreted as waste. Furthermore, Park also discloses including 1-8% by weight of vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal. See MPEP 2144.05 II.
This is a provisional nonstatutory double patenting rejection.
Claims 10, 14, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/859,858 (‘858) in view of Vondran et al. (US20170332664 in IDS filed 02/25/2022), Axelrod et al. (US20130101648 in PTO-892 dated 05/15/2025), RU2416400 C2 (in PTO-892 dated 01/23/2026, an English translation is provided and used as the basis for this rejection), and Dastagir et al. (Pak. J. Pharm. Sci., 2016 in PTO-892 dated 01/23/2026), and GRAS (GRAS notice for marigold extract published on 06/30/2016 from FDA.gov website in PTO-892).
The combination of the claims of ‘858, Vondran, Axelrod, RU’400, and Dastagir are as described above and recite the composition of instant claims 10 and 14 as discussed above.
The combined references, however, do not recite including lutein at the recited g/Mcal range in dog foods.
The teachings of GRAS are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to further include into the dog food kibble composition as disclosed by the combination of the claims of ‘858, Vondran, Axelrod, RU’400, and Dastagir described above the marigold extract not exceeding greater than 5 mg lutein per 1000 kcal ME (0.005 g/Mcal) as disclosed by GRAS to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to include the marigold extract, that contains lutein, into the dog food because GRAS discloses that marigold extract contains a significant amount of lutein, and that dietary lutein has a powerful nutritional benefit to dogs and cats, including promoting healthy immune response and protecting cells form oxidative damage.
One of ordinary skill in the art would have a reasonable expectation of success because the combination of the the claims of ‘858, Vondran, Axelrod, RU’400, and Dastagir described above provide guidance of a nutritionally complete dog food composition that can include vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal, and GRAS also provides guidance of including the marigold extract, which contains lutein, into dog and cat foods and treats and that lutein has been included in dog and cat foods for many years without any ill effects. Furthermore, GRAS discloses including the lutein at no more than 5 mg lutein per 1000 kcal ME (0.005 g/Mcal), which overlaps and renders obvious the recited lutein g/Mcal range. See MPEP 2144.05 I.
This is a provisional nonstatutory double patenting rejection.
Claims 10, 14, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/859,858 (‘858) in view of Vondran et al. (US20170332664 in IDS filed 02/25/2022), Axelrod et al. (US20130101648 in PTO-892 dated 05/15/2025), RU2416400 C2 (in PTO-892 dated 01/23/2026, an English translation is provided and used as the basis for this rejection), and Dastagir et al. (Pak. J. Pharm. Sci., 2016 in PTO-892 dated 01/23/2026), and AAFCO (Pet Food Report 2015 in PTO-892).
The combination of the claims of ‘858, Vondran, Axelrod, RU’400, and Dastagir are as described above and recite the composition of instant claims 10 and 14 as discussed above.
The combined references, however, do not recite including vitamin E at the recited g/Mcal range in dog foods.
The teachings of AAFCO as described above.
An ordinary skilled artisan would have performed routine optimization to arrive at the recited the recited g/Mcal range of the vitamin E as disclosed by the combination of the claims of ‘858, Vondran, Axelrod, RU’400, and Dastagir described above because AAFCO provides guidance of a minimum amount of 50 IU/kg of vitamin E (converts to 0.00335% by weight) and 12.5 IU per 1000 kcal ME (converts to 0.008375 g/Mcal) in the nutrient profiles of dog foods as well as no maximum amount for vitamin E on the basis of there being no information on vitamin E toxicity in dogs (second paragraph page 15). Furthermore, Park provides guidance of including in the pet food composition preferably 1-40% or preferably 5-20% by weight fat and also preferably 1-8% by weight of vitamins, minerals, antioxidants, and other nutrients supporting the needs of the companion animal. See MPEP 2144.05 II.
This is a provisional nonstatutory double patenting rejection
Response to Arguments
Applicant’s arguments filed on 03/04/2026 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 US’912 and US’623 patents are not directed to the same invention as the instant application on the basis that US’912 and US’623 fail to recite the instant amount of EPA/DHA in the dog food composition.
Applicant’s argument described above was not found persuasive because the new nonstatutory double patenting rejections over US’912 and US’623 establish obviousness to arrive at the recited EPA/DHA amounts as described above.
Applicant further requests the provisional nonstatutory double patenting rejections over co-pending application ‘858 to be held in abeyance until the instant claims are found allowable.
Since no allowable subject matter was found for the instant claims, the provisional nonstatutory double patenting rejections over co-pending application ‘858 is maintained.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
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