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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/13/2025 has been entered.
Status of Claims
Claims 1-7 and 10-24 are pending in this application. Claims 1-7 and 10-12 are under examination. Claims 13-24 are withdrawn. Any objections or rejections not repeated below have been withdrawn.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Stilborn et al. US 6391348 in view of USDA, Vegetable Oil, palm, FoodData Central, accessed at: https://fdc.nal.usda.gov/food-details/171015/nutrients, (hereinafter USDA Vegetable Oil; Data on fatty acids updated 6/1/1979) and as evidenced by USDA, Corn grain, yellow, FoodData Central, accessed at: https://fdc.nal.usda.gov/food-details/170288/nutrients, (hereinafter USDA Corn Grain; Data on total fat and fatty acids updated 10/1/1989) and USDA, Soybeans, FoodData Central, accessed at: https://fdc.nal.usda.gov/food-details/172441/nutrients, (hereinafter USDA Soybeans; Data on total fat and fatty acids updated 12/1/1986).
Regarding claims 1 and 10-11, Stilborn teaches a pet foodstuff, as required by claim 1 (a low phytate food source for animals including dogs and cats; C1 L55-60, C2 L40-46). Stilborn discloses the pet foodstuff can comprises 22.5% protein and 4.75% fat, which is a protein:fat ratio of 1:0.21 on a gram-gram basis (C28 Table 25 Nutrient Composition of LPCHOC Diet). While this is near the claimed ratio of protein:fat of 1:037, as required by claim 1, Stilborn also teaches that oil can be added (oil concentration can be increased) to the foodstuff (food source), so that the fat content (oil content) is between 5-15% (C4 L10-25), which would achieve a ratio range that encompasses the claimed protein:fat ratio. Stilborn discloses that the fat content (oil content) at this amount in the foodstuff is sufficient to reduce the cholesterol level of an animal fed the foodstuff (food source) as a substantial part of a total animal diet (C4 L10-25). Stilborn also does not limit the type of oil that can be added to the foodstuff and gives examples of adding a vegetable oil (vegetable fat; C28 Table 24).
USDA Vegetable Oil teaches a vegetable oil, specifically palm oil, which is 100% fat (pg. 1 Sub-Title, pg. 1 Portion and Total lipid fat). As stated above, adding any oil, including palm vegetable oil, in an amount so the oil content, or total fat content of the foodstuff is between 5-15%, would be sufficient to reduce the cholesterol level of an animal fed the foodstuff, as recognized by Stilborn (C4 L10-25). Therefore, Stilborn in view of USDA Vegetable Oil recognizes the addition of at least about 0.25% to 10.25% palm oil to the foodstuff which has a fat content before the addition of vegetable oil of 4.75%, for a total crude fat content (oil content) of about 5% to about 15% when added to the low phytate high oil corn test diet (LPCHOC) of Stilborn (C28 Table 25 Nutrient Test variable of LPCHOC). This would result in a protein to fat ratio range of about 1:0.22 to about 1:0.67 on a gram:gram as fed basis. This encompasses the claimed ratio of protein:fat of 1:0.37, as required by claim 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. See MPEP 2144.05(I).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Stilborn by incorporating the teachings of USDA Vegetable Oil, by adding any vegetable oil, such as palm oil, to the foodstuff so that it is within the claimed ratio of claim 1, because adding oil in this range is sufficient to reduce the cholesterol level of an animal fed the foodstuff, as recognized by Stilborn (C4 L10-25).
Stilborn teaches the foodstuff comprises 2.33% aspartic acid, 1.18% serine, 3.30% glutamic acid, 0.88% glycine, 1.14% alanine, and 1.34% proline, for a total of 10.17% of the claimed amino acids (C29 Table 25 Nutrient Test variable of LPCHOC).
Stilborn teaches the foodstuff comprises palmitic acid, stearic acid, oleic acid and linolenic acid. Stilborn does not teach the fatty acids, myristic acid and palmitoleic acid, in the foodstuff, as required by claim 1. However, as shown above, Stilborn does teach that oil can be added (oil concentration can be increased) to the foodstuff (food source), so that the fat content (oil content) is between 5-15% (C4 L10-25), which is an amount sufficient to reduce the cholesterol level of an animal fed the foodstuff (food source) as a substantial part of a total animal diet (C4 L10-25).
USDA Vegetable Oil teaches palm oil, wherein the palm oil comprises the following claimed fatty acids: 1 g/100 g myristic acid (SFA 14:0), 43.5 g/100 g palmitic acid (SFA 16:0), 4.3 g/100 g stearic acid (SFA 18:0), 0.3 g/100 g palmitoleic acid (MUFA 16:1), 36.6 g/100 g oleic acid (MUFA 18:1) and 0.2 g/100 g linolenic acid (PUFA 18:3) (pg. 1 Sub-Title, pg. 1 Portion, pgs. 4-5 Fatty acids Amount column). As stated above, adding any oil, including palm vegetable oil, in an amount so the oil content, or total fat content of the foodstuff is between 5-15%, would be sufficient to reduce the cholesterol level of an animal fed the foodstuff, as recognized by Stilborn (C4 L10-25). Therefore, Stilborn in view of USDA recognizes the addition of at least about 0.25% to 10.25% palm oil, for a total crude fat content (oil content) of about 5% to about 15% when added to the low phytate high oil corn test diet (LPCHOC) of Stilborn (C28 Table 25 Nutrient Test variable of LPCHOC).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Stilborn by incorporating the teachings of USDA Vegetable Oil, by adding any vegetable oil to the foodstuff, such as palm oil, which comprises the claimed myristic acid and palmitoleic acid, because adding oil in this range is sufficient to reduce the cholesterol level of an animal fed the foodstuff, as recognized by Stilborn (C4 L10-25).
Regarding the ratio of amino acids to fatty acids as claimed, Stilborn teaches 4.75% of total crude fat in low phytate high oil corn test diet (C28 Table 25 Nutrient Test Diet variable of LPCHOC), where the at least 99.8% of the crude fat is from corn (Low Phytate/High Oil corn) and soybeans (soybean meal; C28 Table 24 variable LPCHOC). Therefore, to calculate an approximate percentage of fatty acids based on the total crude fat, evidentiary references were examined to see the average percentage of fatty acids in corn and soybeans combined. As evidenced by USDA Corn Grain, from the total crude fat (total fat) present in corn grain, about 86% of the total crude fat is from fatty acids (pg. 1 Total lipid fat, pg. 4 Fatty acids, total saturated, total monounsaturated and total polyunsaturated). As evidenced by USDA Soybeans, from the total crude fat (total fat) present in soybeans, about 93% of the total crude fat is from fatty acids (pg. 1 Total lipid fat, pg. 3 Fatty acids, total saturated, total monounsaturated and total polyunsaturated). Thus, approximately 89.5% of the total crude fat is from fatty acids in the LPCHOC diet.
Continuing the discussion of the ratio of amino acids to fatty acids, Stilborn teaches, based on percent of total fatty acid content, the foodstuff comprises 11.5% palmitic acid, 2.0% stearic acid, 37.8% oleic acid and 0.9% linolenic acid; resulting in these fatty acids in the total composition at about 2.22%, when accounting for the total crude fat (4.75%) only containing approximately 89.5% total fatty acids and before the addition of any oil, such as palm oil (C29 Table 29 Nutrient Test variable of LPCHOC). When accounting for the addition of vegetable oil, at for example 0.25% to 10.25%, to add the claimed myristic acid and palmitoleic acid, as discussed above, Stilborn in view of USDA Vegetable Oil teaches a total amount of the claimed fatty acids in the total composition ranges from about 2.43% to 11%. Please see paragraph above disclosing the amounts of the claimed fatty acids in USDA Vegetable Oil. Thus, Stilborn in view of USDA Vegetable Oil teaches a ratio range of the claimed amino acids (10.17) to the claimed fatty acids (about 2.43% to 11%) of 1:0.24 to 1:1:1. This is within the claimed ratio range of 1:0.006 to 1:4.5, as required by claim 1; within the claimed ratio range of 1:0.014 to 1:3.5, as required by claim 10; and within the claimed ratio range of 1:0.025 to 1:2.5, as required by claim 11.
Regarding the recitation in claim 1, “wherein, when fed to a companion animal, lipid metabolite levels including one or more of palmitic acid, diacylglycerol (DAG), triacylglycerol (TAGs), or ceramides of the companion animal measured within five hours after eating the foodstuff have a fold change of less than 1.0,” given that Stilborn is identical to the claimed composition, when the pet food is fed to a companion animal it would inherently exhibit the recited property. Therefore, the composition of Stilborn is considered to possess the property of lipid metabolite levels in a companion animal having a fold change of less than 1.0 after eating the composition when measured within five hours after eating, as required by claim 1, absent convincing arguments or evidence to the contrary. See MPEP 2112.01(I).
Regarding claims 2-5, Stilborn teaches the pet foodstuff of claim 1 that is identical to the claimed composition. Claims 2-5 recite properties of the claimed composition. Claim 2 recites the property of reducing a risk of one or more of insulin resistance, adipose tissue, or skeletal muscle inflammation in the companion animal. Claim 3 recites the property of reducing a risk of one or more of impaired neurological function, nerve cell damage, or cell death in the companion animal. Claim 4 recites the property of when the composition is fed to a companion animal, an endogenous level of margaric acid of the companion animal is greater for at least five hours after eating the foodstuff compared to a companion animal fed a diet without the claimed protein and fat ratio in claim 1. Claim 5 recites the property of the companion animal having fasted plasma levels of lipotoxic acid… measured within five hours after eating the foodstuff does not increase post-prandially. Since claims 2-5 all recite properties of the composition when fed to a companion animal and the composition of Stilborn is identical to the claimed composition; the composition of Stilborn is considered to possess the properties recited above and required by claims 2-5, absent convincing arguments or evidence to the contrary. See MPEP 2112.01(I).
Regarding claim 6, Stilborn teaches the foodstuff is a dry product comprising a dry matter % of 91.74, or a moisture content of 8.26% (C28 Table 25 Nutrient Test variable of LPCHOC). This is within the claimed range of 5-15% moisture.
Regarding claim 12, Stilborn teaches the companion animal is a dog or a cat (animals including dogs and cats; C2 L40-46).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Stilborn et al. US 6391348 in view of USDA, Vegetable Oil, palm, FoodData Central, as applied to claim 1 above, and further in view of ScratchnAll, Hot Mash, Accessed at: https://scratchnall.com/blog/hot-mash/?srsltid=AfmBOoqnKzRZD8z7okJG4ppo740jxkk3Gk5caMeGkw-KyD9AmImMaflz.
Please note the rejection below is based off of paragraph numbers added to ScratchnAll reference and supplied with the rejection.
Regarding claim 7, Stilborn teaches a pet foodstuff as required by claim 1. Stilborn teaches the pet foodstuff is in mash form, which is an uncooked form of animal food (C6 L7). Stillborn is silent with respect to a cooked product.
ScratchnAll teaches pet foodstuff that has been cooked (hot mash, where the mash mixture has hot water added to it and is left to steep, and then more hot water is added, forming a hot mash, which is cooked; [0002]), animals “go gaga over” the hot mash during cold winter months, enjoying the cooked food [0002].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Stilborn in view of USDA Vegetable Oil to incorporate the teachings of ScratchnAll by cooking (steeping) the pet foodstuff (mash) since animals enjoy the hot cooked food during cold winter months, as recognized by ScratchnAll [0002].
Response to Arguments
Applicant’s arguments with respect to claims 1-6 and 8-12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759