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 .
Applicants' arguments, filed February 2, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims
Claim Rejections - 35 USC § 103 – Obviousness (Maintained)
1 ) Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (WO 2021/127701). The rejection is maintained and further applied to claims 52-55, 57-61 and 63-71.
Jackson et al. disclose pet food compositions comprising greater than 35 wt.% fat, greater than 10 wt.% fiber, protein, low levels of carbohydrates, and a ketogenic ratio greater than or equal to 1.5 (Abstract). The composition of the present disclosure comprises a blend of fibers and proteins that is designed to largely replace starch in a dry food form for companion animals (paragraph 0071). The fat comprises medium chain triglycerides (MCT) such as caproic acid, hexanoic acid, CH3(CH2) COOH, C6:0, caprylic acid, octanoic acid, CH3(CH2)6COOH, C8:0, capric acid, decanoic acid, CH3(CH2)8COOH, and C10:0 (paragraph 0085). The MCT comprises at least 20 wt% of the fat. Both caprylic (C8:0) and capric acids (C10:0) are the more common forms of medium chain fatty acids (MCFA), because they decrease gastrointestinal upset while increasing ketone production to a much greater extent than longer chain fatty acids (i.e., ≥C12:0). The oxidative stability of the MCT lend themselves to increased taste preservation and reduced rancidity, which would improve food intake, particularly in pets with poor appetites due to disease or preference ingredients providing MCT may be derived from fractionated palm, coconut or butter fats. These sources preferably supply greater than 50% fat energy as MCT having as constituent fatty acids C8:0 octanoate and/or 00:0 decanoate. The C8:0 and the C10:0 will be preferably in a ratio of C8:0/C10:0 from 0.99 to 0.01, more preferably from 0.99 to 0.2 and most preferably from 0.99 to 0.4 (meeting octanoate comprising 5 wt% or more of the fat) (paragraph 00143). One embodiment comprises the composition of the present disclosure is an adult canine or feline dry maintenance kibble comprising a protein level of 7.5 g/100 kcal ME or less, at. least 16 wt.% fiber on a dry matter basis, 3.5 wt.% of digestible starch and/or sugar (meeting starch and carbohydrate), at least 35 wt.% fat on a dry matter basis; wherein at least 20% of fat are medium chain triglycerides, 6 wt.% or less of ash, 0.6 wt% or less of phosphorus (instant claim 67), and a ketogenic ratio (KR) greater than 1.7 with all nutrients scaled to AAFCO and NRC levels on a ME density basis (paragraph 0074). The dietary/composition for a companion animal comprises greater than 35 wt.% of fat, protein, less than 6 wt % of carbohydrates or less than 3.5 wt.% of carbohydrates, and greater than about 10 wt.% of fiber, wherein (0.9 F + 0.46 P) / (0.1 F + 0.58 P + C) is greater than about 1.5, wherein F, P, and C, are wt % of fat, protein, and carbohydrates, respectively (meeting the formula of the instant claims) (paragraph 0090). The ketogenic pet food composition disclosed may include one or more of chicken fat, dried eggs, meat protein isolate (pork), dried meat (chicken), met oil (C8:0, C10:0), hydrolyzed dried chicken, pecan shell fiber, whole flax seed, cellulose fiber, hydrolyzed casein protein isolate, hydrolyzed whey protein isolate, palatant, minerals, gelatin, potato amylose, amino acids, beet pulp fiber, citrus pulp fiber, lactic acid, soluble oat fiber, potassium citrate, apple pulp fiber, fish oil, psyllium husk fiber, vitamins, betaine, carnitine, alginate fiber, cranberry pulp fiber, methyl cellulose fiber, pectin fiber, taurine, antioxidant, or combinations thereof (paragraph 00164). The composition may further comprise a low level of phosphorus. Reducing the level of dietary phosphorus has been shown to slow progression of kidney disease and prolong life (paragraph 00133).
An example comprises dried chicken meat, chicken fat, meat protein, dried eggs, MCT oil (C8, C10, 7%), flax seed (1.1, omega 3/omega 6), potato amylopectin (2%, meeting less than 5% starch), beet pulp fiber, citrus pulp fiber, soluble oat fiber, psyllium husk fiber, alginate fiber, taurine (0.1%) and protein isolates; wherein the composition had a ketogenic ratio of 2.17 (meeting greater than 1.5 and 2), protein of 33.8g, fat of 43.5g, digestible carbohydrate of 1.3g (all gram per 100 grams) and total dietary fiber of 10.8g (Tables 1-3 (Ex. II). Another example comprises chicken fat (15.09%), meat protein isolate (pork, 11.25%) dried eggs (10.5%), MCT oil (C8:0, C10:0, 8%) dried chicken meat (8%), whole flax seed (6%, omega 3 and omega 6), palatant (5.2%), pecan shell fiber (5%, instant claims 69-71), cellulose fiber (4%), hydrolyzed casein protein isolate (3%), potato amylose (2%), beet pulp (instant claim 68), lactic acid (1.5%), potassium citrate (0.32%), fish oil (1%), betaine (0.75%), taurine (0.25%), carnitine (0.075%), and lipoic acid (0.025%). The composition had a ketogenic ratio of 1.65 (meeting greater than 1.5), protein of 33.2g, fat of 33.5g, digestible carbohydrate of 4.7g (all gram per 100 grams) and total dietary fiber of 14.7g (Tables 6-7 (Ex. III).
The amounts of the two examples fall within the ranges recited in the instant claims.
In regards to the omega-3 to omega-6 ratio of claim 60, flax seed comprises omega-6 and omega-3 in a 0.3:1 to as low as 0.22:1 ratio. This ratio is encompassed by the ratio of instant claim 60 reciting omega-3 to omega-6 ratio of about 0.5:1 to about 7:1.
Jackson et al. differ from the instant claims insofar as they do not disclose the composition has a weight ratio of octanoate to decanoate as 200:1 to about 500:1.
Caprylic and capric acids decrease gastrointestinal upset while increasing ketone production to a much greater extent than longer chain fatty acids, making them result effective variables. It would have taken no more than the relative skill of one ordinary skill in the art to have adjusted the ratio of octanoic acid to decanoic acid have a weight ratio of 200:1 to about 500:1 motivated by the desire to obtain the desired therapeutic function. See MPEP 2144.05.
Response to Arguments
The Examiner submits that in regards to teaching the opposite ratios, when looking to the examples of the Jackson, octanoic acid is used in excess of decanoic acid. Therefore it is reasonable to conclude that Jackson does allow for compositions to have a higher amount of octanoic acid. The octanoic acid and decanoic acid decrease gastrointestinal upset. Therefore, one of ordinary skill in the art would reasonably adjust the ratio to give the desired nutritional effect. The ratio could be achieved because the secondary reference teaches octanoic acid and decanoic acid increases ketone production. One of ordinary skill in the art would reasonably conclude that each acid affects this function. Therefore one would optimize the ratio to get the desired effect, absent of evidence to the contrary. In regards to the ketogenic ratio, the composition of Jackson uses amounts that fall withing the scope of the instant claims. Therefore one would calculate the ketogenic ratio to fall within or overlap that of the instant claims.
2) Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (WO 2021/127701) in view of Nonaka et al. (JP 20000247900). The rejection is maintained.
Jackson et al. is discussed above and discloses that the composition may comprise a fiber blend including a lignin.
Jackson et al. differ from the instant claims insofar as they do not disclose the type of lignin that may be used.
Nonaka et al. disclose an antibacterial agent that can inhibit periodontal disease bacteria, tooth decay bacteria, or Streptococcus pyogenes, from proliferating without disturbance of the sound balance of intestinal flora. The antibacterial agent comprises lignin. The antibacterial agent comprising lignin suppresses the growth of oral harmful bacteria in humans, companion animals, and/or industrial animals, and may be incorporated into, food, pet food, feed, and the like (paragraph 0001). Lignin includes coniferyl alcohol, coumaryl alcohol, and sinapyl alcohol.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used coniferyl alcohol, coumaryl alcohol, and sinapyl alcohol as the lignin in the pet food of Jackson et al. motivated by the desire to inhibit periodontal disease bacteria, tooth decay bacteria, or Streptococcus pyogenes, from proliferating without disturbing the sound balance of intestinal flora.
Response to Arguments
The Examiner submits that in regards to Jackson, see response above. Nonaka et al. cure the deficiencies of Jackson by disclosing types of lignins, which Jackson discloses are suitable for the disclosed compositions. Therefore the rejection is maintained.
Obvious-Type Double Patenting (Revised)
1) Claims 52-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-9, 11, 15, 17, 19-20 and 23 of copending Application No. 17/250,440 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as they both recite pet foods comprising fat comprising medium chain triglycerides, protein, carbohydrates and fiber with ketogenic ratio. The instant claims differ from the copending claims insofar as the instant claims are genus claims and do not recite the amounts in the first independent claims. Therefore the instant claims are obvious over the copending claims. In regards to the ratio, the ratio of the instant claims are encompassed by that of the copending claims because the copending claims do no limit the amount of each component.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejection is maintained.
2) Claims 52-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34-53 of copending Application No. 18/335,194 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as they both recite pet foods comprising fat, protein, carbohydrates and fiber. The instant claims differ from the copending claims insofar as the instant claims are genus claims and do not recite the amounts in the first independent claims. However, the amounts are recited in the dependent claims and overlap those of the copending claims. Therefore the instant claims are obvious over the copending claims. In regards to the ratio, the ratio of the instant claims are encompassed by that of the copending claims because the copending claims do no limit the amount of each component.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejection is maintained.
Conclusion
Claims 52-71 are rejected.
No claims allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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