DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims/Application
The claim amendments and remarks filed on 04/20/2026 is acknowledged. Claim 5 is amended. Claim 16 is newly added.
Accordingly, claims 1 – 16 are currently pending, and are being examined on the merits herein.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e)
or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The instant application,
filed on 08/22/2023 claims domestic benefit of the prior-filed applications, Application
No. 63/411,743, filed on 09/30/2022 and Application No. 63/424,307, filed on 11/10/2022.
Withdrawn Objections/Rejections
The objection to the specification is withdrawn in view of the amendment to the specification to remove the use of hyperlink.
The objection to claim 5 is withdrawn in view of the newly amended claim that includes a period at the end of the claim.
The following grounds of rejection are maintained from the previous Office Action dated 01/28/2026, with the exception of including a new rejection over claim 16 in view of the applicant’s amendment to include new claim 16.
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 - 16 are rejected under 35 U.S.C. 103 as being unpatentable over US
2020/0375937 A1 (IDS 01/26/2024) and Tanya’s comprehensive guide to feline chronic
kidney disease, https://www.felinecrf.org/vitamin_b.htm (September, 2020) (PTO-892, 01/28/2026) .
US’937 teaches a method for treating sarcopenia or muscle atrophy in an animal
which can comprise orally administering a composition comprising a therapeutically
effective amount of medium chain triglycerides (MCTs) to the animal. Compositions and
methods using MCTs for controlling or lowering blood pressure or treating kidney or
renal disease in a companion animal is presented in one or more embodiments in
US’937 ([0041], pg. 4, col. 2). The medium chain triglycerides can be about 0.5 wt % to
about 60 wt % of the composition. In one aspect, the medium chain triglycerides can be
from 1 wt % to about 20 wt % of the composition. The MCTs can include an MCT
selected from the group consisting of caprylic acid, capric acid, and a mixture thereof
([0028], pg. 3, col. 1). The pet food compositions disclosed in US’937 can optionally include additional ingredients, such as starches, humectants, oral care ingredients,
preservatives, amino acids, fibers, prebiotics, sugars, animal oils, aromas, other oils
additionally or alternatively to vegetable oil, salts, vitamins, minerals, probiotic microorganisms, bioactive molecules or combinations thereof ([0037], pg. 4, col. 1). The
term "pet food" means any food composition intended to be consumed by a companion
animal. Such food compositions can include main meal, treats, beverages, supplements,
etc. ([0012], pg. 1, col. 2). The composition can be a supplement. Such a supplement can
be added to a food composition or be administered in conjunction with a food
composition, or administered separately. As such, in some embodiments, the US’937
compositions can be complete and nutritionally balanced pet foods ([0032], pg. 4, col. 1,
continuation from the previous page). The animal can be a companion animal. In one
aspect, the companion animal can be a cat. In one embodiment, the animal can be a
senior animal or an aging animal. In one aspect, the animal can be a senior cat. In
another aspect, the animal can be an aging cat ([0031], pg. 3, col. 2). The composition
can be administered to the companion animal for a period of at least one week. The
composition can be administered in an amount that provides about 0.001g to 50 g of
the MCTs per kg body weight of the companion animal per day ([0030], pg. 3, col. 2). The composition is administered to the animal daily for at least one week (claim 11, pg.
5, col. 2). The US’937 disclosure relates to compositions comprising medium-chain
triglycerides and methods comprising administering the compositions to an animal to
provide a health benefit. More specifically, the US’937 disclosure relates to
compositions that comprise medium-chain triglycerides (MCT) and, in some aspects, can
optionally include one or more of omega-3 fatty acids, antioxidants, or arginine ([0005], pg. 1, col. 1). The composition can further comprise a component selected from the
group consisting of an omega-3 fatty acid, antioxidants (including vitamin E, vitamin C,
selenium, and/or polyphenols), arginine, and mixtures thereof ([0027], pg. 3, col. 1). The
suitable omega-3 fatty acids include eicosapentaenoic acid (EPA), docosahexaenoic acid
(DHA), alpha-linolenic acid (ALA), and mixtures thereof. In one embodiment, the omega-
3 fatty acids can range from about 0.2 wt % to about 3 wt % of the composition. In some
embodiments, the omega-3 fatty acids are at least about 0.2 wt %, at least about 1.0 wt
%, or at least about 2.0 wt % ([0029], pg. 3, col. 2). US’937 states that they have
discovered that the MCT compositions can treat sarcopenia or muscle atrophy in an
animal as well as increase weight gain, increase fat gain, or maintain lean body mass in
an animal in need thereof. Such effect can help treat such animals suffering from
cancer, AIDS, congestive heart disease, chronic obstructive pulmonary disease, renal
failure, severe burns, and cachexia. The methods can comprise orally administering a
composition comprising a therapeutically effective amount of medium chain triglycerides to the animal ([0006], pg. 1, col. 2).
The teaching of US’937 differ from that of the instantly claimed invention in that
US’937 does not teach a composition that includes B vitamins.
Tanya talks about diet and nutrition for cats, especially cats suffering from
chronic kidney disease (CKD). Tanya teaches that the B vitamins are essential for good
health. Tanya teaches the different types of B vitamins, their importance in the diet, and their total daily requirement. Total daily requirement for vitamin B1 (Thiamine) is 0.01
mg/lb, vitamin B2 (Riboflavin) is 0.05 mg/lb, vitamin B3 (Niacin) is 0.12 mg/lb, vitamin
B5 (Pantothenic acid) is 0.10 mg/lb, vitamin B6 (Pyridoxine) 0.010 mg/lb, vitamin B7
(Biotin) is 0.001 mg/lb, vitamin B9 (Folic acid) is 0.002 mg/lb, and vitamin B12
(cyanocobalamin or methylcobalamin) is 0.00025 mg/lb. The following table is from
Tanya about recommendations from the National Research Council for B vitamins for a
healthy cat compared with the recommendations for a CKD cat from Nutritional
management of renal disease (2008) Sturgess K, Presentation to the world small animal
veterinary association world congress.
Healthy Cat (The National
Research Council)
CKD Cat (Nutritional
management of renal
disease)
B Vitamin
9 lb (4 kg) cat eating 250
calories per day
9 lb (4 kg) cat
B1 (Thiamine)
0.33 mg
0.32 – 1.0 mg
B2 (Riboflavin)
0.27 mg
0.36 – 1.28 mg
B3 (Niacin)
2.5 mg
3.6 – 7.2 mg
B5 (Pantothenic acid)
0.4 mg
0.3 – 0.72 mg
B6 (Pyridoxine)
0.16 mg
0.28 – 0.8 mg
B7 (Biotin)
Na
6.0 – 12.0 µg
B9 (Folic acid)
47 µg
64 – 160 µg
B12 (cobalamin)
1.4 µg
1.2 – 4.0 µg
It would have been obvious to combine the teaching of US’937 and Tanya before
the effective filing date of the claimed invention by including an effective amount of B
vitamins to be added in the compositions of the pet food to arrive at the instantly
claimed invention. One of ordinary skill in the art would have been motivated to include
B vitamins into the composition with a reasonable expectation of success because Tanya
teaches that B vitamin supplements are safe and can often help a CKD cat feel better.
As MPEP states, In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
It would have been prima facie obvious for one of ordinary skill in the art to
optimize the recommended daily allowance, RDA, of the various B vitamins to address
any vitamin deficiencies and to provide the necessary renal and health benefit to an
animal.
Regarding claim 16, as Tanya teaches the total daily requirement of the B vitamins, and the recommendations for a healthy cat and a CKD cat in the table above, suggested quantities of vitamins B1, B3, B6, and B9 for the CKD cat are 5 – 11, 5 – 6, 5 – 8, and 5 – 8 times the RDA respectively.
Response to Arguments
Applicant’s arguments filed on 04/20/2026 have been fully considered, but were not persuasive.
Applicant argues that all the limitations of claim 1, “A method of treating glomerular hyperfiltration, reducing glycogen storage in tissues, or reduce uremic toxins in an animal”, are not met by the cited references, US’937 and Tanya. Applicant states that US’937 does not teach a method for treating glomerular hyperfiltration, reducing glycogen storage in tissues, or reducing uremic toxins in an animal. Applicant notes that Tanya mentions glomerular filtration only in the teaching that “B vitamin therapy is beneficial in patients with good renal function, but harmful in patients with significantly impaired renal function (a glomerular filtration rate < 50).”, and argues that Tanya’s teaching also seems to teach away from use of B vitamins for patients having impaired renal function. Applicant’s arguments were not found persuasive. As US’937 teaches compositions and methods using MCTs for controlling or lowering blood pressure or treating kidney or renal disease in a companion animal ([0041], pg. 4, col. 2), the compositions and methods will result in lowering uremic toxins, which are biological solutes retained and accumulated due to kidney impairment that contribute to uremia/chronic kidney disease. The claim does not specifically require that the animal have a need for reducing glycogen storage in tissues, or a need to reduce uremic toxins. Specifically, claim does not recite “animal in need thereof.” Therefore, one would reasonably expect that since the same composition is administered to a patient being treated for kidney or renal disease which is what is taught by ‘937, the limitation “reducing glycogen storage in tissues or reduce uremic toxins in an animal” would necessarily result. The teaching from Tanya regarding glomerular filtration is in the discussion about the forms of Vitamin B12: Methylcobalamin versus Cyanocobalamin, and states that methylcobalamin might be more effective based on a human study, B vitamin therapy for homocysteine: renal function and vitamin B12 determine cardiovascular outcomes (2013) Spence JD Clinical Chemistry and Laboratory Medicine 51(3) pp633-7, which found that “high-dose cyanocobalamin leads to accumulation of cyanide in patients with renal failure. B vitamin therapy is beneficial in patients with good renal function, but harmful in patients with significantly impaired renal function (a glomerular filtration rate <50). It seems likely that in patients with renal impairment, methylcobalamin should be used instead cyanocobalamin.” Therefore, the Examiner respectfully submits that the reference from Tanya has to be read fully.
Applicant also argues that as US’937 teaches methods of treating sarcopenia or muscle atrophy, which is not the same as chronic kidney disease, a person of ordinary skill in the art would not have a sufficient rationale to combine US’937 with Tanya. Applicant’s arguments were not found to be persuasive. US’937 teaches a method of treating sarcopenia or muscle atrophy in an animal, and teaches that one of the factors that cause muscle atrophy is renal failure (pg. 1, col. 1, [0003]). US’937 teaches that MCT compositions can treat sarcopenia or muscle atrophy, and as a result help treat animals suffering from renal failure among other conditions (pg. 3, col. 1, [0025]). US’937 teaches that the method can further comprise identifying an animal suffering from renal failure among other conditions (pg. 3, col. 1, [0026]). US’937 teaches compositions and methods using MCTs for controlling or lowering blood pressure or treating kidney or renal disease in a companion animal ([0041], pg. 4, col. 2). Tanya teaches about diet and nutrition for cats, especially cats suffering from chronic kidney disease (CKD). As both references are about diet and nutrition that offer health benefits in animals that result in treating kidney or renal disease in animals that are afflicted, a person of ordinary skill in the art would have a sufficient rationale to combine their teachings.
Applicant also submits that the present claims provide unexpected results, that the combination of MCTs with the B vitamins was effective at reducing uremic toxins. The specification in Table I discloses control, RPB (control + B vitamins & more), RPB+ (control + B vitamins & more + MCT) compositions. Applicant’s arguments about unexpected results is based on the above three. However, US’937’s composition (control + MCT + Arginine + vitamin E + vitamin C) is not considered. US’937 exemplifies the above composition in Table 1 (pg. 4, col.2, [0042]). Applicant states that the specification explains that it was surprising and unexpected that the combination of MCTs with the B vitamins was so effective at reducing uremic toxins, even more effective than B vitamins without the MCTs. This conclusion is not complete without providing data for MCT alone for purposes of comparison.
Conclusion
Claims 1 – 16 are rejected. No claims are 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 JANAKI ANANTH MAHADEVAN whose telephone number is (571)272-0230. The examiner can normally be reached Monday-Friday 8-5PM.
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/J.A.M./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
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