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 .
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.
Status of Claims/Application
Claims 1-15, filed on 08/22/2023, are currently pending and are examined on the merits herein. No preliminary amendment was submitted.
Information Disclosure Statement
Information disclosure statement (IDS) submitted by the applicant on 1/24/2024 is in compliance with the provisions of 37 CFR 1.97. It has been considered by the examiner.
Specification Objection
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
In [0050] on pg. 16, a hyperlink is provided by the applicant.
Claim Objections
Claim 5 is objected to because of the following informalities: a period is missing at the end of the sentence. Appropriate correction is required.
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.
Claims 1 - 15 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) .
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.
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.
Conclusion
No claims are allowed.
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/JANAKI ANANTH MAHADEVAN/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693