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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/13/2026 has been entered.
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) 1-5,7-10, 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Casebolt(US 2018/0021410) in view of White(WO 00/64283).
Regarding claims 1-5,7,13, Casebolt teaches a supplement comprising active IGF-1 in an amount of at least 50ng/kg of animal or human to no greater than 150,000ng/kg of animal or human weight(abstract, para 6,para 40) . This would equate to 0.050 micrograms to 150 micrograms per kg of animal or human. Casebolt teaches an animal weight of 290 lb(131kg)(table 2). Therefore, the supplement comprises 6.55 to 19,650 micrograms of active IGF-I.
Casebolt does not teach the presence of glutamine, leucine, and arginine. However, White teaches a nutritional supplement comprising free amino acids glutamine, leucine and arginine salts, wherein the supplement increases IGF-1 levels(abstract). White teaches that the supplement comprises glutamine in an amount of 500 to 1000mg, leucine in an amount of 400mg to 1000mg, and 500 to 1500mg of arginine(p.7, line 12-21). Therefore, selecting 1000mg of glutamine, 400mg of leucine, and 500mg of arginine and converting to mols(based on the molar mass of glutamine 146.14g/mol, leucine 131.17g/mol, and arginine 174g/mol), the molar ratio of 2.3:1:1. It would have been obvious to modify Casebolt with White by including glutamine, leucine, and arginine with IGF-1 in the claimed ratio because White teaches that these amino acids help to increase IGF-1 levels in the body.
The supplement as a whole comprises 6.55 to 19,650 micrograms of active IGF-I as taught in Casebolt and 1000mg of glutamine, 400mg of leucine, and 500mg of arginine as taught in White. Casebolt teaches feeding of 1.20lb(0.54) of food(the supplement) to an animal(table 1, see ADFI Average daily feed intake). Therefore, the supplement would comprise 12.11 to 36,355 micrograms of active IGF-1/kg of supplement, which overlaps the claimed range of at least 100 micrograms to no greater than 2000 micrograms active IGF-1/kg of supplement and renders it obvious.
Regarding claim 8, Casebolt teaches that the IGF-1 is a recombinant IGF-1(para 25)
Regarding claims 9,10,14-16, Casebolt teaches that the supplement can be present in animal feed(para 5). Casebolt is silent on the amount of supplement per ton. However, since Casebolt teaches an amount of IGF-I per kg of animal and White teaches amounts of amino acids to be consumed daily, it would have been obvious to adjust the amount of supplement per ton in order to deliver the correct amount of amino acids and IGF-1 to the human or animal.
Regarding claim 12, White teaches that the supplement comprises 8 amino acids all with similar dosages of 500mg to 1500mg(p.7, line 12-21). Therefore, the total wt% percent of L-glutamine, L-leucine, and L-arginine is less than the total wt% of other amino acids in the supplement.
Response to Arguments
Applicant's arguments filed 4/13/2026 have been fully considered but they are not persuasive.
The applicant argues that Casebolt does not teach at least 100 micrograms to no greater than 2000 micrograms active IGF-1/kg of supplement. However, the supplement as a whole comprises 6.55 to 19,650 micrograms of active IGF-I as taught in Casebolt and 1000mg of glutamine, 400mg of leucine, and 500mg of arginine as taught in White. Casebolt teaches feeding of 1.20lb(0.54) of food(the supplement) to an animal(table 1, see ADFI Average daily feed intake). Therefore, the supplement would comprise 12.11 to 36,355 micrograms of active IGF-1/kg of supplement, which overlaps the claimed range of at least 100 micrograms to no greater than 2000 micrograms active IGF-1/kg of supplement and renders it obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D LEBLANC whose telephone number is (571)270-1136. The examiner can normally be reached 8AM-4PM EST M-F.
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/KATHERINE D LEBLANC/Primary Examiner, Art Unit 1791
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