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 the Application
Receipt is acknowledged of the amendment and response filed 4/6/2026. Claims 1,4 and 8 were amended and claim 2 was canceled.
Claim Rejections - 35 USC § 103
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 1 and 3-8 are rejected under 35 USC 103 as being unpatentable over Gastner et al. (US20130296231A1).
Regarding claims 1,3 and 6-8, Gastner discloses the use of guanidinoacetic acid and/or salts thereof as feed additive, in predominantly vegetarian diets, in particular use being made of salts with hydrochloric acid, hydrobromic acid and phosphoric acid.
The use proceeds especially in individual doses from 0.01 to100 g/kg of feed in the form of powders, granules, pastilles or capsules, the feed additive also being able to be used in combination with other physiologically active materials of value. The claimed use which is suitable especially for breeding and growing livestock, has recourse to a compound which is in particular stable in aqueous solution, can be converted to creatine under physiological conditions, and, in contrast to other guanidine derivatives, is completely available to physiological sectors of use.
Gastner discloses that depending on the respective specific application, to use guanidinoacetic acid and salts thereof as feed additive in combination with other physiologically active compounds, in particular carbohydrates, fats, amino acids proteins, vitamins, minerals, trace elements and derivatives thereof and any desired mixtures thereof being particularly suitable. Preference is given to methionine, betaine and choline and also other physiologically active methyl group donors. Betaine and choline, in the presence of homocysteine, can be converted to methionine in the body, which especially plays a role in the synthesis of creatine from guanidinoacetic acid. Here, methyl groups are required which are transferred from S-adenosylmethionine with formation of homocysteine. If betaine or choline are insufficiently available, methionine is consumed and a methionine deficit can occur in metabolism. Regarding ither trace minerals and selenium supplementation, trace minerals and vitamins are routinely added to animal feeds and the role of selenium supplementation in modulating plasma homocysteine levels was known at the time of the invention. In effect, maintaining redox balance is known to benefit health and well- being. Gastner discloses adding carnitine to feed compositions [0034].
It would have been obvious to one of ordinary skill in the art to have added known vitamins and minerals to a composition of guanidinoacetic acid methionine betaine and other methyl group donors to maintain cellular redox balance with a reasonable expectation of successfully preparing a feed additive composition with targeted health benefits.
The effect “improves ATP utilization in animal muscle cells” is not qualified by a relationship between ATP utilization and feed efficiency or growth as described in the disclosure and quantitative improvement over the untreated group. The open-ended transitional phrase “includes” in the independent claim does not preclude additional components. Gastner discloses a method comprising improving feed uptake, increasing
growth performance, increasing muscle meat gain, increasing meat quality or increasing reproduction performance in an animal by administering a sufficient amount of
feed additive as a part of a diet for the animal, wherein the feed additive comprises guanidinoacetic, acid or a salt thereof (for example see claim 10). Individual doses are
generally in the range from about 10 mg and about 600 mg, preferably in the range from about 25 to about 125 mg. In the case of pigs, daily doses, per kg of live mass, are, for example, in the range from about 10 mg and about 1000 mg [0026]. It would have been obvious to one of ordinary skill in the art to include suitable amounts in mixed formulations with methionine, betaine, choline, vitamins, trace minerals in generally used amounts to prepare a composition effecting improved ATP utilization in an animal, with a reasonable expectation of success.
Gastner discloses [0018] that in contrast to creatine and creatine monohydrate,
guanidinoacetic acid and salts thereof are more stable in acidic aqueous solution and therefore gastric environment, and they are not converted to creatine until under physiological conditions after resorption, principally in the liver. Thus in contrast to creatine, they are therefore available in the corresponding physiological metabolic reactions and the energy cycle and improve ATP utilization in animals.
Regarding the claims 4 and 5, the method steps claimed are routinely employed in making enteric-coated pellets with active ingredients in the core.
Claims 1 and 3-8 are therefore prima facie obvious in view of the art.
Response to Arguments
Claim amendments and applicant’s arguments render the previous rejection of claims under 35 USC 112(b) and 35 USC 102(a)(1) moot.
Regarding the rejection of claims under 35 USC 103, applicant’s arguments have been considered, but are not commensurate in scope with the claimed invention:
The open-ended transitional phrase “includes” does not preclude other components in the claimed composition.
The effect “improves ATP utilization in animal muscle cells” is not qualified by a relationship between ATP utilization and feed efficiency or growth as described in the disclosure and quantitative improvement over the untreated group.
Although the term “synergistic” is applied to the composition in the disclosure, there is no evidentiary support for the “synergy” between the components in the claimed ratios alone.
For these reasons, the rejection under 35 USC 103 is maintained.
Conclusion
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 Subbalakshmi Prakash whose telephone number is (571)270-3685. The examiner can normally be reached Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUBBALAKSHMI PRAKASH/Primary Examiner, Art Unit 1793
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