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 .
This office action is written in response to the Applicants Remarks filed 7/13/26. Claims 1, 5-7, 9-23 are pending. Claims 19-23 are new. Claims 2-4 have been cancelled. Claim 8 was previously cancelled. Claims 10-18 were withdrawn. Claims 1, 5-7, 9, 19-23 have been examined on the merits.
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, 5-7, 9, 19-23 are rejected under 35 U.S.C. 103 as being obvious over Shibahara et al. WO 2018/079748 (Pub 5/3/18) corresponding to (US 2019/0246666) in view of Mehta (WO 2005/020705).
Regarding Claims 1, 6, 7: Shibahara discloses a feed additive for ruminants containing a hydrogenated vegetable oil having a melting point of higher than 50°C and lower than 90°C [abstract; 0044]; an agent which modifies the surface of an active agent and aids in even distribution of the agent (surfactant) which is not less than 0.05% and generally not more than 6% an wherein the surfactant is an emulsifier which is lecithin [0049]; a biologically active substance which can be lysine and which can be choline and wherein the active substance is not less than 30% and generally less than 65% [0050, 0052, 0055, 0056]; anticaking agents (hygroscopic agent) including calcium silicate [0067]; lubricants which can be calcium stearate or magnesium stearate (stearic acid metal salts) [0067]. Shibahara discloses that the lecithin acts to uniformly disperse the active substances; where choline and L-lysine are active agents [0047; 0029; 0050-0055]. Shibahara discloses lubricants as calcium stearate and magnesium stearate [0067]. Shibahara discloses L-lysine hydrochloride [0073]. Shibahara discloses L-lysine as being dispersed [0073]. Therefore Shibahara discloses (C) choline and (D) L-lysine or an L-Lysine salt being substantially dispersed.
Further, Shibahara discloses that the biologically active substance can be at least one member selected from the group consisting of an amino acid and a vitamin or a vitamin like substance [claims 14-16]. This is indicative of amino acids and vitamins or vitamin like substances being used in combination. Lysine is an amino acid and choline is a vitamin like substance [0050; 0052; 0055]. Shibahara also discloses lysine as being a favorably used amino acid [0052]. Since Shibahara discloses a group containing at least one of an amino acid and a vitamin like substance, it would have been obvious to one of ordinary skill in the art to use of lysine and choline in the same formulation/in combination.
Although Shibahara does not disclose 10 to 60% choline salt and 1 to 40% L-lysine or salt thereof, since Shibahara discloses that the active agent can be one or more of active ingredients including choline and lysine and a total amount of active agent at between 30% and 65% it would have been obvious to modify Shibahara to include choline and lysine in combination of amounts of more than 30% and less than 65%. For example, both choline and lysine can be present at 30% and fulfill the claim limitation.
Shibahara does not explicitly disclose an amount of its disclosed stearic acid metal salts at 0.1% to 3%.
Shibahara does not explicitly disclose a ratio of choline to silica.
Mehta discloses a free flowing feed additive containing choline powder, fat, and hygroscopic and hydrophobic ingredients [abstract]. Mehta discloses that the feed additive is for livestock [pg. 2, 2nd full paragraph]. Mehta discloses the feed additive containing choline chloride between 2% and 85%; fat between 10 to 98% that is a hydrogenated oil and has a melting point of higher than 40°C; a hygroscopic excipient (silicon oxide/silicon) at 0 to 45%; and a hydrophobic adjuvant 0 to 1% which can be calcium stearate [claims 1-4 original and amended claims]. Mehta is drawn to increasing the nutritive properties of the choline containing additive in that silica does not contribute nutritional value. Mehta incorporates oil/fat and also utilizes stearate in addition to silica thereby improving the nutritional value of the composition and continuing to improve the flowability of the composition [Mehta pg. 2].
At the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the composition of Shibahara to include the silicon to choline at a ratio of 1:1 to 1:20 (e.g. 30% silicon; 30% choline; 1.5% silicon, 30% choline) since Mehta discloses choline salt at 2 to 85% and silicon at 0 to 45% and discloses the effectivity of the silicon and choline in the range.
Further, it would have been obvious to one of ordinary skill in the art to modify the composition of Shibahara to include its calcium or magnesium stearate in the amount of 0 to 1% as disclosed in Mehta in order to further improve the flow of characteristic of the feed additive [pg. 6, top partial paragraph]. This is important for the homogeneous dispersion of the feed additive into animal feed.
Although Mehta does not explicitly disclose 10-60% choline salt one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Mehta overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Although Shibahara does not explicitly disclose 1-40% L-Lysine or a salt thereof one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Shibahara overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Although Mehta does not disclose the stearic acid metal salt at 0.1 to 3%, one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Mehta overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Regarding Claim 5: Shibahara discloses as discussed above in claim 1. Shibahara discloses including talc which is an inorganic ingredient [0067].
Regarding Claim 9: Shibahara discloses as discussed above in claim 1. Shibahara discloses water at not less than 0.1% and not more than 5% [0065].
Regarding Claim 19: Shibahara discloses as discussed above in claim 1. Shibahara discloses hydrogenated oil as hydrogenated soybean oil [0044; 0045;] the surfactant is an emulsifier which is lecithin [0049]; choline salt as choline chloride [0055].
Regarding Claim 20: Shibahara as modified discloses as discussed above in claim 1. Shibahara discloses a biologically active substance which can be lysine and which can be choline and wherein the active substance is not less than 30% and generally less than 65% [0050, 0052, 0055, 0056]. For example, both choline and lysine can be present at 30% and fulfill the claim limitation. Shibahara discloses a stearic acid salt as discussed above.
Mehta discloses a hydrophobic adjuvant 0 to 1% which can be calcium stearate [claims 1-4 original and amended claims].
Although Shibahara does not explicitly disclose 3-40% L-Lysine or a salt thereof one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Shibahara overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Although Mehta does not disclose the stearic acid metal salt at 0.7 to 1.5%, one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Mehta overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Regarding Claim 21: Shibahara as modified discloses as discussed above in claim 20. Shibahara discloses the hydrogenated vegetable oil (A) present at an amount not less than 30% and not more than 50% [0046]. Shibahara discloses lecithin/surfactant (B) at 0.5% to not more than 2% [0049]. Shibahara discloses a biologically active substance which can be lysine and which can be choline (C) and wherein the active substance is not less than 30% and generally less than 65% [0050, 0052, 0055, 0056]. For example, both choline and lysine can be present at 30% and fulfill the claim limitation. Shibahara discloses anticaking agents (hygroscopic agent) including calcium silicate [0067].
Mehta discloses a hygroscopic excipient (silicon oxide/silicon) at 0 to 45% a hygroscopic [Claims 2 and 3]. Mehta discloses the feed additive containing choline chloride between 2% and 85%; fat between 10 to 98% that is a hydrogenated oil and has a melting point of higher than 40°C; a hygroscopic excipient (silicon oxide/silicon) at 0 to 45%; and a hydrophobic adjuvant 0 to 1% which can be calcium stearate [claims 1-4 original and amended claims].
Although Mehta does not disclose the silica at 1.5 to 5 %, one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Mehta overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Although Mehta does not disclose choline chloride at 15 to 45% one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Mehta overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Regarding Claim 22: Shibahara as modified discloses as discussed above in claim 21. Shibahara discloses hydrogenated oil as hydrogenated soybean oil [0044; 0045]; the surfactant is an emulsifier which is lecithin [0049]; choline salt as choline chloride [0055].
Regarding Claim 23: Shibahara as modified discloses as discussed above in claim 1. Shibahara discloses hydrogenated oil as hydrogenated soybean oil (A) [0044; 0045]. Shibahara discloses the hydrogenated vegetable oil (A) present at an amount not less than 30% and not more than 50% [0046]. Shibahara discloses the surfactant is an emulsifier which is lecithin and which is not less than 1% and generally not more than 1% [0049]. Shibahara discloses a biologically active substance which can be lysine and which can be choline (C) and wherein the active substance is not less than 30% and generally less than 65% [0050, 0052, 0055, 0056]. For example, both choline and lysine can be present at 30% and fulfill the claim limitation. Shibahara discloses anticaking agents (hygroscopic agent) including calcium silicate [0067].
Mehta discloses a hygroscopic excipient (silicon oxide/silicon) at 0 to 45% a hygroscopic [Claims 2 and 3]. Mehta discloses the feed additive containing choline chloride between 2% and 85%; fat between 10 to 98% that is a hydrogenated oil and has a melting point of higher than 40°C; a hygroscopic excipient (silicon oxide/silicon) at 0 to 45%; and a hydrophobic adjuvant 0 to 1% which can be calcium stearate [claims 1-4 original and amended claims].
Although Shibahara does not explicitly disclose 38 to 46% hydrogenated soybean oil thereof one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Shibahara overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Although Shibahara does not explicitly disclose 1.1 to 1.3% lecithin thereof one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Shibahara overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Although Mehta does not disclose choline chloride at 15 to 45% one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Mehta overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Although Shibahara does not explicitly disclose 5-36% L-Lysine or a salt thereof one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Shibahara overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Although Mehta does not disclose the silica at 2.0 to 4.8%, one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Mehta overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Although Mehta does not disclose the stearic acid metal salt at 0.4 to 1.4%, one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Mehta overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness.
Response to Arguments
The Applicant asserts a synergistic effect of L-lysine hydrocholoride and calcium stearate, the synergistic effect being reducing the mixing load.
The Examiner notes that Shibahara discloses L-lysine hydrocholoride and calcium stearate used together in an animal feed formulation. Further Applicants own specification attributes easier mixing to the combination of L-lysine hydrocholoride, choline, calcium stearate and hygroscopic agent reduces blockage of discharge ports [Instant specification; 0010].
The Examiner acknowledges the Applicants declaration filed 7/13/26.
The Examiner notes that Applicants arguments are not commensurate with the scope of the claims. The claims are not directed to the mechanical process of mixing and extruding. The claims are directed to a feed additive composition having the recited ingredients. It is not clear how the effect of the lysine hydrochloride and calcium stearate on the movement of the composition through a mixer and its effect on a screw is relevant to a feed additive composition.
The rejections are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
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/Felicia C Turner/Primary Examiner, Art Unit 1793
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