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 .
Reopened Prosecution
In view of the Appeal Brief filed on 11/20/25, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/EMILY M LE/ Supervisory Patent Examiner, Art Unit 1793
This office action is written in response to the Applicants Remarks filed 11/20/25. Claims 1-7, 9-18 are pending. Claim 8 has been cancelled. Claims 10-18 were withdrawn. Claims 1-7, and 9 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 1-7, and 9 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 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 2: Shibahara discloses as discussed above in claim 1. Shibahara discloses lubricants as calcium stearate and magnesium stearate [0067].
Regarding Claims 3 and 4: Shibahara discloses as discussed above in claim 1. Shibahara discloses L-lysine hydrochloride [0073].
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].
Response to Arguments
6. The Applicants assert that there is no teaching of lysine and choline chloride being used together.
The Examiner disagrees because Shibahara discloses using lysine and choline as biologically active agents. Further, Shibahara discloses that its (C) biologically active agent is selected from at least one member of the group consisting of an amino acid, a vitamin and a vitamin like substance. This is indicative of more than just one biologically active agent being used together. Since lysine is an amino acid and since choline is a vitamin like substance, it would have been obvious to one of ordinary skill in the art to use them together in the feed additive.
Further, it is known in the art to generally use choline and lysine in animal feed formulations. Peoples et al. (US 6,207,217), which was not used in the above rejection but is used here to illustrate that using lysine and choline in combination in animal feed is known in the art, discloses lysine and choline in animal feed [Tables 1 and 2]. Chi et al. (US 2007/0172514), which was not used in the above rejection but is used here to illustrate that using lysine and choline in combination in animal feed is known in the art, discloses lysine and choline in animal feed [Tables 13; 15].
Further, lysine and choline in a feed additive in addition to being shown in primary reference Shibahara, is also shown in Zhu et al. (US 2018/0303130). Zhu was not used in the above rejection but is used here to illustrate that using lysine and choline in combination in a feed additive is known in the art [Claims 1, 6, 7; Claim 16].
7. The Applicants assert hindsight reasoning to reach the claim limitations.
The Examiner maintains that contrary to the Applicants assertions, that given the information above, it is evident that the Examiner's rejection was not based upon hindsight reasoning. The prior art clearly disclosed each and every limitation of the Applicant’s claims without gleaning only from the Applicant’s disclosure. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. All of the components of Applicants claims were found in the primary reference Shibahara. Shibahara was modified for the teachings of amounts of choline and silicon in relation to each other in a ratio.
8. The Applicants assert that Shibahara was silent as to the amount of stearic acid metal salt.
The rejection has been modified to the address this argument. The Examiner notes that Shibahara did disclose stearic acid metal salts as discussed above.
9. The Applicants assert that there was no motivation to combine the references.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, both references disclose animal feed additives and both incorporate fat, choline, stearate, and silica in its formulation. Mehta is drawn to improving the flowability of a choline containing animal feed additive. Mehta is aware of the issue of the hygroscopicity of choline and incorporates silica as a hydrophobic carrier. However, Mehta is also drawn to increasing the nutritive properties of the choline containing additive in that silica does not contribute nutritional value. Mehta incorporates oil and also utilizes stearate in addition to silica thereby improving the flowability and nutritional value of the composition [Mehta pg. 2]. Given that Mehta (2008) predates Shibahara (2018), Mehta shows that it was known in the art to combine choline with a silica carrier in an animal feed additive. It would have been obvious to modify the ratio of choline to silica in Shibahara to reflect that which was disclosed in Mehta since Mehta discloses the effectivity of the choline and silica within these ranges.
10. The Applicants assert unexpected effects of the feed additive in that the instant invention resulted in low mixing load/smooth slurry state/stably produced feed additive.
The Examiner disagrees. Shibahara in view of Mehta discloses the same composition as instantly recited. Mehta acknowledges the issues with the hygroscopicity of choline and discloses silica and stearates as able to aid in the stability of free flowing condition of the feed additive and the ability of the additive to be mixed evenly in animal feed.
Applicants assert that lysine and stearic acid salts as critical for a stable feed. The Examiner notes that Shibahara discloses lysine and stearates and that Shibahara and Mehta acknowledge stearic acid salts/stearates as hydrophobic lubricants/adjuvants.
In the absence of unexpected results, it is not seen how the claimed invention differs from the teachings of the prior art. Applicant's claims are drawn to a combination of known components which produces expected results, see In re Kerkhoven 205 USPQ 1069 and In re Gershon 152 USPQ 602.
Conclusion
11. 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