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 .
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 after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.114 has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114.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 08/21/2025 has been entered.
Claim status
The examiner acknowledged the amendment made to the claims on 08/21/2025.
Claims 21-40 are pending in the application. Claims 21 and 24 are currently amended. Claims 22-23 and 25-26 are previously presented. Claims 27-40 are withdrawn without traverse in response to the restriction requirement. Claims 21-26 are hereby examined on the merits.
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.
Claims 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Belliere-Baca WO 2018/167405 A1 (US Patent Application Publication No. 2021/0188769 relied upon as English Equiv., hereinafter referred to as Belliere-Baca) in view of Mahoney US Patent Application Publication NO. 2017/0369434 A1 (hereinafter referred to as Mahoney).
Regarding claims 21-25, Belliere-Baca teaches a method for manufacturing HMTBA comprising:
-hydrolyzing HMTBN into HMTBA in the presence of a mineral acid in aqueous medium (0018; Fig. 2);
-neutralizing the medium by adding a base (e.g., ammonia solution, 0058) to obtain a first phase comprising HMTBA along with salts, and a second phase the major ingredients of which are salts (e.g., ammonia sulfate and ammonia bisulfate) (0020; 0033; 0061; Fig. 2);
-separating the first phase from the second phase by decanting (0020; 0034; 0061; Fig. 2);
-separating HMTBA from the salt of the first phase by chromatography into two phases: an HMTBA enriched phase, and the other that is enriched in salt, wherein the chromatography is carried out in a static or non-static bed in one, or several columns such that the salt is largely removed (0022-0023; 0064-0065; Fig. 2); and
-condensing the HMTBA enriched phase by evaporation, and in one example, the final HMTBA enriched phase after evaporation contains 88% HMTBA and 11.2% water (0035-0036; 0077-0078; 0078; Table of 079; Fig. 2).
Belliere-Baca further teaches that HMTBA is widely used in animal nutrition (0002).
The HMTBA enriched phase upon evaporation reads on the composition of claim 21, since it contains HMTBA, water and residual salt of ammonia sulfate and ammonia bisulfate.
88% HMTBA as disclosed by the aforementioned example of Belliere-Baca falls with the ranges as recited in claim 21.
11.2% water as disclosed by the aforementioned example of Belliere-Baca, although does not overlaps with the range of 11.5-13.5% (or 11.5-12.5%) as recited in claims 21 and 24, is very close to the lower bound 11.5% of ranges that one skilled in the art would have expected them to have the same properties, given that both Belliere-Baca and the claimed invention are directed to compositions that comprise HMTBA, water and sulfate salt. It has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (MPEP 2144.05).
Further, Mahoney teaches a specialty formulation comprising a hydroxy methionine analog such as HMTBA (0023-0024; 0033), sulfate and/or bisulfate derived from sulfuric acid used in the manufacture of the hydroxy methionine (0023; 0037-0038), and water (0023; 0036), wherein the concentration of the hydroxy methionine analog is at least 85% by weight of the formulation (0035), the hydroxy methionine analog exists as a mixture of monomer, dimer, trimer, tetramer, and longer oligomers (0031), the water content is 15% or less (0036), the sulfate content is 0.27% (e.g., 2700 ppm, 0023; 0037) and the bisulfate content is 0.05% (e.g., 500 ppm) or less (0023; 0038). Further, Mahoney teaches that the specialty formulation is obtained by subjecting feed grade formulation comprising the hydroxy methionine analog, sulfate/bisulfate and water to ion exchange to remove sulfate and bisulfate, followed by evaporation to remove water till the final formulation has a water content of less than 15% (0045-0047; 0063; 0069; 0036). Further, Mahoney teaches that the specialty formulation can find its use in food / feed composition, dietary supplements, etching agents, electronic chemicals, or agrochemical formulations (0070).
Both Belliere-Baca and Mahoney are directed to formulations comprising at least 85% HMTBA existing as a mixture of monomer and oligomers; water; and low amount of sulfate and/or bisulfate resulting from a process of removing sulfate/bisulfate followed by evaporation to remove water (e.g., Belliere-Baca uses chromatographic column to remove salt followed by evaporation to remove water, and Mahoney uses ion exchange to remove salts followed by evaporation to remove water). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Belliere-Baca by condensing the HMTBA enriched phase of Belliere-Baca by evaporation to a water content of less than 15% with reasonable expectation of success, for the reason that prior art has established that such an amount of water in the final formulation is suitable in a process to remove sulfate/bisulfate from an HMTBA enriched phase for the purpose of delivering a composition for animal nutritional use.
The amount of water as disclosed by Mahoney overlaps with the ranges as recited in claims 21 and 24. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Regarding the amount of ammonia sulfate and ammonia bisulfate salts, 0078-0079 of Belliere-Baca teaches an ammonia sulfate content of 0.8%; further, Belliere-Baca teaches that the chromatography separation by one or several columns is able to efficiently reduce salt to a content of at most 0.5%, and even at most 0.3%, and even salt only in the form of traces (0040; 0022). As such, the limitations about the salts content as recited in claims 21, 24 and 25 are obvious over the teaching of Belliere-Baca.
Regarding the limitation about the amount of HMTBA monomer, dimer and trimer by weight of the overall HMTBA, and ratios of HMTBA monomer: dimer: trimer as recited in claims 21 and 22: the composition as disclosed by Belliere-Baca (e.g., the HMTBA enriched phase upon evaporation) inherently comprises HMTBA monomer, dimer and trimer because of the thermodynamic equilibrium (see 0012); further, Belliere-Baca recognizes that the proportion of HMTBA oligomers (e.g., dimer, trimer, tetramer, etc.) in the composition is a parameter of the concentration of ammonium salt (e.g., a higher concentration of ammonium salt, e.g. 1-2% results in a higher concentration of HMTBA oligomers, 0012), and Belliere-Baca further teaches that the chromatography separation method results in a very low amount of salt (e.g., at most 0.5%, at most 0.3% or even trace amount of salt), which results in a reduced amount of HMTBA oligomers as compared to prior art (0040; 0069). As such, where prior art teaches an amount of salt that is comparable with the ranges as recited in claim 21, the content of HMTBA monomer +dimer + trimer and the ratios of HMTBA monomer: dimer: trimer as recited in claims 21 and 22 are reasonably encompassed by the prior art.
Regarding the limitation about the viscosity of the composition as recited in claims 21 and 23, the viscosity of a composition depends on the components and contents thereof in the composition; further, Belliere-Baca teaches that the viscosity of the composition also depends on the proportion of HMTBA oligomer (e.g., higher proportion of HMTBA leads to higher viscosity, 0012); thus, given that Belliere-Baca as modified by Mahoney teaches a composition comprising essentially the same amount of salt, water, HMTBA and ratio of HMTBA monomer: dimer: trimer, it logically follows that the viscosity as recited in claims 21 and 23 are encompassed by prior art.
Regarding claim 26, The preamble language about a “feed additive” is not considered to further limit the composition. It is the examiner’s position that the intended use recited in the present claims do not result in a structural difference between the presently claimed composition and the prior art composition and further that the composition of the prior art is capable of performing the intended uses. Given that Belliere-Baca teaches the same HMTBA composition as that recited in the claim and that the HMTBA is widely used in animal nutrition (see Belliere-Baca para. 0002), etc., it is clear that the HMTBA composition of Belliere-Baca could be used a feed additive.
Response to Arguments
Applicant's arguments filed 08/21/2025 have been fully considered but they are moot over the new ground of rejection set forth in the instant office action.
Conclusion
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/CHANGQING LI/Primary Examiner, Art Unit 1791