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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites a Markush grouping of specific oils, “and other hydrophobic plant-based oils known in the art”, which renders the claim indefinite since it is not a closed group of alternatives. it is unclear what other alternatives are intended to be encompassed by the claim, as the generic recitation of “other hydrophobic plant-based oils known in the art” encompasses a massive number of distinct alternative members, and one skilled in the art cannot determine its metes and bounds due to an inability to envision all of the compounds defined by the Markush group. Clarification is requested. See MPEP 2173.05(h)(I).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ueda et al. (USP 5,429,832, 07/04/1995, IDS reference) (hereinafter Ueda) in view of Prud’Homme et al. (USP 5,616,339, 04/01/1997, IDS reference) (hereinafter Prud’Homme).
Ueda discloses stably rumen-protected compositions comprising cores each containing a biologically active substance (abs; col.2, lines 33-40) including amino acids such as methionine (i.e. instantly claimed physiologically active ingredient) (col.4, lines 18-20), coated with a coating composition comprising: (a) a fatty acid source, (b) chitosan, and (c) emulsifiers (col.2, lines 40-50). Suitable emulsifiers include lecithin (col. 5, line 27). The coating composition may be 10-60% by weight of the total weight of the coated particle (col.3, lines 51-53). The amount of chitosan in the coating composition may be 1-15% by wt.; and the emulsifiers and fatty acid source may be 1-30% wt., each of the total weight of the coating composition (col. 5, lines 35-41). Suitable proportions of the component of fatty acids and emulsifiers and that of chitosan in the coating composition are selected from the respective defined ranges in order to form a coating layer which is capable of sufficiently protecting the biologically active substance in the rumen (co. 5, last ¶).
Ueda differs from the instant claims insofar as not explicitly disclosing wherein the chitosan is a chitosan organic salt.
However, Prud’Homme discloses compositions for administration to ruminants which are able to substantially retain the active ingredient in the rumen without degradation for a specified amount of time (col.2, lines 19-24). The compositions contain generally well known in the art chitosan salts, particularly for nutrient or medicinal application, and preferably chitosan acetate (col.4, lines 43-52).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included chitosan acetate in the composition of Ueda since it is a known and effective form of chitosan suitable for rumen protected compositions as taught by Prud’Homme.
Regarding claims 1 and 19 reciting wherein the coating is at least 10% by dry weight of the composition, such amounts would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. 10-60% by weight). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claims 1 and 12, or claim 19, reciting a ratio of chitosan organic salt to emulsifier, or chitosan acetate to lecithin, respectively, it would have been obvious to one of ordinary skill in the art to have selected an amount of chitosan/chitosan acetate from the disclosed range of 1-15% by weight, and an amount of emulsifier/lecithin from the disclosed 1-30% by weight; such amounts selected would have equated to a ratio that overlaps with the claimed ratio (i.e. less than about 2.5 : 1, or less than about 2:1, respectively), thus making the claimed ratio obvious. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 20 reciting a method of making a rumen-protected composition, since Ueda discloses composition comprising cores containing bioactive substances including methionine, coated by a coating composition comprising emulsifier, chitosan (e.g. chitosan acetate), and fatty acid source, a method of coating the core with a coating composition would have also been obvious.
Regarding claims 3-4 and 10 reciting ranges of total bioavailability and/or rumen bypass rate of the physiologically active ingredient, Ueda further discloses wherein exemplary embodiments have rumen release rates ranging from 5% to 32%, and small intestine release rates ranging from 50 to 80% (Table 1). Accordingly, the claimed ranges (i.e. a total bioavailability of at least about 70%; a rumen bypass rate of at least about 70%; or a total bioavailability rate of at least 50% and a rumen bypass rate of at least about 50%, respectively) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. 50-80%). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, since Ueda discloses a general guidance that proportions of chitosan, fatty acid source, and emulsifiers are selected to sufficiently protect the active substance in the rumen, it would appear that the rumen bypass and total bioavailability rate require no more than routine experimentation on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed total bioavailability and/or rumen bypass rate. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claims 9, 16, and 18, Ueda further discloses an exemplary core comprising 375g of methionine and 125g of excipients (col. 7, lines 44-45).
Accordingly, the claimed range of the physiologically active ingredient in the bioactive core would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. 75% by weight). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 9 reciting amounts of chitosan organic salt, emulsifier, and fatty acid source, it would have been obvious to one of ordinary skill in the art to have selected an amount of chitosan (e.g. chitosan acetate) from the disclosed range of 1-15% by weight; and an amount of emulsifier (e.g. lecithin) and an amount of the fatty acid source, such that the total amount of fatty acid source and emulsifier is within the range of about 1-30% by weight. The claimed ranges (i.e. about 2-3% wt.; about 0.5-3% wt.; and about 10-20% wt.) would have been obvious from selecting from this range.
Regarding claim 11, Ueda does not disclose wherein the coating must include a fat. Accordingly, it would have been obvious to one of ordinary skill in the art that the coating of Ueda does not include a fat.
Regarding claim 17, Ueda further discloses wherein the biologically active substance includes fish powder (col.4, line 25). Accordingly, it would have been obvious to one of ordinary skill in the art that the core of Ueda includes a fatty acid source, since fish powder/meal contains fatty acids.
Regarding claim 19, it would have been obvious to formulate the composition of claim 19 for the same reasons discussed above as applied to each claim limitation.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ueda et al. (USP 5,429,832, 07/04/1995, IDS reference) (hereinafter Ueda) in view of Prud’Homme et al. (USP 5,616,339, 04/01/1997, IDS reference) (hereinafter Prud’Homme), further in view of Pellet Machinery (“Why Feed Pellet Fat/Oil Coating is Needed?”, 05/18/2019 as evidenced by Wayback Machine) (hereinafter Pellet).
The disclosures of Ueda and Prud’Homme are discussed in detail above. Ueda further discloses wherein the cores may be prepared by extrusion granulation (col.4, line 45).
Ueda and Prud’Homme differ from the instant claims insofar as not explicitly disclosing wherein the core is coated with a sub-coating, or wherein the sub-coating comprises a plant-based oil.
However, Pellet discloses improving feed quality by adding a fat/oil coating to animal feed. The fat/oil coating may be plant oils, and can be added after pelletizing, improving the productivity without affecting the solidness of pellets, which works well for producing extruded animal feed (¶1). There are many advantages of fat/oil coating feed pellets, including supplying extra energy, helping fat-soluble vitamin absorption, and increasing sales revenue as it gives the pellets higher quality (¶2, § 4, 5, 7, 8).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included a plant oil (i.e. instantly claimed plant-based hydrophobic oil of claim 14) coating on the core of Ueda, before coating with the coating composition of Ueda, motivated by the improved feed quality to supply extra energy and help fat-soluble vitamin absorption without affecting the solidness of pellets as taught by Pellet.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY M TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Friday 10:00 AM - 6:00 PM EST.
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/LUCY M TIEN/Examiner, Art Unit 1612
/FREDERICK F KRASS/Supervisory Patent Examiner, Art Unit 1612