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 .
DETAILED ACTION
Claims 1-14 are pending.
Domestic Benefit
Applicant’s claim to the domestic benefit of US Provisional 63/236,399 filed 24 August 2021, 17/818,182 filed 08 August 2022, and 17/818,591 filed 09 August 2022 is acknowledged. The effective filing date is 24 August 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05 December 2024, 01 August 2025, 24 September 2025, 20 October 2025, and 13 March 2026 are being considered by the examiner.
Claim Objections
Claims 1 and 13 are objected to because of the following informalities:
Claim 1 misspells the species “L. plantarum” as “L. planitarum”.
Claim 1 recites the bacteria L. casei, L. rhamnosus, L. plantarum, L. paracasei, and B. lactis. The genus names should be spelled out to align with standard nomenclature.
Claim 1 recites the limitation “wherein the probiotic mixture, prebiotic, and starch reducing enzyme are, collectively, a probiotic composition”. This limitation is redundant because the claim already recites that the probiotic composition comprises the probiotic mixture, prebiotic, and starch reducing enzyme. The “wherein” clause should be deleted due to this redundancy.
Claim 13 recites that the livestock feed is formed by adding the probiotic composition is added to the post-pelleting feed. The second phrase “is added” is redundant, so it should be deleted.
Appropriate correction is required.
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 5 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 5 a recites the probiotic mixture further comprises a Bifidobacterium, Bacillus subtilis, or Bacillus lichenformis, and mixtures thereof. It is not clear if the claim term “mixtures thereof” is intended to be further comprised in the probiotic mixture in addition to the Bifidobacterium, Bacillus subtilis, or Bacillus lichenformis listed immediately before it, or if the “mixtures thereof” are intended to be one of the alternative options, such that the limitation should read “wherein the probiotic mixture further comprises a Bifidobacterium, Bacillus subtilis, Bacillus lichenformis, or mixtures thereof”.
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.
Claims 1-5, 11-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman et al. (US 20210100854 A1, published 08 April 2021) in view of Noziere et al. (Amylase addition increases starch ruminal digestion in first-lactation cows fed high and low starch diets, J. Dairy Sci. 97 :2319–2328, 2014), as evidenced by Hong et al (Bacillus subtilis isolated from the human gastrointestinal tract, Research in Microbiology 160 (2009) 134-143).
Claim 2 recites the gastric-juice probiotic is “capable of surviving the gastric juices of pre- and/or post-hatching poultry and establishing a biofilm within pre- and/or post-hatching poultry GI tracts”, and claim 3 recites the heat-resistant probiotic is “capable of surviving a temperature of up to 180°F and establishing a biofilm after being exposed to a temperature of up to 180°F, said heat-resistant probiotics also capable of surviving a pelleting process”. These limitations of claims 2 and 3 are interpreted as being intended capabilities of the claimed probiotic mixture, but do not add any new method steps to the claimed method, or structural limitations to the probiotic mixture; thus, where all the method steps are taught in the prior art, instant claims 2 and 3 will be considered to be rendered obvious.
Regarding claims 1, 5 and 14, Goodman teaches a method of treating diseases by introducing a healthy bacteria biofilm that outcompetes pathogenic bacteria in a subject (Goodman [0168]), said method comprising administering a composition comprising a biofilm-generating bacteria and a prebiotic to livestock (Goodman [0166], claims 72 and 76-77). Goodman teaches the biofilm generating bacteria are selected from: L. casei , L. paracasei, L. plantarum, L. rhamnosus, B. lactis, other species of Bifidobacterium, Bacillus subtilis (Goodman claim 74-75). Goodman also teaches their composition comprises water-soluble carbohydrate starch (Goodman claim 77).
Goodman does not teach their composition comprises a complex starch reducing enzyme.
Noziere teaches that adding exogenous starch reducing enzymes such as amylase into animal feed can improve starch digestion in livestock (Noziere Abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to modify Goodman's method of administering an animal feed probiotic composition by adding an exogenous starch reducing enzymes such as amylase into animal feed in order to improve starch digestion in livestock, as suggested by Noziere. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because adding exogenous starch reducing enzymes such as amylase can improve starch digestion in livestock, as taught by Noziere. Thus, one of ordinary skill in the art would have concluded that adding an exogenous starch reducing enzyme into Goodman's animal feed composition comprising starch would be reasonably expected to improve the digestibility of the starch within Goodman's animal feed.
Regarding claims 2-4 and 11, Goodman and Noziere do not explicitly teach the probiotics to be gastric-juice- and/or heat-resistant, nor to be capable of biofilm formation in the GI tract. However, gastric juice and heat resistance of some probiotic organisms were already known in the art, including in spore-forming species such as Bacillus subtilis, as evidenced by Hong. Hong demonstrates that Bacillus subtilis strains were able to be isolated in the gastrointestinal environment, and thus have gastric juice resistance (Hong Abstract). Hong also demonstrates heat-resistance where samples were grown at 50°C (Hong Pg. 139 sec. 3.3), and treated at 65°C while still being recoverable, and spore suspensions were also treated at 68°C (Hong Pg. 135 sec. 2.1.1 and 2.3). Notably, Goodman teaches the species Bacillus subtilis to be a probiotic organism for their invention (Goodman claim 74-75 and Salomon [0378]).
Regarding claim 12, Goodman teaches their composition comprises 105 to 1011 CFU of biofilm-generative probiotic bacteria (Goodman [164]).
Claims 6-10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman in view of Noziere as applied to claims 1-5, 11-12, and 14 above, and further in view of Salomon et al. (US 20190352627 A1, published November 21, 2019), and as evidenced by Abdi et al. (Prebiotic Potential of Cereal Components, Foods 2021, 10, 2338).
Regarding claim 6, Goodman and Noziere do not teach that the animal feed composition comprises a pH modifier selected from the group consisting of citric acid, acetic acid, fumaric acid, glutamic acid, phosphoric acid, salts thereof, and mixtures thereof.
Salomon teaches an animal feed composition comprising one or more organic acids (Salomon claim 9), which include citric acid (citrate), acetic acid (acetate), and fumaric acid (Salomon [0394]). The organic acids taught in Salomon read on the instant claims’ recitation of a pH modifier because instant claim 6 attributes the taught organic acids to be pH modifiers.
Regarding claim 7, Goodman and Noziere do not teach that the animal feed composition comprises an enzymatic co-factor, said enzymatic co-factor is selected from the group consisting of: fat soluble vitamins, water soluble vitamins, divalent cations, and mixtures thereof.
Salomon teaches an animal feed composition comprising one or more vitamins and minerals (Salomon claim 9), including fat-soluble and/or water-soluble vitamins, as well as divalent cation minerals calcium and magnesium (Salomon [0398] and [0403]).
Regarding claim 8, Goodman and Noziere do not specifically teach a complex-starch reducing enzyme selected from the group consisting of: α-amylase, β-amylase, esterase, α-galactosidase, β-glucosidase, hemicellulose, invertase, lactase, β-mannase, pectinase, pullulanase, xylase, cellulase, xylosidase, β-glucanase, xyloglucanase, lipase, phytase, and mixtures thereof.
Salomon teaches an animal feed comprising one or more additional enzymes (Salomon claim 9), wherein the additional enzymes are complex starch reducing enzymes α-amylase, β-amylase, esterases, α-galactosidase, β-mannase, pectinase, pullulanase, xylanase, cellulase, xylosidase, β-glucanase, β-glucosidase, lipase, phytase, or any combination thereof (Salomon [0369]).
Regarding claim 9, Goodman and Noziere do not teach that the animal feed composition comprises a prebiotic selected from the group consisting of plant based oils, xylo-oligosaccharides, fructo-oligosaccharides, galacto-oligosaccharides, xylan, pullulan, gentibiose, polydextrose, lactitol, and mixtures thereof.
Salomon teaches their composition comprises plant-based materials including cereals such as barley, wheat, rye, oat, corn, rice, and sorghum (Salomon [0352]), which are known in the art to include high amounts of prebiotic compounds, including galacto- and fructo-oligosaccharides, as evidenced by Abdi (Abdi Introduction paragraph 3 and Table 1).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to modify Goodman and Noziere’s animal feed by adding (1) Salomon’s citric acid (citrate), acetic acid (acetate), and fumaric acid organic acids; (2) Salomon’s fat soluble and/or water soluble vitamins, and divalent cation minerals calcium and magnesium; (3) Salomon’s specific complex starch reducing enzymes α-amylase, β-amylase, esterases, α-galactosidase, β-mannase, pectinase, pullulanase, xylanase, cellulase, xylosidase, β-glucanase, β-glucosidase, lipase, and phytase; and (4) Salomon’s plant-based materials including cereals such as barley, wheat, rye, oat, corn, rice, and sorghum, which contain prebiotic material as evidenced by Abidi.
One of ordinary skill in the art would have been motivated to do so to improve the nutritional quality of the feed by including beneficial organic acids, vitamins, minerals, and prebiotics in the feed. There would have been a reasonable expectation of success because Salomon taught that these ingredients can be easily incorporated into animal feeds without issue, since Goodman and Noziere already taught that adding a complex starch reducing enzyme increases the digestibility of starches, one of ordinary skill in the art would have found it prima facie obvious prior to the effective filing date of the present invention to use Salomon’s specific complex starch reducing enzymes α-amylase, β-amylase, esterases, α-galactosidase, β-mannase, pectinase, pullulanase, xylanase, cellulase, xylosidase, β-glucanase, β-glucosidase, lipase, and phytase as one of those obvious complex starch reducing enzymes because Salomon taught that those complex starch reducing enzymes are able to be incorporated into an animal feed without issue.
Regarding claims 10 and 13, Goodman and Noziere do not teach that the probiotic composition is added to a pre-pelleting feed as a mash, or that the animal feed is formed by adding the probiotic composition to the post-pelleting feed as a wet or dry spray.
Salomon teaches their animal feed composition is in the form of a mash or a pellet (Salomon [22], [353], and claim 11). Salomon also teaches their pelleted animal feed is formed by either a) their liquid or solid probiotic composition is added before or during the feed ingredient mixing step prior to pelleting, or b) spraying their liquid or solid composition onto the food pellets after the pelleting step (Salomon [353]).
One of ordinary skill in the art would have found it prima facie obvious prior to the effective filing date of the present invention to manufacture Goodman and Noziere’s animal feed composition using Salomon’s methods of pelleting their animal feed by either a) adding their liquid or solid probiotic composition before or during the feed ingredient mixing step prior to pelleting, or b) spraying their liquid or solid composition onto the pellets after the pelleting step, as taught by Salomon (Salomon [353]). One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Salomon taught their animal feed manufacturing methods were able to create useful pelleted animal feeds that retain the desirable attributes of incorporated active ingredients.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander M Duryee whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/Alexander M Duryee/Examiner, Art Unit 1657
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