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
Status of Claims
Claims 1-44 and 52-71 are cancelled. Claims 45-51 and 72-84 are pending and currently under examination and the subject matter of the present Office Action.
Objection
Claim 81 is objected to under 37 CFR 1.75 as being a substantial duplicate of Claim 46. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). In this instant application, Claim 46 recites “wherein the DFMs exhibit decreased settling and/or survival in the water line compared to identical DFMs that are not administered in the composition; Claim 81 recites “wherein the DFMs exhibit decreased settling and/or improved survival in the composition compared to identical DFMs that are not in a composition comprising a buffer sufficient to maintain pH of water at about or greater than about 6.5.” Both claims depend from Claim 45, which recites “composition comprising a) a buffer sufficient to maintain pH of water at about or greater than about 6.5…through a water line…” As such, Claims 46 and 81 are essentially the same.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 46 and 81 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 46 and 81 recite relates properties that would be observed from the claimed administration of the DFM-containing composition. These claims do not further limit Claim 45 from which they depend because they do not add features that narrow the scope of the parent claim. Regardless of the recitation of its name/role/use, a method claim is examined based on the steps and not by what results manifest from its use.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 45-47, 50-51 and 72-83 are rejected under 35 U.S.C. 103(a) as being unpatentable over Rehberger et al. (US 10,201,574 B1), hereinafter Rehberger, in view of Kiarie et al. (WO 2017/083196 A1), hereinafter Kiarie, and Yan et al. (CN 103583896 A, machine translation from IP.com).
Rehberger discloses methods of administering Bacillus strains to poultry to improve bacterial homeostasis in the gastrointestinal tract, thereby facilitating weight gain and improved feed conversion (Abstract; Claim 1).
Regarding Claim 45, Rehberger teaches administration of the bacteria to the animal is in the form of a direct fed microbial (DFM) composition, which is dosed through the drinking water line (Col. 4, lines 56-60; Col. 6, lines 54-63). Rehberger expressly teaches administration to poultry (Example 6).
Rehberger does not expressly teach the DFM-containing composition also comprises a buffer sufficient to maintain the pH of water at about or greater than about 6.5.
Kiarie similarly discloses a feed additive composition consisting essentially of a DFM, with at least one protease, and is suitable for poultry (p. 24, lines 29-31). The DFMs of Kiarie include strains of Bacillus pumilis, Bacillus licheniformis, Lactobacillus reuteri, and a 3-strain Bacillus combination consisting of 3 strain of B. subtilis (p. 59, lines 5-7). Kiarie teaches embodiments wherein the DFM is diluted with a diluent, such as starch powder, lime stone or the like; and for liquid formulation of the composition, it is preferred that the liquid consumption contains one or more of the following: a buffer, salt, sorbitol and/or glycerol (p. 19, lines 4-8). Kiarie teaches cultivating the different cultures, which comprises a step of diluting the culture with media and 100 mM MES buffer, pH 6.2 (pp. 59-60). The pH of 6.2 is about 6.5. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05.
Kiarie does not expressly teach a motivation to incorporate buffer except indicating that it is preferred in liquid formulation. Yan is in a related field and provides the motivation in using buffer systems in the drinking water containing DFMs for chicken. Yan discloses a method for delivering a composition comprising DFM to poultry through drinking water, wherein the composition comprises yeast extract, saccharomyces and a buffer system comprising citrate, citric acid etc. (Abstract; Claim 1). Yan relates that the drinking water as having no precipitate, and is stable (p. 2, 2nd to last paragraph). Yan further teaches at pH 4-7, the propagation of harmful intestinal tract bacteria is suppressed, while the beneficial bacterium increases, which results in improved immunity of the chicken, improved meat production etc. (p. 2, last paragraph to p. 3, 1st paragraph).
Using buffer in the composition comprising DFM for animal administration is known in the art, as Kiarie and Yan have shown. As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine Kiarie and Yan with Rehberger and use buffer in the composition of Rehberger to maintain the pH of water and prevent precipitation, as well as get additional benefits such as suppression of the growth of harmful bacteria.
Regarding Claims 46 and 81, Rehberger has taught the water line (Col. 6, lines 54-63). Yan has taught that using buffer prevents precipitation and increases DFM propagation, which reads on the claimed feature of DFMs exhibit decreased settling and/or survival in the water line compared to identical DFMs that are not administered in the composition (p. 2, last 2 paragraphs to p. 3, 1st paragraph).
Regarding Claim 47, Rehberger teaches administration of DFM concentrate by adding it to the drinking water system via a proportioner and diluted into the nipple drinkers (Col. 8, 41-52).
Regarding Claims 50-51, Rehberger teaches the method is for chicken and turkey, and expressly relates the effect of Bacillus DFM composition on the pathogen load of turkeys (Example 6; Claims 2-3).
Regarding Claims 72 and 74, Rehberger teaches freeze-dried Bacillus DFM is added to a carrier, such as starch and gums (Col. 8, line 55-Col. 9, line 3).
Regarding Claim 73, Rehberger does not teach a specific type of gum. However, Kiarie teaches using that other components suitable for animal consumption and is capable of providing a medical or physiological benefit to the consumer may be included such as prebiotics (p. 30, line 21-28). Prebiotics are typically non-digestible carbohydrate or a sugar alcohol which is not degraded or absorbed in the upper digestive tract, which includes inter alia xanthan gum (p. 30, line 21-28). One would have been motivated to add xanthan gum because Rehberger already identified gum as a useful carrier for DFM, and Kiarie has identified xanthan gum to be a prebiotic suitable for animal consumption and is capable of providing a medical or physiological benefit.
Regarding Claim 75, Rehberger teaches using cryoprotectant prior to freeze-drying (Col. 9, lines 10-20).
Regarding Claims 76-77, Kiarie has taught the dilution of the bacterial culture with 100 mM MES buffer as discussed supra (p. 60, 2nd and 3rd paragraphs).
Regarding Claims 78-80, Rehberger teaches the DFM is selected from the group consisting of Bacillus subtilis, Bacillus licheniformis, Bacillus pumilus, Bacillus amyloliquefaciens, Bifidobacterium spp, Lactobacillus acidophilus, Lactobacillus farciminus, lactobacillus rhamnosus, Lactobacillus reuteri, Megasphaera elsdenii, Propionibacteria sp etc. and combinations thereof (Claims 1-5).
Regarding Claim 82, Rehberger does not expressly teach a means for inactivating chloramine or chlorine. However, Yan teaches vitamin and amino acid are functional additives. The instant Specification recites Vitamin C and amino acid neutralize chlorine compounds in water ([0166], [0168]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to add the functional additives in the DFM-containing composition according to the method of Rehberger for poultry consumption of these functional additives.
Further, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in fact situation of the instant case. At page 234, the Court stated as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected and useful function. In re Benjamin D. White, 17 C.C.P.A. (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Regarding Claim 83, Rehberger teaches polysorbate 80 (Col. 8, line 62 to Col. 9, line3 ). Applicant has identified polysorbates as wetting agent [0170].
Claims 48-49 are rejected under 35 U.S.C. 103(a) as being unpatentable over Rehberger in view of Kiarie and Yan, as applied to Claim 45, and in further view of Little et al. (Animals 11.8 (2021): 2362), hereinafter Little.
Rehberger is silent with regards to the distance of the water line.
Little teaches piped water system for growing pigs, wherein the water system is also used to medicate pigs with antimicrobials to keep them healthy and productive (Abstract). Little tracked the antimicrobial concentration in water available to pigs and relates that the water system’s design and the pigs’ water usage and drinking patterns had a large influence on water flow and (Abstract). The parameters Little studied included distance of drinkers from the dosing pump, which is indicated according to the outlet node distance (Table 1). The nodes were distributed at distances ranging from 28.5m to 220.5m (Table 1). Little discloses that the distance from the junction where water entered the loop to the furthest junction on the right arm was 115.6 m and the distance on the left arm was 105.8 m. (p. 9, 1st paragraph). This resulted to an imbalance in the number of pigs drawing water from the right arm vs. the left arm (p. 9, 1st paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Little with that of Rehberger and use a water line with varying distances of nodes from which the poultry of Rehberger can drink the DFM liquid composition, and optimize the distance of the water line and the nodes depending on multiple factors including number of chickens/turkey, desired dosing etc.
Claim 84 is rejected under 35 U.S.C. 103(a) as being unpatentable over Rehberger in view of Kiarie and Yan, as applied to Claim 45, and in further view of Guerino et al. (US 2004/0247568 A1), hereinafter Guerino.
Rehberger is silent with regards to the claimed temperature.
Guerino also teaches administering feed additives and formulation comprising DFM (Abstract; Claims 1 and 10). Guerino comprehends that bacteria are sensitive to environmental conditions inter alia temperature extremes [0004]. Guerino teaches an embodiment wherein the DFM dispersed in a liquid carrier, and stored at a controlled temperature that allow the direct-fed microbial to remain viable, e.g. about -1.1 ° C-12.8° C, 1.7° C-10° C, and still more preferably at about 4.4° C-7.2°C; when it is applied, the DFM composition is diluted [0027].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine Guerino with Rehberger and store the DFM at the temperatures Guerino has taught in order to ensure viability.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached on M-F, 10-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached on (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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