DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Claim Amendments
2. The amendment filed Nov 17, 2023 has been entered. Claims 3-11 have been amended. Claims 1-11 are under consideration in this Office Action.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on Nov 17, 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
4. Claims 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 1-8 are determined to be directed to natural products and do not recite something “significantly different” than the natural product. Natural products are “judicial exemptions”. The rationale for this determination is explained below: The claims are drawn to a composition comprising: Bacillus spores suspended in water and an organic acid with a pKa lower or equal than 5 or a mixture of the organic acid and a salt of the organic acid.
The Bacillus spores are naturally occurring strains in water. Naturally occurring Bacillus spores are abundant in soil worldwide, with other natural habitats including the air, water, and the gastrointestinal tracts of various animals. Naturally occurring organic acids include citric acid in citrus fruits, malic acid in apples, lactic acid in fermented milk products, and acetic acid in vinegar. Other examples are tartaric acid found in grapes and formic acid produced by ants. These compounds are prevalent in plants and animals, and some are byproducts of fermentation processes.
Thus, all of the ingredients are therefore not markedly different from their counterparts found in nature. Furthermore, there is no structural difference because of the mere aggregation of natural occurring Bacillus spores and organic acid, because the composition does not change the structure of the naturally occurring Bacillus spores and organic acid. Additionally, the product claims as a whole do not recite something significantly different from the judicial exceptions because the additional components do not impose meaningful limits on the claim scope therefore substantially all practical applications of the judicial exception are covered. Moreover, the additional elements in dependent claims are all recited at a high level of generality, and/or are well-understood, purely conventional and routine in the field, and/or are merely appended to the judicial exception without a significant change in the structure of the judicial exception itself as evidenced by the prior art recited within the rejections. If the applicant chooses to amend the instant claims, the examiner recommends that applicant consider the U.S. Supreme Court ruling that the additional steps should consist of more than well-understood, routine, conventional activity already engaged in by the scientific community. Such putative additional steps, when viewed as a whole, might add nothing significant beyond the sum of their parts taken separately. The Court has made clear that to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words "apply it." Essentially, appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June 13, 2013). Also see the December 4, 2014 and May 4, 2016 Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products (the Guidance). Based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are held to claim a law of nature and natural products, and are therefore rejected as ineligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102 & 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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
5. Claims 1-8 and 11 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Jeffries et al. (WO2021022128 published 2021-02-04; priority to Aug 19, 2019).
The claims are drawn to a disinfection composition for surface, comprising: Bacillus spores suspended in water and an organic acid with a pKa lower or equal than 5 or a mixture of the organic acid and a salt of the organic acid.
Jeffries et al., disclose preservation solutions for stabilizing at least one microbial species, stable aqueous microbial compositions, and agronomic applications using the compositions [abstract]. The stable aqueous microbial composition comprising: (a) at least one microbial species, (b) at least one preservative agent, (c) at least one suspending agent, and (d) a buffering agent in an amount sufficient to maintain the composition at a pH greater than 4.2 [para 5]. The composition comprises about 0.01 wt% to 10.0 wt% preservative agent [para 9]. Thus teaching claim 7-8. In some embodiments, the preservative agent is an organic acid having a molecular weight of no more than 200 and at least one pKa greater than 4.2 [para 9]. The organic acid is acetic acid, citric acid, ascorbic acid, sorbic acid, propanoic acid, butyric acid, oxalic acid, succinic acid, malic acid, tartaric acid, fumaric acid, aconitic acid, dipicolinic acid, an amino acid, or a combination thereof [para 16]. Thus teaching claims 4-5. The preservation solution or stable aqueous microbial composition can include about 0.05 wt% to about 1 wt% low molecular weight organic acid [para 58]. Thus teaching claims 3 and 6.
The at least one microbial species includes Bacillus [para 24]. FIG. 1 is a graph showing stability of liquid mixture of B. subtilis, B. amyloliquefaciens, B. licheniformis, and B. pumilus endospores [para 34]. Spores or whole microorganisms, including harvested and/or lyophilized microbial colonies containing spores, are added to the preservation solution, which promotes long-term storage stability across a broad range of conditions [para 92]. The solutions can be formulated for use in agricultural applications requiring viable microbial spores and/or colonies. Water miscible dry powders and/or granules such as lyophilized preparations of spores and/or colonies are preferred in many embodiments [para 92].
Thus describing claim 1. The stable aqueous microbial composition has a microbial concentration from about 1X106 to about 1X1012 CFU/mL [para 92Thus describing claim 2.
The composition comprises about 0.01 wt% to 10.0 wt% suspending agent In some embodiments, the suspending agent is can be a surfactant [para 20]. Thus describing claims 7-8.
The stable aqueous microbial composition may be combined with other agrochemicals such as fungicides, herbicides, or insecticides in a tank mix and applied via spray application. The stable aqueous microbial composition may also be applied via foliar application [para 98]. Thus teaching claim 11.
It is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claims.
In the case where the claimed ranges overlaps ranges disclosed by the prior art a prima facie case of obviousness exists. Therefore Jeffries et al., anticipates and/or makes obvious the rejected claims.
Claim Rejections - 35 USC § 102/103
6. Claims 1, 3-8 and 10-11 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Schalitz et al. (WO 2003002704 published 2003-01-09; priority to June 27, 2001).
The claims are drawn to a disinfection composition for surface, comprising: Bacillus spores suspended in water and an organic acid with a pKa lower or equal than 5 or a mixture of the organic acid and a salt of the organic acid.
Schalitz et al., describe an aqueous cleaning composition comprising: an effective mineral dissolving amount of an organic acid of at least 5% by weight of the cleaning compositions; an effective amount of a spore forming microbial composition; an effective cleaning amount of a blend of wetting agents; an effective amount of a thickening agent and water [abstract]. Also described is a method of cleaning a soiled hard surface comprising applying the above composition to the surface and drying the surface thereby cleaning the surface. The composition is particularly useful for the overall desires of the present application for cleaning and disinfecting hard surfaces [Summary of Invention]. Thus teach claim 11.
The present invention utilizes an effective amount of a spore forming microbial composition. The biological products that are desirable in liquid or lyophilized form and are generally based upon the bacteria from the genus Bacillus. These organisms are preferred because they are easy to be formulated due to their ability to go into a dormant spore state. In addition, the organic degradation abilities of certain species within the Bacillus genus are appropriate for the types of applications described herein for cleaning purposes. The bacterial content of the formulations as described herein are desirable based upon their stability in the presence of the other components of the formulation, in particular, the antimicrobial quaternary and/or organic acid materials. Preferred organisms are Bacillus amyloliquefaciens, Bacillus licheniformis, Bacillus megaterium and Bacillus subtilis. The invention is a ready-to-use thickened natural acid bowl cleaner/disinfectant that incorporates viable microbial spores for augmentation of downstream wastewater treatment systems. [DESCRIPTION OF PREFERRED EMBODIMENTS]. Thus teaching claim 1.
Schalitz et al., describes the Table of page 8 to comprise organic acid at 1%-10%. The table at 15 shows Citric Acid, an organic acid commonly known to have a pKa of 3.13 with an amount of 0.1% to 4.0% having a purpose of cleaning and disinfecting. The same table shows at thickener with an amount of 0.1 to 2.0%; trace amounts of fragrance and preservative and surfactants at 1 to 10%. Thus teaching claims 3 and 6-8.
The organic acids that may be utilized are mono or polycarboxylic acids such as those having from 1-12 carbon atoms such as ethanoic, butanoic, hexanoic, dexanoic acid and the like or polycarboxylic acid such as citric acid, glycolic, lactic acid, and the like [page 18]. Thus teaching claim 5.
An additional component utilized in the disinfectant cleaning composition of the present invention is a surfactant. The use of surfactants is to assist in decreasing the surface tension of water and remove soils from the substrate. A particularly desirable group of surfactants are those that maintain the stability of the cationic disinfectant and the microbiological materials. The surfactants that are preferably utilized are non-ionic and amphoteric materials. These materials provide efficient wetting of the substrate to be cleaned, emulsification of oily soils and are ionically compatible with the cationic components of the cleaning composition. Non-ionic materials that may be utilized include alkyl polyglucosides and preferably linear alcohol ethoxylates [page 18-19]. Suitable thickening agents include ethoxylated soyamine.
The surfactants used are a combination of both high and low HLB linear alcohol ethoxylate blended ratio. This system provides improved wetting and emulsification characteristics over most single surfactant systems. Other nonionic surfactants and most amphoterics are also compatible with the system and possible materials for use. In formulations not incorporating cationic antimicrobials, anionic surfactants such as sodium lauryl sulfonate and sodium dodecylbenzene sulfonate can be utilized. [DESCRIPTION OF PREFERRED EMBODIMENTS]. Thus teaching claim 7 and in part 10. Various amide chemistries, amine oxides and nonionic associative thickeners can be utilized [DESCRIPTION OF PREFERRED EMBODIMENTS].
It is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claims.
In the case where the claimed ranges overlaps ranges disclosed by the prior art a prima facie case of obviousness exists. Therefore Schalitz et al., anticipates and/or makes obvious the rejected claims.
Claim Rejections - 35 USC § 102
7. Claims 1, 5, 7 and 9 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Cho et al., (WO2017010945 published 2017-01-19; priority to 2015-12-04).
Cho et al., describe whole spores engineered to capsulate a compound(s) or substance(s). In certain embodiments, the whole spore encapsulating the compound(s) or substance(s) is coated with or co-encapsulated with a hydrogel or other agent(s) to control the rate release of the compound(s) or substance(s) from the spore [abstract]. In one embodiment, an whole spore is a Bacillus subtilis spore [para 21]. In certain embodiments, the solvent is water [para 111]. A compound(s) and/or substance(s) for encapsulation in whole spores is a flavour. In some embodiments, flavours include natural flavoring substances, nature-identical flavoring substances, or artificial flavoring substances. In some embodiments, flavours are sour additives, such as organic acids [para 125]. A flavoring agent can be citric acid [para 186]. In certain embodiments, a compound(s) and/or substance(s) for encapsulation in whole spores is a phytochemical. Examples of phytochemicals include organic acids [para 130]. A stabilizer can be citric acid or acetic acid [para 186]. A preservative can be sodium benzoate [para 186].
It is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claims.
Therefore, Cho et al., anticipates the rejected claims.
Pertinent Art
8. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
WO2013162926 teach aqueous hard surface cleaner compositions comprising castor oil ethoxylates.
US 20200038316 (Rodolfi et al.,) teach a detergent product for cosmetic use, comprising: a base compound having a detergent action selected from the group consisting of PEG-6-caprylic/capric glycerides, sodium laureth sulfate, sodium lauryl sulfate, acrylates/steareth-20 methacrylate copolymer, phenoxyethanol, ethylhexylglycerin, potassium hydroxide or a mixture thereof;
spores of probiotic bacteria of the Bacillus genus spores mixed with the base compound wherein the spores are at a concentration of 103 CFU/ml.
See also EP3170392 (Wilson et al).
Mulder et al., (WO2018229236 published 2018-12-20; priority to 2018-06-14).
Mulder et al., describe A composition comprising: (i) a Bacillus bacterial strain, and (ii) one or more organic acids and sodium benzoate.
Gantz et al., (US20180140540 published 2018-05-24; priority to Nov 23, 2016). Gantz et al., describe a topical cleansing composition includes about 0.005 wt. % to 15.0 wt. % of an active ingredient that is one or more of a probiotic, probiotic derivative, prebiotic, and at least one primary and at least one secondary surfactant. [abstract]. In some exemplary embodiments, the active ingredient is a probiotic or probiotic derived ingredient, which can be strains and derivatives of Bacillus. In some exemplary embodiments, the probiotic or probiotic derived ingredient is a Bacillus ferment [para 09]. Bacillus can be either aerobic or, under certain conditions, anaerobic and produces endospores. Bacillus exhibits a wide range of physiologic properties that allows it to thrive in a number of different habitats—most Bacillus strains are resistant to heat, cold, radiation, and disinfectants [para 32]. Many different types of preservatives are envisioned as being applicable in the current topical composition. Non-limiting examples of preservatives include organic acids [para 75]. Organic acids, such as citric acid, lactic acid, formic acid, acetic acid, propionic acid, butyric acid, caproic acid, oxalic acid, maleic acid, benzoic acid, carbonic acid, and the like [para 83]. Some examples of acceptable deposition enhancers include sodium lauryl sulfate (SLS) [para 70].
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Vanessa Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANA A HINES/Primary Examiner, Art Unit 1645