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 .
Claim Amendments
2. The amendment filed July 20, 2026 has been entered. Claims 1, 4, and 9-10 have been amended. Claims 5-7 have been cancelled. Claims 1-4 and 9-11 are under consideration in this Office Action.
Withdrawal of Rejections
3. The rejection of claims 5-7 under 35 U.S.C. 101; is withdrawn in view of Applicants amendments and cancellation of the rejected claims.
4. The rejection of claims 5-7 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and/or 102(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Jeffries et al; is withdrawn in view of Applicants amendments and cancellation of the rejected claims.
5. The rejection of claims 1, 3-8 and 10-11 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102(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Schalitz et al., is withdrawn in view of Applicants amendments.
6. The rejection of claims 1, 5, 7 and 9 under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Cho et al., is withdrawn in view of Applicants amendments.
Maintained Grounds of Rejection
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.
7. Claims 1-4 and 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 1-4 and 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 disinfection composition for surface, comprising: Bacillus spores suspended in water and an organic acid with a pKa lower or equal than 5, wherein the organic acid is selected from the group consisting of lactic acid, butyric acid, ascorbic acid, salts thereof, and mixtures thereof; wherein the composition has a pH between 3 and 4.5; and wherein the composition further comprises a preservative, a surfactant, a fragrance, and/or a thickener.
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 lactic acid in fermented milk products. Vitamin C, also known as L-ascorbic acid, is a water-soluble vitamin that is naturally present in some foods, added to others, and available as a dietary supplement. Butyric acid’s natural occurrence in dairy products makes it useful in the food industry, while its reactivity with alcohols and other compounds makes it valuable in manufacturing esters and other chemical intermediates. Natural preservatives, such as salt, vinegar, acetic acid, ascorbic acid, herbs and spices and celery juice are substances derived from plants, animals, fungi, and microbes that prevent spoilage and extend shelf life. A thickening agent, such as starches, pectin, seaweed extracts, gums, and/or animal proteins, is a natural or processed substance that increases the viscosity of a liquid without changing its other properties. A surfactant thickener, such as salt or sodium chloride is a specialized additive used to increase the viscosity and improve the texture of soap, shampoo, and body wash formulations.
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.
Response to Arguments
8. Applicant's arguments filed July 20, 2026 have been fully considered but they are not persuasive.
Applicants assert that the dual functional profile is materially different from the naturally occurring qualities of the components. However, Applicants arguments were not persuasive because the preservative only functions as it naturally does. The naturally occurring salt preservative will naturally draw water out of microbial cells, dehydrating bacteria and fungi. The Bacillus spores will naturally exhibit an antimicrobial action. Natural preservatives, such as salt, vinegar, acetic acid, ascorbic acid, herbs and spices and celery juice are substances derived from plants, animals, fungi, and microbes that prevent spoilage and extend shelf life. A thickening agent, such as starches, pectin, seaweed extracts, gums, and/or animal proteins, is a natural or processed substance that increases the viscosity of a liquid without changing its other properties. A surfactant thickener, such as salt or sodium chloride is a specialized additive used to increase the viscosity and improve the texture of soap, shampoo, and body wash formulations. Applicants have presented no materially different qualities, then what their naturally occurring qualities are. Therefore, Applicants are not found persuasive and the rejection is maintained.
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.
9. Claims 1-3, 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, wherein the organic acid is selected from the group consisting of lactic acid, butyric acid, ascorbic acid, salts thereof, and mixtures thereof; wherein the composition has a pH between 3 and 4.5; and wherein the composition further comprises a preservative, a surfactant, a fragrance, and/or a thickener.
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 is at a pH of about 4.3 [para 29]. The pH of the aqueous composition is selected to maximize shelf life of the spores and/or colonies stored in the aqueous composition for extended periods. pH’s less than about 4 may have a detrimental effect on stability of certain bacterial spores at elevated temperatures. For example, Bacillus spores can demineralize at low pH, losing their resistance to high temperature storage. Therefore, a pH greater than about 4.2 is desirable for improving the biological stability of Bacillus spores [para 74]. The microbial composition has a pH in the range of 4.5 [para 95].
The composition comprises about 0.01 wt% to 10.0 wt% preservative agent [para 9]. Thus teaching claim 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 ascorbic acid and/or butyric acid, or a combination thereof [para 16]. Thus teaching claims 4. 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 claim 3. In some embodiments, the polymer is polyethylene glycol [para 21].
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 claim 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 of being a disinfection composition, 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.
Response to Arguments
10. Applicant's arguments filed July 20, 2026 have been fully considered but they are not persuasive.
Applicants assert that Jeffries does not disclose the specific combination of: (i) a surface disinfection composition; (ii) Bacillus spores suspended in water; (iii) the presently selected organic acid system; (iv) a pH between 3.0 and 4.5; and (v) the recited formulation components. Contrary to Applicants assertion, Jeffries et al., clearly and specifically teach Jeffries et al., teach the surfactant includes a mixture of 38.0-42.0% water [para 66]. 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]. Example 1, teaching the preparation of Bacillus endospores where bacterial culture was added to 100 mLs of distilled deionized water, thus teaching Bacillus spores suspended in water. Jeffries et al., teach the stable aqueous microbial composition comprising an organic acid which is ascorbic acid and/or butyric acid [para 16[; thus teaching the organic acid. Jeffries et al., teach the composition at a pH greater than 4.2 and a pH 4.3. Finally, Jeffries et al., teach at least one preservative agent and/or a buffering agent, [para 5]; Therefore, each and every limitation is taught by Jeffries et al.
Applicants argue that Jeffries teaches such systems in the context of maintaining microbial stability for agricultural use and the intended purpose of the organic acid. In response to applicant's argument, 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 claim. In this case, there is no structural difference between the bacillus spores in water, organic acid and a preservative and/or buffering agent(s) between the composition of Jeffries et al., and the claimed composition.
Therefore, neither of Applicants arguments were found persuasive; thus the rejection is maintained.
Pertinent Art
11. 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].
12. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
13. 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 Peter Paras, can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/JANA A HINES/Primary Examiner, Art Unit 1645
Prosecution Insights