DETAILED ACTION
Applicant’s amendment submitted 9/29/2025 is acknowledged. Claim 1 is currently amended. Claim 51 is newly added. Claims 2-8, 11-14, 17, 26-38, 40-42, and 45-50 are canceled. Claims 1, 9-10,15-16, 18-25, 39, 43-44, and 51 are pending in the instant application.
Applicant is reminded of the proper submission of an amendment to include
appropriate markups (e.g. double brackets for deletions of five characters or less, etc.). See MPEP § 714.
Claims 9-10, 15-16, 19-25, 39, and 43-44 remain withdrawn pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 1, 18, and 51 are the subject of this office 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/29/2025 has been entered.
Priority
The instant application is a U.S. National Phase of PCT/IL2019/050095 filed on 1/23/2019 and claims Domestic Benefit to U.S. Provisional Patent Application No. 62/623,029 filed on 1/28/2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/8/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Applicant’s amendment to claim 1 renders moot the 35 U.S.C. § 112(a) new matter rejection previously set forth in the Final Rejection mailed on 5/28/2025. Accordingly, the rejection is withdrawn.
Applicant’s cancelation of claim 17 renders moot the 35 U.S.C. § 112(b) rejection of claim 17 previously set forth in the Final Rejection mailed on 5/28/2025. Accordingly, the rejection is withdrawn.
Claim Objections
Claims 1 and 51 are objected to because of the following informalities:
Claim 1 redundantly recites “emulsion” twice in lines 15 and 16.
Claim 51 redundantly recites “emulsion” twice in lines 13 and 14.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 18, and 51 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 51 recite new matter that was not previously disclosed. Claims 1 and 51 newly recite “a filler,” which is not disclosed in the specification as previously filed. No example discloses support for a filler as claimed and none of the support cited by Applicant for the claim amendments disclose a filler. Therefore, claims 1 and 51 recite new matter.
Claim 18 is also rejected for being dependent on a rejected base claim.
Claim Rejections - 35 USC § 112(b) – Indefinite
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.
Claims 1, 18, and 51 are 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 1 recites the limitation "said microbial strain" in lines 10-12. There is insufficient antecedent basis for this limitation in the claim. As currently amended, Claim 1 is drawn to a preparation comprising a microbial component consisting of 1 or 2 microbial strains including EVO33401 microbial strain or functionally homologous strain thereof as specified in claim 1. Since the microbial component consists of 1 or 2 microbial strains, it is unclear to which strain “said microbial strain” is intended to refer to in claim 1. Therefore, the metes and bounds of claim 1 cannot be determined, and claim 1 is indefinite.
Claim 51 recites the limitation "said microbial strain" in lines 8-10. There is insufficient antecedent basis for this limitation in the claim. As currently amended, Claim 1 is drawn to a preparation comprising a microbial component consisting of 1 or 2 microbial strains including EVO33394 microbial strain or functionally homologous strain thereof as specified in claim 1. Since the microbial component consists of 1 or 2 microbial strains, it is unclear to which strain “said microbial strain” is intended to refer to in claim 1. Therefore, the metes and bounds of claim 1 cannot be determined, and claim 1 is indefinite.
Claim 18 is also rejected for being dependent on a rejected base claim and failing to remedy the issues set forth above.
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.
Claims 1, 18, and 51 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Claim 1 recites a preparation comprising: a carrier and a filler; and a microbial component consisting of 1 or 2 microbial strains including an EVO33401 microbial strain, deposited as Accession Number 42923 at NCIMB or a functionally homologous strain, wherein said functionally homologous strain has at least 99.5% sequence identity to a genome of said EVO33401 microbial strain or at least 99.5% sequence identity to a 16S sequence of said EVO33401 microbial strain; and wherein the preparation improves yield of a cultivated plant heterologous to said microbial strains or said functionally homologous strains as compared to a control plant not treated with said microbial strains or said functionally homologous strains, and wherein said microbial strain or said functionally homologous strain is present in the preparation at a concentration of at least 107/gr or 107/ml and wherein the preparation is in a form selected from the group consisting of an emulsion, a colloid, a dust, a granule, a pellet, a powder, a spray, or a solution. Claim 51 differs from claim 1 in that claim 51 recites an EVO33394 microbial strain, deposited as Accession Number 42928 at NCIMB or a functionally homologous strain, wherein said functionally homologous strain has at least 99.5% sequence identity to a genome of said EVO33394 microbial strain or at least 99.5% sequence identity to a 16S sequence of said EVO33394 microbial strain instead of the EVO33401 microbial strain of claim 1. The preparation of the claimed invention is directed to a product of nature without significantly more because the preparation comprises naturally-occurring microbial strains without significantly more. This judicial exception is not integrated into a practical application because the additional limitations are not meaningful limitations that apply the judicial exception. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements do not meaningfully integrate the judicial exception.
The microbial strains of the claimed invention were isolated from nature, and thus are naturally-occurring, as disclosed in the instant specification (see p.60-61, Example 1, p.61, lines 16-17, Table 1). The microbial strains were sourced from plants sampled from various relevant habitats across Israel. Example 1 further explains that the inventors assumed that plants growing in the wild are dependent on functions provided by their microbiome for survival and reproduction, and in contrast, domesticated plants are nurtured by farmers and therefore do not need the full extent of microbiome functions and therefore are not a good source for beneficial microbial strains (see p.60, lines 25-28). Additionally, the inventors assume that native plants to Israel, such as wheat and other native wild cereals, co-evolved with the local microbial diversity to exploit the functional diversity available for their survival and reproduction, and therefore are a better source for microbial strains with plant bio-stimulatory activity than non-native plants (see p.61, lines 7-10). Furthermore, the specification discloses that microbial strains were sourced from several sources combining one or more of the assumptions set forth in Example 1 and as disclosed in Table 1 (see p.61, lines 11-13). Table 1 shows that EVO33394 was isolated from the rhizosphere of Atriplex halimus, a wild plant, and that EVO33401 was isolated from the seed coat of Triticum aestivum, a landrace (domesticated) plant. Thus, the microbial strains of the claimed invention are naturally-occurring as disclosed in the specification. The characteristics of the claimed microbial strains are not markedly different from the product’s naturally-occurring counterpart in its natural state, because the claimed microbial strains are not altered in a meaningful way so as to integrate the judicial exception. The addition of a carrier and filler do not meaningfully alter the microbial strains of claims 1 and 51 and do not impart markedly different structural or functional characteristics to the naturally-occurring products. The additional elements of “improves yield of a cultivated plant heterologous to said microbial strains or said functionally homologous strains as compared to a control plant not treated with said microbial strains or said functionally homologous strains, and wherein said microbial strain or said functionally homologous strain is present in the preparation at a concentration which exceeds that found in nature” fail to add meaningful limitations to the judicial exception identified above. The limitation of improving a yield of a cultivated plant is a natural phenomenon of the naturally-occurring microbial strains, as disclosed in the specification, and thus does not meaningfully integrate the judicial exception. Moreover, improving a yield of a cultivated plant is not required as the claimed invention is a composition and not a method. The concentration of the microbial strains does not impart any markedly different structural or functional characteristics to the naturally-occurring products. The form of the preparation (i.e. an emulsion, a colloid, a dust, a granule, a pellet, a powder, a spray, or a solution) do not appear to meaningfully integrate the judicial exception nor structurally or functional alter the naturally-occurring products of the claimed invention. The specification has not disclosed any markedly different characteristics that are the result of a preparation as recited in claims 1 and 51. Therefore, claims 1 and 51 as a whole are directed to a judicial exception of a product of nature without significantly more.
Claim 18 recites “being soil-free” which fails to meaningfully integrate the judicial exception in any way. Thus, the claim is directed to a natural product without significantly more.
Response to Arguments
Applicant's arguments filed 9/29/2025 have been fully considered but they are not persuasive.
In Applicant’s Remarks, see p.7, last paragraph-paragraph bridging p.8-9, Applicant argues the inventions of claims 1 and 51 are directed to man-made preparations having markedly different structural and functional characteristics than any naturally occurring counterpart since they include a carrier and a filler, neither of which are found in nature in conjunction with the strains, are in concentrations of at least 107/gr or 107/ml, and are limited to an emulsion, colloid, granule, pellet, powder, spray or solution. Applicant further argues the strains occur sporadically and at low, variable concentrations in their natural habitats. Applicant further argues the claimed preparations require human intervention to achieve controlled concentrations, to combine microorganisms with carriers and fillers, and to present them in defined pharmaceutical or agricultural forms. Applicant further argues that Tables 3, 4, 6, 8, 9, and 29-41 demonstrate that the claimed preparations provide functional characteristics not found in nature when applied to cultivated plants that are heterologous to the plant. Applicant further argues the combination of defined strains at non-natural concentrations with carrier and fillers results in preparations with new and useful properties. Applicant further argues that the preparations are designed for agricultural use to improve yield of cultivated plants and are patent eligible. This is not found persuasive. Applicant has not demonstrated any markedly different structural or functional characteristics of the naturally-occurring microbial strains EVO33401 or EVO33394 that arise as a result of the claimed preparations. The improvement of yield of a cultivated plant heterologous to the microbial strains is not commensurate in scope with the claimed invention. The claimed invention is to a composition and not to a method of improving a yield of a cultivated plant heterologous to the microbial strain. Furthermore, Tables 3 and 4 of the specification discloses results for early vigor and biomass establishment and stem conductance traits in Zea maize (corn) cultivated with EVO33394 and are silent with regards to EVO33401. Table 6 discloses improvement of corn photosynthetic capacity and leaf transpiration rate when cultivated with EVO33401 but is silent with regards to EVO33394. Tables 8 and 9 disclose Brachypodium distachyon cultivated with EVO33401 improves plant height, vegetative dry weight, total dry matter, spikelets dry weight, total grains yield per plant, and grain number and is silent with regards to EVO33394. Table 29 demonstrates that EVO33394 and EVO33401 possess nitrogen fixation capabilities. Table 30 demonstrates that EVO33401 possesses phosphate solubilization capabilities and is silent with regards to EVO33394. Table 31 does not list either of the claimed microbial strains. Table 32 reveals the biofilm formation capabilities of EVO33394 and EVO33401. Tables 33-41 demonstrate the carbon utilization of the strain EVO33401 and are silent with regards to EVO33394. The specification does not support Applicant’s claim that a preparation of the inventions of claims 1 and 51 broadly improve the yield of a cultivated plant heterologous to the strains EVO33394 and EVO33401 nor does the specification disclose any structural or functional characteristics that are changed in the naturally-occurring strains by including a carrier and filler, a concentration of 107/gr or 107/ml, and are limited to an emulsion, colloid, granule, pellet, powder, spray or solution. Therefore, the claimed inventions are directed to the judicial exception of a product of nature without significantly more.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN PAUL SELWANES whose telephone number is (571)272-9346. The examiner can normally be reached Mon-Fri 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.P.S./Examiner, Art Unit 1657
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1657