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 .
Information Disclosure Statement
2. The information disclosure statements (IDS) submitted on 06/22/23; 08/02/23; 08/22/23; 04/22/24; 04/26/24; 10/01/24; 06/09/25; 10/28/25; and 12/11/25 were filed and entered. The submissions are in compliance with the provisions of 37 CFR 1.97 and have been considered by the Examiner.
Election/Restrictions
3. Applicant’s election, without traverse, of Group 1 and SEQ ID NO:3, in the reply filed on 12/01/25, is acknowledged.
Claim Status
4. The amendment, filed 12/01/25, has been entered. Claims 1-5 and 10-16 are pending and under examination. Claims 6-9 and 17-51 are cancelled. Claim 1 is amended.
Claim Objections
5. Claim 1 is objected to because of the following informalities: improper formatting. MPEP 608.01(m) states that “Each claim begins with a capital letter and ends with a period”. However instant claim 1 also uses periods to separate the required elements (e.g. “a.” line 2); therefore, the periods should be removed and only the period at the completion of the claim should remain. The office suggests the use of parenthesis (e.g. “(a)”). Appropriate correction is required.
6. Claim 1 is also objected to because of the following informalities: improper recitation of species names. Latin names of microorganisms are properly recited with the genus name (i.e. first part of binomial identifier) capitalized and species name (i.e. second part of binomial identifier) in lower case, with both in italics, and having the genus name spelled out upon first usage, in order to be understood without requiring reference to the specification (emphasis added; see MPEP 2173.05(s); claims are to be complete in themselves). Thus, “…wherein the microbe is NRRL Deposit No. B-67815” is properly written as “…wherein the microbe is Bacillus amyloliquefaciens deposited as NRRL Accession No. B-67815” (see Specification at [0106]). Appropriate correction is required.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 1-5 and 10-16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 is indefinite because it is unclear what the composition requires based on the second part (labeled “b”). For example, the claim ultimately reads “A synthetic composition, comprising: … at least one heterologous composition” (i.e. a composition comprising a composition? And/or heterologous relative to what?) “…selected from the group consisting of: a plant element, a formulation component, an agricultural composition…” wherein two of the choices (a plant element and a formulation component) are not actually compositions. Thus “A … composition comprising … a … composition” is redundant, heterologous is a relative term (again heterologous to what?), and at least two of the apparent choices for the second component are required to be a composition but are not actually compositions. Accordingly, clarification is required to ascertain what is included and/or excluded in the synthetic composition of claim 1.
Each of claims 2-5, 10-11, and 14-16 are indefinite because each is dependent on “Claim 0”. Consequently, the metes and bounds of these claims cannot be ascertained because their dependencies cannot be ascertained and clarification is required. In the interest of compact prosecution, wherever practical, dependent claims will be interpreted to be dependent on claim 1; however, it is noted that dependent claim 5 would not further limit claim 1 (if it were dependent upon claim 1) because claim 5 includes options that further broaden the option for “plant element” (e.g. whole plant); and similarly, dependent claims 10 and 11 (if dependent upon claim 1) lists options which are also not compositions per se, but rather only components thereof (i.e. a surfactant). Therefore, clarification is required.
Claim 4 is also indefinite for referring to a Table in a claim because where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." See Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993); see MPEP 2173.05(s).
Further, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired; See MPEP § 2173.05(c). In the present instance,
Claim 5 recites the broad recitation “a whole plant”, and the claim also recites a seed, a leaf, a root, a transgene, each of which are narrower statements of the limitation.
Claim 12 recites the broad recitation “a container”, and the claim also recites a shipping container which is the narrower statement of the limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Further, Claim 12 is drawn to a plurality of compositions of claim 1 but the compositions are confined within an object selected from the group consisting of inter alia: a bottle, a jar, etc. It is unclear how the plurality of compositions confined to the same physical space remain distinguishable (i.e. a plurality); thus, clarification is required.
Other dependent claims do not clarify the issues identified above; therefore clarification is required to remove scope ambiguity.
Claim Rejections - 35 USC § 101
9. 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.
10. Claims 1-5 and 10-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. nature-based product) without significantly more.
The claims recite a microbe, exudate therefrom, or culture broth therefrom, wherein the microbe is NRRL Deposit No. B-67815, which appears to be a naturally occurring microorganism classified as Bacillus amyloliquefaciens and directly isolated from a plant (see Figure 3); and Chowdhury et al. 2015 (Biocontrol mechanism by root-associated Bacillus amyloliquefaciens FZB42 – a review; Frontiers in Microbiology 6:780; p 1-11; Introduction and Figure 1). Therefore, the product claims are directed to a statutory category and Step 1 of the subject matter eligibility analysis is yes.
However, this judicial exception is not integrated into a practical application because the naturally occurring bacterium (and by extension any exudates therefrom) does/do not appear to be markedly different from their naturally occurring counterpart, in its natural state, since the bacteria and/or exudates per se are not modified in any way. Therefore, the product claims are directed to a judicial exception (i.e. nature-based products; Step 2A prong 1 is yes) that is not integrated into a practical application (i.e. Step 2A, prong 2 is no).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the “at least one heterologous composition” in claim 1, encompasses water (i.e., a carrier, see claim 10 and/or a growth medium, see claim 15). With regards to the concentration in claim 1, it is noted that if one naturally occurring bacterium is ineligible, then merely concentrating the bacteria does not transform an otherwise patent ineligible item into something patentable since concentration per se does not markedly change the structure or the function of the individual bacterial cells. Further, the additional elements in claims 2, 3, and 4 (i.e. an additional microbe); 5 and 14 (i.e. the plant on which the microbe is found); and 16 (i.e. soil) are themselves judicial exceptions (i.e. also nature-based products). With regards to the container in claim 12, it is noted that putting a nature-based product in a container does not transform an otherwise patent ineligible item into something patentable; see Funk Brothers Seed Co. v. Kalo Inoculant Co. 333 U.S 127 (1948)). There are no additional elements in claim 13. The additional element in claim 11 encompasses adding, for example, a fungicide to bacteria which the ordinary artisan would recognize has no affect on the bacteria; thus, this additional element is not sufficient to amount to significantly more than the judicial exception because there is no indication it (e.g. fungicide) changes any structural or functional features of the judicial exception (i.e. bacteria). Therefore, all the components in the composition function as they would individually, and a mere mixture or aggregation of products, natural or not, does not structurally and/or functionally change the nature-based product from what exists in the environment and that in order to be eligible, every embodiment within the broadest reasonable interpretation of the claim must be eligible.
Thus, taken alone, the additional elements do not amount to significantly more than the above identified judicial exceptions (e.g. naturally occurring bacteria). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually because the additional element(s) are recited at a high level of generality and are well-understood, routine, conventional activities already engaged in by the scientific community (e.g. see Chowdhury et al. 2015; Introduction and Figure 5). Consequently, the additional element(s) are not sufficient to make the judicial exception eligible for patent protection and Step 2B is no.
Therefore, 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 consequently rejected as ineligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
11. 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.
12. Claims 1-5 and 10-16 are rejected under 35 U.S.C. 112(a) 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 had possession of the claimed invention.
Instant claims are drawn to a microbe, exudate therefrom, or culture broth therefrom, wherein the microbe is NRRL Deposit No. B-67815, which is a bacteria classified as Bacillus amyloliquefaciens and isolated from a plant (see Figure 3). The asserted utility of the exudates and culture broths is “Broth and/or exudate may improve the traits of plants with which they become associated” (i.e. see specification at [0279]). However, it is the Office’s position that the exudates and culture broths have not been described with sufficient particularity, such that one skilled in the art would recognize that Applicant had possession of the claimed invention, at the time of filing, because of (A) a lack of a correlation, known or disclosed, between the claimed functional requirements and the structures that meet those requirements; and/or (B) a lack of a representative number and variety of species; for either to constitute possession of the full scope of the claimed genus.
For example, the only description of either exudates or broths in the instant specification is “As used herein, “exudate” refers to one or more compositions excreted by or extracted from one or more microbial cell(s). As used herein, “broth” refers to the collective composition of a cell culture medium after microbial cells are placed in the medium. The composition of the broth may change over time, during different phases of microbial growth and/or development. Broth and/or exudate may improve the traits of plants with which they become associated.” [0279]. However, the specification does not describe or define any examples of compositions comprising less than whole cell microorganisms having the functional ability to improve traits in plants. Thus, the claims amount to a mere wish or plan for possession and MPEP 2163 states an adequate written description of a chemical invention requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed; emphasis added; see, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004); See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Therefore, the specification does not provide adequate written description to identify the broad genus of the claims because, inter alia, the specification does not disclose a correlation between the necessary structure of the exudate or culture broth and the function to be maintained and does not describe a sufficient number and/or a sufficient variety of representative species to reflect the breadth and variation within the claimed genus.
With regards to the state of the art, elucidating the effects of microbial exudates on plants was still under development and thus necessarily unpredictable. For example, Chowdhury et al. 2015 (Biocontrol mechanism by root-associated Bacillus amyloliquefaciens FZB42 – a review; Frontiers in Microbiology 6:780; p 1-11) teaches future work needs to focus on elucidating the effects exerted by secondary metabolites produced by plant-growth-promoting Bacilli within plant rhizosphere on plant health and growth; and that the response of the plant in simultaneous presence of the beneficial Bacillus and the pathogens would be of special interest to evaluate (see conclusion, page 9). Thus, the art cannot be relied upon to predictably determine which exudates and/or culture broths will maintain the asserted utility of promoting plant health.
Consequently, it is the Office’s position that even one of skill in the art would not conclude that Applicant was in possession of the entire genus. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.).
Therefore, it is the Office’s position that Applicant has not satisfied the requirements as set forth under 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 112
13. Claims 1-5 and 10-16 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is a biological deposit rejection.
The invention appears to employ novel biological materials, specifically a microbe (i.e. Bacillus amyloliquefaciens) is NRRL Deposit No. B-67815. Since the biological materials are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant's attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that "the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination." The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
Although Applicants have noted in paragraph [0150] of the specification that the biological material was deposited according to the Treaty of Budapest, a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent is additionally required.
Claim Rejections - 35 USC § 102/103
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. Claims 1-2, 4-5, 10, 12, and 15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Reva et al. 2004 (Taxonomic characterization and plant colonizing abilities of some bacteria related to Bacillus amyloliquefaciens and Bacillus subtilis; FEMS Microbiology Ecology 48: 249-259).
Reva teaches a plurality of compositions comprising Bacillus amyloliquefaciens associated with (i.e. isolated from) plant elements, including roots of seedlings, in comparison to other microbes such as B. subtilis and B. mojavensis which all co-occur in the plant rhizosphere (e.g. see abstract; sections 2.1 and 3.1-3.2; and Figure 3; meeting limitations found in instant claims 1, 2, 4, and 5). Reva cultured Bacillus amyloliquefaciens on agar plates (i.e. a carrier; a growth medium; and a container) to generate compositions having 107 per ml for coating on sterilized seeds (i.e. a plant element) and incubating in standard sphagnum based soil (see section 2.2; meeting limitations found in instant claims 1, 10, 12, and 15).
While Reva does not teach the Bacillus amyloliquefaciens is deposited as NRRL B-67815, the bacteria are deemed to be the same, or substantially the same, as evidenced by the same Latin name and being useful for the same purpose of improving plant growth. Therefore, absence convincing evidence to the contrary, Reva anticipates the invention as claimed because Bacillus amyloliquefaciens and its functional properties cannot be separated; see MPEP 2112.01. Further, MPEP 2112.01 also states that “When the PTO shows a sound basis for believing that the inventions of the Applicant and the prior art are the same, the Applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Alternatively, it would have been prima facie obvious to substitute one Bacillus amyloliquefaciens strain for another because both would be used for the same purpose as desired. Accordingly, Reva teaches, or at least renders obvious, the composition because (1) Bacillus amyloliquefaciens cannot be separated from its properties, and/or (2) the prior art teaches a product that only differ from the claimed invention by the substitution of a single component (i.e. substitution of the Bacillus amyloliquefaciens strain) and KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill.
Therefore, the claimed invention is at least prima facie obvious, if not anticipatory, in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
20. No claims are allowed.
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. 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, 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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/MARY MAILLE LYONS/Examiner, Art Unit 1645
December 29, 2025