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 .
Notice of New Examiner
Please note that the correspondence for this application has changed (see Conclusion section).
Claim Status
The amended claim set filed 30 June 2026 is acknowledged. Claims 1-5, 10-16, and 52-53 are currently pending. Of those, claims 1-5, and 10-16 are currently amended, and claims 52-53 are new. Claims 6-9, 17-51 are cancelled. Claims 1-5, 10-16, and 52-53 will be examined on the merits herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5 May 2026 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. A signed copy of the statement is attached with this action.
Response to Arguments
The Applicants’ arguments filed 30 June 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 30 Jan 2026 will be referred to as “NFOA.”
Objection(s) and Rejection(s) Withdrawn
The objections to claim 1 are withdrawn in view of the claim amendments and arguments.
The rejections of claims 1-5 and 10-16 under 35 U.S.C. 112(b) are withdrawn in view of the claim amendments and arguments. With regard to “at least two of the apparent choices for the second component are required to be a composition but are not actually compositions” (NFOA pg. 4 par. 1), the broadest reasonable interpretation of “composition” includes “compositions of matter” (see the text of 35 U.S.C. 101, for example), and the plant element and formulation component are compositions of matter. With regard to “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.” (NFOA pg. 5 par. 3), the compositions can be individually packaged and placed within a larger container, or otherwise separated within the container. Multiple compositions that become mixed into a single composition when placed into a container are in the form of a single composition and are not within the scope of the “plurality of compositions” claimed.
The rejection of claims 1-5 and 10-16 under 35 U.S.C. 112(a) (written description) are withdrawn in view of the amendment to claim 1 and arguments.
The rejection of claims 1-5 and 10-16 under 35 U.S.C. 112(a) (enablement/deposit) are withdrawn in view of the “statement in accordance with 37 CFR 1.801-1.809” and evidence of deposit (Remarks pg. 9). This includes the statement of 37 CFR 1.808(a)(2) that “Subject to paragraph (b) of this section, all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.”
The Williams declaration under 37 CFR 1.132 filed 30 June 2026, and related arguments, are sufficient to overcome the rejection of claims 1-2, 4-5, 10, 12, and 15 based upon 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.
Claim Interpretation
The following definitions are noted:
A composition is “heterologously disposed” when mechanically or manually applied, artificially inoculated, associated with, or disposed onto or into a plant element, seedling, plant or onto or into a plant growth medium or onto or into a treatment formulation so that the treatment exists on or in the plant element, seedling, plant, plant growth medium, or formulation in a manner not found in nature prior to the application of the treatment, e.g., said combination which is not found in nature in that plant variety, at that stage in plant development, in that plant tissue, in that abundance, or in that growth environment (for example, drought). In some embodiments, such a manner is contemplated to be selected from the group consisting of: the presence of the microbe; presence of the microbe in a different number of cells, concentration, or amount; the presence of the microbe in a different plant element, tissue, cell type, or other physical location in or on the plant; the presence of the microbe at different time period, e.g., developmental phase of the plant or plant element, time of day, time of season, and combinations thereof. [0200]
A “plant element” is intended to reference either a whole plant or a plant component, which may comprise differentiated and/or undifferentiated tissues, for example but not limited to plant tissues, parts, and cell types. [0171]
Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 101
Claims 1-5 and 10-16 remain rejected and claims 52-53 are newly 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); and claim 52 (i.e. an extrudate from the microbe) are themselves judicial exceptions (i.e. also nature-based products). With regards to the container in claims 12 and 53, 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 effect 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.
Response to Arguments
Applicant argues (Remarks pg. 8) that “Claim 1 has been amended to recite that the microbe is "heterologously disposed", see specification as filed at para [0200]. As amended, the claims recite a synthetic composition with synthetic components that are not directed to a naturally occurring microorganism in its natural state and thus not directed to a judicial exception.”
This argument has been carefully considered but is not found persuasive. The arguments use the incorrect standard for a natural product analysis by arguing that a non-naturally occurring product is not directed to a judicial exception. Instead, the correct analysis is “the markedly different characteristics analysis”. See MPEP 2106.04: “If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible (Step 2A: NO) at Pathway B unless the claim recites another exception (such as a law of nature or abstract idea, or a different natural phenomenon). … If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception, and requires further analysis in Step 2A Prong Two to determine whether the claim as a whole integrates the exception into a practical application.” The courts have made clear that not all non-natural products are patent eligible; some products lack markedly different characteristics. See MPEP 2106.04.II.C.2, and its citations to isolated genes (Myriad), DNA fragments used as primers (Ambry Genetics), cloned animals (Roslin). In all these cases, objects that do not exist in nature are nevertheless not patent eligible because they lack markedly different characteristics relative to their natural counterpart. See also MPEP 2016.04.II.A “assume that applicant claims an inoculant comprising a mixture of bacteria from different species, e.g., some bacteria of species E and some bacteria of species F. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature);”
In this case, the markedly different characteristics analysis was performed above: “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 … 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).”
Applicant has not identified any markedly different characteristics in the isolated bacteria compared to the natural bacteria, and has not pointed out any other errors in the rejection. Therefore, the rejection is maintained for the reasons of record.
New Rejection(s)
Claim Rejections - 35 USC § 112(b)
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 4, 5, 10, 12, 16, and 52-53 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.
Regarding claim 4, the claim has been amended to recite numerous bacterial strains that are identified only by a lab name, for example “Bacillus megaterium 255”, rather than a universal identifier like a deposit number or a name that is well-known to the art at the time of filing. However, different labs may use the same name to refer to different strains and one of ordinary skill in the art would not be able to determine which strain is referred to in the absence of an unambiguous name that is well-known to the art. Therefore, the claim is indefinite because the required bacterial strains cannot be clearly identified.
Regarding claim 5, the claim recites “the plant element is selected from the group consisting of: a seed, a transgene, a leaf, a root, a whole plant, and any combination or plurality of the preceding.” The art at the time of filing defines the term “transgene” as “A gene that is taken from one organism and inserted into the germ line of another organism so that it is replicated as part of the genome and present in all the recipient's cells. The resulting organism is described as transgenic." (Martin and Hine; PTO-892). As defined in the specification, “a composition is “heterologously disposed” when mechanically or manually applied, artificially inoculated, associated with, or disposed onto or into a plant element” [0200]. One of ordinary skill in the art would be unsure how to interpret the requirement for many different bacteria (at least about 10^2 CFU/mL in a liquid formulation, or at least about 10^2 CFU/gram in a non- liquid formulation) to be “applied, artificially inoculated, associated with, or disposed onto or into” a gene. As a result, the claim scope is indefinite. Applicant is warned that an amendment to include a variant of the deposited B. amyloliquefaciens strain that is comprising or expressing transgenes would broaden the scope of claim 1 by broadening the bacteria that can be used. Applicant is warned that an amendment to recite a transgenic plant instead of a transgene would raise indefiniteness issues for reciting both a broader claim scope (any whole plant) and narrower claim scope (transgenic whole plants specifically). In the interest of compact prosecution, the interpretation of the term will be explained in this action where relevant for rejections.
Regarding claim 10, the claim uses the term “anticomplex agent”. This term is not defined in the specification and does not have a well understood definition in the field at the time of filing. Accordingly, the claim scope is indefinite because one of ordinary skill in the art at the time of filing would not be able to determine which components are or are not anticomplex agents. In the interest of compact prosecution, the interpretation of the term will be explained in this action where relevant for rejections.
Regarding claims 12 and 53, the claims recite the relative term “substantially” (“substantially confined within”), which is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One of ordinary skill in the art would not be able to determine what types of confinement are encompassed by the claim. In the interest of compact prosecution, the interpretation of the term will be explained in this action where relevant for rejections.
Regarding claim 16, the terms “regular” and “substantially” (“in a regular pattern with substantially equal spacing”) are relative terms which renders the claim indefinite. The terms “regular” and “substantially” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One of ordinary skill in the art would not be able to determine what types of placements in the soil are encompassed by the claim. In the interest of compact prosecution, the interpretation of the term will be explained in this action where relevant for rejections.
Regarding claim 52, the claim recites “wherein the composition further comprises a culture broth or extrudate therefrom.” The claim is indefinite because it does not clearly establish whether “therefrom” references back to the microbe of claim 1(a), the at least one composition of claim 1(b), or the culture broth. In the interest of compact prosecution, the claim will be interpreted as referring to an extrudate from the microbe to better correspond with the previous claim set’s limitations.
Claim Rejections - 35 USC § 112(a)
Claim 4 is 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 deposit rejection.
It is apparent that the strains in the table of claim 4 are required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the strains.
The specification does not disclose how the deposited strains were obtained, and the invention will not work with commonly available material because the claim requires that the specific strain be used rather than other, commonly available strains from the same species. It is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. It is noted that Applicants have deposited biological material for some of the claimed strains, but there is no indication in the specification as to public availability. Therefore, a deposit at a recognized depository may be made to obviate this rejection. This rejection applies to all strains that are listed in claim 4, not only those with deposit numbers listed.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the 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 enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 5, 10-13, 15-16, and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15, 20-22 of copending Application No. 18/876,175 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant is notified the instant application has the earlier patent term filing date. Per MPEP 804: “If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.”
Regarding claim 1, ‘175 claim 1 recites “at least one microbe of Table 1”, which includes B. amyloliquefaciens deposited as NRRL Accession No. B-67815. Table 1 is printed on pg. 67 of the specification of ‘175; MPEP 804 states “The specification can be used as a dictionary to learn the meaning of a term in the claim”, in this case, the term Table 1. 2 recites a synthetic composition comprising the consortia of claim 1. ‘175 claims 2-4 teach a synthetic composition comprising the consortia of Claim 1 and further comprising a formulation component and/or an agricultural composition wherein the microbe is present at a concentration of at least about 10^2 CFU/mL in a liquid formulation, or at least about 10^2 CFU/gram in a non-liquid formulation.
Regarding claim 2, ‘175 claims 1 and 5 teach that the composition can comprise additional microbes.
Regarding claim 5, ‘175 claims 6-11 teach that there can be a plant element that is a seed, seed comprising a transgene, leaf, root, whole plant, or plant reproductive element.
Regarding claim 10, ‘175 claim 12 teaches wherein the formulation component is selected from the group consisting of: a compound that improves the stability of the microbe, a preservative, a carrier, a surfactant, an anticomplex agent, and any combination thereof.
Regarding claim 11, ‘175 claim 13 teaches wherein the agricultural composition comprises a fungicide, a nematicide, a bactericide, an insecticide, an herbicide, or any plurality and/or combination of the preceding.
Regarding claims 12 and 53, ‘175 claim 14 teaches wherein said synthetic compositions are substantially confined within an object selected from the group consisting of: a tube, a bottle, a jar, an ampule, a package, a vessel, a bag, a box, a bin, an envelope, a carton, a container, a silo, a shipping container, a truck bed, and a case.
Regarding claim 13, ‘175 claim 15 teaches wherein the synthetic compositions are at a temperature below zero degrees Celsius.
Regarding claim 15-16, ‘175 claims 20-22 teach wherein the agricultural composition comprises a growth medium wherein the growth medium comprises soil wherein the plurality of synthetic compositions is placed in the soil in a regular pattern with substantially equal spacing between each of the synthetic compositions.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-F 8:30-4:30 (EDT/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, Samira Jean-Louis can be reached at (571) 270-3503. 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.
/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
Prosecution Insights