DETAILED 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 .
Status of Claims
Receipt of Remarks filed on 12/29/2025 is acknowledged. Claims 1, 7-13, and 29-49 remain cancelled while claims 2-6, 24, and 26-28 remain withdrawn as being drawn to a nonelected group and claims 17-20 remain withdrawn as being drawn to a nonelected species.
Claims 14-16, 21-23, and 25 are examined on the merits herein.
Priority
The instant application filed 07/21/2022, is a 371 filing of PCT/US2021/014705, filed 01/22/2021, which claims priority to provisional application No. 62/965625, filed 01/24/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/29/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112(a)
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.
Written Description
Claims 14-16, 21-23, and 25 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention.
The instant claims recite a method of treating a CLas infection and/or HLB in a plant, comprising introducing to the plant at least one microbial isolate(s) selected from the group consisting of Cladosporium cladosporioides, Epicoccum nigrum, Pantoea agglomerans, Pantoea vagans, Bacillus sp., Curtobacterium sp., Alternaria radicina and Cochliobolus sp., or an extract thereof.
To satisfy the written description requirement, applicants may convey 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 written description requirement of 35 U.SC. 112 exists independently of enablement requirement, and the requirement applies whether or not the case involves questions of priority. The requirement applies to all inventions and includes chemical inventions. The fact that the patent is directed to method entailing use of compounds, rather than to compounds per se, does not remove patentee’s obligation to provide a description of the compound sufficient to distinguish infringing methods from non-infringing methods. See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ 2d 1886, 1890-93 (Fed. Cir. 2004).
With regard to the description requirement, applicants’ attention is invited to consider the decision of the Court of Appeals for the Federal Circuit, which holds that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1405 (1997), quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original) [The claims at issue in University of California v. Eli Lilly defined the invention by function of the claimed DNA (encoding insulin)].
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species or by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d at 1568, 43 USPQ2d at 1406.
Claim 14 is drawn to several microorganism genera (i.e., Bacillus sp., Curtobacterium sp., and Chochliobolus sp.). Claim 14 is also drawn to a genus of extracts, which includes any extract of the claimed microbial isolates. Neither the instant specification nor the claims have demonstrated common structure and/or function for the claimed genus of microbes or their extracts. Countless extracts exist depending on the microorganism which it is extracted from as well as the specific extraction method used. In addition, no representative number of species for each claimed genus is provided to show possession of the claimed genus of microorganisms and genus of extracts.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. (see MPEP 2163 II).
The specification discloses microorganism genera in terms of their relative abundance percentages in the citrus microbiome (Table 1). There is no disclosure in the instant specification of specific Bacillus sp. microorganisms being investigated for CLas inhibition, nor for Curtobacterium sp. and Chochliobolus sp.. Given the broadness of an entire microorganism genus and the lack of a functional correlation between all species in the genus, the applicant has not shown possession of an entire genus of microorganisms much less their use in a method treating CLas or HLB. Regarding the extracts, the only examples of extracts disclosed by the instant specification are supernatants of microbial isolates along with fractions comprising cladosporol, cpicoccamide, and radicinin and its derivatives. Given that these extracts are not representative of every compound which can be extracted from every microorganism claimed, there is not enough evidence to show possession of the entire genus of extracts claimed. The recited method of treating CLas and/or HLB involves providing microbes/compounds which have an inhibitory effect on CLas and applying them to a plant. Without identifying the specific Bacillus sp., Curtobacterium sp., or Chochliobolus microorganism and extract to be used, the claimed method cannot be accomplished.
As discussed above, no specific Bacillus sp., Curtobacterium sp., nor Chochliobolus sp. are described in the specification. Although microorganisms in these genera have been demonstrated in the art to treat CLas and HLB, certainly not all species are described. The specification identifies several microbial isolate extracts that demonstrate an inhibitory effect. However, given the diversity in extraction methods and metabolites, all extracts could not have been known.
Therefore, applicants are not in possession of every microbial isolate of the Bacillus, Curtobacterium, and Chochliobolus genus, nor every extract of the claimed microbes. Applicant’s claimed scope represents only an invitation to experiment regarding possible microbial isolates and extracts thereof that might be used for the purpose of treating CLas and/or HLB.
Scope of Enablement
Claims 14-16, 21-23, and 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for introducing microbial isolate extracts selected from microbial isolate supernatants, radicinin compounds, epicoccamide compounds, and cladosporol compounds, does not reasonably provide enablement for introducing the microbial isolates themselves nor every extract thereof. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to perform the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. §112, first paragraph, have been described In re Wands, 8 USPQ2d 1400(1988). They are:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The predictability or lack thereof in the art
5. The level of skill in the art;
6. The amount of direction or guidance present;
7. The presence or absence of working examples;
8. The quantity of experimentation needed.
The breadth of the claims
The breadth of the claims seems to encompasses a method of treating a Candidatus Liberibacter asiaticus (CLas) infection in a plant and/or treating Huanglongbing (HLB) in a plant, by introducing to the plant at least one microbial isolate(s) selected from the group consisting of Cladosporium cladosporioides, Epicoccum nigrum, Pantoea agglomerans, Pantoea vagans, Bacillus sp., Curtobacterium sp., Alternaria radicina and Cochliobolus sp., or an extract thereof.
The specification does not describe methods of treating such an infection with the microbial isolates themselves or any extract outside of the categories discussed above (i.e., supernatants, radicinin compounds, epicoccamide compounds, and cladosporol compounds).
The nature of the invention
The nature of the invention as recited in the instant claims is a method of treating a Candidatus Liberibacter asiaticus (CLas) infection in a plant and/or treating Huanglongbing (HLB) in a plant by introducing the plant to at least one microbial isolate(s) or an extract thereof.
The state of the prior art/The predictability or lack thereof in the art
Prior studies investigating Huanglongbing (HLB), which is the disease associated with the bacteria Candidatus Liberibacter asiaticus (CLas), have investigated the bacterial and fungal taxa associated with CLas-infected citrus and their relative abundance in the budwood, leaves, and roots of the same citrus trees (Abstract of Ginnan et al. 2018, on record). HLB affects most citrus cultivars, and there currently are no effective prophylactic or therapeutic treatments (p. 65, para. 2). Ginnan et al. investigates the citrus microbiome, stating that the plant microbiome is involved in various aspects of plant health and disease. Understanding how the microbiome influences and interacts with the plant requires implementation of a variety of experimental approaches, including meta-analyses of large microbial datasets (p. 65, para. 3). Ultimately, the prior art draws no direct ties to individual microorganisms nor their role in HLB suppression, however, the researchers express hope that a meta-analyses of their dataset could lead to the identification of individual microorganisms and help direct targeted experiments that aim to understand the in-planta microbe-microbe or microbiome-host interactions associated with HLB (Future Directions).
Blacutt et al. 2020 (on record) indicates that current management of HLB relies heavily on vector control via insecticide applications, and the development of alternative effective management strategies is ongoing (p. 2, para. 1). In the HLB pathosystem, efforts to harness biologicals or their bioactive metabolites for the management of HLB via direct application face significant challenges. Among these is the fastidious nature of the pathogen “Ca. Liberibacter asiaticus,” as it is localized to the phloem, a difficult-to-access sector of the plant endosphere. Moreover, “Ca. Liberibacter asiaticus” is delivered directly to the phloem by its insect vector and has no known epiphytic phase. Thus, anti-“Ca. Liberibacter asiaticus” applications based on direct activity against the pathogen will require entry to the phloem. The next steps of this collective work are to evaluate the cladosporols (and/or other to-be-isolated natural products) for anti-“Ca. Liberibacter asiaticus” activity within citrus trees. Most importantly, assays designed to track the transit pathways of those molecules in planta are necessary to assess bioavailability across tissue compartments. It will also be pertinent to determine whether the “Ca. Liberibacter asiaticus”-inhibitory metabolites are produced by their respective microbes in planta. Empirical assessment of the potential for these microbes to be used, either directly as bioinoculants, or through cultural practices enriching their abundance in planta, to curtail “Ca. Liberibacter asiaticus,” and thus mitigate HLB, are the next steps for this research (final paragraph of discussion).
Thus, the state of the art for treating CLas infection and/or HLB with a microbial isolate or an extract thereof is ongoing and unpredictable. The successful inhibition of CLas in a citrus tree relies on hypotheses made from meta-data analyses and in vitro inhibition assays against a culturable surrogate of CLas. Although there are promising results that pose various microbial isolates and extracts thereof as potential inhibitors of CLas/HLB, invitro validation is necessary and further considerations are necessary for implementing the inhibitors in planta.
The level of one of ordinary skill
The level of skill would be high in order to carry out the method of providing a microbial isolate or extract thereof and introducing it into a plant.
The amount of direction of guidance present/ The presence or absence of working examples
The instant specification discloses a method for screening citrus-associated microbiota with potential anti-CLas properties (Example 1). A Liberibacter crescens inhibition bioassay was developed to identify inhibitory microbes (p. 49 and 60-61 of spec.). Crude supernatants were obtained from the pure cultures of various microbes (i.e., microbial isolates) and tested for activity in the bioassay. Applicant identified supernatants that inhibit the growth of L. Crescens as evidenced by a zone of growth inhibition around the supernatant, indicating that these isolates secrete antimicrobial secondary metabolites (p. 50 of spec.). Organic extracts were then fractionated from crude supernatants to isolate specific metabolites which were then characterized. Cladosporols and epicoccamides where identified (p. 50 of spec.). Additionally, radicinin, a microbial metabolite, and its derivatives were synthesized and tested in a bioassay against L. crescen (Example 2; p. 69-70 of spec.). Thus, the specification only provides guidance for determining the inhibition activity of microbial isolate extracts (i.e., crude supernatants and metabolites such as cladosporol , epicoccamide, and radicinin). While the specification teaches that in certain embodiments, organisms may be present in a bioinoculant composition or as inactivated microbial isolates (e.g., a composition comprising an inactivated culture, such as heat-killed whole culture broth), there is no specific guidance or example of a microbial isolate itself (i.e., the cells) being tested in an inhibition bioassay. Additionally, only specific extracts are investigated, meaning all extracts from all of the claimed microbes are not adequately described. As such, an example of applying the microbial isolate itself (i.e., the cells) and a broader scope of extracts would be required in order to demonstrate potential inhibitory activity that would enable a method of treating CLas/HLB in a plant.
The quantity of experimentation needed
Due to the ongoing and unpredictable nature of developing CLas/HLB treatments (as discussed supra), along with the lack of guidance in the instant specification, undue experimentation would be required to treat CLas/HLB in a plant with a microbial isolate itself or any extracts thereof, apart from those specifically discloses. The art has not demonstrated any level of predictability for treating CLas in a plant using a microbial isolate and extracts thereof. Meta-analyses and bioassay guided testing is necessary to determine potential inhibitors, both processes requiring a high level of skill and experimentation. The instant specification only discloses bioassay testing on specific extracts which have inhibitory effects that could reasonably be translated into a CLas in planta model. One of ordinary skill in the art could not assume from these results that the microbial isolates themselves or any extract, other than those tested, would also have an inhibitory effect. Given that there is no evidence of such compounds, other than those explicitly disclosed, having an inhibitory effect in the L. crescens bioassay, undue experimentation would be required to validate their activity and translate their use into a plant.
Conclusion
Due to the non-routine experimentation necessary to determine the specific compositions capable of being introduced to a plant to treat a CLas infection; the lack of direction/guidance presented in the specification regarding the specific requirements for selecting and applying microbial isolates and all extracts thereof; the unpredictability and complexity of determining effective CLas inhibitors as established by the state of the prior art; and the breadth of the claims, undue experimentation would be required of a skilled artisan to make and/or use the claimed invention in its full scope.
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.
1. Claims 14-16, 21-23, and 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The following flow chart shown in MPEP 2106(III) is used to determine whether claims are subject matter eligible:
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890
597
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Greyscale
Following the above flowchart, claim 14 is to a process (Step 1), the claim is directed to a natural phenomenon (Step 2A), and the claim does not recite additional elements that amount to significantly more than the judicial exception (Step 2B). Therefore, claim 14 is not eligible subject matter under 35 USC 101.
Analysis
Step 1: Claim 14 recites a method of treating a Candidatus Liberibacter asiaticus (CLas) infection in a plant and/or treating Huanglongbing (HLB) in a plant. Therefore, the claim is a process claims.
Step 2A: Step 2A is a two-prong inquiry according to the flowchart shown in MPEP 2106.04(II)(A).
Prong One: Yes. Claim 14 recites a natural phenomenon. The claim recites a method comprising introducing to the plant at least one microbial isolate(s) and extracts thereof. Cladosporium cladosporioides, Epicoccum nigrum and bacterial species of Pantoea, Bacillus, and Curtobacterium are all microbes that were identified in the citrus microbiome (Blacutt et al. 2020, abstract; Table 3). Among the bacteria screened from the citrus microbiome, a Pantoea isolate with high taxonomic identity to Pantoea agglomerans and Pantoea vagans was also identified (Discussion, para. 6). Thus, it is clear that such microbes are a product of nature (i.e. natural phenomenon). Even further, the presence of these microbes on a plant (i.e., citrus) occurs naturally. When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. Although claim 14 is a method claim, where a process claim reciting a nature-based product is drafted in such a way that there is no difference in substance from a product claim, the claim is subject to the markedly different analysis for the recited nature-based product. For example, consider a claim that recites, in its entirety, "a method of providing an apple." Under the broadest reasonable interpretation, this claim is focused on the apple fruit itself, which is a nature-based product. See MPEP 2106.04(c)(I)(C). In the instant case, the method claim is focused on the microbial isolate itself.
Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception. See MPEP 2106.04(c)(II). In the instant case, microbes such as those claimed are found in nature. While claim 14 recites a “microbial isolate”, the claim does not indicate that the microbial isolate was modified or isolated in a way that makes it markedly different from microbes found from nature. Thus, the microbial isolate limitation is a product of nature exception.
Prong Two: No. This judicial exception is not integrated into a practical application because the method recites introducing to the plant at least one microbial isolate(s) and merely reciting the words “apply it” (or an equivalent) with the judicial exception does not integrate a judicial exception into a practical application. See MPEP 2106.04(d)(I).
Step 2B: Claim 14 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because although the claim recites a method of treating a CLas infection of HLB in a plant, it is discussed above that the claimed microbes exist naturally in plants, specifically citrus which is known to suffer greatly from CLas infection/HLB. Thus, introducing the microbial isolates into a plant for treatment of this disease would not necessarily result in a situation different from that which is known to occur in nature (i.e., the presence of the instantly claimed microbes on an citrus plant affected by or susceptible to infection).
As such, the claims do not amount to significantly more than the exception itself, the claim is not patent-eligible.
Claim Rejections - 35 USC § 102
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.
Claims 14-15 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Uday, B. et al. (WO 2016024282 A1, 02/18/2016, IDS dated 12/29/2025), hereinafter Uday.
Uday discloses methods for controlling, preventing, removing and treating the infestation of citrus. The method is capable of controlling the disease of bacteria of the genus Candidatus liberibacter asiaticus and Candidatus liberibacter africanum which cause the disease known as Huanglongbing (HLB) ([0001]). The method comprises the application of several components as a soil drench or foliar spray (claim 1). Specifically, component-2 comprises a consortium of plant growth promoting rhizosphere microbes (claim 6), which are Pseudomonas fluorescens, Bacillus subtilis, Bacillus mycoides and Trichodema viride (claim 9).
Thus, Uday teaches the instantly claimed method of treating a CLas infection and/or HLB in a plant (i.e., a citrus), comprising introducing to the plant at least one microbial isolate selected from Bacillus sp. (i.e., Bacillus subtilis, Bacillus mycoides), as defined in instant claims 14-15. The Pseudomonas fluorescens and Trichodema viride read on the additional therapeutic agent of claim 23.
Claims 14-15, 21-23, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farmer, S., et al. (WO 2019140439 A1, 07/18/2019, PTO-892), hereinafter Farmer.
Farmer discloses compositions and methods for enhancing plant immunity, health, growth and yields, specifically through treatment and/or prevention of plant pathogenic bacterial infections using microbes and/or their growth by-products. The compositions and methods can be used to treat and/or prevent citrus greening disease and citrus canker disease (abstract). The method comprises applying a composition to a plant and/or its surrounding environment (claim 16), wherein the composition comprises a beneficial microorganism (claim 1). The beneficial microorganism are non-plant-pathogenic bacteria selected from Bacillus amyloliquefaciens, Pseudomonas chlororaphis, and Rhodococcus erythropolis (claim 8).
Thus, Farmer teaches the instantly claimed method of treating a CLas infection and/or HLB (i.e., citrus greening disease) in a plant, comprising introducing to the plant at least one microbial isolate selected from Bacillus sp. (i.e., Bacillus amyloliquefaciens), as defined in instant claims 14-15. The pesticidal composition can comprise the fermentation by-products containing a live and/or an inactive culture and/or the microbial metabolites produced by the microorganism (p. 13, lines 17-19). The microorganisms may be in an active or inactive form (p. 13, lines 27). The inactivated embodiment reads on claim 21.
The beneficial microorganisms are in a composition, which further comprises one or more adherent substance (claim 1). The adherent material reads on the carrier of claim 22.
The composition further comprises a low concentration of antibiotics (claim 1), which read on the additional therapeutic agent of claims 23 and 25.
Response to Arguments
(1) Applicant argues against the 112(a) enablement rejection, stating that most models are approximations and that several studies have established L. crescens as a suitable in vitro model organism for CLas (citations provided). Applicant further asserts that a person of ordinary skill in the art could confirm anti-CLas activity of a given microbial isolate using an in planta assay known in the art without undue experimentation (citations provided).
While Examiner is convinced that L. crescens is a suitable in vitro model for CLas and that in planta models are known, an enablement issue still remains regarding the nonroutine experimentation needed to determine the potential inhibitory effect of every microbial isolates and extract claimed. The instant specification only discloses bioassay testing on specific extracts which have inhibitory effects that could reasonably be translated into a CLas in planta model. One of ordinary skill in the art could not assume from these results that the microbial isolates themselves or any extract, other than those tested, would also have an inhibitory effect. Given that there is no evidence of such compounds, other than those explicitly disclosed, having an inhibitory effect in the L. crescens bioassay, undue experimentation would be required to validate their activity and translate their use into a plant.
(2) Applicant argues against the 101 rejection, stating that the instant invention is directed to a “treatment” or “prophylaxis”, wherein an affirmative step of “introducing to the plant” is recited. Thus, Applicant asserts that the judicial exception is integrated into a practical application.
In response to this argument, it is discussed in the above 101 rejection that several of the claimed microbes are naturally found in the citrus microbiome. Citrus is known to suffer from CLas infection/HLB. Thus, even if the instant invention is drawn to treating CLas infection/HLB, the entirety of the method which simply comprises introducing microbes to a plant, results in no difference from situations which are known to occur in nature (i.e., the presence of the instantly claimed microbes on an citrus plant susceptible to or affected by CLas infection). The actual therapeutic effect of said method would be inherent in such natural situations since the claims do not recite an effective amount or a specific means of introduction which set the method apart from nature.
Conclusion
No claims are allowed.
This action is a second non-final.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616