DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Receipt and consideration of Applicant’s arguments/remarks submitted on March 2, 2026 are acknowledged.
All rejections/objections not explicitly maintained in the instant office action have been withdrawn per Applicant’s claim amendments and/or persuasive arguments.
Status of the Claims
Claims 24, 25, 27-29, 32, 34, and 36-38 are pending. Claims 1-23, 26, 30, 31, 33, and 35 are cancelled.
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 24, 25, 27-29, 32, 34, and 36-38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon) without significantly more. The claims recite a composition comprising a Piriformospora indica strain and a Pseudomonas fluorescens strain. Claims 25 and 34 further recites that the P. fluorescens strain is the strain designated as GM41 (ATCC PTA-122788). Claims 28, 29, and 38 further include a binding agent, which encompass naturally occurring products.
As evidenced by Labbé et al. (Frontiers in Plant Science; of record), Pseudomonas fluorescens strain GM41 is a naturally occurring strain known to be found on the roots of trees (p.2, col.1, para.5). As evidenced by Sarma et al. (Journal of Applied Microbiology, of record), Piriformospora indica is a naturally occurring species known to be a symbiont root endophytic fungus that infests roots of a broad range of mono- and di-cotyldedonous plants (p.457, col.1, para.1 and col.2, para.1). As evidenced by Singh et al. (Carbohydrate Polymers; of record), pullulan, a binder recited in claims 28, 29, and 38, for example, is a polysaccharide produced by certain strains of A. pullulans, and thus a naturally occurring product.
There is no indication in the specification that the claimed mixture of bacteria and fungi and excipient (e.g., binder) has any characteristics (structural, functional, or otherwise) that are different from their naturally occurring counterparts.
Although claim 24 incorporates amounts for the bacterial and fungal strains, there does not appear to be evidence demonstrating that mixtures in such amounts will lead to any characteristics (structural, functional, or otherwise) that are different from their naturally occurring counterparts. None of the examples in the instant Specification, for example, appear to test the claimed mixture, nor does there appear to be evidence presented to otherwise demonstrate that the claimed mixture with the components in the claimed amounts would lead to any characteristics that are different from their naturally occurring counterparts. Thus, the mixture as currently claimed does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. The claims do not include any additional features that could add significantly more to the exception.
Response to Arguments
Applicant's arguments filed March 2, 2026 have been fully considered but they are not persuasive.
(1) Applicant argues that the claimed composition comprising a Piriformospora indica strain and a Pseudomonas fluorescens strain GM41 mixture is expected to have functional effects not possessed by either strain alone and more than simple additive of the two strains combined. Applicant asserts that the instant specification has uniquely found that inoculation with the combination of an endophytic fungus and a rhizobacterium exhibits functional effects that are more than merely additive of the two microorganisms combined, pointing to Example 2 and Fig.2 as demonstrating a synergistic effect between the combination of Laccaria bicolor (endophytic fungus) and Pseudomonas fluorescens (rhizobacterium) on the growth and stress tolerance of plants.
Applicant argues that as Piriformospora indica and L. bicolor both belong to the phylum Basidiomycota, both are endophytic fungi that promote plant growth and stress tolerance, and both function through the same mechanisms such as enhanced nutrient uptake and modulation of plant signaling pathways. Thus, Applicant argues that one of skill in the art would reasonably expect that the combination of P. indica and P. fluorescens would have a similar synergistic effect as is shown for the combination of L. bicolor and P. fluorescens.
With regards to Applicant’s argument (1), the traversal argument is not found persuasive. First, it is noted that none of the examples in the instant Specification appear to test the claimed mixture. Example 2 and Fig. 2 noted by Applicant is directed to testing a combination of L. bicolor and P. fluorescens, which is not commensurate in scope with the claims. The instant claims are directed to a combination of P. indica and P. fluorescens.
While Applicant notes that both P. indica and L. bicolor both belong to the phylum Basidiomycota, that does not necessarily indicate that both will have the same results when in mixture with P. fluorescens. Applicant only tests a single species of endophytic fungus of the phylum Basidiomycota in mixtures with P. fluorescens. One data point (i.e. a mixture of P. fluorescens with a single species of an endophytic fungus of the phylum Basidiomycota) is not indicative of a trend or pattern that all mixtures of P. fluorescens with any endophytic fungus of the phylum Basdiomycota will exhibit synergistic effects on the growth and stress tolerance of plants.
Furthermore, Example 2/Figure 2 does not disclose the effect of P. fluorescens alone. Thus, from the data shown, it cannot necessarily be concluded that the effect of adding P. fluorescens to the mixture is not merely an additive effect of each component exhibiting characteristics that are consistent with their naturally occurring counterparts. Thus, the mixture as currently claimed does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. The claims do not include any additional features that could add significantly more to the exception.
Conclusion
Claims 24, 25, 27-29, 32, 34, and 36-38 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONICA A. SHIN whose telephone number is (571)272-7138. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM EST).
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/MONICA A SHIN/Primary Examiner, Art Unit 1616
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