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 .
Election/Restrictions
Applicant’s election without traverse of SEQ ID NO: 1 and SEQ ID NO: 5 in the reply filed on 12/27/2023 is acknowledged.
Response to Arguments
Applicants' arguments, filed 8/25/2025, have been fully considered but they are not deemed to be persuasive, with respect to the rejection under 35 USC 101. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicant’s arguments, see pp. 8-9, filed 8/25/2025, with respect to the rejection(s) of claim(s) 36-55 under 35 USC 103 have been fully considered and are persuasive, in view of the evidence that DSM-36 does not does not solubilize ZnO (Figure 4). Therefore, the prior obviousness rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the references set forth below. Examiner notes there is no SE level of 135.71 required by the claims.
Claim Rejections - 35 USC § 103
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.
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.
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.
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.
Claim(s) 36-49, 52-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sikuljak et al. (WO 2016/142456 A1, Published 09/15/2016; cited in a prior Office action) in view of Spears et al. (WO 2015/023662 A1, Published 02/19/2015; cited in a prior Office action), and Guo-hong et al. (Draft Genome Sequence of Bacillus simplex DSM 1321 for Setting Up Phylogenomics in Genomic Taxonomy of the Bacillus-Like Bacteria, Published 06/23/2016; cited in a prior Office action) as evidenced by NLM (results for BLAST search RID-S4SNEG3G014, accessed 02/04/2026); and GenBank: KT783525.1 (“Paenibacillus polymyxa strain J 16S ribosomal RNA gene, partial sequence”; 2015).
Sikuljak et al. teach pesticidal mixtures comprising B. simplex, Paenibacillus polymyxa, Metarhizium anisopliea, and Quillay extract (page 1, lines 40 -42, page 2, lines 1-34, and page 3, lines 1-30). The mixtures of the present invention can be converted into customary types of agro-chemical compositions such as suspensions … wettable powders (page 41, lines 23-32).
Sikuljak et al. lacks a teaching wherein the B. simplex and Paenibacillus polymyxa have the instantly claimed 16s rRNA as disclosed in SEQ ID NO:1 and SEQ ID NO:5, respectively.
Guo-hong et al. teach B. simplex strain DSM 1321 (abstract). The instant specification at Table II shows that this strain has 99.66% similarity with the 16S rRNA.
The GenBank record: KT783525 locus corresponds to Paenibacillus polymyxa strain J 16S ribosomal RNA gene, partial sequence, from 2015, has 99.41% identity to blast results for RID-S4SNEG3G014 (a search of instant elected SEQ ID NO: 5 for Paenibacillus polymyxia):
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“Identification of a plant growth promoting bacterium”
It would have been prima facie obvious to one of ordinary skill in the art at the time of the instant invention to use the corresponding strain KT783525 of Paenibacillus polymyxia and DSM 1321 strain of Bacillus simplex in the mixture of Sikuljak et al. and have a reasonable expectation of success. One would have been motivated to do so since these are known strains useful in agrochemical formulations, for promotion of plant growth. Therefore, the instant claims are rendered obvious by the teachings of the prior art.
Applicant previously argued that the cited prior art does not teach B. simplex and Paenibacillus polymyxa having the instantly claimed 16s rRNA as disclosed in SEQ ID NO:1 and SEQ ID NO:5 with 100% similarity. Applicant’s argument was previously fully considered but found not to be persuasive. The prior art teaches B. simplex 16s rRNA with 99.6% similarity and Paenibacillus polymyxa J 16S rRNA with 99.41% similarity. While they are not exactly the same they are merely close. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Applicant also argued that absent reliance on impermissible hindsight reconstruction one would not have been motivated to combine B. simplex and Paenibacillus polymyxa in a single composition. Applicant’s argument was previously fully considered but found not to be persuasive. Sikuljak et al. teach that more than one biopesticide may be combined with a carboxamide compound (page 2, line 15). B. simplex and Paenibacellus polymyxa are described as a microbial pesticide that can be added to the composition (page 2, lines 17-26). The combination of two different microbes is expected to have an additive effect. Therefore, the prior art suggests the combination of B. simplex and Paenibacillus polymyxa.
Finally, Applicant argued that the prior art does not teach or suggest the efficient solubilization of phosphor and zinc. Regarding the former P. polymyxa strain, Applicant provided evidence that the species previously cited did not solubilize zinc, as required by the current claims.
However, for the alternate P. polymyxa strain, the close similarity of 99.41 % identity to the elected SEQ ID NO:5 is construed as sufficiently close, which would have the same properties regarding phosphate and zinc solubilization, absent evidence to the contrary.
This language is construed to be an inherent property of the claimed consortium, or alternatively, an intended use, insufficient to overcome the prima facie obviousness. Examiner notes there is no evidence that the individual bacterial strains of Bacillus simplex and Paenibacillus polymyxa do not have the properties contributing to the consortium’s ability. In fact, Figure 4 B is evidentiary of Zn solubilization of each claimed bacteria in isolated form. No evidence of greater than additive Zn solubilization was identified. Clearly this is a property of the individual isolated bacteria.
It is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding the formulations of amended claim 36, both suspensions and wettable powders are taught by Sikuljak, rendering obvious either of these formulation types.
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 36-49, 52-55 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product (a product of nature) without significantly more. The claim(s) recite(s) A microbial consortium comprising an isolated bacterial strain belonging to the genus Bacillus species simplex characterized by at least one species-specific sequence selected from: SEQ ID NO: 1-4, wherein [Applicant elected] SEQ ID NO: 1 refers to 16S rRNA gene, SEQ ID NO: 2 refers to gapA gene, SEQ ID NO: 3 refers to uvrA gene and SEQ ID NO: 4 refers to pgk gene, and an isolated bacterial strain belonging to the genus Paenibacillus, species polymyxa by at least one species-specific sequence selected from: SEQ ID NO: 5-7, wherein [Applicant elected] SEQ ID NO: 5 refers to 16S rRNA gene, SEQ ID NO: 6 refers to rpoB gene, and SEQ ID NO: 7 refers to nifH gene, wherein the consortium is able to solubilize phosphate and/or zinc. This is a product, a combination of two naturally occurring microbes.
This judicial exception is not integrated into a practical application because the solubilization of phosphate and/or zinc is construed as an intended use (or an inherent property of the consortium), which does not modify the combination of two microbes recited. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited intended use (or inherent property) does not structurally change the combination of two bacterium claimed.
Regarding “combination” of the two elected bacteria, each of which have been obtained from two unique specie, this situation is analogous to the combination of two unique bacteria, held to be ineligible subject matter in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948).
There is no indication in the specification that the claimed microbial consortium, comprising the two naturally occurring bacteria, has any characteristics (structural, functional, or other properties) that are different from the naturally occurring bacteria strains, individually.
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As discussed in MPEP 2106, the analysis has been conducted according to the flow charts set forth therein (see above and below):
Step1: The claim is drawn to a Composition of Matter; Yes.
The Analysis cannot be streamlined.
Step 2 A: The Claims are directed to a Natural Phenomenon (a Product of Nature), i.e., a combination of two naturally occurring Bacteria; Yes, a judicial exception applies.
Step 2A is a Two-prong Inquiry, per MPEP 2106.04 (II) (A):
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Prong One: The claim (36) recites a natural Phenomenon (a combination of two naturally occurring bacteria); Yes.
Prong Two: The claim does not recite additional elements that integrate the judicial exception into a practical application; No.
Step 2B: The claim does not recite additional elements that amount to significantly more than the judicial exception; No.
Accordingly, the claim (independent claim 36) is not eligible subject matter.
Regarding the amendment to claim 36, the first wherein clause recites wherein the consortium is able to solubilize phosphate and[[/or]] zinc, wherein the isolated bacterial strain belonging to the genus Paenibacillus, species polymyxa is able to solubilize zinc. These two phrases have to do with properties of the consortium (is able to solubilize phosphate and zinc. These are characteristics of the two bacteria comprising the consortium. The Paenibacillus polymyxa, when isolated (prior to the combination) has properties of being able to solubilize zinc. Both of these recited properties are construed as characteristics of the combination, and characteristics of the Paenibacillus polymyxa. Since these are inherent properties of one or both the bacteria, these are considered part of the law of nature; a natural phenomenon.
The final wherein clause of claim 36 added to the amendment, and wherein the microbial consortium is formulated as water-soluble concentrates, dispersable concentrates, emulsifiable concentrates, emulsions, suspensions, microemulsion, gel. Microcapsules, granules, ultralow volume liquid, wetting powder, dustable powder, or seed coating formulations. This clause adds a series of alternative formulations of the microbial consortium, considered to be added formulation, well known, routine, conventional activity. Review of an article by Martin et al., (“Purdue Extension: Pesticides and Formulation Technology”; 1/11) documents that many of the formulations now named in claim 36 are well known, routine and conventional in the area of soil formulations. A water-soluble concentrate is mentioned on P. 5 and col 1 of p. 11; p. 10 describes dispersible agents mixed with water, requiring further dilution with water before use (i.e. these are dispersable concentrations). Emulsifiable concentrates are described on p. 10 3rd column. An emulsion is depicted at the bottom of p. 11, and described on p. 5, right column. A suspension is described at p. 5, right column. Granules are described on p. 7. A wetting powder is described on p. 8. Dusts (dustable powder) is described on p. 7. This documents at least 8 of the claimed alternatives add a well understood, routine, conventional element. As discussed in MPEP 2106.05 (d), If, however, the additional element (or combination of elements) is no more than well-understood, routine, conventional activities previously known to the industry, which is recited at a high level of generality, then this consideration does not favor eligibility. Each of these alternatives may be characterized in this manner, and their inclusion does not render claim 36 patentable. Thus, the amended claim does not add significantly more than the judicial exception.
Regarding dependent claims, claim 37 recites a deposit with accession numbers for each bacteria strain. Claim 53 recites a named designation. Each of these are simply a way to identify the bacteria, and does not integrate the judicial exception into a practical application (Step 2A, Prong Two, No).
This also does not amount to significantly more than the judicial exception.
Claim 38 simply recites a series of forms in which the isolated bacterial strains are present, which does not integrate the judicial exception into a practical application, or add significantly more than the judicial exception.
Claim 39 indicates the isolated bacterial strains are mutated and/or edited. The disclosure at p. 12, lines 15-20 indicates that SEQ ID NO: 1 of the Bacillus simplex strain of the invention has 80-99.9% identity in Bacillus simplex strain of the invention. The disclosure at 14:22-25 indicates that SEQ ID NO: 5 of Paenibacillus polymyxa strain of the invention has 80-99.9% identity with SEQ ID NO: 5. Thus, mutated or edited are within the scope of the claimed bacterial strains. Accordingly, this limitation does not integrate the judicial exception into a practical application, or add significantly more than the judicial exception. Additionally, the prior art combination discussed in the obviousness rejection is also within the disclosed identity range, and corresponds to two naturally occurring bacterial strains.
Claims 40-41 require the microbial consortium further comprises another microorganism; review of the alternatives of claim 41 demonstrates many alternatives that are also naturally occurring; thus, these claims result in more component naturally occurring combinations of bacteria, also products of nature.
The limitations of claim 42 claim fresh or frozen or dry, lyophilized or liquid suspension, or encapsulated in the form of living and/or dead and/or killed cells and/or spores. These are all construed as routine ways of presenting individual bacterial strains, which does not integrate the judicial exception into a practical application, or add significantly more than the judicial exception.
Claim 43 & 54 recite ratios/ a ratio range, which does not change the recited combination of two naturally occurring bacterial strains; this neither integrates the judicial exception into a practical exception, nor adds significantly more than the judicial exception.
Claim 44-45 adds a biostimulant. This is recited at a high level of generality, and embraces naturally occurring biostimulant materials (claim 46). This includes natural materials, giving a three-component mixture of naturally occurring materials, which also is a judicial exception, without integrating into a practical application or adding significantly more than the judicial exception.
Similarly, the alternative materials of claim 45, 46, add additional natural products, which would give alternative three-component mixtures of naturally occurring materials, each of which would correspond to alternative naturally occurring combination; also corresponding to products of nature
Claims 47, 48, 49, 55 recite medium, extract, etc. or carrier, common vehicles at a high level of generality, which do not integrate into a practical application, nor add significantly more than the judicial exception.
Claims 50-52 recite various forms of the consortium, none of which integrate the judicial exception into a practical application or add significantly more than the judicial exception.
Applicant argues that the rejection does not explain how the additional components fail to integrate the judicial exception into practical application or add significantly more, citing a point made about claims 50-52. Claims 50-51 have been canceled. The amendment to claim 36 has added various alternative formulation types to this claim; these added components are formulations well known, routine, conventional in the field of soil application formulations. At least 8 of these are discussed in the Purdue Extension document on pesticides and formulation technology, documenting each of these fail to convert the microbial consortium into patent eligible subject matter.
Any one of these would render the claims as failing to add significantly more to the judicial exception identified in claim 36. Additional study would be made if claim 36 were to be further limited to formulations not mentioned by the paper cited; each of these are believed to be routine, well-known and conventional, and recited at a high level of generality; this addition does not integrate the subject matter into a practical application.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 TIMOTHY P THOMAS whose telephone number is (571)272-8994. The examiner can normally be reached M-Th 6:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TIMOTHY P. THOMAS
Primary Examiner
Art Unit 1614
/TIMOTHY P THOMAS/Primary Examiner, Art Unit 1614