DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 Jan 2026 has been entered.
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 .
Claim Status
Claims 5-6 & 19-20 are under examination on the merits.
Claims 1-2, 14 & 18 are withdrawn.
Claims 3-4, 7-13, 15-17 & 21-22 are canceled.
Priority
Claims 5-6 & 19-20 receive the U.S. effective filing date of 12/06/2022
Previous rejection of claims 5-6 & 19-22 under 35 U.S.C. 112(b) as being indefinite is withdrawn in light of Applicant’s amendments to the claims.
Claim Objections
Applicant is advised that should claim 5 be found allowable, claim 19 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. The full scope of claim 19, with included limitations of claims 14 & 18, are so close in content as to represent the same method as recited in claim 5, with included limitations of claim 1.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 & 20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 6 & 20 are each dependent from claims that are drawn to a soybean plant having two loci associated with dicamba tolerance, one on chromosome 19 and one on chromosome 10. Claims 6 & 20 attempt to narrow by reciting that the soybean plant with these dicamba loci further ‘exhibits increased tolerance to dicamba as compared to a control soybean plant [lacking the loci]’.
However, as the prior claims 5 and 19 already identify loci which by definition confer ‘dicamba tolerance’, those same alleles would inherently result in plants exhibiting increased dicamba tolerance, relative to plants lacking them. As such, claims 6 & 20 fail to further limit the subject matter. They simply restate the inherent qualities of the dicamba tolerance loci present, as previously recited in claims 5 & 19, using slightly different language.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 5-6 & 19-20 are rejected because the claimed invention is directed to natural phenomena without significantly more. The claim recites a method of identifying and/or selecting alleles for a naturally occurring soybean haplotype. This judicial exception is not integrated into a practical application because Applicant is claiming a natural phenomenon; that of a naturally occurring haplotype already present and observed and/or selected phenotypically.
Due to Applicant’s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 1 Oct 2025, as applied to claims 5-6 & 19-22. Applicant’s arguments filed 1 Dec 2025 have been fully considered but they are not persuasive.
The claims, which are drawn to selection of a naturally occurring allelic variant of a UDP-glycosyltransferase, do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no narrowing of the claim to a meaningful limitation beyond phenotypic selection of a naturally occurring gene in breeding populations; Applicant provides no limitation beyond producing, providing, or crossing a soybean plant of a phenotype that denotes presence of the dicamba tolerance loci, and this phenotype can be visually seen or selected.
This is a natural phenomenon because Applicant is claiming a haplotype which naturally occurs in existing soybean germplasm and is identified phenotypically.
Claims 5 & 19 recite a soybean plant comprising the dicamba tolerance loci on chromosomes 10 & 19. However, Applicant’s claim language only recites ‘selecting’ the loci based on ‘the presence of the favorable alleles’; broadest reasonable interpretation of this would still encompass routine phenotypic selection of natural allelic variants and generation of said plants (i.e. products) via such selection (i.e. process).
Previous press releases from the Applicant describes such natural occurrence of this. In a 2019 report with NPR, Applicant describes the initial observation of damage in their diverse soybean germplasm over the course of three years, as a result of unplanned dicamba drift from nearby commercial production fields. They describe their observation of the phenomenon of drift damage [Charles, Rogue Weedkiller Vapors are Threatening Soybean Science; Published 19 July 2019]. It is notable that these observations were not part of any intentional, directed, or controlled study or experiment intended to find alternate dicamba resistance in soybean – the dicamba damage uncovering the natural genetic variation was simply an accident occurring during unrelated work.
A subsequent press article in 2020 details that Applicant then noticed variation for this potential natural tolerance to dicamba as, “we’ve found some lines that were tolerant, and others that have been susceptible” [Brown, p.1, par.2]. They go on to state that the value of such a naturally occurring trait is it, “would not be protected. It would be free to everybody who could use it” [Brown, p.1, par.12]. A yet third press release was made later in 2020 with Applicant’s research group titled, “Soybeans show natural resistance to dicamba”. In that article they describe their work to molecularly describe the natural variation in the soybean genome responsible for the observed, naturally occurring dicamba tolerance. They outline their efforts to characterize “these seemingly natural dicamba-resistant soybeans” [Ward, par.5].
As written, claims 5 & 19 would merely be providing a plant via the process of selecting ‘less damaged’ plants from those exposed to dicamba, which would reasonably result in obtaining plants with the claimed haplotype. The language of plants ‘comprising’ favorable alleles does not require that one used DNA-based screening or biotech manipulations to arrive at the presence of a particular haplotype. It only means that the plants comprise such loci, which could be selected or carried forward in populations via any selection method relevant to dicamba tolerance. One would reasonably observe this in the natural biodiversity of soybean when examining a field damaged by dicamba drift. Thus, this claim is not directed to significantly more than a natural phenomenon and corresponding natural genetic variation, alleles, and/or haplotype.
Claims 6 & 20 recite the additional element of a plant with both loci as also exhibiting increased tolerance to dicamba. However, such naturally occurring dicamba tolerance is demonstrated in existing germplasm. Referring to Applicant’s embodiments, Example 1 describes their screening of 382 diverse soybean accessions from the USDA, representative of the diversity of global germplasm [Specification, par.0143]. This amounts to a genetic diagnosis existing soybean biodiversity. Applicant detects plants in this collection which possess their claimed haplotype. They do not indicate the identity of the specific lines characterized with the particular haplotypes, or otherwise disclose the germplasm accessions with both beneficial alleles present, although they are depicted categorically in Figure 3. This indicates the loci and specific haplotype claimed are naturally occurring alleles, already present in global breeding germplasm. As such, claim 6 provides such plants via the process of selecting ‘less damaged’ plants from those exposed to dicamba, which would reasonably result in obtaining plants with the claimed haplotype.
Applicant’s disclosure indicates the desirable ‘T’ SNP allele of the chromosome 19 locus to be abundant in germplasm, stating it is relatively common in 28.3% of surveyed material [Specification, par.0169]. This indicates common presence of this gene, its alleles, and enzymes inherently encoded by such sequence. The chromosome 10 locus is similarly found. Applicant describes the chemical structure of the loci, but the core method of ‘producing’ or ‘identifying’ such a soybean can, and has been, performed visually by simply looking at plants less affected by herbicide drift, and then selecting them.
Applicant also shows that although less common, global soybean germplasm includes material that possess ‘favorable alleles’ on both chromosomes 10 and 19 (i.e. the claimed haplotype), and that they exhibit significantly lower dicamba damage than plants lacking the singular ‘favorable alleles’ [See Figures 3 & 4, ‘Allelic Combination’ SNP 0,0,0 vs SNP 1,1,0]. If one were to observe a dicamba damaged field and select the healthiest soybean (i.e. survivor) in diverse germplasm, they would select the plant(s) with both the chromosome 10 & 19 loci.
Routine phenotypic assessment of the USDA soybean collection would reasonably select either the two loci independently, or those individual plants with both loci (i.e. dicamba tolerant haplotype). This phenomenon would also be observed in any field damaged by unintentional herbicide drift harboring a representative swath of naturally occurring soybean biodiversity.
Such genetic diagnosis of naturally occurring genes or alleles describes natural phenomena, and while this can be incredibly informative, it is not inventive subject matter.
Thus, claims 5-6 & 19-20 are rejected as phenomena of nature and therefore non-patentable subject matter.
Response to Arguments
Applicant urges that previous rejection of claims 5-6 & 19-20 is improper because the amended claims specify plants comprising dicamba tolerance loci on both chromosome 10 & 19 (i.e. a haplotype vs single locus), and that “there is no evidence of record that any naturally occurring soybean plant possesses this combination of favorable alleles at both loci and exhibits increased tolerance to dicamba” [Remarks, p.7, par.4 – p.8, par.1]. They argue that methods require a specific combination of favorable alleles at two distinct molecular markers/loci (i.e. a specific haplotype) which does not occur naturally.
This is not found persuasive because Applicant provides evidence of naturally occurring plants possessing both favorable alleles in both Figures 3 & 4 of their specification [Specification, Figures 3 & 4, ‘Allelic Combination’ SNP 0,0,0 vs SNP 1,1,0 & SNP 1,1,1]. Moreover, based on these figures, it appears the soybean plants with this haplotype also have significantly lower dicamba damage than the plants lacking said favorable alleles. Review of data in Figure 3 indicates soybean germplasm can be classified into roughly three groups of ‘susceptible’ (damage score >2.5, n =333), ‘moderate resistant’ (damage score 2-2.5, n = 40), and ‘most resistant (damage score <2, n = 9). The ‘most resistant’ category of soybean germplasm consists only of plants having the claimed haplotype (i.e. SNP 1,1,0 and/or SNP 1,1,1).
Such plants would present themselves clearly as the ‘most resistant’ individuals in a nursery damaged by herbicide drift [Figure 3]. Further, the only 100% ‘dicamba resistant’ plants observed (SNP 1,1,1), which would be the most obvious and desirable to select, possess the claimed chromosome 10 & 19 loci haplotype.
Thus, Applicant’s data directly contradicts their argument that there is no natural occurrence of both ‘favorable alleles’ in existing soybean germplasm. It is clear that there are naturally occurring haplotypes of dicamba-resistant soybean comprising the claimed loci. This is provided directly in Applicant’s data. It is also clear that if one were to select the only completely resistant plants from naturally occurring germplasm, they would reasonably select the claimed haplotype even without any genotypic information and without the use of molecular markers.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571)270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Anne Kubelik/Primary Examiner, Art Unit 1663