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 .
Claim Status
Claims 35-40, 46-48 & 52-64 are under examination on the merits.
Claims 1-34, 41-45, 49-51 & 65 are cancelled.
Priority
Claims 35-40, 46-48 & 52-64 receive the U.S. effective filing date of 08/12/2020.
Rejection of claims 41-46 under 35 U.S.C. 112(d) as being of improper dependent form is withdrawn in light of claim amendments.
Rejection of claims 49-52 under 35 U.S.C. 112(d) as being of improper dependent form is withdrawn in light of claim amendments.
Rejection of claims 36-47 & 54-58 under 35 U.S.C. 112(a) as failing to comply with the written description requirement, with respect to possession, is withdrawn in light of claim amendments.
Rejection of claims 47 & 53 under 35 U.S.C. 112(a), as failing to comply with the written description requirement for lack of possession are withdrawn.
Rejection of claims 59-64 under 35 U.S.C. 112(a) as failing to comply with the written description requirement for lack of possession are withdrawn.
Claim Rejections - 35 USC § 112
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 36, 39 & 40 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.
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 13 June 2025, as applied to claim 36. Applicant's arguments filed 13 October 2025 have been fully considered but they are not persuasive.
Claim 36 is dependent from claim 35 and drawn to a generating a BC1F1 progeny by crossing hybrid progeny to the domestic annual Glycine plant. Common meaning in the art is that a BC1F1 progeny results from crossing an F1 progeny (back) to one of the original parents used in making the initial cross.
As written, it is unclear if Applicant is limiting this claim to a backcross performed to the diploid or tetraploid form of the domestic soybean used in the cross. A backcross to the domestic Glycine parent would require crossing to the doubled, domestic parent (tetraploid) limited to in claim 35, because the tetraploid is the original parental material (i.e. backcrosses are made to parents). Crossing to ‘a domestic annual Glycine plant’ indicates potentially outcrossing progeny to non-parental material (i.e. it indicates crossing to the diploid ancestor of the parent), and thus would not be a BC1F1 progeny.
Furthermore, as amended, this claim remains unclear because reference to either diploid G. max or tetraploid G. max germplasm is presented as ‘a domestic annual Glycine species’ and ‘a doubled domestic annual Glycine plant’ – Applicant has amended and refers to ‘the domestic annual Glycine plant’, which appears to mix this nomenclature. This is because the claim language recites that a ‘doubled’ form refers to plant but the diploid form refers to species.
Applicant’s amendment appears to potentially be referring to the diploid (i.e. recited ‘species’) but comingles the terminology used for the tetraploid (i.e. recited ‘plant’). It is unclear to one skilled in the art what is being claimed by the applicant, which parental material limits the backcross, and where the metes and bounds of the claim lie.
Because of this indefiniteness, the rejection of claim 36 is maintained.
Claim 39 recites the limitation ‘the doubled soy plant’ in line 1. There is insufficient antecedent basis for this limitation in the claim. This is because claim 39 depends from claim 35 which has been amended to remove previous recitation of a ‘doubled soy plant’ and replace it with ‘doubled domestic annual Glycine plant’.
As such, claim 39 is rejected.
Applicant is advised to amend claim 39 to reference the revised language presented in previously amended claim 35.
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 13 June 2025, as applied to claim 40. Applicant's arguments filed 13 October 2025 have been fully considered but they are not persuasive.
Claim 40 has been amended to recite doubling a G. max plant to arrive at a tetraploid. However, as currently written it is unclear whether the claim is referring to the specific tetraploid recited in step (a) of claim 35, or, if it is claiming an unrelated tetraploid plant not used in any further method steps. This renders the claim indefinite.
As such, claim 40 is rejected.
Applicant is advised to amend the claim to either clearly reference the doubled domestic annual Glycine plant having 4nD chromosomes or otherwise clarify the intent of the tetraploid introduced in claim 40.
Response to Arguments
The previous rejection of claims 35, 40, 47 & 53, for reciting a broad range or limitation together with a narrow range or limitation, is withdrawn in light of claim amendments.
Applicant urges that further issues of indefiniteness are remedied by the amendment of claim 36 to recite ‘domestic annual Glycine plant’ [Remarks, p.5, par.5]. They make this amendment to resolve the uncertainty around the use of the term ‘soy plant’ but are silent as to the issues surrounding indefiniteness of the backcross methodology with respect to the tetraploid parent [see previous Office action, p.7, par.3, l.5-7].
This is not found persuasive because while Applicant’s amendments resolve ‘soy plant’ issues surrounding claim 35, they do not address the lack of clarity as to what material is being crossed, if such crosses are limited to the actual parental materials used (i.e. backcrossing to tetraploid parent) or can be outcrossed to related, but non-parental material (i.e. outcrossing to diploid ancestor). This issue is further confounded because the nomenclature used mixes specific terms recited to indicate parental material as either diploid or tetraploid.
Applicant is advised, for the sake of clarity in setting limitations, to use concise and consistent nomenclature for plants referenced. For example, ‘doubled domestic annual Glycine plant’ appears as though it may be more concisely stated as, ‘tetraploid G. max’. Similarly, a ‘domestic annual Glycine species’ appears as though it could be recited ‘diploid G. max’. This would improve readability of the claim set and provide more definite description of Applicant’s invention.
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.
Claims 47, 53 & 59-64 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 tetraploid G. max X diploid G. tomentella crosses, does not reasonably provide enablement for the reciprocal cross or any and all perennial-by-annual polyploid hybridizations. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make use of the invention commensurate in scope with these claims.
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 13 June 2025, as applied to claims 47 & 53. Applicant's arguments filed 13 October 2025 have been fully considered but they are not persuasive.
Claims are drawn to use of the tetraploid G. max as the male parent in crossing.
Applicant’s specification discloses broadly that the interspecific cross can potentially be performed in either direction. However, the embodiments only describe effective use of the tetraploid G. max as the female parent in the cross [Figures 2-4, Example 2]. No indication is given how use of G. max as the male parent, or pollen donor, can be used with an expectation of success. There are related reports in the scientific and technical literature indicating the difficulty of polyploid crosses generally, as well as those specific to G. max X G. tomentella. Such reports indicate use of G. max as a pollen donor may fail and therefore merit verification on a case-by-case basis [See Singh & Nelson (2015); p.1135, col.1, par.2, last sentence in paragraph].
The embodiments only describe effective use of the tetraploid Glycine max as a female parent in the cross [Figures 2-4]. The chromosome counts are shown for only a G. max (female) x G. tomentella (male) cross as being stable enough to undergo successful meiosis or reproduction. Applicant indicates attempts were made to use the doubled male as the pollen donor in Example 2, but results presented in Tables 1 & 2 [Specification, p.11] demonstrate that the only viable embryos or shoots obtained were those using non-domestic pollen donors (i.e. G. tomentella lines ‘M1’, ‘M4’, ‘M5’, ‘M14’, ‘M15’).
Applicant’s disclosure that crosses were made using tetraploid G. max lines as a male parent, followed immediately by a data table lacking any indication of viable progeny from those crosses, suggests using tetraploid G. max as the pollen donor actually failed, absent evidence to the contrary. If such crosses were successful in generating hybrid progeny it is unclear why Applicant would have omitted such critical results from Tables 1 & 2.
Furthermore, the art teaches that success of G. max X G. tomentella crosses are profoundly impacted by cytoplasmic effects (i.e. which species is used as the maternal parent). Singh & Nelson reports that when G. tomentella is used as the female parent, the introduction of the nuclear material from the cultivated species (i.e. G. max) into the alien cytoplasm (i.e. G. tomentella as female parent) has several potential issues [p.1135, col.1, par.2].
Differences in results when making this interspecific cross occurs even when using the exact same parental lines, but in reverse (i.e. alternating the species used as male parent). Singh & Nelson describe major alterations to phenotype/morphological outcomes (i.e. may not be agriculturally suitable), potential loss of chromosomes in progeny (i.e. reversion to parental types), and completely different patterns of chromosome segregation in derived material [id.]. They directly state that experimental evidence indicates reversing the cross direction can lead to failure and these therefore require verification of success [p.1135, col.1, par.2, last sentence in paragraph].
The scientific and technical knowledge pertinent to G. max X G. tomentella hybrids indicates one would not expect equivalent results when reversing the direction of such a cross. Applicant describes an attempt to reverse the cross, but does not disclose whether those attempts were successful [Specification, p.11, Example 2]. Successful crosses in the reverse direction would be contrary to the prevailing scientific and technical knowledge in the art presented by Singh & Nelson.
Because of this, claims 47 & 53 drawn to use of a tetraploid G. max as the pollen donor are not sufficiently enabled by the disclosure provided, and are therefore rejected.
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 13 June 2025, as applied to claims 59-64. Applicant's arguments filed 13 October 2025 have been fully considered but they are not persuasive.
Claims are drawn to broad application of the recited polyploid breeding methodology in potentially any and all plants.
Applicant’s specification describes interspecific crosses of tetraploid G. max X diploid G. tomentella. It is known in the art that polyploid, interspecific crosses in several crop species are possible but that successful application of these methods are often specific to particular germplasm [See Mason, Creating new interspecific hybrid and polyploid crops, p.437, col.1, par.5 – col.2]. No indication is given how one would use this method with a reasonable expectation of success in any plant taxa other than G. max and G. tomentella.
Even within a single genus such as Glycine, it is known in the art that successful intergeneric soybean crosses are dependent on the particular individual germplasm or breeding lines within a crop. It is not enough to simply describe the species involved, as not every individual within that species can be used with an expectation of success [Singh & Nelson; p.1133, col.2, par.1, l.1-3 & par.2, l.1-4].
Applicant directly admits this difficulty in their specification [Specification, p.3, l.4-11] yet only provides one representative species consisting of seven particular Glycine breeding lines. They also make general reference to the hypothetical application of the method in Brassica species. Description of one species in detail, and another in theory, is not sufficient to enable the application of a method across many thousands of plant species (i.e. a broadly claimed genus), all having varied chromosomal makeup and reproductive biology.
As such, Applicant has not reasonably provided enablement for all wild-by-domesticated hybridizations within any and all crops, any and all perennial-by-annual hybridizations, or hybridization of any plant generally beyond the narrow scope of the specific Glycine cross(es) described in their disclosure.
Response to Arguments
Applicant urges enablement is provided for such a broad scope in absence of the Examiner presenting sufficient evidence or reasoning why one skilled in the art would not be able to perform the method(s) limited to in the claim language [Remarks, p.8, par.3; p.10, par.3-5].
This is not found persuasive because they argue this in the context of describing an individual experimental step they present (i.e. one would be able to ‘perform a cross’) rather than successful inventive outcomes (i.e. description of producing a hybrid clearly demonstrating details of how the proposed methodology works). Applicant is silent as to how such pollinations would avoid the issue of sterility and/or failed formation of a viable progeny.
Pointing one to such an open-ended research effort as ‘attempt crossing’ in potentially any plant species is not enabling description for creation of polyploid hybrids generally, and would require undue experimentation on the part of the reader because no guiding description is provided by Applicant other than suggesting a new research project. Such a generic statement does not enable the broad production of claimed hybrids (i.e. progeny) in any and all plants. One can clearly perform or attempt many crosses between plants of different chromosome count, without success.
Claims recite production of hybrid progeny, not mere crossing. Merely describing a cross pollination that is potentially sterile or fails to form a progeny plant is not a description of the limitations of claims at issue.
This basis of questioning Applicant’s claims surrounding scope of enablement is rooted in the abundance of research literature detailing the crop-specific technical difficulties of working with polyploids [cited previous Office action; p.10, par.4; p.12, par.1], as also admitted by Applicant in their disclosure [see specification; p.3, l.4-11]. Thus, the research literature and Applicant both point to the reasonable uncertainty one skilled in the art would have regarding overly broad cross-application of polyploid breeding methodology. This is both evidence and reasoning that an appropriate enabling description need involve more than merely describing an attempted pollination which may be fail or be sterile.
The technical details of breeding polyploid hybrids are complex and require very specific description, often including specific germplasm used in very specific defined ways, depending on the crop plant in question [Mason, p.437, col.1, par.5 – col.2].
Applicant emphasizes this point regarding the specificity of polyploid breeding techniques in their response to 103 obviousness rejections presented in the previous Office action [Remarks, p.12, par.2-3]. They directly state, “one of skill would not…have any expectation of success upon crossing tetraploid soybean with wild perennial Gylcine species” [p.12, par.3].
It is clear that sterility, or failure of the crossing step, is highly likely or perhaps expected when attempting to create polyploid hybrids, absent specific details describing how one would avoid such an outcome in a given crop. Neither crop-specific germplasm or crop-specific methods of overcoming this are sufficiently described by Applicant in enough representative species with respect to the breadth of scope currently claimed.
The argument that generically describing routine experimental procedures (i.e. ‘perform a cross’) in absence of results adequately describes a method broadly applicable is not persuasive. Applicant has not provided sufficient details commensurate to the scope of the claims, particularly in light of scientific knowledge and teachings indicating the high level of specificity required in polyploid systems. Absent such, it is unclear how one would avoid sterility issues when performing pollinations.
Applicant is advised to limit claimed methodology to the breeding systems which they have described (i.e. female tetraploid G. max X male diploid G. tomentella) or otherwise support how their description addresses or overcomes the teachings of the relevant technical literature.
Applicant urges sufficient information is provided in Example 2 of the specification to enable successful production of hybrid progeny when using the tetraploid G. max as the male parent in the proposed cross [Remarks, p.11, par.1].
This is not found persuasive, because Example 2 merely recites the generic and singular step of ‘performing a cross’ using tetraploid G. max as the pollen donor without describing production of hybrid progeny. In the Example, Applicant states in one sentence that such crosses were made. Howeever, in the associated tables describing resulting embryo & shoot counts formation the only successful crosses reported strictly utilize the tetraploid soy as female. There is no indication or description of the crosses made with tetraploid G. max pollen as having produced hybrid progeny.
Applicant further urges sufficient information is provided by additional Example 9 of the specification to enable successful production of hybrid progeny in any and all crops [Remarks, p.11, par.1].
This is not found persuasive, because Example 9 merely recites a generalized, prophetic example of polyploid gene transfer in Brassica. While Brassica species are recognized as having well-established methods of polyploid breeding and gene transfer [Mason, p.438, col.1, par.1], Applicant provides no supporting argument as to why pointing to one additional example (i.e. species) beyond Glycine would be representative as enabling across the broad scope of the entire plant kingdom (i.e. genus).
It is known in the art that the technical details of breeding polyploids are complex and frequently require very crop-specific details. This often includes guidance on specific germplasm used in particular ways, depending on the crop plant in question. This evidence & reasoning was presented in the references cited in the initial Office action 06-13-2025 [p.11, par.4]. Applicant is silent as to how or why description in Glycine, with one additional hypothetical example from Brassica, would be reasonably considered to be enabling for any and all plants. No statement is made as to why those two crops would be particularly unique or descriptive of a method claimed as being enabled for any and all plants.
For these reasons, Applicant’s arguments are unconvincing. The argument that description of two plant genera (i.e. a narrow species example) is representative description for a method enabled across the entire plant kingdom (i.e. a broad genus) is not persuasive. Applicant has not provided sufficient details commensurate to the scope of the claims, particularly in light of scientific knowledge and teachings indicating the high level of specificity required in functional application of polyploid breeding methods.
Applicant clearly describes and enables the method within scope of their specific Glycine breeding populations, but they do not provide sufficient supportive description in other plants representative of the broad scope currently claimed.
Applicant is advised to limit claims to the crops and breeding systems which they have provided appropriate scope of enabling description for (i.e. female tetraploid G. max X male diploid G. tomentella).
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.
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 13 June 2025, as applied to claims 35-36, 38-40, 46-48, 52-56 & 58. Applicant's arguments filed 13 October 2025 have been fully considered but they are not persuasive.
Claims 35-36, 38-40, 46-48, 52-56 & 58 are rejected under 35 U.S.C. 103 as being unpatentable over Singh [US 2007/0261139 A1; Published 11-08-2007] in view of Mujeeb-Kazi [Genetic Resources and Crop Evolution 43: 129-134, 1996; Published 04-18-1995].
Claims are drawn to production of hybrid progeny between a tetraploid domesticated G. max and a diploid wild G. tomentella for the transfer of disease resistance alleles from wild germplasm to domesticated soybean.
Singh teaches methods of polyploidization to improve resistance to soybean rust in their 2007 patent application, ‘METHODS FOR PRODUCING FERTILE CROSSES BETWEEN WILD AND DOMESTIC SOYBEAN SPECIES’. Specifically, they disclose use of G. tomentella as the wild ‘donor’ in interspecific crosses to G. max, use of reciprocal crosses [0064], and backcrossing after polyploidization to transfer genes from the hybrid progeny to cultivated soybean background [Figure 1], as in claims 36, 46-48 & 52-53 of the instant application. They depict the genomes of diploid G. max (GG), allopolyploid G. tomentella (DDEE) and creation of a ‘GGDE’ genotype from such a method [Figure 1], corresponding to Applicant’s claims 40, 54 & 58. In their patent application, they teach the use of applying an auxin, 1-naphthalene acetic acid, to pollinated gynoecia to facilitate seed set when making this interspecific hybrid [0027, l.10] and also describe the common practice of using colchicine to double chromosomes in plants [0024, l.25], as in Applicant’s claims 35 and 39, respectively.
Singh does not teach use of a domesticated tetraploid prior to making the interspecific cross to achieve balanced chromosome number, as their inventive research is focused on doubling after pollination and rescue of infertile hybrid progeny.
Mujeeb-Kazi teaches methods of utilizing a tetraploid parent in polyploid crosses directed to interspecific transfer of rust disease resistance. They disclose an interspecific breeding method relying on a domestic tetraploid wheat as a maternal parent. Their disclosure describes an equivalent process of crossing a tetraploid domesticated parent plant with a diploid wild parent. Specifically, Mujeeb-Kazi teaches the crossing of a cultivated, tetraploid wheat plant/genome (4n = AABB = 28) [p.133, Table 3] to the diploid wild species Aegilops tauschii (2n = DD = 14) [p.129, col.2, par.1]. The domestic tetraploid parent crossed to a wild, diploid relative with the goal of transferring beneficial alleles from the wild species to the domesticated crop.
While Mujeeb-Kazi’s work is in wheat, not soybean, it is drawn to similar creation of polyploids, and teaches use of a tetraploid domestic species to facilitate transfer of rust resistance. Moreover, they teach use of a tetraploid whose genomic complement was already doubled at a point prior to crossing with the diploid wild donor of disease resistance alleles.
It teaches that one can attempt to utilize cultivated tetraploid parents with a diploid relative as a potential means to establish interspecific polyploid hybrids as a ‘bridge’ for transfer of beneficial alleles to domesticated crop species. The use of such approaches to polyploid hybridization are well-known in the art of plant breeding, and domesticated tetraploid X wild diploid ‘synthetic wheats’ have been used extensively to contribute rust and pathogen resistance genes, or other desirable alleles to bread wheat as in Mujeeb-Kazi [Mason, p.438, col.1, par.1-2].
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the soybean interspecific breeding methodology taught by Singh to the use of a doubled, or tetraploid, domesticated parent as described in Mujeeb-Kazi. Doing so would more equally match, or balance, the chromosomes of G. max (2n = 40, 4n = 80) with those of G. tomentella (2n = 80).
One would be motivated to do this to better match the parental chromosome numbers during transfer of disease resistance genes from G. tomentella to G. max, while avoiding the additional embryo rescue and fertile plant recovery steps required using Singh’s methodology. One would be motivated to try the obvious approach of utilizing the domesticated parent as a tetraploid in such polyploid breeding in order to transfer rust resistance alleles, similar to wheat. To do this, they would simply need to make the obvious modification of Singh’s teaching in of interspecific soybean crosses, using the tetraploid wheat parent model from Mujeeb-Kazi to achieve a more balanced chromosome number (i.e. tetraploid G. max 4n = 80 and diploid G. tomentella 2n = 80) and thus a higher likelihood of creating a viable polyploid progeny.
Because this is obvious in view of prior art at the time of filing, claims 35-36, 38-40, 46-48, 52-56 & 58 are rejected.
Response to Arguments
Applicant urges their use colchicine to generate a tetraploid prior to pollination is non-obvious because both Singh and Mujeeb-Kazi utilize colchicine post-pollination [Remarks, p.11, par.3-4].
Regarding arguments specifically directed to timing of colchicine application; only claim 39 recites a limitation drawn to colchicine application. The remaining claims at issue do not recite application of a chromosome doubling agent, or otherwise contain a similar limitation. Those claims merely recite obtaining a doubled domestic annual Glycine plant (i.e. a tetraploid, domesticated parent).
Applicant’s argument is not found persuasive because the previous 103 rejection is based on the fact that it is well-known in the art that to generate a stable hybrid progeny between species having different chromosome numbers a plant breeder needs to ‘balance’ the parental chromosome numbers as closely as possible. This is so progeny have an evenly matched number of chromosomes and can undergo regular cellular division [See ‘polyploidy’ in Griffiths et al. 2012]. The need to balance chromosomes for viable embryo production is one of the first concepts taught in genetics and familiar to much of the general public due to commercial novelties such as triploid seedless watermelons.
For those wanting to generate viable seeds and embryos, chromosome balance is achieved by either (a) crossing parents with similar haploid chromosome numbers, (b) crossing parents with odd-numbered or unevenly matched chromosomes and doubling after embryo formation or (c) altering one parent’s chromosome number prior to crossing so they ‘match’ as closely as possible. In Glycine, G. max 2n = 40 and G. tomentella 2n = 80 so it would logically follow to a plant breeder that they would either need to create a triploid embryo and double with colchicine to restore balance (i.e. approximately 2n amphidiploid hybrid = 120, option ‘b’ above), or, they could initially double the diploid G. max to achieve chromosome count roughly equal to, or balanced with, that of G. tomentella (i.e. 2n amphidiploid hybrid = 160, option ‘c’ above). Either approach would create a potentially stable polyploid, amphidiploid soybean, similar to well-known, amphidiploid ‘synthetic wheats’ used in rust resistance breeding.
Applicant’s argument is directed to the timing of colchicine application as recited in one claim. However, this does not address that the previous obviousness rejection is because they simply describe one of several alternate methods of balancing chromosome numbers to create a viable amphidiploid offspring. Such approaches are well-known in polyploid crop breeding and obvious to try.
One would be motivated to do this because such an approach would reasonably increase the probability of recovering viable progeny while simultaneously avoiding the recovery and chromosome doubling of unstable triploid embryos reported by Singh.
Applicant focuses their argument on colchicine treatments but does not explain why it would be non-obvious for a plant breeder, upon comparison of chromosome numbers, to simply use the approach of utilizing a tetraploid domestic parent, similar to wheat polyploid breeding taught by Mujeeb-Kazi, to better match the chromosome numbers between G. max and G. tomentella in the crossing system initially described by Singh.
Applicant urges that because literature in the field of soybean breeding indicates autotetraploid soybeans are not agronomically competitive with diploid soybeans, one would not be motivated to borrow any concept from polyploid wheat breeding [Remarks, p.12, par.2-3].
They argue one would not be motivated to attempt using a tetraploid parent because Glycine max has undesirable agronomics when grown as an autotetraploid (i.e. when comparing diploid G. max to tetraploid G. max per se). Additionally, they argue that because of this, one would not have motivation to borrow concepts from polyploid wheat breeding research when considering methods of improving rust resistance in soybean [Remarks, p.12, par.3, last sentence].
This is not found persuasive because the claims of the proposed invention are drawn to interspecific polyploid sources of rust resistance. They are not drawn to the creation nor strict use of tetraploid soybeans per se, and no claim recites the production of a tetraploid soybean for its use other than as a stepwise component of creating the intended amphidiploid for transfer of rust resistance.
Wheat amphidiploids (i.e. synthetic wheat/hexaploids) are routinely created using ‘tetraploid domesticated parents’ (i.e. pasta wheat) often specifically to transfer rust resistance from wild diploid wheat relatives. Rust resistance is the same trait targeted in the disclosed soybean breeding methodology.
Mujeeb-Kazi and other research reports clearly indicate the relevance of using tetraploid domesticated parents in polyploid wheat breeding, specifically for generating amphidiploids to transfer rust resistance from wild progenitors. It is known many of these have relatively low success rates due to the challenges associated with challenges of stabilizing chromosome segregation [Mason, p.437, col.1 par.5 – col.2 par.1]. However, the typically low success rates observed in this area of research would not make it any less obvious to try using 4n = 80 tetraploid G. max to emulate methods of polyploid disease resistance breeding that are well-established in wheat.
The rejection is repeated for the reasons of record as set forth in the Office action mailed 13 June 2025, as applied to claim 37. Applicant's arguments filed 13 October 2025 have been fully considered but they are not persuasive.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Singh & Mujeeb-Kazi, as applied to claims 35 & 36 above, and further in view of Priyadarshan [Priyadarshan, P.M. (2019). Backcross Breeding. In: PLANT BREEDING: Classical to Modern. p.203-221; Published 11-10-2019].
As previously described, Singh & Mujeeb-Kazi teach the creation of interspecific polyploid crosses in Glycine using the wild G. tomentella, describe methods of use of a domestic autotetraploid for crossing, and the generation of subsequent BC1 generations using G. max.
They do not teach alternating from the G. max recurrent parent used for the first backcross (BC1) to a wild Glycine recurrent parent for the second backcross (BC2).
However, such breeding methodology is taught by Priyadarshan in their chapter ‘Backcross Breeding’ in Plant Breeding: Classical to Modern. In their text, they describe the use of AB-QTL analysis, wherein one alternates between the recurrent parents used in a backcrossing scheme – this is typically done to map QTL or map genes [p.214, 10.4.2]. In the instant application, alternating from G. max in the first backcross to the wild soybean parent (G. tomentella) in the second backcross is representative of such an AB-QTL analysis. This approach would allow mapping of target genes or QTL in the populations being claimed by applicant. Broadest reasonable interpretation of the claim, as written, would also include any such AB-QTL analysis approach used in a domesticated X wild soybean mapping population.
As stated previously, one skilled in the art is trained to find and cross-apply research methodology. It would be obvious for one to use the methods of generating an interspecific Glycine population as described by Singh & Mujeeb-Kazi, combined with a desire to apply the AB-QTL analysis methodology taught by Priyadarshan to arrive at the claimed method, alternating between the recurrent Glycine parents at the second stage of backcrossing.
One would be motivated to do this because in addition to creating a functional breeding population, the claimed alteration of recurrent parents at the BC2 stage would also generate a mapping resource that could be used to further elucidate the genetic architecture of beneficial traits derived from the applicant’s wide cross. Further, as written, applicant’s method claim would encompass any such domestic X wild AB-QTL mapping population, not limited to G. tomentella, and potentially already in general use by the research community.
Because of this obviousness over prior art, claim 37 is rejected.
Response to Arguments
Applicant urges claim 37 is allowable for the reason of dependence on claim 35 [Remarks, p.13, par.3]. This is not found persuasive because the rejection of claim 35 is maintained and without other comment from Applicant, the argument is unconvincing.
The rejection is repeated for the reasons of record as set forth in the Office action mailed 13 June 2025, as applied to claim 57. Applicant's arguments filed 13 October 2025 have been fully considered but they are not persuasive.
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Singh & Mujeeb-Kazi, as applied to claim 35 above, and further in view of Akperty [Crop Sci. 58:1277–1291 (2018); Published 05-15-2018].
As previously described, Singh & Mujeeb-Kazi teach the creation of interspecific polyploid crosses in Glycine using the wild G. tomentella, and use of a domestic autotetraploid for crossing.
They do not teach the use of the wild relative as a source for improved agronomic traits such as yield, drought tolerance, or other characteristics typically associated with cultivated germplasm.
However, this is remedied by Akperty, who teaches the use of wild germplasm, specifically G. tomentella, to improve agronomic traits such as yield. In, ‘Genetic Introgression from Glycine tomentella to Soybean to Increase Seed Yield’ they specifically describe high-yielding material derived from interspecific wild crosses [p.1289, c.1, par.2]. As such, Akperty points directly to the possibility of transferring alleles with major beneficial yield impact from G. tomentella to cultivated soybean.
It would be obvious for one to use the methods of generating an interspecific Glycine population disclosed by Singh & Mujeeb-Kazi, combined with the teachings of Akperty drawn to agronomic traits. These disclosures combined teach that wild germplasm can improve not only disease resistance, but agronomic traits per se, to arrive at the proposed limitations of claim 57.
One would be motivated to use the wild G. tomentella as a source of such agronomically beneficial alleles because yield has a known value and high priority in crop improvement programs.
Because prior art clearly teaches yield alleles can be donated from wild germplasm in interspecific soybean crosses, claim 57 is rejected as obvious.
Response to Arguments
Applicant urges claim 57 is allowable for the reason of dependence on claim 35 [Remarks, p.13, par.5]. This is not found persuasive because the rejection of claim 35 is maintained and without other comment from Applicant, the argument is unconvincing.
The rejection is repeated for the reasons of record as set forth in the Office action mailed 13 June 2025, as applied to claims 59-61 & 63. Applicant's arguments filed 13 October 2025 have been fully considered but they are not persuasive.
Claims 59-61 & 63 are rejected under 35 U.S.C. 103 as being unpatentable over Mujeeb-Kazi and further in view of Singh and in view of Kumar [Cytologia 83(4): 421–426; Published 07-24-2018].
Mujeeb-Kazi teaches an interspecific breeding method wherein a domestic tetraploid wheat is crossed to a wild, diploid relative with the goal of transferring beneficial alleles from the wild species. Specifically, Mujeeb-Kazi teaches the crossing of cultivated, tetraploid wheat genome (4n = AABB = 28) [p.133, Table 3] to the wild species Aegilops tauschii (2n = DD = 14) [p.129, col.2, par.1]. They obtain a hybrid progeny from the cross whose genetic composition is (3n = ABD = 21). Additionally, they point to the potential spontaneous doubling of such individuals which would generate a fertile plant capable of reproduction after hybridization [p.130, c.2, par.2].
They do not teach the use of auxins, backcrossing to recurrent parents in an interspecific cross, or crops other than wheat.
However, this is remedied by Singh and by Kumar. Singh teaches the use of a polyploid interspecific crossing system that utilizes auxins to improve seed set during pollination. They also describe the crossing of the progeny F1 to the domesticated parent to generate a F1BC1 progeny. They describe this process in Glycine, as previously discussed.
Kumar additionally teaches to the use of polyploidization and interspecific crossing methods to transfer alleles from wild to cultivated species, specifically in Brassica [p.421, c.2, par.2]. Each reference describes the general methodology outlined by Mujeeb-Kazi in crops other than wheat, while addressing the relevant crop-specific issues such as chromosome number and incompatibility issues [Singh, 0058, 0061, Table 1; Kumar, p.421, par.1-2, Table 3].
It would be obvious for one to use the methods described by Mujeeb-Kazi in wheat, combined with the teachings of Singh in soybean and Kumar in Brassica, to arrive at the proposed methods limited to in claims 59-61 & 63.
One would be motivated to do this because a system modeled on Mujeeb-Kazi’s disclosure would bypass the post-pollination tissue culture bottlenecks when combined with Singh or Kumar in soybean or Brassica, thus saving time and resources in any plant that one sought to utilize in such a wide cross or polyploid breeding scheme. Further, Singh’s teaching of the use of auxin to improve pollination success would provide additional improvements to the method of Mujeeb-Kazi.
Because of this obviousness over prior methods disclosed in the art, claims 59-61 & 63 are rejected in their entirety.
Response to Arguments
Applicant urges that the 103 rejection of claims 59-61 & 63 is improper because one skilled in plant breeding would not have any expectation of success of using Brassica breeding concepts in soybean [Remarks, p.14, par.1]. Once again, they point to use of tetraploid soybeans per se as ‘not desirable for breeding’ [Remarks, p.13, par.8].
This is not found persuasive because they do not address the matter at the core of the obviousness rejection, which is that their invention is drawn to polyploid breeding, generally. As discussed above, one skilled in the art of plant breeding would recognize that polyploid breeding systems have common features, namely the manipulation of chromosome numbers to convert uneven numbers of chromosome pairs to balanced counts and achieve fertile progeny or viable seeds. Conversely, plant breeders routinely use this same principle to manipulate chromosomes and generate seedless varieties with uneven (i.e. imbalanced) chromosome numbers. Such manipulations are commonly made in polyploid breeding using various chemical doubling agents, or controlled crosses to particular genetic stocks.
Several crops have deep bodies of research literature directed to polyploid breeding, notably wheat and Brassica [Mason, p.438, col.1, par.1-2]. It would be both logical and obvious for a researcher optimizing a polyploid hybrid system for gene transfer in soybean, or any other potential crop, to look to these well-established models for relevant teachings.
Applicant’s argument focuses on the strict biological differences between tetraploid soybean and other crop species, taking the position that it would not be obvious for a trained plant breeder to translate attempts to manipulate chromosomes from one crop to another. Clearly one working on polyploid breeding in soybean would familiarize themselves with existing literature relevant to the specific area of polyploid breeding, generally, and be aware of the various ways to manipulate chromosomes to generate viable or inviable hybrid progeny. Because this is not addressed by Applicant, their argument presented is unconvincing.
The rejection is repeated for the reasons of record as set forth in the Office action mailed 13 June 2025, as applied to claim 62. Applicant's arguments filed 13 October 2025 have been fully considered but they are not persuasive.
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over Mujeeb-Kazi and Singh, as applied to claims 59 & 61 above, and further in view of Priyadarshan.
Mujeeb-Kazi teaches an interspecific, polyploid breeding method between cultivated and wild plants and Singh describes the further methods of backcrossing the resulting progeny to the cultivated recurrent parent.
They do not teach backcrossing of the hybrid progeny to the wild, recurrent parent.
However, this is remedied by Priyadarshan in their chapter ‘Backcross Breeding’ in Plant Breeding: Classical to Modern. In their text, they teach the use of AB-QTL analysis, wherein one alternates between the recurrent parents used in a backcrossing scheme – this is typically done to map QTL or map genes [p.214, 10.4.2]. In the instant application, alternating from the domesticated parent in the first backcross to the wild parent in the second backcross is representative of such an AB-QTL analysis. This approach would allow mapping of target genes or QTL in the populations being claimed by applicant. Broadest reasonable interpretation of the claim, as written, would include any such AB-QTL analysis approach used in a domesticated tetraploid X wild diploid mapping population.
It would be obvious for one to use the methods of generating an interspecific population described by Singh & Mujeeb-Kazi, combined with the AB-QTL analysis methodology taught by Priyadarshan to arrive at a method of alternating the recurrent parents at the second stage of backcrossing.
One would be motivated to do this because in addition to creating a functional breeding population, the alteration of recurrent parents at the BC2 stage would generate a mapping resource. Such a concurrently generated mapping population could be used to further elucidate the genetic architecture of beneficial traits derived from the applicant’s wide cross. Further, as written, applicant’s method claim would encompass any such domestic tetraploid X wild diploid AB-QTL mapping population, not limited to those disclosed by applicant, including those potentially already in general use by the plant research community.
Because of this obviousness over known and previously disclosed genetic mapping methods of the prior art, claim 62 is rejected in its entirety.
Response to Arguments
Applicant urges that the claim 62 is allowable for the reason of dependence on claim 59 [Remarks, p.14, par.4]. This is not found persuasive because the rejection of claim 59 is maintained and without other comment from Applicant, the argument is unconvincing.
The rejection is repeated for the reasons of record as set forth in the Office action mailed 13 June 2025, as applied to claim 64. Applicant's arguments filed 13 October 2025 have been fully considered but they are not persuasive.
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Singh [US 2007/0261139 A1; Published 11-08-2007] in view of Mujeeb-Kazi [Genetic Resources and Crop Evolution 43: 129-134, 1996; Published 04-18-1995].
Claim 64 is drawn to a method of interspecific crossing of annual and perennial species, wherein an annual plant has its chromosomes doubled (tetraploidization) prior to crossing to a perennial species. Additionally, claim 64 is drawn to use of auxin to improve seed set on said interspecific cross.
Singh teaches methods of polyploidization and use of interspecific crosses to improve disease resistance to soybean rust using annual X perennial hybridization. Specifically, they disclose use of Glycine tomentella as the perennial ‘donor’ in such an interspecific cross, and backcrossing after polyploidization to effect transfer of genes from the hybrid progeny to annual soybean backgrounds [Figure 1]. In their patent application, they teach the use of applying an auxin, 1-naphthalene acetic acid, to pollinated gynoecia to facilitate seed set when making the interspecific hybrid [0027, l.10].
Singh does not teach chromosome doubling prior to making the interspecific cross, as their invention is focused on doubling after pollination and rescue of the infertile hybrid progeny.
However, this change in sequential steps is remedied by Mujeeb-Kazi who teaches an interspecific breeding method wherein a domestic tetraploid wheat is crossed to a wild, diploid relative with the goal of transferring beneficial alleles from the wild species. They describe an equivalent process, but with use of tetraploid, or doubled, cultivated parent. Specifically, Mujeeb-Kazi teaches the crossing of cultivated, tetraploid wheat genome (4n = AABB = 28) [p.133, Table 3] to the diploid species Aegilops tauschii (2n = DD = 14) [p.129, col.2, par.1]. While their work is in wheat, not soybean, it is drawn to similar creation of polyploid interspecific crosses, and points directly to use of an autotetraploid cultivated species, whose genomic complement was doubled at a point prior to crossing to the diploid wild donor of disease resistance alleles.
One would plainly see the advantages of applying the modified process suggested by Mujeeb-Kazi’s disclosure to the annual X perennial breeding methodology disclosed by Singh.
One would be motivated to do this as a potential way to successfully transfer of disease resistance genes from a perennial species to an annual species, while avoiding the additional embryo rescue and fertile plant recovery steps required using Singh’s methodology.
Because of this obviousness over known and previously disclosed methods that teach generation of tetraploid annual X diploid perennial crosses, claim 64 is rejected.
Response to Arguments
Applicant urges claim 64 is allowable for the reason of having elements similar to claims 35 & 59 [Remarks, p.14, par.6]. This is not found persuasive because the rejection of claims 35 & 59 is maintained and without other comment from Applicant, the argument is unconvincing.
Conclusion
No claims are allowed.
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.
Contact Information
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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Anne Kubelik/Primary Examiner, Art Unit 1663