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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 1-9 & 12 are under examination on the merits.
Priority
Claims 1-9 & 12 receive the U.S. effective filing date of 06/14/2021.
Previous objection to claims 1-2 & 9 is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claims 1 & 3-8 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claim 5 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendment to the claim.
Previous rejection of claim 12 under 35 U.S.C. 112(a) as failing to comply with the written description requirement is withdrawn in view of Applicant’s amendment to the claim.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, even as amended [p.31, l.20-21]. Applicant is advised to check such URLs by copy/pasting them into a web browser – if this retrieves an active website, as opposed to displaying search results, the URL is browser-executable. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Appropriate correction is required.
Applicant is advised to remove the use of URLs in referencing ISAAA an CERA, as the website information of each of these organizations is not critical to the written description. Omitting the URLs would remedy this objection and not significantly detract from the specification.
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.
Claims 1, 3-4, 6-7 & 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ryals [US5767369; Published 06-16-1998] in view of Wu [Journal of Experimental Botany, Vol. 66, No. 2 pp. 559–570, 2015; Published 12-11-2014] and Chang [WO03000898A1; Published 01-03-2003].
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 16 May 2025, as applied to claims 1, 3-4, 6-7 & 9. Applicant' s arguments filed 16 October 2025 have been fully considered but they are not persuasive.
The claims are drawn to a method of improvement of yield in a transgenic plant via heterologous expression of both the SAR8.2 and Pti5 genes.
Ryals’ patent teaches transgenic plants with improved pathogen resistance, and therefore yield, comprising heterologous SAR8.2 expression [col.6, l.33-42; col.90, l.30; claims 1 & 5]. They disclose the use of the claimed SAR8.2 gene, which is a known ‘R-gene’, or hypersensitivity response gene, for pest resistance [col.6, l.33-42; col.17, l.48]. They also point to use of genes disclosed in their invention, including SAR8.2, in soybean [col.32, l.26-34]. They emphasize that various genes described in their patent disclosure, including SAR8.2, can be used in conjunction with other disease resistance genes to confer improved crop characteristics such as improved yield [col.6, l.33-42; col.35, l.12-52].
Ryals does not teach the method of use of the Pti5 protein.
Wu teaches use of the Pti5 protein to reduce pest damage caused by aphids, which are a common pest of soybean, and state it can synergize with other disease resistance genes, including ‘R-genes’ [p.559, Abstract]. They describe that Pti5 is an ethylene-response-factor (ERF), a type of transcription factor, that is involved in plant growth and signaling response to a broad array of abiotic and biotic stress factors [p.560, col.1, par.2].
Wu teaches that Pti5 has a ‘synergistic effect’ in disease resistance [p.559, Abstract] and highlights its cross-applicability and wide role in numerous crop species where it has been tested so far, including tomato, melon, cotton, barley, wheat and alfalfa [p.560, col.2, par.1-2]. They also describe Pti5’s role as an ethelyne response factor (ERF) in signaling plant defense response to both bacterial and fungal diseases, and that such responses can also overlap with beneficial aphid resistance [p.566, col.1, par.3, Discussion]. They close by restating that ERFs such as Pti5 interact with R genes (i.e. SAR8.2) and that overexpression of Pti5 can enhance disease resistance in multiple plant species [p.568, col.1, par.1].
Further search of disease resistance literature reveals Chang, whose research is also specifically drawn to use of Pti5 for transgenic yield improvement.
Chang teaches transgenic plants comprising Pti5 that have increased yields under conditions of pathogen infection [p.21, l.8-13]. They describe use of Pti5 in combination with other disease resistance genes [p.16, l.1-8; Table 23, p.384]. Chang also describes the use of Pti5 and other disclosed genes with several types of promoters in heterologous expression cassettes. They describe use of constitutive, inducible, and tissue-specific promoters [p.25, l.14-17]. They describe use of Pti5 in soybean [p.14, l.25].
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 patented use of SAR8.2 taught by Ryals, who describes its use with other disease-resistance genes, to a method or product incorporating the further benefits of the Pti5 gene disclosed by Wu and further emphasized by Chang. One working on stress resistance and the improvement of crop yield would be aware of such publications teaching the commercial relevance and/or utility of known genes involved in plant defense response, particularly those with dramatic and broad beneficial effects, such SAR8.2 & Pti5.
One of ordinary skill in the art would be motivated to combine the two genes because of Pti5’s potential to increase plant defense or stress response and simultaneously improve yield. One would be motivated to combine the method as taught by Ryals (i.e. transformation of soybean with R-gene SAR8.2) with the teachings of Wu and Chang (i.e. synergistic, cross-species beneficial effects of transformation with Pti5) to arrive at the instantly claimed method. One would do so with a reasonable expectation of success in developing a more disease-resistant, correspondingly higher yielding soybean plant due to the combined activity of these two well-known stress resistance genes.
Because this is obvious in view of prior art, claims 1, 3-4, 6-7 & 9 are rejected.
Response to Arguments
Applicant urges because the primary reference of Ryals does not disclose use of Pti5, that one would therefore not be motivated to integrate it with SAR8.2. They do not address the fact that Ryals directly teaches SAR8.2 can be combined with other disease resistance genes, broadly, and that Pti5 was known to be a well-described example of such beneficial gene, available in the art at the time of filing.
This is not found persuasive because it is routine and obvious in the art of plant breeding to combine multiple beneficial genes into an improved cultivar, breeding line, or individual. Such efforts have been the basis of all directed genetic improvement of both plants and animals. It is routine.
At the time of filing, in addition to the patented SAR8.2 gene, the Pti5 gene was known to be widely applicable to disease and stress resistance breeding. A plant breeder searching specifically for beneficial genes having wide effect on a broad range of pathogens in a broad range of plant species, would want to attempt to combine these two highly beneficial disease resistance genes into an improved soybean plant. One would do this as a means of ‘stacking’ multiple beneficial genes to generally improve their breeding stock.
Because of this, Applicant’s argument of lack of motivation is unpersuasive.
Applicant urges their disclosure describes ‘synergy’ or unexpected results [Remarks, p.8, par.9].
This is not found persuasive with regards to unexpected results; it is known that combining multiple disease resistance genes can have a synergistic effect on plant health, as previously cited from Ghislain [See Office action mailed 16 May 2025, p.20]. Applicant argues that because claims are directed to yield, rather than the known disease resistance attributes of SAR8.2 & Pti5, that increased yield would be unexpected. It is well-known that disease resistance will increase yield in presence of corresponding pathogen(s). Applicant’s specification indicates that pathogens were present in their trials [Specification, p.24, Example 2]. One would therefore reasonably expect to see increased yield. Disease resistant plants grown in the presence of diseases would be expected to yield more than susceptible check varieties which do not have such disease resistance genes.
Further, it is not found persuasive with regards to non-additive ‘synergy’ commensurate in scope with that claimed. As written, ‘synergy’ would be expected to show a distinct, non-additive yield improvement over all the ranges (i.e. environments) claimed. Review of Applicant’s data shows that while they may observe instances of synergy [Specification, p.38, Table 2; Figure 3b, Location 2, ‘untreated’], there are also environments where effects do not appear to be synergistic [Specification, p.38, Table 2; Figure 3a, Location 1, ‘untreated’].
In ‘Location 1’ the yield effect of both SAR8.2 + Pti5 considered as unadjusted yield in untreated plants is actually less than the combined additive effects (i.e. 55% < 59%). Applicant refers to use of a ‘Colby formula’ used in herbicide formulations to argue this converts to an adjusted comparison of 51.9% additive effect vs 54.8% ‘synergy’ [Specification, p.38, l.4-6]. However, no statistical measures of variation or standard genetic models are provided to determine if such narrow difference (2.9%) is caused by the random environmental variation(s) known to commonly exist in field trials.
Applicant discloses cases where there appears to be no yield synergy. Applicant’s claims do not include limitations reflecting this apparent environmental specificity of the yield effects of the SAR8.2 + Pti5 combination which is reported in only two locations. Further, lacking standard descriptive measures of trial variation, it is unclear if the wide differences seen between the two environments may have been caused by other, non-genetic factors. As such, arguments made do not support Applicant has shown a distinct, non-additive yield improvement over all the ranges (i.e. environments) as recited in claims.
For these reasons, Applicant’s argument of unexpected results with respect to claims 1, 3-4, 6-7 & 9 is unpersuasive.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ryals, Wu, and Chang as applied to claim 1 above, and further in view of Ascenzi [WO2009027539A2; Published 03-05-2009].
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 16 May 2025, as applied to claim 2. Applicant' s arguments filed 16 October 2025 have been fully considered but they are not persuasive.
The claim is drawn to a reduction in the number of pesticide treatments required per season due to the presence of both SAR8.2 & Pti5 in a transgenic crop.
Ryals, Wu, & Chang teach the use of exogenous SAR8.2 & Pti5, to generate transgenic plants with increased disease resistance and yield potential, as previously discussed above.
Ryals, Wu, & Chang do not teach the relationship of increased disease resistance to reduced pesticide applications.
Ascenzi teaches that enhancing disease resistance of crops will decrease pesticide application. Further, Ascenzi points to the adverse effects of pesticide applications and specifically teaches how a reduction of pesticide applications would be beneficial [par.0004.1.1.1.]. The disclosure of Ascenzi teaches that the minimum quantity of (i.e. ‘any’) reduced applications would therefore be reduced by at least one and beneficial. Thus, their disclosure teaches that use of a functional genetic disease resistance(s) can reduce pesticide applications by at least one treatment.
Before the effective filing date of the claimed invention, it would have been obvious that combining multiple disease resistance genes of known effect, as taught by Ryals, Wu, & Chang, would potentially reduce the need for pesticides. This direct relationship between increased disease resistance and reduced number of pesticide applications is clearly taught by Ascenzi. It is predictable that increasing genetic disease resistance via deployment of SAR8.2 and Pti5 would therefore reduce the number of pesticide treatments required to obtain maximum potential yield.
One of ordinary skill in the art would have been motivated to combine the teaching of the benefit of using disease resistance genes to reduce required pesticide applications by at least one application, and thus solve the economic and environmental problems attendant with frequent pesticide spraying.
Because of this obviousness in view of the prior art, claim 2 is rejected.
Response to Arguments
Applicant urges because the primary reference of Ryals does not disclose use of Pti5, that one would not be motivated to integrate it with Ryals’ SAR8.2. They do not address the fact that Ryals directly teaches SAR8.2 can be combined with other disease resistance genes, broadly, and that Pti5 was known in the art at the time of filing.
This is not found persuasive, because as discussed above, it is routine and obvious in the art of plant breeding to combine multiple beneficial genes into an improved cultivar or breeding line.
Integrating two disease resistance genes to create a more disease resistant cultivar would obviously reduce the pesticides required to be applied for equivalent control of the relevant pathogen. Applicant is silent as to why one would not expect to have reduced pesticide applications in a more disease resistant crop.
Because of this, Applicant’s argument with respect to lack of motivation is unpersuasive.
Applicant urges their disclosure describes ‘synergy’ or unexpected results [Remarks, p.8, par.9].
This is not found persuasive with regards to unexpected results; it is known that combining multiple disease resistance genes can have a synergistic effect on plant health, as previously cited from Ghislain [See Office action mailed 16 May 2025, p.20]. Applicant argues that because claims are directed to yield, rather than the known disease resistance attributes of SAR8.2 & Pti5, that increased yield would be unexpected. It is well-known that disease resistance will increase yield in presence of corresponding pathogen(s). Applicant’s specification indicates that pathogens were present in their trials [Specification, p.24, Example 2]. One would therefore reasonably expect to see increased yield. Disease resistant plants grown in the presence of diseases would be expected to yield more than susceptible check varieties which do not have such disease resistance genes.
Further, it is not found persuasive with regards to non-additive ‘synergy’ commensurate in scope with that claimed. As written, ‘synergy’ would be expected to show a distinct, non-additive yield improvement over all the ranges (i.e. environments) claimed. Review of Applicant’s data shows that while they may observe instances of synergy [Specification, p.38, Table 2; Figure 3b, Location 2, ‘untreated’], there are also environments where effects do not appear to be synergistic [Specification, p.38, Table 2; Figure 3a, Location 1, ‘untreated’].
In ‘Location 1’ the yield effect of both SAR8.2 + Pti5 considered as unadjusted yield in untreated plants is actually less than the combined additive effects (i.e. 55% < 59%). Applicant refers to use of a ‘Colby formula’ used in herbicide formulations to argue this converts to an adjusted comparison of 51.9% additive effect vs 54.8% ‘synergy’ [Specification, p.38, l.4-6]. However, no statistical measures of variation or standard genetic models are provided to determine if such narrow difference (2.9%) is caused by the random environmental variation(s) known to commonly exist in field trials.
Applicant discloses cases where there appears to be no yield synergy. Applicant’s claims do not include limitations reflecting this apparent environmental specificity of the yield effects of the SAR8.2 + Pti5 combination which is reported in only two locations. Further, lacking standard descriptive measures of trial variation, it is unclear if the wide differences seen between the two environments may have been caused by other, non-genetic factors. As such, arguments made do not support Applicant has shown a distinct, non-additive yield improvement over all the ranges (i.e. environments) as recited in claims.
For these reasons, Applicant’s argument of unexpected results with respect to claim 2 is unpersuasive.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ryals, Wu and Chang as applied to claim 1 above, and further in view of Melchers [WO2000060086A1; Published 10-12-2000].
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 16 May 2025, as applied to claim 8. Applicant' s arguments filed 16 October 2025 have been fully considered but they are not persuasive.
The claim is drawn to a cultivation of least 1,000 plants comprising the SAR8.2 & Pti5.
Ryals, Wu, & Chang teach the use of exogenous Pti5 & SAR8.2, specifically to improve yield of a crop plant, as previously discussed above with respect to claim 1 [See p.4-7].
Ryals, Wu, & Chang do not specify the number of plants comprising SAR8.2 & Pti5 which are to be grown.
Melchers teaches expression of disease resistance proteins in plants and describes production of over 1,000 transgenic plants [p.16, l.6-8].
Before the effective filing date of the claimed invention, it would have been obvious to combine the method of incorporating multiple disease resistance genes in a single plant, as taught by Ryals, Wu, & Chang, as applied to a planting of an ensemble of more than 1,000 transgenic plants as described in Melchers.
Growing plants in groups of >1,000 individuals is typical of commercial agricultural production (i.e. growing a crop in a field) or in a breeding and plant selection program (i.e. wherein the breeder is selecting a small number of plants from large initial population sizes).
One of ordinary skill in the art would have been motivated to do this, in that upon combining two sources of disease resistance to create an improved cultivar, they would then want to grow such an improved plant in a relevant commercial production setting (i.e. more than 1,000 plants grown together).
Because of this obviousness in view of prior art, claim 8 is rejected.
Response to Arguments
Applicant urges there would be no motivation to combine references cited, as discussed above. Claim 8 is directed to fields of at least 1,000 plants but Applicant is silent as to why one would not reasonably want to grow such an improved plant or cultivar in a typical field setting.
This is not found persuasive, because it is both routine and obvious to grow plants in various population sizes. Moreover, it is common for commercial crops to be grown in fields comprising at least 1,000 plants. Such considerations are merely a design choice of the grower, often dictated by the size or shape of the field which they are utilizing in a given growing season. This is indicated specifically by the Melchers reference cited in the Office action mailed 16 May 2025.
Because of this, Applicant’s argument of lack of motivation is unpersuasive.
Applicant urges their disclosure describes ‘synergy’ or unexpected results [Remarks, p.8, par.9].
This is not found persuasive with regards to unexpected results; it is known that combining multiple disease resistance genes can have a synergistic effect on plant health, as previously cited from Ghislain [See Office action mailed 16 May 2025, p.20]. Applicant argues that because claims are directed to yield, rather than the known disease resistance attributes of SAR8.2 & Pti5, that increased yield would be unexpected. It is well-known that disease resistance will increase yield in presence of corresponding pathogen(s). Applicant’s specification indicates that pathogens were present in their trials [Specification, p.24, Example 2]. One would therefore reasonably expect to see increased yield. Disease resistant plants grown in the presence of diseases would be expected to yield more than susceptible check varieties which do not have such disease resistance genes.
Further, it is not found persuasive with regards to non-additive ‘synergy’ commensurate in scope with that claimed. As written, ‘synergy’ would be expected to show a distinct, non-additive yield improvement over all the ranges (i.e. environments) claimed. Review of Applicant’s data shows that while they may observe instances of synergy [Specification, p.38, Table 2; Figure 3b, Location 2, ‘untreated’], there are also environments where effects do not appear to be synergistic [Specification, p.38, Table 2; Figure 3a, Location 1, ‘untreated’].
In ‘Location 1’ the yield effect of both SAR8.2 + Pti5 considered as unadjusted yield in untreated plants is actually less than the combined additive effects (i.e. 55% < 59%). Applicant refers to use of a ‘Colby formula’ used in herbicide formulations to argue this converts to an adjusted comparison of 51.9% additive effect vs 54.8% ‘synergy’ [Specification, p.38, l.4-6]. However, no statistical measures of variation or standard genetic models are provided to determine if such narrow difference (2.9%) is caused by the random environmental variation(s) known to commonly exist in field trials.
Applicant discloses cases where there appears to be no yield synergy. Applicant’s claims do not include limitations reflecting this apparent environmental specificity of the yield effects of the SAR8.2 + Pti5 combination which is reported in only two locations. Further, lacking standard descriptive measures of trial variation, it is unclear if the wide differences seen between the two environments may have been caused by other, non-genetic factors. As such, arguments made do not support Applicant has shown a distinct, non-additive yield improvement over all the ranges (i.e. environments) as recited in claims.
For these reasons, Applicant’s argument of unexpected results with respect to claim 8 is unpersuasive.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ryals, Wu and Chang as applied to claim 1 above, and further in view of Ghislain [Plant Biotechnology Journal (2019) 17, pp. 1119–1129; Published 11-22-2018].
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 16 May 2025, as applied to claim 12. Applicant' s arguments filed 16 October 2025 have been fully considered but they are not persuasive.
Claim 12 is drawn to ‘synergistic yield improvement’ of plants possessing both the Pti5 and SAR8.2 pest resistance proteins.
Ryals, Wu, & Chang teach the use of exogenous SAR8.2 & Pti5, specifically to limit pest infestation and improve yield of a crop plant, as previously discussed above [See p.4].
Ryals, Wu, & Chang do not teach non-additive (‘super-additive’) effects of the genes described in their disclosures.
Ghislain teaches the synergistic, non-additive impact of ‘stacking’ multiple disease resistance genes in a plant. The research disclosure of Ghislain is drawn to fungal diseases of potato, and the ‘stacking’ of multiple disease resistance alleles for potato late blight disease into a ‘3R-gene stack’. This is similar to the instant application in that it teaches the effect of the combination of multiple transgenes implicated in disease resistance and corresponding increased yield.
Ghislain teaches this can induce a synergistic response when combining such genes. They describe this synergistic effect of stacking multiple stress resistance genes as generating ‘notorious’ examples of ‘extreme disease resistance’ greater than combined additive effects alone [p.1123, col.2, par.1].
Before the effective filing date of the claimed invention, it would have been obvious to combine or incorporate the specific disease resistance genes, as taught by Ryals, Wu, and Chang into a ‘stack’ capable of eliciting a synergistic response similar to that taught by Ghislain. As described earlier, the disease resistance conferred by the genes of the instant application were known to impact yield as well as pest resistance, similar to the potato model described by Ghislain.
One of ordinary skill in the art would have been motivated to combine multiple disease resistance genes to achieve such ‘notorious’ or ‘extreme disease resistance’ phenotypes (i.e. synergy). Creating such forms of synergistic, beneficial gene action would clearly generate valuable germplasm and cultivars.
Because of this obviousness in view of prior art, claim 12 is rejected.
Response to Arguments
Applicant urges that because the primary reference of Ryals does not disclose use of Pti5, that one would somehow not be motivated to integrate it with Ryals’ SAR8.2. They do not address the fact that Ryals directly teaches SAR8.2 can be combined with other disease resistance genes, broadly, and that Pti5 was known in the art at the time of filing. They do not address that it is both routine and common for plant breeders to identify beneficial genes from other researchers and attempt or try to combine them in their own germplasm.
This is not found persuasive with regards to the argument of lack of motivation to combine, as discussed above [See p.6, ‘Response to Arguments’].
Applicant urges their disclosure describes ‘synergy’ or unexpected results [Remarks, p.8, par.9].
This is not found persuasive with regards to unexpected results; it is known that combining multiple disease resistance genes can have a synergistic effect on plant health, as previously cited from Ghislain [See Office action mailed 16 May 2025, p.20]. Applicant argues that because claims are directed to yield, rather than the known disease resistance attributes of SAR8.2 & Pti5, that increased yield would be unexpected. It is well-known that disease resistance will increase yield in presence of corresponding pathogen(s). Applicant’s specification indicates that pathogens were present in their trials [Specification, p.24, Example 2]. One would therefore reasonably expect to see increased yield. Disease resistant plants grown in the presence of diseases would be expected to yield more than susceptible check varieties which do not have such disease resistance genes.
Further, it is not found persuasive with regards to non-additive ‘synergy’ commensurate in scope with that claimed. As written, ‘synergy’ would be expected to show a distinct, non-additive yield improvement over all the ranges (i.e. environments) claimed. Review of Applicant’s data shows that while they may observe instances of synergy [Specification, p.38, Table 2; Figure 3b, Location 2, ‘untreated’], there are also environments where effects do not appear to be synergistic [Specification, p.38, Table 2; Figure 3a, Location 1, ‘untreated’].
In ‘Location 1’ the yield effect of both SAR8.2 + Pti5 considered as unadjusted yield in untreated plants is actually less than the combined additive effects (i.e. 55% < 59%). Applicant refers to use of a ‘Colby formula’ used in herbicide formulations to argue this converts to an adjusted comparison of 51.9% additive effect vs 54.8% ‘synergy’ [Specification, p.38, l.4-6]. However, no statistical measures of variation or standard genetic models are provided to determine if such narrow difference (2.9%) is caused by the random environmental variation(s) known to commonly exist in field trials.
Applicant discloses cases where there appears to be no yield synergy. Applicant’s claims do not include limitations reflecting this apparent environmental specificity of the yield effects of the SAR8.2 + Pti5 combination which is reported in only two locations. Further, lacking standard descriptive measures of trial variation, it is unclear if the wide differences seen between the two environments may have been caused by other, non-genetic factors. As such, arguments made do not support Applicant has shown a distinct, non-additive yield improvement over all the ranges (i.e. environments) as recited in claims.
For these reasons, Applicant’s argument of unexpected results with respect to claim 12 is unpersuasive.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18023397 (reference application). Claims of the instant application are drawn to the genes claimed in the copending reference application. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitation of the reference application is encompassed by the claim language of the instant application.
The rejections are repeated for the reasons of record as set forth in the Office action mailed 16 May 2025, as applied to claims 1-8. Applicant' s arguments filed 16 October 2025 have been fully considered but they are not persuasive.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant urges that the previous NSDP rejection is improper due to lack of motivation to combine references cited and that evidence of genetic ‘synergy’ makes their proposed invention non-obvious due to evidence of unexpected results.
This is not found persuasive because as stated in response to arguments above, Applicant has not sufficiently addressed issues of obviousness or supported that non-additive, or ‘extreme disease resistance’, would be unexpected in view of prior art.
Because argument of NSDP relies on arguments directed to overcoming previous 103 rejections, which are not persuasive, the argument of NSDP rejection(s) is also unpersuasive. Because of this, previous NSDP rejection of claims 1-8 is maintained.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18023397 (reference application). Claim 9 of the instant application is drawn to a plant comprising SAR8.2 and Pti5, while claim 1 of the copending reference application includes provision of “a plant…comprising a gene selected from Pti5, SAR8.2…” Although the claims at issue are not identical, they are not patentably distinct from each other because the limitation of the reference application is encompassed by the claim language of the instant application.
The rejections are repeated for the reasons of record as set forth in the Office action mailed 05-16-2025, as applied to claim 9. Applicant' s arguments filed 10-16-2025 have been fully considered but they are not persuasive.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant urges that the previous NSDP rejection is improper due to lack of motivation to combine references cited and that evidence of genetic ‘synergy’ makes their proposed invention non-obvious due to unexpected results.
This is not found persuasive because as stated in response to arguments above, Applicant has not sufficiently addressed issues of obviousness or supported that non-additive, or ‘extreme disease resistance’, would be unexpected in view of prior art.
Because argument of NSDP relies on arguments directed to overcoming previous 103 rejections, which are not persuasive, the argument of NSDP rejection(s) is also unpersuasive. Because of this, previous NSDP rejection of claim 9 is maintained.
Claim 12 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending application No. 18023397 in view of Teodoro [Understanding the combining ability for physiological traits in soybean. PLoS ONE 14(12): 1-13; Published 12-17-2019].
Due to Applicant' s amendment of the claims, the rejection is modified from that set forth in the Office action mailed 16 May 2025, as applied to claim 12. Applicant' s arguments filed 16 October 2025 have been fully considered but they are not persuasive.
Claim 10 of Application No. 18023397 teaches producing a hybrid plant having improved yield relative to a control plant, comprising Pti5 and a SAR8.2 gene.
However, the claims of Application No. 18023397 do not teach a ‘synergistic yield improvement’.
In the instant application, applicant defines ‘synergistic yield improvement’ as a ‘super-additive’ yield improvement, commonly understood by one skilled in the art as yield which exceeds the sum of the contributions of individual additive genetic elements, as in discussion of claim 12. This phenomenon has various technical terms used to describe it, including that of ‘specific combining ability’.
In a related disclosure drawn to genetic combining ability in soybean, Teodoro describes both additive and non-additive effects in hybrid soybean plants. They describe the existence of both additive and non-additive genetic effects that impact yield and can be manipulated through production of hybrids [p.9 par.3] They go on to describe that use of specific genetic backgrounds in production of hybrids (F1s) can be manipulated to confer super-additive effects for yield influencing traits. [p.10, par.4, discussion of ‘TMG 7062 IPRO’] This teaches that production of soybean hybrids can be used to create ‘synergistic yield improvement’ (non-additive effects).
It would therefore have been obvious to a person of ordinary skill in the art to have combined the claims of Application No. 18023397 with the teachings of Teodoro to arrive at the method of instant claim 12, which simply substitutes the broader scope of ‘synergistic yield improvement’ for reference application’s ‘hybrids with improved yield’. Claim 12 of the instant application encompasses any non-additive specific combining effects (i.e. synergy) on yield, as claimed via use of hybrids in the reference application. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitation of the copending reference application is encompassed by the claim language of the instant application.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant urges that the previous NSDP rejection is improper due to lack of motivation to combine references cited and that evidence of genetic ‘synergy’ makes their proposed invention non-obvious due to unexpected results.
This is not found persuasive because as stated in response to arguments above, Applicant has not sufficiently addressed issues of obviousness or supported that non-additive, or ‘extreme disease resistance’, would be unexpected in view of prior art.
Because argument of NSDP relies on arguments directed to overcoming previous 103 rejections, which are not persuasive, the argument of NSDP rejection(s) is also unpersuasive. Because of this, previous NSDP rejection of claim 12 is maintained.
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