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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/09/2025 has been entered.
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 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 1-20 remain rejected under 35 U.S.C. 103 as being obvious over Eby (US Patent 8975486) in view of Mason et al (US Patent 9062324) in light of Boehm (2014 Tennessee Research and Creative Exchange Masters Thesis, University of Tennessee pages 1-135).
The claims are directed to soybean variety 92310703 and methods of breeding and F1 hybrid seeds and plants derived therefrom. As indicated above, the breeding history in the instant application appears to be a locus conversion wherein two backcrosses to recurrent parent 11050339-52 were performed and the donor parent, GL480A1-D1YN appears to be donating the A5547-127 event which confers glufosinate resistance. 16 traits are instantly disclosed for describing the instant soybean variety of which 12 are identical or near identical to the recurrent parent 11050339-52 further establishing that the instant variety is a locus conversion of the patented variety. The plant height, seed size, relative maturity and plant lodging differ but would be well within the instant definition of locus conversion wherein a variant might be present. In addition to locus conversions introducing variation through linkage drag, it is also possible that the differences are due to environmental differences. The recurrent patented parent was measured in a different year (2009-2013) than the instant variety (2016-2019 and therefore numerical comparisons of environmentally impacted traits such as plant height and seed size cannot reliably distinguish the two varieties. Additionally, Applicants do not describe donor line GL480A1-D1YN such that one of skill in the art would know what could be expected to be introduced trait-wise from the donor parent such that the resultant variety would have a reasonable expectation of success when evaluating the instantly claimed variety trait table. Applicants further do not provide any statistical error bars for one of skill in the art to determine if a given variety is within the reasonable range for each traits such that it can be distinguished from the instant variety. In order for the differences cited above to distinguish this variety from a locus conversion of the recurrent parent already covered in US Patent 9609831 claim 13, the differences need to be both unexpected and practically significant. See MPEP 716.02(b)
716.02(b) Burden on Applicant [R-08.2012]
I. BURDEN ON APPLICANT TO ESTABLISH RESULTS ARE UNEXPECTED AND SIGNIFICANT
The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c).
This principle was also recently affirmed in Ex parte McGowen (Appeal 2019-006060) wherein the decision affirmed burden for Applicant to establish that the trait differences would be both unexpected and have practical significance.
Eby teaches soybean variety 11050339-52, methods of breeding said variety, F1 hybrid seeds and plants therefrom as well as more specifically a locus conversion (see claim 13) wherein a trait is introgressed such as event A5547-127 and backcrossed to the recurrent parent. Eby additionally teaches a method of transforming a plant of the variety (claim 8), and a plant produced by said transformation (see claim 10), including herbicide tolerance (see claim 9) and methods of introducing a locus conversion (see claim 11).
Eby further states “A single locus conversion of the site-specific integration system allows for the integration of multiple genes at the converted loci” clearly encompassing multiple trait differences in a single locus conversion (see column 25 3rd full paragraph). Eby further teach that fewer backcrosses may be used in locus conversions wherein the donor parent is highly related to the recurrent parent (see columns 25-26) Eby also teaches that pedigree breeding may be combined with backcrossing to introduce one or more traits (see column 29). Although this method appears to be geared towards the development of new varieties, it shares some common features with locus conversions mentioned above including using as few as 2 backcrosses to a recurrent parent, such that the two methods cannot be readily distinguished from one another without knowing the relatedness of the donor variety to the recurrent parent.
Eby does not specifically teach variety GL4808A1-D1YN or event A5547-127.
Mason teaches soybean plants comprising elite events including EE-GM2 wherein EE-GM2 was deposited under NCIMB accession 41660 (column 3, lines 30-32) which is an alternative name to event A5547-127. Mason et al further teaches combining glyphosate and glufosinate resistance genes.
Boehm measures multiple traits in different locations in the process of introgressing traits in soybean using the backcross method (see throughout, specifically tables 5.4 and 5.5). Boehm backcrosses to the recurrent parent for 5 generations, which would be expected to result in substantially higher similarity of the resultant line with the recurrent parent than in the instant application. Table 5.4 demonstrates a considerable range of yield, lodging and height when compared to the recurrent parent, wherein height differs by as much as 19cm, lodging 1.1 and yield by as much as 18.4. Again, it is noteworthy that these differences are with individuals that are closer genetically to the recurrent parent than the instant variety, and yet such variation would be expected given these results. It is of further note that wide ranges are also observed when grown in different locations. As noted above, the recurrent parent of the instant case in the patented disclosure was grown in a different location and in a different year than the instant variety, all of which would lead one of ordinary skill in the art to conclude that a substantial amount of variation in some traits might be observed in a locus conversion, and still be considered a locus conversion within the metes and bounds of the claim 13 of the patented case.
Given the state of the art and the disclosures by Eby, Mason, and Boehm it would have been obvious to introgress event A5547-127 into the soybean variety taught by Eby to combine resistance genes as taught by and suggested by Mason using the backcrossing method taught by Eby, and the amount of variation observed would be well within the expected amounts in light of Boehm.
Response to Arguments
Applicant's arguments filed 07/09/2025 have been fully considered but they are not persuasive.
Applicant's arguments filed 07/09/2025 have been fully considered but they are not persuasive.
Applicant’s urge that Soybean cultivar 92310703 provides substantial improvements over the referenced cultivar S130097 and these differences are practically significant, highly valued by breeders and farmers alike and would not have been expected on the prior art (see page 5 of the Response).
This is not persuasive primarily because the rejection as a whole is not based on the similarity of the instant plant variety with the recurrent parent variety per se, but rather, due to the fact that the patented parent variety has a patented claim drawn to a locus conversion of that variety, which the instant variety appears to be. Moreover, the issued patent with respect to locus conversions is not limited to a single trait change or a single gene addition (see action above). Furthermore, any additional trait that is introduced that is not present in the recurrent parent is deduced to come from the donor parent, the physiological make up of which has heretofore not been disclosed in any detail.
Applicant’s urge that Mr. Mason establishes and concludes that neither A5547-127 nor its counterpart A5547 exhibit any statistical differences in yield, plant emergence, stand count and plant vigor and that the herbicide tolerance trait itself has no relationship to increase in yield (see pages 5-6 of Response).
This is not persuasive because the comparisons are being made with the original event lines and not the lines used in the instant breeding history to introduce the event. Rather, the line used to introduce the event or multiple events is disclosed as GL4808A1-D1YN. The referenced characteristics do not appear to be those of donor line GL4808A1-D1YN and therefore do not provide evidence that such traits would not have been expected to be introduced by said donor variety.
Applicant’s urge that the cited references do not provide evidence of an expectation of increased yield or plant height in backcrossing the EE-GM2 trait and that Boehm explicitly states that the yield of each backcross line was not significantly different than the recurrent parent. Applicant further urges that with respect to reasonable expectation, that this must be demonstrated for the specific invention claimed and not to the mere “gist” or “thrust” of the invention (see pages 6-7 of the response).
This is not persuasive primarily because the characteristics of the donor line have not, in fact been divulged in the instant application. This is important to this determination because of Applicant’s own description of the backcrossing technique. Applicant states “As discussed previously, backcrossing can be used to transfer one or more specifically desirable traits from one cultivar, the donor parent, to a developed cultivar called the recurrent parent, which has overall good agronomic characteristics yet lacks that desirable trait or traits. However, the same procedure can be used to move the progeny toward the genotype of the recurrent parent, but at the same time retain many components of the nonrecurrent parent by stopping the backcrossing at an early stage and proceeding with selfing and selection. For example, a soybean cultivar may be crossed with another cultivar to produce a first generation progeny plant. The first generation progeny plant may then be backcrossed to one of its parent varieties to create a BC1 or BC2. Progeny are selfed and selected so that the newly developed cultivar has many of the attributes of the recurrent parent and yet several of the desired attributes of the nonrecurrent parent. This approach leverages the value and strengths of the recurrent parent for use in new soybean varieties. [00213] Therefore, an embodiment of this invention is a method of making a backcross conversion of soybean cultivar 92310703, comprising the steps of crossing a plant of soybean cultivar 92310703 with a donor plant comprising a desired trait, selecting an F1 progeny plant comprising the desired trait, and backcrossing the selected F1 progeny plant to a plant of soybean cultivar 92310703. This method may further comprise the step of obtaining a molecular marker profile of soybean cultivar 92310703 and using the molecular marker profile to select for a progeny plant with the desired trait and the molecular marker profile of soybean cultivar 92310703” (see page 41 of the specification).
It is clear that it is understood and appreciated that traits that are additional to the transgenic trait could be incorporated into the resultant locus conversion or backcross variety such that more than just stated event was incorporated.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No 8975486 in view of mason (US Patent 9062324) in light of Boehm (2014 Tennessee Research and Creative Exchange Masters Thesis, University of Tennessee pages 1-135).
The claims are directed to soybean variety 92310703 and methods of breeding and F1 hybrid seeds and plants derived therefrom. As indicated above, the breeding history in the instant application appears to be a locus conversion wherein two backcrosses to recurrent parent 11050339-52 were performed and the donor parent, GL480A1-D1YN appears to be donating the A5547-127 event which confers glufosinate resistance. 16 traits are instantly disclosed for describing the instant soybean variety of which 12 are identical or near identical to the recurrent parent 11050339-52 further establishing that the instant variety is a locus conversion of the patented variety. The plant height, seed size, relative maturity and plant lodging all differ but would be well within the instant definition of locus conversion wherein a variant might be present. In addition to locus conversions introducing variation through linkage drag, it is also possible that the differences are due to environmental differences. The recurrent patented parent was measured in a different year (2009-2013) than the instant variety (2016-2019 and therefore numerical comparisons of environmentally impacted traits such as plant height and seed size cannot reliably distinguish the two varieties. Additionally, Applicants do not describe donor line GL480A1-D1YN such that one of skill in the art would know what could be expected to be introduced trait-wise from the donor parent such that the resultant variety would have a reasonable expectation of success when evaluating the instantly claimed variety trait table. Applicants further do not provide any statistical error bars for one of skill in the art to determine if a given variety is within the reasonable range for each traits such that it can be distinguished from the instant variety. In order for the differences cited above to distinguish this variety from a locus conversion of the recurrent parent already covered in US Patent 8975486 claim 13, the differences need to be both unexpected and practically significant. See MPEP 716.02(b)
716.02(b) Burden on Applicant [R-08.2012]
I. BURDEN ON APPLICANT TO ESTABLISH RESULTS ARE UNEXPECTED AND SIGNIFICANT
The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c).
This principle was also recently affirmed in Ex parte McGowen (Appeal 2019-006060) wherein the decision affirmed burden for Applicant to establish that the trait differences would be both unexpected and have practical significance.
Eby teaches soybean variety S130097, methods of breeding said variety, F1 hybrid seeds and plants therefrom as well as more specifically a locus conversion (see claim 13) wherein a trait is introgressed such as event A5547-127 and backcrossed to the recurrent parent. Eby additionally teaches a method of transforming a plant of the variety (claim 8), and a plant produced by said transformation (see claim 10), including herbicide tolerance (see claim 9) and methods of introducing a locus conversion (see claim 11).
Eby further states “A single locus conversion of the site-specific integration system allows for the integration of multiple genes at the converted loci” clearly encompassing multiple trait differences in a single locus conversion (see column 25 3rd full paragraph). Eby further teach that fewer backcrosses may be used in locus conversions wherein the donor parent is highly related to the recurrent parent (see columns 25-26) Eby also teaches that pedigree breeding may be combined with backcrossing to introduce one or more traits (see column 29). Although this method appears to be geared towards the development of new varieties, it shares some common features with locus conversions mentioned above including using as few as 2 backcrosses to a recurrent parent, such that the two methods cannot be readily distinguished from one another without knowing the relatedness of the donor variety to the recurrent parent.
Eby does not specifically teach variety GL480A1-D1YN or event A5547-127.
Mason teaches soybean plants comprising elite events including EE-GM2 wherein EE-GM2 was deposited under NCIMB accession 41660 (column 3, lines 30-32) which is an alternative name to event A5547-127. Mason et al further teaches combining glyphosate and glufosinate resistance genes.
Boehm measures multiple traits in different locations in the process of introgressing traits in soybean using the backcross method (see throughout, specifically tables 5.4 and 5.5). Boehm backcrosses to the recurrent parent for 5 generations, which would be expected to result in substantially higher similarity of the resultant line with the recurrent parent than in the instant application. Table 5.4 demonstrates a considerable range of yield, lodging and height when compared to the recurrent parent, wherein height differs by as much as 19cm, lodging 1.1 and yield by as much as 18.4. Again, it is noteworthy that these differences are with individuals that are closer genetically to the recurrent parent than the instant variety, and yet such variation would be expected given these results. It is of further note that wide ranges are also observed when grown in different locations. As noted above, the recurrent parent of the instant case in the patented disclosure was grown in a different location and in a different year than the instant variety, all of which would lead one of ordinary skill in the art to conclude that a substantial amount of variation in some traits might be observed in a locus conversion, and still be considered a locus conversion within the metes and bounds of the claim 13 of the patented case.
Given the state of the art and the disclosures by Eby, Mason, and Boehm it would have been obvious to introgress event A5547-127 into the soybean variety taught by Eby to combine resistance genes as taught by and suggested by Mason using the backcrossing method taught by Eby, and the amount of variation observed would be well within the expected amounts in light of Boehm.
Response to Arguments
Applicant's arguments filed 07/09/2025 have been fully considered but they are not persuasive.
Applicant’s urge that Soybean cultivar 92310703 provides substantial improvements over the referenced cultivar S130097 and these differences are practically significant, highly valued by breeders and farmers alike and would not have been expected on the prior art (see page 5 of the Response).
This is not persuasive primarily because the rejection as a whole is not based on the similarity of the instant plant variety with the recurrent parent variety per se, but rather, due to the fact that the patented parent variety has a patented claim drawn to a locus conversion of that variety, which the instant variety appears to be. Moreover, the issued patent with respect to locus conversions is not limited to a single trait change or a single gene addition (see action above). Furthermore, any additional trait that is introduced that is not present in the recurrent parent is deduced to come from the donor parent, the physiological make up of which has heretofore not been disclosed in any detail.
Applicant’s urge that Mr. Mason establishes and concludes that neither A5547-127 nor its counterpart A5547 exhibit any statistical differences in yield, plant emergence, stand count and plant vigor and that the herbicide tolerance trait itself has no relationship to increase in yield (see pages 5-6 of Response).
This is not persuasive because the comparisons are being made with the original event lines and not the lines used in the instant breeding history to introduce the event. Rather, the line used to introduce the event or multiple events is disclosed as GL4808A1-D1YN. The referenced characteristics do not appear to be those of donor line GL4808A1-D1YN and therefore do not provide evidence that such traits would not have been expected to be introduced by said donor variety.
Applicant’s urge that the cited references do not provide evidence of an expectation of increased yield or plant height in backcrossing the EE-GM2 trait and that Boehm explicitly states that the yield of each backcross line was not significantly different than the recurrent parent. Applicant further urges that with respect to reasonable expectation, that this must be demonstrated for the specific invention claimed and not to the mere “gist” or “thrust” of the invention (see pages 6-7 of the response).
This is not persuasive primarily because the characteristics of the donor line have not, in fact been divulged in the instant application. This is important to this determination because of Applicant’s own description of the backcrossing technique. Applicant states “As discussed previously, backcrossing can be used to transfer one or more specifically desirable traits from one cultivar, the donor parent, to a developed cultivar called the recurrent parent, which has overall good agronomic characteristics yet lacks that desirable trait or traits. However, the same procedure can be used to move the progeny toward the genotype of the recurrent parent, but at the same time retain many components of the nonrecurrent parent by stopping the backcrossing at an early stage and proceeding with selfing and selection. For example, a soybean cultivar may be crossed with another cultivar to produce a first generation progeny plant. The first generation progeny plant may then be backcrossed to one of its parent varieties to create a BC1 or BC2. Progeny are selfed and selected so that the newly developed cultivar has many of the attributes of the recurrent parent and yet several of the desired attributes of the nonrecurrent parent. This approach leverages the value and strengths of the recurrent parent for use in new soybean varieties. [00213] Therefore, an embodiment of this invention is a method of making a backcross conversion of soybean cultivar 92310703, comprising the steps of crossing a plant of soybean cultivar 92310703 with a donor plant comprising a desired trait, selecting an F1 progeny plant comprising the desired trait, and backcrossing the selected F1 progeny plant to a plant of soybean cultivar 92310703. This method may further comprise the step of obtaining a molecular marker profile of soybean cultivar 92310703 and using the molecular marker profile to select for a progeny plant with the desired trait and the molecular marker profile of soybean cultivar 92310703” (see page 41 of the specification).
It is clear that it is understood and appreciated that traits that are additional to the transgenic trait could be incorporated into the resultant locus conversion or backcross variety such that more than just stated event was incorporated.
No Claims are allowed.
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/BRENT T PAGE/Primary Examiner, Art Unit 1663