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 .
Applicant’s Reply, filed on 04/02/2026 is hereby acknowledged.
Claim Rejections - 35 USC § 112
The rejection of the claims under 35 USC112b for an incomplete accession number is overcome in response to assurances that said deposit will be made and the all the requirements will be satisfied.
Claim Rejections - 35 USC § 112
The rejection of the claims under 35 USC112a for lacking enablement is overcome in response to assurances that said deposit will be made and the all the requirements will be satisfied.
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 Kocak et al (US Patent 119395468) 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 5PQVP10 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 backcrosses to recurrent parent 5PKDW89 were performed and the donor parent appears to be donating a glufosinate tolerance. Many of the traits are instantly disclosed for describing the instant soybean variety of which aside from the glufosinate tolerance are identical or near identical to the recurrent parent 5P further establishing that the instant variety is a locus conversion of the patented variety. The relative maturity differs slightly but would be well within the instant definition of locus conversion wherein a variant might be present and the two lines were crossed and grown in different locations which may account for this difference. 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 than the instant variety and therefore numerical comparisons of environmentally impacted traits such as relative maturity, plant height and seed size cannot reliably distinguish the two varieties. Additionally, Applicants do not describe the donor line 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 11930765 claim 18, 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.
Kocak et al teach soybean variety 5PKDW89, methods of breeding said variety, F1 hybrid seeds and plants therefrom as well as more specifically a locus conversion (see claim 18) wherein a trait is introgressed such as event glufosinate tolerance specifically and backcrossed to the recurrent parent (see 8th paragraph under Introduction of a New Trait or Locus into 5PKDW89). Kocak et al additionally teach a plant produced by transformation (see claim 4), including herbicide tolerance (see claim 5).
Kocak et al further states “A backcross conversion of 5PKDW89 occurs when DNA sequences are introduced through backcrossing with 5PKDW89 utilized as the recurrent parent. Naturally occurring, modified and transgenic DNA sequences may be introduced through backcrossing techniques. A backcross conversion may produce a plant with a trait or locus conversion in at least two or more backcrosses, including at least 2 backcrosses, at least 3 backcrosses, at least 4 backcrosses, at least 5 backcrosses, at least 6 backcrosses or more, depending at least in part on the differences between the parents of the original cross. Molecular marker assisted breeding or selection may be utilized to reduce the number of backcrosses necessary to achieve the backcross conversion” (see 4th paragraph under Introduction of a New Trait of Locus into 5PKDW89).
Kocak et al do not specifically teach variety 5PQVP10. Kocak et al do specifically teach glufosinate tolerance for modifying the recurrent parent, however as instantly claimed (see 2nd paragraph under Genes that Confer Resistance to a Herbicide for example).
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 Kocak et al, Mason, and Boehm it would have been obvious to introgress event A5547-127, or any other known locus with another donor into the soybean variety taught by Kocak et al to combine resistance genes as taught by and suggested by Mason using the backcrossing method taught by Kocak et al, and the amount of variation observed would be well within the expected amounts in light of Boehm.
Response to Arguments
Applicant's arguments filed 04/02/2026 have been fully considered but they are not persuasive.
Applicant’s urge that the soybean variety taught by Kocak et al has two loci for glyphosate and dicamba tolerance that are not comprised by the instantly claimed variety, and there is no teaching or motivation or suggestion to remove those loci within the instantly claimed variety.
This is not persuasive, because Kocak et al specifically mention modifying the soybean of their invention including locus conversions by changing the glyphosate and dicamba resistances (see 12th paragraph under heading “Introduction of a new trait of locus into 5PKDW89”).
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 Kocak et al (US Patent 119395468) 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 5PQVP10 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 backcrosses to recurrent parent 5PKDW89 were performed and the donor parent appears to be donating a glufosinate tolerance. Many of the traits are instantly disclosed for describing the instant soybean variety of which aside from the glufosinate tolerance are identical or near identical to the recurrent parent 5P further establishing that the instant variety is a locus conversion of the patented variety. The relative maturity differs slightly but would be well within the instant definition of locus conversion wherein a variant might be present and the two lines were crossed and grown in different locations which may account for this difference. 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 than the instant variety and therefore numerical comparisons of environmentally impacted traits such as relative maturity, plant height and seed size cannot reliably distinguish the two varieties. Additionally, Applicants do not describe the donor line 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 11930765 claim 18, 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.
Kocak et al teach soybean variety 5PKDW89, methods of breeding said variety, F1 hybrid seeds and plants therefrom as well as more specifically a locus conversion (see claim 18) wherein a trait is introgressed such as event glufosinate tolerance specifically and backcrossed to the recurrent parent (see 8th paragraph under Introduction of a New Trait or Locus into 5PKDW89). Kocak et al additionally teach a plant produced by transformation (see claim 4), including herbicide tolerance (see claim 5).
Kocak et al further states “A backcross conversion of 5PKDW89 occurs when DNA sequences are introduced through backcrossing with 5PKDW89 utilized as the recurrent parent. Naturally occurring, modified and transgenic DNA sequences may be introduced through backcrossing techniques. A backcross conversion may produce a plant with a trait or locus conversion in at least two or more backcrosses, including at least 2 backcrosses, at least 3 backcrosses, at least 4 backcrosses, at least 5 backcrosses, at least 6 backcrosses or more, depending at least in part on the differences between the parents of the original cross. Molecular marker assisted breeding or selection may be utilized to reduce the number of backcrosses necessary to achieve the backcross conversion” (see 4th paragraph under Introduction of a New Trait of Locus into 5PKDW89).
Kocak et al do not specifically teach variety 5PQVP10. Kocak et al do specifically teach glufosinate tolerance for modifying the recurrent parent, however as instantly claimed (see 2nd paragraph under Genes that Confer Resistance to a Herbicide for example).
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 Kocak et al, Mason, and Boehm it would have been obvious to introgress event A5547-127, or any other known locus with another donor into the soybean variety taught by Kocak et al to combine resistance genes as taught by and suggested by Mason using the backcrossing method taught by Kocak et al, and the amount of variation observed would be well within the expected amounts in light of Boehm.
Response to Arguments
Applicant's arguments filed 04/02/2026 have been fully considered but they are not persuasive.
Applicant’s urge that the soybean variety taught by Kocak et al has two loci for glyphosate and dicamba tolerance that are not comprised by the instantly claimed variety, and there is no teaching or motivation or suggestion to remove those loci within the instantly claimed variety.
This is not persuasive, because Kocak et al specifically mention modifying the soybean of their invention including locus conversions by changing the glyphosate and dicamba resistances (see 12th paragraph under heading “Introduction of a new trait of locus into 5PKDW89”).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENT T PAGE whose telephone number is (571)272-5914. The examiner can normally be reached M-F 7-4 EST.
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/BRENT T PAGE/Primary Examiner, Art Unit 1663
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