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 .
Claims 1-20 are pending and examined herein on the merits.
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claims 1, 11 and 13 recite incomplete accession numbers such that it is not clear what the metes and the bounds of the claims are since they are not currently tied to a deposit with an accession number.
Claims 2-10, 12 and 14-20 depend directly or indirectly from said claims and are rejected under the same basis.
Claim Rejections - 35 USC § 112
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.
Claims 1-20 are rejected under 35 U.S.C. 112(a), as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Since the seed and/or plant claimed is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If a seed, or seed of the claimed plant is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a reproducible process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public. If the deposit of the seed is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating the seed have been deposited under the Budapest Treaty and that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become unviable.
Applicant has NOT indicated that Applicant intends to deposit the seeds at the ATCC in accordance with 37 CFR 1.801-1.809. Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809 indicating that all restrictions will be irrevocably be removed upon issuance of a patent, the ATCC Accession No. and evidence of deposit to overcome this rejection.
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 are rejected under 35 U.S.C. 103 as being obvious over Eby (US Patent 10548273) 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 25231708 and methods of breeding and F1 hybrid seeds and plants derived therefrom. The breeding history in the instant application appears to be a locus conversion wherein backcrossing to recurrent parent 15XT305015-02 were performed and the donor parent, 6008-01 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 16 are identical or near identical to the recurrent parent 15XT305015-02 further establishing that the instant variety is a locus conversion of the patented variety. The plant height, and seed size 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 (2013-2017) than the instant variety (2018-2022) as well as different locations including Puerto Rico and Florida 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 6008-01 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 9591827 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 15XT305015-02, 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 6008-01 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.
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No 10548273 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 25231708 and methods of breeding and F1 hybrid seeds and plants derived therefrom. The breeding history in the instant application appears to be a locus conversion wherein backcrossing to recurrent parent 15XT305015-02 were performed and the donor parent, 6008-01 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 16 are identical or near identical to the recurrent parent 15XT305015-02 further establishing that the instant variety is a locus conversion of the patented variety. The plant height, and seed size 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 (2013-2017) than the instant variety (2018-2022) as well as different locations including Puerto Rico and Florida 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 6008-01 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 9591827 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 15XT305015-02, 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 6008-01 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.
Double Patenting
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application NOs 18436649, 18436670, 18436630, 18436725, 18436709, 18436621, 18436608 and 18436687. Although the claims at issue are not identical, they are not patentably distinct from each other because the soybean varieties have the same disclosed breeding history and the traits listed in the trait tables are nearly identical to the instantly claimed soybean variety with a couple of variations that are not believed to not be material to the claimed invention as discussed in detail above, absent evidence to the contrary. The patented and instant soybean variety all appear to be locus conversions of a previously patented variety wherein the locus conversion trait was known in the prior art (see above) and the other trait differences are within the current definitions for locus conversions where an occasional trait may vary.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claims are allowed.
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