DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The disclosure is objected to because of the following informalities:
On page 49, paragraph 0245 the missing information is objected to.
Appropriate correction is required.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains 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.
The invention appears to employ novel plants. Since the plant is essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the plant. A deposit of 650 seeds of each of the claimed embodiments is considered sufficient to ensure public availability. The specification does not disclose a repeatable process to obtain the plant and it is not apparent if the plant is readily available to the public. It is noted that Applicant intends to deposit seed of the plant under the terms of the Budapest Treaty, but there is no deposit number and thus no indication that the seeds have actually been deposited and accepted.
(a) If a deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention has been deposited and accepted, and will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
(b) If a 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 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2);
(iii) 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 effective life of the patent, whichever is longer;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
Claim 18 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 18 is drawn to a mutagenized soybean that comprises a mutation and otherwise comprises all the morphological and physiological characteristics of soybean cultivar 91241408.
EMS mutagensis of soybean can produce over 20,000 mutations per plant (Tsuda et al, 2015, BMC Genomics 16:1014; pg 4, right column, paragraph 1).
Thus, the claim encompasses soybean plants that can have almost any number of mutations in any number of morphological and physiological characteristics relative to soybean cultivar 91241408.
The specification describes no structural features that distinguish soybean plants that differ from morphological and physiological characteristics of soybean cultivar 91241408 in any number of traits from other soybean plants.
Hence, Applicant has not, in fact, described mutagenized soybean plants over the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 6, 10-11, 13 and 16-18 are indefinite in their recitation of “91241408”. Without the deposit number in the independent claims, it is unclear what soybean is being referred to.
Claims 1, 11 and 13 are indefinite because of the presence of a blank line instead of a NCMA Accession No. Because the number is not present, it is unclear to which deposit the claims refer. Because the remainder of the claims depend from the rejected claims they are also indefinite.
Claim Rejections - 35 USC § 103
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(a) as being unpatentable over Eby (2017, US 9,591,827) in view of De Beuckleer (2011, US 8,017,756).
The claims are drawn to soybean variety 91241408, methods of using it, and products and plants produced from it.
Eby teaches soybean variety 11KA71163-56-06, also known as 57160653 (claims 1-2, column 6, lines 43-44, Table 1). Like the instant soybean, 11KA71163-56-06 has purple flowers, gray pubescence, tan pods, gray hila, yellow, dull seed coats, yellow cotyledons, ovate leaflets, the MON889788 and MON87708 events, the Rps1c Phytophthora root rot resistance allele, the rhg1 soybean cyst nematode resistance gene, and indeterminate growth (Table 1; column 7, lines 8-19). 11KA71163-56-06 and the instant soybean have similar values for relative maturity, lodging, plant height, seeds/lb, and % seed oil and protein. Eby does not teach 11KA71163-56-06 as having the A5547-127 event.
Eby teaches cells, tissue culture of the plant (claims 3-4), methods of crossing the soybean with itself or another soybean plant, including a series of crosses to produce a soybean plant derived from the original line (claims 5-6), F1 progeny seeds (claim 7), introducing transgenes into the plant, including those conferring male sterility, herbicide resistance, insect or pest resistance, disease resistance, modified fatty acid metabolism, abiotic stress tolerance, or modified carbohydrate metabolism, and plants thereby produced (claims 8-10), a method of introducing a single locus conversion into the plant, including one conferring male sterility, herbicide resistance, insect or pest resistance, disease resistance, modified fatty acid metabolism, abiotic stress tolerance, or modified carbohydrate metabolism, and plants thereby produced (claims 11-13), a method of using the plant to produce a different inbred soybean plant (claims 14-17), a method of mutagenizing the plant (claim 17), and methods of producing commodity products, including protein isolates, protein concentrate, hulls, meal, flour and oil (claims 18-19).
Eby teaches that backcross conversions of soybean cultivar 57160653 can comprise the desired trait of herbicide resistance (column 25, 3rd and 4th paragraphs) and that genes that confer resistance to an herbicide can include phosphinothricin acetyl transferase (column 16, lines 33-34) as found in the A5547-127 event of De Beuckleer.
De Beuckleer teaches soybean plants with the A5547-127 event (also known as EE-GM2 or LL55), which confers glufosinate tolerance without otherwise compromising agronomic performance (column 25, lines 1-36; column 26, lines 34-42).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to introduce the A5547-127 event into 11KA71163-56-06 by backcrossing. One of ordinary skill in the art would have been motivated to do so because doing so would confer a herbicide resistance to 11KA71163-56-06 by that would allow it to survive in a field sprayed with glufosinate, in addition to glyphosate and/or dicamba, to control weeds. Additionally, Eby suggests introducing glufosinate resistance into the plant (column 16, lines 33-34); the A5547-127 event is one way to achieve that, with the advantage that it does not otherwise compromise agronomic performance (Beuckleer, column 25, lines 1-36; column 26, lines 34-42).
11KA71163-56-06 and the instant soybean cultivar have similar values for relative maturity, lodging, plant height, seeds/lb, and % seed oil and protein. These differences are merely a difference in degree and not in kind, and would be expected by one of ordinary skill in the art introgressing one trait from one plant into another.
One of ordinary skill in the art would have introduced transgenes and single locus conversions into the plant, including those conferring male sterility, herbicide resistance, insect or pest resistance, disease resistance, modified fatty acid metabolism, abiotic stress tolerance, or modified carbohydrate metabolism, as taught by Eby. One of ordinary skill in the art would have been motivated to do so because would introduce further desirable traits; for example, insect resistance would allow the plants to grown in areas with insect pests.
One of ordinary skill in the art would have crossed the resulting soybean with itself or another soybean plant, including a series of crosses to produce a soybean plant derived from the original line, including F1 progeny seeds and plants, as taught by Eby. One of ordinary skill in the art would have been motivated to do so because this would allow one to introduce 11KA71163-56-06’s traits into other, new soybean lines.
One of ordinary skill in the art would have mutagenized the resulting soybean, as taught by Eby. One of ordinary skill in the art would have been motivated to do so because this would allow one to introduce new traits into 11KA71163-56-06.
One of ordinary skill in the art would have produced commodity products, including protein isolates, protein concentrate, hulls, meal, flour and oil from the soybean, as taught by Eby. One of ordinary skill in the art would have been motivated to do so because these are the economically important products produced from soybeans and one of the main reasons farmers grow soybeans.
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 e-Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about e-Terminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of each of copending Application Nos. 18/975,975, 18/782,861, 18/782,869, 18/822,972, 18/443,271, 18/829,948, 19/400,152, 19/004,169, 19/006,409, 18/776,056, 19/097,723, 19/097,756, 19/097,734, 19/097,723, 18/932,315, 19/022,639, 19/034,306, 19/071,635 and 19/071,251. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the instant application and each of ‘975, ‘861, ‘861, ‘972, ‘271, ‘948, ‘152, ‘169, ‘409, ‘056, ‘723, ‘756, ‘734, ‘281, ‘315, ‘639, ‘306, ‘635 and ‘251 are patentably indistinct because the claims differ only in the name of the cultivars in the claims. These names are in-house designations have no art accepted meaning.
However, the cultivars all share parents, 11KA71163-56-06 X (11KA71163-56-06(11KA71163-56-06 x OX3009B4-D0YN)), and were made by the same breeding steps.
All the soybean cultivars claimed in the instant and copending applications have yellow seed coats, a dull seed coat luster, yellow cotyledons, ovate leaflets, purple flowers, gray pubescence, tan pods, gray or imperfect black hilum, the MON889788, A5547-127, and MON87708 events, the Rps1c Phytophthora root rot resistance allele, the rhg1 soybean cyst nematode resistance gene, and indeterminate growth.
The soybean cultivars claimed in the instant and copending applications also share similar values for relative maturity, lodging, plant height, seeds/lb, and % seed oil and protein, as shown in the table below:
Application#
RM
Lodg
Ht
S/lb
%Pro
%Oil
Application#
RM
Lodg
Ht
S/lb
%Pro
%Oil
Instant
2.5
6.8
89
2889
35.5
18.9
19/097,723
2.0
7.4
81
2632
35.1
18.8
18/975,975
2.1
701
79
2689
35.1
19.2
19/097,756
2.2
7.3
81
2727
34.9
19.0
18/782,861
2.3
7.0
81
2695
34.9
18.6
18/782,869
2.6
7.1
81
2732
34.1
19.1
19/097,734
2.1
7.0
79
2749
35.2
18.4
18/822,972
2.5
7.0
84
2823
34.6
18.8
19/097,723
2.0
7.4
81
2632
35.1
18.8
18/443,271
2.6
7.1
81
2663
34.6
18.7
18/932,315
2.1
7.8
89
2727
34.3
20.2
18/829,948
2.4
6.9
84
2612
35.7
19.0
19/022,639
2.8
7.0
89
3037
34.2
19.6
19/400,152
2.6
6.8
84
2783
35.0
18.7
19/034,306
2.4
7.0
94
3202
34.5
20.1
19/004,169
2.2
6.4
86
2711
35.0
19.1
19/071,635
2.7
7.5
86
2794
34.9
19.8
19/071,251
2.4
7.2
94
2705
34.2
20.1
19/006,409
2.2
7.2
81
2823
33.5
19.4
18/776,056
2.3
7.0
81
2642
34.4
19.1
Relative maturity (RM), lodging (Lodg), plant height (HT), seeds/lb (S/lb), and % seed oil (%Oil) and protein (%Pro) are all affected by the environmental conditions in which the plant is grown.
Relative maturity is affected by growing temperature and the amount of daylight (Iowa State University Extension and Outreach, 2018, Soybean Planting and Decision Tool, https://crops.extension.iastate.edu/facts/soybean-planting-decision-tool; see Figure 4).
Lodging score is affected by planting date and seeding rate (Pioneer, 2021, https://www.pioneer.com/us/agronomy/planting_date_effects_lodging_yield_soybeans.html, see Fig 4, 5, pg 5, ¶1, 4).
Plant height is affected by a wide range of environmental conditions (Yang et al, 2021 BMC Plant Biology 21:63; see paragraph spanning the columns on pg 2).
Seed size is affected by weather conditions during seed-filling, particularly extreme late-season stress (Wiebold, 2015, https://ipm.missouri.edu/ipcm/2008/11/Soybean-Seed-Size-Does-Not-Affect-Yield-Performance/, ¶2 and 5) and can vary as much as 20% within a given variety (Staton, 2017, Recommendations for planting large soybean seed, MSU Extension, https://www.canr.msu.edu/news/recommendations_for_planting_large_soybean_seed; ¶1).
Protein and oil concentrations are affected by fertilizer application (Assefa et al, 2019, Front. Plant Sci. 10:298; see pg 10, left column, paragraph 2).
It is clear that the variation in these 6 traits between the instant cultivar and the 38 other cultivars can be accounted for by differing environmental conditions. As none of the traits distinguish the instant cultivar from those claimed the applications listed above, these cultivars are not distinct and thus are obvious variants.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of each of U.S. Patent Nos. 11,234,405 and 11,252,923 and 11,206,797 and 11,234,406.
The claims of the instant application and each of the ‘405, ‘923, ‘797 and ‘406 Patents are patentably indistinct because the claims differ only in the name of the cultivars in the claims. These names are in-house designations have no art accepted meaning.
However, the cultivars all share parents, 11KA71163-56-06 X (11KA71163-56-06(11KA71163-56-06 x OX3009B4-D0YN)), and were made by the same breeding steps.
All the soybean cultivars claimed in the instant and issued Patents have yellow seed coats, a dull seed coat luster, yellow cotyledons, ovate leaflets, purple flowers, gray pubescence, tan pods, gray hila, the MON889788, A5547-127, and MON87708 events, the Rps1c Phytophthora root rot resistance allele, the rhg1 soybean cyst nematode resistance gene, and indeterminate growth.
The soybean cultivars claimed in the instant and the issued Patents also share similar values for relative maturity, lodging, plant height, seeds/lb, and % seed oil and protein.
Relative maturity, lodging, plant height, seeds/lb, and % seed oil and protein are all affected by the environmental conditions in which the plant is grown.
Relative maturity is affected by growing temperature and the amount of daylight (Iowa State University Extension and Outreach, 2018, Soybean Planting and Decision Tool, https://crops.extension.iastate.edu/facts/soybean-planting-decision-tool; see Figure 4).
Lodging score is affected by planting date and seeding rate (Pioneer, 2021, https://www.pioneer.com/us/agronomy/planting_date_effects_lodging_yield_soybeans.html, see Fig 4, 5, pg 5, ¶1, 4).
Plant height is affected by a wide range of environmental conditions (Yang et al, 2021 BMC Plant Biology 21:63; see paragraph spanning the columns on pg 2).
Seed size is affected by weather conditions during seed-filling, particularly extreme late-season stress (Wiebold, 2015, https://ipm.missouri.edu/ipcm/2008/11/Soybean-Seed-Size-Does-Not-Affect-Yield-Performance/, ¶2 and 5) and can vary as much as 20% within a given variety (Staton, 2017, Recommendations for planting large soybean seed, MSU Extension, https://www.canr.msu.edu/news/recommendations_for_planting_large_soybean_seed; ¶1).
Protein and oil concentrations are affected by fertilizer application (Assefa et al, 2019, Front. Plant Sci. 10:298; see pg 10, left column, paragraph 2).
It is clear that the variation in these 6 traits between the instant cultivar and the 4 other cultivars can be accounted for by differing environmental conditions. As none of the traits distinguish the instant cultivar from those claimed the issued Patents listed above, these cultivars are not distinct and thus are obvious variants.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,259,495. The instant soybean cultivar and soybean cultivar 90381408 of the ‘495 Patent were made using the same parental lines and method steps (column 6, line 25-39), and have essentially the same morphological and physiological characteristic (Table 1 at column 6 and instant Table 1). Hence, the instant claims are an obvious variation of those of the ‘495 Patent.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/David H Kruse/
Primary Examiner, Art Unit 1663