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 .
Status
Claims 1-20 as filed on 2 May 2025 are examined herein.
Examiner’s Notes
Citations to Applicant’s specification are abbreviated herein “Spec.”
Examination of the patent application relies on the values presented in Table 1 for the cultivar 16430401. Spec., p. 9.
In particular the search focused on white flowers, brown pod walls, indeterminate growth, maturity group IV (4.5), brown hilum, and light tawny pubescence.
The background regarding the state of the art, a variety is distinguished from other plants of the same species by DUS traits and/or by genetic fingerprint. In the United States, the genetic variation for commercial varieties of soybean is limited with only a limited number of ancestors which may limit the potential for genetic improvement of soybean . E.g. Moore (2008) Farm Industry News) (“A Shallow Gene Pool”), p. 3.
In Fehr (1987) (“Backcross Method” in Principles of Cultivar Development (Macmillan Pub. Co. (New York)) pp. 360-76), the backcross method is described as restoring 75% of the recurrent parent genome after the first backcross and restoring 87.5% of the recurrent parent genome after the second backcross (see Fig. 28-1, p. 362).
Also, Applicant discusses “single locus conversion” in paragraph 0068. Additionally, Applicant explicitly defines “a” for example as being unrestrictive with regard to the number. Spec., para. 0244.
Claim Interpretation
On pages 8-9 of the specification, Applicant teaches that the claimed cultivar 16430401 originated from a cross of SJ1500746 and 11MB43198-43-11. The breeding designation was 17MA311811-04-03. Then it was changed to 16430401.
This soybean designation was also the subject of application serial no. 17/941,982, now abandoned (U.S. Patent Publication No. 2024/0081245 A1).
This application is a continuation of that application filed on 27 May 2025.
Applicant noted that one parent , 11MB43198-43-11, is also known as soybean cultivar 57111348, and is claimed in , U.S. Patent No. 9,961,859; in a document filed in the parent application.
Claim 13 recites a "soybean plant of soybean cultivar 16430401, further comprising a single locus conversion." Applicant defines "soybean plant" as including "any single gene conversions of that cultivar." Spec., para. 187. For this reason, claim 13 is directed to a plant of cultivar 00540608 which can include a single gene conversion, so the plant further comprises a single locus conversion.
For this reason, it is understood that the claimed plant having a single locus conversion will retain the DUS of cultivar 6430401 except for the single locus conversion.
Furthermore, the limitation "a single locus conversion" is specifically defined in the instant specification. Spec., para. 0068. This definition is consistent as producing a plant that differs genetically from the plant represented by the deposited seeds at only a single locus. Therefore, the Examiner interprets the above claims as being directed to a plant of soybean cultivar 6430401 that was transformed with a transgene or had one locus introduced by a backcrossing technique.
The paragraphs following 0193 are interpreted as taking precedence over the broad definition of “a” in paragraph 00244.
Claims 9 and 12 each have the conjunction “or” between “insect” and “pest” in the middle of a Markush group of traits. This is reasonably interpreted as resistance to “insect resistance” or “non-insect pest resistance.” In other words the trait may confer resistance to insect pests as well as non-insect pests or only one type of the pests but not the other or both.
Copending Applications
Applicant should bring to the attention of the Examiner, or other Office officials involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
The Office acknowledges the IDS which was reviewed and signed.
Specification
The disclosure is objected to because of the following informalities.
The disclosure is objected to because the deposit information on page 49 does not provide the deposit number; instead a blank line is present as a placeholder for accession number. Furthermore, a blank line is also used for the date of the deposit.
The specification is also objected to because although 11MB43198-43-11 is necessary for understanding the claimed invention, U.S. Patent No. 9,961,859, which claims it as “soybean cultivar 57111348” is not recited in the specification.
Claim Objections
Claims 1, 5, 11, 13, 14 and 15 are objected to because of the following informalities.
Claims 1, 11 and 13 are objected to because they include the placeholder “______“ instead of the deposit number.
Claims 5, 14 and 15 require crossing a plant with itself as an option. Technically this is incorrect. Cross-pollination is fertilization by the union of two gametes from different plants. E.g. Spec., para. 0025. When pollen from a plant fertilizes a flower from the same plant, it is called “selfing.”
Appropriate correction is requested.
Claim Rejections - 35 USC § 112(b)
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 pre-AIA the applicant regards as the invention.
Claims 1, 6, 10-11, 13, and 16-18 are rejected because they recite the limitation soybean cultivar “6430401” The meaning of cultivar “6430401” in particular is uncertain and creates ambiguity in the claims and thus renders the claims indefinite.
The term cultivar “6430401" is not known in the art other than this application, and the use of said name by itself does not carry art-recognized limitations defining the specific characteristics or essential characteristics that are associated with this denomination. In addition, the name appears to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of a soybean plant that encompasses all of its traits except by deposit. Thus the term in question lacks a general art-accepted meaning and Applicant does not explicitly define the term in the specification.
Furthermore, the meaning of this term could arbitrarily change to designate something different during the lifetime of a patent. Thus, one's ability to determine the metes and bounds of the claim would be impaired. See In re Hammack, 427 F.2d 1378, 1382; 166 USPQ 204, 208 (CCPA 1970).
For example, in the IDS Transmittal letter of the parent application, cited in the instant IDS, Applicant noted that one parent is known by multiple names and is, under one of the names, patented in U.S. Patent No. 9,961,859 (the ‘859 Patent) as Soybean Cultivar 57111348.
As part of the above rejection under 35 USC 112(b), several claims are additionally ejected because they include the placeholder “______“ instead of the deposit number; which of course has no meaning in the art.
Perfecting the deposit and filling in the blanks will obviate these aspects of the rejection.
Claim 6 is rejected because of its use of the word “defined.” It is well-established that Applicant is allowed to be their own lexicographer. It is also well-established that every word in a claim is given meaning and that words are preferentially given their ordinary meaning.
Claim 6 uses “defined” as a limitation. This raises the question as to the comparative scope of claims 5 and 6.. If claim 6 defines claim 5, then claim 5 may be interpreted as also requiring a soybean plant of different genotype. Therefore it raises a question as to the metes and bounds of claims 5 and 6 and whether they are effectively the same claim. If so, then claim 6 would be rejected under 35 USC 112(d).
Dependent claims are included in the above rejections because they fail to provide further limitations obviating the rejections.
Claim Rejections - 35 USC § 112(a)
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Enablement (Deposit)
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 features 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 seeds. A deposit of 625 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 thus it does not appear that the plant is readily available to the public.
Applicant has not deposited seeds relative to his application. Spec., p. 49.
The seeds must be accepted under the terms of the Budapest Treaty or their viability must be tested and results provided. Applicant did state that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent. Neither the specification or the claims, however, contain the deposit number etc.
Applicant prophetically states in the specification that the deposits were accepted under the Budapest Treaty. Id.
Written Description
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.
The claim is directed to a soybean plant produced by introducing a mutation into the genome of the claimed soybean cultivar via EMS, gamma rays, or sodium azide.
However, in view of the expansive definition of “a” in paragraph 0244, the claim encompasses a plant with an unlimited number of mutations relative to the unmutated genome of 16430401. (see also paragraph 0220)
It is known in the art that treating seeds with chemical mutagens such as EMS can lead to multitudes of mutations within the genome. See, for example, Tsuda et al. (2015) that teaches that the average number of base changes per line of soybeans treated with EMS was 12,796. Page 1., Tsuda et al. (2015) BMC Genomics 16:1-18.
Although claim 18 states that the mutagenized plant will comprise all of the morphological and physiological characteristics of soybean cultivar 16430401 other than the changes resulting from "a mutation in the genome", it is clear that there is no limit to the number of mutations that could be introduced. Given how many can be introduced by mutagenesis, there could be numerous physiological and morphological changes as a result of mutagenesis. See, for example, Pavadai et al. (2009) J. Phytology 1:444-47 where the article teaches that mutations in soybean resulted in phenotypes that were recorded as tall, dwarf, stunted, early and late flowering, early and late maturity, green color seed, wrinkled seed, single seeded pod, long pod, tetra foliate leaf, and male sterility (Pavadai 445), and also resulted in changes in protein and oil content (Id. 446).
"An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. " MPEP § 2163(I)(A).
Furthermore, the instant specification does not disclose a single embodiment of a plant produced by mutating the instant cultivar reduced to practice. Given that the underlying genetics can be dramatically changed with thousands of base changes in the genomic DNA, and the physiological and morphological characteristics can be changed due to multiple changes in traits as a result of the mutations, the genus of mutant plants encompassed by claim 18 is not adequately described.
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:
§ 103. Conditions for patentability; non-obvious subject matter
A patent for a claimed invention may not be obtained, . . . . 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 unpatentable over U.S. Patent Publication No. 2021/0051905 (25 February 2021); Mason, Soybean Cultivar 8727283. The instant claims are drawn to soybean variety 16430401, methods of using it, and products and plants produced from it.
Mason, in the ‘905 Publication teaches soybean cultivar 8727283 and parts thereof(claims 1-4). ‘905 Publication teaches 8727283 by a deposit and the traits recited in Table 1 (p. 5, col. 1).
Based on the this, as can be seen in the table infra in the Double Patenting rejection, the characteristics listed are identical or very similar. The two differ primarily in Lodging Score as well as seed size and seed composition (protein / oil). However, these characteristics, although genetically controlled, are influenced by the environment.
Lodging: Ramli et al. (1980) Agronomy J 72 (6):904-06 “Influence of Induced Lodging on Pod Distribution and Seed Yield in Soybeans” (col. 1, para. 1); and Cooper (1971) Agronomy J 63 (3):490-93, “Influence of Soybean Production Practices on Lodging and Seed Yield in Highly Productive Environments,” (p. 492, col. 2).
Seed Composition: Other differences are in seed composition (protein % and oil %) as well as seed size. Seed composition is known to be effected by the environment. Rotundo & Westgate (2009) Field Crops Res 110:147-56 (title). Although seed size is controlled by genetics, the environment also has an impact. Kumar et al. (2006) J Food Compos Anal 19:188–95, 192.
Both cultivars also have the DAS-44406-6 event and the rhg-1 gene.
Claims 1-20 of each are very similar and several claims allow for converted loci and mutations. Therefore the instant claimed 16430401 is obvious over the cultivar 8727283 of the ‘905 Publication.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of co-pending application serial nos.:
16/545,701 (‘701 Application) by the same inventor (2021/0051905 A1 now U.S. Patent No. 11,219,179);
16/545,714 (‘714 Application) by the same inventor (2021/0051906 A1 now U.S. Patent No. 11,212,998); and
16/545,729 (‘729 Application) by the same inventor (2021/0051907 A1 now U.S. Patent No. 11,337,394). All published on 25 February 2021.
Although the conflicting claims might not be identical, they are not patentably distinct from each other. This is a provisional double patenting rejection since the instant claims have not yet been patented and it is reasonable to interpret the claimed subject matter as being plants with at least minor genetic variations.
As seen in the TABLE below, when the instant 16430401 cultivar is compared to the above cultivars (Table 1 of each), there are few differences. One difference is in the lodging score, but lodging is effected by the environment and planting practices. E.g., Ramli et al. (1980) Agronomy J 72 (6):904-06 “Influence of Induced Lodging on Pod Distribution and Seed Yield in Soybeans” (col. 1, para. 1); and Cooper (1971) Agronomy J 63 (3):490-93, “Influence of Soybean Production Practices on Lodging and Seed Yield in Highly Productive Environments,” (p. 492, col. 2).
Other differences are in seed composition (protein % and oil %) as well as seed size. Seed composition is known to be effected by the environment. Rotundo & Westgate (2009) Field Crops Res 110:147-56 (title). Although seed size is controlled by genetics, the environment also has an impact. Kumar et al. (2006) J Food Compos Anal 19:188–95, 192.
All cultivars also have the DAS-44406-6 event and the rhg-1 gene.
Claims 1-20 of each are very similar and several claims allow for converted loci and mutations.
Instant
US 20210051905 A1
US 20210051906 A1
US 20210051907 A1
16430401
86092833
882833
87272833
pod wall
brown
brown
brown
brown
flower
white
white
white
white
pubsence
light tawny
light tawny
light tawny
light tawny
hilum
brown
brown
brown
brown
relative maturity
4.5
4.5
4.5
4.8
lodging
7.0
7.6
7.7
7.8
seed size
2806
3157
3393
3303
100.0%
88.9%
82.7%
85.0%
seed protein
38.6
34.5
34.0
34.0
seed oil
32.2
19.8
20.1
19.8
2,4D
DAS-44406-6
DAS-44406-6
DAS-44406-6
DAS-44406-6
rhg-1
rhg-1
rhg-1
rhg-1
Conclusion
11. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL T BOGGS whose telephone number is (571)272-2805. The examiner can normally be reached Monday - Friday, 0800 to 1830 Mtn.
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/RUSSELL T BOGGS/
Examiner, Art Unit 1663
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