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 .
Claim Status
Claims 1-20 remain pending.
Claim 18 is newly amended.
Claims 1-20 remain rejected.
Copending Applications
Applicants must bring to the attention of the Examiner, or other Office official 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).
Response to Applicant Arguments – Objections to the Specification
In response to Applicant’s arguments dated 08/25/2025 the objections to the specification of record are withdrawn.
Specifically, applicant’s assertion that a deposit will be made and accepted in accordance with 37 CFR 1.801-1.809 and that the specification and the claims will be amended upon allowance to recite the deposit information satisfies the deposit requirement under 37 CFR 1.801-1.809 and as such the objections to the specification of record are withdrawn.
Response to Applicant Arguments – Claim objections
In response to Applicant’s arguments dated 08/25/2025 the claim objections of record are withdrawn.
Specifically, applicant’s assertion that a deposit will be made and accepted in accordance with 37 CFR 1.801-1.809 and that the specification and the claims will be amended upon allowance to recite the deposit information satisfies the deposit requirement under 37 CFR 1.801-1.809 and as such the claim objections of record are withdrawn.
Response to Applicant Arguments – 35 USC § 101 Rejections
In response to Applicant’s arguments and amendments to the claims dated 08/25/2025 the 35 USC § 101 rejections of record are withdrawn.
Response to Applicant Arguments – 35 USC § 112 (Indefiniteness)
The claims have been rejected as indefinite on three different grounds:
There is a blank section of the claims where a deposit number should be and without this information it is unclear which deposit the claims refer to and correspondingly the genetic information conferred by the deposited seeds is also unclear, which renders the claims indefinite.
Applicant’s definition of “soybean plant” in the specification includes single gene converted plants which differ from other plants of that cultivar by at least a single gene and other occasional variant traits that arise during backcrossing or direct introduction of a transgene. Therefore, “soybean cultivar 28040501” includes extensive variation and while applicant has described one example of a member of this genus this limited description is insufficient to demonstrate that applicant was in possession of the full scope of the broad and structurally diverse genus of soybean cultivar 28040501 plants.
The recitation of “single locus conversion” in claims 11 and 13 renders the claims indefinite because scope imparted on the claims by this term is not clear.
With respect to the rejections on the grounds of 1. above, applicant’s arguments dated 08/25/2025 are found to be persuasive and the indefiniteness rejections made on the grounds of the lack of deposit number in the claims are withdrawn.
Specifically, applicant’s assertion that a deposit will be made and accepted in accordance with 37 CFR 1.801-1.809 and that the specification and the claims will be amended upon allowance to recite the deposit information above their signature and registration number satisfies the deposit requirement under 37 CFR 1.801-1.809 and as such the indefiniteness rejections based on the lack of deposit information are withdrawn.
With respect to the rejections on the grounds of 2. and 3. above, applicant’s arguments dated 08/25/2025 have been fully considered and are not found to be persuasive.
Specifically, it does not appear that applicant has adequately addressed the previous rejections made on these grounds. Therefore, applicant’s arguments with respect to these indefiniteness rejections are not found to be persuasive and the indefiniteness rejections of record on these grounds are maintained.
Claim Rejections - 35 USC § 112 (Indefiniteness)
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.
This rejection is maintained for the reasons of record, because the remarks by Applicants in response to Office Action mailed on 6/06/2025, have been fully considered but not deemed persuasive. See above for the response to Applicant's remarks.
Claims 1-20 remain 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 16-17 are indefinite in their recitation of “soybean cultivar 28040501”. Without the deposit number in the independent claims, it is unclear what soybean is being referred to.
Further, the claims are indefinite because of the definition of “soybean plant” in paragraph 00195:
When the term "soybean plant" is used in the context of the present invention, this also includes any single gene conversions of that cultivar. The term single gene converted plant as used herein refers to those soybean plants which are developed by a plant breeding technique called backcrossing wherein essentially all of the morphological and physiological characteristics of a cultivar are recovered in addition to the single gene transferred into the cultivar via the backcrossing technique. By "essentially all" as used herein in the context of morphological and physiological characteristics it is meant that the characteristics of a plant are recovered that are otherwise present when compared in the same environment, other than occasional variant traits that might arise during backcrossing or direct introduction of a transgene. It is understood that a locus introduced by backcrossing may or may not be transgenic in origin, and thus the term backcrossing specifically includes backcrossing to introduce loci that were created by genetic transformation. (Emphasis added by examiner).
It is not clear if this definition only applies when the phrase “soybean plant” is used or if it also applies when “soybean cultivar” or “a plant of soybean cultivar” is used.
When “soybean cultivar” is used is that in this definition, “soybean cultivar” and “soybean plant” appear to be interchangeable terms, as “the term “soybean plant” … includes any single gene conversions of that cultivar” (emphasis added).
Further, the claims use “soybean plant” to refer to “soybean cultivar 28040501”. Claim 11 is a method of introducing a single locus conversion into a soybean plant, where the plant into which the single locus conversion is introduced is a plant of soybean cultivar 28040501.
The recitation “A soybean plant of soybean cultivar 28040501” in claim 13 uses both phrases. In this recitation, “soybean plant”, which by definition “includes any single gene conversions of that cultivar” is a subspecies of “soybean cultivar 28040501”, suggesting that “soybean cultivar 28040501” is even broader than the definition of “soybean plant” in paragraph 00195”.
Regardless, the definition of “essentially all of the phenotypic characteristics or morphological and physiological characteristics” in ¶195 indicates that plants with variant traits are encompassed by “single gene conversions” as well as by “soybean plant”, and under the interpretation above, “soybean cultivar”. (Emphasis added by examiner)
It is not clear what is meant by “occasional variant traits”, as it is not clear how the time word “occasional” applies to a product. It is also not clear how many “variant traits” are encompassed by the phrase.
It thus appears from these definitions that a large amount of variation is encompassed by “soybean plant”, and under the interpretation above, “soybean cultivar 28040501” and that “soybean cultivar 28040501” encompasses a genus of plants.
The “soybean plant of soybean cultivar 28040501, further comprising a single locus conversion” recited in claim 13 has a locus or loci converted relative to their own loci and have variants relative to its own genetic background. This is circular logic and renders this phrase and definition in ¶195 indefinite. The metes and bounds of what a “locus conversion” of 28040501 would be is completely unclear, especially since the loci are converted relative to the undefined genus “28040501”.
Further, it is not clear how many of these variations and conversions it takes for the plant to no longer be a member of the genus of plants encompassed by “soybean plant” or named “soybean cultivar 28040501”.
If the phrase “soybean plant” does not encompass “soybean cultivar”, it is not clear if the definition in ¶195 only applies when “soybean plant” is used or if “soybean seed” is also encompassed. The definition of “plant” includes “seeds” (¶55):
Plant. As used herein, the term "plant" includes reference to an immature or mature whole plant, including a plant from which seed, grain, or anthers have been removed. Seed or embryo that will produce the plant is also considered to be the plant.
For purposes of examination, it was assumed that both “soybean plant” and “soybean seed” “includes any single gene conversions of that cultivar”. Such treatment does not relieve Applicant of the responsibility to respond to this rejection. Dependent claims are included because they depends on an indefinite claim and fail to limit the scope to definite subject matter.
Claims 11 and 13 are indefinite in their recitation of “single locus conversion”.
The specification defines “Single Locus Converted (Conversion)” as follows (¶68):
[0068] Single Locus Converted (Conversion). Single locus converted (conversion), also known as coisogenic plants, refers to plants which are developed by a plant breeding technique called backcrossing and/or by genetic transformation to introduce a given locus that is transgenic in origin, wherein essentially all of the morphological and physiological characteristics of a soybean variety are recovered in addition to the characteristics of the locus transferred into the variety via the backcrossing technique or by genetic transformation.
It is not clear from the phrase “introduce a given locus that is transgenic in origin” if the locus introduced by either backcrossing or transformation is limited to those that are “transgenic in origin” or if the locus introduced by backcrossing can be non-transgenic.
Lastly, it is not clear if “a single locus conversion” means one and only one locus conversion. The specification defines “a” as follows (¶252):
[00252] The use of the terms "a" and "an" and "the" and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms "comprising," "having," "including," and "containing" are to be construed as open-ended terms (i.e., meaning "including, but not limited to,") unless otherwise noted.
This definition implies multiple locus conversions are encompassed by the phrase. However, the word “single” implies one and only one locus conversion.
This is further made confusing in claim 13, which is drawn to a “soybean plant of soybean cultivar 28040501, further comprising a single locus conversion”. As discussed above, “soybean plant”, under any interpretation, “includes any single gene conversions”. In claim 13 the soybean plant with single gene conversions further comprises a single locus conversion. It is unclear how many gene conversions are encompassed by the claimed plant, and how many loci are different from those in “soybean cultivar 28040501”, if “soybean cultivar 28040501” is not itself a genus. Dependent claim 12 is included because it depends on an indefinite claim and fails to limit the scope to definite subject matter.
Claims 10 and 13 are indefinite in their recitation of “otherwise comprises all of the morphological and physiological characteristics of soybean cultivar 28040501”. Because it is not clear what is encompassed by “soybean cultivar 28040501”, it is not clear what its morphological and physiological characteristics are.
Response to Applicant Arguments – 35 USC § 112 (Enablement)
In response to Applicant’s arguments dated 08/25/2025 the enablement rejections of record are withdrawn.
Specifically, applicant’s assertion that a deposit will be made and accepted in accordance with 37 CFR 1.801-1.809 and that the specification and the claims will be amended upon allowance to recite the deposit information satisfies the deposit requirement under 37 CFR 1.801-1.809 and as such the enablement rejections of record are withdrawn.
Response to Applicant Arguments – 35 USC § 112 (Written Description)
Applicant’s arguments dated 08/25/2025 have been fully considered.
These arguments are not found to be persuasive and the written description rejections of record are maintained.
Applicant’s arguments are drawn to the following concept:
“The Action’s assertion that in the absence of a breeding history, the specification has failed to provide an adequate written description of the claimed cultivar is contrary to Ex Parte C, 27 USPQ2d 1492 (BPAI 1992)” (Applicant Remarks, Page 8, Lines 3-5).
These arguments are not found to be persuasive because the written description rejections of record are not drawn to the absence of a breeding history but are instead focused on applicant’s definition of “soybean plant” which expands the meaning of “soybean cultivar 28040501” to include extensive variation and is contrasted by applicant’s limited description of one member of this genus which fails to demonstrate that applicant was in possession of the full scope of the broad and structurally diverse genus of soybean cultivar 28040501 plants at the time of filing.
Therefore, it does not appear that applicant has adequately addressed arguments made in the written description rejections of record. As such applicant’s arguments are not found to be persuasive and the written description rejections of record are maintained.
Claim Rejections - 35 USC § 112 (Written Description)
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.
This rejection is maintained for the reasons of record, because the remarks by Applicants in response to Office Action mailed on 6/06/2025, have been fully considered but not deemed persuasive. See above for the response to Applicant's remarks.
Claims 1-20 remain 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 definitions and interpretations of the phrases “soybean plant”, “soybean seed”, “soybean cultivar 28040501”and “single gene conversion” presented in the rejection under 35 U.S.C. 112(b) above are incorporated herein.
The instant claims are broadly drawn to plants and seeds of soybean cultivar 28040501, and plants and seed derived from said cultivar, and methods of using said cultivar.
Under the interpretation that “soybean cultivar 28040501” encompasses “any single gene conversions of that cultivar”, the specification does not describe the full scope of 28040501 plants with unspecified numbers of locus conversions relative to the plant describe in Table 1 or the plant whose seeds are to be deposited.
The recitation in (¶195) that “single gene converted plant” “refers to those soybean plants which are developed by a plant breeding technique called backcrossing wherein essentially all of the morphological and physiological characteristics of a cultivar are recovered in addition to the single gene transferred into the cultivar” means that plants with variant traits are encompassed by “single gene conversions” as well as by “soybean plant” and “soybean cultivar”.
The specification does not describe soybean plants with an unspecified number of “variant traits” relative to “soybean cultivar 28040501”, whether “soybean cultivar 28040501” means only plants with a single fixed genome or plants that are some genus of genetics and/or morphological and physiological characteristics.
Under the interpretation that “soybean plant” means a plant includes any single gene conversions only when the phrase “soybean plant” is recited, the specification does not describe soybean cultivar 28040501 plants further comprising a single locus conversion.
As single locus converted plants have “essentially all of the morphological and physiological characteristics of a soybean” (¶68), single locus converted plants of soybean cultivar 28040501 have an unspecified number of differences from plants soybean cultivar 28040501. Further, claim 13, which is drawn to a “soybean plant of soybean cultivar 28040501, further comprising a single locus conversion” encompasses a cultivar 28040501 soybean plant with single gene conversions further comprising a single locus conversion.
The specification describes no structural features that distinguish plants of “soybean cultivar 28040501” from other soybean plants. The specification does not describe the structural features and/or morphological and physiological characteristics that are required for a plant to be of “soybean cultivar 28040501”.
The specification describes no structural features that distinguish plants of “soybean cultivar 28040501, further comprising a single locus conversion” from other soybean plants. The specification does not describe the structural features and/or morphological and physiological characteristics that are required for a plant to be of “soybean cultivar 28040501 further comprising a single locus conversion”.
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 28040501, regardless how broadly “soybean cultivar 28040501” is interpreted.
The specification describes no structural features that distinguish soybean plants that differ in any number of morphological and physiological characteristics from soybean cultivar 28040501 from other soybean plants.
The specification describes no plants that differ from morphological and physiological characteristics of soybean cultivar 28040501 in an unspecified number of traits. The specification only describes soybean cultivar 28040501 (Table 1).
Hence, Applicant has not, in fact, described the claimed 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.
Close Prior Art
The claims are deemed free of the prior art.
The closest prior art is soybean cultivar 68391846 of Grams (US 10,548,282 B1, Patented February 4, 2020). Cultivar 68391846 is also known as 13471648-19 and is a parent of the instant variety (‘282, Breeding History, Column 6, Line 48; Instant Specification 09/20/2023, Page 9, Paragraph 0069, Breeding History).
The cultivar of ‘282 shares the following characteristics with the instantly claimed cultivar: seed coat color, seed coat luster, cotyledon color, leaflet shape, growth habit, flower color, hilum color, plant pubescence color, plant lodging score and plant height (‘282, Table 1; Instant Specification 09/20/2023, Page 10, Table 1).
The two cultivars differ in breeding history, parentage, pod wall color, relative maturity, seed size, seed percent protein and seed percent oil and most significantly physiological responses. Specifically, the instant cultivar comprises the DAS-44406-6 transgenic event while the reference variety does not possess this event.
Additionally, the second parent of the instant variety, 16EN338929-24 is also known in the art (Mason, US 20220030820 A1, Published February 3, 2022). While 16EN338929-24 possesses the DAS-44406-6 transgenic event, given the teachings of the references drawn to the two parent varieties, it would not have been obvious to arrive at the instantly claimed cultivar because of the breeding history of the instant variety.
Specifically, the instant variety was produced by first crossing the two parent varieties, advancing F1 seed using modified single seed descent, advancing F2 seed using modified single seed descent, pulling single plants from F3 Bulk populations, growing F4 plants, selecting single F5 plants after yield trials, growing F6 plants, Advancing the instant variety after 2020 yield trials, and finally advancing the instant variety to Elite trials after 2021 yield trials. This breeding strategy in combination with independent assortment would lead to unpredictability with respect to the arrangement of genes in hybrid progeny. This is in contrast to other breeding methods such as backcross breeding to produce single locus conversions.
Therefore, while the two parents were known in the art and one parent shares many traits with the instantly claimed cultivar, the instant soybean cultivar is unobvious and therefore free of the art.
Conclusion
No claims are allowed.
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.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached 7:30 to 5:00.
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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.
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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/BRATISLAV STANKOVIC/Primary Examiner, Art Unit 1663