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 40-57 are pending and examined on the merits.
Claims 40-52, 54, and 56-57 are currently amended.
Response to Arguments – Indefiniteness
Applicant's arguments filed 29 April 2026 have been fully considered but they are not persuasive. The response failed to clarify how the word “known” limits the claims and further complicated the claims by the additional of the indefinite phrase “related to true breeding characteristics.”
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.
Claims 40-57 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.
Embryo explants comprising “at least 4 different known genotypes” is recited in claims 40 and 50. It remains unclear what is required for something to be “known.” Does each explant need to be genotyped prior to inoculating? This is not what was done in the instant examples. Genotyping was performed after shoot formation. Is it enough to know that a population of plant comprises specific polymorphisms? This question is important, because the phenomenon of intravarietal heterogeneity/polymorphisms is well-documented. For example, in the art rejections below the art discusses heterogeneity with the maize inbred lines B73 and Mo17 and within the soybean variety Williams82. Is knowledge in the art of intravarietal heterogeneity/polymorphisms in a variety that is transformed sufficient to meet the limitations of the claims? What about the example of soybean cultivar 54062650 (US 9961858 B1), which reports that that both flower color and hilum color traits are segregating and contemplate transforming the variety? Is doing so enough to anticipate the instant claim, as segregation of the two traits results in combinations of more than four different genotypes in the single variety? Because none of the questions have obvious answers, the metes and bounds of the claims cannot be determined. Additionally, it is noted that claims 40-49 are drawn to products. For a person to determine if the genotypes were “known” prior to formation of the mixture would require the ability to read minds. Still further, it should be noted that knowing a genotype can mean different things. In classical genetics, it is not based on what base pair occurs at what locus, but it more based on the ability to pass a trait to progeny.
The claims directly or indirectly recite, “related to true breeding characteristics.” It is unclear what this phrase is intended to encompass. It cannot mean that the polymorphisms between individuals between the have to be fixed at a given locus, because dependent claim 41 recites such a limitation (assuming that claim 41 further limits claim 40). The specification fails to provide any further clarity. It recites, “correlated to true breeding characteristics” three times at paragraphs 49, 180, 336 without anything further explanation as to what genomic features would or would not be considered, “related to true breeding characteristics.” As such, the metes and bounds of the claims cannot be determined.
Claim 51 recites, “wherein screening further comprises identifying which of the at least 4 different and known genotypes comprises the detectable genetic modification by detecting at least one genetic marker characteristic of the known genotype.” Screening for the modification is different from screening for the different genotypes as the difference in the genotypes had to exist prior to formation of the mixture which existed prior to genetic modification occurring. As such, the metes and bounds of the claims cannot be determined. Claim 52 is also rejected for depending from an indefinite claim and failing to recite additional limitations that would render the claim definite.
Response to Arguments - Failure to Further Limit
Applicant's amendments filed 29 April 2026 have overcome the rejections of record.
Response to Arguments - Claim Rejections - 35 USC § 102
Applicant's amendments filed 29 April 2026 have overcome the rejections of record.
Response to Arguments - Claim Rejections - 35 USC § 103
Applicant's amendments filed 29 April 2026 have overcome the rejections of record.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claim(s) 40-51, 55, 57 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yang et al 2019 (Plant Signaling and Behavior 14:7, p. 1-7) as evidenced by Haun et al 2011 (Plant Physiology 155: p. 645-655).
Yang et al disclose Agrobacterium-based transformation (requiring an inoculation medium) of plants of the Williams82 soybean variety (considered inbred) that results in the modification of that addition of a GFP transgene, a screenable marker. Each explant was derived from a single seed (Sections 2.3.2-2.3.3). Haun et al provide evidence that Williams82 comprises a significant amount of intravitreal variation not only between seed lots, but within individual plants where they note that extensive SNP and structural heterogeneity exists on chromosome 3 (see entire document, especially p.651). In transforming Williams82, Yang et al likely generated the claimed compositions and practiced the claimed methods. Even if they did not, if they were to generate larger numbers of transgenic plants by the same method, they would practice the invention as claimed. Accordingly, claims 40-51, 55, 57 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yang et al as evidenced by Haun et al.
Claim(s) 40-51 and 55-56 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lowe et al 2018 (In vitro Cellular & Developmental Biology – Plant 54: p. 240-252) as evidenced by Tokatlidis 2000 (Journal of Agricultural Science, Cambridge 134: p.391-398).
Lowe et al disclose Agrobacterium-based transformation (requiring an inoculation medium) of plants of the B73 and Mo17 varieties (considered inbreds) that result in the modification of that addition of an herbicide resistance transgene, a selectable marker. Tokatlidis et al provide evidence that individual plants of varieties of B73 and Mo17 have intravarietal variation (see entire document). In transforming B73 and Mo17, Lowe et al likely generated the claimed compositions and practiced the claimed methods. Even if they did not, if they were to generate larger numbers of transgenic plants by the same method, they would practice the invention as claimed. Accordingly, claims 40-51 and 55-56 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lowe et al as evidenced by Tokatlidis.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 40-55 and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mason (US 9961858 B1).
Mason et al teach soybean cultivar 54062650 (considered inbred) which is segregating for the flower color traits and hilum color traits (Table 1). Genetic control of these traits was well-understood prior to filing so the genotypic mixture of plant of soybean cultivar 54062650 was known simply based on the reported flower and hilum colors present in the mixture. Mason et al teach soybean cultivar 54062650 comprising a transgene that can confer traits including herbicide tolerance (claims 8-10). They also teach that the transformation can be carried out by Agrobacterium (columns 20-21). They also teach that genetic marker profiles (fingerprints) can be developed for soybean cultivar 54062650 and related plants (columns 21-23).
Mason et al do not reduce to practice transforming soybean cultivar 54062650 using Agrobacterium.
At the time of filing, it would have been prima facie obvious for a person of ordinary skill in the art to transform soybean cultivar 54062650 using Agrobacterium to add a transgene to confer a beneficial trait such as an herbicide tolerance trait to the plant. In addition to be suggested by Mason et al, methods of Agrobacterium transformation of soybean were known in the art (see cited above Yang et al reference for example). Accordingly, claims 40-55 and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mason.
Conclusion
No claims are allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
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