`
`A.
`
`Status of the Claims
`
`Claims 1-17 and 19-20 were pendingat the time of this Action.
`
`B.
`
`Specification Objection
`
`The Action maintains the objection to the specification for an informality. Regarding the
`
`use of non-metric units of measure (lb or pound) in paragraph [0065] on page 8, Applicant notes
`
`that the Specification is amended herein in the interest of compact prosecution. The objection is
`
`thus believed to be moot and withdrawalthereofis respectfully requested.
`
`Cc.
`
`Rejection of Claims Under 35 U.S.C. §103(a)
`
`The Action maintains the rejection of claims 1-17 and 19-20 over Eby (US 9,210,899),
`
`which teaches soybean cultivar 37273791, in view of Lussenden (US 9,844,201), which teaches
`
`soybean variety 01050745; and further in view of De Beuckeleer (US 8,017,756), which teaches
`
`event A5547-127. The Action asserts that it would have been obvious to modify soybean cultivar
`
`37273791 via backcrossing to introduce event A5547-127 and event MONS87708 in order to
`
`obtain the instantly claimed cultivar; and further asserts that backcrossing would account for any
`
`trait variation. Applicants respectfully traverse.
`
`Contrary to the assertions made in the Action, the significant increase in yield, lodging
`
`resistance, and height exhibited by the claimed cultivar represents an unexpected advance over
`
`soybean cultivar 37273791; and a skilled artisan would readily appreciate the practical, real world
`
`impact such differences provide.
`
`In this regard, Applicants note that submitted herewith is the
`
`Declaration of James Hampton, Ph.D. under 37 C.F.R. § 1.132. Dr. Hampton’s Declaration
`
`confirmsthat the comparative analysis of the claimed and referenced cultivars, using check varieties
`
`MGL1972, PG20E08N, PE200X, and 15MB60707-82-05 for yield, check varieties PE1900,
`
`15MB60707-82-05, and PE1700 for lodging resistance, and check varieties MGL1972 and
`
`PG20E08N,represents a valid means to comparethe yield, lodging resistance, and height of soybean
`
`cultivar 94112440 and 37273791 without confounding environmental influence; and indicates that
`
`the claimed cultivar exhibits significantly increased yield,
`
`lodging resistance, and height
`
`in
`
`comparison to soybean cultivar 37273791, when grown under the same environmental conditions.
`
`In particular, Dr. Hampton explains:
`
`
`
`The difference in yield observed is not a slight or trivial variation.
`Rather, this difference is practically significant and highly valued by
`breeders and farmers alike.
`I note in this regard that while soybean
`farmers evaluate many factors whenselecting a variety for planting,
`yield is the single most important agronomic trait in commercial
`soybean production. Simply, maximizing yield is the most direct
`means to increase revenue per acre of arable land. The real world
`impact of a significant
`increase in yield is
`therefore critically
`important, especially in view of the millions of acres of soybeans
`planted in the US every year.
`
`Dr. Hamptonalso explainsthat:
`
`[T]hose of skill in the art would also readily appreciate the practical,
`real world impactofthis significant increase. For example, increasing
`lodging resistance can reduce crop loss and improveyield consistency.
`Furthermore,
`the claimed soybean cultivar exhibits significantly
`increased height comparedto the referenced variety; and those of skill
`in the art would also readily appreciate the practical, real world impact
`of this significant trait difference. For example, increasing height can
`improvea plant’s ability to compete for light and limit smaller weeds
`from growing in between soybean rows.
`
`Applicants also note that the comparative data supporting Dr. Hampton’s statements (See
`
`Exhibit A) was analyzed using a two-tailed t-test, which is one of the most commonstatistical
`
`tests used to compare the meansof two groups. Thet-test statistics provided in Exhibit A clearly
`
`show that the referenced cultivar shows nosignificant difference in yield compared to any of the
`
`check varieties, whereas soybean cultivar 94112440 shows increasedyield at a 0.05 significance
`
`level to check varieties MGL1972X, PE200X, and 15MB60707-82-05 and at a 0.01 significance
`
`level for check variety PG20EO8N. Furthermore, Applicants note that the 2021 production value
`
`of US soybeans was 57.5 billion dollars. See, e.g., Shahbandeh. Production value of soybeans in
`
`the
`
`US.
`
`2000-2021.
`
`Statista,
`
`2022.
`
`Available
`
`at
`
`https://www.statista.com/statistics/19207 1/production-value-of-soybeans-for-beans-in-the-us-
`
`since-2000/. The real world impact of these significant differences can therefore be appreciated
`
`from both an agronomic and economic perspective.
`
`These real world, significant differences would not have been expected. One ofskill in the
`
`art would have had no expectation of producing a soybean cultivar exhibiting a significant increase
`
`in yield, lodging resistance, and height by introducing an herbicide tolerancetrait via backcrossing
`
`with the referenced cultivar 37273791. For example, Dr. Hamptonaffirms:
`
`
`
`Soybean yield, soybean lodging resistance, and soybean heightareall
`complex quantitative traits, and there would be no expectation that
`these traits would be improved when introducing herbicide tolerance
`traits as cited by the Examiner.
`
`Dr. Hampton also describes in molecular detail the unexpected nature of the unique
`
`combination of chromosomes found in soybean cultivar 94112440, which directly underlie the
`
`significant increase in yield, lodging resistance, and height observed (See, e.g. Declaration of
`
`James Hampton, Ph.D.; paragraph 11). In view of this, Dr. Hampton concludes:
`
`[T]he occurrence of the unique combination of chromosomes in
`94112440 could not have been predicted. Moreover, there would be
`no reasonable expectation that
`those chromosome combinations
`would be beneficial, let alone result in a significant increase in yield,
`lodging resistance,
`and height compared to soybean cultivar
`37273791.
`
`The referenced art does not teach or suggest a plant with all of the morphological and physiological
`
`traits of the claimed cultivar. The claimed cultivar is therefore in no way obviousin view of soybean
`
`cultivar 37273791.
`
`Applicants also note that the teachings of the cited references do not support a prima facie
`
`case of obviousness. It is well settled that in order to support an obviousness rejection there must
`
`be some expectation of success in arriving at the claimed invention based on the prior art and
`
`knowledge in the art. See MPEP § 2143.02. Furthermore, the reasonable expectation must be
`
`shownasto the specific invention claimed, and not to the mere “gist” or “thrust” of the invention,
`
`consistent with the requirementto analyze all elements of the claimed invention as a whole. W.L.
`
`Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied,
`
`469 U.S. 851 (1984).
`
`Taken together, the surprising and unexpected results discussed supra, along with the lack
`
`of any reasonable expectation in significantly improving yield, lodging resistance, and height
`
`illustrates that the claimed cultivar is in no way obvious in view of soybean cultivar 37273791.
`
`The rejection is thus believed to be moot and withdrawalthereofis respectfully requested.
`
`
`
`D.
`
`Non-statutory Double Patenting
`
`The Action maintains the rejection of claims 1-17, 19, and 20 over the US Application No.
`
`17/410,679, which teaches soybean variety 03230124; and US Application No. 17/410,667, which
`
`teaches soybean variety 04130514.
`
`Regarding US Application No. 17/410,679, and US Application No. 17/410,667,
`
`Applicants respectfully traverse. Under MPEP § 804(I)B(1)(b), if a provisional nonstatutory
`
`double patenting rejection is the only rejection remaining in an application andthat application has
`
`the earliest effective U.S. filing date compared to the reference application, the examiner should
`
`withdraw the rejection in the application having the earliest effective U.S. filing date and permit
`
`that application to issue. Applicant notes that the instant application has an effective filing date of
`
`September 11, 2020, whereas the referenced applications were each filed on August 24, 2021. As
`
`MPEP§ 804(I)B(1)(b) is believed to be applicable in the present case, withdrawalof the rejection
`
`and allowanceofthe case is respectfully requested.
`
`The Action also maintains the rejection of claims 1-17, 19, and 20 over claims 1-20 of Eby
`
`(US 9,210,899), which teaches soybean cultivar 37273791, in view of Lussenden (US 9,844,201),
`
`which teaches soybean variety 01050745, and De Beuckleer (US 8,017,756), which teaches event
`
`A5547-127. The Action asserts that the claimed and referenced soybean cultivars share identical
`
`or similar trait descriptions. Therefore, the claimed cultivar is obvious in view of soybean cultivar
`
`37273791. In response, Applicant respectfully traverses.
`
`Applicants note that submitted herewith is the Declaration of James Hampton, Ph.D. under
`
`37 C.F.R. § 1.132. Dr. Hampton confirms the comparative analysis of the claimed and referenced
`
`cultivars that demonstrates that the phenotypes of the claimed and referenced cultivars differ
`
`significantly and that
`
`the phenotypic differences observed between these cultivars were not
`
`predictable or expected to one of ordinary skill in the art, as discussed supra. Dr. Hampton explains
`
`in this regard that:
`
`Producing the claimed cultivar was not a routine process and one of
`skill in the art would not characterize the differences identified as
`expected variation, nor optimized variables
`lacking practical
`significance.
`Instead, the differences observed are the outcome of a
`serendipitous combination of the selection and advancing methods
`applied during the breeding protocols used to produce the claimed
`cultivar, and the complex nature of genetic inheritance (e.g.,
`chromosomal segregation,
`independent assortment of loci due to
`meiotic crossovers, pleiotropy, and phenotypic penetrance).
`
`
`
`The claimed cultivar is therefore in no way an obvious variant of the referenced cultivar.
`
`In view of the foregoing, the rejection is thus believed to be moot and withdrawal thereof is
`
`respectfully requested.
`
`E.
`
`Conclusion
`
`This is submitted to be a complete response to the referenced Final Office Action. In
`
`conclusion, Applicants submit that, in light of the foregoing remarks, the present case is in
`
`condition for allowance and such favorable action is respectfully requested.
`
`The Examineris invited to contact the undersigned at (214) 259-0990 with any questions,
`
`commentsor suggestionsrelating to the referenced patent application.
`
`Respectfully submitted,
`
`/Christopher L. Schardon/
`
`Christopher L. Schardon
`Reg. No. 77,561
`Agent for Applicant
`
`Dentons US LLP
`2000 McKinney Avenue, Suite 1900
`Dallas, Texas 75201
`(214) 259-0931
`
`Date: May 2, 2023
`
`10
`
`