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 .
DETAILED ACTION
1. The Office acknowledges the receipt of Applicant’s amendment filed August 6, 2025. The Terminal Disclaimer filed August 6, 2025 has been approved. Claims 1-20 are pending and are examined in the instant application.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is made FINAL.
Specification
2. The disclosure is objected to because of the following: in paragraph [00253], the Deposit Information is incomplete. Compliance with the deposit requirements may be held in abeyance until allowability is indicated. Appropriate correction is required.
Applicant states that the Specification will be amended upon allowance.
Accordingly, the objection is maintained.
Claim Rejections - 35 USC § 101
3. Claims 18 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process and a routine activity without significantly more. The claims recite a detecting step by marker analysis or storing the results of said detecting on a computer readable medium. No particular method for detecting the polymorphism or the polymorphism to be detected is recited. This judicial exception is not integrated into a practical application because the detecting step is a mental determination process or data gathering step, and the additional generic computer readable medium does not add a meaningful limitation to the mental determination step because it amounts to simply implementing the mental determination step onto a computer readable medium. This is considered an insignificant extra-solution activity that is a well-understood, routine and conventional in the art. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the detecting step and storing the results of said detecting on a computer readable medium do not add significantly more to the inventive concept. In claim 19, “genetic marker analysis” is also a mental step. Thus, the claimed method is not an inventive concept. Moreover, it should be noted that the claimed method would preclude the public from the mere determination of whether or not Applicant’s invention is infringed.
Applicant traverses primarily that (1) “a method of determining the genotype of the plant of claim 1” requires more than a process that can be performed in the human mind or by using pen and paper; (2) claim 18 is directed to a “plant of claim 1 or a progeny plant thereof, or a part thereof” which is a novel soybean cultivar that is eligible under 35 USC 101 as directed to a composition of matter; (3) to practice claims 18 and 19, one must obtain the plant of claim 1, or progeny, or part thereof, further showing that these claims are not drawn solely to a mental process; and (4) the flowchart for analyzing claims for eligibility shows that subject matter not directed to an abstract idea (mental process) is eligible under Step 2A of this analysis and does not pass to Step 2B for further analysis under the “significantly more” standard.
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. With regard to traversal (1), claim 18 recites the single step of “detecting at least a first polymorphism”. Applicant implies this step would require various techniques, e.g., single molecule sequencing, prior to the detecting step, but these limitations cannot be read into the claims because they are not present in the claims. That is, “detecting at least a first polymorphism” is not the same as “obtaining a first plant or a progeny plant or a part thereof; isolating genomic nucleic acids from said first plant, progeny plant or said part thereof; perform techniques such as sequencing, etc. to obtain a genetic profile of said first plant, progeny plant or said part thereof; obtaining a second plant, progeny plant or part thereof; isolating genomic nucleic acids from said second plant, progeny plant or part thereof; perform techniques such as sequencing, etc. to obtain a genetic profile of said second plant, progeny plant or said part thereof; compare the genetic profile of the first plant, progeny plant or said part thereof to the genetic profile of the second plant, progeny plant, or part thereof; generate a list of possible polymorphisms between these two plants, progeny plants or parts thereof; and detecting at least a first polymorphism in a sample of nucleic acids from said first plant, progeny plant or part thereof.” This is not a reasonable interpretation of claim 18, as limitations from the specification cannot be read into the claims. “Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not a part of the claim.” SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). “[I]t is the language itself of the claims which must particularly point out and distinctly claim the subject matter which the applicant regards as his invention, without limitations imported from the specification. … Limitations in the specification not included in the claims may not be relied upon to impart patentability to an otherwise unpatentable claim.” In re Lundberg, 244 F.2d 543, __, 113 USPQ 530, 534 (CCPA 1957). The Office maintains that the claimed “detecting” step is not significantly more than making a mental determination from the generated genetic data.
With regard to traversal (2), claim 18 is clearly not directed to a “plant of claim 1 or a progeny plant thereof, or a part thereof” as argued. The first two words of claim 18 are “A method”.
With regard to traversal (3), this traversal has been addressed in the response to traversal (1) above.
With regard to traversal (4), no polymorphism is disclosed in claim 18 to indicate that the detected undisclosed polymorphism is not a product of nature. Polymorphisms naturally exist in nature. Thus, in the flowchart, the answer to Step 2A is “Yes” and Step 2B analysis is applied.
Accordingly, the rejection is maintained.
Claim Rejections - 35 USC § 112(b)
4. 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.
In claims 1, 11 and 13, the deposit information is missing. Cultivar 24090316 is not an art-recognized term. Absent a deposit, the metes and bounds of cultivar 24090316 cannot be determined. Compliance with the deposit requirements may be held in abeyance until allowability is indicated.
Clarification and/or correction is required.
Applicant states that the seed of the claimed cultivar will be deposited.
Accordingly, the rejection is maintained.
Claim Rejections - 35 USC § 112(a)
5. 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.
Since the seed is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a reproducible process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public. If the deposit of the seed is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating the seed have been deposited under the Budapest Treaty and that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the 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, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) 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 enforceable life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become unviable.
The specification and claims must be updated to include the deposit information. Proof of an accepted deposit is requested.
Applicant states that the seed of the claimed cultivar will be deposited.
Accordingly, the rejection is maintained.
6. 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 written description requirement. The instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide a description sufficient to conduct an examination, including search of the prior art, nor does it provide enough description to be sufficient to aid in the resolution of questions of infringement.
MPEP 2163 (I) states “The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").”
MPEP 2163(I) states “The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
In the instant application, a full examination cannot be conducted because Applicant failed to provide a complete breeding history for the instantly claimed plant cultivar. Specifically, in claim 1, Applicant claims a new soybean plant cultivar. A plant cultivar is defined by both its genetics (breeding history) and its traits. In the instant application, Applicant has only provided a description of the plant traits as shown in the specification. The instant application is silent or incomplete as to the breeding history used to produce the claimed plant cultivar.
The criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”. Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties. A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the variety new” (See “Applying for a Plant Variety Certificate of Protection”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023, (previously cited)). Additionally, the International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (UPOV, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30 (previously cited)). While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected.
The breeding history is also necessary to aid in the resolution of patent infringement by providing information necessary to determine whether differences in the plants are genetic differences, differences caused by the environment, or differences within the accepted variation within a variety. Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety. (See Ex Parte C (USPQ 2d 1492 (1992) (previously cited) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (previously cited)). In both of these cases, there were many differences cited by the Applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
Moreover, a specification devoid of a complete breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. Haun et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (previously cited)) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 645, left column). Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (previously cited), p. 5430, left column, 1st full paragraph, and right column, 2nd full paragraph). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed to adequately describe a newly developed plant.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, Applicant must amend the specification/drawing to provide the breeding history used to develop the instant cultivar. When identifying the breeding history, Applicant should identify any and all other potential names for all parental lines utilized in the development of the instant cultivar and all other potential names for the claimed cultivar. If Applicant’s breeding history uses proprietary cultivar names, Applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar information. If the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line as well (i.e., grandparents). Applicant should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant cultivar). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
In the instant application, Applicant included some breeding history for cultivar 24090316 in the Specification and additional names for one parent in a separate Transmittal Letter communication. However, this disclosure is insufficient because it does not address all the issues set forth above, and the information provided in the Transmittal Letter with regard to additional names of one parent should be set forth in the specification. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
Correction and/or clarification is required.
Applicant traverses the following: (1) The requirement of a breeding history for written description is contrary to Ex parte C, which states that based on the description provided and the deposit, Applicant has successfully taught the claimed soybean variety, and “[w]hile the examiner may want to possess additional information regarding the inventive process, in this case the inheritable characteristics of parent species of plants and the particular procedure used to select for the claimed plant, in order to carry out a thorough examination, there is nothing in the statute which commands its inclusion in the specification.” (2) A deposit of representative seeds of soybean cultivar 24090316 has been made, exemplary morphological and physiological characteristics of the cultivar are described at least in Table 1, and a person of ordinary skill would conclude that Applicant had possession of the claimed subject matter. (3) In PGR2024-00023 (Exhibit B), the Board states that “by depositing the seeds, Patent Owner is making the genetic sequence (genotype) of [variety] available.” (4) The genotype is readily identifiable, for example, by DNA sequencing, and represents a description of the characteristics defining the claimed plants, distinguishing them from other plants. (5) The Regents of The University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997) noted that a name alone does not satisfy the written description requirement where “it does not define any structural features commonly possessed by members of the genus that distinguish them from others. One skilled in the art therefore cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus” (emphasis added). Here, all members of the claimed genus of soybean cultivars and seeds share the structural feature of comprising the phenotypic characteristics found in Table 1 and having a similar genotype, and one of skill in the art viewing the specification could readily identify the members of the genus.
Applicant’s traversals have been carefully considered but are deemed unpersuasive for the following reasons. 35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. This is a question of fact, not a question of law, as to whether the Specification provides adequate written description for the claimed invention (MPEP 2163(I)). The facts are as follows. The claims indicate Applicant intends to deposit seeds representative of the claimed cultivar. The claims are not directed to the deposited seeds or plants grown therefrom. As stated in Applicant’s traversals (p. 10), the claims are directed to a “genus of soybean cultivars and seeds [that] share the structural feature of comprising the phenotypic characteristics found in Table 1 and having a similar genotype.” Paragraph [0195] states the term “soybean plant” includes any single gene conversions of that cultivar, and said plant has essentially all the morphological and physiological characteristics of the cultivar. The Specification discloses some morphological and physiological characteristics of the claimed cultivar (Table 1, [0072], [0073]). The Specification also discloses the names of two parent plants that were crossed to produce the claimed cultivar [0069] and an alternate name for the claimed cultivar [0070]. No information is provided in the Specification to indicate whether the parents are publicly available. In a separate Transmittal Letter filed October 27, 2023, Applicant discloses that one of the parents (15EN305923-02) is also known by three other names, one of which is the same as that of a claimed cultivar in an issued patent (cultivar 78320329, US Pat. No. 10,349,605). No genotypic or phenotypic information, or alternate name, is given for the second parent (15CV305321-10). Thus, absent the disclosure in the Transmittal Letter, one skilled in the art would not have known that the 15EN305923-02 parent is publicly available, is known by other names and is a prior art cultivar. However, a Transmittal Letter is not part of the Specification and cannot provide the written description required to be in the Specification. Thus, the breeding history for the claimed cultivar as disclosed in the Specification is incomplete.
With regard to traversal (1), an adequate written description is not to help the examiner carry out a thorough examination but to preclude the issuance of a patent that would otherwise issue due to Applicant’s omission of critical information from the Specification. The Office has made a finding of fact that for the instant variety, the minimum description is the combination of the phenotype and genotype (breeding history). To support the finding of fact, the Office has cited other plant-related intellectual property organizations (USDA, UPOV) and relevant court cases (Ex parte C, Ex Parte McGowen) dealing with plant varieties in which both the phenotype and genotype were analyzed. Haun et al. and Großkinsky et al. were cited to show that a trait table is insufficient to differentiate varieties by itself, because intracultivar heterogeneity exists in crop species and environmental variation may lead to phenotypic variation within a cultivar. The Office did not cite these findings to clarify the law. They are solely to clarify the findings of fact, i.e., what is an adequate written description for the claimed cultivar. Applicant’s arguments ask the Office to not consider the actual statute and to base its decision solely on statements from court or Board cases that do not directly decide what is an adequate written description for a plant variety. These arguments are not persuasive.
With regard to traversal (2), Applicant has many other deposited plant cultivars with nearly identical traits, and the term “soybean plant” is defined to encompass a plant having single gene conversions and essentially all the morphological and physiological characteristics of the cultivar. Two provisional nonstatutory patenting rejections were made in the instant application, and Applicant has filed Terminal Disclaimers disclaiming any patent term extending beyond the expiration date of a patent grant of these two applications. The trait similarity and the lack of explanation of the value of the instant soybean cultivar makes the analysis on the breeding history more important. MPEP 2163(I) states “a showing of possession alone does not cure the lack of a written description”, citing Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). “The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880). The Office needs more specific breeding history primarily due to the phenotypic similarities between the instant cultivar and other cultivars, and to distinguish the claimed “genus of soybean cultivars and seeds [that] share the structural feature of comprising the phenotypic characteristics found in Table 1 and having a similar genotype” from other plants.
Traversals (3) and (4) are not on point because Applicant is claiming a “genus of soybean cultivars and seeds [that] share the structural feature of comprising the phenotypic characteristics found in Table 1 and having a similar genotype.” Applicant is not claiming a deposited seed or a plant having a particular genetic sequence. When two inbred parents are crossed, one skilled in the art would reasonably expect to obtain a population of progeny plants that shares most of the phenotypic characteristics but are not necessarily genetically identical due to naturally-occurring genetic and environmental factors [0071]. Thus, the question is not whether one skilled in the art can distinguish the claimed plant from other plants, but whether one skilled in the art can distinguish the genus of claimed plants from other plants. Thus, the disclosure of the parents, i.e., breeding history, used to produce the claimed genus is essential to determine the patentability of the claimed genus. Moreover, contrary to Applicant’s allegations, the Patent Owner is not making the genetic sequence (genotype) of the claimed cultivar available because claims 18 and 19 would preclude anyone from performing a marker analysis or DNA sequencing to detect a polymorphism without infringing the claimed invention. If a marker analysis cannot be performed, then Applicant’s assertion that written description can be satisfied by way of the deposit is misleading. Applicant’s claims 18 and 19 in effect would make the public an infringer to genotype the instant variety as a means to distinguish their plant from the instant cultivar. Moreover, Applicant does not provide marker information to distinguish the claimed genus of plants from other plants when Applicant is in the best position to do so. Polymorphisms exist within the genus of plants claimed. Applicant’s failure to provide this information is evidence that it is not practical to do a marker analysis to distinguish plants from one another.
With regard to Applicant’s traversal (5), the Office agrees and complies with the decision in The Regents of The University of California v. Eli Lilly and Co., that a name alone does not satisfy the written description requirement where “it does not define any structural features commonly possessed by members of the genus that distinguish them from others.” In the instant application, the Specification discloses that the claimed cultivar is obtained by crossing parent plants 15CV305321-10 with 15EN305923-02. No genotypic, phenotypic or public availability information is given for these two parent plants. Thus, the parent name designations are not given patentable weight, consistent with the holding in The Regents of The University of California v. Eli Lilly and Co. Applicant acknowledges that the claimed genus encompasses plants having genotypic variations and variant phenotypic traits in a population of one or more individuals ([0163], [0174]). Thus, in addition to the phenotypic characteristics, the above requested information is also material to patentability.
To obviate the rejection, it is suggested the Specification be amended to include the information in the Transmittal Letter with regard to the alternate names for the 15EN305923-02 parent (cultivar 78320329 claimed in US Pat. No. 10,349,605, PG14E08N and 13EA12), and provide any additional names for the second parent (15CV305321-10) and its public availability, if applicable.
Accordingly, the rejection is maintained.
7. Claim 10 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 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, at the time the application was filed, had possession of the claimed invention.
In addition to the lack of adequate written description with regard to the breeding history of cultivar 24090316 as set forth above, the claimed invention further lacks adequate written description for the following reasons.
Claim 10 is directed to a plant produced by introducing a transgene conferring a desired trait selected from the traits listed in claim 9 into a plant of cultivar 24090316, wherein the plant comprises the transgene and otherwise comprises all of the morphological and physiological characteristics of soybean cultivar 24090316. Paragraph [0252] states that “a” and “an” are to be construed to cover both the single and the plural. Paragraph [0076] states that cultivar 24090316 may contain up to 15 transgenes. Thus, the claimed plant may contain up to 15 transgenes, one of which is a trait selected from the traits listed in claim 9, and introduced by any method, including multiple outcrossings with undisclosed plants. Applicant has no working example of a plant comprising transgenes and its morphological and physiological characteristics. It is unpredictable what morphological and physiological characteristics of cultivar 24090316 are retained, lost or altered upon the introduction of transgene(s). The claimed plant lacks adequate written description because it is not known what methods were utilized to introduce the transgenes. Thus, the claimed plant further comprising a transgene selected from the traits listed in claim 9 lacks adequate written description. It is suggested Applicant amends the claim to indicate that the transgene is introduced by backcrossing or transformation.
Accordingly, one skilled in the art would not have recognized Applicant was in possession of the claimed invention at the time of filing. See Written Description Guidelines, Revision 1, March 25, 2008, published online at http://www.uspto.gov/web/menu/written/pdf.
Applicant traverses primarily that (1) claim 10 has been amended to depend from claim 9; (2) claim 10 encompasses a plant produced by introducing a transgene conferring a desired trait into soybean cultivar 24090316, wherein the desired trait is selected from the group consisting of male sterility, herbicide tolerance, insect or pest resistance, disease resistance, modified fatty acid metabolism, and modified carbohydrate metabolism, and wherein the plant otherwise comprises all of the morphological and physiological characteristics of soybean cultivar 24090316; and (3) the specification teaches the morphological and physiological characteristics of soybean cultivar 24090316, non-limiting examples of transgenes conferring a trait selected from the traits listed in claim 9, well-known techniques for introducing transgenes into soybean cultivars, and a deposit of seed of soybean cultivar 24090316.
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. Claim 10 does not indicate that the deposit is representative of the plant of claim 10, which comprises a transgene. Claim 10 does not state that all the morphological and physiological characteristics of soybean cultivar 24090316 are representative of the plant of claim 10. Claim 10 is not limited to having one added transgene in addition to all the morphological and physiological characteristics of cultivar 24090316. The “otherwise” language in the Specification is understood by the Office to mean all the morphological and physiological characteristics of cultivar 24090316 that are retained after the introduction of the transgene. Claim 10 is also not limited to having a single introduced transgene conferring one trait from the list of traits listed in claim 9. The scope of claim 10 encompasses a plant having up to 15 transgenes conferring an undisclosed number of traits, one of which is a trait listed in claim 9, wherein the up-to-15-transgenes can be introduced by outcrossings with an undisclosed number of plants (15 plants?), and otherwise having all the morphological and physiological characteristics of cultivar 24090316 after the introduction of the 15 transgenes. It is highly unpredictable what morphological and physiological characteristics of cultivar 24090316 are retained after one outcrossing, let alone after 15 outcrossings. The specification does not teach the morphological and physiological characteristics of soybean cultivar 24090316 after the introduction of 15 transgenes by outcrossings with undisclosed plants. Applicant has not made a deposit of seeds of soybean cultivar 24090316 having 15 transgenes introduced by outcrossings with undisclosed plants. The deposit and traits listed in the Specification are not representative of a plant having up to 15 transgenes introduced by outcrossings with undisclosed plants. Accordingly, the rejection is maintained.
Conclusion
8. No claim is allowed. The Office interprets “cell” to be a regenerable cell.
9. 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 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached M-F 8am-5pm.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663