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
1. Claims 1-20 are pending and under examination on the merits.
Information Disclosure Statement
2. The Information Disclosure Statement (IDS) submitted on July 10, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered to the extent of the English translations provided. A signed copy is attached.
Specification
3. The disclosure is objected to because of the following:
The specification is objected to because the recitations of “NCMA Accession Number XXXX” are incomplete. The incomplete accession numbers cannot be tied to a compliant biological deposit with an accession number. Thus, it is unknown which deposit will be linked to the instant soybean of variety 5PGSE72. The soybean variety name “5PGSE72” is indefinite as the variety has no meaning without its linkage to a deposit.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
4. 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.
5. 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 4, 18, and 19 are indefinite due to the recitations of “NCMA Accession Number XXXX”. The metes and bounds of the claims are unclear because the incomplete accession numbers cannot be tied to a compliant biological deposit with an accession number. Thus, it is unknown which deposit will be linked to the instant soybean of variety 5PGSE72. The failure to provide a deposit also renders the recitation of the soybean variety name “5PGSE72” as indefinite as the variety has no meaning without its linkage to a deposit.
Claim 15 comprises several recitations that lack proper antecedence. Claim 1 does not recite a “plant part” or “plant cell”.
Dependent claims are included.
Claim Rejections - 35 USC § 112(a)
6. 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.
Enablement
7. 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 claims contain 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 claims all require the seed of soybean variety 5PGSE72.
Since the seed claimed 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.
The specification does not disclose a repeatable 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 a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. So long as the number of seeds deposited complies with the requirements of the IDA where the deposit is made, the USPTO considers such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809.
It is noted that Applicant intends to deposit seeds for soybean variety 5PGSE72 at the NCMA[0192], but there is no indication that the seeds have been deposited. Further, there is no affirmative statement in the specification that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
If the deposit of these seeds is made and accepted 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 that the seeds 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.
If the deposit has not been made and accepted under the Budapest Treaty, then in order to certify that the deposit, meets the requirements 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; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
Written Description
8. Claims 13-14, 16, and 19-20 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 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.
With regard to claims 13 and 14, claim 13 is directed to a soybean plant produced by the method of claim 12, wherein the soybean plant comprises the locus conversion and otherwise comprises all of the physiological and morphological characteristics of soybean variety 5PGSE72. As evidenced by the “comprises the locus conversion” language, the claims are not limited to having a single introduced locus conversion conferring one trait. Claim 12 states that the claimed seed is obtained by introducing a locus conversion into the plant of claim 1. Paragraph [0136] states that up to nine locus conversions may be introduced to the instant variety by backcrossing, introgression, or transformation. Therefore, the claims encompass plants that differ genotypically and phenotypically from soybean variety 5PGSE72 by having multiple unspecified locus conversions. It should be noted that “less than ten” locus conversions does not require less than ten traits that are different from variety 5PGSE72, because each locus conversion can affect multiple traits simultaneously. Applicant does not have working examples of a plant of variety 5PGSE72 comprising up to nine locus conversions to allow one skilled in the art to predict the morphological and physiological characteristics of the claimed converted plant. It is highly unpredictable which characteristics in Table 1 for variety 5PGSE72 are retained and which are lost or altered due to up to nine outcrossings of variety 5PGSE72 with unknown plants. Thus, the deposit of the variety 5PGSE72 cannot adequately describe the genus of plants comprising multiple locus conversions relative to variety 5PGSE72. The specification does not describe structural features of plants that differ in any of the characteristics set forth in Table 1. It is possible that the claimed plant has significantly different descriptions for most of the traits listed in Table 1. The single species, variety 5PGSE72, is not representative of the claimed genus of plants obtained from up to nine outcrossings with plants having undisclosed morphological and physiological characteristics. Accordingly, claim 13 lacks adequate written description.
Claim 14 further limits the locus conversion of claim 13 to herbicide tolerance but does not exclude the addition of other locus conversions as discussed above. Accordingly, claim 14 also lacks adequate written description.
Claim 16 is drawn to a modified soybean that comprises a genome edit and otherwise comprises all the morphological and physiological characteristics of soybean cultivar 5PGSE72. Thus, the claim encompasses soybean plants that can have almost any number of mutations/edits in any number of morphological and physiological characteristics relative to soybean cultivar 5PGSE72. The specification describes no structural or functional features that distinguish the claimed plants of claim 16 from other soybean plants. The specification only describes soybean cultivar 07230211 (Table 1). There is no description of any modified/edited soybean plants, nor any description of what structure or function needs to be retained by the genus of plants encompassed by class 16. Thus, 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. Accordingly, claim 16 lacks adequate written description.
Additionally, claims 19 and 20 lack adequate written description because it is unclear what morphological and physiological characteristics of variety 5PGSE72 the claimed seed and plant retained after the introduction of the single locus conversion. Paragraph [0136] states that the single locus conversion may contain several transgenes or modifications. No method of introduction of the single locus conversion is recited in the claims. Outcrossings with undisclosed plants would not only add the single locus conversion to the base genome but would also alter the base genome resulting in deletions and alterations of the morphological and physiological characteristics of variety 5PGSE72. However, it is unpredictable what morphological and physiological characteristics the resulting converted plant would have. Applicant does not disclose a representative number of plants comprising a single locus conversion. Accordingly, a seed and plant of variety 5PGSE72 further comprising a single locus conversion introduced by any means having undisclosed morphological and physiological characteristics lack adequate written description. These claims are “reach through” claims in which the specification has described a starting material and at least one method step, however, it does not describe the resulting product that is currently claimed, where the genus of products that can be produced by the recited method steps and materials is so large that one skilled in the art is not able to envision the members of the genus. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)). Also, see Vas-Cath Inc. v. Mahurkar 1991 (CAFC) 19 USPQ2d 1111, 1115, which teaches that the purpose of written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from ostensible objects, that the patentee is required to distinguish his invention in his specification.
Accordingly, the specification fails to provide an adequate written description to support the claimed genus of plants/seeds.
Conclusion
9. No claim is allowed.
10. The closest prior art, Carden et al teaches soybean variety XB29AE14, which the instant specification indicates is a grandparent of soybean variety 5PGSE72[0193]. Like the plant described in the instant Table 1, XB29AE14 has light tawny pubescence, black hila, an indeterminate growth habit, the 1K,3A Phytophthora resistance gene, and resistance to glyphosate (Table 1). The two plants have the same scores for harvest standability, resistance to iron-deficiency chlorosis, resistance to cyst nematode race 3, and resistance to white mold. The plants have differences in quantitative traits like relative maturity, emergence, iron chlorosis, Phytophthora filed tolerance, resistance to charcoal rot, and oil and protein percentages. The plants have differences in qualitative traits such as flower color and pod color. Note that in both Carden and the instant specification[0006], “Preliminary scores are reported as double digits, for example ‘55’ indicates a preliminary score of 5 on the scale of 1 to 9”. See throughout Carden’s definitions in the instant specification such as paragraph [0011].
Examiner’s Contact Information
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS J SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached at (571)-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEQUANTARIUS JAVON SPEED/Assistant Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
