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 are pending and are examined in this Office Action.
Rejections that are withdrawn
Objection to specification is withdrawn in light of applicant’s assurance that specification will be amended upon allowance to recite the deposit information (Response to Rejection, page 5, paragraph 2).
Objection to claims 9 and 12 are withdrawn in light of applicant’s amendment of claims to replace “insect or pest resistance” with - - insect resistance, pest resistance - -.
35 USC § 112 – Indefiniteness rejection is withdrawn in light of applicant’s assurance that “Applicant notes that seed of the claimed cultivar will be deposited with a Budapest Treaty approved depository in accordance with Budapest Treaty requirements and 37 C.F.R. § 1.801-1.809. The Specification as well as the claims will be amended to recite the appropriate deposit information upon allowance.” (Response to rejection, page 5, paragraph 3).
35 USC § 112 – enablement rejection is withdrawn in light of applicant’s assurance that “cultivar will be deposited with a Budapest Treaty approved depository in accordance with Budapest Treaty requirements and 37 C.F.R. § 1.801-1.809”, specification will be amended upon allowance (Response to rejection, page 5, last paragraph).
Claim Rejections - 35 USC § 112 – Written Description Rejection
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.
Claims 1-20 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.
Applicant states soybean cultivar “36560917” was developed from the cross with parentage EC1611800 X (EW1600596 x EC1611800) involving further selections in segregating selfed populations and yield trails (Spec, page 9, paragraph 0069).
The prior art search of the parental lines EC1611800 and EW1600596 used in the cross showed that the line EC1611800 is unknown line and there is no record of the line that it was described or used anywhere in the past.
Regarding the line EW1600596. For example, Gao et al. (Published: 2024, Journal: Plant Biotechnology Journal 22: 2145–2156) teaches soybean variety EW1600596(MG0) has high yield and it is an early maturing commercial line adapted in Shunyi (page 2151, Figure 5). It is not clear whether the line is publicly available.
Since applicant has not described about the parental lines EC1611800 and EW1600596, it is not clear whether the parental lines were publicly available or proprietary and what are their characteristics, or a mix of both.
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)).
Description parents is essential and is the least burdensome way for Applicant to provide genetic information needed by the Office and the public to adequately describe a newly developed plant.
To overcome the rejection, applicant should amend the specification to provide more details whether the parental lines were publicly available or proprietary and what are their characteristics, or a mix of both.
Response to Arguments
Applicant's arguments filed 05/04/2026 have been fully considered but they are not persuasive.
Applicant points to a Federal Circuit Court decision and several decisions from the PTAB as examples where a biological deposit was deemed sufficient for providing an adequate written description (Response to rejection, pages 6-9). This is not persuasive, however, because none of these applications were directed to a new plant variety/cultivar, therefore, the structures that needed to be adequately described were very different than the entire genome of a new plant variety. Applicant points to the Ex Parte C decision of the BPAI as an example of a biological deposit providing an adequate written description and about (Response to rejection pages 7 and 8). This is not persuasive, however, because in Ex Parte C the biological deposit was provided in addition to the breeding history rather than as a substitution for a breeding history.
Furthermore, the Examiner agrees that an assurance of providing deposit is included in the written description, but it is not a substitution for a breeding history.
Applicants further point to USPTO’s position, and issuing a Request for Information under § 1.105 (Response to rejections, pages 9 and 10).
35 USC 112 (a) states that “The specification shall contain a written description of the invention”. In evaluating written description, the threshold question is what is “an adequate written description”. This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new soybean variety. So, the examiner evaluated what was an adequate written description for a new soybean variety. In reviewing this question of fact, the examiner analyzed how plant varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety has a trait table and genetic information (via a breeding history). In reviewing applicant’s specification there is a phenotypic description as is seen in table 1. However, there is no accompanying complete breeding history in the specification. Because the specification lacks a complete breeding history and that complete breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification.
Therefore, the rejection has been maintained.
Summary
No claim is allowed.
Closest Prior Art
The claims appear to be free of the prior art. The closest prior art is Mason (US patent No.: US 10,609,884 B1, Date of Patent: Apr. 7, 2020) who teaches soybean cultivar 85380644. The morphological and physiological traits are similar (see cols. 6 and 7, Table 1). However, the Applicant’s soybean cultivar and Mason’s soybean cultivar are produced by using distinct parental lines (col. 6, lines 27-51), therefore the underlying genetics of the cultivars are different.
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.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANTOSH SHARMA whose telephone number is (571)272-8440. The examiner can normally be reached Mon-Fri 8:00 AM - 5:00 PM.
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 A. 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.
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/SANTOSH SHARMA/Examiner, Art Unit 1663
/DAVID H KRUSE/Primary Examiner, Art Unit 1663
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