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 under examination on the merits.
Priority
Claims 1-20 receive the U.S. effective filing date of 28 Feb 2025.
Specification
The disclosure is objected to because of the following informalities:
The specification indicates a seed deposit was made but does not provide the deposit number associated with this deposit, apparently designated with a placeholder ‘XXXX’ [par. 192]. Specifications are to be complete upon filing. Unless ‘XXXX’ is the actual deposit identifier, this placeholder must be replaced with the correct deposit number.
Appropriate correction is required.
Examiner’s Comment
Duty of Disclosure
Applicant is reminded of their “Duty of Disclosure, Candor, and Good Faith” (see 37 C.F.R. § 1.56 and MPEP § 2001). Information that would be considered pertinent to patentability includes: 1) any progeny, siblings, half-siblings, or other closely genetically related plants that are either co-pending applications or previously published or publicly disclosed, 2) if backcrossing was used in the breeding history, then the recurrent parent should be disclosed along with any publications or public disclosures of the recurrent parent, and what events/loci/transgenes/traits were donated from the non-recurrent parent along with any publications or public disclosures of the events/loci/transgenes/traits or of the donor parent line itself, 3) if the parental varieties were developed via backcrossing this should be disclosed along with the grandparents, including which grandparent was the recurrent parent along with any publications or public disclosures of the recurrent parent and what events/loci/transgenes/traits were donated from the non-recurrent parent, 4) any alternative designations, experimental names, tradenames, etc. for the instant plant, parent plants, and grandparent plants should be disclosed. All of this information is pertinent for patentability. If, for example, one of the parent plants is published but with a different name/designation, then the publication should be included in the IDS along with an explanation that the different name/designation is a synonym and how this plant is related to the instantly claimed plant.
The instant application is drawn to soybean variety ‘5PCEB14’. Review of the specification describes the pedigree of ‘5PCEB14’ as a cross between ‘5PUMB18’ and an unnamed proprietary soybean variety. Literature search appears to indicate that ‘5PUMB18’ is not a publicly available variety. Because of this, the specification is unclear with respect to access to parental lines of ‘5PCEB14’.
Applicant is advised to amend the specification to indicate that parental line ‘5PUMB18’ is proprietary soybean germplasm not sold or made available to the public.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
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 recite ‘Accession Number XXXX’. This is indefinite because there is no indication of the Accession number used to identify the claimed seed deposit. As such, one reading the claims would not be able to ascertain their metes and bounds or avoid infringing. Because of this, the claim is indefinite and rejected.
Applicant is advised to provide the correct, corresponding accession number.
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 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.
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 5PCEB14 at the NCMA, 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.
Claims 13-14, 16 & 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.
Claims 13-14, 16 & 19-20 are drawn to a genus of plants, being soybean plants derived from ‘5PCEB14’.
Claims 13-14 & 16 recite soybean plants comprising characteristics of ‘5PCEB14’ and at least one locus conversion. Broadest reasonable interpretation of such claims would include any and all plants comprising the recited traits also possessing any number of other varied, unspecified phenotypic characteristics and/or multiple other locus conversions not specifically directed to herbicide tolerance per se. The claims are not limited to any defined germplasm accession or material deposit, and thus broadly encompass a wide genus of soybean plants not described by Applicant.
Similarly, claim 19 provides no phenotypic description to limit the claimed plant. Broadest reasonable interpretation of such a claim is that it would encompass plants of varied, undefined phenotypic characteristics comprising those traits of ‘5PCEB14’ but otherwise not described by Applicant. Because of this, its dependent claim 20 is also rejected.
As such, the subject matter was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the broad genus of claimed plants recited based on the limited number of representative species provided.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Carden (2018) [U.S. Patent 10,064,364; Published 04 Sep 2018] in view of Carden (2023) [U.S. Patent Application Publication US2023/0240233A1; Published 03 Aug 2023] and Coser [Coser et al. (2017) Front. Plant Sci. 8:1626; Published 21 Sep 2017].
Carden (2018) teaches the soybean variety ‘5PHGS54’ and phenotypically describes the cultivar for various traits [col.37, Table 1]. They indicate the variety has a single herbicide resistance, being tolerant to glyphosate [id].
Carden (2018) does not teach a soybean plant having herbicide resistance to glufosinate and 2,4-D in addition to glyphosate resistance. Carden does not teach variability in disease resistance scores when phenotyping charcoal rot.
Carden (2023) teaches a soybean plant which has three transgenic herbicide resistances to glyphosate, glufosinate, and synthetic auxins such as 2,4-D [¶.182, 184 & 188].
Coser teaches that environmental factors are known to have major effect on severity of charcoal rot [p.7, col.2, ¶.2]. As such, slight variations in quantitative phenotypic scores of this characteristic would be reasonably expected, owing to the impact of environmental conditions in the field.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the line ‘5PHGS54’ taught by Carden (2018) to a soybean plant having two additional herbicide resistances to glufosinate and 2,4-D as described in Carden (2023). It would be obvious that such a plant would reasonably have slight differences in phenotypic ratings for quantitative, environmentally-conditioned traits such as charcoal rot resistance.
One of ordinary skill in the art would have been motivated to combine these teachings because application of additional known transgenic herbicide tolerances to a soybean plant already having the attributes of ‘5PHGS54’ (i.e. glyphosate resistance) would produce a soybean plant able to be sprayed with the additionally listed herbicides and survive. Applying such known methods of stacking multiple herbicide resistances in soybean would provide growers with a wider range of weed control options and simultaneously protect such a transgenic plant from damage due to herbicide drift of glufosinate and/or 2,4-D.
Regarding claims 1-20; these recite soybean variety ‘5PCEB14’, locus conversions thereof, and methods of producing said soybean plants. Review of the specification indicates the pedigree of ‘5PCEB14’ includes an ancestral line ‘5PHGS54’ utilized in the trait conversion process, as well as providing a phenotypic trait table of ‘5PCEB14’ [Specification, ¶.193 & Table 1]. Comparison of the trait tables from these two related lines indicates ‘5PCEB14’ and ‘5PHGS54’ are nearly identical except for a two-point difference in response to charcoal rot and two additional resistances to glufosinate and 2,4-D which are present in ‘5PCEB14’. Thus, the distinguishing characteristics of ‘5PCEB14’ which are presented in the trait table of the instant application and define the claimed cultivar are met by Carden (2018) via description of ‘5PHGS54’. The limitation of the two additional herbicide resistances is met by Carden (2023) who describes such a ‘triple stack’ of herbicide resistance in soybean.
Regarding the difference in charcoal rot scores between the two described soybean varieties; environmental factors are known to have major effect on severity of diseases under field conditions, including charcoal rot, and slight variations in such quantitative phenotypic scores commonly occur [Coser, p.7, col.2, ¶.2]. This would be expected and routine in a cultivar development program.
As such, the variety claimed in the instant application appears to be merely a derivative conversion line of the existing cultivar ‘5PHGS54’, with two additional herbicide resistances (i.e. glufosinate and 2,4-D). Because simply adding additional, well-known transgenic herbicide resistances to existing elite soybean cultivars is routine, all claims drawn to ‘5PCEB14’ are rejected as obvious in view of prior art.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 EST.
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 on (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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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
