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. Claims 1-20 are pending.
Election/Restrictions
2. Applicant's election with traverse of Group I, claims 1-16, promoter region and promoter position being 421-460 of SEQ ID NO:764, Tf11.1 in table 10, a timer of 12-nt ocs orthologue and 441-450 of SEQ ID NO:764 as species election in the reply filed on 8/14/2025 are acknowledged.
Applicants argue the reference fails to teach the technical feature linked Group I-III in light of the amendment of claim 1 which adds an additional limitation that modification of GmDR1 comprising an insertion of enhancer of SEQ ID NO:184.
Applicant’s arguments are found persuasive.
The restriction requirements among Groups I-III are withdrawn.
However, due to the species election, claims 7 is withdrawn for being drawn to non-elected species.
Claims 1-6 and 8-20 are examined on the merits.
The requirement is still deemed proper and is therefore made FINAL.
Specification
3. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01. See, for example, paragraph [00230].
4. The abstract is objected to because it should be within the range of 50-150 words.
Claim Objections
5. Claims 5-6 and 10 are objected to for containing non-elected species.
Claim Rejections - 35 USC § 112
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.
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.
6. Claims 1-6 and 8-20 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.
In claims 1, the recitation, “GmDR1 gene”, renders the claims indefinite. The sole designation of a nucleotide sequence by “GmDR1 gene” is arbitrary and creates ambiguity in the claims. For example, the nucleotide sequence in this application could be designated by some other arbitrary means, or the assignment of said name could be arbitrarily changed to designate a different nucleotide sequence. If either event occurs, one’s ability to determine the metes and bounds of the claim would be impaired. See In re Hammack, 427 F .2d 1378, 1382; 166 USPQ 204, 208 (CCPA 1970). Amendment of the claim to refer to a specific SEQ ID NO would obviate this rejection.
Claims 2, 6 and 10 recites “allelic variant thereof”. It is unclear what gene is considered as allelic variant of GmDR1 gene. The metes and bounds are unclear.
In claim 8, the recitation of “Table 10” renders the claim indefinite, Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). The metes and bounds are not clear.
In claim 9: the recitation, “functional equivalent thereof”, renders the claim indefinite. It is unclear what is considered to be a functional equivalent of SEQ ID NO:184. The metes and bounds are not clear.
In claims 11, 13 and 16-17, the recitation “the endogenous GmDR1 gene set forth in claim 1” renders the claims indefinite. Claim 1 is directed to a modified soybean plant rather than an endogenous GmDR1 gene set forth in claim 1. The metes and bounds are not clear.
Claim Rejections - 35 USC § 103
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.
7. Claim(s) 1-6 and 8-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ngaki et al. (October 2020 Plant Biotechnol J. 19:502-516) further in view of Abbitt et al. (WO 2018/183878) and Bhattacharyya et al. (US Patent Application Publication No. 2016/0194657).
The instant claims are drawn to a modified soybean plant comprising at least one targeted modification in an endogenous GmDR1 gene resulting in increased expression of the endogenous GmDR1 gene relative to a reference plant lacking the modification, wherein the targeted modification in the GmDR1 gene comprises an insertion comprising at least one 12 nt ZmOCS enhancer (SEQ ID NO: 184) and wherein the increase of expression in the GmDR1 gene results in an improvement in resistance to a pest or pathogen in the modified soybean plant relative to the reference plant lacking the modification; or wherein the pest is a spider mite or Fusarium virguliforme; or wherein the target modification is located within a GmDR1 promoter; or wherein the endogenous GmDR1 gene comprises the DNA molecule set forth in SEQ ID NO: 762 or an allelic variant thereof; or wherein the promoter is modified at position 421-460 of SEQ ID NO:764; or wherein the targeted modification in an endogenous GmDR1 gene comprises the modified GmDR1 gene of SEQ ID NO: 770 or an allelic variant thereof. Instant is also drawn to soybean meal or soybean part; or wherein the par the is a seed; or wherein the soybean meal has less mycotoxin. Instant claims are also drawn to DNA molecule comprising the modified endogenous soybean GmDR1 gene containing the targeted modification(s) in the endogenous GmDR1 gene set forth in claim 1 and at least 100 base pairs of adjoining endogenous soybean chromosomal DNA located centromere-proximal and telomere-proximal to the modified endogenous soybean GmDR1 gene. Instant claims are also drawn to a method for producing a soybean plant by crossing the modified soybean plant with itself or a second soybean plant.
Ngaki et al. disclose a modified soybean plant comprising at least one targeted modification in an endogenous GmDR1 gene resulting in increased expression of the endogenous GmDR1 gene relative to a reference plant lacking the modification (Summary-"GmDR1-overexpressedtransgenicsoybeanlines"; page 503,Col.2, para1-"GmDR1 transgenes were expressed among the F. virguliforme-resistant R1 progenies; but not among the SDS susceptible progenies(Figure 1e; Figure 2c).";Fig.1e; Fig. 3e), wherein the targeted modification in the GmDR1 gene comprises an insertion, replacement, and/or deletion of one or more nucleotides in the GmDR1gene (page 503, Col.1 para4-"To test this hypothesis, we fused GmDR1 to three infection-inducible promoters and created three fusion GmDR1 genes (Figure 9), and wherein the increase of expression in the GmDR1 gene results in an improvement in resistance to a pest or pathogen in the modified soybean plant relative to the reference plant lacking the modification (Summary-“Overexpression of the protein led to enhanced resistance against not only against F.virguliforme...We, therefore, name this protein as Glycine max disease resistance1 (GmDR1...defense pathways maybe one of the mechanisms involved in generating broad-spectrum resistance among the GmDR1-overexpressed transgenic soybean lines against two serious pathogens and two pests including spider mites, against which no known resistance genes have been identified in soybean and among the most other crop species; Fig.5). Ngaki et al. disclose the modification is located within GmDR1 promoter or 5’UTR or allelic variants thereof (page 503, col. 1, para 4, also Figure S1). Ngaki et al. disclose F. virguliforme produce phytotoxin to cause foliar SDS (page 503, col. 1 2nd para.)
Ngaki et al. do not teach ZmOCS enhancer of SEQ ID NO:184 being inserted into GmDR1 gene.
Abbitt et al. teach expression modulation element of SEQ ID NO: 36, which comprising instant SEQ ID NO:184 (see alignment below). Abbitt et al. teach EME is present within about 10- about 5000 bp from transcription start site and could be present 2x to 10x copies (the paragraph bridging pages 1-2). Abbitt et al. teach EME is inserted into the regulatory region to increase the expression of the gene (page 2, lines 17-23). Abbitt et al. teach EME is operably linked to a heterologous sequence that is a disease resistance gene (page 3, line 29).
Given that overexpression of GmDB1 produces disease resistant soybean plant, it would have been obvious to incorporate the enhancer of Abbitt et al. into the promoter region to further increase the expression of GmDB1 gene resulting in instant invention with reasonable expectation for success. One would have been motivated for performing such modification given the teaching of Abbitt et al. that EME (such as 2x to 10x copies) can be operably linked to a heterologous sequence that is a disease resistance gene.
Although the combined teachings do not teach mycotoxin is reduced in modified soybean plant, such feature would have been obviously exhibited given that the modified soybean plant is resistant to F. virguliforme which produce phytotoxin to cause foliar SDS.
Although the combined teachings do not teach the modified endogenous soybean GmDR1 gene containing the targeted modification(s) in the endogenous GmDR1 gene set forth in claim 1 and at least 100 base pairs of adjoining endogenous soybean chromosomal DNA located centromere-proximal and telomere-proximal to the modified endogenous soybean GmDR1 gene, such construct is merely considered as an obvious design choice.
It would also have been obvious to cross the modified soybean plant with itself or another soybean plant since it would be an obvious routine procedure for plant breeding to generate disease resistant soybean lines.
Although the combined teachings do not teach wherein the endogenous GmDR1 comprising SEQ ID NO: 762, such feature would have been obviously exhibited given the GmDR1 of the reference has the same gene name from the same plant species as instant GmDR1. Further Bhattacharyya et al. further teaches SEQ ID NO:17 that is 100% identical to instant
Although the combined teachings do not teach the promoter is modified at position 421-460 of SEQ ID NO:764, such construct is merely considered as an obvious design choice as enhancer can be located in any wherein upstream of the start site.
RESULT 3
US-16-498-447-36
(NOTE: this sequence has 3 duplicates in the database searched.
See complete list at the end of this report)
Sequence 36, US/16498447
Publication No. US20210324401A1
GENERAL INFORMATION
APPLICANT: Pioneer Hi-Bred International, Inc.
TITLE OF INVENTION: EXPRESSION MODULATING ELEMENTS AND USE THEREOF
FILE REFERENCE: 7243USP1
CURRENT APPLICATION NUMBER: US/16/498,447
CURRENT FILING DATE: 2019-09-27
PRIOR APPLICATION NUMBER: 62/479,781
PRIOR FILING DATE: 2017-03-31
NUMBER OF SEQ ID NOS: 68
SEQ ID NO 36
LENGTH: 13
TYPE: DNA
ORGANISM: Zea mays
Query Match 100.0%; Score 12; Length 13;
Best Local Similarity 100.0%;
Matches 12; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GTAAGCGCTTAC 12
||||||||||||
Db 1 GTAAGCGCTTAC 12
Conclusion
No claim is allowed.
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/LI ZHENG/Primary Examiner, Art Unit 1662