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 .
Priority
Application draws priority to three applications, CN202110376902.5, CN202110632185.8, and PCT/CN2021/110762, with the earliest priority date of 04/08/2021. A certification of English translation is not provided.
Status of the Claims
Claims 1-18 are pending.
Claims 8-18 were elected in the Applicant Argument/Remarks filed on 04/22/2026 and are examined herein. Applicant’s elections were without traverse.
Response to Previous Communication
Examiner acknowledges the newly submitted specification document and claims, which were submitted on 04/22/2026, and used for examination of this office action.
Specification
The specification has some grammatical errors such as on page 1 line 26 in the phrase “been become” and on page 3 line 23 “clonedfrom”. Applicant is encouraged to check specification for other grammatical issues. The description of figure 9 on page 11 references “electrophorectogram” results but figure 9 appears to show gel electrophoresis results of PCR reactions.
Information Disclosure Statement
Non-Patent literature document 2, Guo et al 2015, does not seem to be uploaded and was not reviewed by the examiner. Also, the Liang et al 2017 NPL reference in IDS has an incorrect date. References in Specification such as Ren et al on page 4 line 24 are not listed in the IDS. For example, 37 CFR § 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Interpretation
It is noted that SEQ ID NOs: 3 and 4 listed in claim 8 are codon optimized nucleotide sequences encoding a GR79 (i.e. EPSPS gene) and GAT genes. Translation of them yields proteins already known to convey glyphosate resistance. The GR79 protein is listed in publication US 20110173716 A1 while the GAT protein is identified as a glyphosate resistance protein in NCBI since 19-Aug-2004 (See Castle et al 2004 below which encodes a protein with ~98.6% similarity ) and SEQ ID NO:1 of CN 1772908 A (see IDS filed 11/30/2023) encodes the same protein.
The regions of SEQ ID NO:8 referenced in claims 9 and 10 are understood to be the maize genomic DNA and not part of the construct used to transform the plant. Primer with the SEQ ID NO: 12 is understood to map to the left border region while primer with SEQ ID NO: 9 is understood to map to the right border region. Primers with SEQ ID NOs: 11 and 10 are understood to map to the exogenous construct inserted into the genome.
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Claim Objections
Claims 12 and 14 are each drawn to a primer pair. However, they later recite “comprising a sequence” which implies one sequence. Additionally, the two listed sequences in each claim should be separated with “and” to make them grammatically correct.
Claim 16 teaches a PCR reaction with a specific primer pair in the third line but lists two pairs.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because "use" claims are not proper process claims. The claim recites no method steps, further demonstrating that the claim is not to a process.
Claim Rejections - 35 USC § 112(b)
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 11, 13, 15-18 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 11, 13, and 18 and dependent claim 15 which does not clarify the particular primer sequences are rejected for using the term “specific primer pair”. These claims are directed to specific regions bordering a transgene in glyphosate-resistant corn. This phrase indicates there are particular sequences the claims are drawn to but are undisclosed. There is indefiniteness as one having ordinary skill in the art would not know what “specific” sequences the Applicant is referencing in claims 11 and 13 or what primers are directed to in claim 18.
Claim 15 is rejected for lack of antecedent basis. Claim 15 is drawn to a PCR reaction detection method and references a specific primer pair according to claim 11, which does not list specific primers.
Claim 16 draws dependence from claim 15, which references a detection method using primer pairs designed according to the left border flanking sequence. However, claim 16 also teaches the use of primers with SEQ ID NOs: 9 and 10 which were directed for use in detecting the right border sequence (i.e. Claim 14). Additionally, Claim 16 teaches a PCR reaction with a specific primer pair in the third line but lists two pairs. This leads to indefiniteness as it is unclear which primers should be used in a PCR reaction.
Claim 17 is directed to a kit for detecting a glyphosate-resistant corn using a specific primer pair for PCR reactions designed according to one or more of the left border flanking sequences. However, claim 9, which is the claim that referenced claim 11 draws dependence from, clearly defines the only left border flanking sequence. Claim 17 also references the left border sequence of claims 11-12, but claim 12 is directed to specific primers which can be mapped to the left border flanking sequence.
Claim 18 recites the use of flanking sequences according to claim 9 and a specific primer pair according to claim 11 which are only directed to the left border flanking sequences. Claim 17, which is also referenced in this claim, encompasses a kit with primers designed using the right border flanking sequence. As written, it is unclear if the kit can be used to detect the right border flanking sequence, which is indefinite. Additionally, Claim 18, recite a “use” without any active, positive steps delimiting how this use is actually practiced.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Liang, Chengzhen, et al. "Co‐expression of GR79 EPSPS and GAT yields herbicide‐resistant cotton with low glyphosate residues." Plant biotechnology journal 15.12 (2017): 1622-1629 (see IDS filed 11/30/2023) in view of Owen, Micheal DK. "Current use of transgenic herbicide-resistant soybean and corn in the USA." Crop Protection 19.8-10 (2000): 765-771.
Claim 8 is directed to a glyphosate resistant corn transformed with genes GR79 and GAT using the codon optimized sequences SEQ ID NOs:3 and 4.
Liang et al 2017 discloses tobacco and cotton plants engineered to express codon optimized sequences for GR79 and GAT. This is explained in the abstract, page 2 paragraphs 4 and 5 as well as figures 1 and 3. The use of codon optimization is described on page 2 paragraph 2 and supplementary figures 1 and 2.
Liang et al 2017 does not disclose the use of these genes in corn, but it does teach “Microbial EPSPS enzyme variants that are not inhibited by glyphosate, particularly CP4 EPSPS, have formed the basis of commercially available genetically engineered glyphosate resistant crops” and cites Owen et al 2004 (page 1 paragraph 1).
Owens et al 2004 teaches corn is another crop species that can be engineered with glyphosate resistance. This is disclosed on page 2 paragraph 7.
Liang et al 2017 and Owens et al 2004 do not disclose sequences outlined in SEQ ID NOs: 3-4. However, it would have been prima facie obvious to express these genes in corn and use codon optimized genes (i.e. SEQ ID NOs:3-4). The motivation for why a person with ordinary skill in the art would engineer corn with glyphosate resistance genes is stated in Liang et al 2017 page 2 paragraph 1 in the passage “both the GAT and GR79 EPSPS genes appear to have great potential for use in the genetic engineering of glyphosate-resistant plants. These studies prompted us examine whether the co-expression of glyphosate-resistant EPSPS and GAT genes could be an effective strategy for developing high- glyphosate-resistant, low-glyphosate-residue crops”. Additionally codon optimization is routinely performed in the art1. Because codon optimization has previously been performed on these genes, the optimized genes encode the same proteins as non-optimized genes, and the protein encoded by these genes have conveyed glyphosate resistance in multiple species (i.e. cotton and tobacco), one of ordinary skill in the art would have a high expectancy of success that expressing these genes would convey glyphosate-resistance in corn.
Subject Matter Free of Art
Claims 9-18 contain subject matter free of prior art.
Claims 9-14 referencing left and right border flanking sequences of an exogenous insertion in glyphosate-resistant corn as well as primer pairs that map to these regions contain subject matter free of prior art.
Liang et al 2017 discloses glyphosate resistant crop plants with a left and right border sequence flanking GR79 and GAT genes as directed to in claims 9-10. They can be seen in supplemental figures 5 and 7 (See Figure 1 below), described on page 2 paragraph 6, while an explanation on how plants were made is on page 6 paragraph 5. Supplementary figure 7 and supplementary table 2 (Table 1 below) also teaches primers that map to the left (i.e. claims 11-12) and right border (i.e. claims 13-14).
Publication US 20080256669 A1 (See IDS filed 11/30/2023) teaches multiple plants, including corn, can be engineered with multiple transgenes for imparting traits to said seed or its plant in the abstract. Glyphosate-resistance genes EPSPS (i.e. GR79) and GAT are specifically mentioned in paragraph 33.
Liang et al 2017 and US 20080256669 A1 do not teach left and right border flanking regions of SEQ ID NO:8 (i.e. claim 9 - 10) or primers taught in SEQ ID NOs: 9-12 (i.e. claims 12 and 14).
Claims 15 – 16 referencing a PCR reaction detection method of a transgenic glyphosate-resistant corn using specific primer pairs (SEQ ID NOs: 9-12) to obtain specific fragment sizes ( i.e. 734 and 1773 bps) contain subject matter free of prior art.
Liang et al 2017 teaches PCR reactions that were used to identify transgenic heterozygous and homozygous plants as was directed to in claim 15. (See Figure 1 below and Figure S7).
Yan, L. I. U., et al. "Optimization of Agrobacterium tumefaciens-mediated immature embryo transformation system and transformation of glyphosate-resistant gene 2mG2-EPSPS in maize (Zea mays L.)." Journal of Integrative Agriculture 12.12 (2013): 2134-2142 teaches a PCR reaction to detect transgenic corn plants harboring the glyphosate resistant gene 2mG2-EPSPS on page 8 paragraph 5, page 5 paragraph 2, and figure 4.
Specific primer pairs and PCR products with specifics sizes, drawn to in Claims 15 and 16, appear to be free of art.
Claims 17-18 drawn to a kit for detecting glyphosate resistant corn comprising specific primer pairs designed to amplify the left and right border flanking sequences using PCR and the use of the kit contain subject matter free of prior art.
PH 12012500341 B1 teaches corn plants transformed with the AAD-1 gene, which conveys resistance to herbicides 2,4-dichlorophenoxyacetic acid and aryloxyphenoxypropionate, (see page 12 paragraph 1). It also teaches “the subject invention can be combined with, for example, traits encoding glyphosate resistance (e.g., resistant plant or bacterial EPSPS, GOX, GAT) on page 27 paragraph 2. This application is also drawn towards assays for detecting the presence of the gene, kits, and conditions useful for such assays. The kit and PCR detection assays for detecting these transgenic corn lines are referenced in the abstract and page 22 paragraphs 1-2.
PH 12012500341 B1 does not teach the specific left and right border sequences referenced in claims 9-10 or primers with SEQ ID NOs: 9-12
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Table 1
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Citation of Relevant Prior Art
The prior art made of record and not relied upon but is considered pertinent to the Applicant’s disclosure.
Guo, Bingfu, et al. "Co-expression of G2-EPSPS and glyphosate acetyltransferase GAT genes conferring high tolerance to glyphosate in soybean." Frontiers in Plant Science 6 (2015): 847.
Conclusion
No claims are allowed.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W MEYER whose telephone number is (571)272-3733. The examiner can normally be reached Monday - Friday 8:00 am- 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEORGE W MEYER/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
1 The motivation for why a person of ordinary skill in the art would perform codon optimization is also disclosed in WO 2015172269 A1 page 11 paragraph 5 of the translated document uploaded with this office action. It teaches that genes from different organisms, such as GAT and GR79, need to be artificially modified (i.e. codon optimized) for improved expression efficiency and stability in the new organism.
Prosecution Insights