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
Status of claims
1. The Office acknowledges the receipt of Applicant’s amendment filed February 10, 2026. Claims 1-12 are pending. Claims 4-12 are withdrawn. Claims 1-3 are examined.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is made FINAL.
Priority
2. The Office acknowledges the receipt of Applicant’s foreign priority benefit document CN202211088062.3 filed September 7, 2022. A certified English translation has been submitted February 10, 2026.
Claim Rejections - 35 USC § 112(b)
3. Claims 1-3 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 pre-AIA the Applicant regards as the invention.
In claim 1, it is unclear what product is being claimed. Event CAL16 is not an art-recognized term and it is not clear whether the claim is directed to a DNA sequence, a plant, a seed, a cell, a glyphosate resistance gene cassette and an insect resistance gene cassette, the DNA sequence flanked by SEQ ID Nos. 27 and 28 excluding SEQ ID Nos. 27 and 28, the DNA sequence flanked by SEQ ID Nos. 27 and 28 including SEQ ID Nos. 27 and 28, a DNA sequence between SEQ ID NO:27 and SEQ ID NO:28, chromosome 18, entire genomic DNA, etc. For examination purpose, the Office interprets the event as being a glyphosate resistance gene cassette and an insect resistance gene cassette. Applicant states that the definition is clearly described on pp. 24-25 of the specification. Applicant’s traversal is unpersuasive because pp. 24-25 do not provide a definition for “soybean event CAL16”.
In claim 2, it is unclear what sequence structure corresponds to “gene g10evo-epsps”. It is suggested a SEQ ID No. be recited. Applicant states that as shown in Table 1, the g10evo-epsps gene is nucleotides 7390-8706 of SEQ ID NO:10. Applicant’s traversal is unpersuasive because “gene g10evo-epsps” is not limited to any particular sequence structure. It is noted that “the” before the recitation of “gene g10evo-epsps” has been deleted from claim 1. This is further evidence that Applicant does not intend to limit said recitation to a particular SEQ ID NO. Moreover, limitations or examples set forth in the specification are not read into the claims. “[I]t is the language itself of the claims which must particularly point out and distinctly claim the subject matter which the applicant regards as his invention, without limitations imported from the specification. … Limitations in the specification not included in the claims may not be relied upon to impart patentability to an otherwise unpatentable claim.” In re Lundberg, 244 F.2d 543, __, 113 USPQ 530, 534 (CCPA 1957).
In claim 2, it is unclear what sequence structure corresponds to “a cry1Abg/vip3Da fusion gene”. It is suggested a SEQ ID No. be recited. Applicant states that as shown in Table 1, “cry1Abg/vip3Da fusion gene” is nucleotides 1373-5722 of SEQ ID NO:10. Applicant’s traversal is unpersuasive because ““a cry1Abg/vip3Da fusion gene” is not limited to any particular sequence structure. It is noted that “the” before the recitation of “cry1Abg/vip3Da fusion gene”” has been amended to “a” in claim 1. This is further evidence that Applicant does not intend to limit said recitation to a particular SEQ ID NO. Moreover, limitations or examples set forth in the specification are not read into the claims. “[I]t is the language itself of the claims which must particularly point out and distinctly claim the subject matter which the applicant regards as his invention, without limitations imported from the specification. … Limitations in the specification not included in the claims may not be relied upon to impart patentability to an otherwise unpatentable claim.” In re Lundberg, 244 F.2d 543, __, 113 USPQ 530, 534 (CCPA 1957).
Correction and/or clarification is required.
Claim Rejections - 35 USC § 102
4. Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jimenez-Juarez et al. (US Pub. No. 20200224216 (previously cited)).
As indicated in the 35 USC 112(b) rejection above, event CAL16 is not an art-recognized term and it is not clear what is being claimed. Jimenez-Juarez teaches event MON802 which contains exogenous gene cassettes for glyphosate resistance and insect resistance (Table 5F). Event MON802 appears to be the same as event CAL16. The recitation of “soybean” is not given patentable weight because no structure is recited to distinguish a soybean event from other events. Accordingly, the claimed invention is anticipated by the prior art.
Applicant’s Traversals
Applicant traverses primarily the following. (1) The prior art MON802 contains the cry1Ab and cp4 epsps genes, while the present invention CAL16 comprises the cry1Ab/vip3Da fusion gene and g10evo-epsps gene. (2) The exogenous genes are inserted between the 3’ end shown in SEQ ID NO:27 and the 5’ end shown in SEQ ID NO:28 on chromosome 18 of the soybean genome, and this site has not been disclosed in the prior art.
Response to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. With regard to traversal (1), Applicant is arguing limitations not present in the claim. Claim 1 does not require the cry1Ab/vip3Da fusion gene and g10evo-epsps gene. With regard to traversal (2), as indicated in the 35 USC 112(b) rejection above, it is unclear what is encompassed by the recitation of “event CAL16”. The Office interprets the event as being a glyphosate resistance gene cassette and an insect resistance gene cassette, which are taught by the prior art. Accordingly, the rejection is maintained.
5. Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berman et al. (J. Agric. Food Chem, 2011, Vol. 59, pp. 11643-11651 (previously cited)).
As indicated in the 35 USC 112(b) rejection above, event CAL16 is not an art-recognized term and it is not clear what is being claimed. Berman teaches transgenic soybean MON 87701 x MON 89788 event which has exogenous gene cassettes expressing the cry1Ac gene and the cp4 epsps gene for insect resistance and glyphosate resistance, respectively (Abstract). Event MON 87701 x MON 89788 appears to be the same as event CAL16. Accordingly, the claimed invention is anticipated by the prior art.
Applicant’s Traversals
Applicant traverses primarily the following. (1) MON87701 x MON89788 disclosed by Berman is a hybrid of two independent transgenic events containing the cry1Ac and cp4 epsps gene, while the present invention is a single copy T-DNA insertion event harboring the cry1Ab/vip3Da fusion gene and g10evo-epsps gene at a specific locus on chromosome 18 between SEQ ID NO:27 and SEQ ID NO:28. (2) G10evo EPSPS has significantly higher glyphosate tolerance than CP4 EPSPS, shows no phytotoxicity under glyphosate treatment at 4x the recommended dosage, and has stable protein expression across generations.
Response to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. With regard to traversal (1), Applicant is arguing limitations not present in the claim. Claim 1 does not require the cry1Ab/vip3Da fusion gene and g10evo-epsps gene. Claim 1 does not require a single insert, as the claim language recites “inserting exogenous genes”. Moreover, as indicated in the 35 USC 112(b) rejection above, it is unclear what is encompassed by the recitation of “event CAL16”. The Office interprets the event as being a glyphosate resistance gene cassette and an insect resistance gene cassette, which is taught by the prior art. With regard to traversal (2), claim 1 does not require G10evo EPSPS. Accordingly, the rejection is maintained.
Conclusion
6. THIS ACTION IS MADE FINAL. 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.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached M-F 8am-5pm.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663
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