DETAILED ACTION
Claims 29 and 32-38 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The terminal disclaimer filed on 15 August 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,198,887 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The objection to specification is withdrawn in light of Applicant’s amendment.
The rejection of claims 12 and 22-23 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the subject matter that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention is withdrawn in light of Applicant’s cancellation of the claims.
The rejection of claims 2, 12 and 30-31 under 35 U.S.C. 112(d) or 35 U.S.C. 112(pre-AIA ), fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in light of Applicant’s amendment to the claims.
The rejection of claims 1-2, 8, 12, 14-17, 19, 21-22, 26-27, and 29-39 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35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in light of Applicant’s amendment to the claims and Applicant’s deposit statement.
The rejection of claims 1-2 under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 11,198,887 is withdrawn in light of Applicant’s cancellation of the claims.
The rejection of claims 1-2, 8, 12, 14-17, 19, 21-22, 26-27, and 29-39 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,198,887 is withdrawn in light of Applicant’s filing a terminal disclaimer.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 29 and 32-38 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 15 August 2025, as applied to claims 29-39. Applicant’s arguments filed 8 September 2025 have been fully considered but they are not persuasive.
Neither the instant specification nor the originally filed claims appear to provide support for corn plants, plant parts, seeds, or cell comprising nucleotides 863 to 14,027 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 1 to 862 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 14181 to 15216 of SEQ ID NO:10.
Nucleotides 863 to 14,027 of SEQ ID NO:10 are the transgenic insert portion of corn event MON 95379 (Table 1).
The only recitations of “25 consecutive nucleotides” in the specification occur in ¶68, 109 and 110. ¶68 recites that fragments of SEQ ID NO:10 include sequences of “25 consecutive nucleotides of the complete sequence of SEQ ID NO:10. ¶109 and 110 recite 25 contiguous nucleotides of SEQ ID NO:10 as probes or primers for detecting the MON 95379.
None of these provide support for corn plants plant parts, seeds, or cell comprising nucleotides 863 to 14,027 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 1 to 862 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 14181 to 15216 of SEQ ID NO:10.
Claim 37 is drawn to a plant cell comprising nucleotides 863 to 14,027 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 1 to 862 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 14181 to 15216 of SEQ ID NO:10. In addition to the lack of support discussed above, there is no support for a plant of any species other than corn comprising any part of SEQ ID NO:10.
Thus, such concepts constitute NEW MATTER. In response to this rejection, Applicant is required to point to support for the concepts or to cancel the new matter.
Claims 29-39 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 15 August 2025, as applied to claims 29-39. Applicant’s arguments filed 8 September 2025 have been fully considered but they are not persuasive.
The claims require corn plants, plant parts, seeds, cells or nonliving plant material comprising nucleotides 863 to 14,027 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 1 to 862 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 14181 to 15216 of SEQ ID NO:10. Such plants are not required to have the remainer of the genomic flanking sequences of SEQ ID NO:10.
The only species described in the specification are corn plants, plant parts, seeds, cells and nonliving plant material comprising corn event MON 95379, which comprises SEQ ID NO:10 at a particular site in the corn genome.
The specification does not describe any plants that have nucleotides 863 to 14,027 of SEQ ID NO:10 and only a portion the genomic flanking sequences of SEQ ID NO:10. Applicant was not in possession of this claimed genus.
Thus, corn plants, plant parts, seeds, cells and nonliving plant material comprising corn event MON 95379 are insufficient to describe the claimed genus.
Hence, Applicant has not, in fact, described corn plants, plant parts, seeds, cells and nonliving plant material comprising nucleotides 863 to 14,027 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 1 to 862 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 14181 to 15216 of SEQ ID NO:10 over the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Response to Arguments against both written description rejections
Applicant urges that the specification describes the parts of SEQ ID NO:10, which include the flanking sequences of nucleotides 863-14,180 and nucleotides 14,181-15,216, and ¶68 states that "fragments" of these flanking sequences, including those of at least 25 consecutive nucleotides, are useful for detection and are unique to the event (response pg 9-10).
This is not found persuasive because flanking sequences useful for detection do not provide support for a corn plant comprising nucleotides 863 to 14,027 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 1 to 862 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 14181 to 15216 of SEQ ID NO:10.
Applicant urges that the claim require the presence of the full insert (nucleotides 863-14,027), flanked by at least 25 nucleotides of the native genomic context on each side, which is unique to the event and precisely how the event is described and exemplified in the Specification, Table 1, and in the deposited seed (response pg 10).
This is not found persuasive because the event is not described and exemplified in the Specification, Table 1, and in the deposited seed as requiring the presence of the full insert (nucleotides 863-14,027), flanked by at least 25 nucleotides of the native genomic context on each side. The event is described as comprising all of SEQ ID NO:10, that is all of nucleotides 1 to 862 of SEQ ID NO:10, all of nucleotides 863-14,027 of SEQ ID NO:10, and all of nucleotides 14181 to 15216 of SEQ ID NO:10 (see, for example, Table 1). It is not described as only comprising a portion of SEQ ID NO:10. Applicant has not pointed to any portion of the specification that provides support for a corn plant comprising nucleotides 863 to 14,027 of SEQ ID NO:10 and at least 25 consecutive nucleotides o.f nucleotides 1 to 862 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 14181 to 15216 of SEQ ID NO:10
Applicant urges that the deposited seed (ATCC Accession No. PTA-125027) contain the insert and the flanking sequences as defined in the claim, and the deposit is referenced in the Specification, providing a physical embodiment and further supporting the written description requirement (response pg ).
This is not found persuasive because the deposited seed does not contain the insert and the flanking sequences as defined in the claim; the deposited seed contains all of SEQ ID NO:10, i.e., the insert and the entire flanking sequences. Applicant has not pointed to where the specification provides support for a corn plant comprising nucleotides 863 to 14,027 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 1 to 862 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 14181 to 15216 of SEQ ID NO:10. Applicant has also not pointed to where the specification demonstrates possession of such a corn plant.
Applicant has also not pointed to where the specification demonstrates possession of or support for a plant cell of any species comprising nucleotides 863 to 14,027 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 1 to 862 of SEQ ID NO:10 and at least 25 consecutive nucleotides of nucleotides 14181 to 15216 of SEQ ID NO:10, as recited in claim 37.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:30 am - 6:00 pm Eastern.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shubo (Joe) Zhou, can be reached at (571) 272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anne Kubelik/Primary Examiner, Art Unit 1662