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 .
Claims
The amendments received on Mar. 16, 2026, have been entered. Claims 2-6 have been canceled. Claims 1 and 7-17 are pending and are examined in this Office Action.
Grounds of Rejection and Objections That Are Withdrawn
The objections to claims 10, 12, and 17 for informalities are withdrawn in light of Applicant’s amendments to the claims.
All rejections of claims 2-6 are moot in light of Applicant’s cancelation of these claims.
The rejection of claims 1-17 under 35 USC 112B for indefiniteness is withdrawn in light of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112
Indefiniteness
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 1-17 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. NOTE: this is a new ground of rejection that was necessitated by Applicant’s amendments to the claims.
All dependent claims are included in this rejection.
Claim 1 recites: “A transgenic maize plant comprising event 4588.652, or a part or seed thereof comprising wherein the event comprises the sequence set forth in SEQ ID NO: 8, and comprises a sequence selected from the group consisting of SEQ ID NOs: 29-31.”. This appears to be missing some words. “comprising wherein the event” is missing whatever the seed thereof should be comprising. In the absence of an amendment to clarify what the seed needs to comprise, the claim is indefinite.
Inadequate Written Description
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 1-17 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim. Applicant’s arguments in the response received on Mar. 16, 2026, have been fully considered but were not found to be persuasive.
The claims are drawn to a transgenic maize plant comprising event 4588.652, or a part or seed thereof comprising wherein the event comprises the sequence set forth in SEQ ID NO: 8, and comprises a sequence selected from the group consisting of SEQ ID NOs: 29-31; and to animal feedstock comprising the maize plant, part or seed thereof and methods that utilize the maize plant.
What is Described
Applicant describes expression vector pAG4588 which carries a single feed glucanase expression unit (Spec 4 ¶ 21) and comprises SEQ ID NO: 8 (Spec 16 ¶ 80). pAG4588 is described as Glu:mZ27:AGR2314:SEKDEL:T35S (Id. 51 Table 1).
Applicant describes different maize “events” carrying this plasmid which produced corn flour that had dramatically different amounts of b-glucanase activity (Figure 9 Spec 5 ¶ 28).
Applicant describes Event 4588.652 as integrated in chromosome 7 of the maize genome in BxA genotype, and the T-DNA insertion occurred between nucleotides 141683320-141683357 of the publicly available reference B73 genome (Id. 5 ¶ 30, Id. 64 ¶ 204).
Applicant describes that multiple alignments of the left border specific sequences from multiple wild-type maize genotypes revealed that these 1.8 kb sequences are nearly 100% identical between all genotypes and alignments with the right border revealed the 2.2 kb sequences are also nearly 100% identical (Id. 65 ¶¶ 206-8).
Applicant describes an “advanced progeny” of 4588_652 as having a right border flanking region that comprises SEQ ID NO: 30 (Id. 66-7). SEQ ID NO: 30 has two mismatches relative to SEQ ID NO: 29 (see alignment provided in the in indefiniteness rejection mailed on Sept. 24, 2024). SEQ ID NO: 29 is described as the extended right border flank isolated from the original 4588_652 and SEQ ID NO: 31 is described as the extended left border flank for the event (Id.).
Applicant describes that PCR is used to detect events by amplifying a larger PCR product from genomic DNA containing the T-DNA insertion and a smaller PCR product for genomic DNA that does not contain the insertion (Figures 15-6 Spec 5 ¶¶ 34-5).
Applicant states that the target sequence for a diagnostic PCR test “may be” a sequence included in a junction between a genomic sequence of a transformed plant and a sequence of the T-DNA insertion and “may have” at least 70% identity to SEQ ID NOs: 29-31 (Id. 24 ¶ 103).
In the response received on Aug. 21, 2025, Applicant provided Exhibit B and argued that it lists the complete sequence of the transgenic locus of event 4588.652 (8/21/25 Resp 5-9 and Exhibit B).
Analysis
Discussion of Exhibit B:
1) the table showing the nucleotide positions for the elements of the transgenic locus does not include the actual sequences for each of the elements;
2) the sequence provided after the table does not cover the total of 16158 required according to the table of nucleotide positions; and
3) any description is required to be in the originally filed specification, claims, drawings, or sequence listing.
There does not appear to be a sequence that is 16158 nucleotides in length contained in the originally filed sequence listing.
The Examiner agrees that Applicant was in possession of a transgenic maize plant comprising Event 4588.652 which comprises the nucleic acid of SEQ ID NO: 8 and comprises at least one of the polynucleotides of SEQ ID NOs: 29, 30, and 31. If seeds comprising this Event were deposited and all conditions of 37 CFR 1.801-1.809 were met, then this would be adequately described without disclosing the entirety of the 16158 nucleotides.
Applicant states that they have made a deposit of 625 seeds of maize event 4588.652 with the ATCC and are awaiting confirmation of the deposit and assignment of the deposit. Applicant states that the specification and claim 1 will be amended to include the reference to the deposit. (Resp 7-8).
Because the specification and claims have not, yet, been amended to include the references to the ATCC deposit, the written description rejection is maintained.
Lack of Enablement
Claims 1-17 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 claim(s) contains 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim. Applicant’s arguments in the response received on Mar. 16, 2026, have been fully considered but were not found to be persuasive.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
The claims are drawn to a transgenic maize plant comprising event 4588.652, or a part or seed thereof comprising wherein the event comprises the sequence set forth in SEQ ID NO: 8, and comprises a sequence selected from the group consisting of SEQ ID NOs: 29-31; and to animal feedstock comprising the maize plant, part or seed thereof and methods that utilize the maize plant.
As discussed in the previous Office Action, a reliable source for obtaining event 4588.652 is required for enablement of the claimed invention.
Because a plant comprising the claimed event 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. If the plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the seeds. A deposit of 625 seeds comprising the claimed event is considered sufficient to ensure public availability. The specification does not disclose a repeatable process to obtain the plant. It is noted that Applicant states that they have made a deposit of 625 seeds of maize event 4588.652 with the ATCC and are awaiting confirmation of the deposit and assignment of the deposit. Applicant states that the specification and claim 1 will be amended to include the reference to the deposit. (Resp 7-8). However, Applicant has not yet provided the accession number, date of deposit, and viability testing nor has Applicant amended the specification or claims. Furthermore, they have not stated if the deposit was made under the Budapest Treaty or not.
(a) If a deposit is made AND ACCEPTED under the terms of the Budapest Treaty, then the specification must include the street address of the depository and Applicant must provide a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over their signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
(b) If a deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2);
(iii) 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 effective life of the patent, whichever is longer, and the specification will include the street address of the depository;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
Summary
No claim is allowed.
Finality
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.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached M-F 9:00 - 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 A 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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CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1662
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