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 1-19 are pending.
Election/Restrictions
2. Applicant's election without traverse of Group II, claims 3-4, in the reply filed on 6/1/2026 is acknowledged. Applicants further elected SEQ ID NO:1 as species election over the phone 6/16/2026.
Applicants argue that claims have amended such that Group II and III should examined together and that SEQ ID NO:4 is significantly similar to elected SEQ ID NO:1 (response, pages 7-8).
Applicant’s argument is found persuasive. Restriction requirement between Group II-III as well as species election requirement between SEQ ID NO:1 and 4 are withdrawn.
As a result, claims 1-2, 10, 13-19 are withdrawn for being drawn to non-elected inventions.
Claims 3-5, 7-9 and 11-12 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, pages 30 and 92.
Claim Objections
4. Claims 3 and 12 are objected to for missing recitation “and “ before the recitation “which comprises gcsgtct “ in part (e).
Improper Markush Grouping
5. Claims 3-5, 7-9 and 11-12 are rejected under the judicially-created basis that it contains an improper Markush grouping of alternative. See In re Harnisch, 631 F.2d 716, 721-722 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. and Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or common use that flows from the substantial structural feature and/or common use that flows from the substantial structural feature for the following reasons:
In claims 3 and 12, elected SEQ ID NO: 1 and 4 have distinct structures with other SEQ ID NOs listed in instant claims. Therefore, parts (a)-(d) and (f)-(g) of instant claims are rejected.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or groupings of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 USC 134 and 37 CFR 41.31 (a)(1).
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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 5, 7-9 and 11 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.
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In claims 5 and 11, the recitation “the polynucleotide as defined in claim 3” renders the claims indefinite. The claim 3 is drawn to a maize plant or plant part rather than a polynucleotide. The metes and bounds are unclear.
In claim 7: the recitation, “(or offspring thereof)”, renders the claim indefinite. It is the recitation in the parenthesis is considered as a limitation or not. The metes and bounds are not clear.
Scope of Enablement
7. Claims 3-4, 7, 9 and 12 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for maize plant or plant part as deposited as NCIMB 43997 does not reasonably provide enablement for any maize plant or plant parts comprising SEQ ID NO: 1 or 4 or variants thereof having sequence identity more than 90% to SEQ ID NO:1 or 4. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
A review of the language of claims indicates that the claims are broadly drawn to a genus of maize plant or plant parts or an isolated polynucleotide comprising SEQ ID NO: 1 or 4 or variants thereof having sequence identity more than 90% to SEQ ID NO:1 or 4.
The specification teaches that maize plant deposited as NCIMB 43997 which comprises SEQ ID NO:4 and which comprises a 7 bp insertion into wild type F35H gene (specification, page 91). The specification teaches that maize plant deposited as NCIMB 43997 is more stable than 200 bp insertion (specification, page 92).
First, instant claims read on any isolated polynucleotide that have sequence identity more than 90% to SEQ ID NO:1 or 4. The variants would have up to 422 unmatched bp scatter along the SEQ ID NO:1 or 4. Without a functional language associated with those claimed variants, undue experimentation would have been required for skilled in the art to develop assay for each individual species and test for their functionality.
Secondly, instant claims read on any maize plant or plant parts comprising SEQ ID NO: 1 or 4 or variants thereof having sequence identity more than 90% to SEQ ID NO:1 or 4. However, the only species exemplified are the maize plant deposited as NCIMB 43997 which comprises SEQ ID NO:4 and which comprises a 7 bp insertion into wild type F35H gene, whereas any other transgenic maize plant comprises with SEQ ID NO: 1 or 4 integrated into the other sites or the genome would have both wild type F35H and knockout allele, which are not enabled in that it is not known that the knockout allele is dominant.
Further, for other knockout lines for variant of SEQ ID NO: 1 or 4, a deposit is required wherein the specification only provide deposit for one species among the genus which is NCIMB 43997. Undue experimentation would have been required to identify maize plant with F35H orthologs of SEQ ID NO: 4, to isolated wild type F35H, to design knockout strategy, to perform knockout and test its digestibility.
Still further, even for the maize plant with the wild type allele replaced with SEQ ID NO:4, the deposit is required to enable the invention. However, the deposit information for NCIMB 43997 still needs to be perfected.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a reproducible process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public. If the deposit of the seed is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating the seed have been deposited under the Budapest Treaty and that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. A minimum deposit of 2500 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the 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, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) 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 enforceable life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become unviable.
Applicant has NOT indicated that Applicant has deposited the seeds at the NCIMB in accordance with 37 CFR 1.801-1.809. Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809 to overcome this rejection. Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Therefore, given the claim breadth, lack of further guidance and additional working example, unpredictability of the art, undue experimentation would be required for a person skilled in the art to practice the invention.
Conclusion
No claim is allowed.
However, instant claims are free from the prior art for the failure of the prior art to teach or fairly suggest SEQ ID NO:1 or 4. The closest prior art is WO 2019206927, which teach a sequence that is identical to instant SEQ ID NO:1 or 4 except for 8 bp insertion region.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI ZHENG whose telephone number is (571)272-8031. The examiner can normally be reached Monday-Friday (9-5).
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/LI ZHENG/Primary Examiner, Art Unit 1662
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