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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 2, 4, 6, 8, 11-13 and 17, in addition to species SEQ ID NO: 69, 78 and 120 in the reply filed on 18 June 2026 is acknowledged.,
Claims 57, 61-63, 67 70, 72, 76, 77, 80 and 82 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 18 June 2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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.
Claims 1, 2, 4, 6, 8 and 11-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) at least on mutation in an endogenous IPT7 gene. This judicial exception is not integrated into a practical application because the specification implies that the mutation can be naturally occurring on page 2, lines 17-27. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed mutations can and do occur in nature. An example can be found in Brugiere (U.S. 8,916,749) who teaches an IPT7 variation (mutation) relative to instant SEQ ID NO: 71 having one conserved and one non-conserved substitution (and thus a base substitution in the encoding nucleotide sequence) at SEQ ID NO: 15.
Claim Rejections - 35 USC § 112
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.
Claim 17 is 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.
Claim 17 is indefinite because it is unclear if the mutated IPT7 gene in the corn plant or part thereof comprises the mutation found in elected SEQ ID NO: 120 (an insertion) since it needs only be 90% identical to SEQ ID NO: 120. Hence, the metes and bounds of the claim are unclear.
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, 2, 4, 6, 8, 11-13 and 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.
Applicant claims a corn plant or plant part thereof comprising at least one mutation in an endogenous Adenosine phosphate-isopentenyltransferase 7 (IPT 7) gene encoding an IPT7 polypeptide. The plant comprises a nucleotide sequence having at least 80% sequence identity to elected SEQ ID NO: 69 (5,059bp) and/or a region having at least 80% sequence identity to elected SEQ IDNO: 78 (197bp) and/or encodes an amino acid sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 71 (352aa). Applicant claims that the mutation increases expression (claim 4), comprises a base substitution, a base deletion and/or a base insertion, results in a dominant allele and/or a hypermorphic allele (claim 11), is non-natural, produces improved yield traits or is a mutated IPT7 gene having at least 90% sequence identity to elected SEQ ID NO: 120.
Applicant describes a group of promoter edited versions of instant SEQ ID NO: 69 in Table 2 on pages 102-104. Applicant teaches that the various mutations have significantly different effects on yield and ear/kernel characteristics in Tables 3-5 on pages 103-107.
Applicant does not describe any structure/function relationship between the “mutation” in the promoter region of a corn IPT7 gene, especially the functions recited in instant claims 4, 11 and 13.
Hence, it does not appear that Applicant had possession of the invention as broadly claimed.
See University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424, 1433 (DC WNY 2003) which teaches knowing the "starting point" is not enough; that is little more than a research plan. The court held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112.
Claims 1, 2, 4, 6, 8, 11-13 and 17 are 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 a corn plant or part thereof comprising the specific and useful “mutation(s)” in the IPT7 gene promoter as listed in Table 7 on page 110, does not reasonably provide enablement for any mutation in the endogenous IPT7 gene in maize. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Applicant teaches a group of promoter edited versions of instant SEQ ID NO: 69 in Table 2 on pages 102-104. Applicant teaches that the various mutations have significantly different effects on yield and ear/kernel characteristics in Tables 3-5 on pages 103-107. Further, Applicant teaches in Table 8 on pages 110-111, that the various “mutation(s)” in the promoter of the endogenous IPT7 gene has widely variable effects on a yield trait (instant claim 13), often time a negative characteristic.
Where the specification discloses only a starting point for further iterative research in an unpredictable and poorly understood field and offers no guidance or predictions about particular substitutions to be made, and where there is a need to engage in a systematic screening process for each of the candidate compounds, experimentation is considered to be excessive. See Wyeth v. Abbott Laboratories, Nos 12-1223,-1224 (Fed. Cir. 2013). In the instant case, it would have required undue trial and error experimentation to make and use the invention within the full scope of the claims.
The Examiner notes that Applicant does not appear to have taught any useful mutation in the coding or intron regions of a corn IPT7 gene, hence Applicant has taught a very limited number of examples of the claimed invention. Further, Applicant’s own evidence shows that the result of the mutations reduced to practice have unpredictable results on yield traits.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 6 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brugiere (U.S. 8,916,749).
Brugiere disclose an IPT7 variation (mutation) relative to instant SEQ ID NO: 71 having one conserved and one non-conserved substitution (and thus a base substitution in the encoding nucleotide sequence) at SEQ ID NO: 15. Hence, Brugiere had previously disclosed the claimed invention.
Claim Rejections - 35 USC § 103
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(s) 1, 2, 4, 8, 12, 13 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brugiere (U.S. 8,916,749).
Brugiere teaches an IPT7 variation (mutation) relative to instant SEQ ID NO: 71 having one conserved and one non-conserved substitution (and thus a base substitution in the encoding nucleotide sequence) at SEQ ID NO: 15. Instant SEQ ID NO: 120 is 96% identical to instant SEQ ID NO: 69 which encodes instant SEQ ID NO: 71.
Brugiere does not reduce to practice mutations in the promoter region of the endogenous IPT7 gene, insertions or deletions of the endogenous IPT7 gene.
Brugiere teaches that methods are provided to increase the activity and/or concentration of the IPT polypeptide. Brugier teaches that the level and/or activity of the IPT7 polypeptide may be increased by altering the gene encoding the IPT polypeptide or its promoter (column 31, lines 6-28).
The instant claims are prima facie obvious to one of ordinary skill in the art before the effective filing date of the claims. Brugiere literally motivates one of ordinary skill in the instant art to modify the activity of a corn endogenous IPT7 gene including the promoter region. Brugiere teaches the corn endogenous IPT7 gene at SEQ ID NO: 14, the coding sequence at SEQ ID NO: 16 and the enzyme amino acid sequence at SEQ ID NO: 15. Given the teachings of Brugiere and the level of skill in the instant art, one would have had a reasonable expectation of success in making the claimed corn plant or part thereof.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad 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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/David H Kruse/
Primary Examiner, Art Unit 1663
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