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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Applicant’s response filed 06/29/2026 in reply to the office action of 04/01/2026 has been entered. Claims 1, 4, 9 and 11 have been amended. The terminal disclaimer has been approved. Claims 1-13 are pending.
Claims 1-13 are examined.
Withdrawn Objections and Rejections
The 102 rejection to claims 4-5 and 11 is withdrawn in view of Applicant’s amendment to the claims. The non-statutory double patenting rejection to the claims has been withdrawn in view of the terminal disclaimer filed 06/29/2026.
Claim Rejections - 35 USC § 112
Claims 1-5 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. This rejection is repeated for the reasons of record as set forth in the last Office action of 04/01/2026. Applicant’s arguments have been fully considered but are not deemed persuasive.
Claim 1 is indefinite in the recitation of the accession no. “Zm00001d013465” that is not being defined as limited to SEQ ID NO: but rather correspond to materials from non-patent references (i.e. polynucleotide/protein names and genomic databases that are modifiable in content and thus non-static of information). For example, the instant specification [page 3) identifies the “Zm00001d013465” as a maize Dwarf9 gene. A search of the prior art shows the Zm00001d01365 has other names such as ABI84226.1 and is described as dwarf plant9 or (Maize (AGPV4)) Zm00001d013465_P001) and is described as Transcription factor and protein kinase (Source: ITAK). Thus, it is unclear if Zm00001d01365 is a single gene or a genus of genes. It is also unclear as to whether ZM00001d013465 has nucleotide sequences other than SEQ ID NO: 1. Dependent claims do not obviate the rejection so are included in the rejection.
Applicant argues that claim 1 as amended explicitly ties ZM00001d013465 gene to SEQ ID NO: 1. This is not found persuasive because the recitation of the accession no. “Zm00001d013465” in the claim is not necessary if the gene is limited to SEQ ID NO: 1. The amended claim does not clarify that the ZM00001d013465 is a single gene having the nucleotide sequence of SEQ ID NO: 1. In addition, “Zm00001d01365” can be modified at anytime leading to a new matter into the issued patent claims.
Clarification is required to more clearly define the metes and bounds of the claims.
Claim Rejections - 35 USC § 112
Claims 1-13 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. Claims 2 and 8 ( depending from claims 1 and 6, respectively) were in advertently omitted in the rejection in the last office action. This rejection is repeated for the reasons of record as set forth in the last Office action of 04/01/2026. Applicant’s arguments have been fully considered but are not deemed persuasive.
The claims as amended are drawn to a modified corn plant or part thereof comprising a non-synonymous mutation in corn gene ZM00001D013465, wherein the mutation corresponds to an addition, substitution, or deletion within the codon corresponding to nucleotide position 130 of SEQ ID NO: 1 or a “homolog” thereof, wherein said corn plant has an improved agronomic characteristic relative to the same characteristic in a control plant; wherein the mutation is a substitution of G to A at the position corresponding to nucleotide position 130 of SEQ ID NO: 1; wherein said improved agronomic characteristic is a reduced plant height. The claims are also drawn to a method of generating a modified corn plant having an improved agronomic characteristic by introducing into a population of corn plant cells a modification through gene editing at a target site in SEQ ID NO:1, or a homolog thereof; said modification is within the codon corresponding to nucleotide position 130 of SEQ ID NO: 1; wherein said modification is a substitution of a G to A at the position corresponding to nucleotide 130 of SEQ ID NO: 1; said method further comprising regenerating a plant from the population of corn plant cells and selecting plants having said improved agronomic characteristic; and a plant produced by said method. The claims are further drawn to a modified polynucleotide having a G to A substitution at a position corresponding to nucleotide position 130 of SEQ ID NO: 1, which is SEQ ID NO: 2 or a homolog thereof.
The specification describes identification of the maize dwarf mutant E5779 resulted from one base change in SEQ ID NO: 1 after an EMS mutation of maize population with maize inbred line B73 genetic background. Fig. 1 of the specification shows plants of hybrid B73xE5779 and mutant E5779 having reduced plant height, increased stem diameter and increased brunch number of tassels as compared to a plant of maize inbred line B73. Figure 3B of the specification shows sequencing analysis of the SNP mutation point at (GGG; Glycine) in wild type maize line B73 that resulted in the E5778 mutant (AGG; Arginine) at position 130 of the wildtype dwarf d9 gene known in the prior art (see alignment of sequences shown below; US 7,557,266).
The scope of the claims encompasses a genus of modified corn plants comprising a genus of modified homologs of SEQ ID NO: 1, wherein the modification results in improvement of any agronomic characteristics including a reduced plant height; and genus of homologs of the modified polynucleotide of SEQ ID NO: 2. The specification, however, does not describe a representative species of the genus of homologs of SEQ ID NO: 1 or 2. The specification fails to describe a single homolog of SEQ ID NO: 1 or 2 that confers an improved characteristics to corn. The specification fails to define a “homolog” with respect to sequence identity to SEQ ID NO: 1 or 2.
Furthermore, the specification fails to describe structural features common to the members of the claimed genus of polynucleotide sequences as broadly claimed . Therefore, the specification has not met either of the two elements of the written description requirement as set forth in the court's decision in Eli Lilly and has not shown her/his possession of the claimed genus at the time of the application. Since the specification fails to describe homologs of SEQ ID NO: 1 and 2, corn plants comprising said homologs and methods of using said homologs to generate modified corn plants are similarly not described.
Therefore, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that Applicant was in possession of the invention as broadly claimed at the time of filing.
Response to Arguments
Applicant argues that the claims that recite "homolog" are limited by “the functional requirement that the mutation must correspond to an addition, substitution, or deletion within the codon corresponding to nucleotide position 130 of SEQ ID NO:1”…, and that the corn plant must have an improved agronomic characteristic”. Applicant asserts that a "homolog" in this context refers to a gene having sufficient sequence similarity to SEQ ID NO: 1 and a mutation at specific location that results in a specific phenotype, demonstrating that Applicants were in possession of the claimed invention at the time of filing.
These arguments are not found persuasive because the word “homolog” is not structurally defined in the specification, and the functional requirement alone is insufficient to provide written description to the claimed plant or part thereof. Applicant’s statement of “sufficient sequence similarity” has no basis in the specification. It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date” (AbbVie, 759 F.3d at 1298, reiterating Enzo Biochem, Inc., 323 F.3d at 964)(emphasis added). However, in the instant application, there is insufficient evidence of such an established structure-function correlation. In addition, the specification describes no single species of homologs of SEQ ID NO: 1 or 2.
As stated above, the scope of the claims encompasses a genus of modified corn plants comprising a non-synonymous mutation in a genus of homologs of SEQ ID NO: 1 or 2, wherein the mutation corresponds to any addition or deletion within the codon corresponding to nucleotide position 130 of SEQ ID NO: 1 or a homolog thereof, and the mutation results in improvement of a genus of agronomic characteristics including a reduced plant height. In contrast, the specification describes a modified corn plant comprising a non-synonymous mutation in SEQ ID NO: 1 in corn, wherein the mutation is a substitution of G to A at a position corresponding to nucleotide position 130 of SEQ ID NO: 1. These are genus claims.
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number* of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus” (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) (emphasis added). In the instant case, the specification has not described a representative species of polynucleotide sequences of the genus claimed.
Therefore, for all the reasons discussed above and in the last Office action, the claimed invention is not adequately described.
Conclusion
No claim is allowed.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/Primary Examiner, Art Unit 1662
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