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 .
Claim status
Claims 1-13, 32-33 and 35-37 are pending.
Claims 1-7, 13, 32-33 and 35-37 are withdrawn for being non-elected.
Claims 8-12 are examined on the merits in the present Office action.
Restriction/election
Applicant’s election of Group IV in the reply filed on 06/29/2026 is acknowledged. In response to the requirement for species election, the applicant elected SEQ ID NO: 2. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim interpretation
The applicant provides guidance regarding “genomic locus” on page 14 of the specification, see screen capture below. Because a genomic locus is not limited to the native genomic locus, transgenic art is encompassed by the limitations of claim 8 i.e. “a targeted genetic modification at a genomic locus that encodes a polypeptide comprising an amino acid sequence that is at least 98% identical to an amino acid sequence selected from… [SEQ ID NO: 1-10 and 13-51])”.
Claim 9 appears to have a typo (see rejection of claim 9 under 112(b) below). The claim presently recites that it is dependent on itself. The claim is being interpreted to be dependent on claim 8.
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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.
Claim 9 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 9 recites that it is dependent on claim 9; therefore, it is not clear what the metes and bounds of the limitations of the claim are.
Scope of Enablement - How to use
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.
Claims 8-12 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 using the products comprising a DNA construct encoding a polypeptide at least 95% identical to elected SEQ ID NO: 2 that is able to confer increased yield in maize, does not reasonably provide enablement for using the products comprising a DNA encoding a polypeptide at least 98% identical to SEQ ID NO : 2 that is not able to confer an increased yield in a plant. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
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 broadly drawn to a plant cell of any species with a modification to a locus encoding a protein with 98% identity to SEQ ID NO: 2, regardless of whether DNA is able to confer any useful phenotype to a plant of the polypeptide encoded by said DNA has any function whatsoever.
Applicant describes increased expression of SbMADS28 (SEQ ID NO: 2) under ZmGOS2 promoter enhanced grain yield in maize (example 2, page 30).
Applicant does not teach how one of skill in the art could use all of the products that read on a plant cell of any species encoding a polypeptide with at least 98% identity to SEQ ID NO: 2 wherein the polypeptide encoded by the DNA construct is non-functional.
The state-of-the-art is such that one of skill in the art cannot predict how one of skill in the art could use any of the products that comprise a DNA encoding a polypeptide at least 95% identical to SEQ ID NO: 1-10 and 12-51 wherein the polypeptide encoded by the DNA is non-functional. Guo (Guo et al. PNAS 101: 9205-9210. 2004) provides that function cannot be predicted from sequence alone, and even a single nucleotide change can abolish or alter function of a protein. Guo provides that an inactivation probability for each amino acid change of a specific protein to be 34% (p.9209, last paragraph), though this number differs for all proteins. In fact, the inactivation probability for a specific protein cannot easily be predicted from sequence or structure alone.
Given the lack of guidance in the instant specification, undue trial and error experimentation would have been required for one of ordinary skill in the art to use the claimed invention throughout the broad scope of the claims.
Therefore, given the breadth of the claims; the lack of guidance and working examples; the unpredictability in the art; and the state-of-the-art as discussed above, undue experimentation would have been required to practice the claimed invention, and therefore the invention is not enabled throughout the broad scope of the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over ‘717 (US20090094717).
Claim 8 is drawn to a plant cell comprising a targeted genetic modification at a genomic locus that encodes a polypeptide with at least 98% identity to elected SEQ ID NO: 2, wherein the targeted genetic modification increases the expression level or activity of the encoded polypeptide.
Claim 9 is drawn to the plant cell of claim 9 (being interpreted to be dependent on claim 8, see Claim Interpretation and rejection of claim 9 under 112(b) above), wherein the modification results in increased expression level of the polynucleotide.
Claim 10 includes the plant cell of claim 8 wherein the modification is a polynucleotide modification.
Claim 11 includes the plant cell of claim 8 wherein the modification is present in the coding region of the genomic locus that encodes the polypeptide.
Claim 12 includes that the plant cell of claim 9 is from a monocot.
Regarding claims 8 and 9, ‘717 discloses a plant cell comprising a nucleic acid of the sequence listing from Sorghum (claim 9). The sequence listing of ‘717 includes SEQ ID NO: 8315, which is a nucleic acid encoding a protein with 100% identity to instant SEQ ID NO: 2 (see alignment below).
Regarding claim 10, ‘717 discloses the nucleic acid is operably linked to a heterologous nucleic acid in the plant cell (claim 9).
Regarding claim 11, ‘717 discloses the nucleic acid encodes a polypeptide (claim 1).
Regarding claim 12, ‘717 discloses the plant is from genus Zea, which is a monocot [0100].
Therefore, the claimed invention is anticipated by ‘717.
Alignment of instant SEQ ID NO: 2 to SEQ ID NO: 8315 of ‘717
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Conclusion
Claims 8-12 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID R BYRNES/Examiner, Art Unit 1662
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