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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 19, 2025 has been entered.
Claim Status
1. Claims 1-3, 5-12, 25, and 27-29 are pending and under examination to the extent of the elected species of SEQ ID NO:17.
Claims 21-24 and 26 are withdrawn from further consideration pursuant to 37 CFP 1.142(b) as being directed to a non-elected species, there being no allowable generic or linking claim.
Claims 4 and 13-20 are canceled.
Restrictions/Elections
2. Applicant’s election of the species of SEQ ID NO:17 in the reply filed March 13, 2025 has been treated as without traverse because Applicant did not distinctly and specifically point out any supposed errors in the species election requirement (MPEP 818.01(a)).
The requirement was deemed proper and made FINAL in the Non-Final Office Action dated April 24, 2025.
Response to Arguments – Claim Objections
3. Applicant’s amendments filed August 19, 2025 have necessitated new grounds for objection.
Claim Objections
4. Claims 25 and 27-29 are objected to because of the following:
Claim 25 contains a grammatical and/or typographical error in the recitation of “cell of claims 9”. It is recommended “claims 9” be amended to “claim 9” for grammatical correctness.
Claims 27-29 each contain an identical grammatical and/or typographical error in the recitation of “cell of claims 10”. It is recommended “claims 10” be amended to “claim 10” for grammatical correctness.
Appropriate correction is required.
Response to Arguments – Claim Rejections - 35 USC § 112(b)
5. Regarding claim 11, Applicant’s arguments and amendments filed August 19, 2025 have overcome the rejections(s) of record.
Response to Arguments – Claim Rejections - 35 USC § 103
6. Applicant’s arguments and amendments filed August 19, 2025 have been fully considered but are not persuasive and do not overcome the rejections of record.
Applicant argues primarily that: 1) the cited documents do not teach or suggest all features of any claim; 2) the cited documents do not provide a reasonable expectation of success; and 3) the inventor’s own path itself never leads to a conclusion of obviousness.
Regarding Applicant’s first argument, the Office respectfully disagrees; the cited documents teach or suggest all features of the rejected claims. While the cited art is silent with regard to specifically mutating a region downstream of the RING domain, Applicant has not provided any evidence that suggests that mutating this specific region of ZmGW2 provides any surprising or unexpected results in comparison to mutating the RING domain or other regions of ZmGW2, which the cited art teaches results in a reduction in protein activity and resulting increase in grain size/yield. Thus, Applicant has not provided any evidence that mutating a region downstream of a RING domain provides a distinct phenotype in comparison causing loss-of-function mutations within other regions of ZmGW2. Applicant also appears to imply that the Office’s argument relies on the use of common sense or basic knowledge to establish the presence of obviousness. The Office respectfully notes that the Office’s assertion of obviousness does not rely on the use of common sense or basic knowledge to establish the presence of obviousness; neither the current or previous Office action asserts any claim of basic knowledge or common sense. However, MPEP 2141 details the examination guidelines for determining obviousness under 35 U.S.C. 103 and explicitly states that examiners are not precluded from employing common sense in obviousness determinations but must support such an invocation with “evidence and a reasoned explanation”.
Regarding Applicant’s second argument, the cited prior art does provide a reasonable expectation of success to one of ordinary skill in the art. Applicant incorrectly asserts that the teachings of Deshaies suggest that targeting mutations to the regions downstream of the RING domain will yield a different effect from targeting mutations to the RING domain. Respectfully, the Office disagrees with this interpretation of the teachings of Deshaies. Deshaies simply teaches that introducing frameshift mutations into the RING domain of a ubiquitin ligase can inactivate the protein; one of ordinary skill could further predict, with a reasonable expectation of success, that introducing frameshift mutations downstream of said domain would similarly reduce protein activity. Thus, the teachings of Deshaies provides reasonable motivation for one of ordinary skill in the art to introduce loss-of-function mutations to regions of ZmGW2 downstream of the RING domain.
Regarding Applicant’s third argument, Applicant has incorrectly interpreted a comparison between Applicant’s disclosure and the teachings of the prior art; the Office’s conclusion of obviousness does not rely upon a hindsight analysis of Applicant’s disclosure. When asserting that the prior art teaches that frameshift mutations and early terminations of the ZmGW2 gene results in a loss-of-function similar to Applicant’s disclosure regarding mutations to the RING domain, the Office was asserting that Applicant’s findings do not provide any unique, surprising, or unexpected results when compared to the teaching of the cited prior art.
Accordingly, the rejection of the claims under 35 USC § 103 is maintained.
Claim Rejections - 35 USC § 103
7. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
8. Claims 1-3, 5-12, 25, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Kelliher et al. (US-2018/0273963-A1, published 08/27/2018 (previously cited)) as evidenced by NCBI Reference Sequence XM_008678795.4 (NCBI. 2020 (previously cited)), further in view of Deshaies and Jozeiro (Annual Review of Biochemistry. 2009; 78:399-434 (previously cited)), and further in view of Li et al. (BMC Plant Biology. 2010; 10:143 (Applicant’s IDS)).
Regarding claim 1, Kelliher teaches a modified corn plant, corn plant seed, corn plant part, or corn plant cell comprising a genomic modification that reduces or disrupts the activity of ZmGW2, as compared to the activity of ZmGW2 in an otherwise identical corn plant, corn plant seed, corn plant part, or corn plant cell that lacks the modification[0072], [0166], [0168]; wherein the modification is in a transcribable region of the ZmGW2 gene[0167].
Kelliher does not teach a modification in a region of the ZmGW2 gene downstream of a sequence coding for a RING domain nor increased yield, grain yield estimate per plant, or grain yield estimate.
Deshaies teaches that mutations to the RING domain of a ubiquitin ligase can inactivate the protein (p. 405, left column, first full paragraph).
Li teaches that rice GW2 is orthologous to ZmGW2 (Abstract), functions as a negative regulator of rice grain width (Abstract), that a frameshift mutation in rice GW2 results in increased rice grain width and weight (Abstract; p. 02, left column, second full paragraph), and that mutations in ZmGW2 are associated with increased yield-related traits (Abstract).
The combination of Kelliher, Deshaies, and Li teaches a modified corn plant, corn plant seed, corn plant part, or corn plant cell comprising a genomic modification that reduces or disrupts the activity of ZmGW2, as compared to the activity of ZmGW2 in an otherwise identical corn plant, corn plant seed, corn plant part, or corn plant cell that lacks the modification[0072], [0166], [0168]; wherein the modification results in a frameshift mutation and/or early termination and wherein the modified corn plant exhibits increased yield, grain yield estimate per plant, grain yield estimate, or combinations of any thereof, as compared to an otherwise identical plant that lacks the modification.
The level of ordinary skill in the plant biotechnology art is high as evidenced by Kelliher and Li. It would have been prima facie obvious for one of ordinary skill in the art to modify the ZmGW2 taught by Kelliher and Li because Deshaies teaches that modifying the RING domain of a ubiquitin ligase can abolish protein function and Li teaches that a loss of rice GW2 activity results in increased grain size. One of ordinary skill in the art would have been motivated to modify the maize ZmGW2 to abolish protein function because Li teaches that loss of GW2 activity increases grain yield in rice and that mutations in ZmGW2 are associated with increased yield-related traits in maize. Though the cited prior art is silent with regard to mutating a region specifically downstream of the RING domain, Applicant’s specification indicates that disruption to the RING domain results in frameshifts, early terminations, and/or splice site disruptions that reduce the activity of ZmGW2[0154]; thus, such a mutation would not provide any surprising or unexpected results over the combination of Kelliher, Deshaies, and Li, which teaches that frameshift mutations and/or early terminations of GW2 genes results in a reduction in protein activity. Applicant has not provided any evidence that suggests that mutating this specific region of ZmGW2 provides any surprising or unexpected results in comparison to mutating the RING domain or other regions of ZmGW2, which the prior art teaches results in a reduction in protein activity and resulting increase in grain size/yield. Furthermore, the claims suggest that desired yield phenotypes are achievable via a variety of distinct mutations in the ZmGW2 gene; claim 5 suggests that insertions into either coding or non-coding regions can yield the desired phenotype and claim 7 further suggests that distinct mutations on either allele can yield the desired phenotype. Therefore, the claim limitation regarding a gene modification located in a region downstream of a sequence coding for a RING domain in not sufficient to distinguish the claimed invention from the teachings of the prior art. Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention without any surprising or unexpected results.
Regarding claim 2, in addition to the teachings above, Kelliher teaches a modification present in at least one allele of an endogenous ZmGW2 gene[0072].
Regarding claim 3, in addition to the teachings above, Kelliher teaches a modification in an endogenous ZmGW2 gene (GRMZM2G007288) encoding a protein having at least 99% sequence identity to SEQ ID NO:2[0166].
Regarding claim 5, in addition to the teachings discussed above, Kelliher teaches a modification in an exon region of the gene[0167].
Regarding claim 6, in addition to the teachings discussed above, Kelliher teaches a plant, plant seed, plant part, or plant cell that is homozygous for the mutation[0169].
Regarding claim 7, Kelliher is silent regarding a plant having a first modification in a first allele of the ZmGW2 gene and a second modification in a second allele of the ZmGW2 gene, the first modification and second modification being different from one another. However, Applicant has provided no evidence that such a limitation would not provide any surprising or unexpected results when compared to homozygous mutations in the same gene. Accordingly, the teachings of Kelliher, as discussed above, satisfy this claim limitation.
Regarding claim 8, in addition to the teachings discussed above, Kelliher teaches a modification comprising a deletion, an insertion, a substitution, an inversion, a duplication, or a combination of any thereof[0072].
Regarding claims 9 and 25, Kelliher is silent regarding SEQ ID NO:17. However, Applicant has provided no evidence that such a limitation would not provide any surprising or unexpected results when compared to other loss-of-function mutations in the same gene. Furthermore, given the teachings of the references as discussed above, it would have been obvious to make any deletion resulting in a frameshift mutation and/or disrupting the activity of ZmGW2, including deleting the residues resulting in instant SEQ 17. Accordingly, the teachings of Kelliher, as discussed above, render these claim limitations obvious.
Regarding claims 10, 12, and 27-29, Kelliher is silent regarding a modification comprised within a genomic region from nucleotide position 2007 to nucleotide position 2493 of reference sequence SEQ ID NO:3 (see claims: 10 and 27); a modification comprised within a genomic region from nucleotide position 2007 to nucleotide position 2280 of reference sequence SEQ ID NO:3(see claims: 10 and 28); and a modification comprised within a genomic region from nucleotide position 2142 to nucleotide position 2151 with reference to sequence SEQ ID NO:3 (see claims: 10, 12, and 29). However, Applicant has provided no evidence that such a limitation would not provide any surprising or unexpected results when compared to other loss-of-function mutations in the same gene. Accordingly, the teachings of Kelliher, as discussed above, satisfy this claim limitation.
Regarding claim 11, in addition to the teachings discussed above, Kelliher teaches a chromosomal sequence in the ZmGW2 gene (GRMZM2G170088) that comprises a deletion of at least 1 consecutive nucleotide and/or a modification that alters the ubiquitin ligase activity of ZmGW2[0072], [0166], [0168].
Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention without any surprising or unexpected results.
Conclusion
9. No claim is allowed.
Examiner’s Contact Information
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS JAVON SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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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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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663