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 .
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Claims 21-24 and 26 are withdrawn from further consideration pursuant to 37 CFP 1.142(b) as being directed to a non-elected species, there being no allowable generic or linking claim.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.
Response to Arguments – Claim Objections
2. Applicant’s amendments filed April 14, 2026 have overcome the objections of record.
Response to Arguments – Claim Rejections - 35 USC § 103
3. Applicant’s arguments and amendments filed April 14, 2026 have been fully considered but are not persuasive and do not overcome the rejections of record.
Applicant argues primarily that: 1) the previous office action has not established a prima facie case of obviousness; 2) the previous office action attempts to improperly shift the burden; and 3) no motivation to combine has been established.
Applicant’s argument that no prima facie case of obviousness has been established because the cited art teaches mutations within and upstream of the RING domain of ZmGW2 but not downstream of the RING domain has been carefully considered. However, the Office respectfully disagrees; the cited documents teach or suggest all features of the rejected claims or features equivalent thereto. While the cited art appears 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 or assertion 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. The elements taught by the prior art (i.e., mutations within or upstream of the RING domain) performs the identical function specified in the claim (i.e., a reduction or disruption in the activity of ZmGW2) in substantially the same way (i.e., a mutation resulting in the truncation of ZmGW2) and produces substantially the same results (i.e., increased yield) as the corresponding element disclosed in the specification (i.e., mutations downstream of the RING domain). Therefore, a mutation within or upstream of the RING domain of ZmGW2 is considered prima facie equivalent to a mutation downstream of the RING domain. Accordingly, the combined teachings of the cited art teach or suggest all features of the rejected claims and/or equivalents thereof; therefore, the claimed invention is prima facie obvious in view of the combined teachings of Kelliher et al. (US-2018/0273963-A1, published 08/27/2018 (previously cited)), 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)). See MPEP 2141 and MPEP 2183.
Regarding Applicant’s argument that the burden is improperly shifted to Applicant, the Office respectfully disagrees. Applicant argues that the Office has not established a prima facie case of obviousness due to cited prior art teaching mutations within and upstream of the RING domain of ZmGW2. However, as stated above in the Office’s response to Applicant’s first argument, the mutations taught by the prior art are prima facie equivalent to those recited in the instant claims be cause the prior art elements perform the same function as specified in the claim in substantially the same way and produces substantially the same results. Furthermore, the Office has provided articulated reasoning with rationale underpinning as to why a person of ordinary skill in the art would have been motivated to arrive at the claimed invention (see Non-Final Rejection dated February 02, 2026, p. 03-10). Additionally, Applicant’s response appears to misinterpret the Office’s assertion regarding Applicant’s lack of an assertion of surprising or unexpected results. Applicant appears to suggest the Office is demanding Applicant demonstrate surprising or unexpected results. The Office does not. The Office reaffirms that the claimed mutations downstream of the RING domain of ZmGW2 appear prima facie equivalent to the prior art teachings regarding mutations within and upstream of the RING domain and Applicant has provided no assertion and/or evidence of surprising or unexpected results.
Furthermore, Applicant is incorrect in stating the previous office action asserts that a person of ordinary skill in the art would have been motivated to make modifications downstream of the RING domain. The Non-Final Rejection dated February 02, 2026 makes no such assertion. The action asserts that mutations downstream of the RING domain of ZmGW2 do not appear to provide any surprising or unexpected results, and Applicant has made no assertion thereof, in comparison to the teachings of the cited prior art regarding mutations upstream of or within the RING domain of ZmGW2. Accordingly, no Official Notice has been constituted; therefore, there is no Office Notice to be traversed.
Regarding Applicant’s argument that the previous action did not provide an articulated reasoning with some rational underpinning that one of ordinary skill in the art would have had motivation to combine the teachings of the cited documents with a reasonable expectation of success. The Office disagrees with this statement. The Examiner clearly articulates the motivation to combine the teachings of the cited prior art on pp. 07-08 of the Non-Final Rejection dated February 02, 2026 (see the paragraph beginning “The level of ordinary skill”). Applicant argues that the previous office action does not provide an adequate articulated reasoning as to why one of ordinary skill in the art would have been motivated to modify a region downstream of the RING domain of ZmGW2 and, therefore, relies of impermissible hindsight. The previous action does not provide reasoning as to why one of ordinary skill in the art would have been motivated to modify a region downstream of the RING domain of ZmGW2 because neither the previous action nor the instant action asserts that one of ordinary skill in the art would have been motivated to make a mutation downstream of the RING domain. Both the previous and instant office actions assert that mutations within and upstream of the RING domain of ZmGW2 are prima facie equivalent to mutations downstream of the RING domain and, therefore, the claimed invention is prima facie obvious in view of the combined teachings of the cited prior art. Furthermore, the Office agrees that the biotechnology field is characterized by unpredictability. Accordingly, it is unpredictable that the barley GW2 gene and the corn GW2 genes, and mutations therein, would function identically between the two distinct species. Phenomena observed in barley do not teach away from phenomena observed in other species.
Accordingly, the rejection of the claims under 35 USC § 103 is maintained.
Claim Rejections - 35 USC § 103
4. 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.
5. 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 rice GW2 is orthologous to ZmGW2, 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. The elements taught by the prior art (i.e., mutations within or upstream of the RING domain) performs the identical function specified in the claim (i.e., a reduction or disruption in the activity of ZmGW2) in substantially the same way (i.e., a mutation resulting in the truncation of ZmGW2) and produces substantially the same results (i.e., increased yield) as the corresponding element disclosed in the specification (i.e., mutations 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 prior art teaches results in a reduction in protein activity and resulting increase in grain size/yield. Therefore, a mutation within or upstream of the RING domain of ZmGW2 is considered prima facie equivalent to a mutation downstream of the RING domain. Therefore, the claim limitation regarding a gene modification located in a region downstream of a sequence coding for a RING domain is 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
6. 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.
Examiner’s Contact Information
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS J SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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