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
The restriction requirement as set forth in the Office Action dated [Insert Date of Non-Final Office Action] is hereby made FINAL. In the response filed 11/13/2025, Applicant acknowledged the restriction requirement and elected of DBB4 (SEQ ID NO:71) as the species for initial examination on the merits. Claims 1, 10, 13, 15, 24, 25, 27, 67, 73, 74, 76, 89, 91, 93, 106, 111, 113, 114, 115 and 116 read on the elected species, without traverse. Accordingly, claims [List non-elected claims] are withdrawn from further consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.
Claim Status
This is a final office action in response to Applicants’ remarks and amendments filed on December 9, 2015. Claims 25, 27, 73, 93, 106 and 111 are currently amended; Claims 1, 10, 13, 15, 24, 25, 27, 67, 73, 74, 76, 89, 91, 93, 106, 111, 113, 114, 115 and 116 are pending and examined.
Response to Amendment
Objection to claim 25 informality: in page 2, “plant yield on a per plant basis optionally, wherein”, a coma is missed between "basis" and "optionally” is withdrawn in light of Applicants’ amendment to claim 25.
Rejection to claims 27, 93, 106, and 111 under 35 U.S.C. 112 (pre-AIA ), second paragraph for being indefinite over containing an improper Markush grouping of alternatives “and/or”, is withdrawn in light of Applicants’ amendment to claim 27, 93, 106, and 111.
Rejection to claim 73 under 35 U.S.C. § 112(b) as being indefinite for reciting "e.g.," is withdrawn in light of Applicants’ amendment to claim 73.
Rejection to claims 13, 15, 25, 76, 91 and 116 under 35 U.S.C. § 112(b) as being indefinite by using “optionally” is withdrawn.
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.
Claims 1, 10, 13, 15, 24, 25, 27, 67, 73, 74, 76, 89, 91, 93, 106, 111, 113, 114, 115 and 116 are rejected under 35 U.S.C. §103 as being unpatentable over “Expression analysis of genes encoding double B-box zinc finger proteins in maize” (Wenlan Li et al., 2017, Funct Integr Genomics) in view of WO2022129856A1 (Mullineaux and Stallard, 2022), “Role of Arabidopsis BBX proteins in light signaling” (Arpita Yadav et al., 2020, Journal of Plant Biochemistry and Biotechnology, Volume 29, pages 623–635) and further in view of US20210238579A1 (Nicholas and Yongjoo, 2021).
This rejection is maintained for reasons of record filed in the office action mailed 11/13/2025, with further explanation provided below. Applicants’ arguments filed on 12/09/2025 have been considered but are not deemed persuasive.
Regarding claim 1, Li et al. teaches ZmDBB4 (GRMZM2G019335) protein shows 100% homologous (https://maizegdb.org/gene_center/gene/GRMZM2G019335 ) to the sequences of SEQ ID NO: 71 (BBX10; DBB4; Zm00001d051018) of the instant claims.
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Li also teaches that the ZmDBB4 gene plays an essential role in the photomorphogenesis and light signaling pathway. ZmDBB4 is shown to be light-responsive by showing a number of cis-acting elements involved in light responses in the promoter regions (Table 2, and page 657, paragraph 3). ZmDBB4 exhibits diurnal expression patterns. The expression is higher under short-day (SD) than under long-day (LD) conditions and peaks at dawn (page 653, paragraph 1, and Fig. 8). The results indicate that the ZmDBB4 (SEQ ID NO: 71) gene participates in the light signaling pathway.
Li doesn’t teach mutating SEQ ID NO: 71 at least one mutation to increase photosynthesis, reduce shade avoidance response, and increase the yield of plants.
Mullineaux and Stallard teach in Arabidopsis that the BBX32 gene is related to photosynthesis, and is a negative regulator of photosynthetic capacity (page 2, line20-35). Mullineaux and Stallard also teach that a method of increasing photosynthetic capacity in a plant comprising modulating Cryptochrome1-directed signaling in the plant, which comprises reducing or abolishing the expression of BBX32 polypeptide (claim 4). Mullineaux and Stallard also teach a method wherein a transgenic construct is introduced into the plant, and the transgenic construct is capable of reducing or abolishing the expression of the nucleic acid encoding a BBX32 (claim 12). Yadav et al., “Role of Arabidopsis BBX proteins in light signaling” teaches light regulates numerous aspects of plant growth and development like seed germination, pigment accumulation, cotyledon opening, shade avoidance response and flowering through BBX family genes acting as signal transducers in the light signaling pathway. B-Box (BBX) family of transcription factors is one of the largest family of light-regulated proteins acting as signal transducers in the light signaling pathway. B-box proteins are known for their role in light-mediated regulation of seed germination, hypocotyl elongation, flowering, circadian movements and stress tolerance (page 623 and page 631). BBX4, BBX6, BBX7, BBX10, BBX19, BBX24, BBX30, BBX31 and BBX32 proteins in Arabidopsis are involved in regulating flowering and light signaling pathways (page 623, paragraph 1, line 1-10; page 630, paragraph 3, lines 7-13 and Figure 3d).
Nicholas and Yongjoo teach that applying CRISPR to modify light-signaling transcription factors in maize, such as HD-Zip, results in maize exhibiting reduced shad-avoidance, shorter height, and improved yield at high density (paragraph 0004, 0053, 0298 and 0299).
It would have been obvious to one of ordinary skills in the art at the time of the invention to mutate or edit the endogenous maize BBX gene SEQ ID NO: 71, which relates to light-response reaction using CRISPR-based methods which Mullineaux as taught by the combination of Li et al., and Nicholas and Yongjoo to obtain a corn plant exhibiting reduced shade avoidance response and improved yield as claimed.
A person of ordinary skills in the art (POSITA) would have been motivated to apply the genome-editing methods of Nicholas and Yongjoo to the known maize BBX genes SEQ ID NO: 71, disclosed by Li et al., in view of the teaching of Mullineaux that modulation of BBX transcription factors in plants alters light-responsive and agronomic trait.
Furthermore, Nicholas and Yongjoo, as well as Yadav provide motivation that, reducing shade avoidance behavior enhances yield and photosynthesis, thereby encouraging targeted modification of BBX genes known to regulate light response.
APOSITA would have had a reasonable expectation of success in achieving reduced shade avoidance phenotypes, given the conserved role of BBX transcription factors in light signaling across species (Arabidopsis, maize, soybean, rice). Claim 1 is rejected under 35 U.S.C. §103 as being unpatentable.
Claims 10 and 13 are rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1. The term “at least one mutation” includes deletion, substitution, and insertion, as these represent the standard types of sequence alterations achievable by conventional gene-editing or mutagenesis methods. The limitation that the mutation is a deletion, substitution, or insertion (including up to 100 base pair deletions) represents routine variations of the “at least one mutation” encompassed by claim 1, which would have been obvious to one of ordinary skill in the art.
Claim 15 is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1, since the limitation that the mutation occurs in the B-BOX domain represents an obvious modification of the “at least one mutation” of claim 1. As Yadav teaches, B-box domains in BBX proteins are crucial for protein–protein interactions with their paralogs or with other proteins. Interactions of BBX32 with BBX4 is mediated through their B-box domains. Site-directed mutagenesis revealed that the first B-box domain (B1) is crucial in interaction with HY5 or HYH (page 625, right col). One of ordinary skill in the art would have expected that introducing mutations into the B-BOX domain could lead to reduced or abolished the function of BBX gene.
Claim 24, is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1. Mullineaux further mentions releasing negative controls that cause genes such to constrain photosynthetic capacity and thereby achieve a substantial increase in photosynthesis and therefore yield (page 2, line 35-37 and page 3, line 1-4). The additional recitation of agronomic phenotypes (such as increased yield, decreased height, decreased shoot: root ratio, decreased leaf length, etc.) represents inherent or expected results of plants exhibiting reduced Shade Avoidance Response as taught or suggested by the prior art. Nicholas and Yongjoo (paragraph 0004, 0053, 0298 and 0299).
Claim 25 is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1. The limitation of the increased yield of about 5–75% relies on inherency and represents expected results of a plant exhibiting suppressed Shade Avoidance Response, as plants with decreased SAR are known to allocate more resources to reproductive growth and yield.
Claim 27, is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1. The limitation that the muted gene is similar to its edited alleles represents an obvious variation, since the prior art teaches or suggests that edited alleles highly similar to the target sequence except at the edited site, and one of ordinary skill in the art would have expected such sequence similarity as natural consequence of targeted editing.
Claim 67 is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1. Mullineaux introduces a specific target site mutation in the SAR-related gene in Arabidopsis using gene-editing methods such as CRISPR (page 29, line6-30), and such modifications would have been within the routine skill of one of ordinary skills in the art. The other limiting the mutation to partial regions of the gene represents an obvious variation of the general mutation recited in claim 1.
Claim 73 is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1, for the same reasons as set forth therein.
Claim 74 and 76 are rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1. Mullineaux introduces a specific target site mutation in the SAR-related gene in Arabidopsis using gene-editing methods such as CRISPR (page 29, line6-30), and such modifications would have been within the routine skill of one of ordinary skills in the art. Since the limitation that the mutation is a deletion, substitution, or insertion (including at least one mutation is a base deletion, optionally a deletion of one or more base pairs) represents routine variations of the “at least one mutation” encompassed by claim 1, which would have been obvious to one of ordinary skill in the art.
Claim 89 is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1. Mullineaux introduces a specific target site mutation in the SAR-related gene in maize using gene-editing methods such as CRISPR (page 29, line6-30), and such modifications would have been within the routine skill of one of ordinary skills in the art. Since the additional recitation of agronomic phenotypes (such as increased yield, decreased height, decreased shoot: root ratio, decreased leaf length, etc.) represents inherent or expected results of plants exhibiting reduced Shade Avoidance Response as taught or suggested by the prior art. Nicholas and Yongjoo (paragraph 0004, 0053, 0298 and 0299).
Claim 91 is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1, since Mullineaux introduces a specific target site mutation in the SAR-related gene in Arabidopsis using gene-editing methods such as CRISPR (page 29, line6-30), and such modifications would have been within the routine skill of one of ordinary skills in the art. Since the additional recitation of agronomic phenotypes (such as increased yield, decreased height, decreased shoot: root ratio, decreased leaf length, etc.) represents inherent or expected results of plants exhibiting reduced Shade Avoidance Response as taught or suggested by the prior art. Nicholas and Yongjoo (paragraph 0004, 0053, 0298 and 0299). The limitation of the increased yield of about 5–75% relies on inherency and represents expected results of a plant exhibiting suppressed Shade Avoidance Response, as plants with decreased SAR are known to allocate more resources to reproductive growth and yield.
Claim 93 is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1. since Mullineaux introduces a specific target site mutation in the SAR-related gene in Arabidopsis using gene-editing methods such as CRISPR (page 29, line6-30), and such modifications would have been within the routine skill of one of ordinary skills in the art. The limitation that the muted gene is similar to its CRISPR alleles represents an obvious variation, since ethe prior art teaches or suggests that CRIPSR induced mutations results in alleles highly similar to the target sequence except at the edited site, and one of ordinary skill in the art would have expected such sequence similarity as natural consequence of targeted editing.
Claim 106 is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1. since the limitation that the mutation occurs in the B-BOX domain represents an obvious modification of the “at least one mutation” of claim 1. As Yadav (page 625, right col) teaches, B-box domains in BBX proteins are crucial for protein–protein interactions with their paralogs or with other proteins. Interactions of BBX32 with BBX4 is mediated through their B-box domains. Site-directed mutagenesis revealed that the first B-box domain (B1) is crucial in interaction with HY5 or HYH. One of ordinary skill in the art would have expected that introducing mutations into the B-BOX domain could lead to reduced or abolished the function of BBX gene. The limitation that the muted gene is similar to its CRISPR alleles represents an obvious variation, since ethe prior art teaches or suggests that CRIPSR induced mutations results in alleles highly similar to the target sequence except at the edited site, and one of ordinary skill in the art would have expected such sequence similarity as natural consequence of targeted editing.
Claim 111 is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1. As Yadav (page 625, right col) teaches, B-box domains in BBX proteins are crucial for protein–protein interactions with their paralogs or with other proteins. Interactions of BBX32 with BBX4 is mediated through their B-box domains. Site-directed mutagenesis revealed that the first B-box domain (B1) is crucial in interaction with HY5 or HYH. One of ordinary skill in the art would have expected that introducing mutations into the B-BOX domain could lead to reduced or abolished the function of BBX gene. The limitation that the modified transcription factor is similar to its edited alleles represents an obvious variation, since the prior art teaches or suggests that edited alleles highly similar to the target sequence except at the edited site, and one of ordinary skill in the art would have expected such sequence similarity as natural consequence of targeted editing.
Claim 113 is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1. Since the limitation that the mutation occurs in the B-BOX domain represents an obvious modification of the “at least one mutation” of claim 1, As Yadav (page 625, right col) teaches, B-box domains in BBX proteins are crucial for protein–protein interactions with their paralogs or with other proteins. Interactions of BBX32 with BBX4 is mediated through their B-box domains. Site-directed mutagenesis revealed that the first B-box domain (B1) is crucial in interaction with HY5 or HYH. One of ordinary skill in the art would have expected that introducing mutations into the B-BOX domain could lead to reduced or abolished the function of BBX gene. The limitation that the muted gene is similar to its CRISPR alleles represents an obvious variation, since the prior art teaches or suggests that CRIPSR-induced mutations results in alleles highly similar to the target sequence except at the edited site, and one of ordinary skill in the art would have expected such sequence similarity as natural consequence of targeted editing. The other limitation distinguishing the claimed subject matter from the cited references is that the gene is in a corn plant. It would have been obvious to one of the ordinary skills in the art to apply the known gene modification to corn with CRISPR technology.
Claim 114 is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1, Since the limitation that the mutation occurs in the B-BOX domain represents an obvious modification of the “at least one mutation” of claim 1, As Yadav (page 625, right col) teaches, B-box domains in BBX proteins are crucial for protein–protein interactions with their paralogs or with other proteins. Interactions of BBX32 with BBX4 is mediated through their B-box domains. Site-directed mutagenesis revealed that the first B-box domain (B1) is crucial in interaction with HY5 or HYH. One of ordinary skill in the art would have expected that introducing mutations into the B-BOX domain could lead to reduced or abolished the function of BBX gene. The limitation that the muted gene is similar to its CRISPR alleles represents an obvious variation, since the prior art teaches or suggests that CRIPSR-induced mutations results in alleles highly similar to the target sequence except at the edited site, and one of ordinary skill in the art would have expected such sequence similarity as natural consequence of targeted editing. The other limitation distinguishing the claimed subject matter from the cited references is that the gene is in a corn plant. It would have been obvious to one of the ordinary skills in the art to apply the known gene modification to corn with CRISPR technology. APOSITA would have had a reasonable expectation of success in achieving reduced shade avoidance phenotypes.
Claim 115 is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1, Mullineaux further mentions releasing negative controls that cause genes such to constrain photosynthetic capacity and thereby achieve a substantial increase in photosynthesis and therefore yield (page 2, line 35-37 and page 3, line 1-4). The additional recitation of agronomic phenotypes (such as increased yield, decreased height, decreased shoot: root ratio, decreased leaf length, etc.) represents inherent or expected results of plants exhibiting reduced Shade Avoidance Response as taught or suggested by the prior art. Nicholas and Yongjoo (paragraph 0004, 0053, 0298 and 0299).
Claim 116 is rejected under 35 U.S.C. §103 as being unpatentable over the same combination of references applied to claim 1. The additional limitation that the corn plant can be planted at an increased density without a decrease in yield on a per-plant basis would have been an obvious and expected result of reduced Shade Avoidance Response, as plants exhibiting that phenotype are known in the art to tolerate denser planting without yield penalty. The limitation of the increased yield of about 5–75% relies on inherency and represents expected results of a plant exhibiting suppressed Shade Avoidance Response, as plants with decreased SAR are known to allocate more resources to reproductive growth and yield.
Response to Applicant’s Remarks:
Applicant traversed the rejection. Applicant invoked MPEP § 2145. The Applicant provides specific, objective technical evidence—namely, the low 17% amino acid sequence identity—to rebut the proposed rationale for a reasonable expectation of success as articulated under MPEP § 2143.
Applicant argues that (1) Li identifies the specific corn protein (ZmDBB4), but does not teach that mutating it would increase photosynthesis or yield, (2) Yadav and Mullineaux (specifically Mullineaux) deal with a different plant (Arabidopsis) and a protein that shares less than 17% similarity with the corn protein in question, (3) because the sequence identity is so low, a scientist would not assume the proteins perform the same function (they are not "orthologs"). Therefore, there was no reason or "motivation" to apply the findings from one plant to the corn protein in the claimed manner.
These arguments have been fully considered but not deemed persuasive.
Regarding (1), the Applicant’s argument is not persuasive because the presently claimed subject matter (e.g., claim 24) is directed to reduced shade avoidance response (SAR), and does not require a showing of increased photosynthesis or yield. Li shows the maize DBB/BBX gene family, including DBB4, and reports that DBB genes are photoregulation/light-responsive genes in maize (p657 and p660). The prior art mentions “The pair of segmental duplication genes, ZmDBB4 and ZmDBB6, showed the same diurnal expression pattern, which indicated that similar gene structures may share similar gene functions. All the results suggest that ZmDBB genes might play an essential role in the light signaling pathway”(page 660). Further, “ZmDBB4 is the most responsive gene to light, which is upregulated 7-fold when the plumule under light/dark treatments. The ZmDBB6 and ZmDBB10 genes were upregulated 6-fold when the plumule is exposed to light compared to its level under dark conditions. …… The results indicated that ZmDBB genes may play essential roles in light regulation”(page 660); and “In addition, five genes (ZmDBB1, ZmDBB4, ZmDBB6, ZmDBB10 and ZmDBB11) were found to response to both phytohormone and light treatments, suggesting that ZmDBB genes may play critical roles in a crosstalk between phytohormone and light signals”(page 666). Li concludes, “Further functional and biochemical analyses of ZmDBB genes will help us to better understand the diverse roles of DBB genes in maize”(page 666). After conducting an in-depth expression analysis of maize genes, Li cites additional BBX/DBB references (Chang et al. 2008; Datta et al. 2008; Kumagai et al. 2008)(page 663) reporting similar findings and indicating that “Obviously, a direct approach to defining the physiological function of a given DBB gene is to characterize each loss-of-function (or null) mutant” (Kumagai). “Physiological function of a given DBB gene” in “loss-of-function (or null) mutant” which has been well known to skilled artisan as an “obvious and direct approach”.
Furthermore, DBB4 is a BBX-family protein sharing the same domain architecture category as Arabidopsis BBX24 (two B-Box w/o CCT domain) )(Li, page 653, abstract), and BBX24 is described as participating in shade/light-response pathways (page 630 and fig 2, fig 3). Accordingly, the applied references support selecting DBB4/BBX as a reasonable target for mutagenesis and provide an expectation that perturbation of such a photoregulation-associated BBX gene would be associated with altered SAR, as recited in the claims.
Regarding (2), Applicant’s argument that Mullineaux and Yadav are direct to “other plant species” is not persuasive. The cited references are in the same field of endeavor: plant photoregulation /light signaling mediated by B-Box (BBX/DBB) transcription factors. Yadav expressly describes 32 BBX proteins as components of red/far-red, blue and UV-B light signaling pathways (32 BBXs) (p626-627, fig 2), and further notes roles of BBX proteins not only in Arabidopsis but also in some crop species, demonstrating that BBX/DBB light-signaling framework is broadly applicable across plants (p631). Li’s publication treats DBB proteins as a cross-species gene family: it reports phylogenic and analysis DBB proteins from maize, rice, sorghum, Arabidopsis, and poplar (p657, fig 2), it already frames DBB/BBX function as knowledge a POSITA would generalize across plant species.
“<17% similarity” is not persuasive because the prior arts rely on membership in the BBX/DBB family (conserved B-Box domains, CCT domain, and associated regulatory roles in light signaling such as SAR), as discusses before, not on high full-length sequence identity between any two proteins.
Similarly, reviews describing BBX proteins emphasize their roles as light-regulated signal transducers in light signaling new works (function/family-based teaching), and domain structure related phenotype, such as BBX24 relates to promotes shade avoidance response by interacting with DELLA protein (Yadav, p623, 630, abstract and fig 3 ). Rather than requiring high global amino acid identity.
Further, based on the phylogenetic/tree-based classification and domain-architecture similarity, the applied references would have led a person of ordinary skill in the art to reasonably expect that mutating the maize DBB4/BBX/SEQ ID NO:71 gene, categorized within the same BBX structural class as Arabidopsis BBX24 (i.e., conserved B-box domain architecture and lacking a CCT domain), could yield plants exhibiting altered light/shade response behavior.
Regarding (3), The rejection does not depend on DBB4 being orthologous to any particular protein in the prior arts. Applicant argues that the cited teachings are not applicable due to an alleged lack of orthology and/or low sequence identity. The argument is not persuasive because the rejection does not rely on a finding that the claimed DBB4 is an orthology of any specific BBX/DBB protein disclosed in the prior arts, nor does that rejection require a particular threshold of full-length sequence identity. As discusses before, the rejection relies on the applied references’ teachings regarding BBX/DBB gene family membership, phylogenetic grouping, and conserved domain architecture.
Applicant’s argument that there is no reason to apply findings from one plant species to corn is not persuasive because the prior arts are directed to the same technological field and problem: plant light signaling/photoregualtion controlled by BBX/DBB transcription factors. A POSITA would reasonably consider such teachings when selecting candidate regulators for modification in corn/maize, particularly where the evidence shows DBB-family genes are light responsive in crop contexts.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims [1, 10, 13, 15, 24, 27, 67, 73, 74, 76, 89, 91, 93 ] provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims [ 8-20 ] of copending Application No. [ US18664352 ] (reference application). Although the instant claims and the reference claims are not identical, they are not patentably distinct from each other because both inventions target the same BBX genes and regions and achieve the same functional outcome (reduced Shade Avoidance Response).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The reference application claims a CRISPR/Cas-based gene-editing system comprising a guide RNA that specifically targets endogenous B-BOX genes (SEQ ID NO: 71), as well as methods for editing the SEQ ID NO: 71 gene in a plant cell to generate plants with reduced shade avoidance response.
The instant application claims a corn plant comprising mutations in the same endogenous BBX gene, SEQ ID NO: 71. The instant application also claims a method with nuclease comprising a cleavage domain and a nucleic acid binding domain which binds to a target site of a BBX gene for producing nucleic acids encoding a mutated BBX transcription factor, and further produces corn plants with mutation, which results in reduced shade avoidance response of corn plants.
Regarding claim 8-20, the claimed method differs only in that it specifies the nuclease as a CRISPR-Cas effector protein complexed with a guide nucleic acid, whereas the instant application claims more broadly recites a nuclease comprising a cleavage domain and a nucleic acid binding domain. However, limiting a generic nuclease(as recited in claims 67, 73, 74, 76, 89, 89, 91 and 93) to a specific embodiment of such a nuclease (a CRISPR-Cas gene editing system) does not render the claimed subject matter patentably distinct. Because a species anticipates and render obvious the genus absent evidence of criticality or unexpected results.
Therefore, the claims of the instant application are considered to be an obvious variation of those in the reference application.
Both the instant claims and the reference clams are directed to engineered nucleases for targeted genome modification, and no distinct utility is provided for the claimed nuclease modifications. Thus, the claimed subject matter is an obvious variation of the claims of the reference.
The applicant has not provided evidence demonstrating that the recited nuclease modifications confer unexpected properties compared to the species of CRISPR nuclease already claimed in the reference.
Accordingly, the claims are not patentably distinct from the claims of the reference application and a provisional obviousness-type double patenting rejection is appropriate.
Response to Applicant’s Remarks:
Applicant’s request to hold the provisional nonstatutory double patenting rejection in abeyance is noted but is denied. A rejection under 35 U.S.C. 103 or a nonstatutory double patenting rejection is a substantive rejection and is not a requirement 'as to form' that can be held in abeyance under 37 CFR 1.111(b). Consequently, the provisional nonstatutory double patenting rejection of claims [1, 10, 13, 15, 24, 27, 67, 73, 74, 76, 89, 91, 93] over the claims of Application No. 18/664,352 is maintained.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YANXIN SHEN whose telephone number is (571)272-7538. The examiner can normally be reached Monday-Friday.
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/YANXIN SHEN/Examiner, Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663