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
The Office acknowledges the receipt of Applicant’s amendment filed November 14, 2025. Claims 1-3, 5-6, 8-11, 15, 17-22, 24, 26, 31-36, 38-40 and 42-44 are pending. Claims 19-20, 31-36, 38-40, and 42-44 are withdrawn. Claims 4, 7, 12-14, 16, 23, 25, 27-30, 37 and 41 are cancelled. Claims 1-3, 5-6, 8-11, 15, 17-18, 21-22, 24 and 26 are examined in the instant application.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is made FINAL.
Response to Amendments
Rejections withdrawn from action:
The rejection for claims 1-3, 5-6, 8-11, 15, 17-18, 21-22, 24 and 26, under Double patenting is maintained in view of amendment. Applicant states that Applicant may file a Terminal Disclaimer when allowability is indicated. Accordingly, the rejection is maintained.
The rejection for claims 1-3, 5-6, 8-11, 15, 24 and 26, under 102 is withdrawn in view of amendment. Because Applicant added SEQ ID NO: 4.
The rejection for claims 1-3, 5-6, 8-11, 15, 17-18, 21-22, 24 and 26, under 103 is modified in view of amendment.
Double Patenting(Nonstatutory)
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.
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Claims 1-3, 5-6, 8-11, 15, 17-18, 21-22, 24 and 26 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 18/643394.
In regards to claims 1-2, 5-6, 8-11, 17-18, 21 and 24, Brower-Toland teaches a modified soybean plant wherein the modification is in the promoter (non-coding) region of an endogenous TFL1b gene resulting in reduced expression compared to a plant that lacks the modification (see claim 1). Additionally, Brower-Toland teaches 100% sequence identity to SEQ ID NO: 4 (see claim 1 and previous Office Action for sequence alignment). Bower-Toland teaches that a “284 base pair deletion from nucleotide 1366 to nucleotide 1649, as compared to reference sequence SEQ ID NO: 4”, which covers Applicants “283 base pair deletion from nucleotide 1366 to nucleotide 1648, as compared to reference sequence SEQ ID NO: 4.” Meaning that since the deletion is in the similar 1366 to nucleotide 1648 region then it implies that the modification is located at about 200 nucleotides or more from the 3' end of the promoter of TFL1b gene.
In regards to claim 3, Brower-Toland teaches 100% sequence identity to SEQ ID NO: 2 (see claim 2 and previous Office Action for sequence alignment).
In regards to claim 15, Brower-Toland teaches that the modification is a deletion (see claim 1), and wherein the modification alters expression of activity of the TFL1b protein (see claim 1).
In regards to claims 22, Brower-Toland teaches SEQ ID NO: 96 because it is SEQ ID NO: 4 with a 284 base pair deletion from nucleotide 1366 to nucleotide 1649, (see claim 1).
In regards to claims 26, Brower-Toland teaches the modification increases the determinacy of the plant, as compared to the determinacy of an otherwise identical plant that lacks the modification (see claim 11).
Claim Rejections - 35 USC § 103(amended)
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.
Claims 1-3, 5-6, 8-11, 15, 17-18, 21-22, 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (The soybean stem growth habit gene Dt1 is an ortholog of Arabidopsis TERMINAL FLOWER1. Plant physiology vol. 153,1 (2010): 198-210. doi:10.1104/pp.109.150607 (previous cited)), in view of Serrano-Mislata et al. (Separate elements of the TERMINAL FLOWER 1 cis-regulatory region integrate pathways to control flowering time and shoot meristem identity. Development 15 September 2016; 143 (18): 3315–3327 (previously cited)).
In regards to claims 1, 11, 15, 24 and 26, the claims are interpreted as the following: the claim requires the recited any plant or plant part being modified in any way to reduce expression or activity of TFL1 or homolog (an ortholog exhibiting the same phenotype). Specifically, the modifications are located about 200 nucleotides or more from the 3’ end of SEQ ID NO: 4 (2000 nucleotides), which may include 1800 nucleotides up stream except those 200 nucleotides from the end and coding regions. The broad scope of the claim includes any modification as long as it reduces expression or activity of TFL1 or homolog directly or indirectly. For example, may include mutations such as deletions, substitutions, additions, transformation, gene silencing, or single nucleotide polymorphisms (SNP’s). Therefore, taking this approach through the broadly claimed genus encompasses numerous types of modifications. Knowing that altering non-coding regions such as intron and promoter regulatory regions through genetic modification techniques (e.g. CRISPR editing system) would have led to a more determinate phenotype, this course of action would have been obvious.
In regard to claims 1, 11, 15, 24 and 26, Liu teaches on an endogenous TFL1 gene in soybean. Liu teaches sequence ID AB511820.1 which has 99% sequence identity to Applicants SEQ ID NO: 4. Even though the sequence of Liu has 99% sequence identity to Applicant’s SEQ ID NO:4, their coding regions are identical and thus would encode the same protein and would produce a plant/seed having the same phenotypes upon expression in said plant/seed. Additionally, Liu shows that GmTFL1b is an ortholog to Arabidopsis TFL1 having at least 76.5% sequence identity (see page 200 right column second to last paragraph, figure 2 and previous Office Action for sequence alignment), which would allow one skilled in the art to find homologs of the TFL1. Liu specifically, teaches that dt1 allele were more determinate than the control (see page 200 figure one) and further mentions that Dt1/dt1 heterozygotes is result of “a fragment length polymorphism (FLP) in intron 1, which detected a six-nucleotide difference in length due to a SS in intron 1” (see page 200 figure one page 207 right column last paragraph) having a semi-determinate phenotype. Next, the mutation just needs to be located further than 200 nucleotides from the 3’ end, which the Applicant teaches that “sequence substitution (SS) in intron 1 (position 279)” (i.e. non-coding region and located at about 200 nucleotides or more)(see page 205 left column tope paragraph). Lastly, mentions that the “dt1 isoline tested flowered only 1 to 2 d earlier than the Dt1”(i.e. flowering date sooner)(see page 206 right column last sentence). Further, teaches that “the SS in intron 1 were identical to those in the dt1 allele” (see page 205 left column middle paragraph), which shows that dt1 variants have reduced GmTFL1b expression compared to the indeterminate plants (see figures 5 and 7). Lastly, references that (Searle et al., 2006) teaches the “role of the SS in intron 1 in controlling GmTFL1b expression. The Arabidopsis FT gene is regulated by FLOWERING LOCUS C, a MADS box transcription factor, through binding to the first intron in the FT gene” (see page 206 right column top paragraph). Taken altogether this shows that mutations in intron 1 resulted in a more determinate or semi-determinate phenotype. Liu’s work shows that a natural mutation occurs in an intron (non-coding region) of a GmTFL1b, and this mutation led to a determinate and/or semi-determinate phenotype in soybean.
In regards to claims 1, 11, 15, 24 and 26, Liu does not teach where the genetic modification is located at about 200 nucleotides or more from the 3’ end.
In regards to claims 1, 11, 15, 24 and 26, Serrano-Mislata teaches how the promoter region influence TFL1 activity in the model plant Arabidopsis. Specifically, teaches how the 2.2 kb of the 5′ region and 4.6 kb of the 3′ region include all essential elements of the TFL1 promoter such as conserved regions (See pages 3316-3317 and Figure 1). Furthermore, Serrano-Mislata teaches deleting both 5’ and 3’ promoter regions from TFL1 stating that they are necessary for “correct regulation of TFL1 expression” (See pages 3317-3318 and Figure 2). Serrano-Mislata shows the expression of TFL1 is reduced as more of the promoter region is removed mentioning that “the intensity of the GUS signal gradually decreased in the deletion series (Fig. 3G-K). The decrease in GUS signal apparently started earlier in the lateral coflorescences before decreasing in the main inflorescence (Fig. 3L), correlating with the coflorescences forming terminal flowers before the main shoot.” (see pages 3318-3319 and Figures 3G-L). Additionally, “the 0.3 kb 5′ region upstream of the TFL1 CDS contains cis-regulatory elements required for TFL1 to reach a suitable level of expression” (see pages 3318-3319). Finally, teaches that “regulatory elements contained in region II (+1.0/+1.3) are required to control flowering time”, (see page 3321 right column 1st sentence). Suggesting, that these regulatory elements regulate the level of expression resulting in earlier florescence’s (i.e. plant reaches its terminal flowering). Overall, Serrano-Mislata shows how the promoter regions of TFL1 regulate gene expression and determinacy activity in plants.
Given Liu‘s teaching of the limitation of a mutated plant having reduces GmTFL1b expression or activity, and Serrano-Mislata addresses the limitation of specifically segmentally deleting the promoter region altering TFL1 expression and pinpointing the regions that alter determinacy and flowering, it would have been obvious to try to mimic Liu’s mutated plant having mutations in the non-coding regions of the GmTFL1b gene in soybean and segmentally deleting regions in the promoter. This would have been considered a reason to combine along with the technical ability to optimize given that both Liu and Serrano-Mislata disclose teachings of reduced TFL1 activity resulting in a more determinant plant. Therefore, combining soybean GmTFL1b and deletion in the promoter region to reduce TFL1 expression or activity, given the known effects of using the known soybean genes, alignments, and successful editing strategies disclosed in the prior art, would have been an obvious and routine optimization for one skill in the art to try with a reasonable expectation of success modifying the promoter region resulting in reduction of GmTFL1b expression or activity and a determinant phenotype. Furthermore, both Liu and Serrano-Mislata teach on how the mutations cause the plant to reach flowering date sooner. Suggesting that the modification at the 200+ nucleotide from the 3’ end of SEQ ID NO:4 as taught by both Liu and Serrano-Mislata would inherently produce the sooner terminal flowering date phenotype.
It is the Office’s position, based on the teachings, is that a targeting a non-coding regulatory region of the TFL1b gene, is well-known and well characterized in the art make it a well-known option to reduce TFL1b expression or activity. Therefore, the Office’s position is that it would be obvious for those ordinary skill in the art to modify a non-coding regulatory region of the TFL1b gene in a soybean plant with known plant transgenic techniques using known targeting sites and TFL1b determinacy roles.
In regards to claims 2 and 8-10, the claims are interpreted as the following: the claim requires any one of parts (a)-(e). Therefore, taking this approach the broadest reasonable interpretation would be any plant listed in part (e). Liu teaches working on a soybean which is a leguminous plant (See Title, Abstract, Introduction, Materials and Methods, and Results), which reads on leguminous plant.
In regards to claim 3, Liu discloses accession numbers AB511820.1 and protein ID BAI66119.1 which has at least 99.1% sequence identity to Applicants SEQ ID NO: 2 (See page 208 bottom right column and see previous Office action for sequence alignment) which reads on at least 70% sequence identity to SEQ ID NO: 2.
In regards to claims 5-6, both Liu and Serrano-Mislata teach on mutations in the non- coding regions. Specifically, Liu teaches that Dt1/dt1 heterozygotes is result of “a fragment length polymorphism (FLP) in intron 1, which detected a six-nucleotide difference in length due to a SS in intron 1” (see page 200 figure one page 207 right column last paragraph) having a semi-determinate phenotype. Liu found that “two single nucleotide polymorphisms (SNPs; one at a cis-element referred to as a sequence overrepresented in light induced promoters 1 [SORLIP1; Hudson and Quail, 2003] in the promoter [position 21,487]” and “a sequence substitution (SS) in intron 1 (position 279) were detected consistently between determinate and indeterminate lines” (see pages 204-205 left column top paragraph and page 206 left column last paragraph) which reads on the modification being in a non-coding region such as a promoter or intron. Additionally, Serrano-Mislata teaches on deleting regions in the promoter, an intron, a 5' -untranslated region, and a 3' -untranslated region (see figures 3 and 6). Taken altogether this shows that mutations in the non-coding regulatory regions results in a more determinate and/or semi-determinate phenotype.
Regarding claims 17-18 and 21, and the teaching of Liu as discussed above. Liu teaches sequence ID AB511820.1 which has 99% sequence identity to Applicants SEQ ID NO: 4 (see previous Office action for sequence alignment). Additionally, Liu shows that GmTFL1b is an ortholog to Arabidopsis TFL1 having at least 76.5% sequence identity (see page 200 right column second to last paragraph and figure 2).
In regards to claims 17-18 and 21, Liu does not specifically teach SEQ ID NO: 96 (283 base pair deletion from nucleotide 1366 to nucleotide 1648), as compared to reference sequence SEQ ID NO: 4.
In regards to claims 17-18 and 21, Serrano-Mislata teaches deleting different segments ranging from 100-600 base pairs upstream from the TFL1 start codon (See page 3318 and Figure 3). Serrano-Mislata determined that anything within 100-300 base pair results in 37% of plants showed determinate co-florescence’s (See page 3318 and Figure 3). Additionally, Serrano-Mislata also segmentally deleted 400-4,600 base pairs downstream of the TFL1 gene and noticed similar results (See pages 3320-3321 Figures 4 and 5). Finally, Serrano-Mislata shows the expression of TFL1 is reduced as more of the promoter region is removed mentioning that “the intensity of the GUS signal gradually decreased in the deletion series (Fig. 3G-K). The decrease in GUS signal apparently started earlier in the lateral coflorescences before decreasing in the main inflorescence (Fig. 3L), correlating with the coflorescences forming terminal flowers before the main shoot.” (see page 3318-3319 and Figures 3G-L). Therefore, since Liu segmentally deletes regions in either 5’ or 3’ direction this would cover Applicant’s 283 base pair deletion.
In regards to claims 17-18 and 21, Given that Liu teaches mutations in the non-coding region result in a more determinant phenotype, along with the teachings of segmentally deleting non-coding regulatory regions (e.g., introns and promoters) either 5' or 3' -untranslated regions of the TFL1 gene resulting in a more determinant plant, as disclosed by Serrano-Mislata, these combined teachings would render these regions as precise positions to genetically modify using CRISPR editing systems, in order to pinpoint the specific deletion regions to achieve a more determinate plant.
In regards to claim 22, Liu teaches sequence ID AB511820.1 which has 81.1% sequence identity to Applicants SEQ ID NO: 96 (see previous Office action for sequence alignment), which contains the deletion of a 283 base pair deletion from nucleotide 1366 to nucleotide 1648. However, as discussed above in claims 17-18 and 21 knowing the teachings of Liu and Serrano-Mislata one skilled in the art would have found it obvious to modify said regions.
Response to Applicant's Remarks:
Since the rejections have been modified to reflect the amendment to the claims, only the arguments that are relevant to the current rejections are responded below:
Firstly, Applicant argued that the prior art fails to teach “the modified plant reaches its terminal flowering date sooner than an otherwise identical plant that lacks the modification.” (Remarks, 11/14/2025, page 11).
This argument has been fully considered but not found persuasive.
MPEP says, "the Board stated that when there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. KSR, 550 U.S. at 402-03, 82 USPQ2d at 1390” (MPEP, 2143/section E).
In the instant case, Applicant is reminded that this is a 103-obviousness rejection and not a 102-anticipation rejection. Regarding the first argument, that the prior art does not teach “the modified plant reaches its terminal flowering date sooner than an otherwise identical plant that lacks the modification”. The combination of Liu, which discloses mutations of the intron 1 and promoter regulatory region resulting in reduced GmTFL1b expression to produce a more determinate or semi-determinate plants, and Serrano-Mislata’s teachings on transgenically altering the promoter region of the TFL1 (ortholog of GmTFL1b) gene which controls determinacy and florescence’s (i.e. flowering) in plants, make it obvious to try altering the promoter to reduce TFL1 expression or activity.
Liu taught the fundamentals of a mutated TFL1 non-coding e.g. intron 1 and promoter region which results reduction of expression or activity needed to achieve the desired determinacy in soybean plants. Serrano-Mislata, on the other hand, focused on the specific deletions of the non-coding regulatory region such as the intron and promoter region, which makes alterations to the promoter region. Additionally, Liu mentions that it is already known in the prior art that determinate plants “generally reach much shorter heights with increased lodging resistance” (see page 199 right column middle paragraph). Liu doesn’t need to explicitly teach non-naturally modifying a plant to reduce expression or activity of TFL1 gene. Along with Serrano-Mislata teaching segmentally deleting both the 5’ and 3’ to identify the regulatory regions in the TFL1 gene responsible for determinacy and florescence.
Since both Liu and Serrano-Mislata identified a limited number of modifications to the promoter region of TFL1 to achieve a more determinate phenotype or reduce TFL1 expression or activity, combining these reference makes the claim obvious to produce a plant that is more determinate and flowers earlier than a plant not having the mutations.
At least for these reasons, the rejection is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/C.J.O./Examiner, Art Unit 1663
/PHUONG T BUI/Primary Examiner, Art Unit 1663