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 .
Claims Status
The Office acknowledges the receipt of Applicant’s Request for Continued Examination filed May 12, 2026. 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 Claims 19-20, 31-36, 38-40 and 42-44 are withdrawn.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 1-3, 5-6, 8-11, 15, 17-18, 21-22, 24 and 26 are examined to the extent of the species soybean and SEQ ID NO:96. It is noted that claims 2(d), 8 and 9 are examined to the extent of the soybean species.
All previous rejections not set forth below have been withdrawn.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.
Specification
3. The disclosure is objected to because of the following:
The specification recites “Casual Lesion” and “Casual Deletion”. It is unclear how they differ. What does “Casual Lesion” mean?
Appropriate correction is required.
Double Patenting (Nonstatutory)
4. Claims 1-3, 5-6, 8-11, 15, 17, 18, 21, 24 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6 and 8-15 of co-pending Application No.18/643394 (hereinafter ‘394). Although the claims at issue are not identical, they are not patentably distinct from each other because:
With regard to claims 1, 5, 6, 8-11, 15, 17, 24 and 26, ‘394 discloses a modified soybean plant comprising a modification that reduces the expression of TFL1b, wherein the modification is a deletion at various specific positions that are about 200 nucleotides or more from the 3’ end of SEQ ID NO:4. Even though claim 1 of the instant application recites TFL1, SEQ ID NO:4 is the promoter sequence for the TFL1b gene. The specific deletions set forth in claim 1 of ‘394 renders obvious the broader limitation of “at about 200 nucleotides or more from the 3’ end of SEQ ID NO:4”. The modification increases the determinacy phenotype of the plant, and the plant reaches its terminal flowering date sooner than a control plant (see claims 10-12 of ‘394).
With regard to claim 2, claims 3-5 of ‘394 discloses heterozygous and homozygous for the modification, as well as modification of two different TFL1 alleles.
With regard to claim 3, claim 2 of ‘394 discloses 70-100% sequence identity to SEQ ID NO:2.
With regard to claim 15, in addition to the deletion mutation set forth in claim 1 of ‘394, claims 13-15 of ‘394 discloses reduced lodging, increased yield and lower susceptibility to fungal disease.
Claim 18 is included because “is” in line 3 is interpreted by the Office to be open language and encompasses a 284 deletion from nucleotide 1366 to 1649 of SEQ ID NO:4 of ‘394.
With regard to claim 21, claim 6 of ‘394 discloses 70-100% sequence identity to SEQ ID NO:4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant requests that the rejection be held in abeyance until allowability is indicated.
Accordingly, the rejection is maintained.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-3, 5-6, 8-11, 15, 17-18, 21-22, 24 and 26 are 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.
In claim 1, does TFL1 or a homolog thereof’ encompass homologs of the TFL1 promoter sequence? Is Applicant claiming homologs of SEQ ID NO:4? The claim does not recite homologs of SEQ ID NO:4. However, as different TFL1 genes have different promoter structures, the Office interprets “homolog” to encompass homologs of SEQ ID NO:4 in addition to homologs of TFL1 gene.
In claim 1, the metes and bounds of “about 200” are unclear. The term “about” is not clearly defined in Applicant’s disclosure. It is suggested that the word “about” is deleted.
In claim 2(c), how is the first modification “different” from the second modification? Are they different because they are different alleles? Is Applicant referring to a structural modification, a functional modification, or a phenotypic modification?
In claim 15(d), the recitation “substantially” is unclear. The term is not properly defined in the specification. It is suggested that the word “substantially” is deleted.
In claim 21, 70-99.5% to SEQ ID NO:4 in the regions outside of the deletion, insertion, substitution or inversion cannot be determined without a disclosure of what the deletion, insertion, substitution or inversion is, because the 70-99.5% also encompasses deletions, insertions, substitutions and inversions.
In claim 26, it is unclear how “increases the determinacy” is defined. Is Applicant referring to the sooner-terminal-flowering-date phenotype of claim 1 or is this in addition to the phenotype of claim 1? If Applicant intends the latter, it is unclear how the sooner-terminal-flowering-date phenotype is distinguishable from the “increases the determinacy” phenotype.
Dependent claims are included.
Correction and/or clarification is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-6, 15, 21 and 26 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 5-6 are not further limiting because SEQ ID NO:4 of claim 1 is inherently a promoter.
Claim 15(b), the recitation “alters the expression level” is broader than “reduced expression or activity” of claim 1. Dependent claims 21 and 26 are included because they do not further limit claim 15(b).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)(Written Description)
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-3, 5-6, 8-11, 15, 17-18, 21-22, 24 and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant’s disclosure is as follows.
SEQ ID NO:4 is a promoter sequence of the soybean GmTFL1b gene. Deletion mutations at various positions of SEQ ID NO:4 are made. One promoter mutation is lethal (Table 2), some deletion mutations increase protein expression, and some deletion mutations reduce protein expression compared to wildtype control (Table 5). One mutated promoter has two deletion mutations and one inversion mutation (S430) that results in reduced protein expression (Table 5) and a sooner terminal flowering date (Table 7). Only mutant promoters having reduced protein expression reach their terminal flowering date later and have better lodging scores (except for one) than wildtype control (Table 7). Two mutants having optimal lodging scores showed increased yield in pods/plant in soybean (Table 8). The approximately 200 nucleotides at the 3’ end of the TFL1 promoter is avoided because Applicant does not want to render the promoter completely nonfunctional [0159].
The claimed invention lacks adequate written description for the following reasons.
A modification that reduces the expression or activity of TLF1 protein is not adequately described. As indicated above, some modifications of SEQ ID NO:4 (promoter) increase protein expression. The modifications encompassed by the claims encompass deletions, insertions, substitutions, inversions of any nucleotide(s), and any combination thereof, anywhere in SEQ ID NO:4. Applicant has only shown deletion mutations in SEQ ID NO:4, and one deletion mutant also contains an inversion. The recitation of “about 200” does not allow one skilled in the art to predict the type of modification to make to reduce expression. Because the “about 200 nucleotides or more from the 3’ end” of SEQ ID NO:4 indicates that Applicant intends to retain some functional activity instead of rending the promoter completely nonfunctional [0159], there is insufficient description of the type of modification(s) that would reduce expression of TFL1 and result in a sooner terminal flowering date phenotype. The working examples are not representative of the claimed scope of modifications. It is unpredictable whether deleting 1800 nucleotides of SEQ ID NO:4 at the 5’ end would produce a functional promoter, reduce TFL1 expression and result in a sooner terminal flowering date. There is no known or disclosed structure and function relationship of a particular promoter modification that would result in a sooner flowering date phenotype. Claim 17 does not address this issue because the claim does not indicate where “about 200 nucleotides or more” the deletion occurs, and which positions of SEQ ID NO:4 are being deleted.
Homologs of TFL1 are not adequately described. Other than TFL1b proteins, the specification does not disclose other TFL1 proteins. TFL1b proteins are not representative of TFL1 proteins. One skilled in the art cannot predict the structures of other TFL1 proteins from the disclosure of TFL1b. The specification discloses SEQ ID Nos. 52-66, 78 and 80 are TFL1b protein sequences from 17 plant species [0034]. It is unclear what sequence identities these sequences have to SEQ ID NO:2 from soybean and what regions of these sequences must be retained to be identified as a TFL1 or TFL1b protein. It is further unclear what sequence identities other undisclosed TFL1b sequences have to SEQ ID NO:2. One skilled in the art cannot predict the structures of other undisclosed TFL1b sequences from the disclosed TFL1b sequences. Claims 18 and 22 do not address this issue because they only address the promoter sequence.
Homologs of SEQ ID NO:4 (a TFL1b soybean promoter) are not adequately described. The specification only discloses TFL1b promoters. TFL1b promoters are not representative of TFL1 promoters. One skilled in the art cannot predict the structures of TFL1 promoters from the disclosure of TFL1b promoters. The specification discloses SEQ ID Nos. 67-77, 79 and 81 as the TFL1b promoter sequences of the 17 TFL1b proteins [0035]. It is unclear what sequence identities these sequences have to SEQ ID NO:4 from soybean and what regions of these sequences must be retained to be identified as a TFL1 promoter or a TFL1b promoter. It is further unclear what sequence identities other undisclosed TFL1b promoters have to SEQ ID NO:4. One skilled in the art cannot predict the structures of other undisclosed TFL1b promoters from the disclosed TFL1b promoters.
Claim 2(c), directed to a second modification in second allele of the TFL1 gene, is not adequately described. There is no disclosure as to how the second modification affect the plant phenotype, TFL1 function or TFL1 structure. There is no disclosure as to where in the TFL1 gene the modification occurs. There is no disclosure as to what the modification is. Accordingly, a second modification in a second allele of the TFL1 gene lacks adequate written description.
Claim 3, which recites at least 70% sequence identity to SEQ ID NO:2, is not adequately described. While one skilled in the art can generate a population of sequences having 70-99.5% to SEQ ID NO:2, one skilled in the art cannot predict which sequence(s) within said population are TFL1 sequences. The claim further encompasses mutants and allelic variants of SEQ ID NO:2 and mutants and allelic variants of TFL1 sequences having 70-99.5% to SEQ ID NO:2. However, no mutants and allelic variants having at least 70% sequence identity to SEQ ID NO:2 are disclosed. Accordingly, TFL1 gene or homolog thereof encoding a protein having at least 70% sequence identity to SEQ ID NO:2 lacks adequate written description.
Claim 21, which recites at least 70% sequence identity to SEQ ID NO:4, is not adequately described. The promoter must be modified such that expression of the TFL1 gene is reduced and the sooner-terminal-flowering-date phenotype is achieved. The claim does not specify the type of deletion, insertion, substitution or inversion to SEQ ID NO:4 to achieve these objectives. The claim does not indicate what regions of SEQ ID NO:4 within the 70-100% sequence identity, outside of the deletion, insertion, substitution or inversion, are retained to reduce TFL1 expression and produce the sooner-terminal-flowering-date phenotype. As indicated in the 35 USC 112(b) rejection above, the at least 70% sequence identity to SEQ ID NO:4 outside of the deletion, insertion, substitution or inversion to SEQ ID NO:4 encompasses additional deletions, insertions, substitutions and/or inversions to SEQ ID NO:4. Accordingly, at least 70% sequence identity to SEQ ID NO:4 outside of the deletion, insertion, substitution or inversion region lacks adequate written description.
Accordingly, there is lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published in Federal Register/ Vol.66, No. 4/ Friday, January 5, 2001/ Notices; p. 1099-1111.
Claim Rejections - 35 USC § 112 (Enablement)
Claims 1-3, 5-6, 8-11, 15, 17-18, 21-22, 24 and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Enablement factors to consider include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Applicant’s disclosure is as set forth above. The claimed invention is not enabled for the following reasons.
The nature of the claimed invention is a plant comprising a modification at about 200 nucleotides or more from the 3’ end of a TFL1 promoter as represented by SEQ ID NO:4 that reduces the expression of TFL1 and produces the sooner terminal flowering date phenotype.
Modification of SEQ ID NO:4 and its homologs at about 200 nucleotides or more from the 3’ end is not enabled for the following reasons. As indicated in the written description rejection above, the promoter retains functionality at some level, the promoter modification reduces the expression of TFL1, and the modification results in a sooner terminal flowering date phenotype. The scope of sequence modification encompasses nucleotide deletions, insertions, substitutions, inversions and any combination thereof anywhere in SEQ ID NO:4, so long as said modification is at about 200 nucleotides or more from the 3’ end of SEQ ID NO:4. The working examples show that the modifications can be lethal, can decrease expression of TFL1, or can increase expression of TFL1. Applicant has no working examples of insertion, substitution, and inversion (by itself) modifications. The working examples further disclose that not all deletions produce the claimed phenotype. Of all the deletion modifications made (Tables 2-5), only six modifications showed reduced TFL1b expression and a sooner terminal flowering date compared to wildtype (Table 7). From the virtually ad infinitum number of possible modifications to SEQ ID NO:4 at about 200 nucleotides or more from the 3’ end, it is highly unpredictable which modification(s) would reduce TFL1 expression and produce the claimed phenotype absent further guidance. It would require excessive burden and undue experimentation to introduce a construct comprising each and every one of these modifications into a plant cell, grow the cell into a plant until flowering, and determine which modification produces the sooner-terminal-flowering-date phenotype. Because modifications to SEQ ID NO:4 are not enabled, modifications of undisclosed homologs of SEQ ID NO:4 are also not enabled.
With regard to claim 15(d), the breadth of yield is not enabled for the following reasons. Yield encompasses all plant products, e.g., vegetative, reproductive, oils, proteins, seeds, tubers, etc. The only yield in the working examples is mean pods per plant for two edited plants (Table 8). The state of the prior art does not teach a single promoter operably linked to a sequence that can increase all plant yields. It is unclear and unpredictable how the claimed invention can be used to increase the yield of other plant parts, such as leaves. Accordingly, Applicant has not enabled increasing all plant yields by a modification of about 200 nucleotides or more from the 3’ end of SEQ ID NO:4 as commensurate in scope with the claims without undue experimentation.
With regard to claim 15(d), lower susceptibility to fungal disease is not enabled for the following reasons. The breadth of the claim encompasses all fungal pathogens. Applicant discloses that the modification would lower susceptibility to fungal disease because the more compact plant type resulting from semi-determinate traits should permit improved airflow under the canopy, thereby reducing humidity and fungal disease susceptibility [0156]. However, Applicant does not have any working examples of lower susceptibility to fungal disease. The state of the prior art does not teach that all fungal pathogens need a high humidity environment for pathogenicity. Moreover, the specification states that the plants can be grown in narrow rows and higher densities [0156], which would increase humidity under the canopy and increase susceptibility to fungal disease.
Given the breadth of the claim, the state of the prior art, the lack of predictability, and the lack of guidance and working examples, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation required to make the claimed invention would likely be extensive and undue.
Accordingly, weighing all the Wands factors based on the totality of the record as discussed above, the Office determines that it would require undue experimentation for a person of ordinary skill in the art to make and use the invention as claimed.
Claim Rejections - 35 USC § 102
Claims 1-3, 5-6, 15, 17, 24 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Serrano-Mislata et al. (Development, Vol. 143 (18): Pgs. 3315–3327, https://doi.org/10.1242/dev.135269, 2016 (previously cited) in light of Serrano-Mislata et al. (NCBI Database, Accession No. KX139000, Development, Vol. 143 (18): Pgs. 3315–3327, https://doi.org/10.1242/dev.135269, 2016, (U),
In regard to claims 1, 5-6, 15, 17, 24 and 26, as indicated in the 35 USC 112(b) rejection above, since the claims encompasses TFL1 homologs, homologs of SEQ ID NO: 4 are encompassed by the claims. Serrano-Mislata teaches a plant comprising a deletion in the promoter of an Arabidopsis TFL1 gene that reduces expression of TFL1, wherein the modification alters the determinacy phenotype of the plant and the modified plant reaches its terminal flowering date sooner than a control plant (pp. 3318-3319, “The 5’ region of the promoter ensures high expression levels of TFL1”).
In regard to claim 2, the plant can be heterozygous or homozygous for the modification.
In regard to claim 3, Serrano-Mislata discloses NCBI Accession No. KX139000 of the Arabidopsis TFL1 (p. 3326) which has at least 79% sequence identity to Applicant’s SEQ ID NO:2 (see sequence alignment (U)).
Therefore, the claimed invention is anticipated by the art.
Applicant’s traversals and the Declaration of Brower-Toland do not apply to the rejection above and thus are not addressed here.
Claim Rejections - 35 USC § 103
Claims 1-3, 5-6, 8-11, 15, 17, 21, 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Serrano-Mislata et al. (Development, Vol. 143 (18): Pgs. 3315–3327, https://doi.org/10.1242/dev.135269, 2016 (previously cited) in light of Serrano-Mislata et al. (NCBI Database, Accession No. KX139000, Development, Vol. 143 (18): Pgs. 3315–3327, https://doi.org/10.1242/dev.135269, 2016, (U), as applied to claims 1-3, 5-6, 15, 17, 24 and 26 above, and further in view of Liu et al. (Plant physiology vol. 153,1 : Pgs.198-210, 2010 (previously cited) and Liu et al. (NCBI Database, Accession No. AB511820, Plant Physiol., Vol.153, Issue 1: pgs. Pgs.198-210, 2010, https://doi.org/10.1104/pp.109.150607 (V)).
The teachings of Serrano-Mislata have been discussed above.
Serrano-Mislata does not teach on soybean, TFL1b, and SEQ ID NO: 4.
Liu teaches that soybean TFL1b gene and its promoter having 99% sequence identity to Applicant’s SEQ ID NO: 4 (GenBank Accession No. AB511820.1) (p. 208).
Therefore, prior to the effective filing date of the instant application, it would have been prima facie obvious to one of ordinary skill in the art to substitute the Arabidopsis TFL1 gene of Serrano-Mislata with the soybean TFL1b gene of Liu, including the modifications to the promoter as taught by Serrano-Mislata for the purpose of increasing the determinacy phenotype and produce a soybean plant that reaches its terminal flowering date sooner than a control plant. One skilled in the art would have been motivated to do so with a reasonable expectation of success.
Applicant’s traversals and the Declaration of Brower-Toland do not apply to the rejection above and thus are not addressed here.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JOSE ORDAZ whose telephone number is (703)756-1967. The examiner can normally be reached 8:30 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.J.O./Examiner, Art Unit 1663
/PHUONG T BUI/Primary Examiner, Art Unit 1663
Prosecution Insights