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 .
DETAILED ACTION
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
1. Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1, 2, 5, 10 and 12-14, drawn to a plant having an increased sugar content.
Group II, claim(s) 15, 16, 19, 20, 27, 32 and 34-36, drawn to a method of producing a plant having an increased sugar content.
Group III, claim(s) 37, 38, 41 and 42, drawn to a nucleic acid sequence encoding a mutated SIRT element.
2. The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-III lack unity of invention because even though the inventions of these groups require the technical feature of a mutated SIRT element, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Sagor et al. (Plant Biotechnology Journal, Vol. 14, Issue 4, pp. 1116-1126, 2016 (Applicant’s IDS)). Sagor teaches a tomato plant expressing a bZIP transcription factor comprising a SIRT element having a mutation in the upstream open reading frame (uORF) produces fruits having high sugar contents (Summary). The plant of Group I can be made by the method of Group II or by cross hybridization with a plant having a mutated SIRT element. The nucleic acid sequence of Group III is chemically, structurally and biologically distinct from the plant of Group I. The nucleic acid sequence can be used for diagnostic purposes.
3. This application contains claims directed to the following patentably distinct species:
If Applicant elects Group I, Applicant is required to further elect one from (i) and (ii):
SEQ ID Nos. 3 (a.a. SEQ ID NO:5), 4 (a.a. SEQ ID NO:6), and 7-10; and
(ii) SEQ ID NO: 21 (SlbZIP1) or SEQ ID NO:22 (SlbZIP2).
The election in (ii) must correspond to the election in (i).
If Applicant elects Group II, Applicant is required to further elect one from each of (i), (ii) and (iii):
SEQ ID Nos. 3 (a.a. SEQ ID NO:5), 4 (a.a. SEQ ID NO:6), and 7-10.;
SEQ ID NO: 21 (SlbZIP1) or SEQ ID NO:22 (SlbZIP2); and
SEQ ID Nos. 12-19.
The elections in (i), (ii) and (iii) must correspond to each other.
If Applicant elects Group III, Applicant is required to further elect one of SEQ ID Nos. 7-10 and the corresponding SEQ ID NO: 21 (SlbZIP1) or SEQ ID NO:22 (SlbZIP2).
The species are independent or distinct because each sequence is chemically, structurally and biologically distinct from each other. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 1, 5, 10, 14, 15, 19, 27, 32 and 36 are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: each sequence would require a separate search of the databases and consideration under 35 USC 112(a). Rejoining them would cause undue burden on Office resources.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
4. During a telephone conversation with Seiko Okada on November 19, 2025, a provisional election was made to prosecute the invention of Group I, claims 1, 2, 5, 10 and 12-14, and the species of SEQ ID NO:3 (a.a. SEQ ID NO:5) and SlbZIP1 (SEQ ID NO:21). Affirmation of this election must be made by applicant in replying to this Office action. Claims 15, 16, 19, 20, 27, 32, 34-38, 41 and 42 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
5. Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
6. The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claims Status
7. Claims 1, 2, 5, 10, 12-16, 19, 20, 27, 32, 34-38, 41 and 42 are pending. Claims 15, 16, 19, 20, 27, 32, 34-38, 41 and 42 are withdrawn. Claims 1, 2(i), 5, 10 and 12-14, to the extent of SEQ ID NO:3 (a.a. SEQ ID NO:5) and SlbZIP1 (SEQ ID NO:21), are examined in the instant application.
Information Disclosure Statement (IDS)
8. Applicant’s IDS filed April 19, 2024 has been considered. A signed copy is attached.
Claim Objections
9. Claims 2 and 12-14 are objected to because of the following:
In claim 2(i)(a), “No:” should be deleted because it is redundant.
In claim 12, “SlbZIP1” should be spelled out the first time it is recited, with the acronym in parentheses.
In claim 14, “tomato” should be inserted after the second recitation of “plant part”.
Dependent claims are included.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
10. 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.
11. Claims 1, 2, 5, 10 and 12-14 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 pre-AIA the applicant regards as the invention.
Claim 1 recites “altered expression or function of a basic region/leucine zipper motif (bZIP) transcription factor gene”. However, it is unclear whether “altered expression” means a different level of expression or a structurally different protein is expressed. Additionally, because no function for the transcription factor gene is recited, it is unclear how one skilled in the art can distinguish altered function from unaltered function.
In claim 1, because no function is recited for the transcription factor gene, the metes and bounds of “a homolog thereof” cannot be determined. It is further unclear how a homolog of a bZIP transcription factor is structurally defined.
Claim 1 recites “alter function of the SIRT element”. However, no function for the SIRT element is recited. It is unclear how one skilled in the art can distinguish altered function from unaltered function. Page 13 states that “SIRT function” refers to the ability of the SIRT element to regulate a downstream ORF. However, “regulate” is not defined and the downstream ORF is only identified as an example, e.g., bZIP.
In claim 2(i), because no function is recited for the SIRT element, the metes and bounds of “a homolog thereof” cannot be determined. It is further unclear how a homolog of a SIRT element is structurally defined.
Claim 2(i) recites “the SIRT element … in which the one or more insertions, substitutions, or deletions are located comprises a nucleic acid molecule”, and claim 2(i)(a) further recites “having at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO: 5, wherein the SIRT element retains SIRT function.” It is unclear whether the 90% sequence identity to SEQ ID NO:5 is before or after the “one or more insertions, substitutions, or deletions”. Claim 2(a)(i) does not appear to further limit claim 1. See also claim 2(i)(c).
In claim 5(i), “a bZIP transcription factor” should be amended to “the bZIP transcription factor” for proper antecedence, because claim 5 depends from claim 1.
In claim 5(ii)(a)-(c), after the word “function”, it is suggested that “of the molecule regulated by the bZIP transcription factor” be inserted to clarify that Applicant is referring to the regulated molecule and not the bZIP transcription factor.
In claim 5, all recitations of “the function” are rejected because no function is recited. The function of an unspecified molecule regulated by the bZIP transcription factor cannot be determined. Thus, the metes and bounds of “function” are unclear.
In claim 5(iii) and (iv), the metes and bounds of “about” are unclear. The claim specifies a range with an upper and lower limit. However, “about” encompasses values above and below the limits. Page 8 gives examples of “about” but this is not a definition. It is unclear what values are encompassed by the recited ranges. It is suggested “about” be deleted.
In claim 10, it is suggested “a level of total soluble solids” be amended to “the level of total soluble solids” because “a” suggests more than level of total soluble solids in a plant, which does not appear to be Applicant’s intention.
In claim 13, it is unclear whether the 80% sequence identity to SEQ ID NO:21, and SEQ ID NO:21, are determined before or after the “one or more insertions, substitutions, or deletions”.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 112(a)
12. 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.
13. Claims 1, 2, 5, 10 and 12-14 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 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, at the time the application was filed, had possession of the claimed invention.
The specification discloses the 5’ UTR of the bZIP transcription factor gene comprises an upstream open reading frame (uORF) having a sucrose induced repression of translation (SIRT) element that operates through feedback inhibition by sucrose. A reduced or loss-of-function mutation of the SIRT element results in an increase in sugar content. Deletion and substitution mutations in the SlbZIP1 uORF including an SIRT element (SEQ ID NO:3) showed an increase in GFP (green fluorescence protein marker) expression.
The claimed invention lacks adequate written description for the following reasons. A homolog of a bZIP transcription factor gene is not adequately described. Applicant does not disclose a common structure for homologs of bZIP transcription factor genes. Homologs are understood by those skilled in the art to be genes that have a common ancestor. The disclosure of SEQ ID NO:21 does not allow one skilled in the art to predict the structures of other bZIP transcription factor genes having the same ancestor. Accordingly, a homolog of a bZIP transcription factor gene lacks adequate written description.
In claim 1, “altered expression or function of a basic region/leucine zipper motif (bZIP) transcription factor gene” lacks adequate written description because there is no description as to how expression is altered, or how function is altered. An increase in the expression or functional activity of a bZIP transcription factor gene is not representative of the scope of “altered expression or function”, which encompasses increasing expression, decreasing expression, expression of a different protein, increasing functional activity, decreasing functional activity and changing the functional activity, none of which is clearly defined. Accordingly, an altered expression or function of a bZIP transcription factor gene lacks adequate written description. An altered function of the SIRT element also lacks adequate written description for the same reasons, as the function of the SIRT is not clearly defined.
Additionally, there is inadequate written description with regard to what insertions, substitutions or deletions in an uORF of the bZIP transcription factor gene would increase the sugar content in a plant. It should be noted that the SIRT element is not required to be mutated. There is also no requirement that the insertions, substitutions or deletions in the uORF result in a reduced or loss-of-function in the SIRT element. Claim 1 states that the insertions, substitutions or deletions alter the function of the SIRT element, but “alter” is not the same as reduced or loss-of-function. It is unpredictable whether a mutation that increases the activity of the SIRT element would also result in an increase in plant sugar content. Accordingly, insertions, substitutions or deletions in an uORF of the bZIP transcription factor gene for increasing the sugar content in a plant is not adequately described.
The generic recitations of bZIP transcription factor gene, SIRT element, SlbZIP transcription factor, 90% sequence identity to SEQ ID NO:5 or to SEQ ID NO:3, and 80% sequence identity to SEQ ID NO:21 lack adequate written description because the claims are directed to SIRT and bZIP transcription factor sequences obtained from sources other than Solanum lycopersicum, whereby their structure and identity are not disclosed, so long as they share an undefined function, 90% sequence identity to SEQ ID NO:3 or 5, or 80% sequence identity to SEQ ID NO:21. It should be noted that the generic recitations of bZIP transcription factor gene and SlbZIP transcription are not required to share any percent sequence identity to the recited SEQ ID Nos. The claims encompass mutants and allelic variants of SEQ ID Nos. 3 and 5, and SEQ ID NO:21, thus imply that structural variants exist in nature, yet no structural variant has been disclosed. The implication is that there is a gene and a protein other than that disclosed which exists in nature, but the structure thereof is not known. The disclosure of SEQ ID NO:3 or SEQ ID NO:21 isolated from Solanum lycopersicum is not representative of other bZIP transcription factor sequences from other sources having SIRT or bZIP transcription factor function, however that is defined. Thus, there are insufficient relevant identifying characteristics to allow one skilled in the art to predictably determine such mutants and allelic variants of SIRT sequences, or of bZIP transcription factor sequences, from another S. lycopersicum or a plant other than S. lycopersicum, absent further guidance. Moreover, while one skilled in the art can generate a population of sequences having 90% sequence identity to SEQ ID NO:3 or 5, or 80% sequence identity to SEQ ID NO:21, it is unpredictable which species within the population would also have SIRT function or bZIP transcription factor activity. Applicant failed to disclose a representative number of species within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Accordingly, the generic recitations of bZIP transcription factor gene, SIRT element, SlbZIP transcription factor, 90% sequence identity to SEQ ID NO:5 or to SEQ ID NO:3, and 80% sequence identity to SEQ ID NO:21 lack adequate written description
In claim 5, “a molecule regulated by the bZIP transcription factor” lacks adequate written description because Applicant does not disclose a representative number of molecules regulated by the bZIP transcription factor. It is unclear whether the molecules that are regulated by the bZIP transcription factor share a common structure or function, and whether said molecules are DNAs or proteins. Transcription factors initiate and regulate transcription of genes. However, it is unpredictable what genes the bZIP transcription factor regulate. There is no evidence that a bZIP transcription factor only regulates molecules in the sugar biosynthetic pathway. Also, since all plant metabolic processes are directly or indirectly connected, it is unclear what molecules are encompassed by said recitation. From the molecules listed in claim 5(v), it is unpredictable what other molecules are regulated by a bZIP transcription factor, because the molecules in claim 5(v) do not share a common structure or function to allow one skilled in the art to predict other molecules that are regulated by a bZIP transcription factor. Thus, the scope of “a molecule regulated by the bZIP transcription factor” lacks adequate written description.
Accordingly, one skilled in the art would not have recognized Applicant was in possession of the claimed invention at the time of filing. See Written Description Guidelines, Revision 1, March 25, 2008, published online at http://www.uspto.gov/web/menu/written/pdf.
Claim Rejections - 35 USC §§ 102 and 103
14. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
15. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
16. Claims 1, 2, 5, 10 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Sagor et al. (Plant Biotechnology Journal, Vol. 14, Issue 4, pp. 1116-1126, 2016 (Applicant’s IDS)). Sagor teaches a tomato plant expressing a tomato SlbZIP1 transcription factor gene whereby the 5’-leader regions containing the uORF2 of the SIRT (sucrose induced repression of translation) element were eliminated (Summary, p. 1119, first column, last sentence). The tomato fruit of Sagor has higher sugar content than the sugar content of a wildtype tomato fruit (Abstract). Asparagine synthase and proline dehydrogenase genes are under the control of the SlbZIP transcription factor (Summary). With regard to claim 2, the claimed plant is not required to comprise SEQ ID NO:3 or SEQ ID NO:5 because this is the region that is targeted for deletion. With regard to claim 13, the SlbZIP1 transcription factor of Sagor inherently has at least 80% sequence identity to Applicant’s SEQ ID NO:21, because both the sequence of Sagor and Applicant are tomato bZIP1 transcription factors.
Accordingly, the claimed invention is anticipated by the prior art.
Conclusion
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached at 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663