DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first-inventor-to-file provisions of the AIA .
Election/Restrictions
1. Claims 1,4-17,25-28,31-32 and 35-40 as filed amended 23 July 2024 were pending. A restriction requirement was posted on 13 February 2026.
Applicant elected without traverse SEQ ID NO:15 and Group I in the reply filed on 15 April 2026. The office acknowledges this response and deems the requirement proper and the requirement is therefore made FINAL.
Claims 1 and 4-17are examined herein. Claims 25-28,31-32 and 35-40 are withdrawn as being drawn to a non-elected invention.
Applicant is reminded that upon the cancellation of claims, the inventorship should be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Examiner’s Notes & Claim Interpretation & Allowable Subject Matter
Citations to Applicant’s specification are abbreviated herein “Spec.”
Occasionally, “SIN:” is used as an abbreviation “SEQ ID NO:” herein.
2. The elected species, SEQ ID NO:15, was searched against the Office databases and appears to be free of the prior art of record. Claims directed to SEQ ID NO:15 as an embodiment should be allowable. As noted below, SEQ ID NO:15 satisfies the requirements of 35 USC 112(a).
3. Claim 1 requires a “unique tissue expression pattern”
In the specification on page 6 (the large paragraph), Applicant states that
a "gene expression pattern" is any pattern of transcription of an operably linked nucleic acid molecule into a transcribed RNA molecule. Expression may be characterized by its temporal, spatial, developmental, tissue, environmental, physiological, pathological, cell cycle, and/or chemically responsive qualities as well as by quantitative or qualitative indications. The transcribed RNA molecule may be translated to produce a protein molecule or may provide an antisense or other regulatory RNA molecule, such as a dsRNA, a tRNA, an rRNA, a miRNA, and the like. As used herein, a "unique gene expression pattern" is any pattern of transcription of an operably linked nucleic acid molecule into a transcribed RNA molecule that differs from another regulatory element by its specific tissue or sub-tissue regional transcriptional expression pattern, or cell type or cell state expression pattern and not merely a difference in the quantitative amount of transcription. A "unique gene expression pattern," as used herein, does not include a constitutive expression pattern. In one embodiment, a unique gene expression pattern includes a reduction or elimination of transcription of a heterologous nucleic acid in a particular tissue. In another embodiment, a unique gene expression pattern includes an increase or production of transcription of a heterologous nucleic acid in a particular tissue. As used herein, a "regional transcriptional expression pattern" or "sub-regional transcriptional expression pattern" is intended to mean any expression pattern that is not ubiquitous, only has detectable expression in certain regions of a certain tissue(s), and any other expression outside of the region or regions should be at nominal baseline levels ("ectopic expression"). The term "aerial expression" refers to a gene expression pattern of a polynucleotide in one or more above ground tissues of a plant. In one embodiment, heterologous polynucleotide sequence of interest is expressed in a ubiquitous root expression pattern or a ubiquitous aerial expression pattern. In one embodiment, aerial expression does not include expression in the pollen of a plant.
(underlining added)
Claim Objections
4. Claim 13 is objected to because of the following informality.
Applicant is advised that should claim 12 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
The limitation “of interest” is so broad as to be meaningless. How is placing the claimed heterologous regulatory region in a DNA construct not attaching it to a sequence of interest? Suggested alternate limitations include “transcribable nucleic acid segment” or “gene” or “open reading frame.”
Appropriate correction is requested.
Claim Rejections - 35 USC§ 112
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 and 4-17 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.
5. Claims 1, 4, 5, 9, 10 and 11 are indefinite in their use of "heterologous” and “an assembly of heterologous regulatory element segments" in claim 1.
It is indefinite what “heterologous” is intended to mean and the limits of the limitation. The specification defines "heterologous" (p. 15) “sequence that originates from a foreign species or, if from the same species, is substantially modified from its native form in composition and/or genomic locus by deliberate human intervention.”
However, it is unclear whether, in the context of the claims, it appears that nucleic acid segments in any hybrid regulatory element would be considered "heterologous," given that any cloned nucleic acids would not be in their original form. Further, some of the elements can be very short (e.g. Benfey & Chua (1990) Science 250:959-966, throughout). Thus the species origin of, for example the short polynucleotide sequences recited on page 964, col. 1; and e.g. a TATA box cannot be determined. Thus whether or not they are “heterologous” is indefinite.
Furthermore, claim 1 recites “an assembly of heterologous regulatory element segments” but subsequent claims 4, 5, 9, 10, 11 appear to refer back to “the heterologous assembly . . . “ Additionally, the use of “the assembly” in claims 4 and 5 is ambiguous.
These terms thus lack clarity in antecedent basis.
6. Claim 1 is also indefinite in the recitation of "unique expression pattern." The specification defines "unique expression pattern" (p. 8, top) as “compared to the source or parent regulatory element.”
Therefore, "unique", with regard to an expression pattern, is a relative term that can only be determined by comparison to another regulatory element but that element is not defined relative to the claims, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 4-5 and 8-11 are indefinite in the recitation of "parent regulatory element", given that is unclear what would constitute a "parent regulatory element," and how that would be differentiated from any other regulatory element.
Therefore, the metes and bounds of the claimed invention cannot be determined.
Dependent claims are included in this rejection because none provide limitations obviating this rejection.
Claim Rejections - 35 USC § 112(a), written description
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
7. Claims 1 and 4-17 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Federal Circuit held that a written description of an invention "’requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials." Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1405 (Fed. Cir. 1997) (quoting Fiers v. Revel, 984 F.2d 1164, 1171, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993)). The court also stated "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of is not a description of that material." Id., 119 F.3d at 1568, 43 USPQ2d at 1406. The court held that “[a] description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus.” Id., 119 F. 3d at 1569, 43 USPQ2d at 1406.
Claim 1 is drawn to a hybrid regulatory element comprising an assembly of heterologous regulatory element segments that produce a unique tissue expression pattern. SEQ ID NO:15 is the elected species.
The claims are rejected under 35 USC 112(b).
The claim requires the activity of producing a unique tissue expression pattern. This is reasonably interpreted herein as if the “hybrid regulatory element” is a promoter that is assemble from various “heterologous regulatory element segments.”
This “hybrid regulatory element” will transcribe an operably linked transcribable polynucleotide molecule. See for example the bottom of page 41.
“Example 2: Construction of Hybrid Root Regulatory Element Sequences” begins on page 46. Page 47 has “Table 1: Expression Pattern of Root Promoters in Transgenic Maize Plants” lists 18 SEQ ID NOs as embodiments. SEQ ID NO:15 is described in Table 2 as having 3 elements (with one being a TATA box from Brachypodium distachyon). Element 1 is SEQ ID NO:9 from maize. Element 2 is SEQ ID NO:5 from Setaria italica. Table 3 (p. 50) provides results.
In the sequence Listing, SEQ ID NO:9 is “ZM-ROOTMET2 PRO.” When searched using NCBI’s BLAST® server (23 June 2026) the first match is “Zea mays metallothionein-like protein 1 (LOC100284159), mRNA.”
The claims, however, are open ended with regard to all combinations of all transcriptional regulatory elements.
The claimed genus includes a vast array of combinations of nucleic acid segments with a huge variety of sequences.
The elected species, SEQ ID NO:15, complies with the written description requirement of 35 USC 112(a). Proceeding from that point, as an allowable species, the claims are examined as written.
The promoter art in general describes a promoter as a linear assembly of structures related to binding transcription factors, with the bulk of the binding sites upstream of the TATA box which directs RNA polymerase II binding. The combination of these structures generally determines the activity and the specificity of the promoter. See, e.g. Potenza et al. (2004) In Vitro Cell Dev Biol Plant 40:1-22, 2 and Fincher et al., US 6,462,258 B1, issued 8 October 2002, cols. 9-10.
In the promoter art, several publications describe that changes to the primary structure of a promoter nucleic acid molecule might have significant effects on the variant or fragment nucleotide sequence’s ability to be active as a promoter or otherwise provide gene regulatory activity. See, e.g., Donald & Cashmore (1990) EMBO J 9:1717-26, abstract.
An ordinary artisan would not envision the full scope of the claimed embodiments as routinely active in the instant invention. Applicant thus fails to describe a representative number of species in comparison to the size of the genera claimed.
However, in addition to describing a representative number of species, there is an alternate route to satisfying the written description requirement. In the 1997 UC v. Lilly decision the Federal Circuit set forth a two-prong approach to satisfying the written description requirement in a 1997 decision. The court held that in the event that a sufficient number of species are not described, the written description requirement may be satisfied by describing structural features that are necessary and/or sufficient for activity for members of the claimed genus. U.C. v. Lilly, 119 F. 3d at 1569, 43 USPQ2d 1406 (Fed. Cir. 1997). The court held that “[a] description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus.” Id.
However, in the case of the instant invention, neither the specification nor the art describes conserved structures that are necessary and/or sufficient for the promoter activity and tissue specificity as broadly claimed in, e.g., claim 1.
Applicant fails to describe or correlate any individual structural feature(s) of the claimed sequences as necessary and/or sufficient for the gene regulatory activity in the instant invention. Nor does the art describe universal necessary and sufficient structural features required for a promoter with tissue specificity. For example, in an introduction to a 2007 publication of an in silico analysis of plant promoters, Saha et al. teaches that computational analysis of promoters is only a starting point for physical analysis, and experimental verification is still required. Saha et al. (2007) In Silica Biol 7(1 ):7-19, 8.
Applicant only describes a few SEQ ID NOs with SEQ ID NO:15 being examined.
Thus Applicant fails to describe a representative number of species when compared to the size of the genera claimed. Applicant also fails to describe the structural elements that are necessary and/or sufficient for full activity.
Given the lack of written description in the specification plus the lack of knowledge in the prior art as it relates to, for example, SEQ ID NO:15, one of skill in the art would not believe that Applicant was in possession of the broad genera claimed at the time of filing the instant application.
Dependent claims are included in this rejection because none provide further limitations obviating this rejection.
35 USC § 102-Based Claim Rejections
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 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.
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.
8. Claim(s) 1, and 4-17 are rejected under 35 U.S.C. 102(a)(l) as being anticipated by Benfey & Chua (1990) Science 250:959-966.
Claim 1 is drawn to a hybrid regulatory element comprising an assembly of heterologous regulatory element segments that produce a unique tissue expression pattern.
Dependent claim 4 requires at least three parent regulatory elements.
Dependent claim 5 requires at least four parent regulatory elements.
Dependent claim 6 requires a tissue expression pattern of aerial or root.
Dependent claim 7 requires a tissue expression pattern of ubiquitous aerial.
Dependent claim 8 requires a tissue expression pattern of ubiquitous root but has an additional limitation concerning each parent element.
Dependent claim 9 requires that the hybrid regulatory element has more than one copy of the same segment.
Dependent claim 10 requires that the segments come from more than one species. Dependent claim 11 requires that one component is from (“derived”) a plant or a virus.
Dependent claim 12 places this in a construct; 13 requires a heterologous sequence of interest; 14 places it in a cassette. Dependent claim 17 places it in a transgenic plant. Figure 1 also depicts root expression and aerial expression as determined by which subdomains are present in the hybrid regulatory element. Thus Benfey & Chua discloses a hybrid regulatory element comprising an assembly of heterologous regulatory element segments that produce a unique tissue expression pattern.
/ As seen in Figure 1, six subdomains are depicted along with the TATA element.
, including at least 3, or at least four parent regulatory elements, and wherein the tissue expression pattern is in root at least.
Thus Benfey & Chua anticipates claims 1, 4, 5, and 6.
In at least the paragraph bridging pages 963-964 Benfey & Chua discloses a hybrid regulatory element producing various expression patterns.
This anticipates claim 8.
In the disclosure at p. 964, l. 9 (Fig. 5F), Benfey & Chua anticipates claim 7.
Benfey & Chua also discloses a hybrid regulatory element that comprises more than one copy of the same segment (see Fig. 2, at least), or the segments come from more than one species (see Fig. 5, at least), or at least one segment is from the CaMV virus (see the abstract least and throughout).
This disclosure anticipates claims 9, 10, and 11.
Benfey & Chua discloses a hybrid regulatory element in a DNA construct, and linked to a polynucleotide of interest, and in an expression cassette, and in a host cell, and in a transgenic plant (see at least at page 960 and throughout). Thus Benfey & Chua anticipates claims 12, 13, 14, 15, 16 and 17.
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 obviousness-type 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). MPEP § 804.
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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
9. Claims 1, 4-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,065,653 B2 (‘653 Patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the reasons as follows.
The ‘653 Patent arose from the parent Application of the instant application. Claims of the ‘653 Patent are drawn to SEQ ID NO:12.
As above, once SEQ ID NO:15 was found to appear to be allowable, the broader scope of the pending claims is examined. From that viewpoint, the claims of the ‘653 Patent are species of the instant claimed genus.
Again as above, claims directed at SEQ ID NO:15 itself should obviate this rejection. Especially in view of the restriction requirement.
Claims 12-15 of the 16/376,169 application relate to methods for improving the productivity of a plant by using a transcription factor-plus-functional peptide chimeric protein. One such transcription factor is AT1G18330, which is a MYB-family member. Claims 29-33 of the instant application are directed towards plants with improved the fat and oil content, a type of plant productivity, transformed with a MYB-family transcription factor-plus-functional peptide chimeric protein of instant claims 29-33 and teaches all the steps of method claims 12-15 of the 13/376,169 application.
Conclusion
No claim is allowed.
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/RUSSELL T BOGGS/Examiner, Art Unit 1663
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