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 .
Priority
Acknowledgment is made of applicant’s claim for domestic benefit under 35 U.S.C. 119(e). As such, the effective filing date of Claims 1-23 is 04/12/2022.
Election/Restrictions
Applicant’s election of Group I encompassing Claims 1-9 and SEQ ID NO: 11 in the reply filed on 06/02/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Additionally, Applicant urges that expression element SEQ ID NO: 10, which comprises the promoter encoded by SEQ ID NO: 11, should be examined with SEQ ID NO: 11 as being part of the same species (Response to Election/Restriction, pg. 2).
This is found to be persuasive, and as such, SEQ ID NO: 10 has been rejoined with SEQ ID NO: 11 and will be searched and examined herein.
Status of the Claims
Amendments dated 06/02/2026 have been entered.
Claims 1-23 are pending.
Claims 10-23 are withdrawn from consideration as being directed to a non-elected invention.
Claims 1-9 are examined herein.
Information Disclosure Statement
The Information Disclosure Statements filed on 10/10/24, 12/07/2024, 09/05/2025, 03/26/2026, and 07/06/2026 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. Signed copies of the lists of references cited are included with this Office Action.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms TaqMan® or TAQMAN® on pgs. 40, 44, 46, and 48 and Invader® on pg. 40, which are trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
Claims 1-9 are objected to because of the following informalities:
Claim 1 is objected to because it recites “said DNA regulatory sequence is operably linked to a heterologous transcribable DNA sequence” in the last line of the claim. Applicant is understood to being using the word “sequence” to refer to a nucleic acid molecule of a defined sequence. Nevertheless, the term “sequence” is information and it is impossible to operably link such information to a heterologous transcribable DNA sequence that is also merely information. The same logic applies to other recitations of the term “sequence(s)” in Claim 3, part (j) and (k), Claim 6, and Claim 7.
Claim 2 part(c) is objected to because it recites the limitation “the DNA regulatory sequence” as having gene regulatory activity. Since the sequence is merely information, it cannot have gene regulatory activity.
Claim 3 recites the terms “LoxP”, “FRT”, “RS”, and “GIX” which are not defined acronyms. As Claim 3 is the first recitations of “LoxP”, “FRT”, “RS”, and “GIX” in the claim set, Applicant is advised to clearly define the full names of the acronyms.
All dependent claims thereof are included in these objections for the same reasons as given above.
Appropriate correction is required.
Improper Markush Grouping
Claims 1-9 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of SEQ ID NOs: 1-15 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
Claims 1-9 either recite or depend from a claim that recites a recombinant DNA construct comprising a DNA regulatory sequence selected from the group consisting of a sequence with at least 80% sequence identity to any of SEQ ID NOs: 1-15.
An ABSS sequence search of SEQ ID NO: 11 (elected species) (See file wrapper for 20260803_104321_us-18-855-973-11.rnpbm ) returned results down to 10.8% sequence identity relative to SEQ ID NO: 11, wherein, other than SEQ ID NO: 10 (which had 100% sequence identity relative to SEQ ID NO: 10), all other non-elected sequences as they appear in the claims had less than 10.8% sequence identity relative to instant SEQ ID NO: 11. An ABSS Sequence search for SEQ ID NO: 1 (non-elected species) (See file wrapper for 20260803_104321_us-18-855-973-11.rnpbm) returned results down to 6.3% sequence identity relative to SEQ ID NO: 1, wherein, other than SEQ ID NO: 2 (which had 73.8% sequence identity relative to SEQ ID NO: 1), all other sequences as they appear in the claims had less than 19.4% sequence identity relative to SEQ ID NO: 1.
Hence, the included species of the claimed invention do not share both a substantial structural feature and a common function that flows from the substantial structural feature.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
Indefiniteness
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 2-4 and 7 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.
Claim 2, part(g), lines 2-3 recite “one or both of the heterologous transcribable DNA sequences encoding the site specific recombinase…” (emphasis added by Examiner) which renders the claim indefinite. Claim 1, from which Claim 2 depends, only recites a singular heterologous transcribable DNA sequence encoding a site-specific recombinase included in the recombinant DNA construct. The other parts of Claim 2 do not introduce a second heterologous transcribable DNA sequence encoding a site-specific recombinase in the recombinant DNA construct. It is unclear to one of ordinary skill in the art if Claim 2 part(g) is meant to encompass the first heterologous transcribable DNA sequence encoding a site-specific recombinase recited in Claim 1 and a second heterologous transcribable DNA sequence encoding a site-specific recombinase that is being introduced to the claim set for the first time in Claim 2 part(g), or, if Claim 2 part(g) is only meant to encompass the first heterologous transcribable DNA sequence encoding a site-specific recombinase recited in Claim 1. As such, one of ordinary skill in the art is not reasonably apprised of the metes and bounds of the claimed invention.
All dependent claims thereof are included in the rejection for the same reasons as given above.
Claim Rejections - 35 USC § 112
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 1-9 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.
Claims 1-4 are broadly directed to a recombinant DNA construct comprising a DNA regulatory sequence selected from the group consisting of a sequence with at least 80 percent sequence identity to any of SEQ ID NOs: 10-11, or a fragment of any of SEQ ID NOs: 10-11 that has gene-regulatory activity, and fragments of any sequence with at least 80% sequence identity relative to SEQ ID NOs: 10-11 that has gene-regulatory activity; wherein said DNA regulatory sequence is operably linked to a heterologous transcribable DNA sequence encoding a site-specific recombinase.
Claims 5-7 are broadly directed to a DNA molecule, DNA vector, or DNA transformation vector comprising a DNA regulatory sequence selected from the group consisting of a sequence with at least 80 percent sequence identity to any of SEQ ID NOs: 10-11, a fragment of any of SEQ ID NOs: 10-11 that has gene-regulatory activity, and fragments of any sequence with at least 80% sequence identity relative to SEQ ID NOs: 10-11 that has gene-regulatory activity; wherein said DNA regulatory sequence is operably linked to a heterologous transcribable DNA sequence encoding a site-specific recombinase.
Claims 8-9 are broadly directed to a transgenic plant, plant part, or plant cell, or bacterial cell comprising a DNA regulatory sequence selected from the group consisting of a sequence with at least 80 percent sequence identity to any of SEQ ID NOs: 10-11, or a fragment of any of SEQ ID NOs: 10-11 that has gene-regulatory activity, and fragments of any sequence with at least 80% sequence identity relative to SEQ ID NOs: 10-11 that has gene-regulatory activity; wherein said DNA regulatory sequence is operably linked to a heterologous transcribable DNA sequence encoding a site-specific recombinase.
Applicant describes regulatory elements were identified that provided efficient autoexcision, including SEQ ID NO: 10 (elected species), which comprises SEQ ID NO: 11 (promoter sequence; elected species) (pg. 42, Table 1).
Applicant describes corn plants that were transformed with recombinant plant transformation constructs, comprising EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) driving expression of a Cre-recombinase to assess the ability and efficiency of the Cre-recombinase expressed under the control of EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) and 2 different 3' UTRs to drive autoexcision of the Cre-recombinase expression cassette along with the selectable marker expression cassette. Applicant describes that EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) was able to drive efficient autoexcision using either of the two 3' UTRs (SEQ ID NOs: 14 and 15) resulting in a population of hemizygous marker free R1 plants (Example 3, pgs. 45-47).
Applicant describes corn plants that were transformed with recombinant plant transformation constructs, comprising EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) driving expression of a Cre-recombinase to assess the ability and efficiency of the Cre-recombinase expressed under the control of EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) and 2 different 3' UTRs to drive autoexcision of the Cre-recombinase expression cassette along with three other expression cassettes flanked by LoxP sites. Applicant describes that EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) was able to drive efficient autoexcision using either of the two 3' UTRs (SEQ ID NOs: 14 and 15) resulting in a population of hemizygous marker free R1 plants (Example 4, pgs. 47-48).
Applicant describes corn plants that were transformed with recombinant plant transformation constructs, comprising EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) and 2 different 3' UTRs driving expression of a B-glucuronidase (GUS) transgene, wherein the resulting plants were analyzed for GUS protein expression, to assess the effect of the regulatory element group (EXP) on expression. Applicant describes that EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) was able to drive GUS expression in most tissues sampled when operably linked to either of the 3' UTRs (SEQ ID NO: 14 and 15), wherein expression was highest in VT Pollen and Spikelet (Example 5, pgs. 48-50).
With the exception of the full-length sequence of the SEQ ID NO: 10 which encompasses SEQ ID NO: 11 (promoter), Applicant has not described any other of the recited DNA sequence variants or sequence fragments suitable for the practice of the invention.
Applicants have not described any other DNA regulatory sequences from the broadly claimed genera of (1) sequences with at least 80 percent sequence identity to any of SEQ ID NOs: 10-11, (2) unspecified fragments of any of SEQ ID NOs: 10-11 that have gene-regulatory activity, or (3) unspecified fragments of any sequence with at least 80% sequence identity relative to SEQ ID NOs: 10-11 that have gene-regulatory activity; nor has Applicant described the structural properties of such fragments which encompass any segments of SEQ ID NOs: 10-11 and variants thereof, and therefore encompasses a vast number of candidate species.
When looked at the elected species, SEQ ID NO: 11, the shortest of the two examined species is 1,730 bp in length. If the first approximately 1,384 base pairs (80%) were held constant, and the remaining 346 (20%) were varied, that would result in 3464 unique sequence variants. However, that is only a small fraction of the disclosed species claimed, because different regions could be held constant. Furthermore, fragments of SEQ ID NO: 11 are claimed without any lower limit to the length; which expands the claimed genus even further.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. The court stated 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." University of California v. Eli Lilly and Co., 119 F. 3d 1559; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
Since the disclosure fails to describe the common attributes that identify members of the broadly claimed genera of DNA regulatory sequences (at least 80% identical to SEQ ID NOs: 10-11, or unspecified fragments of SEQ ID NOs:10-11 that have gene-regulatory activity, or unspecified fragments having at least 80% sequence identity relative to SEQ ID NOs: 10-11 that have that have gene-regulatory activity), and because the genera encompass a vast number of candidate sequences, the description of the single embodiment of full-length gene-regulatory sequences set forth in SEQ ID NOs: 10-11 are insufficient to describe the claimed genera of DNA regulatory sequences.
For example, BLASTing® SEQ ID NOs: 10 and 11 in GenBank does not reveal any nucleic acid sequences with significant sequence identity and query coverage relative to SEQ ID NOs: 10 and 11 (See NCBI_Blast_Nucleotide_Sequence_SEQ_ID_NO_10.pdf and NCBI_Blast_Nucleotide_Sequence_SEQ _ID_NO_11.pdf in file wrapper) Regarding instant SEQ ID NO: 10, no other significant alignments were produced over the entire query (including at least 80% sequence identity to SEQ ID NOs: 10-11). Since the disclosure fails to describe the common attributes that identify members of the broadly claimed genera, and because the genera are highly variant, SEQ ID NOs: 10-11 alone are insufficient to describe the claimed genera of DNA sequences having the required function.
Additionally, in the case of the instant invention, neither the specification nor the art describes conserved structures that are necessary and/or sufficient for, e.g. the promoter activity of SEQ ID NO: 11. 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, pg. 2 and Fincher et al., WO 01/44457 A2, published 21 June 2001, pgs. 12-13.
Applicant fails to describe or correlate any individual structural feature(s) of the claimed sequences as necessary and/or sufficient for activity in the instant invention. Nor does the art describe the necessary and sufficient structural features required for a promoter. For example, in an introduction to a 2007 publication of an in silica analysis of a plant promoter, 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, pg. 8). Applicant only describes the full-length promoter-plus-leader-plus-intron that is SEQ ID NO:10 and the full-length promoter that is SEQ ID NO: 11.
Applicant fails to describe a representative number of recombinant DNA constructs comprising DNA regulatory sequences that are at least 80% identical to instant SEQ ID NOs: 10-11, DNA regulatory sequences that are an unspecified fragment of SEQ ID NOs: 10-11 having gene regulatory activity, and DNA regulatory sequences that are fragments of any sequence having at least 80$ identity relative to SEQ ID NOS: 10-11 having gene regulatory activity; wherein said DNA regulatory sequences are operably linked to a heterologous transcribable DNA sequence encoding a site-specific recombinase. Applicant fails to describe the physicochemical properties of such recombinant DNA constructs. Hence, Applicant fails to meet the test set forth by Eli Lilly.
Furthermore, one of ordinary skill in the art would not be able to visualize or recognize the identity of the members of the broadly claimed genus because of the lack of disclosure from the Applicant regarding the structure/function relationship of recombinant DNA constructs comprising DNA regulatory sequences at least 80% identical to SEQ ID NOs: 10-11, DNA sequences that are unspecified fragments of SEQ ID NOs: 10-11, or DNA sequences that are unspecified fragments of sequences having at least 80% identity relative to SEQ ID NOs: 10-11, wherein the fragments would have the required function of gene regulatory activity.
In the promoter art, several publications describe that changes to the primary structure of a promoter sequence such as SEQ ID NO: 11, changes that would still fall within the scope of claim 1, might have significant effects on the variant’s/fragment’s ability to function as a promoter within the instant invention. See, e.g., Donald & Cashmore (1990) EMBO J 9:1717-26, abstract; Kim et al. (1994) Plant Mol Biol 24:105-17, abstract; and Dolferus et al. (1994) Plant Physiol 105:1075-87, abstract.
Additionally, although Applicant sets no limit on the fragment size, it is generally accepted that plant promoters require a certain minimum length to be active. For example, Cho & Cosgrove found that deletions below 145 bp in their studied promoter were inactive (Cho & Cosgrove (2002), Plant Cell 14:3237-53, pg. 3246).
Applicant has not provided an adequate description of the recombinant DNA construct(s) comprising the recited DNA regulatory sequence(s) and fragments thereof, wherein the recited fragments confer of gene-regulatory activity, and the specification fails to provide an adequate written description to support the breadth of the claims. Therefore, one skilled in the art would not have recognized the Applicants to be in possession of the claimed invention at the time the application was filed.
Claim Rejections - 35 USC § 112
Scope of Enablement
Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a recombinant DNA construct comprising a DNA regulatory sequence selected from the group consisting of SEQ ID NO: 10 and SEQ ID NO: 11, does not reasonably provide enablement for sequence variants and fragments as broadly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Claims 1-4 are broadly directed to a recombinant DNA construct comprising a DNA regulatory sequence selected from the group consisting of a sequence with at least 80 percent sequence identity to any of SEQ ID NOs: 10-11, or a fragment of any of SEQ ID NOs: 10-11 that has gene-regulatory activity, and fragments of any sequence with at least 80% sequence identity relative to SEQ ID NOs: 10-11 that has gene-regulatory activity; wherein said DNA regulatory sequence is operably linked to a heterologous transcribable DNA sequence encoding a site-specific recombinase.
Applicant defines gene regulatory activity as: “the ability to affect the expression of an operably linked transcribable DNA molecule, for instance by affecting the transcription and/or translation of the operably linked transcribable DNA molecule. Regulatory elements, such as promoters, leaders, enhancers, introns and 3′ UTRs that function in plants are therefore useful for modifying plant phenotypes through genetic engineering” (Specification, paragraph 0061)
Claims 5-7 are broadly directed to a DNA molecule, DNA vector, or DNA transformation vector comprising a DNA regulatory sequence selected from the group consisting of a sequence with at least 80 percent sequence identity to any of SEQ ID NOs: 10-11, a fragment of any of SEQ ID NOs: 10-11 that has gene-regulatory activity, and fragments of any sequence with at least 80% sequence identity relative to SEQ ID NOs: 10-11 that has gene-regulatory activity; wherein said DNA regulatory sequence is operably linked to a heterologous transcribable DNA sequence encoding a site-specific recombinase.
Claims 8-9 are broadly directed to a transgenic plant, plant part, or plant cell, or bacterial cell comprising a DNA regulatory sequence selected from the group consisting of a sequence with at least 80 percent sequence identity to any of SEQ ID NOs: 10-11, or a fragment of any of SEQ ID NOs: 10-11 that has gene-regulatory activity, and fragments of any sequence with at least 80% sequence identity relative to SEQ ID NOs: 10-11 that has gene-regulatory activity; wherein said DNA regulatory sequence is operably linked to a heterologous transcribable DNA sequence encoding a site-specific recombinase.
The Federal Circuit in In re Wands lists eight considerations for determining whether or not undue experimentation would be necessary to practice an invention. In re Wands, 858 F2d 731, 8 USPQ2d 1400, 1406 (Fed. Cir. 1988). These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims. Id.
When looked at the elected species, SEQ ID NO: 11, the shortest of the two examined species is 1,730 bp in length. If the first approximately 1,384 base pairs (80%) were held constant, and the remaining 346 (20%) were varied, that would result in 3464 unique sequence variants. However, that is only a small fraction of the disclosed species claimed, because different regions could be held constant. Furthermore, fragments of SEQ ID NO: 11 are claimed without any lower limit to the length; which expands the claimed genus even further.
Applicant teaches regulatory elements were identified that provided efficient autoexcision, including SEQ ID NO: 10 (elected species), which comprises SEQ ID NO: 11 (promoter sequence; elected species) (pg. 42, Table 1).
Applicant teaches corn plants that were transformed with recombinant plant transformation constructs, comprising EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) driving expression of a Cre-recombinase to assess the ability and efficiency of the Cre-recombinase expressed under the control of EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) and 2 different 3' UTRs to drive autoexcision of the Cre-recombinase expression cassette along with the selectable marker expression cassette. Applicant teaches that EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) was able to drive efficient autoexcision using either of the two 3' UTRs (SEQ ID NOs: 14 and 15) resulting in a population of hemizygous marker free R1 plants (Example 3, pgs. 45-47).
Applicant teaches corn plants that were transformed with recombinant plant transformation constructs, comprising EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) driving expression of a Cre-recombinase to assess the ability and efficiency of the Cre-recombinase expressed under the control of EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) and 2 different 3' UTRs to drive autoexcision of the Cre-recombinase expression cassette along with three other expression cassettes flanked by LoxP sites. Applicant teaches that EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) was able to drive efficient autoexcision using either of the two 3' UTRs (SEQ ID NOs: 14 and 15) resulting in a population of hemizygous marker free R1 plants (Example 4, pgs. 47-48).
Applicant teaches corn plants that were transformed with recombinant plant transformation constructs, comprising EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) and 2 different 3' UTRs driving expression of a B-glucuronidase (GUS) transgene, wherein the resulting plants were analyzed for GUS protein expression, to assess the effect of the regulatory element group (EXP) on expression. Applicant teaches that EXP-SETvi.SPO11-1_Eef7 (SEQ ID NO:10) was able to drive GUS expression in most tissues sampled when operably linked to either of the 3' UTRs (SEQ ID NO: 14 and 15), wherein expression was highest in VT Pollen and Spikelet (Example 5, pgs. 48-50).
In Claim 1, the claimed sequence variants in part (a) of each are not required to have any activity at all other than reference to an operably linked heterologous transcribable DNA sequence (e.g. a gene). Also in Claim 1, the claimed sequence fragments in part (c) are broadly required to have gene-regulatory activity even though SEQ ID NO: 11 is only taught to be a promoter. Applicant provides no teachings that all the claimed variants will be functional in the instant invention or that the claimed fragments will have any form of gene-regulatory activity aside from promoter activity.
The promoter art in general teaches that changes to the primary structure of a promoter such as SEQ ID NO: 11 or a fragment of SEQ ID NO: 10, changes that would still fall within the scope of Claim 1, might have significant effects on the variant nucleotide sequence's ability to function to as a promoter within the instant invention. See, e.g., Donald & Cashmore, EMBO J 9:1717-26 (1990), abstract; Kim et al., Plant Mal Biol 24:105-17 (1994), abstract; and Dolferus et al., Plant Physiol 105:1075-87 (1994), abstract. The art therefore teaches that variants or fragments of SEQ ID NO: 11 are not intrinsically active.
While the claimed sequence variants would have a real-world value if claimed as, for example, functional promoters or 5′-gene-regulatory units, if the variants and fragments are not functional as a promoter, then Applicant fails to teach how to use the instant claimed invention. This is especially true in the case of SEQ ID NO: 11.
In this aspect, the pending claims are similar to the In re Fisher decision of the Federal Circuit. In re Fisher, 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005). In that 2005 decision, a general disclosure in the patent application was provided to support claims to a nucleic acid whose particular function is not disclosed. Id., 76 USPQ2d 1231. The court found that none of the utilities generally suggested for the claimed nucleic acids and compositions in the Fisher case was enough to overcome the utility requirement. Id., 76 USPQ2d 1234. The instant case is similar in that the specification merely provides an asserted use for the full-length sequence and its fragments, but not the variants. Without claiming a promoter activity for the variants, and narrowing the focus of activity of the claimed fragments to promoters, Applicant fails to teach how to use the invention as broadly as claimed.
Regarding Claim 1, Applicant does not teach any sequence variants with at least 80% identity to SEQ ID NOs: 10-11, sequence variants that are fragments of SEQ ID NOs: 10-11 that are purported to have any regulatory activity, or fragments of SEQ ID NOs: 10-11 that are purported to have any regulatory activity.
For example, in an introduction to a 2007 publication of an in silica analysis of a plant promoter, 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, pg. 8). Applicant only teaches the full-length promoter-plus-leader-plus-intron that is SEQ ID NO: 10 and the full-length promoter that is SEQ ID NO: 11. Therefore, it is unpredictable and would require undue experimentation to be able to make sequences with at least 80% sequence identity to SEQ ID NO: 11 that would still be functionally active as a promoter.
Therefore, given the breadth of the claims; the lack of guidance and working examples; the unpredictability in the art; and the state-of-the-art as discussed above, undue experimentation would be required to make and use the claimed invention, and therefore, the invention is not enabled throughout the broad scope of the claims.
Closest Prior Art
Claims 1-9 appear to be free of the prior art with respect to elected SEQ ID NOs: 10-11. The closest prior art to Claims 1-9 with respect to SEQ ID NOs: 10-11 can be found in GenBank Accession CP050803.1 (dated 07/07/2020), which teaches the Setaria viridis cultivar ME034v chromosome 9, which has 95% query coverage and 95.89% sequence identity relative to SEQ ID NO: 11. However, neither GenBank Accession CP050803.1, which is a portion the whole chromosome 9 of a Setaria viridis cultivar, nor it’s associated publication teach any information beyond the sequence being derived from Setaria viridis, and does not disclose, teach, or otherwise render obvious a recombinant DNA construct comprising said portion of chromosome 9 of Setaria viridis cultivar ME034v, wherein said portion of chromosome 9 of Setaria viridis cultivar ME034v is operably linked to anything, much less a heterologous transcribable DNA sequence encoding a site-specific recombinase.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY L. MCWILLIAMS whose telephone number is (703)756-4704. The examiner can normally be reached M-F 08:00-17:30.
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 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.
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.
/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
Prosecution Insights