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
Claims 1-26 as posted 8 July 2024 were subject to a requirement to elect a species posted on 5 January 2026. Applicant responded on 4 March 2026 selecting SEQ ID NO:4 without traverse. Applicant amended the claims to focus on the elected species.
Claims 1-26 are examined herein.
Examiner’s Notes
Citations to Applicant’s specification are abbreviated herein “Spec.”
Occasionally, “SEQ ID NO:” is used as an abbreviation “SEQ ID NO:” herein.
Claim Objections
Claims 1-4, 8, 10, 11, 20, 21,and 22 are objected to because of the following informalities.
Claim 1 is objected to because it uses hybrid Markush group terminology. The conjunction “or” should be used without “selected from the group consisting of.” Or, at the end of part (c), replace the “and” with “or”.
In parts (a), (b), and (c) the word “of” can be interpreted as ‘derived from’ which would broaden the scope of the claim. Deletion of the word is requested.
In part (b) please correct the plural “NOs” to “NO”.
Deletion of part (c) is requested because it has the same scope as (b).
Claim 2 is objected to because it uses hybrid Markush group terminology. The conjunction “and” should be used with “selected from the group consisting of.” Or, use “or.”
Claim 3 is objected to because it recites “the regulatory element” when “regulatory element” does not appear before the recitation.
Further, in parts (a), (b), and (c) the word “of” can be interpreted as “derived from” which would broaden the scope of the claim. Deletion of the word is requested. See the rejection under 35 USC 112(a)’s written description requirement below.
In part (c) please correct the plural “NOs” to “NO”.
Claim 4 is objected to because it recites “comprises” instead of “comprising” although the claim could also be rewritten to accommodate using the verb “comprises.”
Claim 8 objected to because it recites “the nucleic acid molecule of claim 1” instead of “the recombinant polynucleotide of claim 1.”
Claims 10 and 11 are objected to because the “transgenic plant” referenced in line 1 of each cannot be a “plant cell” except in the embodiment of single-cell plants such as algae. However that is not relevant given the requirements of dicot or monocot.
Claim 20 is objected to because In part (a) it recites “a nucleotide sequence comprising the nucleotide sequence of SEQ ID NO:4” which has redundant limitations; see for example claim 1, part (a) which uses “polynucleotide” for the first “nucleotide sequence.”
In parts (a),and (c) the word “of” can be interpreted as ‘derived from’ which would broaden the scope of the claim. Deletion of the word is requested. See also the rejection under 35 USC 112(a)’s written description requirement below.
In part (c) please correct the plural “NOs” to “NO”.
Claim 20 is further objected to because it actually does not require the presence of a heterologous polynucleotide even though that seems to be Applicant’s intention. This is reflected in some of the rejections (e.g. under 35 USC 112(b)).
Claim 21 is objected to because it uses hybrid Markush group terminology. The conjunction “or” should be used without “selected from the group consisting of.” Or, at the end of the claim, replace the “and” with “or”.
Claim 22 is objected to because it recites the limitation “said a” – “a” should be deleted.
Appropriate correction is requested.
35 USC § 112(b)-Based Claim Rejections
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 3-12, 21-23 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 3 is rejected because it recites “the regulatory element polynucleotide.” This limitation lacks an antecedent basis.
Claim 8 is rejected because it recites the limitation “the nuclei acid molecule of claim 1.” Claim 8 should be amended to conform with the terminology use in claim 1 (“polynucleotide”). As it stands “the nuclei acid molecule of claim 1” lacks an antecedent basis.
Claim 21 and 23 are rejected because the limitation “the heterologous polynucleotide” lacks an antecedent basis. Claim 22 is included in this because of its use of “said” instead of “the” used in claims 21 and 23.
Claim 22 because is rejected because it states that “said [
Therefore the metes and bounds of these claims cannot be determined.
35 USC § 112(a) based Claim Rejections
The following is a quotation of 35 U.S.C. 112(a):
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.
Claims 3-26 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 claims contain 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.
Claim 1 is drawn to a recombinant polynucleotide at least 95% sequence identical to SEQ ID NO:4 or fragments thereof. Independent claim 3 adds a heterologous polynucleotide to a genus that is similar in scope to that of claim 1.
Claim 20 is drawn to a method of using the same polynucleotide to increase expression of a heterologous polynucleotide.
Claim 1 does not require any activity associated with the polynucleotide – it is merely an abstract claim to a polynucleotide.
Several claims, such as 3, 5 and 6 also have a limitation of a heterologous polynucleotide so an activity can be inferred given the “the regulatory element polynucleotide” limitation.
The genus encompassed by, for example, claim 1, includes molecules with sequences at least 95% sequence-identical to SEQ ID NO:4. If such a molecule is used as a promoter or another expression-enhancing sequence, this genus satisfies the written description requirement of 35 USC 112(a).
However, claim 1 also includes the genus of fragments of SEQ ID NO:4 with no lower limit on the size of the fragment.
Certainly the TATA box is known to have promoter activity tin the art, but the same cannot be said for other fragments of SEQ ID NO:4.
Further, claims 3 and 20 use the terminology “of SEQ ID NO” then referencing SEQ ID NO:4. One meaning of “of” is “derived from” and thus using the term here broadens the scope of the claimed genus.
The Federal Circuit court 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. Further, the court stated that to adequately describe a claimed genus, Applicant must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of members of the genus." Id.
Applicant describes in Table 2 that SEQ ID NO:4 is from “BYDV (Bean Yellow Dwarf Virus, para. 0017). In Table 1, following that paragraph, it is “full length” and NOT synthetic.
In Table 2, Applicant describes the results of using SEQ ID NO:12 as a promoter expressing the GUS gene. Id., p. 37. Also Table 3. Id., p. 38.
Applicant does not describe, however, sequence variants of SEQ ID NO:4 or fragments of SEQ ID NO:4.
Given the promoter art, if the nucleic acid molecules are indeed claimed as promoters, given a working example, it is reasonable to interpret the genus of sequence-variants at least 95% sequence identical to SEQ ID NO:4 as being fully described. However that does not apply to fragments.
The art generally describes promoters 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 in general describes 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.
Applicant only describes the full-length sequence of SEQ ID NO:4
The claimed genera include all fragments of any length of SEQ ID NO:4. In contrast, the art teaches that “[e]ndogenous plant promoters are generally considered to be long and weak — they are generally more than 1 kb in size and are much weaker than virus-based constitutive promoters that have been commonly used in plant biotechnology.” Liu et al. (2013) “Advanced genetic tools for plant biotechnology,” Nat Rev Genet 14:781-93, 782. In a specific example, Cho & Cosgrove found that deletions below 142 base pairs of the studied promoter were inactive. Cho & Cosgrove (2002) Plant Cell 14:3237-53, 3246.
The instant specification fails to provide sufficient descriptive information, such as definitive structural characteristics of the features necessary and sufficient for a nucleotide comprising SEQ ID NO:4 to act as a promoter or other type of expression-enhancing nucleotide sequence.
Given the lack of written description in the specification plus the lack of knowledge in the prior art as it relates to SEQ ID NO:4, one of skill in the art would not believe that Applicant was in possession of the broad genus of fragments claimed at the time of filing the instant application. Dependent claims are included in this rejection because none provide further limitations obviating this rejection.
Claims 1 and 2 are not included because no activity or function is required. However, see below.
Claims 1 and 2, 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.
The enablement requirement requires that Applicant teaches how to make and use the claimed invention. There is no teachings in the Application how to use the full genus of claimed fragments. The claims read on fragments of as little as two nucleotides. No use is taught for such fragments.
Further, claim 1, for example, does not recite a functional limitation. Not does claim 2. The nucleic acid molecules are being claimed as if they are an abstract DNA synthesis experiment. Although the molecules may have use as promoters, for example, that is not required by the above claims.
The genera claimed are not obviously and intrinsically functional therefore they fail to satisfy the “make and use” part of the enablement requirement.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
6. Claims 1, 13, 14, 20, and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to a natural phenomenon without significantly more.
As seen in the alignment below, fragments of SEQ ID NO:4 are found in the Chickpea chlorotic dwarf virus. Further, on page 4 Applicant teaches that SEQ ID NO:4 is a “Full Length” sequence from BYDV (“Bean Yellow Dwarf Virus”) and is NOT “Synthetic.”
Claim 1 reads on fragments of SEQ ID NO:4. Thus at least the embodiment of claim 1 in the alignment below represents a naturally-occurring nucleic acid molecule.
Applicant does not define “recombinant” as requiring heterologous sequences. Applicant defines “recombinant” on paragraph 0033 of the specification but the definition equates the term with “isolated: and thus it can merely be interpreted as a step in how a sequence is assembled and thus can be interpreted as a product-by-process claim. See, e.g. MPEP § 2113. Since “recombinant” does not necessarily result in a structural difference, it is interpreted as reading on the native sequence.
Thus the claimed invention is directed to non-statutory subject matter because the claimed invention is directed to a naturally-occurring nucleic acid or fragment thereof, whether isolated or not, that is not patent-eligible pursuant to the Supreme Court decision in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 133 S.Ct. 2107, 186 L.Ed.2d 124, 106 USPQ2d 1972 (2013).
Claims 20-25 are included in this rejection because claim 20 recites the limitation “capable of increasing expression of a heterologous polynucleotide.” Thus claim 20 actually does not require the presence of a heterologous polynucleotide, let alone operably linkage. Further, the life cycle of a virus includes entry into a cell.
Additionally, the genera of claimed nucleotide molecules includes fragments such as a TATA box.
Claim 24 is included because beans are dicots.
Claims 13 and 14 are included in this rejection because Fang et al. teaches that SEQ ID NO:1 is a viral promoter. Fang et al., para. 0257. Fang et al. U.S. Patent Publication No. 2011/0287936 A1. (The alignment of SEQ ID NO:1 with Fang et al.’s SEQ ID NO:581 is provided below a rejection under 35 USC 102).
KM229770/c
LOCUS KM229770 2573 bp ss-DNA circular VRL 16-DEC-2014
DEFINITION Chickpea chlorotic dwarf virus isolate CpCDV_C_SD_SD16_2013,
complete genome.
ACCESSION KM229770
VERSION KM229770.1
KEYWORDS .
SOURCE Chickpea chlorotic dwarf virus
ORGANISM Chickpea chlorotic dwarf virus
Viruses; Monodnaviria; Shotokuvirae; Cressdnaviricota;
Repensiviricetes; Geplafuvirales; Geminiviridae; Mastrevirus;
Mastrevirus cicerparvi.
REFERENCE 1 (bases 1 to 2573)
AUTHORS Kraberger,S., Kumari,S.G., Hamed,A.A., Gronenborn,B., Thomas,J.E.,
Sharman,M., Harkins,G.W., Muhire,B.M., Martin,D.P. and Varsani,A.
TITLE Molecular diversity of Chickpea chlorotic dwarf virus in Sudan:
High rates of intra-species recombination - a driving force in the
emergence of new strains
JOURNAL Infect. Genet. Evol. 29, 203-215 (2015)
PUBMED 25444941
REFERENCE 2 (bases 1 to 2573)
AUTHORS Kraberger,S., Kumari,S.G., Hamed,A.A., Gronenborn,B., Martin,D.P.
and Varsani,A.
TITLE Direct Submission
JOURNAL Submitted (24-JUL-2014) Biological Sciences, University of
Canterbury, Level 2 Biology Building, Christchurch 8014, New
Zealand
COMMENT ##Assembly-Data-START##
Assembly Method :: DNA Baser v. V4
Sequencing Technology :: Sanger dideoxy sequencing
##Assembly-Data-END##
FEATURES Location/Qualifiers
source 1..2573
/organism="Chickpea chlorotic dwarf virus"
/mol_type="genomic DNA"
/isolate="CpCDV_C_SD_SD16_2013"
/host="Cicer arietinum"
/db_xref="taxon:463360"
/geo_loc_name="Sudan"
/collection_date="2013"
CDS 1..279
/codon_start=1
/product="movement protein"
/protein_id="AIY32715.1"
/translation="MERILYQVFPTDTNYSYDPPPVNTYSQGSSQTDFGKVVVALVVI
LVSVGVFYLAYSLFLKDCILLFKAKKQRTTTEIGFGQTPARNQDHPQP"
CDS 292..1029
/codon_start=1
/product="capsid protein"
/protein_id="AIY32717.1"
/translation="MSTVTWGNKRKRSDRSSKAKSKSSGSYVPRSVSSRRESLQVATF
SWTSSGSGIKFSTGGAAYLVGNFPQGANDNCRHTNKTVLYKFMAKNTVYLDPSHYPKV
FKCPFTFWLVYDKAPGASVPSTGDIFEGPSLFPANPWTWTVSRAACHRFVVKKTWSVV
VESNGVDPGKAQSSSYYGPGPCNQIKSCNKFFKRLGVSTEWKNSSTGDVGDIKEGALY
IVGAPSQKSDVYVNGYFRVYFKSVGNQ"
CDS complement(join(1188..1601,1688..2278))
/codon_start=1
/product="replication-associated protein"
/protein_id="AIY32716.1"
/translation="MPSANKNFRFQSKYVFLTYPKCSSQRDDLFEFLWEKLTPFLIFF
LGVATELHQDGTTHYHALIQLDNRPHIRDPSFFDFEGNHPNIQPARNSKQVLDYISKD
GDIKTRGDFRDHKVSPRKSDARWRTIIQTATSKEEYLDMIKEEFPHEWATKLQWLEYS
ANKLFPPQPETYVSPFNESDLRCHEDLAQWRDTHLYQDERRLGARVPSLYICGPTRTG
KTTWARSLGRHNYWNGTIDFTTYDEHATYNVIDDIPFKFVPLWKQLIGCQFDFTVNPK
YGKKKKIKGGVPSIILTNRDEDWIPCMSEHQKEYFTDNCEIHYMDDGETFFARESSSH
"
CDS complement(1400..2278)
/codon_start=1
/product="RepA"
/protein_id="AIY32718.1"
/translation="MPSANKNFRFQSKYVFLTYPKCSSQRDDLFEFLWEKLTPFLIFF
LGVATELHQDGTTHYHALIQLDNRPHIRDPSFFDFEGNHPNIQPARNSKQVLDYISKD
GDIKTRGDFRDHKVSPRKSDARWRTIIQTATSKEEYLDMIKEEFPHEWATKLQWLEYS
ANKLFPPQPETYVSPFNESDLRCHEDLAQWRDTHLYQVSIDAYTLVHPVSYQQAQSDL
EWMADLTRTREGLELESPASTSADQLVPERPPGLEASDDTTTGMGPSTSPRTTNTRPT
MSLTTSLSSSSHCGSN"
ORIGIN
Query Match 68.3%; Score 176.8; Length 2573;
Best Local Similarity 87.5%;
Matches 217; Conservative 0; Mismatches 27; Indels 4; Gaps 2;
Qy 14 AACCCTAGTGGGCGGGAACTTTTCTACTTTAAATCTGGACCGCTCGTGCTAAAGCACTCG 73
||||||||||||||||||||||| | || |||||| |||||||| |||||| ||||
Db 2524 AACCCTAGTGGGCGGGAACTTTTTCAAATTCAATCTGAACCGCTCGCACTAAAGTGCTCG 2465
Qy 74 CGATAAGGTGGGGCCACGCCGGTAATATTAAAATTCGGCGTGGGCCCCCCTTGTCGCAAG 133
||||||||||||||||||||||||||||| ||| |||||||| ||||||||||||||||
Db 2464 CGATAAGGTGGGGCCACGCCGGTAATATT--AATGCGGCGTGGACCCCCCTTGTCGCAAG 2407
Qy 134 ACTTCGTCTTTAAGTAAATG--ACGTCATTTTCCACTAACTACTTAAATTACCAAAATGC 191
|||||||||||||||||||| |||| | ||||||| ||| | |||| |||| ||| |
Db 2406 ACTTCGTCTTTAAGTAAATGCCACGTAAGCTTCCACTTTCTATTCAAATGACCATAATAC 2347
Qy 192 CCTTGCCTCCATGCCTCCACGCCGGTTATAAGATAGAGTTTGAGGCAACCCCTCGGAGTC 251
||||| ||||||| ||||||||| |||||| ||||||||||||||||||||||||||||
Db 2346 CCTTGGCTCCATGGCTCCACGCCAGTTATATAATAGAGTTTGAGGCAACCCCTCGGAGTC 2287
Qy 252 ACAACAAC 259
||||||||
Db 2286 ACAACAAC 2279
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.
Claims 1, 3, 8 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by D’Aoust et al. (“DAeA”), WO 2012/058762 A1, published 10 May 2012.
As seen in the alignment below, SEQ ID NO:4 was known in the prior art to D’Aoust et al. as its SEQ ID NO:9. At the bottom of page 8, D’Aoust et al. writes “Figure 1E shows the nucleotide sequence of LIR-MCS-SIR+LIR (SEQ ID NO:9). UR (long intergenic region)- MCS (Multiple cloning site)- short intergenic region (SIR)+LIR sequence of 849 construct.
Claim 1 only requires the presence of SEQ ID NO:4 in a polynucleotide construct. It is clear from the discussion in the last full paragraph of page 49 (D’Aoust et al.) that is a recombinant construct. Thus D’Aoust et al. anticipates claim 1.
The use of constructs to express heterologous nucleotide sequences is disclosed in D’Aoust et al. (e.g. paras. 0045, 0074, 0075, and 0104. Thus D’Aoust et al. anticipates claim 3.
D’Aoust et al. discloses stable transformation (para. 0102) and thus anticipates claim 8.
Claim 20 features the construct of claim 1 used in a method to express an operably linked gene. D’Aoust et al.’s paragraph 0105 anticipates claim 20.
D’Aoust et al.’s SEQ ID NO:4
US-15-778-542-4
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 4, US/15778542
Publication No. US20180346924A1
GENERAL INFORMATION
APPLICANT: Pioneer Hi-Bred International, Inc.
APPLICANT: E.I. du Pont De Nemours and Company
TITLE OF INVENTION: PLANT REGULATORY ELEMENTS AND METHODS OF USE THEREOF
FILE REFERENCE: 5307WOPCT
CURRENT APPLICATION NUMBER: US/15/778,542
CURRENT FILING DATE: 2018-05-23
NUMBER OF SEQ ID NOS: 14
SEQ ID NO 4
LENGTH: 259
TYPE: DNA
ORGANISM: Bean Yellow Dwarf Virus
Query Match 100.0%; Score 259; Length 259;
Best Local Similarity 100.0%;
Matches 259; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TGTGAACACCTTTAACCCTAGTGGGCGGGAACTTTTCTACTTTAAATCTGGACCGCTCGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 TGTGAACACCTTTAACCCTAGTGGGCGGGAACTTTTCTACTTTAAATCTGGACCGCTCGT 60
Qy 61 GCTAAAGCACTCGCGATAAGGTGGGGCCACGCCGGTAATATTAAAATTCGGCGTGGGCCC 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GCTAAAGCACTCGCGATAAGGTGGGGCCACGCCGGTAATATTAAAATTCGGCGTGGGCCC 120
Qy 121 CCCTTGTCGCAAGACTTCGTCTTTAAGTAAATGACGTCATTTTCCACTAACTACTTAAAT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 CCCTTGTCGCAAGACTTCGTCTTTAAGTAAATGACGTCATTTTCCACTAACTACTTAAAT 180
Qy 181 TACCAAAATGCCCTTGCCTCCATGCCTCCACGCCGGTTATAAGATAGAGTTTGAGGCAAC 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 TACCAAAATGCCCTTGCCTCCATGCCTCCACGCCGGTTATAAGATAGAGTTTGAGGCAAC 240
Qy 241 CCCTCGGAGTCACAACAAC 259
|||||||||||||||||||
Db 241 CCCTCGGAGTCACAACAAC 259
35 USC § 102 Based Claim Rejections (2nd)
Claims 12-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fang et al. U.S. Patent Publication No. 2011/0287936 A1.
As seen in the alignment in the rejection under 35 USC 103 below, SEQ ID NO:1 was known in the prior art as SEQ ID NO:851 to Fang et al.
Fang et al. discloses using its SEQ ID NO:851 in a construct. Fang et al., para. 0257. Therefore Fang et al. anticipates claims 12-14.
Claim 15 requires stable transformation and claims 16-18 recite various plant cells. Fang et al. discloses stable transformation in paragraph 0134. Fang et al.’s claim 6 claims transformed tobacco and wheat cells and thus anticipates claims 15-18. Fang et al.’s claim 1 anticipates claim 19.
35 USC § 103-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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
§ 103. Conditions for patentability; non-obvious subject matter
A patent for a claimed invention may not be obtained, . . . . if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 3, 4, 5, 6, 7, 8, 9-11, 12, 13-19, 20, 21, 23, 24-26, are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over D’Aoust et al. WO 2012/058762 A1, published 10 May 2012 in view of Fang et al. 2011/0287936 A1.
As seen in the alignment above in the rejection under 35 USC 102, D’Aoust et al. teaches SEQ ID NO:4 as its SEQ ID NO:9. At the bottom of page 8, D’Aoust et al. writes “Figure 1E shows the nucleotide sequence of LIR-MCS-SIR+LIR (SEQ ID NO:9). UR (long intergenic region)- MCS (Multiple cloning site)- short intergenic region (SIR)+LIR sequence of 849 construct.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims at issue.
c. Resolving the level of ordinary skill in the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1 only requires the presence of SEQ ID NO:4 in a polynucleotide construct.
Thus claim 1 is obvious since it is also anticipated (supra).
Anticipation is the epitome of obviousness (MPEP § 1207.03(a)(ll)(2) (quoting In re May, 574 F.2d 1082, 1089 (CCPA 1978) (citing In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974)).
D’Aoust et al. teaches the use of constructs to express heterologous nucleotide sequences (e.g. paras. 0045, 0074, 0075, and 0104).
Thus claim 3 is obvious and also anticipated (supra).
D’Aoust et al. does not teach the limitations in some of the dependent claims listed below. However, the additional limitations were known in the prior art and an ordinary artisan would be motivated to combine there references to use the expression-enhancing sequence taught by D’Aoust et al. in different contexts. An ordinary artisan would have a reasonable expectation of success since the combinations use techniques firmly established in the art.
As seen in the alignment below, SEQ ID NO:1 is taught by the prior art as a promoter and/or an enhancer; Fang et al.’s SEQ ID NO:481. Fang et al., para. 0257. Using SEQ ID NO:1 as a promoter or enhancer in conjunction and in a construct with instant SEQ ID NO:4 is obvious, and thus claims 2 and 4 are obvious.
Claim 5 broadly claims a gene of agronomic interest. This is obvious at least in view of Fang et al.’s claim 3 and its discussion in the bottom of paragraph 0102. Since herbicide tolerance is taught in paragraph 0102, claim 6 is obvious. Since insect tolerance is taught in paragraph 0102, claim 7 is obvious.
D’Aoust et al. teaches stable transformation (para. 0102) and thus claim 8 is obvious and also anticipated (supra).
Claims 9-11 require transformation of monocot and dicot plant cells and these claims are obvious in view of Fang et al.’s claim 6 (tobacco and wheat). Claim 12 is obvious in view of the seed in Fang et al. claim 1.
Claim 20 features the construct of claim 1 used in a method to express an operably linked gene. Claim 20 is obvious in Fang et al.’s paragraph 0105.
Claim 21 is obvious in view of the listing of beneficial traits in Fang et al.’s paragraph 0102 (growth stimulation and yield). Claim 23’s herbicide resistance is also obvious in view of the same paragraph.
Claims 24-26 are also obvious in view of the claim limitations discussed above.
As seen above, claims 13-19 as well as claim 12 are anticipated by Fang et al.
Since anticipation is the epitome of obviousness (MPEP § 1207.03(a)(II)(2) (quoting In re May, 574 F.2d 1082, 1089 (CCPA 1978) (citing In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974)) these claims properly included in the instant rejection under 35 USC 103.
Fang et al.’s SEQ ID NO:851
US-13-086-765-851
; Sequence 851, Application US/13086765
; Publication No. US20110287936A1
; GENERAL INFORMATION
; APPLICANT: Fang, Jin
; APPLICANT:Gordon-Kamm, William
; APPLICANT:Lowe, Keith
; APPLICANT:McBride, Kevin E.
; APPLICANT:McGonigle, Brian E.
; APPLICANT:Simmons, Carl
; TITLE OF INVENTION: GENE SWITCH COMPOSITIONS AND METHODS OF USE
; FILE REFERENCE: 035718/403001
; CURRENT APPLICATION NUMBER: US/13/086,765
; CURRENT FILING DATE: 2011-04-14
; PRIOR APPLICATION NUMBER: US 61/327,172
; PRIOR FILING DATE: 2010-04-23
; NUMBER OF SEQ ID NOS: 866
; SOFTWARE: PatentIn version 3.5
; SEQ ID NO 851
; LENGTH: 384
; TYPE: DNA
; ORGANISM: Mirabilis mosaic virus
US-13-086-765-851
Query Match 100.0%; Score 187; DB 41; Length 384;
Best Local Similarity 100.0%;
Matches 187; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CCACTAAAACATTGCTTTGTCAAAAGCTAAAAAAGATGATGCCCGACAGCCACTTGTGTG 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 75 CCACTAAAACATTGCTTTGTCAAAAGCTAAAAAAGATGATGCCCGACAGCCACTTGTGTG 134
Qy 61 AAGCATGAGAAGCCGGTCCCTCCACTAAGAAAATTAGTGAAGCATCTTCCAGTGGTCCCT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 135 AAGCATGAGAAGCCGGTCCCTCCACTAAGAAAATTAGTGAAGCATCTTCCAGTGGTCCCT 194
Qy 121 CCACTCACAGCTCAATCAGTGAGCAACAGGACGAAGGAAATGACGTAAGCCATGACGTCT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 195 CCACTCACAGCTCAATCAGTGAGCAACAGGACGAAGGAAATGACGTAAGCCATGACGTCT 254
Qy 181 AATCCCA 187
|||||||
Db 255 AATCCCA 261
35 USC § 103-based Claim Rejections – 2nd
Claim 22 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over D’Aoust et al. WO 2012/058762 A1, published 10 May 2012 in view of Fang et al. 2011/0287936 A1 in further view of Vance et al.; 2004/0268441 A1.
Neither D’Aoust et al. nor Fang et al. reference teaches increasing the expression of an endogenous gene. However, that is obvious in view of the prior art. See, for example, Vance et al.; 2004/0268441 A1 (abstract). Therefore claim 22 is obvious.
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).
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.
Claims 1-3, 5-12 and 20-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 U.S. Patent No. 7,411,112 B2 (2008-08-12) “Maize Promoter Named CRWAQ81.”
Although the claims at issue are not identical, they are not patentably distinct from each other because of the reasons as follows.
In the description of Figures 2A and 2B at the top of column 3, Diehn et al. teaches a TATA box. With no minimum length in part (d)s of claims 1 and 20, claim 1, for example, reads on the construct claimed in Diehn et al.’s claim 1.
The claims that are not rejected also require one of SEQ ID NOs:1-3.
Conclusion
No claim is allowed.
The following art, though not relied upon, is considered pertinent to Applicant’s claimed invention.
The alignment shows that SEQ ID NO:4 matches to Mason et al.’s SEQ ID NO:1 as a complement, but the claim includes within its scope DNA polynucleotides.
Mason et al. identifies is as from bean yellow dwarf virus.
Mason et al. US Patent Publication No. 2003/0079248 A1.
US-10-151-336-1/c
Sequence 1, US/10151336
Publication No. US20030079248A1
GENERAL INFORMATION
APPLICANT: Mason, Hugh
APPLICANT: Palmer, Kenneth
APPLICANT: Hefferon, Kathleen
APPLICANT: Mor, Tsafrir
APPLICANT: Arntzen, Charles
TITLE OF INVENTION: Gemini Virus Vectors for Gene Expression in Plants
FILE REFERENCE: 4868/84453
CURRENT APPLICATION NUMBER: US/10/151,336
CURRENT FILING DATE: 2002-05-20
PRIOR APPLICATION NUMBER: US/09/414,276
PRIOR FILING DATE: 1999-10-07
NUMBER OF SEQ ID NOS: 22
SEQ ID NO 1
LENGTH: 303
TYPE: DNA
ORGANISM: bean yellow dwarf virus
Query Match 100.0%; Score 259; Length 303;
Best Local Similarity 100.0%;
Matches 259; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TGTGAACACCTTTAACCCTAGTGGGCGGGAACTTTTCTACTTTAAATCTGGACCGCTCGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 265 TGTGAACACCTTTAACCCTAGTGGGCGGGAACTTTTCTACTTTAAATCTGGACCGCTCGT 206
Qy 61 GCTAAAGCACTCGCGATAAGGTGGGGCCACGCCGGTAATATTAAAATTCGGCGTGGGCCC 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 205 GCTAAAGCACTCGCGATAAGGTGGGGCCACGCCGGTAATATTAAAATTCGGCGTGGGCCC 146
Qy 121 CCCTTGTCGCAAGACTTCGTCTTTAAGTAAATGACGTCATTTTCCACTAACTACTTAAAT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 145 CCCTTGTCGCAAGACTTCGTCTTTAAGTAAATGACGTCATTTTCCACTAACTACTTAAAT 86
Qy 181 TACCAAAATGCCCTTGCCTCCATGCCTCCACGCCGGTTATAAGATAGAGTTTGAGGCAAC 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 85 TACCAAAATGCCCTTGCCTCCATGCCTCCACGCCGGTTATAAGATAGAGTTTGAGGCAAC 26
Qy 241 CCCTCGGAGTCACAACAAC 259
|||||||||||||||||||
Db 25 CCCTCGGAGTCACAACAAC 7
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/RUSSELL T BOGGS/Examiner, Art Unit 1663
Prosecution Insights