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 .
Election/Restrictions
Applicant's election with traverse of Group I comprising claims 1-2, 6 and 8 in the reply filed on 3/27/2026 is acknowledged. The traversal is on the ground(s) that the restriction requirement between Group I and Group II because both groups of inventions are directed to a nucleic acid molecule comprising the subject matter recited in claim 1, and should have been grouped together (response, bridging paragraph between page 14 and 14).
This is not found persuasive because the invention of Group I is directed to a promoter sequence having at least 95% sequence identity to any one of SEQ ID NOs: 1-3. The invention of Group I does not need sequence identity to SEQ ID NOs: 6-8 and 12-35 and also does not require any guide RNA unlike invention of Group II. In contrast, Group II is drawn to a DNA construct comprising: (a) the nucleic acid molecule of claim 1; a promoter molecule comprising a nucleic acid sequence that has at least 80% sequence identity to any one of SEQ ID NOs: 6-8 and 12-35; or a promoter molecule comprising a nucleic acid sequence of any one of SEQ ID NOs: 6-8 and 12-35. Invention of Group II comprises guide RNA.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-2, 6, 8, 12-13, 19, 22, 25-26, 36-37, 39, 40, 51, 54, 59-61, and 63 are pending.
Claims 12-13, 19, 22, 25-26, 36-37, 39, 40, 51, 54, 59-61 and 63 are withdrawn. As part of non-elected groups.
Claim 1-2, 6 and 8 are being examined.
It is noted that claims 2 and 6 have the status indicator “Currently Amended”, but do not comprise an amendment. The status should be “Previously Presented”. MPEP 714(II)(C)
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 6 and 8 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.
Claim 8 recites, “… (a) wherein the promoter sequence comprises: (i) a nucleic acid sequence that has at least 80% sequence identity to SEQ ID NO: 6, further comprising the one or more synthetic motif sequences inserted therein; or (ii) the nucleic acid sequence of SEQ ID NO: 6…” (line 2-4); “(b) wherein the promoter sequence comprises: (i) a nucleic acid sequence that has at least 80% sequence identity to any one of SEQ ID NOs: 9-11, and 79-81, or (ii) the nucleic acid sequence of any one of SEQ ID NOs: 9-11, and 79-81…” (line 6-8) (emphases added).
Claim 8 depends from claim 1 which recites “…. the promoter sequence has transcription initiation function and comprises one or more synthetic motif sequences…” (line 2-3). The promoter sequence recited in claim 1 already comprises “one or more synthetic motif sequences”. It is not clear if the 80% sequence identity to SEQ ID NO: 6, as recited in claim 8, includes “one or more synthetic motif sequences” on top of “one or more synthetic motif sequences” in the promoter recited in claim 1.
Claim 6 recites the limitation "… inserted into the 5' untranslated region (UTR)…" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 6 depends from claim 1. Neither claim 1 nor claim 6 recite any 5' untranslated region (UTR) before reciting the “… inserted into the 5' untranslated region (UTR)”.
It is suggested to replace the underlined “the” with “a”.
Similarly, “5’ intron of said promoter sequence.” (line 3) renders the claim indefinite, as it has not previously been established that the promoter has an intron.
Claim Rejections - 35 USC § 102(a)(1)
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xia et al. (Pea polyubiquitin genes: (I) structure and genomic organization, 1998, Gene, 215:445–452).
Xia et al. describes a pea ((Pisum sativum) polyubiquitin gene, PUB1 (abstract), GenBank Accession No. L81139 (page 445, left column, footnote para 2, line 2-3).
GenBank Accession No. L81139 describes a pea plant (Pisum sativum) comprising a promoter sequence having at least 95% (96.3%) sequence identity to instant SEQ ID NOs: 2, as shown below.
RESULT 4
L81139
LOCUS L81139 2536 bp DNA linear PLN 07-JAN-1999
DEFINITION Pisum sativum (Alaska) ubiquitin (PUB1) gene, complete cds.
ACCESSION L81139
VERSION L81139.1
SOURCE Pisum sativum (garden pea)
ORGANISM Pisum sativum
Eukaryota; Viridiplantae; Streptophyta; Embryophyta; Tracheophyta;
Spermatophyta; Magnoliopsida; eudicotyledons; Gunneridae;
Pentapetalae; rosids; fabids; Fabales; Fabaceae; Papilionoideae; 50
kb inversion clade; NPAAA clade; Hologalegina; IRL clade; Fabeae;
Pisum.
REFERENCE 1 (bases 1 to 2536)
AUTHORS Xia,X. and Mahon,J.
TITLE Pea polyubiquitin genes: (I) structure and genomic organization
JOURNAL Gene 215 (2), 445-452 (1998)
PUBMED 9714844
COMMENT GSDB:S:1048240.
FEATURES Location/Qualifiers
source 1..2536
/organism="Pisum sativum"
/mol_type="genomic DNA"
/variety="ponderosum"
/cultivar="Alaska"
/db_xref="taxon:3888"
/dev_stage="seedling"
gene 1..1962
/gene="PUB1"
exon <1..4
/gene="PUB1"
/note="putative"
intron 5..588
/gene="PUB1"
/note="putative"
CDS 589..1962 (cDNA sequence)
/gene="PUB1"
/note="putative"
/codon_start=1
/product="ubiquitin"
/protein_id="AAD03341.1"
/translation="MQIFVKTLTGKTITLEVESSDTIDNVKAKIQDKEGIPPDQQRLI
FAGKQLEDGRTLADYNIQKESTLHLVLRLRGGMQIFVKTLTGKTITLEVESSDTIDNV
KAKIQDKEGIPPDQQRLIFAGKQLEDGRTLADYNIQKESTLHLVLRLRGGMQIFVKTL
TGKTITLEVESSDTIDNVKAKIQDKEGIPPDQQRLIFAGKQLEDGRTLADYNIQKEST
LHLVLRLRGGMQIFVKTLTGKTITLEVESSDTIDNVKAKIQDKEGIPPDQQRLIFAGK
QLEDGRTLADYNIQKESTLHLVLRLRGGMQIFVKTLTGKTITLEVESSDTIDNVKAKI
QDKEGIPPDQQRLIFAGKQLEDGRTLADYNIQKESTLHLVLRLRGGMQIFVKTLTGKT
ITLEVESSDTIDNVKAKIQDKEGIPPDQQRLIFAGKQLEDGRTLADYNIQKESTLHLV
LRLRGGF
Best Local Similarity 96.3%; Query Match 94.1%; Score 25.4; Length 2536;
Matches 26; Conservative 0; Mismatches 1; Indels 0; Gaps 0;
Qy 1 ATTAAATTTTCAGATCTGATTATGTAT 27
||||||||||| |||||||||||||||
Db 319 ATTAAATTTTCGGATCTGATTATGTAT 345
Sequence analysis indicates that the sequence identity to instant SEQ ID NO: 2 starts at position 319 and ends at 345, as shown above. Further sequence analysis reveals that the mRNA it encodes starts at position 589 and ends at 1962, as shown below within the black box. Sequence at position 5 to 588 in GenBank Accession number L81139 is identified as an intron, which is also described by Xia et al. (Fig. 2), as recited in claim 6, as shown above. Transcription start site of the gene is identified at position (+) 1 (Xia et al.; Fig. 2; p. 448, right column, para 3, line 1-7) and as described by GenBank Accession number L81139.
The term “synthetic” does not confer any structure but merely recites how the nucleic acid is made. The claims reciting “synthetic motif sequence” is not patentably distinct and does not differentiate the product from naturally occurring products.
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Regarding claim 2, Xia et al. describe the promoter sequence comprises a TATA box and a CAAT box motifs (page 448, right column, para 3, line 5-8). Xia et al. also describes other short sequences (which reads on “motifs”, as defined by the Applicant) similar to the heat shock elements found in Drosophila and the conserved G-box motif in plant light inducible gene family (page 448, right column, para 3, line 8-17) in the promoter of pea polyubiquitin gene(s). All these specific short sequences read on to “motifs”, as defined by the Applicant as follows, “the synthetic motif sequence can be a sequence that is not present in the original promoter sequence to which the synthetic motif sequence is inserted (e.g. heterologous to the original promoter sequence). The synthetic motif sequence can be a sequence that shares less than 80% similarity with any part of the original promoter sequence to which the synthetic motif sequence is inserted. Alternatively, the synthetic motif sequence can be a sequence that shares at least 80-100% sequence similarity with, or identical to, part of the original promoter sequence (Spec, page 26, para 1, line 21-28).
Any nucleotide sequence linking those motifs and other polynucleotide sequences upstream and/or downstream of such motifs read on to “linkers”, as defined by the Applicant as, “a linker as used herein refers to a nucleic acid molecule that connects two nucleic acid molecules or structures (Spec, page 26, last para, line 1-2).
Regarding claim 8, Sequence alignment between the upstream promoter sequence in the polyubiquitin PUB1 gene (sequence from position 1 to 596 of GenBank Accession No. L81139) and instant SEQ ID NO: 11 shows mutations from 167-1894, 2229-2231, 2239 and 2241, as shown below (mutations at the positions highlighted in grey). Any sequence deleted or having a mismatch in the nucleic acid sequence set forth by GenBank Accession No. L81139 are considered as mutations in relation to instant SEQ ID NO: 11.
Title: US-18-708-497-11
Perfect score: 2604
Sequence: 1 gttgctgaatcagaagttga..........gtttgtttctgataatatag 2604
Searched: 1 seqs, 588 residues
Database : NASEQ2_04222026_103831.fasta:*
RESULT 1
NASEQ2_04222026_103831
Best Local Similarity 51.0%;Query Match 1.9%; Score 48.2; DB 1; Length 588;
Matches 175; Conservative 0; Mismatches 153; Indels 15; Gaps 2;
Qy 2206 TTCGTTCAATATTTTTATGATCGAAGGACGTCCATTTCTGTTTTTAGGGTTTGTATACTA 2265
|| ||| | ||| | || | ||| || | | |||| | | | ||
Db 259 TTGATTCGTTCAATTTTGTGTTGATCAAGGTCGATCTTTTGATTTATGATAACGCTGTTA 318
Qy 2266 AATTTCTCATAGCAGAGGATTATATAGCTTAGTTATAGAACCTTCTTTATTTAGATTAGT 2325
| | | | | | |||||| || || | | |||| || || |||||||
Db 319 ATTAAATTTTCGGATCTGATTATGTATTCTATGATTCTAGAGTTCTCTAATTGGATTAGT 378
Qy 2326 CCAGGGGTACTTGTTGCCTTTATATATGCATCATGTCTCTAGTTTTGTCTGAATTTTTTT 2385
|||| || | || | || | | || | | | | ||| |
Db 379 TTAGGGATATTGATTTCGATT--------------TATATATTGATTTGAAATGATTTAT 424
Qy 2386 CTTCTGTATATGTGTAATTTAGTATTGCTACCCAAATTAATTATTGATTGATTAGGGGAA 2445
| || | | | || ||| | | ||||| ||| ||| | ||
Db 425 TGAATTGTAATTTTGTAATCAGGGTTGTTGTTTGATTTAATGATT-ATTTAGGAGTTTGG 483
Qy 2446 CTTGAAGTTTATAAGATGTTTCCTGTAAATAGAAGTGGTTATATTGGTTGATTTTATGCT 2505
| | ||| || | | |||| |||||| || |||| | |||| |||||||
Db 484 TTGATTGCATATTTGAAATGTTGTGTATATAGAATTGATTATTTCTACTGATGTTATGCT 543
Qy 2506 TCTTTTGTTTGTTACATGTGGTTTTTCTGTGTTGTAATGATCT 2548
| | || ||| | ||| || | ||| || ||||| |
Db 544 TGTAGTGATTGATTCATTGTTTTCGTTTGTTTTTGTATGATAT 586
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.
Claims 1-2, 6 and 8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more. The claims are drawn to a nucleic acid molecule comprising a promoter sequence, wherein the promoter sequence has transcription initiation function and comprises one or more synthetic motif sequences, wherein each synthetic motif sequence comprises: (i) a nucleic acid sequence that has at least 95% sequence identity to any one of SEQ ID NOs: 1-3; or (ii) the nucleic acid sequence of any one of SEQ ID NOs: 1-3.
The claims are drawn to a “product”- a nucleic acid molecule. All the elements of the polynucleotide sequence, as part of the limitations of the claims, are naturally occurring in pea PUB1 gene (GenBank Accession No. L81139) and the promoter sequence thereof, as discussed in 35 USC 102 rejection above.
The transcription initiation function, as recited in the claims, is part of the naturally occurring promoter and does not amount to significantly more.
This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no active step involved by the Applicant to achieve the nucleic acid sequence present in naturally occurring PUB1 gene in a pea plant, as described by Xia et al. and in view of GenBank Accession No. L81139. All the limitations of the claims 1-2, 6 and 8 are described by Xia et al., as discussed above.
Moreover, the term “synthetic” does not confer any structure but merely recites how the nucleic acid is made. The claims reciting “synthetic motif sequence” is not patentably distinct and does not differentiate the product from naturally occurring products. As discussed in the rejection above, the pea PUB1 gene promoter comprises a sequence that has at least 95% sequence identity to instant SEQ ID NO: 2. The term, “synthetic”, does not impart any markedly different characteristics to the claimed nucleic acid molecule. The structure of the naturally occurring PUB1 promoter sequence has a structure encompassed by the instant claims, and has transcription initiation function.
Regarding claim 2, the claim recites, “… one or more linkers…”. As discussed above, any nucleotide sequence linking the motifs and other polynucleotide sequences upstream and/or downstream of such motifs read on to “linkers”, as defined by the Applicant (Spec, page 26, last para, line 1-2). Thus, the naturally occurring sequences linking different motifs already present in the pea ubiquitin promote read on to linkers and does not add “significantly more” to the claim 2.
Regarding claim 6, the naturally occurring pea ubiquitin promoter comprises an intron. Sequence at position 5 to 588 in GenBank Accession number L81139 is identified as an intron, as discussed above. Thus, the naturally occurring pea ubiquitin promoter comprises an intron and does not add “significantly more” to the claim 6.
Conclusion
No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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/Jay Chatterjee/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
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