DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to an amendment filed 10/31/2025.
Claims 1-3, 6-8, 10, 13, 15, 18, 20, 25, 27-30, 32, 33, 36 and 37 are pending. Claims 25, 27, 28, 36 and 37 are withdrawn as directed to non-elected subject matter. Therefore, claims 1-3, 6-8, 10, 13, 15, 18, 20, 29, 30, 32 and 33 are under examination. The election was made without traverse.
The instant application is a 371 filing of PCT//US2020/056890 filed 11/22/2020 which claims priority to provisional application U.S. 62/924,567 filed 10/22/2019.
Election/Restrictions
Applicant's election without traverse of Group I (claims 1-3, 6-8, 10, 13, 15, 18, 20, 29, 30, 32 and 33) in the reply filed on 10/31/2025 is acknowledged. Claims 25, 27, 28, 36 and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.
Information Disclosure Statement
Information disclosure statements filed 10/23/2024, 7/18/2024 and 1/20/2023 have been identified and the documents considered. The corresponding signed and initialed PTO Form 1449 has been mailed with this action. Initials indicate that the document has been considered even if the reference is lined through.
Claim Objections
Claims 1, 2 and 7 are objected to because of the following informalities: claim 1 requires an article for grammatical purposes prior to “ORF in line 4.
It is noted that once allowable subject matter is identified only one set of abbreviation for ORF and OTC are required. Hence, claim 2 if claim 1 is found allowable will require amendment.
“ORF” is misspelled in claim 7 as OFR. Appropriate correction is required.
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.
Claim 33 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The term “cells” defined by the specification at ¶0020 states that the cell is in vivo. The scope of the claims, therefore encompasses a human being, which is non-statutory subject matter. As such, the recitation of the limitation “non-human” or “isolated” would be remedial. See 1077 O.G. 24, April 21, 1987.
Claim Rejections - 35 USC § 102
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.
Claims 2, 29, 30, 32 and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Monahan et al (US 20160206750).
As regards claim 2, Monahan teaches a construct comprising a sequence encoding OTC wherein the sequence is mRNA and comprises 99.5% identity to SEQ ID NO:4 (RNI search database). The first nucleotide alone is different. The sequence is mRNA and encodes OTC.
RESULT 2
US-14-908-351-114
(NOTE: this sequence has 4 duplicates in the database searched.
See complete list at the end of this report)
Sequence 114, US/14908351
Patent No. 9867885
GENERAL INFORMATION
APPLICANT: PhaseRx, Inc.
TITLE OF INVENTION: BLOCK COPOLYMERS
FILE REFERENCE: 3800.PCT1
CURRENT APPLICATION NUMBER: US/14/908,351
CURRENT FILING DATE: 2016-01-28
NUMBER OF SEQ ID NOS: 122
SEQ ID NO 114
LENGTH: 1221
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: mRNA encoding human ornithine transcarbamylase, codon-optimized
for human expression
Query Match 99.5%; Score 1220; Length 1221;
Best Local Similarity 100.0%;
Matches 1220; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 2 GGAAAUAAGAGAGAAAAGAAGAGUAAGAAGAAAUAUAAGAGCCACCAUGCUGUUUAACCU 61
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2 GGAAAUAAGAGAGAAAAGAAGAGUAAGAAGAAAUAUAAGAGCCACCAUGCUGUUUAACCU 61
Qy 62 GAGGAUUCUGCUGAACAACGCUGCUUUUCGGAACGGCCACAACUUUAUGGUGCGGAACUU 121
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 62 GAGGAUUCUGCUGAACAACGCUGCUUUUCGGAACGGCCACAACUUUAUGGUGCGGAACUU 121
Qy 122 UCGGUGCGGACAGCCACUGCAGAACAAAGUGCAGCUGAAGGGGAGGGACCUGCUGACCCU 181
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 122 UCGGUGCGGACAGCCACUGCAGAACAAAGUGCAGCUGAAGGGGAGGGACCUGCUGACCCU 181
Qy 182 GAAAAAUUUCACAGGAGAGGAAAUCAAGUACAUGCUGUGGCUGUCUGCCGAUCUGAAGUU 241
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 182 GAAAAAUUUCACAGGAGAGGAAAUCAAGUACAUGCUGUGGCUGUCUGCCGAUCUGAAGUU 241
Qy 242 CCGGAUCAAGCAGAAGGGCGAAUAUCUGCCACUGCUGCAGGGCAAAAGUCUGGGGAUGAU 301
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 242 CCGGAUCAAGCAGAAGGGCGAAUAUCUGCCACUGCUGCAGGGCAAAAGUCUGGGGAUGAU 301
Qy 302 CUUCGAAAAGAGGAGUACUCGGACCAGACUGUCAACAGAGACUGGAUUCGCUCUGCUGGG 361
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 302 CUUCGAAAAGAGGAGUACUCGGACCAGACUGUCAACAGAGACUGGAUUCGCUCUGCUGGG 361
Qy 362 AGGACACCCAUGCUUUCUGACCACACAGGACAUUCAUCUGGGCGUGAACGAGUCACUGAC 421
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 362 AGGACACCCAUGCUUUCUGACCACACAGGACAUUCAUCUGGGCGUGAACGAGUCACUGAC 421
Qy 422 CGACACAGCUCGAGUCCUGAGCUCCAUGGCAGAUGCCGUGCUGGCACGGGUCUACAAACA 481
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 422 CGACACAGCUCGAGUCCUGAGCUCCAUGGCAGAUGCCGUGCUGGCACGGGUCUACAAACA 481
Qy 482 GAGCGACCUGGAUACCCUGGCUAAGGAAGCAAGCAUCCCCAUCAUUAAUGGGCUGUCCGA 541
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 482 GAGCGACCUGGAUACCCUGGCUAAGGAAGCAAGCAUCCCCAUCAUUAAUGGGCUGUCCGA 541
Qy 542 CCUGUAUCACCCUAUCCAGAUUCUGGCCGAUUACCUGACCCUGCAGGAGCAUUAUUCUAG 601
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 542 CCUGUAUCACCCUAUCCAGAUUCUGGCCGAUUACCUGACCCUGCAGGAGCAUUAUUCUAG 601
Qy 602 UCUGAAAGGCCUGACACUGAGCUGGAUUGGGGACGGAAACAAUAUCCUGCACUCCAUUAU 661
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 602 UCUGAAAGGCCUGACACUGAGCUGGAUUGGGGACGGAAACAAUAUCCUGCACUCCAUUAU 661
Qy 662 GAUGUCUGCCGCUAAGUUUGGAAUGCAUCUGCAGGCAGCCACACCAAAAGGCUACGAACC 721
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 662 GAUGUCUGCCGCUAAGUUUGGAAUGCAUCUGCAGGCAGCCACACCAAAAGGCUACGAACC 721
Qy 722 CGAUGCCAGUGUGACUAAGCUGGCCGAACAGUAUGCUAAAGAGAACGGCACUAAGCUGCU 781
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 722 CGAUGCCAGUGUGACUAAGCUGGCCGAACAGUAUGCUAAAGAGAACGGCACUAAGCUGCU 781
Qy 782 GCUGACCAAUGACCCUCUGGAGGCUGCACACGGAGGCAACGUCCUGAUCACUGAUACCUG 841
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 782 GCUGACCAAUGACCCUCUGGAGGCUGCACACGGAGGCAACGUCCUGAUCACUGAUACCUG 841
Qy 842 GAUUUCCAUGGGCCAGGAGGAAGAGAAGAAAAAGCGCCUGCAGGCAUUCCAGGGGUACCA 901
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 842 GAUUUCCAUGGGCCAGGAGGAAGAGAAGAAAAAGCGCCUGCAGGCAUUCCAGGGGUACCA 901
Qy 902 GGUGACAAUGAAAACUGCCAAGGUCGCCGCUUCUGAUUGGACUUUUCUGCAUUGUCUGCC 961
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 902 GGUGACAAUGAAAACUGCCAAGGUCGCCGCUUCUGAUUGGACUUUUCUGCAUUGUCUGCC 961
Qy 962 CCGAAAACCUGAAGAGGUGGACGAUGAGGUCUUCUAUUCACCUAGGAGCCUGGUGUUUCC 1021
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 962 CCGAAAACCUGAAGAGGUGGACGAUGAGGUCUUCUAUUCACCUAGGAGCCUGGUGUUUCC 1021
Qy 1022 AGAAGCCGAGAAUCGCAAGUGGACAAUCAUGGCUGUGAUGGUGUCCCUGCUGACUGAUUA 1081
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1022 AGAAGCCGAGAAUCGCAAGUGGACAAUCAUGGCUGUGAUGGUGUCCCUGCUGACUGAUUA 1081
Qy 1082 UUCCCCCCAGCUGCAGAAACCUAAGUUCUGAGCGGCCGCUUAAUUAAGCUGCCUUCUGCG 1141
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1082 UUCCCCCCAGCUGCAGAAACCUAAGUUCUGAGCGGCCGCUUAAUUAAGCUGCCUUCUGCG 1141
Qy 1142 GGGCUUGCCUUCUGGCCAUGCCCUUCUUCUCUCCCUUGCACCUGUACCUCUUGGUCUUUG 1201
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1142 GGGCUUGCCUUCUGGCCAUGCCCUUCUUCUCUCCCUUGCACCUGUACCUCUUGGUCUUUG 1201
Qy 1202 AAUAAAGCCUGAGUAGGAAG 1221
||||||||||||||||||||
Db 1202 AAUAAAGCCUGAGUAGGAAG 1221
Claim 29 is taught by Monahan as well. The sequence below is found in search database SEQ ID NO:8, RNI. It shows the relationship is 99.9% related between SEQ ID NO:111 and SEQ ID NO:8. As to expression constructs, the sequences is linked to a T7 promoter (see below) and used to express OTC to produce OTC (see ¶0319).
RESULT 1
US-14-908-351-111
(NOTE: this sequence has 4 duplicates in the database searched.
See complete list at the end of this report)
Sequence 111, US/14908351
Patent No. 9867885
GENERAL INFORMATION
APPLICANT: PhaseRx, Inc.
TITLE OF INVENTION: BLOCK COPOLYMERS
FILE REFERENCE: 3800.PCT1
CURRENT APPLICATION NUMBER: US/14/908,351
CURRENT FILING DATE: 2016-01-28
NUMBER OF SEQ ID NOS: 122
SEQ ID NO 111
LENGTH: 1262
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: cDNA encoding human ornithine transcarbamylase, codon-optimized
for human expression
FEATURE:
NAME/KEY: promoter
LOCATION: (1)..(20)
OTHER INFORMATION: T7 promoter
Query Match 99.9%; Score 1225; Length 1262;
Best Local Similarity 100.0%;
Matches 1225; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 2 GGAAATAAGAGAGAAAAGAAGAGTAAGAAGAAATATAAGAGCCACCATGCTGTTTAACCT 61
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 19 GGAAATAAGAGAGAAAAGAAGAGTAAGAAGAAATATAAGAGCCACCATGCTGTTTAACCT 78
Qy 62 GAGGATTCTGCTGAACAACGCTGCTTTTCGGAACGGCCACAACTTTATGGTGCGGAACTT 121
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 79 GAGGATTCTGCTGAACAACGCTGCTTTTCGGAACGGCCACAACTTTATGGTGCGGAACTT 138
Qy 122 TCGGTGCGGACAGCCACTGCAGAACAAAGTGCAGCTGAAGGGGAGGGACCTGCTGACCCT 181
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 139 TCGGTGCGGACAGCCACTGCAGAACAAAGTGCAGCTGAAGGGGAGGGACCTGCTGACCCT 198
Qy 182 GAAAAATTTCACAGGAGAGGAAATCAAGTACATGCTGTGGCTGTCTGCCGATCTGAAGTT 241
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 199 GAAAAATTTCACAGGAGAGGAAATCAAGTACATGCTGTGGCTGTCTGCCGATCTGAAGTT 258
Qy 242 CCGGATCAAGCAGAAGGGCGAATATCTGCCACTGCTGCAGGGCAAAAGTCTGGGGATGAT 301
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 259 CCGGATCAAGCAGAAGGGCGAATATCTGCCACTGCTGCAGGGCAAAAGTCTGGGGATGAT 318
Qy 302 CTTCGAAAAGAGGAGTACTCGGACCAGACTGTCAACAGAGACTGGATTCGCTCTGCTGGG 361
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 319 CTTCGAAAAGAGGAGTACTCGGACCAGACTGTCAACAGAGACTGGATTCGCTCTGCTGGG 378
Qy 362 AGGACACCCATGCTTTCTGACCACACAGGACATTCATCTGGGCGTGAACGAGTCACTGAC 421
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 379 AGGACACCCATGCTTTCTGACCACACAGGACATTCATCTGGGCGTGAACGAGTCACTGAC 438
Qy 422 CGACACAGCTCGAGTCCTGAGCTCCATGGCAGATGCCGTGCTGGCACGGGTCTACAAACA 481
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 439 CGACACAGCTCGAGTCCTGAGCTCCATGGCAGATGCCGTGCTGGCACGGGTCTACAAACA 498
Qy 482 GAGCGACCTGGATACCCTGGCTAAGGAAGCAAGCATCCCCATCATTAATGGGCTGTCCGA 541
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 499 GAGCGACCTGGATACCCTGGCTAAGGAAGCAAGCATCCCCATCATTAATGGGCTGTCCGA 558
Qy 542 CCTGTATCACCCTATCCAGATTCTGGCCGATTACCTGACCCTGCAGGAGCATTATTCTAG 601
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 559 CCTGTATCACCCTATCCAGATTCTGGCCGATTACCTGACCCTGCAGGAGCATTATTCTAG 618
Qy 602 TCTGAAAGGCCTGACACTGAGCTGGATTGGGGACGGAAACAATATCCTGCACTCCATTAT 661
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 619 TCTGAAAGGCCTGACACTGAGCTGGATTGGGGACGGAAACAATATCCTGCACTCCATTAT 678
Qy 662 GATGTCTGCCGCTAAGTTTGGAATGCATCTGCAGGCAGCCACACCAAAAGGCTACGAACC 721
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 679 GATGTCTGCCGCTAAGTTTGGAATGCATCTGCAGGCAGCCACACCAAAAGGCTACGAACC 738
Qy 722 CGATGCCAGTGTGACTAAGCTGGCCGAACAGTATGCTAAAGAGAACGGCACTAAGCTGCT 781
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 739 CGATGCCAGTGTGACTAAGCTGGCCGAACAGTATGCTAAAGAGAACGGCACTAAGCTGCT 798
Qy 782 GCTGACCAATGACCCTCTGGAGGCTGCACACGGAGGCAACGTCCTGATCACTGATACCTG 841
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 799 GCTGACCAATGACCCTCTGGAGGCTGCACACGGAGGCAACGTCCTGATCACTGATACCTG 858
Qy 842 GATTTCCATGGGCCAGGAGGAAGAGAAGAAAAAGCGCCTGCAGGCATTCCAGGGGTACCA 901
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 859 GATTTCCATGGGCCAGGAGGAAGAGAAGAAAAAGCGCCTGCAGGCATTCCAGGGGTACCA 918
Qy 902 GGTGACAATGAAAACTGCCAAGGTCGCCGCTTCTGATTGGACTTTTCTGCATTGTCTGCC 961
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 919 GGTGACAATGAAAACTGCCAAGGTCGCCGCTTCTGATTGGACTTTTCTGCATTGTCTGCC 978
Qy 962 CCGAAAACCTGAAGAGGTGGACGATGAGGTCTTCTATTCACCTAGGAGCCTGGTGTTTCC 1021
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 979 CCGAAAACCTGAAGAGGTGGACGATGAGGTCTTCTATTCACCTAGGAGCCTGGTGTTTCC 1038
Qy 1022 AGAAGCCGAGAATCGCAAGTGGACAATCATGGCTGTGATGGTGTCCCTGCTGACTGATTA 1081
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1039 AGAAGCCGAGAATCGCAAGTGGACAATCATGGCTGTGATGGTGTCCCTGCTGACTGATTA 1098
Qy 1082 TTCCCCCCAGCTGCAGAAACCTAAGTTCTGAGCGGCCGCTTAATTAAGCTGCCTTCTGCG 1141
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1099 TTCCCCCCAGCTGCAGAAACCTAAGTTCTGAGCGGCCGCTTAATTAAGCTGCCTTCTGCG 1158
Qy 1142 GGGCTTGCCTTCTGGCCATGCCCTTCTTCTCTCCCTTGCACCTGTACCTCTTGGTCTTTG 1201
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1159 GGGCTTGCCTTCTGGCCATGCCCTTCTTCTCTCCCTTGCACCTGTACCTCTTGGTCTTTG 1218
Qy 1202 AATAAAGCCTGAGTAGGAAGTCTAG 1226
|||||||||||||||||||||||||
Db 1219 AATAAAGCCTGAGTAGGAAGTCTAG 1243
As set forth in the text, the sequence comprises the T7 promoter as required of claim 30.
As recited in claim 32 and 33, cells are delivered of plasmids (see ¶0046) comprising the OTC (claim 269).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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 1-3, 6-8, 10, 13, 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Monahan et al (US 20160206750) in view of Zhou et al (U.S. 20200299652).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claim 1 is drawn to an OTC sequence with at least 95% identity to SEQ ID NO:1. As shown below, SEQ ID NO:114 is 99.5% identical to SEQ ID NO:1.
RESULT 2
US-14-908-351-114
(NOTE: this sequence has 4 duplicates in the database searched.
See complete list at the end of this report)
Sequence 114, US/14908351
Patent No. 9867885
GENERAL INFORMATION
APPLICANT: PhaseRx, Inc.
TITLE OF INVENTION: BLOCK COPOLYMERS
FILE REFERENCE: 3800.PCT1
CURRENT APPLICATION NUMBER: US/14/908,351
CURRENT FILING DATE: 2016-01-28
NUMBER OF SEQ ID NOS: 122
SEQ ID NO 114
LENGTH: 1221
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: mRNA encoding human ornithine transcarbamylase, codon-optimized
for human expression
Query Match 99.5%; Score 1220; Length 1221;
Best Local Similarity 100.0%;
Matches 1220; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 2 GGAAAUAAGAGAGAAAAGAAGAGUAAGAAGAAAUAUAAGAGCCACCAUGCUGUUUAACCU 61
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2 GGAAAUAAGAGAGAAAAGAAGAGUAAGAAGAAAUAUAAGAGCCACCAUGCUGUUUAACCU 61
Qy 62 GAGGAUUCUGCUGAACAACGCUGCUUUUCGGAACGGCCACAACUUUAUGGUGCGGAACUU 121
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 62 GAGGAUUCUGCUGAACAACGCUGCUUUUCGGAACGGCCACAACUUUAUGGUGCGGAACUU 121
Qy 122 UCGGUGCGGACAGCCACUGCAGAACAAAGUGCAGCUGAAGGGGAGGGACCUGCUGACCCU 181
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 122 UCGGUGCGGACAGCCACUGCAGAACAAAGUGCAGCUGAAGGGGAGGGACCUGCUGACCCU 181
Qy 182 GAAAAAUUUCACAGGAGAGGAAAUCAAGUACAUGCUGUGGCUGUCUGCCGAUCUGAAGUU 241
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 182 GAAAAAUUUCACAGGAGAGGAAAUCAAGUACAUGCUGUGGCUGUCUGCCGAUCUGAAGUU 241
Qy 242 CCGGAUCAAGCAGAAGGGCGAAUAUCUGCCACUGCUGCAGGGCAAAAGUCUGGGGAUGAU 301
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 242 CCGGAUCAAGCAGAAGGGCGAAUAUCUGCCACUGCUGCAGGGCAAAAGUCUGGGGAUGAU 301
Qy 302 CUUCGAAAAGAGGAGUACUCGGACCAGACUGUCAACAGAGACUGGAUUCGCUCUGCUGGG 361
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 302 CUUCGAAAAGAGGAGUACUCGGACCAGACUGUCAACAGAGACUGGAUUCGCUCUGCUGGG 361
Qy 362 AGGACACCCAUGCUUUCUGACCACACAGGACAUUCAUCUGGGCGUGAACGAGUCACUGAC 421
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 362 AGGACACCCAUGCUUUCUGACCACACAGGACAUUCAUCUGGGCGUGAACGAGUCACUGAC 421
Qy 422 CGACACAGCUCGAGUCCUGAGCUCCAUGGCAGAUGCCGUGCUGGCACGGGUCUACAAACA 481
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 422 CGACACAGCUCGAGUCCUGAGCUCCAUGGCAGAUGCCGUGCUGGCACGGGUCUACAAACA 481
Qy 482 GAGCGACCUGGAUACCCUGGCUAAGGAAGCAAGCAUCCCCAUCAUUAAUGGGCUGUCCGA 541
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 482 GAGCGACCUGGAUACCCUGGCUAAGGAAGCAAGCAUCCCCAUCAUUAAUGGGCUGUCCGA 541
Qy 542 CCUGUAUCACCCUAUCCAGAUUCUGGCCGAUUACCUGACCCUGCAGGAGCAUUAUUCUAG 601
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 542 CCUGUAUCACCCUAUCCAGAUUCUGGCCGAUUACCUGACCCUGCAGGAGCAUUAUUCUAG 601
Qy 602 UCUGAAAGGCCUGACACUGAGCUGGAUUGGGGACGGAAACAAUAUCCUGCACUCCAUUAU 661
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 602 UCUGAAAGGCCUGACACUGAGCUGGAUUGGGGACGGAAACAAUAUCCUGCACUCCAUUAU 661
Qy 662 GAUGUCUGCCGCUAAGUUUGGAAUGCAUCUGCAGGCAGCCACACCAAAAGGCUACGAACC 721
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 662 GAUGUCUGCCGCUAAGUUUGGAAUGCAUCUGCAGGCAGCCACACCAAAAGGCUACGAACC 721
Qy 722 CGAUGCCAGUGUGACUAAGCUGGCCGAACAGUAUGCUAAAGAGAACGGCACUAAGCUGCU 781
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 722 CGAUGCCAGUGUGACUAAGCUGGCCGAACAGUAUGCUAAAGAGAACGGCACUAAGCUGCU 781
Qy 782 GCUGACCAAUGACCCUCUGGAGGCUGCACACGGAGGCAACGUCCUGAUCACUGAUACCUG 841
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 782 GCUGACCAAUGACCCUCUGGAGGCUGCACACGGAGGCAACGUCCUGAUCACUGAUACCUG 841
Qy 842 GAUUUCCAUGGGCCAGGAGGAAGAGAAGAAAAAGCGCCUGCAGGCAUUCCAGGGGUACCA 901
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 842 GAUUUCCAUGGGCCAGGAGGAAGAGAAGAAAAAGCGCCUGCAGGCAUUCCAGGGGUACCA 901
Qy 902 GGUGACAAUGAAAACUGCCAAGGUCGCCGCUUCUGAUUGGACUUUUCUGCAUUGUCUGCC 961
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 902 GGUGACAAUGAAAACUGCCAAGGUCGCCGCUUCUGAUUGGACUUUUCUGCAUUGUCUGCC 961
Qy 962 CCGAAAACCUGAAGAGGUGGACGAUGAGGUCUUCUAUUCACCUAGGAGCCUGGUGUUUCC 1021
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 962 CCGAAAACCUGAAGAGGUGGACGAUGAGGUCUUCUAUUCACCUAGGAGCCUGGUGUUUCC 1021
Qy 1022 AGAAGCCGAGAAUCGCAAGUGGACAAUCAUGGCUGUGAUGGUGUCCCUGCUGACUGAUUA 1081
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1022 AGAAGCCGAGAAUCGCAAGUGGACAAUCAUGGCUGUGAUGGUGUCCCUGCUGACUGAUUA 1081
Qy 1082 UUCCCCCCAGCUGCAGAAACCUAAGUUCUGAGCGGCCGCUUAAUUAAGCUGCCUUCUGCG 1141
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1082 UUCCCCCCAGCUGCAGAAACCUAAGUUCUGAGCGGCCGCUUAAUUAAGCUGCCUUCUGCG 1141
Qy 1142 GGGCUUGCCUUCUGGCCAUGCCCUUCUUCUCUCCCUUGCACCUGUACCUCUUGGUCUUUG 1201
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1142 GGGCUUGCCUUCUGGCCAUGCCCUUCUUCUCUCCCUUGCACCUGUACCUCUUGGUCUUUG 1201
Qy 1202 AAUAAAGCCUGAGUAGGAAG 1221
||||||||||||||||||||
Db 1202 AAUAAAGCCUGAGUAGGAAG 1221
Monahan et al also teach that the 3’ UTR associated with this sequence in copending SEQ ID NO:111 is 100% identical to SEQ IS NO:3.
RESULT 7
US-14-908-351-111
(NOTE: this sequence has 4 duplicates in the database searched)
Sequence 111, US/14908351
Patent No. 9867885
GENERAL INFORMATION
APPLICANT: PhaseRx, Inc.
TITLE OF INVENTION: BLOCK COPOLYMERS
FILE REFERENCE: 3800.PCT1
CURRENT APPLICATION NUMBER: US/14/908,351
CURRENT FILING DATE: 2016-01-28
NUMBER OF SEQ ID NOS: 122
SEQ ID NO 111
LENGTH: 1262
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: cDNA encoding human ornithine transcarbamylase, codon-optimized
for human expression
FEATURE:
NAME/KEY: promoter
LOCATION: (1)..(20)
OTHER INFORMATION: T7 promoter
Query Match 100.0%; Score 114; Length 1262;
Best Local Similarity 68.4%;
Matches 78; Conservative 36; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GCGGCCGCUUAAUUAAGCUGCCUUCUGCGGGGCUUGCCUUCUGGCCAUGCCCUUCUUCUC 60
||||||||::||::||||:|||::|:|||||||::|||::|:|||||:||||::|::|:|
Db 1130 GCGGCCGCTTAATTAAGCTGCCTTCTGCGGGGCTTGCCTTCTGGCCATGCCCTTCTTCTC 1189
Qy 61 UCCCUUGCACCUGUACCUCUUGGUCUUUGAAUAAAGCCUGAGUAGGAAGUCUAG 114
:|||::|||||:|:|||:|::||:|:::|||:||||||:|||:||||||:|:||
Db 1190 TCCCTTGCACCTGTACCTCTTGGTCTTTGAATAAAGCCTGAGTAGGAAGTCTAG 1243
As well, the 5’ end of the sequence of SEQ ID NO:111 is the same as SEQ ID NO:2 absent a single nucleotide.
PNG
media_image1.png
284
740
media_image1.png
Greyscale
However OTC mRNA flanked by a 5’ UTR and 3’ UTR are known in the art. Zhou teaches such a construct and to this end teaches a 5’ UTR that has 100% identity to SEQ ID NO:2.
RESULT 1
US-16-765-604-196
(NOTE: this sequence has 5 duplicates in the database searched.
See complete list at the end of this report)
Sequence 196, US/16765604
Patent No. 11859215
GENERAL INFORMATION
APPLICANT: MODERNATX, INC.
TITLE OF INVENTION: POLYNUCLEOTIDES ENCODING ORNITHINE TRANSCARBAMYLASE
TITLE OF INVENTION: FOR THE TREATMENT OF UREA CYCLE DISORDERS
FILE REFERENCE: 45817-0021WO1
CURRENT APPLICATION NUMBER: US/16/765,604
CURRENT FILING DATE: 2020-05-20
PRIOR APPLICATION NUMBER: PCT/US2018/062226
PRIOR FILING DATE: 2018-11-21
PRIOR APPLICATION NUMBER: 62/765,354
PRIOR FILING DATE: 2018-08-20
PRIOR APPLICATION NUMBER: 62/590,157
PRIOR FILING DATE: 2017-11-22
NUMBER OF SEQ ID NOS: 226
SEQ ID NO 196
LENGTH: 47
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
NAME/KEY: source
OTHER INFORMATION: /note="Description of Artificial Sequence: Synthetic
oligonucleotide"
Query Match 100.0%; Score 47; Length 47;
Best Local Similarity 100.0%;
Matches 47; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AGGAAAUAAGAGAGAAAAGAAGAGUAAGAAGAAAUAUAAGAGCCACC 47
|||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AGGAAAUAAGAGAGAAAAGAAGAGUAAGAAGAAAUAUAAGAGCCACC 47
These relationships served to render obvious claim 3 as well which requires SEQ ID NO;4 as shown above to be met by Monahan and further comprises SEQ ID NO:2 and 3 which as set forth above are known UTR sequences for OTC expression.
Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made that OTC would be flanked by the 5’ UTR and 3’ UTR of SEQ ID NO:2 and 3. As noted above: 1) Monahan teaches OTC with a 5’ and 3’ UTR that overlaps those of the instant claims wherein the only difference is a slight variation in the 5’ UTR; 2) However Zhou teaches use of a 5’ UTR for OTC that has 100% identity. Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the 5’UTR of Zhou et al would serve in the construct of Monahan et al.
As claimed in claim 6, Zhou teaches the OTC of SEQ IDNO:7
RESULT 10
US-16-765-604-14
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 14, US/16765604
Patent No. 11859215
GENERAL INFORMATION
APPLICANT: MODERNATX, INC.
TITLE OF INVENTION: POLYNUCLEOTIDES ENCODING ORNITHINE TRANSCARBAMYLASE
TITLE OF INVENTION: FOR THE TREATMENT OF UREA CYCLE DISORDERS
FILE REFERENCE: 45817-0021WO1
CURRENT APPLICATION NUMBER: US/16/765,604
CURRENT FILING DATE: 2020-05-20
PRIOR APPLICATION NUMBER: PCT/US2018/062226
PRIOR FILING DATE: 2018-11-21
PRIOR APPLICATION NUMBER: 62/765,354
PRIOR FILING DATE: 2018-08-20
PRIOR APPLICATION NUMBER: 62/590,157
PRIOR FILING DATE: 2017-11-22
NUMBER OF SEQ ID NOS: 226
SEQ ID NO 14
LENGTH: 1062
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
NAME/KEY: source
OTHER INFORMATION: /note="Description of Artificial Sequence: Synthetic
polynucleotide"
Alignment Scores:
Length: 1062
Score: 1831.00 Matches: 354
Percent Similarity: 100.0% Conservative: 0
Best Local Similarity: 100.0% Mismatches: 0
Query Match: 100.0% Indels: 0
Gaps: 0
US-17-771-421-7 (1-354) x US-16-765-604-14 (1-1062)
Qy 1 MetLeuPheAsnLeuArgIleLeuLeuAsnAsnAlaAlaPheArgAsnGlyHisAsnPhe 20
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AUGCUGUUCAACCUGCGGAUCCUGCUGAACAACGCCGCCUUCCGGAACGGCCACAACUUC 60
Qy 21 MetValArgAsnPheArgCysGlyGlnProLeuGlnAsnLysValGlnLeuLysGlyArg 40
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AUGGUGCGGAACUUCCGGUGCGGCCAGCCCCUGCAGAACAAGGUGCAGCUGAAGGGCCGG 120
Qy 41 AspLeuLeuThrLeuLysAsnPheThrGlyGluGluIleLysTyrMetLeuTrpLeuSer 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GACCUGCUGACCCUGAAGAACUUCACCGGCGAGGAGAUCAAGUACAUGCUGUGGCUGAGC 180
Qy 61 AlaAspLeuLysPheArgIleLysGlnLysGlyGluTyrLeuProLeuLeuGlnGlyLys 80
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GCCGACCUGAAGUUCCGGAUCAAGCAGAAGGGCGAGUACCUGCCCCUGCUGCAGGGCAAG 240
Qy 81 SerLeuGlyMetIlePheGluLysArgSerThrArgThrArgLeuSerThrGluThrGly 100
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 AGCCUGGGCAUGAUCUUCGAGAAGCGGAGCACCCGGACCCGGCUGAGCACCGAGACCGGC 300
Qy 101 PheAlaLeuLeuGlyGlyHisProCysPheLeuThrThrGlnAspIleHisLeuGlyVal 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 UUCGCCCUGCUGGGCGGCCACCCCUGCUUCCUGACCACCCAGGACAUCCACCUGGGCGUG 360
Qy 121 AsnGluSerLeuThrAspThrAlaArgValLeuSerSerMetAlaAspAlaValLeuAla 140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 AACGAGAGCCUGACCGACACCGCCCGGGUGCUGAGCAGCAUGGCCGACGCCGUGCUGGCC 420
Qy 141 ArgValTyrLysGlnSerAspLeuAspThrLeuAlaLysGluAlaSerIleProIleIle 160
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 CGGGUGUACAAGCAGAGCGACCUGGACACCCUGGCCAAGGAGGCCAGCAUCCCCAUCAUC 480
Qy 161 AsnGlyLeuSerAspLeuTyrHisProIleGlnIleLeuAlaAspTyrLeuThrLeuGln 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 AACGGCCUGAGCGACCUGUACCACCCCAUCCAGAUCCUGGCCGACUACCUGACCCUGCAG 540
Qy 181 GluHisTyrSerSerLeuLysGlyLeuThrLeuSerTrpIleGlyAspGlyAsnAsnIle 200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 GAGCACUACAGCAGCCUGAAGGGCCUGACCCUGAGCUGGAUCGGCGACGGCAACAACAUC 600
Qy 201 LeuHisSerIleMetMetSerAlaAlaLysPheGlyMetHisLeuGlnAlaAlaThrPro 220
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 CUGCACAGCAUCAUGAUGAGCGCCGCCAAGUUCGGCAUGCACCUGCAGGCCGCCACGCCC 660
Qy 221 LysGlyTyrGluProAspAlaSerValThrLysLeuAlaGluGlnTyrAlaLysGluAsn 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 AAGGGCUACGAGCCCGACGCCAGCGUGACCAAGCUGGCCGAGCAGUACGCCAAGGAGAAC 720
Qy 241 GlyThrLysLeuLeuLeuThrAsnAspProLeuGluAlaAlaHisGlyGlyAsnValLeu 260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 GGCACCAAGCUGCUGCUGACCAACGACCCGCUGGAGGCCGCCCACGGCGGCAACGUGCUG 780
Qy 261 IleThrAspThrTrpIleSerMetGlyGlnGluGluGluLysLysLysArgLeuGlnAla 280
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 AUCACCGACACCUGGAUCAGCAUGGGCCAGGAGGAGGAGAAGAAGAAGCGGCUGCAGGCC 840
Qy 281 PheGlnGlyTyrGlnValThrMetLysThrAlaLysValAlaAlaSerAspTrpThrPhe 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 UUCCAGGGCUACCAGGUGACCAUGAAGACCGCCAAGGUGGCCGCCAGCGACUGGACCUUC 900
Qy 301 LeuHisCysLeuProArgLysProGluGluValAspAspGluValPheTyrSerProArg 320
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 CUGCACUGCCUGCCCCGGAAGCCCGAGGAGGUGGACGACGAGGUGUUCUACAGCCCACGG 960
Qy 321 SerLeuValPheProGluAlaGluAsnArgLysTrpThrIleMetAlaValMetValSer 340
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 AGCCUGGUGUUCCCCGAGGCCGAGAACCGGAAGUGGACCAUCAUGGCCGUGAUGGUGAGC 1020
Qy 341 LeuLeuThrAspTyrSerProGlnLeuGlnLysProLysPhe 354
||||||||||||||||||||||||||||||||||||||||||
Db 1021 CUGCUGACCGACUACAGCCCACAGCUGCAGAAGCCCAAGUUC 1062
As set forth in claim 7, the sequence is 100% identical to SEQ ID NO:1.
And in claim 8, as set forth above varies from SEQ IDNO:4 by one nucleotide.
Zhou teaches a cap and polyA as required of claim 10 (see ¶0020 and 0124). The polyA tail is between 50 and 150 which overlaps the required 80-1000 nucleotides by sharing nucleotides 80-150 in length. This meets claim 13.
As recited in claim 15 and as taught by Zhou et al, uridine such as pseudo uridine is incorporated (see e.g. ¶0222).
The construct is part of a composition with a LNP for example (see e.g. abstract).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Monahan et al (US 20160206750) in view of Zhou et al (U.S. 20200299652) as applied to claims 1-3, 6-8, 10, 13, 15 and 18 above, and further in view of Heyes et al (US 20160151284).
The exact formulations were not provided for by Zhou. However, those claimed in claim 20 were known in the art. Heyes et al teach use of this formulation for mRNA delivery.
[0294] The following LNP formulation was used to prepare nucleic acid-lipid particles that were examined using Cryo-TEM: PEG-lipid (PEG2000-C-DMA) (1.6 mol %); 13-B43 lipid (54.6 mol %); cholesterol (32.8 mol %); and DSPC (10.9 mol %). LNP were prepared at a 0.95 mg (mRNA) scale, using the general procedures described above. The lipid stock was prepared in ethanol (12.6 mM total lipid). The mRNA stock was prepared at 0.366 mg/mL in 40 mM EDTA. The two stocks were combined and diluted into 4.9 mL of PBS. Buffer exchange was then performed via overnight bag dialysis against 10× volume of PBS. Samples were then concentrated to ˜1 mg/mL mRNA by centrifugation in Vivaspin-20 units (MWCO 100 k) from GE Healthcare. The LNP were then sterile filtered. Concentration of the LNP was determined using RiboGreen and a Varian Cary Eclipse Fluorimeter. Particle size and polydispersity were determined using a Malvern Nano Series Zetasizer.
Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the LNP of Heyes et al in the composition of Monahan in view of Zhou et al. Such a modification would have resulted in a composition encompassed by claim 20. As noted above: 1) Monahan in view of Zhou et al teach a composition comprising mRNA requiring an LNP for delivery; 2) Heyes et al teach that mRNA can be delivered with an LNP comprising PEG2000-C-DMA: 13-B43-cholesterol and DSPG. Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the detailed LNP of Heyes et al would be useful for the delivery of OTC.
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
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. See 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
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).
Claims 2 and 29, 30, 32 and 33 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-30 of U.S. 10,660,970.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1-30 of U.S. 10,660,970. That is, the cited claims of U.S. Patent 10,660,970 anticipate and fall entirely within the scope of the rejected claims of the instant application. The facts are set forth below. It is noted that the copending method claims are included as the safe harbor for non-statutory double patenting only applies for applications filed as divisional applications. The courts have determined the relevant claims of the two applications are not patentably distinct, when the claims at issue merely recited methods of administering therapeutically-effective amounts of the compositions claimed or means of making and no safe harbor exists.
Claim 2 recites a construct with an mRNA sequence comprising no more than 5 nucleic acids different from SEQ ID NO:4. This sequence with 99.5% identity to SEQ ID NO:114 is shown below in copending U.S. Patent 10,660,970 (U.S. application 16/543,324 and with full sequence provided for in search results associated with related application 14/908,351). While the sequence below shows the DNA sequence, the application intends that the sequence be RNA (see copending claim 1).
US-16-543-324-114
Filing date in PALM: 2019-08-16
Sequence 114, US/16543324
Patent No. 10660970
GENERAL INFORMATION
APPLICANT: GENEVANT SCIENCES GMBH
TITLE OF INVENTION: NUCLEIC ACID CONSTRUCTS AND METHODS OF USING THE SAME
FILE REFERENCE: 4170.0030004/BNC/PMR/LBR
CURRENT APPLICATION NUMBER: US/16/543,324
CURRENT FILING DATE: 2019-08-16
PRIOR APPLICATION NUMBER: US 15/827,793
PRIOR FILING DATE: 2017-11-30
PRIOR APPLICATION NUMBER: US 14/908,351
PRIOR FILING DATE: 2016-01-28
PRIOR APPLICATION NUMBER: PCT/US14/48839
PRIOR FILING DATE: 2014-07-30
PRIOR APPLICATION NUMBER: US 61/860,136
PRIOR FILING DATE: 2013-07-30
PRIOR APPLICATION NUMBER: US 61/868,122
PRIOR FILING DATE: 2013-08-21
NUMBER OF SEQ ID NOS: 122
SEQ ID NO 114
LENGTH: 1221
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: mRNA encoding human ornithine transcarbamylase, codon-optimized
for human expression
RESULT 2
US-14-908-351-114
(NOTE: this sequence has 4 duplicates in the database searched.
See complete list at the end of this report)
Sequence 114, US/14908351
Patent No. 9867885
GENERAL INFORMATION
APPLICANT: PhaseRx, Inc.
TITLE OF INVENTION: BLOCK COPOLYMERS
FILE REFERENCE: 3800.PCT1
CURRENT APPLICATION NUMBER: US/14/908,351
CURRENT FILING DATE: 2016-01-28
NUMBER OF SEQ ID NOS: 122
SEQ ID NO 114
LENGTH: 1221
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: mRNA encoding human ornithine transcarbamylase, codon-optimized
for human expression
Query Match 99.5%; Score 1220; Length 1221;
Best Local Similarity 100.0%;
Matches 1220; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 2 GGAAAUAAGAGAGAAAAGAAGAGUAAGAAGAAAUAUAAGAGCCACCAUGCUGUUUAACCU 61
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2 GGAAAUAAGAGAGAAAAGAAGAGUAAGAAGAAAUAUAAGAGCCACCAUGCUGUUUAACCU 61
Qy 62 GAGGAUUCUGCUGAACAACGCUGCUUUUCGGAACGGCCACAACUUUAUGGUGCGGAACUU 121
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 62 GAGGAUUCUGCUGAACAACGCUGCUUUUCGGAACGGCCACAACUUUAUGGUGCGGAACUU 121
Qy 122 UCGGUGCGGACAGCCACUGCAGAACAAAGUGCAGCUGAAGGGGAGGGACCUGCUGACCCU 181
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 122 UCGGUGCGGACAGCCACUGCAGAACAAAGUGCAGCUGAAGGGGAGGGACCUGCUGACCCU 181
Qy 182 GAAAAAUUUCACAGGAGAGGAAAUCAAGUACAUGCUGUGGCUGUCUGCCGAUCUGAAGUU 241
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 182 GAAAAAUUUCACAGGAGAGGAAAUCAAGUACAUGCUGUGGCUGUCUGCCGAUCUGAAGUU 241
Qy 242 CCGGAUCAAGCAGAAGGGCGAAUAUCUGCCACUGCUGCAGGGCAAAAGUCUGGGGAUGAU 301
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 242 CCGGAUCAAGCAGAAGGGCGAAUAUCUGCCACUGCUGCAGGGCAAAAGUCUGGGGAUGAU 301
Qy 302 CUUCGAAAAGAGGAGUACUCGGACCAGACUGUCAACAGAGACUGGAUUCGCUCUGCUGGG 361
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 302 CUUCGAAAAGAGGAGUACUCGGACCAGACUGUCAACAGAGACUGGAUUCGCUCUGCUGGG 361
Qy 362 AGGACACCCAUGCUUUCUGACCACACAGGACAUUCAUCUGGGCGUGAACGAGUCACUGAC 421
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 362 AGGACACCCAUGCUUUCUGACCACACAGGACAUUCAUCUGGGCGUGAACGAGUCACUGAC 421
Qy 422 CGACACAGCUCGAGUCCUGAGCUCCAUGGCAGAUGCCGUGCUGGCACGGGUCUACAAACA 481
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 422 CGACACAGCUCGAGUCCUGAGCUCCAUGGCAGAUGCCGUGCUGGCACGGGUCUACAAACA 481
Qy 482 GAGCGACCUGGAUACCCUGGCUAAGGAAGCAAGCAUCCCCAUCAUUAAUGGGCUGUCCGA 541
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 482 GAGCGACCUGGAUACCCUGGCUAAGGAAGCAAGCAUCCCCAUCAUUAAUGGGCUGUCCGA 541
Qy 542 CCUGUAUCACCCUAUCCAGAUUCUGGCCGAUUACCUGACCCUGCAGGAGCAUUAUUCUAG 601
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 542 CCUGUAUCACCCUAUCCAGAUUCUGGCCGAUUACCUGACCCUGCAGGAGCAUUAUUCUAG 601
Qy 602 UCUGAAAGGCCUGACACUGAGCUGGAUUGGGGACGGAAACAAUAUCCUGCACUCCAUUAU 661
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 602 UCUGAAAGGCCUGACACUGAGCUGGAUUGGGGACGGAAACAAUAUCCUGCACUCCAUUAU 661
Qy 662 GAUGUCUGCCGCUAAGUUUGGAAUGCAUCUGCAGGCAGCCACACCAAAAGGCUACGAACC 721
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 662 GAUGUCUGCCGCUAAGUUUGGAAUGCAUCUGCAGGCAGCCACACCAAAAGGCUACGAACC 721
Qy 722 CGAUGCCAGUGUGACUAAGCUGGCCGAACAGUAUGCUAAAGAGAACGGCACUAAGCUGCU 781
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 722 CGAUGCCAGUGUGACUAAGCUGGCCGAACAGUAUGCUAAAGAGAACGGCACUAAGCUGCU 781
Qy 782 GCUGACCAAUGACCCUCUGGAGGCUGCACACGGAGGCAACGUCCUGAUCACUGAUACCUG 841
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 782 GCUGACCAAUGACCCUCUGGAGGCUGCACACGGAGGCAACGUCCUGAUCACUGAUACCUG 841
Qy 842 GAUUUCCAUGGGCCAGGAGGAAGAGAAGAAAAAGCGCCUGCAGGCAUUCCAGGGGUACCA 901
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 842 GAUUUCCAUGGGCCAGGAGGAAGAGAAGAAAAAGCGCCUGCAGGCAUUCCAGGGGUACCA 901
Qy 902 GGUGACAAUGAAAACUGCCAAGGUCGCCGCUUCUGAUUGGACUUUUCUGCAUUGUCUGCC 961
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 902 GGUGACAAUGAAAACUGCCAAGGUCGCCGCUUCUGAUUGGACUUUUCUGCAUUGUCUGCC 961
Qy 962 CCGAAAACCUGAAGAGGUGGACGAUGAGGUCUUCUAUUCACCUAGGAGCCUGGUGUUUCC 1021
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 962 CCGAAAACCUGAAGAGGUGGACGAUGAGGUCUUCUAUUCACCUAGGAGCCUGGUGUUUCC 1021
Qy 1022 AGAAGCCGAGAAUCGCAAGUGGACAAUCAUGGCUGUGAUGGUGUCCCUGCUGACUGAUUA 1081
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1022 AGAAGCCGAGAAUCGCAAGUGGACAAUCAUGGCUGUGAUGGUGUCCCUGCUGACUGAUUA 1081
Qy 1082 UUCCCCCCAGCUGCAGAAACCUAAGUUCUGAGCGGCCGCUUAAUUAAGCUGCCUUCUGCG 1141
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1082 UUCCCCCCAGCUGCAGAAACCUAAGUUCUGAGCGGCCGCUUAAUUAAGCUGCCUUCUGCG 1141
Qy 1142 GGGCUUGCCUUCUGGCCAUGCCCUUCUUCUCUCCCUUGCACCUGUACCUCUUGGUCUUUG 1201
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1142 GGGCUUGCCUUCUGGCCAUGCCCUUCUUCUCUCCCUUGCACCUGUACCUCUUGGUCUUUG 1201
Qy 1202 AAUAAAGCCUGAGUAGGAAG 1221
||||||||||||||||||||
Db 1202 AAUAAAGCCUGAGUAGGAAG 1221
Claim 29 recites an expression cassette with at least 85% identity to SEQ ID NO:8. This sequence is shown below in copending U.S. Patent 10,660,970 (U.S. application 16/543,324 and with full sequence provided for in search results associated with related application 14/908,351). The promoter as indicated below is T7 (see underlining) thus reading on claim 30. The cassette is part of a plasmid (oligonucleotide defined in the disclosure see bridging ¶ col 16-17 as a plasmid and claim 1 reciting an oligonucleotide) and host cell (claim 19).
US-16-543-324-111
Filing date in PALM: 2019-08-16
Sequence 111, US/16543324
Patent No. 10660970
GENERAL INFORMATION
APPLICANT: GENEVANT SCIENCES GMBH
TITLE OF INVENTION: NUCLEIC ACID CONSTRUCTS AND METHODS OF USING THE SAME
FILE REFERENCE: 4170.0030004/BNC/PMR/LBR
CURRENT APPLICATION NUMBER: US/16/543,324
CURRENT FILING DATE: 2019-08-16
PRIOR APPLICATION NUMBER: US 15/827,793
PRIOR FILING DATE: 2017-11-30
PRIOR APPLICATION NUMBER: US 14/908,351
PRIOR FILING DATE: 2016-01-28
PRIOR APPLICATION NUMBER: PCT/US14/48839
PRIOR FILING DATE: 2014-07-30
PRIOR APPLICATION NUMBER: US 61/860,136
PRIOR FILING DATE: 2013-07-30
PRIOR APPLICATION NUMBER: US 61/868,122
PRIOR FILING DATE: 2013-08-21
NUMBER OF SEQ ID NOS: 122
SEQ ID NO 111
LENGTH: 1262
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: cDNA encoding human ornithine transcarbamylase, codon-optimized
for human expression
FEATURE:
NAME/KEY: promoter
LOCATION: (1)..(20)
OTHER INFORMATION: T7 promoter
RESULT 1
US-14-908-351-111
(NOTE: this sequence has 4 duplicates in the database searched.
See complete list at the end of this report)
Sequence 111, US/14908351
Patent No. 9867885
GENERAL INFORMATION
APPLICANT: PhaseRx, Inc.
TITLE OF INVENTION: BLOCK COPOLYMERS
FILE REFERENCE: 3800.PCT1
CURRENT APPLICATION NUMBER: US/14/908,351
CURRENT FILING DATE: 2016-01-28
NUMBER OF SEQ ID NOS: 122
SEQ ID NO 111
LENGTH: 1262
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: cDNA encoding human ornithine transcarbamylase, codon-optimized
for human expression
FEATURE:
NAME/KEY: promoter
LOCATION: (1)..(20)
OTHER INFORMATION: T7 promoter
Query Match 99.9%; Score 1225; Length 1262;
Best Local Similarity 100.0%;
Matches 1225; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 2 GGAAATAAGAGAGAAAAGAAGAGTAAGAAGAAATATAAGAGCCACCATGCTGTTTAACCT 61
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 19 GGAAATAAGAGAGAAAAGAAGAGTAAGAAGAAATATAAGAGCCACCATGCTGTTTAACCT 78
Qy 62 GAGGATTCTGCTGAACAACGCTGCTTTTCGGAACGGCCACAACTTTATGGTGCGGAACTT 121
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 79 GAGGATTCTGCTGAACAACGCTGCTTTTCGGAACGGCCACAACTTTATGGTGCGGAACTT 138
Qy 122 TCGGTGCGGACAGCCACTGCAGAACAAAGTGCAGCTGAAGGGGAGGGACCTGCTGACCCT 181
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 139 TCGGTGCGGACAGCCACTGCAGAACAAAGTGCAGCTGAAGGGGAGGGACCTGCTGACCCT 198
Qy 182 GAAAAATTTCACAGGAGAGGAAATCAAGTACATGCTGTGGCTGTCTGCCGATCTGAAGTT 241
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 199 GAAAAATTTCACAGGAGAGGAAATCAAGTACATGCTGTGGCTGTCTGCCGATCTGAAGTT 258
Qy 242 CCGGATCAAGCAGAAGGGCGAATATCTGCCACTGCTGCAGGGCAAAAGTCTGGGGATGAT 301
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 259 CCGGATCAAGCAGAAGGGCGAATATCTGCCACTGCTGCAGGGCAAAAGTCTGGGGATGAT 318
Qy 302 CTTCGAAAAGAGGAGTACTCGGACCAGACTGTCAACAGAGACTGGATTCGCTCTGCTGGG 361
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 319 CTTCGAAAAGAGGAGTACTCGGACCAGACTGTCAACAGAGACTGGATTCGCTCTGCTGGG 378
Qy 362 AGGACACCCATGCTTTCTGACCACACAGGACATTCATCTGGGCGTGAACGAGTCACTGAC 421
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 379 AGGACACCCATGCTTTCTGACCACACAGGACATTCATCTGGGCGTGAACGAGTCACTGAC 438
Qy 422 CGACACAGCTCGAGTCCTGAGCTCCATGGCAGATGCCGTGCTGGCACGGGTCTACAAACA 481
||||