DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-74 are canceled.
Claims 75-94 are pending.
Claims 83-94 are withdrawn from consideration as being drawn to a non-elected invention.
Claims 75-82 are examined herein.
Claims 75-82 are rejected.
Priority
Application No. 18/577,942 filed on 01/09/2024 is a 371 of PCT/US22/73556 filed on 07/08/2022, and also claims benefit to provisional application nos. 63/343,810 filed on 05/19/2022 and 63/220,008 filed on 07/09/2021.
Election/Restrictions
Applicant’s election without traverse of Group I, encompassing claims 75-82 drawn to an engineered nuclease, and a fusion protein, nucleic acid molecule, vector, composition, or cell comprising the engineered nuclease, and Applicant’s election of species SEQ ID NO: 29 in the reply filed on 06/03/2026 is acknowledged.
Improper Markush Grouping
Claim 75 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of SEQ ID NOs: 1-23, 26-29, and 32-236 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
An ABSS sequence search of elected SEQ ID NO: 29 (see filed wrapper 20260609_140118_us-18-577-942-29.rapbm) returned results as low as 43.1 % identity to SEQ ID NO: 29. In the returned results, SEQ ID NOs: 8, 26-28, 32-33 and 35-36 appear and have approximately 98.8% or greater sequence identity to SEQ ID NO: 29, and SEQ ID NO: 34 has approximately 95% sequence identity to SEQ ID NO: 29 over its entire length (SEQ ID NO: 34 comprises a sequence with 100% identity to SEQ ID NO: 29, and further comprises an additional 79 amino acids at the terminal end). None of the other non-elected species as they appear in claim 75 appeared in the returned results. Hence, except for the sequence identifiers listed above, all other species of the claimed invention have less than 43.1% sequence identity to SEQ ID NO:29. This low sequence identity evidences that the polypeptides represent distinct groups of nucleases that do not share a single structural similarity. Accordingly, these polypeptides do not share a substantial structural feature and a common function that flows from the substantial structural feature.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 75-82 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 75-82 are broadly drawn to an engineered nuclease comprising an amino acid sequence having at least 80% identity to elected SEQ ID NO: 29. The claims encompass sequences having as little as 80% sequence identity to SEQ ID NO: 29.
Regarding elected SEQ ID NO: 29, Applicant describes a large list of nucleases and among the list includes SEQ ID NO: 29 at 100% identity.
Except for SEQ ID NOs: 8, 26-28, 32-34 and 36 which comprise a sequence with approximately 98.8% or greater sequence identity to SEQ ID NO: 29, Applicant has not described any sequence with as low as 80% sequence identity to SEQ ID NO: 29 that is able to confer nuclease function.
The prior art fails to remedy this deficiency. Regarding elected SEQ ID NO: 29 which is an engineered nuclease, there appears to be a dearth of description of the polypeptide sequences that would be expected to encode a protein and have the required nuclease function at as low as 80% sequence identity. A review of sequences that share identity with elected SEQ ID NO: 29 reveals a large identity gap between two search results of SEQ ID NO: 29 that were available at the time of filing (see file wrapper 20260609_140118_us-18-577-942-29.rapbm). The first result (result 10) is SEQ ID NO: 33 from the instant invention and has 99.8% sequence identity (see below). The next most similar result (result 17) that was available at the time of filing has 45.2% identity (see below). Thus, sequences below 98.8% and with as little as 80% identity were not described in the prior art at the time of filing.
RESULT 10
US-18-577-942-33
Sequence 33, US/18577942
Publication No. US20240309349A1
GENERAL INFORMATION
APPLICANT: ACRIGEN BIOSCIENCES (en)
TITLE OF INVENTION: COMPOSITIONS AND METHODS FOR NUCLEIC ACID MODIFICATIONS (en)
FILE REFERENCE: ACRIG-39644.601
CURRENT APPLICATION NUMBER: US/18/577,942
CURRENT FILING DATE: 2024-01-09
NUMBER OF SEQ ID NOS: 488
SEQ ID NO 33
LENGTH: 1300
TYPE: PRT
FEATURE:
NAME/KEY: source
LOCATION: 1..1300
QUALIFIERS: mol_type = protein
organism = unidentified
Query Match 99.8%; Score 6744; Length 1300;
Best Local Similarity 99.8%;
Matches 1298; Conservative 0; Mismatches 2; Indels 0; Gaps 0;
Qy 1 MNFQPFFQKFVHLYPISKTLRFELIPQGATQKFISEKQVLLQDEIRARKYPEMKQAIDGY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MNFQPFFQKFVHLYPISKTLRFELIPQGATQKFISEKQVLLQDEIRARKYPEMKQAIDGY 60
Qy 61 HKDFIQRALSNIDSQVFEQALNTFEDLFLRSQAERATDAYKKDFETAQTKLRELIVHSFE 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 HKDFIQRALSNIDSQVFEQALNTFEDLFLRSQAERATDAYKKDFETAQTKLRELIVHSFE 120
Qy 121 KGEFKQEYKSLFDKNLITNLLKPWVEQQNQIGDSNYTYHEDFNKFTTYFLGFHRNRKNIY 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KGEFKQEYKSLFDKNLITNLLKPWVEQQNQIGDSNYTYHEDFNKFTTYFLGFHRNRKNIY 180
Qy 181 SKDPHKTALAYRLIHENLPKFLENNKILLKIQNDHPSLWEQLQTLNQTMPQLFDGWDFSQ 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SKDPHKTALAYRLIHENLPKFLENNKILLKIQNDHPSLWEQLQTLNQTMPQLFDGWDFSQ 240
Qy 241 LMQVSFFSNTLTQTGIDQYNTIIGGISEGENRQKIQGINELINLYNQKQDKKNRVAKLKQ 300
|||||||||||||||||||||||||||||||||||||||||| |||||||||||||||||
Db 241 LMQVSFFSNTLTQTGIDQYNTIIGGISEGENRQKIQGINELIALYNQKQDKKNRVAKLKQ 300
Qy 301 LYKQILSDRSTLSFLPEKFVDDTELYHAINMFYLEHLHHQSMINGHSYTLLERVQLLINE 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 LYKQILSDRSTLSFLPEKFVDDTELYHAINMFYLEHLHHQSMINGHSYTLLERVQLLINE 360
Qy 361 LANYDLSKVYLAPNQLSTVSHQMFGDFGYIGRALNYYYMQVIQPDYEQLLASAKTTKKIE 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LANYDLSKVYLAPNQLSTVSHQMFGDFGYIGRALNYYYMQVIQPDYEQLLASAKTTKKIE 420
Qy 421 ATEKLKTIFLDTPQSLVVIQAAIDEYIQLQPSTKPHTQLTDFIISLLKQYETVADDQSIK 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 ATEKLKTIFLDTPQSLVVIQAAIDEYIQLQPSTKPHTQLTDFIISLLKQYETVADDQSIK 480
Qy 481 VINVFSDIEGKYSCIKGLVNTKSESKREVLQDEKLATDIKAFMDAVNNVIKLLKPFSLNE 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 VINVFSDIEGKYSCIKGLVNTKSESKREVLQDEKLATDIKAFMDAVNNVIKLLKPFSLNE 540
Qy 541 KLVASVEKDARFYSDFEEIYQSLLIFVPLYNKVRNYITQKPYSTEKFKLNFNKPTLLRGW 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||| ||
Db 541 KLVASVEKDARFYSDFEEIYQSLLIFVPLYNKVRNYITQKPYSTEKFKLNFNKPTLLSGW 600
Qy 601 DANREADNLSILLRKNGNYYLAIMDTAKGANKAFEPKTLNQLKVDDTTDCYEKMVYKLLS 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 DANREADNLSILLRKNGNYYLAIMDTAKGANKAFEPKTLNQLKVDDTTDCYEKMVYKLLS 660
Qy 661 GPSKMFPKAFKAKNNEGNYYPTPELLTSYNNNEHLKNDKNFTLASLHAYIDWCKEYINRN 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 GPSKMFPKAFKAKNNEGNYYPTPELLTSYNNNEHLKNDKNFTLASLHAYIDWCKEYINRN 720
Qy 721 PSWHQFNFKFSPTQSFQDISQFYSEVSSQSYKVHFQTIPSDYIDQLVAEGKLYLFQIYNK 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 PSWHQFNFKFSPTQSFQDISQFYSEVSSQSYKVHFQTIPSDYIDQLVAEGKLYLFQIYNK 780
Qy 781 DFSPNAKGKENLHTLYFKALFSDENLKQPVFKLSGEAEMFYRPASLQLANTTIHKAGEPM 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 DFSPNAKGKENLHTLYFKALFSDENLKQPVFKLSGEAEMFYRPASLQLANTTIHKAGEPM 840
Qy 841 AAKNPLTPNATRTLAYDIIKDRRFTTDKYLLHVPISLNFHAQESMSIKKHNDLVRQMIKH 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 AAKNPLTPNATRTLAYDIIKDRRFTTDKYLLHVPISLNFHAQESMSIKKHNDLVRQMIKH 900
Qy 901 NHQDLHVIGIDRGEKHLLYVSVIDLKGNIVYQESLNSIKSEAQNFETPYHQLLQHREEGR 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 NHQDLHVIGIDRGEKHLLYVSVIDLKGNIVYQESLNSIKSEAQNFETPYHQLLQHREEGR 960
Qy 961 AQARTAWGKIENIKELKDGYLSQVVHRIQQLILKYNAIVMLEDLNFGFKRGRFKIEKQIY 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 AQARTAWGKIENIKELKDGYLSQVVHRIQQLILKYNAIVMLEDLNFGFKRGRFKIEKQIY 1020
Qy 1021 QKFEKALIHKLNYVVDKSTQADELGGVRKAYQLTAPFESFEKLGKQSGVLFYVPAWNTSK 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 QKFEKALIHKLNYVVDKSTQADELGGVRKAYQLTAPFESFEKLGKQSGVLFYVPAWNTSK 1080
Qy 1081 IDPVTGFVDLLKPKYENLDKAQAFFNAFDSIHYNAQKNYFEFKVNLKQFAGLKAQAAQAE 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 IDPVTGFVDLLKPKYENLDKAQAFFNAFDSIHYNAQKNYFEFKVNLKQFAGLKAQAAQAE 1140
Qy 1141 WTICSYGDERHVYQKKNAQQGETVIVNVTEELKVLFAKNNIEVAQSVELKETICTQTQVD 1200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 WTICSYGDERHVYQKKNAQQGETVIVNVTEELKVLFAKNNIEVAQSVELKETICTQTQVD 1200
Qy 1201 FFKRLMWLLQVLLALRYSSSKDKLDYILSPVANAQGEFFDSRHASVQLPQDSDANGAYHI 1260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1201 FFKRLMWLLQVLLALRYSSSKDKLDYILSPVANAQGEFFDSRHASVQLPQDSDANGAYHI 1260
Qy 1261 ALKGLWVIEQLKAADNLDKVKLAISNDDWLHFAQQKPYLA 1300
||||||||||||||||||||||||||||||||||||||||
Db 1261 ALKGLWVIEQLKAADNLDKVKLAISNDDWLHFAQQKPYLA 1300
RESULT 17
US-18-336-922-84
(NOTE: this sequence has 5 duplicates in the database searched.
See complete list at the end of this report)
Sequence 84, US/18336922
Publication No. US20240026322A1
GENERAL INFORMATION
APPLICANT: GIGAMUNE, INC. (en)
TITLE OF INVENTION: NOVEL NUCLEIC ACID-GUIDED NUCLEASES (en)
FILE REFERENCE: 38102-55950/US
CURRENT APPLICATION NUMBER: US/18/336,922
CURRENT FILING DATE: 2023-06-16
NUMBER OF SEQ ID NOS: 888
SEQ ID NO 84
LENGTH: 1313
TYPE: PRT
FEATURE:
NAME/KEY: REGION
LOCATION: 1..1313
QUALIFIERS: note = Sequence from GenBank assembly GCA_002377945.1
FEATURE:
NAME/KEY: source
LOCATION: 1..1313
QUALIFIERS: mol_type = protein
organism = unidentified
Query Match 45.2%; Score 3053; Length 1313;
Best Local Similarity 47.2%;
Matches 627; Conservative 249; Mismatches 395; Indels 56; Gaps 23;
Qy 9 KFVHLYPISKTLRFELIPQGATQKFISEKQVLLQDEIRARKYPEMKQAIDGYHKDFIQRA 68
:| : | ::|||:||| | | | : : :| : || | | :|: || |||||| ||
Db 4 RFTNQYSVTKTLKFELRPMGKTLEHVQKKGFVETDEKLATNYKRIKKTIDVYHKDFISRA 63
Qy 69 LSNIDSQVFEQALNTFEDLFLRSQAERATDAYKKDFETAQTKLRELIVHSFEKGEFKQEY 128
|| : :: | ::|| : | || | ||: | :| ||| |:
Db 64 LSQLSISNLDEFLASYED-----NKKNPDDKTKKQLVRIQDNLRKQITSAFTAAEFKTEF 118
Qy 129 KSLFDKNLITNLLKPWVEQQNQIGDSNYTYHEDFNKFTTYFLGFHRNRKNIYSKDPHKTA 188
|| | |:| |: :| : |: |:: : :|| | |||:||| ||||||| | ||
Db 119 SELFKKELLTKNLESFVLEYNKKNDADLFFVDDFKNFATYFIGFHENRKNIYSADAKHTA 178
Qy 189 LAYRLIHENLPKFLENNKILLKIQNDHPSLWEQLQTLNQTMPQLFD----GWDFSQLMQV 244
||:|:||||||||:|| | |::|:|:|:| || || :| |: :: :
Db 179 LAFRIIHENLPKFIENMNSLQLIKDDYPALYESLQ--NQVSTELSSIFSAGFVLDDVLNI 236
Qy 245 SFFSNTLTQTGIDQYNTIIGGISEGENRQKIQGINELINLYNQKQDKK--NRVA-KLKQL 301
||:: |:| |||::| :|||:| :| ||:||||| |||: : || | |:: |
Db 237 SFYNELLSQQGIDRFNQLIGGVSTQSGAKKTQGLNELINEYNQQSPRSSGNRKAPKIRPL 296
Qy 302 YKQILSDRSTLSFLPEKFVDDTELYHAINMFYLEHLHHQSMINGHS--YTLLERVQLLIN 359
|||||||| :|||||||| || ||| ||| :|| || |: | :|||: :: |:
Db 297 YKQILSDRGSLSFLPEKFADDRELYDAINDYYLSHL---LMVPNDSSEHTLLDSLKHLVA 353
Qy 360 ELANYDLSKVYLAPNQ-LSTVSHQMFGDFGYIGRALNYYYMQVIQPDYEQLLASAKTTKK 418
| ::||:|:|| :: :|::|:::|||: : || ||| | ||: ||:||: ||
Db 354 SLPSFDLTKIYLKNDKAISSISNRLFGDYSVLPIALGYYYDHHINPDHLDQLAAAKSQKK 413
Qy 419 IEATEKLKTIFLDTPQSLVVIQAAIDEYIQLQPSTKPHTQL-TDFIISLLKQYET----- 472
| | | |: |:|| |: || | ||: :: | |
Db 414 TSDLYKKKDAFTKGYHSVATIEAAYQAYL---ASTDSDNGLRKSGIINPVQDYFTRYFVN 470
Qy 473 VADDQSIKVINVFSDIEGKYSCIKGLVNTK-SESKREVLQDEKLATDIKAFMDAVNNVIK 531
: ::: ||: ||: |||::|:: | |::|| :|| |:||| |:|
Db 471 EPKEDGKAAVDLLRDIDNKYTTIKGVLNSEIEEGTRQLLQKGAEVANIKHFLDAVMNLIH 530
Qy 532 LLKPFSLNEKLVASVEKDARFYSDFEEIYQSLLIFVPLYNKVRNYITQKPYSTEKFKLNF 591
:|| : : :: |||||:|| :|: | :| ||||||||||:||||| |:|||||
Db 531 FVKPLGSVIEEDSLLDIDARFYNDFLPLYEELKLFFPLYNKVRNYISQKPYSNEQFKLNF 590
Qy 592 NKPTLLRGWDANREADNLSILLRKNGNYYLAIMDTAKGANKAFEPKTLNQLKVDDTTDCY 651
|| ||| |:| ||:||:::| ||||:|| | | || ::: |
Db 591 ENANLLEGWDVNKEKSRLSVLLQRDGRYYLALMD--KSHKKVFEQAPEITPGSENSNSPY 648
Qy 652 EKMVYKLLSGPSKMFPKAFKAKNNEGNYYPTPELLTSYNNNEHLKNDKNFTLASLHAYID 711
:|| |||| ||:||||| | || | : |: :|| :| | | | :| : | ||
Db 649 QKMRYKLLPGPNKMFPKVFFAKGNIDYFAPSQQLLENYEKGTHKKGD-DFNIEHCHQLID 707
Qy 712 WCKEYINRNPSWHQFNFKFSPTQSFQDISQFYSEVSSQSYKVHFQTIPSDYIDQLVAEGK 771
: |: : :: ||:| |||| | :::|||:||:||| | ||| |: : :|||| || |:
Db 708 FFKQSVAKHKDWHEFGFKFSDTSTYKDISEFYNEVSKQGYKVTFEDVDADYIDTLVENGQ 767
Qy 772 LYLFQIYNKDFSPNAKGKENLHTLYFKALFSDENLKQPVFKLSGEAEMFYRPASLQLANT 831
||||:||||||| |::|| ||||:|||||| ||||| |:||:|| |:||| ||: ||
Db 768 LYLFEIYNKDFSVNSRGKPNLHTIYFKALFDDENLKDAVYKLNGEGELFYRKASIDPENT 827
Qy 832 TIHKAGEPMAAKNPLTPNATRTLAYDIIKDRRFTTDKYLLHVPISLNFHAQESMSIKKHN 891
|| || : :||||||:|:| | |:|:||:|:| ||:|||:|:::|| | : : : |
Db 828 IKHKKGERVYSKNPLTPDASRVLDYEIVKDKRYTADKFLLHLPVTMNFKA-DGIGPGQFN 886
Qy 892 DLVRQMIKHN-HQDLHVIGIDRGEKHLLYVSVIDLKGNIVYQESLNSIKSEAQNFETPYH 950
:||: |: : ::|:|:|||||||:||||::||: | |::||||| : | : ||||
Db 887 NLVKDTIRDDQNKDMHLIGIDRGERHLLYLTVINQDGLIIHQESLNDVVSSNKTV-TPYH 945
Qy 951 QLLQHREEGRAQARTAWGKIENIKELKDGYLSQVVHRIQQLILKYNAIVMLEDLNFGFKR 1010
|| ||: | || || |||||:|| ||||||||:: :|| :|||:|:||||||||||
Db 946 TLLDTREKERDDARKNWGVIENIKDLKKGYLSQVVHKLAKLIYEYNAVVVLEDLNFGFKR 1005
Qy 1011 GRFKIEKQIYQKFEKALIHKLNYVVDKSTQADELGGVRKAYQLTAPFESFEKLGKQSGVL 1070
||||:|||:|| |||||| ||||:| | ::| ||| ||| |||: | :|: ||||:| |
Db 1006 GRFKVEKQVYQAFEKALIDKLNYLVFKEFESDALGGARKALQLTSAFTAFKDLGKQTGFL 1065
Qy 1071 FYVPAWNTSKIDPVTGFVDLLKPKYENLDKAQAFFNAFDSIHYNAQKNYFEFKVNLKQFA 1130
|||||||||||||||||||||||||||:::|: | : |||| || :|::|||: : |
Db 1066 FYVPAWNTSKIDPVTGFVDLLKPKYENVEQAKDFIDRFDSIRYNKEKDFFEFEFDYSNF- 1124
Qy 1131 GLKAQAAQAEWTICSYGDERHVYQKK-NAQQGETVIVNVTEELKVLFAKNNIEVAQSV-- 1187
| :|| : :|||||:| :|:|| | | :| ::| ||| ||: :|: :
Db 1125 GTRAQDTRTDWTICSHGTKRYVYDKNANNNKGGQKQIDVNTELKALFSSYDIDYHGELAG 1184
Qy 1188 -ELKETICTQTQVDFFKRLMWLLQVLLALRYSSSKDKL--DYILSPVANAQGEFFDSR-- 1242
:|: | :: : :::||: |||:||| : |:|||||:| | |||:|
Db 1185 RDLRPMIKSKGDKSMYSSIIFLLKTLLAMRYSKTNGSKVEDFILSPVSNDAGVFFDTRDY 1244
Qy 1243 ---------HASVQLPQDSDANGAYHIALKGLWVIEQLKA--ADNLDKVKLAISNDDWLH 1291
| ||:|:|||||||||||||||: |::: |: : | |:| :||
Db 1245 DGMDADSSSETSTVLPKDADANGAYHIALKGLWVMRQIQSHTGDDYKGLDLKITNKNWLE 1304
Qy 1292 FAQQKPY 1298
| | |||
Db 1305 FVQTKPY 1311
The instant specification does not provide enough sequences to describe the
genus of nuclease sequences at as low as 80% sequence identity to SEQ ID NO: 29. The specification fails to provide an adequate written description to support the sequences recited in claim 75 with 80% identity that are able to effectively confer the functions of a nuclease. The limited examples of 98.8% identity or greater to the recited sequence(s) do/does not describe the claimed genus by virtue of example. There also is a dearth of description in the prior art of the elected sequence that would be expected to have the required function of a nuclease. As such, the structural features that distinguish polypeptides with as low as 80% identity to SEQ ID NO: 29 that are nuclease sequences from other polypeptides with 80% identity to SEQ ID NO: 29 is not described in the specification nor the prior art. Therefore, one of ordinary skill in the art would not have recognized the Applicant to be in possession of the claimed invention at the time the application was filed.
Claim Rejections - 35 USC § 102/103
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 75-82 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Barghetti (US Patent No. US-12319932-B2, patented 06/03/2025 with an effective filing date of 02/25/2021).
Claim 75 is drawn to an engineered nuclease comprising an amino acid sequence having at least 80% identity to any of SEQ ID NOs: 1-23, 26-29, or 32-236.
Claim 76 is drawn to the engineered nuclease of claim 75, wherein the amino acid sequence of the engineered nuclease does not comprise an amino acid sequence having SEQ ID NO: 488.
Claim 77 is drawn to the engineered nuclease of claim 75, wherein the amino acid sequence of the engineered nuclease has less than 50% identity with SEQ ID NO:24.
Claim 78 is drawn to a fusion protein comprising the engineered nuclease of claim 75.
Claim 79 is drawn to a nucleic acid molecule comprising a sequence encoding the engineered nuclease of claim 75.
Claim 80 is drawn to a vector comprising the nucleic acid of claim 79.
Claim 81 is drawn to a composition comprising at least one guide RNA (gRNA) and the engineered nuclease of claim 75.
Claim 82 is drawn to a cell comprising the engineered nuclease of claim 75.
Regarding claim 75, Barghetti discloses a type V-A Cas nuclease named ART10, represented by SEQ ID NO: 959, that has 99.8% sequence identity to instant SEQ ID NO: 29 (Col. 115, Table 25, Col. 191 lines 53-59) (see alignment below). Barghetti further discloses the Cas protein may be engineered to alter, e.g., the activity of Cas, PAM specificity, broaden the range of recognized PAMs, increased targeting efficiency, and decreased off-target binding, and Barghetti explicitly provides known and routine methods to achieve the desired engineered Cas protein (Col. 101, lines 3-45, and Col. 146, lines 21-67, and Col. 147, lines 1-52). Barghetti discloses in an example of generating a Cas protein lacking substantially all DNA cleavage by introducing one or more mutations into the naturally occurring Cas nuclease and thus the Cas protein may comprise, e.g., a mutation in the RuvC domain of a type V-A Cas protein and be used as a generic DNA binding protein with or without fusion to an effector domain (Col. 145, lines 40-61).
RESULT 1
US-17-958-973-959
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 959, US/17958973
Patent No. 12319932
GENERAL INFORMATION
APPLICANT: ARTISAN BIO, INC. (en)
TITLE OF INVENTION: COMPOSITIONS AND METHODS FOR TARGETING, EDITING, OR MODIFYING HUMAN GENES (en)
FILE REFERENCE: ARTN-003.CON-T1
CURRENT APPLICATION NUMBER: US/17/958,973
CURRENT FILING DATE: 2022-10-03
NUMBER OF SEQ ID NOS: 1136
SEQ ID NO 959
LENGTH: 1300
TYPE: PRT
FEATURE:
NAME/KEY: source
LOCATION: 1..1300
QUALIFIERS: mol_type = protein
organism = Acinetobacter indicus
Query Match 99.8%; Score 6744; Length 1300;
Best Local Similarity 99.8%;
Matches 1297; Conservative 1; Mismatches 2; Indels 0; Gaps 0;
Qy 1 MNFQPFFQKFVHLYPISKTLRFELIPQGATQKFISEKQVLLQDEIRARKYPEMKQAIDGY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MNFQPFFQKFVHLYPISKTLRFELIPQGATQKFISEKQVLLQDEIRARKYPEMKQAIDGY 60
Qy 61 HKDFIQRALSNIDSQVFEQALNTFEDLFLRSQAERATDAYKKDFETAQTKLRELIVHSFE 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 HKDFIQRALSNIDSQVFEQALNTFEDLFLRSQAERATDAYKKDFETAQTKLRELIVHSFE 120
Qy 121 KGEFKQEYKSLFDKNLITNLLKPWVEQQNQIGDSNYTYHEDFNKFTTYFLGFHRNRKNIY 180
||||||||||||||||||||||||||||||||||||||||||||||||||||| ||||||
Db 121 KGEFKQEYKSLFDKNLITNLLKPWVEQQNQIGDSNYTYHEDFNKFTTYFLGFHENRKNIY 180
Qy 181 SKDPHKTALAYRLIHENLPKFLENNKILLKIQNDHPSLWEQLQTLNQTMPQLFDGWDFSQ 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SKDPHKTALAYRLIHENLPKFLENNKILLKIQNDHPSLWEQLQTLNQTMPQLFDGWDFSQ 240
Qy 241 LMQVSFFSNTLTQTGIDQYNTIIGGISEGENRQKIQGINELINLYNQKQDKKNRVAKLKQ 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 LMQVSFFSNTLTQTGIDQYNTIIGGISEGENRQKIQGINELINLYNQKQDKKNRVAKLKQ 300
Qy 301 LYKQILSDRSTLSFLPEKFVDDTELYHAINMFYLEHLHHQSMINGHSYTLLERVQLLINE 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 LYKQILSDRSTLSFLPEKFVDDTELYHAINMFYLEHLHHQSMINGHSYTLLERVQLLINE 360
Qy 361 LANYDLSKVYLAPNQLSTVSHQMFGDFGYIGRALNYYYMQVIQPDYEQLLASAKTTKKIE 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LANYDLSKVYLAPNQLSTVSHQMFGDFGYIGRALNYYYMQVIQPDYEQLLASAKTTKKIE 420
Qy 421 ATEKLKTIFLDTPQSLVVIQAAIDEYIQLQPSTKPHTQLTDFIISLLKQYETVADDQSIK 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 ATEKLKTIFLDTPQSLVVIQAAIDEYIQLQPSTKPHTQLTDFIISLLKQYETVADDQSIK 480
Qy 481 VINVFSDIEGKYSCIKGLVNTKSESKREVLQDEKLATDIKAFMDAVNNVIKLLKPFSLNE 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 VINVFSDIEGKYSCIKGLVNTKSESKREVLQDEKLATDIKAFMDAVNNVIKLLKPFSLNE 540
Qy 541 KLVASVEKDARFYSDFEEIYQSLLIFVPLYNKVRNYITQKPYSTEKFKLNFNKPTLLRGW 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||| ||
Db 541 KLVASVEKDARFYSDFEEIYQSLLIFVPLYNKVRNYITQKPYSTEKFKLNFNKPTLLSGW 600
Qy 601 DANREADNLSILLRKNGNYYLAIMDTAKGANKAFEPKTLNQLKVDDTTDCYEKMVYKLLS 660
|||:||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 DANKEADNLSILLRKNGNYYLAIMDTAKGANKAFEPKTLNQLKVDDTTDCYEKMVYKLLS 660
Qy 661 GPSKMFPKAFKAKNNEGNYYPTPELLTSYNNNEHLKNDKNFTLASLHAYIDWCKEYINRN 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 GPSKMFPKAFKAKNNEGNYYPTPELLTSYNNNEHLKNDKNFTLASLHAYIDWCKEYINRN 720
Qy 721 PSWHQFNFKFSPTQSFQDISQFYSEVSSQSYKVHFQTIPSDYIDQLVAEGKLYLFQIYNK 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 PSWHQFNFKFSPTQSFQDISQFYSEVSSQSYKVHFQTIPSDYIDQLVAEGKLYLFQIYNK 780
Qy 781 DFSPNAKGKENLHTLYFKALFSDENLKQPVFKLSGEAEMFYRPASLQLANTTIHKAGEPM 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 DFSPNAKGKENLHTLYFKALFSDENLKQPVFKLSGEAEMFYRPASLQLANTTIHKAGEPM 840
Qy 841 AAKNPLTPNATRTLAYDIIKDRRFTTDKYLLHVPISLNFHAQESMSIKKHNDLVRQMIKH 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 AAKNPLTPNATRTLAYDIIKDRRFTTDKYLLHVPISLNFHAQESMSIKKHNDLVRQMIKH 900
Qy 901 NHQDLHVIGIDRGEKHLLYVSVIDLKGNIVYQESLNSIKSEAQNFETPYHQLLQHREEGR 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 NHQDLHVIGIDRGEKHLLYVSVIDLKGNIVYQESLNSIKSEAQNFETPYHQLLQHREEGR 960
Qy 961 AQARTAWGKIENIKELKDGYLSQVVHRIQQLILKYNAIVMLEDLNFGFKRGRFKIEKQIY 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 AQARTAWGKIENIKELKDGYLSQVVHRIQQLILKYNAIVMLEDLNFGFKRGRFKIEKQIY 1020
Qy 1021 QKFEKALIHKLNYVVDKSTQADELGGVRKAYQLTAPFESFEKLGKQSGVLFYVPAWNTSK 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 QKFEKALIHKLNYVVDKSTQADELGGVRKAYQLTAPFESFEKLGKQSGVLFYVPAWNTSK 1080
Qy 1081 IDPVTGFVDLLKPKYENLDKAQAFFNAFDSIHYNAQKNYFEFKVNLKQFAGLKAQAAQAE 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 IDPVTGFVDLLKPKYENLDKAQAFFNAFDSIHYNAQKNYFEFKVNLKQFAGLKAQAAQAE 1140
Qy 1141 WTICSYGDERHVYQKKNAQQGETVIVNVTEELKVLFAKNNIEVAQSVELKETICTQTQVD 1200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 WTICSYGDERHVYQKKNAQQGETVIVNVTEELKVLFAKNNIEVAQSVELKETICTQTQVD 1200
Qy 1201 FFKRLMWLLQVLLALRYSSSKDKLDYILSPVANAQGEFFDSRHASVQLPQDSDANGAYHI 1260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1201 FFKRLMWLLQVLLALRYSSSKDKLDYILSPVANAQGEFFDSRHASVQLPQDSDANGAYHI 1260
Qy 1261 ALKGLWVIEQLKAADNLDKVKLAISNDDWLHFAQQKPYLA 1300
||||||||||||||||||||||||||||||||||||||||
Db 1261 ALKGLWVIEQLKAADNLDKVKLAISNDDWLHFAQQKPYLA 1300
Regarding claim 76, SEQ ID NO: 959 does not comprises SEQ ID NO: 488, and an NCBI alignment of SEQ ID NO: 595 of Barghetti and SEQ ID NO: 488 did not recognize and return any alignment result with even low similarity levels.
Regarding claim 77, an alignment of SEQ ID NO: 959 of Barghetti with instant SEQ ID NO: 24 revealed SEQ ID NO: 959 of Barghetti (Query) has 34% sequence identity to SEQ ID NO: 24 (Sbjct) (i.e., less than 50% identity) (see alignment below).
Score
Identities
Positives
Gaps
653 bits(1684)
476/1390(34%)
703/1390(50%)
190/1390(13%)
Query 7 FQKFVHLYPISKTLRFELIPQGATQKFISEKQVLLQDEIRARKYPEMKQAIDGYHKDFIQ 66
F+ F +LY +SKTLRFELIPQG T K I E+ + +D+ R Y E+K ID +K +
Sbjct 4 FEGFTNLYQVSKTLRFELIPQGKTLKHIQEQGFIEEDKARNDHYKELKPIIDRIYKTYAD 63
Query 67 RALSNIDSQVFEQALNTFEDLFLRSQAERATDAYKKDFETAQTKLRELIVHSFEK----- 121
+ L + Q+ + L+ D + + + E +A ++ T + + + + +
Sbjct 64 QCLQLV--QLDWENLSAAIDSYRKEKTEETRNALIEEQATYRNAIHDYFIGRTDNLTDAI 121
Query 122 -GEFKQEYKSLFDKNLITN-LLKPWVEQQNQIGDSNYTYHED-----FNKFTTYFLGFHE 174
+ YK LF L +LK Q+G T HE+ F+KFTTYF GF+E
Sbjct 122 NKRHAEIYKGLFKAELFNGKVLK-------QLGTVTTTEHENALLRSFDKFTTYFSGFYE 174
Query 175 NRKNIYSKDPHKTALAYRLIHENLPKFLENNKILLKIQNDHPSLWEQLQTLNQTMPQLFD 234
NRKN++S + TA+ +R++ +N PKF EN I ++ PSL E + + + + +F
Sbjct 175 NRKNVFSAEDISTAIPHRIVQDNFPKFKENCHIFTRLITAVPSLREHFENVKKAI-GIFV 233
Query 235 GWDFSQLMQVSFFSNTLTQTGIDQYNTIIGGISEGENRQKIQGINELINLYNQKQDKKNR 294
++ F++ LTQT ID YN ++GGIS +KI+G+NE++NL QK D+
Sbjct 234 STSIEEVFSFPFYNQLLTQTQIDLYNQLLGGISREAGTEKIKGLNEVLNLAIQKNDETAH 293
Query 295 VA-----KLKQLYKQILSDRSTLSFLPEKFVDDTELYHAINMFYLEHLHHQSMINGHSYT 349
+ + L+KQILSDR+TLSF+ E+F D E+ + +++++ +
Sbjct 294 IIASLPHRFIPLFKQILSDRNTLSFILEEFKSDEEVIQSF-------CKYKTLLRNEN-- 344
Query 350 LLERVQLLINELANYDLSKVYLAPNQLSTVSHQMFGDFGYIGRALNYYYMQVIQPDYEQL 409
+LE + L NEL + DL+ ++++ +L T+S + + + AL Y + I ++
Sbjct 345 VLETAEALFNELNSIDLTHIFISHKKLETISSALCDHWDTLRNAL---YERRISELTGKI 401
Query 410 LASAKTTKKIEATEKLKTIFLDTPQSLVVIQAAIDEYIQLQPSTKPHTQLTDFIISLLKQ 469
SAK +K++ + K + I L +I AA E ++ Q T I+S
Sbjct 402 TKSAK--EKVQRSLKHEDINLQE-----IISAAGKEL------SEAFKQKTSEILS---- 444
Query 470 YETVADDQSIKVINVFSDIEGKYSCIKGLVNTKSESKREVLQDEKLATDIKAFMDAVNNV 529
+ A DQ + K + ++E+L+ + +D++ +
Sbjct 445 HAHAALDQPLPT------------------TLKKQEEKEILKSQ---------LDSLLGL 477
Query 530 IKLLKPFSLNEKLVASVEKDARFYSDFEEIYQSLLIFVPLYNKVRNYITQKPYSTEKFKL 589
LL F+++E S E D F + I + + YNK RNY T+KPYS EKFKL
Sbjct 478 YHLLDWFAVDE----SNEVDPEFSARLTGIKLEMEPSLSFYNKARNYATKKPYSVEKFKL 533
Query 590 NFNKPTLLSGWDANKEADNLSILLRKNGNYYLAIMDTAKGANKA--FEPKTLNQLKVDDT 647
NF PTL SGWD NKE +N +IL KNG YYL IM KG KA FEP + T
Sbjct 534 NFQMPTLASGWDVNKEKNNGAILFVKNGLYYLGIMPKQKGRYKALSFEP-------TEKT 586
Query 648 TDCYEKMVYKLLSGPSKMFPKA---FKAKNNEGNYYPTPELLTS------------YNNN 692
++ ++KM Y +KM PK KA + TP LL++ Y+ N
Sbjct 587 SEGFDKMYYDYFPDAAKMIPKCSTQLKAVTAHFQTHTTPILLSNNFIEPLEITKEIYDLN 646
Query 693 EHLKNDKNFTLA-------------SLHAYIDWCKEYINRNPSWHQFNFK-FSPTQSFQD 738
K K F A +L +ID+ ++++++ + P+ ++D
Sbjct 647 NPEKEPKKFQTAYAKKTGDQKGYREALCKWIDFTRDFLSKYTKTTSIDLSSLRPSSQYKD 706
Query 739 ISQFYSEVSSQSYKVHFQTIPSDYIDQLVAEGKLYLFQIYNKDFSPNAKGKENLHTLYFK 798
+ ++Y+E++ Y + FQ I I V GKLYLFQIYNKDF+ GK NLHTLY+
Sbjct 707 LGEYYAELNPLLYHISFQRIAEKEIMDAVETGKLYLFQIYNKDFAKGHHGKPNLHTLYWT 766
Query 799 ALFSDENLKQPVFKLSGEAEMFYRPASLQLANTTIHKAGEPMAAK--------------- 843
LFS ENL + KL+G+AE+FYRP S H+ GE M K
Sbjct 767 GLFSPENLAKTSIKLNGQAELFYRPKSRM--KRMAHRLGEKMLNKKLKDQKTPIPDTLYQ 824
Query 844 ------------------NPLTPNA-TRTLAYDIIKDRRFTTDKYLLHVPISLNFHAQES 884
L PN T+ ++++IIKDRRFT+DK+ HVPI+LN+ A S
Sbjct 825 ELYDYVNHRLSHDLSDEARALLPNVITKEVSHEIIKDRRFTSDKFFFHVPITLNYQAANS 884
Query 885 MSIKKHNDLVRQMIKHNHQDLHVIGIDRGEKHLLYVSVIDLKGNIVYQESLNSIKSEAQN 944
S K N V +K H + +IGIDRGE++L+Y++VID G I+ Q SLN+I Q
Sbjct 885 PS--KFNQRVNAYLKE-HPETPIIGIDRGERNLIYITVIDSTGKILEQRSLNTI----QQ 937
Query 945 FETPYHQLLQHREEGRAQARTAWGKIENIKELKDGYLSQVVHRIQQLILKYNAIVMLEDL 1004
F+ Y + L +RE+ R AR AW + IK+LK GYLSQV+H I L++ Y A+V+LE+L
Sbjct 938 FD--YQKKLDNREKERVAARQAWSVVGTIKDLKQGYLSQVIHEIVDLMIHYQAVVVLENL 995
Query 1005 NFGFKRGRFKI-EKQIYQKFEKALIHKLNYVVDKSTQADELGGVRKAYQLTAPFESFEKL 1063
NFGFK R I EK +YQ+FEK LI KLN +V K A+++GGV YQLT F SF K+
Sbjct 996 NFGFKSKRTGIAEKAVYQQFEKMLIDKLNCLVLKDYPAEKVGGVLNPYQLTDQFTSFAKM 1055
Query 1064 GKQSGVLFYVPAWNTSKIDPVTGFVD-LLKPKYENLDKAQAFFNAFDSIHYNAQKNYF-- 1120
G QSG LFYVPA TSKIDP+TGFVD + +N + + F FD +HY+ + F
Sbjct 1056 GTQSGFLFYVPAPYTSKIDPLTGFVDPFVWKTIKNHESRKHFLEGFDFLHYDVKTGDFIL 1115
Query 1121 EFKVNLKQFAGLKAQAAQAEWTICSYGDERHVYQKKNAQQGETVIVNVTE---------- 1170
FK+N W I +E K IV V E
Sbjct 1116 HFKMNRNLSFQRGLPGFMPAWDIVFEKNETQFDAKGTPFIAGKRIVPVIENHRFTGRYRD 1175
Query 1171 -----ELKVLFAKNNIEVAQSVELKETICTQTQVDFFKRLMWLLQVLLALRYSSSKDKLD 1225
EL L + I + + ++ L++ +L +R S++ D
Sbjct 1176 LYPANELIALLEEKGIVFRDGSNILPKLLENDDSHAIDTMVALIRSVLQMRNSNAATGED 1235
Query 1226 YILSPVANAQGEFFDSRHASVQLPQDSDANGAYHIALKGLWVIEQLKAADNLDKVKLAIS 1285
YI SPV + G FDSR + + P D+DANGAYHIALKG ++ LK + +L K++ IS
Sbjct 1236 YINSPVRDLNGVCFDSRFQNPEWPMDADANGAYHIALKGQLLLNHLKESKDL-KLQNGIS 1294
Query 1286 NDDWLHFAQQ 1295
N DWL + Q+
Sbjct 1295 NQDWLAYIQE 1304
Regarding claim 78, as stated above, Barghetti discloses in an example of generating a Cas protein lacking substantially all DNA cleavage by introducing one or more mutations into the naturally occurring Cas nuclease and thus the Cas protein may comprise, e.g., a mutation in the RuvC domain of a type V-A Cas protein and be used as a generic DNA binding protein with or without fusion to an effector domain (Col. 145, lines 40-61). Because Barghetti discloses the V-A Cas protein and be used as a generic DNA binding protein with fusion to an effector domain, Barghetti discloses in an embodiment a fusion protein comprising the engineered nuclease.
Regarding claims 79-80 and 82, Barghetti discloses the modified guide CRISPR-Cas system as described in Barghetti’s disclosure may be introduced into cells via various delivery systems, including a delivery system wherein the DNA can be provided in a DNA plasmid (a non-viral vector delivery system) and result in constitutive expression of Cas protein in the target cell (Col. 154, lines 14-33, Col. 155, lines 24-31).
Regarding claim 81, Barghetti discloses the modified guide CRISPR-Cas system is, e.g., a modified dual guide CRISPR-Cas system as described throughout the entire disclosure of Barghetti that is delivered into a cell via a delivery system such as DNA plasmid vector (Col. 154, lines 14-33). Because it is a modified dual guide CRISPR-Cas system that is delivered into a cell via plasmid DNA/ vector, this vector is reasonably interpreted to comprise at least one gRNA in addition to the engineered nuclease.
The disclosure of Barghetti appears to anticipate the rejected claims, however, in
the alternative, claims 75-82 are obvious in view of Barghetti. Barghetti discloses a nuclease having 98.8% identity to elected SEQ ID NO: 29, and discloses various examples of single mutations to engineer the nuclease for various purposes. Thus, the claimed engineered nuclease is anticipated and/or obvious in view of the disclosure of Barghetti. Furthermore, the depending claims are also anticipated and/or obvious because the additional embodiments of Barghetti’s disclosure encompass the limitations of the instant depending claims. Because the structure of the claimed engineered nuclease, the fusion protein, the nucleic acid molecule, the vector, the composition, and the cell as recited in instant claims 75-82 are disclosed in the patent of Barghetti, the claimed products are anticipated, or in the alternative are obvious, in view of Barghetti.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA N STOCKDALE whose telephone number is (703)756-5395. The examiner can normally be reached M-F 8:30-5:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JESSICA N. STOCKDALE
Examiner
Art Unit 1663
/JESSICA NICOLE STOCKDALE/Examiner, Art Unit 1663
/CHARLES LOGSDON/Primary Examiner, Art Unit 1662
Prosecution Insights