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 .
Response to Amendment
1. The Amendment filed June 22, 2026 in response to the Office Action of March 23, 2026, is acknowledged and has been entered. Claims 1, 4, and 8-12 are currently pending. Applicant cancelled claims 2, 3, 5, 6, and 7. Applicant amended claims 1, 8, and 10.
Withdrawn Objections
2. The Office Action of March 23, 2026 objected to the specification due to embedded hyperlinks. In response, Applicant has properly amended the specification. Thus, the objection is withdrawn.
Withdrawn Rejections
3. The Office Action of March, 23, 2026 rejected claims 10-12 under 35 U.S.C. 112(a) for scope of enablement. In response, Applicant has amended claim 10 to remove “preventing” in accordance with examiner’s suggestion. Thus, the rejection under 35 U.S.C. 112(a) is withdrawn.
4. The Office Action of March 23, 2026 rejected claim 8 under 35 U.S.C. 101 for being directed to encompassing a human organism. In response, Applicant amended claim 8 to recite “an isolated cell” in accordance with examiner’s suggestion. Thus, the rejection is withdrawn.
5. The Office Action of March 23, 2026 rejected claims 1 and 3-12 under 35 U.S.C. 103 as being unpatentable over Yang (WO 2019/025984, pub. 2/7/2019) in further view of Powell, et al. (Discover Med., July 17, 2015, 19(102):49-57). In light of the new rejection under 35 U.S.C. 103 below, this rejection is withdrawn.
6. The Office Action of March 23, 2026 rejected claim 2 under 35 U.S.C. 103 as being unpatentable over Yang (WO 2019/025984, pub. 2/7/2019) and Powell, et al. (Discover Med., July 17, 2015, 19(102):49-57) as applied to claims 1 and 3-12 and in further view of Liu (WO 2019/222569). In light of the new rejection under 35 U.S.C. 103 below, this rejection is withdrawn.
7. The Office Action of March 23, 2026 rejected claims 1-2 and 4-12 on the grounds of non-statutory double patenting as being unpatentable over claims 1, 6, 9, 13, and 17 of U.S. Patent No. 12065663. In light of the new double patenting rejection below, this rejection is withdrawn.
Maintained Rejection
(with new arguments necessitated by amendments)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
8. Claims 1, 4, and 8-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 10, 14, 17, and 22, of copending Application No. 17/756,996 (reference application) in view of Yang (WO 2019/025984 A1, pub. 2/7/2019), Liu (WO 2019/222569 A1, pub. 11/21/2019), and Ahlers (WO 2019/018383 A1, pub. 1/24/2019). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a method for treating retinal pigment epithelium using a CYP4V2 vector.
Both the present claimed invention and the co-pending application claim a method for treating a human subject with retinal pigment epithelium, including Bietti’s crystalline dystrophy, by administering an AAV vector, a cell containing the vector, or a pharmaceutical composition using the vector or the cell along with an acceptable adjuvant. Both applications also claim a vector comprising in the 5’ to 3’ direction a CAG promoter comprising the nucleotides of SEQ ID NO: 4, CYP4V2 comprising the amino acid sequences of SEQ ID NO: 76 and the nucleotide sequences of SEQ ID NO: 62 and a PolyA signal site.
New Arguments in Response to Amendments:
Regarding instant claim 1, App. ‘996 claims an AAV vector encoding a CPY4V2 nucleic acid (‘996 claim 10) where the CYP4V2 nucleic acid is encoded by SEQ ID NO: 76 (claim 3, see alignment below) and a promoter at the 5’ end of the vector that is operably linked to the CYP4V2 polynucleotide (claim 14) and a polyA signal site located at the 3’ end (‘996 claim 17) (‘996 claim 22).
Regarding instant claim 4, App. ‘996 claims a polynucleotide encoding the CYP4V2 nucleic acid sequence set forth in SEQ ID NO: 62 (claim 3, see alignment below).
Regarding instant claims 10-12, App. ‘996 claims a method for treating or alleviating a disease or disorder associated with RPE, where the disease is BCD, which is a human disease.
App. ‘996 does not claim the vector being an AAV2/8, the CAG promoter sequence of SEQ ID NO: 4, and a polyA signal site that comprises the nucleic acid sequences of SEQ ID NOs: 17 and 19-21. App. ‘996 does not claim an isolated cell comprising the vector or a pharmaceutical composition comprising the vector and a pharmaceutically acceptable adjuvant.
Yang discloses an expression cassette design for a vector for use in CYP4V2 gene therapy of an AAV2/8 vector with a 5’ to 3’ design comprising a CAG promoter, a CYP4V2 cDNA, and polyA signal site. (See Yang, pg. 155 line 3).
Liu discloses the use of a CAG promoter comprising the nucleotide sequence of SEQ ID NO: 4 in a gene therapy vector for cancer treatment as an example of a CAG promoter amino acid sequence that is generally known in the art. (See Liu, abstract, and pg. 17 lines 17-19, and alignment below).
Ahlers discloses a polyA signal site comprising SEQ ID NO: 17 as a part of vector for gene therapy. (See Ahlers, abstract, also alignment below).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to use the CYP4V2 vector disclosed in App. ‘996 with the AAV2/8 vector disclosed in Yang, the CAG promoter sequence disclosed in Liu and the polyA signal site sequence disclosed in Ahlers for the present claimed invention. It would have been obvious because the vector of AAV2/8 has been successfully used for a CYP4V2 as disclosed in Yang and the CAG promoter and polyA signal site sequences disclosed in Liu and Ahlers are well known in the art. Therefore, it would have been obvious for a person of ordinary skill in the art prior to the effective filing date to combine the vector disclosed in App. ‘996 with the disclosed vector, CAG promoter, and polyA signal site sequences disclosed through Yang, Liu, and Ahlers with a reasonable expectation of success at developing the present claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
9. Applicant argues that the present claims have been amended to overcome the double patenting rejection. Specifically, the Applicant argues the amendment of the claims to recite an AAV2/8 vector, a CAG promoter of the nucleotide sequence of SEQ ID NO: 4, a CYP4V2 comprising the amino acid sequence of SEQ ID NO: 76, and a polyA signal site comprising nucleic acid sequences selected from SEQ ID NOs: 17 and 19-21 narrow the present claims to make is patentably distinct from App. ‘996.
Applicant argues App. ‘996 is patentably distinct from the present claimed invention because it is directed to methods fo treating RPE through administration of CYP4V2 and RdCVF.
10. Applicant's arguments have been fully considered but they are not persuasive.
Applicant’s amendments have narrowed the subject matter from App. ‘996 but not made it patentably distinct from the present claimed invention. First, the narrowing to the claimed sequence of SEQ ID NO: 76 does not make it patentably distinct because App. ‘996 claims SEQ ID NO: 76 in claim 3. Second, the narrowing of the vector to AAV2/8 is not patentably distinct because App. ‘996 claims an AAV vector can be used. Third, the CAG promoter and polyA signal site sequences are not patentably distinct because App. ‘996 claims these elements generically and Liu and Ahlers teach that they are well know sequences in the art. Therefore, the present claimed invention is not patentably distinct because it is an obvious version of the CYP4V2 vector claimed in co-pending App. ‘996.
App. ‘996 is not patentably distinct from the present claimed invention according to the recitation of the RdCVF vector because claim 22 recites the method as being directed to “the vector sequentially comprising, in 5’ to 3’ direction: the promoter, the polynucleotide encoding CYP4V2 and the polyA signal site;” allowing for the claims to be directed just to the CYP4V2 vector and not the RdCVF. Thus, the obvious double patenting rejection is maintained.
SEQ ID NO: 76 is identical to SEQ ID NO: 76 (App. ‘996):
US-17-756-996A-76
Filing date in PALM: 2023-01-24
Sequence 76, US/17756996A
GENERAL INFORMATION
APPLICANT: GHIGENOVO CO., LTD.
APPLICANT: PEKING UNIVERSITY THIRD HOSPITAL
APPLICANT: (PUK THIRD CLINICAL MEDICAL COLLEGE)
TITLE OF INVENTION: USE OF CYP4V2 AND RDCVF IN THE MANUFACTURE OF MEDICAMENT
FILE REFERENCE: 0138-PA-007
CURRENT APPLICATION NUMBER: US/17/756,996A
CURRENT FILING DATE: 2022-06-07
NUMBER OF SEQ ID NOS: 155
SEQ ID NO 76
LENGTH: 525
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: human CYP4V2 polypeptide sequence
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
1 2775 100.0 525 PCT-US03-28227-4116 2003-09-12 90 MOLECULES FOR DIAGNOSTICS AND THERAPEUTICS
ALIGNMENT:
Query Match 100.0%; Score 2775; Length 525;
Best Local Similarity 100.0%;
Matches 525; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MAGLWLGLVWQKLLLWGAASALSLAGASLVLSLLQRVASYARKWQQMRPIPTVARAYPLV 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAGLWLGLVWQKLLLWGAASALSLAGASLVLSLLQRVASYARKWQQMRPIPTVARAYPLV 60
Qy 61 GHALLMKPDGREFFQQIIEYTEEYRHMPLLKLWVGPVPMVALYNAENVEVILTSSKQIDK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GHALLMKPDGREFFQQIIEYTEEYRHMPLLKLWVGPVPMVALYNAENVEVILTSSKQIDK 120
Qy 121 SSMYKFLEPWLGLGLLTSTGNKWRSRRKMLTPTFHFTILEDFLDIMNEQANILVKKLEKH 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SSMYKFLEPWLGLGLLTSTGNKWRSRRKMLTPTFHFTILEDFLDIMNEQANILVKKLEKH 180
Qy 181 INQEAFNCFFYITLCALDIICETAMGKNIGAQSNDDSEYVRAVYRMSEMIFRRIKMPWLW 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 INQEAFNCFFYITLCALDIICETAMGKNIGAQSNDDSEYVRAVYRMSEMIFRRIKMPWLW 240
Qy 241 LDLWYLMFKEGWEHKKSLQILHTFTNSVIAERANEMNANEDCRGDGRGSAPSKNKRRAFL 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 LDLWYLMFKEGWEHKKSLQILHTFTNSVIAERANEMNANEDCRGDGRGSAPSKNKRRAFL 300
Qy 301 DLLLSVTDDEGNRLSHEDIREEVDTFMFEGHDTTAAAINWSLYLLGSNPEVQKKVDHELD 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 DLLLSVTDDEGNRLSHEDIREEVDTFMFEGHDTTAAAINWSLYLLGSNPEVQKKVDHELD 360
Qy 361 DVFGKSDRPATVEDLKKLRYLECVIKETLRLFPSVPLFARSVSEDCEVAGYRVLKGTEAV 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 DVFGKSDRPATVEDLKKLRYLECVIKETLRLFPSVPLFARSVSEDCEVAGYRVLKGTEAV 420
Qy 421 IIPYALHRDPRYFPNPEEFQPERFFPENAQGRHPYAYVPFSAGPRNCIGQKFAVMEEKTI 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 IIPYALHRDPRYFPNPEEFQPERFFPENAQGRHPYAYVPFSAGPRNCIGQKFAVMEEKTI 480
Qy 481 LSCILRHFWIESNQKREELGLEGQLILRPSNGIWIKLKRRNADER 525
|||||||||||||||||||||||||||||||||||||||||||||
Db 481 LSCILRHFWIESNQKREELGLEGQLILRPSNGIWIKLKRRNADER 525
SEQ ID NO: 62 is identical to SEQ ID NO: 62 (App. ‘996):
US-17-756-996A-62
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 62, US/17756996A
GENERAL INFORMATION
APPLICANT: GHIGENOVO CO., LTD.
APPLICANT: PEKING UNIVERSITY THIRD HOSPITAL
APPLICANT: (PUK THIRD CLINICAL MEDICAL COLLEGE)
TITLE OF INVENTION: USE OF CYP4V2 AND RDCVF IN THE MANUFACTURE OF MEDICAMENT
FILE REFERENCE: 0138-PA-007
CURRENT APPLICATION NUMBER: US/17/756,996A
CURRENT FILING DATE: 2022-06-07
NUMBER OF SEQ ID NOS: 155
SEQ ID NO 62
LENGTH: 1575
TYPE: DNA
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: CYP4V2 coding sequence
Query Match 100.0%; Score 1575; Length 1575;
Best Local Similarity 100.0%;
Matches 1575; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ATGGCGGGGCTCTGGCTGGGGCTCGTGTGGCAGAAGCTGCTGCTGTGGGGCGCGGCGAGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ATGGCGGGGCTCTGGCTGGGGCTCGTGTGGCAGAAGCTGCTGCTGTGGGGCGCGGCGAGT 60
Qy 61 GCCCTTTCCCTGGCCGGCGCCAGTCTGGTCCTGAGTCTGCTGCAGAGGGTGGCGAGCTAC 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GCCCTTTCCCTGGCCGGCGCCAGTCTGGTCCTGAGTCTGCTGCAGAGGGTGGCGAGCTAC 120
Qy 121 GCGCGGAAATGGCAGCAGATGCGGCCCATCCCCACGGTGGCCCGCGCCTACCCACTGGTG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GCGCGGAAATGGCAGCAGATGCGGCCCATCCCCACGGTGGCCCGCGCCTACCCACTGGTG 180
Qy 181 GGCCACGCGCTGCTGATGAAGCCGGACGGGCGAGAATTTTTTCAGCAGATCATTGAGTAC 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GGCCACGCGCTGCTGATGAAGCCGGACGGGCGAGAATTTTTTCAGCAGATCATTGAGTAC 240
Qy 241 ACAGAGGAATACCGCCACATGCCGCTGCTGAAGCTCTGGGTCGGGCCAGTGCCCATGGTG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 ACAGAGGAATACCGCCACATGCCGCTGCTGAAGCTCTGGGTCGGGCCAGTGCCCATGGTG 300
Qy 301 GCCCTTTATAATGCAGAAAATGTGGAGGTAATTTTAACTAGTTCAAAGCAAATTGACAAA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 GCCCTTTATAATGCAGAAAATGTGGAGGTAATTTTAACTAGTTCAAAGCAAATTGACAAA 360
Qy 361 TCCTCTATGTACAAGTTTTTAGAACCATGGCTTGGCCTAGGACTTCTTACAAGTACTGGA 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 TCCTCTATGTACAAGTTTTTAGAACCATGGCTTGGCCTAGGACTTCTTACAAGTACTGGA 420
Qy 421 AACAAATGGCGCTCCAGGAGAAAGATGTTAACACCCACTTTCCATTTTACCATTCTGGAA 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 AACAAATGGCGCTCCAGGAGAAAGATGTTAACACCCACTTTCCATTTTACCATTCTGGAA 480
Qy 481 GATTTCTTAGATATCATGAATGAACAAGCAAATATATTGGTTAAGAAACTTGAAAAACAC 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 GATTTCTTAGATATCATGAATGAACAAGCAAATATATTGGTTAAGAAACTTGAAAAACAC 540
Qy 541 ATTAACCAAGAAGCATTTAACTGCTTTTTTTACATCACTCTTTGTGCCTTAGATATCATC 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 ATTAACCAAGAAGCATTTAACTGCTTTTTTTACATCACTCTTTGTGCCTTAGATATCATC 600
Qy 601 TGTGAAACAGCTATGGGGAAGAATATTGGTGCTCAAAGTAATGATGATTCCGAGTATGTC 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 TGTGAAACAGCTATGGGGAAGAATATTGGTGCTCAAAGTAATGATGATTCCGAGTATGTC 660
Qy 661 CGTGCAGTTTATAGAATGAGTGAGATGATATTTCGAAGAATAAAGATGCCCTGGCTTTGG 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 CGTGCAGTTTATAGAATGAGTGAGATGATATTTCGAAGAATAAAGATGCCCTGGCTTTGG 720
Qy 721 CTTGATCTCTGGTACCTTATGTTTAAAGAAGGATGGGAACACAAAAAGAGCCTTCAGATC 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 CTTGATCTCTGGTACCTTATGTTTAAAGAAGGATGGGAACACAAAAAGAGCCTTCAGATC 780
Qy 781 CTACATACTTTTACCAACAGTGTCATCGCGGAACGGGCCAATGAAATGAACGCCAATGAA 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 CTACATACTTTTACCAACAGTGTCATCGCGGAACGGGCCAATGAAATGAACGCCAATGAA 840
Qy 841 GACTGTAGAGGTGATGGCAGGGGCTCTGCCCCCTCCAAAAATAAACGCAGGGCCTTTCTT 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 GACTGTAGAGGTGATGGCAGGGGCTCTGCCCCCTCCAAAAATAAACGCAGGGCCTTTCTT 900
Qy 901 GACTTGCTTTTAAGTGTGACTGATGACGAAGGGAACAGGCTAAGTCATGAAGATATTCGA 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 GACTTGCTTTTAAGTGTGACTGATGACGAAGGGAACAGGCTAAGTCATGAAGATATTCGA 960
Qy 961 GAAGAAGTTGACACCTTCATGTTTGAGGGGCACGATACAACTGCAGCTGCAATAAACTGG 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 GAAGAAGTTGACACCTTCATGTTTGAGGGGCACGATACAACTGCAGCTGCAATAAACTGG 1020
Qy 1021 TCCTTATACCTGTTGGGTTCTAACCCAGAAGTCCAGAAAAAAGTGGATCATGAATTGGAT 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 TCCTTATACCTGTTGGGTTCTAACCCAGAAGTCCAGAAAAAAGTGGATCATGAATTGGAT 1080
Qy 1081 GACGTGTTTGGGAAGTCTGACCGTCCCGCTACAGTAGAAGACCTGAAGAAACTTCGGTAT 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 GACGTGTTTGGGAAGTCTGACCGTCCCGCTACAGTAGAAGACCTGAAGAAACTTCGGTAT 1140
Qy 1141 CTGGAATGTGTTATTAAGGAGACCCTTCGCCTTTTTCCTTCTGTTCCTTTATTTGCCCGT 1200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 CTGGAATGTGTTATTAAGGAGACCCTTCGCCTTTTTCCTTCTGTTCCTTTATTTGCCCGT 1200
Qy 1201 AGTGTTAGTGAAGATTGTGAAGTGGCAGGTTACAGAGTTCTAAAAGGCACTGAAGCCGTC 1260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1201 AGTGTTAGTGAAGATTGTGAAGTGGCAGGTTACAGAGTTCTAAAAGGCACTGAAGCCGTC 1260
Qy 1261 ATCATTCCCTATGCATTGCACAGAGATCCGAGATACTTCCCCAACCCCGAGGAGTTCCAG 1320
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1261 ATCATTCCCTATGCATTGCACAGAGATCCGAGATACTTCCCCAACCCCGAGGAGTTCCAG 1320
Qy 1321 CCTGAGCGGTTCTTCCCCGAGAATGCACAAGGGCGCCATCCATATGCCTACGTGCCCTTC 1380
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1321 CCTGAGCGGTTCTTCCCCGAGAATGCACAAGGGCGCCATCCATATGCCTACGTGCCCTTC 1380
Qy 1381 TCTGCTGGCCCCAGGAACTGTATAGGTCAAAAGTTTGCTGTGATGGAAGAAAAGACCATT 1440
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1381 TCTGCTGGCCCCAGGAACTGTATAGGTCAAAAGTTTGCTGTGATGGAAGAAAAGACCATT 1440
Qy 1441 CTTTCGTGCATCCTGAGGCACTTTTGGATAGAATCCAACCAGAAAAGAGAAGAGCTTGGT 1500
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1441 CTTTCGTGCATCCTGAGGCACTTTTGGATAGAATCCAACCAGAAAAGAGAAGAGCTTGGT 1500
Qy 1501 CTAGAAGGACAGTTGATTCTTCGTCCAAGTAATGGCATCTGGATCAAGTTGAAGAGGAGA 1560
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1501 CTAGAAGGACAGTTGATTCTTCGTCCAAGTAATGGCATCTGGATCAAGTTGAAGAGGAGA 1560
Qy 1561 AATGCAGATGAACGC 1575
|||||||||||||||
Db 1561 AATGCAGATGAACGC 1575
SEQ ID NO:4 100% identical to SEQ ID NO:29 (Liu):
WO2019222569-A1.
XX
CC PD 21-NOV-2019.
XX
CC PF 17-MAY-2019; 2019WO-US032772.
XX
PR 17-MAY-2018; 2018US-0672749P.
XX
CC PA (UABR ) UAB RES FOUND.
XX
CC PI Liu X, Zhou L, Zhang J, Ernst PJ, Xu N;
XX
DR WPI; 2019-98228N/92.
XX
CC PT Fusion protein comprises Chloromonas oogama channelrhodopsin
CC PT photoreceptor linked to inner mitochondrial membrane-mitochondrial
CC PT localization signal.
XX
CC PS Disclosure; SEQ ID NO 29; 78pp; English.
XX
Query Match 100.0%; Score 937; Length 937;
Best Local Similarity 100.0%;
Matches 937; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CCATTGACGTCAATAATGACGTATGTTCCCATAGTAACGCCAATAGGGACTTTCCATTGA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 CCATTGACGTCAATAATGACGTATGTTCCCATAGTAACGCCAATAGGGACTTTCCATTGA 60
Qy 61 CGTCAATGGGTGGAGTATTTACGGTAAACTGCCCACTTGGCAGTACATCAAGTGTATCAT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 CGTCAATGGGTGGAGTATTTACGGTAAACTGCCCACTTGGCAGTACATCAAGTGTATCAT 120
Qy 121 ATGCCAAGTACGCCCCCTATTGACGTCAATGACGGTAAATGGCCCGCCTGGCATTATGCC 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ATGCCAAGTACGCCCCCTATTGACGTCAATGACGGTAAATGGCCCGCCTGGCATTATGCC 180
Qy 181 CAGTACATGACCTTATGGGACTTTCCTACTTGGCAGTACATCTACGTATTAGTCATCGCT 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 CAGTACATGACCTTATGGGACTTTCCTACTTGGCAGTACATCTACGTATTAGTCATCGCT 240
Qy 241 ATTACCATGGTCGAGGTGAGCCCCACGTTCTGCTTCACTCTCCCCATCTCCCCCCCCTCC 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 ATTACCATGGTCGAGGTGAGCCCCACGTTCTGCTTCACTCTCCCCATCTCCCCCCCCTCC 300
Qy 301 CCACCCCCAATTTTGTATTTATTTATTTTTTAATTATTTTGTGCAGCGATGGGGGCGGGG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 CCACCCCCAATTTTGTATTTATTTATTTTTTAATTATTTTGTGCAGCGATGGGGGCGGGG 360
Qy 361 GGGGGGGGGGGGCGCGCGCCAGGCGGGGCGGGGCGGGGCGAGGGGCGGGGCGGGGCGAGG 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 GGGGGGGGGGGGCGCGCGCCAGGCGGGGCGGGGCGGGGCGAGGGGCGGGGCGGGGCGAGG 420
Qy 421 CGGAGAGGTGCGGCGGCAGCCAATCAGAGCGGCGCGCTCCGAAAGTTTCCTTTTATGGCG 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 CGGAGAGGTGCGGCGGCAGCCAATCAGAGCGGCGCGCTCCGAAAGTTTCCTTTTATGGCG 480
Qy 481 AGGCGGCGGCGGCGGCGGCCCTATAAAAAGCGAAGCGCGCGGCGGGCGGGAGTCGCTGCG 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 AGGCGGCGGCGGCGGCGGCCCTATAAAAAGCGAAGCGCGCGGCGGGCGGGAGTCGCTGCG 540
Qy 541 ACGCTGCCTTCGCCCCGTGCCCCGCTCCGCCGCCGCCTCGCGCCGCCCGCCCCGGCTCTG 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 ACGCTGCCTTCGCCCCGTGCCCCGCTCCGCCGCCGCCTCGCGCCGCCCGCCCCGGCTCTG 600
Qy 601 ACTGACCGCGTTACTCCCACAGGTGAGCGGGCGGGACGGCCCTTCTCCTCCGGGCTGTAA 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 ACTGACCGCGTTACTCCCACAGGTGAGCGGGCGGGACGGCCCTTCTCCTCCGGGCTGTAA 660
Qy 661 TTAGCGCTTGGTTTAATGACGGCTTGTTTCTTTTCTGTGGCTGCGTGAAAGCCTTGAGGG 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 TTAGCGCTTGGTTTAATGACGGCTTGTTTCTTTTCTGTGGCTGCGTGAAAGCCTTGAGGG 720
Qy 721 GCTCCGGGAGGGCCCTTTGTGCGGGGGGAGCGGCTCGGGGCTGTCCGCGGGGGGACGGCT 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 GCTCCGGGAGGGCCCTTTGTGCGGGGGGAGCGGCTCGGGGCTGTCCGCGGGGGGACGGCT 780
Qy 781 GCCTTCGGGGGGGACGGGGCAGGGCGGGGTTCGGCTTCTGGCGTGTGACCGGCGGCTCTA 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 GCCTTCGGGGGGGACGGGGCAGGGCGGGGTTCGGCTTCTGGCGTGTGACCGGCGGCTCTA 840
Qy 841 GAGCCTCTGCTAACCATGTTCATGCCTTCTTCTTTTTCCTACAGCTCCTGGGCAACGTGC 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 GAGCCTCTGCTAACCATGTTCATGCCTTCTTCTTTTTCCTACAGCTCCTGGGCAACGTGC 900
Qy 901 TGGTTATTGTGCTGTCTCATCATTTTGGCAAAGAATT 937
|||||||||||||||||||||||||||||||||||||
Db 901 TGGTTATTGTGCTGTCTCATCATTTTGGCAAAGAATT 937
SEQ ID NO: 17 is 100% identical to SEQ ID NO: 65 (Ahlers):
WO2019018383-A1.
XX
CC PD 24-JAN-2019.
XX
CC PF 17-JUL-2018; 2018WO-US042471.
XX
PR 18-JUL-2017; 2017US-0533719P.
PR 07-AUG-2017; 2017US-0541931P.
PR 06-APR-2018; 2018US-0653913P.
XX
CC PA (CALI-) CALIMMUNE INC.
CC PA (CALI-) CALIMMUNE AUSTRALIA PTY LTD.
XX
CC PI Ahlers J, Bartlett J, Lee C, Ringpis GE, Symonds GP, Yan M;
XX
DR WPI; 2019-096004/12.
XX
CC PT Vector comprises first expression control sequence linked to first
CC PT nucleic acid sequence, first nucleic acid sequence encoding RNAi to
CC PT knockdown hypoxanthine-guanine phosphoribosyltransferase and second
CC PT expression control sequence.
XX
CC PS Example 3; SEQ ID NO 65; 157pp; English.
Query Match 100.0%; Score 122; Length 128;
Best Local Similarity 100.0%;
Matches 122; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AACTTGTTTATTGCAGCTTATAATGGTTACAAATAAAGCAATAGCATCACAAATTTCACA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AACTTGTTTATTGCAGCTTATAATGGTTACAAATAAAGCAATAGCATCACAAATTTCACA 60
Qy 61 AATAAAGCATTTTTTTCACTGCATTCTAGTTGTGGTTTGTCCAAACTCATCAATGTATCT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AATAAAGCATTTTTTTCACTGCATTCTAGTTGTGGTTTGTCCAAACTCATCAATGTATCT 120
Qy 121 TA 122
||
Db 121 TA 122
New Rejections
(not previously presented)
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
9. Claims 1, 4, and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (WO 2019/025984 A1, pub. 2/7/2019) in view of Liu (WO 2019//222569 A1, pub. 11/21/2019) and Ahlers (WO 2019/018383 A1, pub. 1/24/2019).
Yang discloses an expression cassette design for a vector for use in CYP4V2 gene therapy of an AAV2/8 vector with a 5’ to 3’ design comprising a CAG promoter, a CYP4V2 cDNA, and polyA signal site. (See Yang, pg. 155 line 3). Yang discloses the CYP4V2 of the amino acid sequence of SEQ ID NO: 76 and nucleotide sequence of SEQ ID NO: 62. (SEQ ID NO: 4, and SEQ ID NO:3, see alignments below) as the cDNA encoded within the expression vector. (See Yang pg. 154 line 13). Yang discloses the CYP4V2 sequence can be operably linked to the promoter sequence. (See Yang pg. 36 lines 7-8, also pg. 39 line 6).
Regarding claims 8-12, Yang discloses an isolated cell comprising the vector (See Yang pg. 40, line 3), in a composition along with a pharmaceutically acceptable adjuvant (See Yang, pg. 40, line 1-2), for treatment of a retinal disease including Bietti’s crystalline dystrophy (BCD) (See Yang, pg. 40, lines 8-12), in a human subject (See Yang, pg. 11, lines 13-14).
Yang does not disclose the CAG promoter as the nucleotide sequence of SEQ ID NO: 4. But Yang does teach that the promoter chosen in the design needs to work well to drive the expression in target cells and depends on the target tissue for expression. In the case of a CYP4V2 gene expression vector for use in treating BCD, Yang teaches that the CAG promoter was chosen for the expression cassette because the CYP4V2 gene is ubiquitously expressed and treatment of BCD requires targeting several different cell types. Further, Yang teaches that the CAG promoter is stronger and longer lasting than the CMV promoter which is more commonly used. (See Yang pg. 151 line 29- pg. 152 line 21).
Yang does not disclose the polyA signal site comprising the nucleic acid sequences of SEQ ID NOs:17 and 19-21. Yang does teach that polyA signal sites of various sequences can be used and provides exemplary sequences including a sequence that aligns with instant SEQ ID NO: 21 and SEQ ID NO: 17. (See SEQ ID NOs: 34 and 39 and alignments below).
Liu discloses the use of a CAG promoter comprising the nucleotide sequence of SEQ ID NO: 4 in a gene therapy vector for cancer treatment as an example of a CAG promoter amino acid sequence that is generally known in the art. (See Liu, abstract, and pg. 17 lines 17-19, and alignment below).
Ahlers discloses a polyA signal site comprising SEQ ID NO: 17 as a part of vector for gene therapy. (See Ahlers, abstract, also alignment below).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to combine the AAV2/8 vector for CYP4V2 gene therapy disclosed in Yang with the CAG promoter sequence disclosed in Liu and the polyA signal site disclosed in Ahlers for the present claimed invention. It would have been obvious because Yang uses a CAG promoter in the vector used with the same sequence for the CYP4V2 gene, Yang teaches that CAG promoters are ideal for gene therapy in treating diseases like BCD because they target several different cell types for effective therapy, and Yang teaches polyA signal site nucleotide sequences are common and known in the art. It would have a reasonable expectation of success because the AAV2/8 vector of Yang had already used similar sequences in their vector with success and the CAG promoter nucleic acid sequences of Liu and polyA signal site nucleic acid sequences are known in the art. Therefore, it would have been obvious to a person of ordinary skill in the art to combine the vector disclosed in Yang with the CAG promoter nucleic acid sequences of Liu and the polyA signal site sequences of Ahlers with a reasonable expectation of success at producing a CYP4V2 vector for the treatment of BCD.
Response to Arguments
10. Applicant argues the previous 103 rejection citing current references Yang and Liu did not provide a basis for obviousness over the current claimed invention. Particularly, Applicant argues that the current claimed inventions use of a CAG promoter, CYP4V2 sequence and AAV vector serotype present superior technical effect not taught or suggested in the references. Additionally, Applicant’s argue that the observed superiority was not predictable from the prior art.
11. Applicant's arguments have been fully considered but they are not persuasive. As discussed above in the 103 rejection above, Yang does recite an expression vector including the claimed components of the CAG promoter to a CYP4V2 sequence expressed in an AAV2/8 vector. Yang teaches that the CAG promoter was chosen for the expression cassette because the CYP4V2 gene is ubiquitously expressed and treatment of BCD requires targeting several different cell types. Further, Yang teaches that the CAG promoter is stronger and longer lasting than the CMV promoter which is more commonly used. (See Yang pg. 151 line 29- pg. 152 line 21). From Yang’s teachings, it would be obvious for a person of ordinary skill in the art to predict superior results in a CYP4V2 expression vector using a CAG promoter.
SEQ ID NO: 76 is 100% identical to SEQ ID NO: 4 (Yang):
WO2019025984-A1.
XX
CC PD 07-FEB-2019.
XX
CC PF 31-JUL-2018; 2018WO-IB055755.
XX
PR 31-JUL-2017; 2017US-0539473P.
XX
CC PA (REFL-) REFLECTION BIOTECHNOLOGIES LTD.
XX
CC PI Yang RR;
XX
DR WPI; 2019-14016U/14.
DR N-PSDB; BGB71554, BGB71555.
DR REFSEQ; NP_997235.3.
XX
CC PT Composition for treating or preventing an ocular disease in human
CC PT subject, comprises vector comprising expression cassette comprising
CC PT nucleic acid molecule encoding a functional or non-mutant cytochrome P450
CC PT 4V2 (CYP4V2) protein.
XX
CC PS Claim 15; SEQ ID NO 4; 316pp; English.
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
1 2775 100.0 525 ABM83867 -- 40 Human diagnostic and therapeutic pprotein SEQ ID NO:4116.
ALIGNMENT:
Query Match 100.0%; Score 2775; Length 525;
Best Local Similarity 100.0%;
Matches 525; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MAGLWLGLVWQKLLLWGAASALSLAGASLVLSLLQRVASYARKWQQMRPIPTVARAYPLV 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAGLWLGLVWQKLLLWGAASALSLAGASLVLSLLQRVASYARKWQQMRPIPTVARAYPLV 60
Qy 61 GHALLMKPDGREFFQQIIEYTEEYRHMPLLKLWVGPVPMVALYNAENVEVILTSSKQIDK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GHALLMKPDGREFFQQIIEYTEEYRHMPLLKLWVGPVPMVALYNAENVEVILTSSKQIDK 120
Qy 121 SSMYKFLEPWLGLGLLTSTGNKWRSRRKMLTPTFHFTILEDFLDIMNEQANILVKKLEKH 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SSMYKFLEPWLGLGLLTSTGNKWRSRRKMLTPTFHFTILEDFLDIMNEQANILVKKLEKH 180
Qy 181 INQEAFNCFFYITLCALDIICETAMGKNIGAQSNDDSEYVRAVYRMSEMIFRRIKMPWLW 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 INQEAFNCFFYITLCALDIICETAMGKNIGAQSNDDSEYVRAVYRMSEMIFRRIKMPWLW 240
Qy 241 LDLWYLMFKEGWEHKKSLQILHTFTNSVIAERANEMNANEDCRGDGRGSAPSKNKRRAFL 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 LDLWYLMFKEGWEHKKSLQILHTFTNSVIAERANEMNANEDCRGDGRGSAPSKNKRRAFL 300
Qy 301 DLLLSVTDDEGNRLSHEDIREEVDTFMFEGHDTTAAAINWSLYLLGSNPEVQKKVDHELD 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 DLLLSVTDDEGNRLSHEDIREEVDTFMFEGHDTTAAAINWSLYLLGSNPEVQKKVDHELD 360
Qy 361 DVFGKSDRPATVEDLKKLRYLECVIKETLRLFPSVPLFARSVSEDCEVAGYRVLKGTEAV 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 DVFGKSDRPATVEDLKKLRYLECVIKETLRLFPSVPLFARSVSEDCEVAGYRVLKGTEAV 420
Qy 421 IIPYALHRDPRYFPNPEEFQPERFFPENAQGRHPYAYVPFSAGPRNCIGQKFAVMEEKTI 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 IIPYALHRDPRYFPNPEEFQPERFFPENAQGRHPYAYVPFSAGPRNCIGQKFAVMEEKTI 480
Qy 481 LSCILRHFWIESNQKREELGLEGQLILRPSNGIWIKLKRRNADER 525
|||||||||||||||||||||||||||||||||||||||||||||
Db 481 LSCILRHFWIESNQKREELGLEGQLILRPSNGIWIKLKRRNADER 525
SEQ ID NO: 62 is 99.8% identical to SEQ ID NO: 3 (Yang):
WO2019025984-A1.
XX
CC PD 07-FEB-2019.
XX
CC PF 31-JUL-2018; 2018WO-IB055755.
XX
PR 31-JUL-2017; 2017US-0539473P.
XX
CC PA (REFL-) REFLECTION BIOTECHNOLOGIES LTD.
XX
CC PI Yang RR;
XX
DR WPI; 2019-14016U/14.
DR P-PSDB; BGB71558.
XX
CC PT Composition for treating or preventing an ocular disease in human
CC PT subject, comprises vector comprising expression cassette comprising
CC PT nucleic acid molecule encoding a functional or non-mutant cytochrome P450
CC PT 4V2 (CYP4V2) protein.
XX
CC PS Claim 16; SEQ ID NO 3; 316pp; English.
Query Match 99.8%; Score 1571.8; Length 1578;
Best Local Similarity 99.9%;
Matches 1573; Conservative 0; Mismatches 2; Indels 0; Gaps 0;
Qy 1 ATGGCGGGGCTCTGGCTGGGGCTCGTGTGGCAGAAGCTGCTGCTGTGGGGCGCGGCGAGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ATGGCGGGGCTCTGGCTGGGGCTCGTGTGGCAGAAGCTGCTGCTGTGGGGCGCGGCGAGT 60
Qy 61 GCCCTTTCCCTGGCCGGCGCCAGTCTGGTCCTGAGTCTGCTGCAGAGGGTGGCGAGCTAC 120
||||||||||||||||||||||||||||||||||| ||||||||||||||||||||||||
Db 61 GCCCTTTCCCTGGCCGGCGCCAGTCTGGTCCTGAGCCTGCTGCAGAGGGTGGCGAGCTAC 120
Qy 121 GCGCGGAAATGGCAGCAGATGCGGCCCATCCCCACGGTGGCCCGCGCCTACCCACTGGTG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GCGCGGAAATGGCAGCAGATGCGGCCCATCCCCACGGTGGCCCGCGCCTACCCACTGGTG 180
Qy 181 GGCCACGCGCTGCTGATGAAGCCGGACGGGCGAGAATTTTTTCAGCAGATCATTGAGTAC 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 GGCCACGCGCTGCTGATGAAGCCGGACGGGCGAGAATTTTTTCAGCAGATCATTGAGTAC 240
Qy 241 ACAGAGGAATACCGCCACATGCCGCTGCTGAAGCTCTGGGTCGGGCCAGTGCCCATGGTG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 ACAGAGGAATACCGCCACATGCCGCTGCTGAAGCTCTGGGTCGGGCCAGTGCCCATGGTG 300
Qy 301 GCCCTTTATAATGCAGAAAATGTGGAGGTAATTTTAACTAGTTCAAAGCAAATTGACAAA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 GCCCTTTATAATGCAGAAAATGTGGAGGTAATTTTAACTAGTTCAAAGCAAATTGACAAA 360
Qy 361 TCCTCTATGTACAAGTTTTTAGAACCATGGCTTGGCCTAGGACTTCTTACAAGTACTGGA 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 TCCTCTATGTACAAGTTTTTAGAACCATGGCTTGGCCTAGGACTTCTTACAAGTACTGGA 420
Qy 421 AACAAATGGCGCTCCAGGAGAAAGATGTTAACACCCACTTTCCATTTTACCATTCTGGAA 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 AACAAATGGCGCTCCAGGAGAAAGATGTTAACACCCACTTTCCATTTTACCATTCTGGAA 480
Qy 481 GATTTCTTAGATATCATGAATGAACAAGCAAATATATTGGTTAAGAAACTTGAAAAACAC 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 GATTTCTTAGATATCATGAATGAACAAGCAAATATATTGGTTAAGAAACTTGAAAAACAC 540
Qy 541 ATTAACCAAGAAGCATTTAACTGCTTTTTTTACATCACTCTTTGTGCCTTAGATATCATC 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 ATTAACCAAGAAGCATTTAACTGCTTTTTTTACATCACTCTTTGTGCCTTAGATATCATC 600
Qy 601 TGTGAAACAGCTATGGGGAAGAATATTGGTGCTCAAAGTAATGATGATTCCGAGTATGTC 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 TGTGAAACAGCTATGGGGAAGAATATTGGTGCTCAAAGTAATGATGATTCCGAGTATGTC 660
Qy 661 CGTGCAGTTTATAGAATGAGTGAGATGATATTTCGAAGAATAAAGATGCCCTGGCTTTGG 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 CGTGCAGTTTATAGAATGAGTGAGATGATATTTCGAAGAATAAAGATGCCCTGGCTTTGG 720
Qy 721 CTTGATCTCTGGTACCTTATGTTTAAAGAAGGATGGGAACACAAAAAGAGCCTTCAGATC 780
|||||||||||||||||||||||||||||||||||||||||||||||||||||| |||||
Db 721 CTTGATCTCTGGTACCTTATGTTTAAAGAAGGATGGGAACACAAAAAGAGCCTTAAGATC 780
Qy 781 CTACATACTTTTACCAACAGTGTCATCGCGGAACGGGCCAATGAAATGAACGCCAATGAA 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 CTACATACTTTTACCAACAGTGTCATCGCGGAACGGGCCAATGAAATGAACGCCAATGAA 840
Qy 841 GACTGTAGAGGTGATGGCAGGGGCTCTGCCCCCTCCAAAAATAAACGCAGGGCCTTTCTT 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 GACTGTAGAGGTGATGGCAGGGGCTCTGCCCCCTCCAAAAATAAACGCAGGGCCTTTCTT 900
Qy 901 GACTTGCTTTTAAGTGTGACTGATGACGAAGGGAACAGGCTAAGTCATGAAGATATTCGA 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 GACTTGCTTTTAAGTGTGACTGATGACGAAGGGAACAGGCTAAGTCATGAAGATATTCGA 960
Qy 961 GAAGAAGTTGACACCTTCATGTTTGAGGGGCACGATACAACTGCAGCTGCAATAAACTGG 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 GAAGAAGTTGACACCTTCATGTTTGAGGGGCACGATACAACTGCAGCTGCAATAAACTGG 1020
Qy 1021 TCCTTATACCTGTTGGGTTCTAACCCAGAAGTCCAGAAAAAAGTGGATCATGAATTGGAT 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 TCCTTATACCTGTTGGGTTCTAACCCAGAAGTCCAGAAAAAAGTGGATCATGAATTGGAT 1080
Qy 1081 GACGTGTTTGGGAAGTCTGACCGTCCCGCTACAGTAGAAGACCTGAAGAAACTTCGGTAT 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 GACGTGTTTGGGAAGTCTGACCGTCCCGCTACAGTAGAAGACCTGAAGAAACTTCGGTAT 1140
Qy 1141 CTGGAATGTGTTATTAAGGAGACCCTTCGCCTTTTTCCTTCTGTTCCTTTATTTGCCCGT 1200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1141 CTGGAATGTGTTATTAAGGAGACCCTTCGCCTTTTTCCTTCTGTTCCTTTATTTGCCCGT 1200
Qy 1201 AGTGTTAGTGAAGATTGTGAAGTGGCAGGTTACAGAGTTCTAAAAGGCACTGAAGCCGTC 1260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1201 AGTGTTAGTGAAGATTGTGAAGTGGCAGGTTACAGAGTTCTAAAAGGCACTGAAGCCGTC 1260
Qy 1261 ATCATTCCCTATGCATTGCACAGAGATCCGAGATACTTCCCCAACCCCGAGGAGTTCCAG 1320
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1261 ATCATTCCCTATGCATTGCACAGAGATCCGAGATACTTCCCCAACCCCGAGGAGTTCCAG 1320
Qy 1321 CCTGAGCGGTTCTTCCCCGAGAATGCACAAGGGCGCCATCCATATGCCTACGTGCCCTTC 1380
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1321 CCTGAGCGGTTCTTCCCCGAGAATGCACAAGGGCGCCATCCATATGCCTACGTGCCCTTC 1380
Qy 1381 TCTGCTGGCCCCAGGAACTGTATAGGTCAAAAGTTTGCTGTGATGGAAGAAAAGACCATT 1440
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1381 TCTGCTGGCCCCAGGAACTGTATAGGTCAAAAGTTTGCTGTGATGGAAGAAAAGACCATT 1440
Qy 1441 CTTTCGTGCATCCTGAGGCACTTTTGGATAGAATCCAACCAGAAAAGAGAAGAGCTTGGT 1500
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1441 CTTTCGTGCATCCTGAGGCACTTTTGGATAGAATCCAACCAGAAAAGAGAAGAGCTTGGT 1500
Qy 1501 CTAGAAGGACAGTTGATTCTTCGTCCAAGTAATGGCATCTGGATCAAGTTGAAGAGGAGA 1560
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1501 CTAGAAGGACAGTTGATTCTTCGTCCAAGTAATGGCATCTGGATCAAGTTGAAGAGGAGA 1560
Qy 1561 AATGCAGATGAACGC 1575
|||||||||||||||
Db 1561 AATGCAGATGAACGC 1575
SEQ ID NO: 21 aligned to SEQ ID NO: 34 (Yang)
PNG
media_image1.png
424
654
media_image1.png
Greyscale
SEQ ID NO: 17 aligned with SEQ ID NO: 39 (Yang):
PNG
media_image2.png
283
668
media_image2.png
Greyscale
SEQ ID NO:4 100% identical to SEQ ID NO:29 (Liu):
WO2019222569-A1.
XX
CC PD 21-NOV-2019.
XX
CC PF 17-MAY-2019; 2019WO-US032772.
XX
PR 17-MAY-2018; 2018US-0672749P.
XX
CC PA (UABR ) UAB RES FOUND.
XX
CC PI Liu X, Zhou L, Zhang J, Ernst PJ, Xu N;
XX
DR WPI; 2019-98228N/92.
XX
CC PT Fusion protein comprises Chloromonas oogama channelrhodopsin
CC PT photoreceptor linked to inner mitochondrial membrane-mitochondrial
CC PT localization signal.
XX
CC PS Disclosure; SEQ ID NO 29; 78pp; English.
XX
Query Match 100.0%; Score 937; Length 937;
Best Local Similarity 100.0%;
Matches 937; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CCATTGACGTCAATAATGACGTATGTTCCCATAGTAACGCCAATAGGGACTTTCCATTGA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 CCATTGACGTCAATAATGACGTATGTTCCCATAGTAACGCCAATAGGGACTTTCCATTGA 60
Qy 61 CGTCAATGGGTGGAGTATTTACGGTAAACTGCCCACTTGGCAGTACATCAAGTGTATCAT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 CGTCAATGGGTGGAGTATTTACGGTAAACTGCCCACTTGGCAGTACATCAAGTGTATCAT 120
Qy 121 ATGCCAAGTACGCCCCCTATTGACGTCAATGACGGTAAATGGCCCGCCTGGCATTATGCC 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ATGCCAAGTACGCCCCCTATTGACGTCAATGACGGTAAATGGCCCGCCTGGCATTATGCC 180
Qy 181 CAGTACATGACCTTATGGGACTTTCCTACTTGGCAGTACATCTACGTATTAGTCATCGCT 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 CAGTACATGACCTTATGGGACTTTCCTACTTGGCAGTACATCTACGTATTAGTCATCGCT 240
Qy 241 ATTACCATGGTCGAGGTGAGCCCCACGTTCTGCTTCACTCTCCCCATCTCCCCCCCCTCC 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 ATTACCATGGTCGAGGTGAGCCCCACGTTCTGCTTCACTCTCCCCATCTCCCCCCCCTCC 300
Qy 301 CCACCCCCAATTTTGTATTTATTTATTTTTTAATTATTTTGTGCAGCGATGGGGGCGGGG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 CCACCCCCAATTTTGTATTTATTTATTTTTTAATTATTTTGTGCAGCGATGGGGGCGGGG 360
Qy 361 GGGGGGGGGGGGCGCGCGCCAGGCGGGGCGGGGCGGGGCGAGGGGCGGGGCGGGGCGAGG 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 GGGGGGGGGGGGCGCGCGCCAGGCGGGGCGGGGCGGGGCGAGGGGCGGGGCGGGGCGAGG 420
Qy 421 CGGAGAGGTGCGGCGGCAGCCAATCAGAGCGGCGCGCTCCGAAAGTTTCCTTTTATGGCG 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 CGGAGAGGTGCGGCGGCAGCCAATCAGAGCGGCGCGCTCCGAAAGTTTCCTTTTATGGCG 480
Qy 481 AGGCGGCGGCGGCGGCGGCCCTATAAAAAGCGAAGCGCGCGGCGGGCGGGAGTCGCTGCG 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 AGGCGGCGGCGGCGGCGGCCCTATAAAAAGCGAAGCGCGCGGCGGGCGGGAGTCGCTGCG 540
Qy 541 ACGCTGCCTTCGCCCCGTGCCCCGCTCCGCCGCCGCCTCGCGCCGCCCGCCCCGGCTCTG 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 ACGCTGCCTTCGCCCCGTGCCCCGCTCCGCCGCCGCCTCGCGCCGCCCGCCCCGGCTCTG 600
Qy 601 ACTGACCGCGTTACTCCCACAGGTGAGCGGGCGGGACGGCCCTTCTCCTCCGGGCTGTAA 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 ACTGACCGCGTTACTCCCACAGGTGAGCGGGCGGGACGGCCCTTCTCCTCCGGGCTGTAA 660
Qy 661 TTAGCGCTTGGTTTAATGACGGCTTGTTTCTTTTCTGTGGCTGCGTGAAAGCCTTGAGGG 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 TTAGCGCTTGGTTTAATGACGGCTTGTTTCTTTTCTGTGGCTGCGTGAAAGCCTTGAGGG 720
Qy 721 GCTCCGGGAGGGCCCTTTGTGCGGGGGGAGCGGCTCGGGGCTGTCCGCGGGGGGACGGCT 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 GCTCCGGGAGGGCCCTTTGTGCGGGGGGAGCGGCTCGGGGCTGTCCGCGGGGGGACGGCT 780
Qy 781 GCCTTCGGGGGGGACGGGGCAGGGCGGGGTTCGGCTTCTGGCGTGTGACCGGCGGCTCTA 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 GCCTTCGGGGGGGACGGGGCAGGGCGGGGTTCGGCTTCTGGCGTGTGACCGGCGGCTCTA 840
Qy 841 GAGCCTCTGCTAACCATGTTCATGCCTTCTTCTTTTTCCTACAGCTCCTGGGCAACGTGC 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 GAGCCTCTGCTAACCATGTTCATGCCTTCTTCTTTTTCCTACAGCTCCTGGGCAACGTGC 900
Qy 901 TGGTTATTGTGCTGTCTCATCATTTTGGCAAAGAATT 937
|||||||||||||||||||||||||||||||||||||
Db 901 TGGTTATTGTGCTGTCTCATCATTTTGGCAAAGAATT 937
SEQ ID NO: 17 is 100% identical to SEQ ID NO: 65 (Ahlers):
WO2019018383-A1.
XX
CC PD 24-JAN-2019.
XX
CC PF 17-JUL-2018; 2018WO-US042471.
XX
PR 18-JUL-2017; 2017US-0533719P.
PR 07-AUG-2017; 2017US-0541931P.
PR 06-APR-2018; 2018US-0653913P.
XX
CC PA (CALI-) CALIMMUNE INC.
CC PA (CALI-) CALIMMUNE AUSTRALIA PTY LTD.
XX
CC PI Ahlers J, Bartlett J, Lee C, Ringpis GE, Symonds GP, Yan M;
XX
DR WPI; 2019-096004/12.
XX
CC PT Vector comprises first expression control sequence linked to first
CC PT nucleic acid sequence, first nucleic acid sequence encoding RNAi to
CC PT knockdown hypoxanthine-guanine phosphoribosyltransferase and second
CC PT expression control sequence.
XX
CC PS Example 3; SEQ ID NO 65; 157pp; English.
Query Match 100.0%; Score 122; Length 128;
Best Local Similarity 100.0%;
Matches 122; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AACTTGTTTATTGCAGCTTATAATGGTTACAAATAAAGCAATAGCATCACAAATTTCACA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AACTTGTTTATTGCAGCTTATAATGGTTACAAATAAAGCAATAGCATCACAAATTTCACA 60
Qy 61 AATAAAGCATTTTTTTCACTGCATTCTAGTTGTGGTTTGTCCAAACTCATCAATGTATCT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AATAAAGCATTTTTTTCACTGCATTCTAGTTGTGGTTTGTCCAAACTCATCAATGTATCT 120
Qy 121 TA 122
||
Db 121 TA 122
New Rejections
(Not Previously Presented)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
12. Claims 1, 4, 8-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, and 9 of U.S. Patent No. 12065663 (hereinafter Patent ‘663) in view of Ahlers (WO 2019/018383 A1, pub. 1/24/2019).
In regard to instant claim 1, Patent ‘663 claims an AAV2/8 vector comprising a polynucleotide encoding a promoter operably linked to a polynucleotide encoding CYP4V2 wherein the polynucleotide vector comprises the nucleotide sequence of SEQ ID NO: 11, see alignments below is 100% identical to instant SEQ ID NO: 4 and 100% identical to translated to instant SEQ ID NO:76 (Patent ‘663 claim 1, see alignments below). Patent ‘663 claims the vector is sequentially comprising from the 5’ to 3’ direction: the promoter, CYP4V2, and a polyA signal site (Patent ‘663 claim 2).
Regarding instant claim 4, Patent ‘663 claims the vector encoding the polynucleotide is encoded by SEQ ID NO: 11 (Patent ‘663 claim 1) which is 99.8% identical to instant SEQ ID NO: 62 (See alignment below).
Regarding instant claim 8, Patent ‘663 claims a cell comprising the vector (Patent ‘663 claim 3).
Regarding instant claim 9, Patent ‘663 claim a pharmaceutical composition comprising the vector and a pharmaceutically acceptable adjuvant in claims 4 and 5.
Regarding instant claims 10-12, Patent ‘663 claims a method for treating Bietti’s crystalline dystrophy (BCD) comprising administering the vector to a human subject in claims 7 and 9.
Patent ‘663 does not claim the polyA signal site sequence comprising the nucleic acid sequences of any of SEQ ID NOs:17 and 19-21.
Ahlers discloses a polyA signal site comprising SEQ ID NO: 17 as a part of vector for gene therapy. (See Ahlers, abstract, also alignment below).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to use the disclosed CYP4V2 vector of Patent ‘663 with the disclosed polyA signal site sequences disclosed in Ahlers for the present claimed invention. It would have been obvious because the polyA signal sites disclosed in Alers were used successfully for gene therapy and are well known in the art. Therefore, it would have been obvious for a person of ordinary skill in the art to use combine the CYP4V2 vector of Patent ‘663 with the disclosed poly A signal site sequences disclosed in Ahlers with a reasonable expectation of success at producing the present claimed invention.
Response to Arguments
13. Applicant argues that the amendments to claim 1 have narrowed the claimed subject matter to overcome the non-statutory double patenting rejection. Specifically, Applicant argues that the amended claims narrowing to a vector of AAV2/8, the CAG promoter comprising the nucleotide sequence of SEQ ID NO: 4, the CYP4V2 comprises an amino acid sequence of SEQ ID NO: 76 and the polyA signal site comprising the nucleic acid sequence of SEQ ID NOs: 17 and 19-21 make it patentably distinct from the invention of Patent ‘663. Applicant argues the claims of Patent ‘663 are directed to methods of treatment and the present claimed invention is directed to the specific vector.
14. Applicant's arguments have been fully considered but they are not persuasive.
First, as discussed in the rejection above Patent ‘663 claims an AAV2/8 vector encoding the CYP4V2 amino acid sequence of SEQ ID NO: 76 linked to the CAG promoter of SEQ ID NO: 4. Patent ‘663 also claims a polyA signal site used at the 3’ end of the vector sequence. While the specific sequence is not claimed, the sequence does not make the present claimed vector patentably distinct version of the invention of Patent ‘663 but an obvious variant of it, as is discussed above in the new double patenting rejection citing the disclosed sequence from Ahlers.
Second, Applicant asserts Patent ‘663 is patentably distinct because it is directed to methods of treatment. However, Patent ‘663 claims 1-5 are directed to a vector, a cell comprising the vector, and a pharmaceutical composition. Claims 7 and 9 are directed to a method for treatment but mirror present claims 10-12 as being directed to ame thod for treatment.
SEQ ID NO: 62 matched to SEQ ID NO:11 (US Pat. No. 12065663):
RESULT 6
US-17-812-425-11
Sequence 11, US/17812425
Patent No. 12065663
GENERAL INFORMATION
APPLICANT: CHIGENOVO CO.,LTD. (en)
TITLE OF INVENTION: VECTOR AND METHOD FOR TREATING BIETTI'S CRYSTALLINE DYSTROPHY (en)
FILE REFERENCE: FI220208US
CURRENT APPLICATION NUMBER: US/17/812,425
CURRENT FILING DATE: 2022-07-13
NUMBER OF SEQ ID NOS: 23
SEQ ID NO 11
LENGTH: 2943
TYPE: DNA
FEATURE:
NAME/KEY: source
LOCATION: 1..2943
QUALIFIERS: mol_type = other DNA
organism = synthetic construct
Query Match 99.8%; Score 1571.8; Length 2943;
Best Local Similarity 99.9%;
Matches 1573; Conservative 0; Mismatches 2; Indels 0; Gaps 0;
Qy 1 ATGGCGGGGCTCTGGCTGGGGCTCGTGTGGCAGAAGCTGCTGCTGTGGGGCGCGGCGAGT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 965 ATGGCGGGGCTCTGGCTGGGGCTCGTGTGGCAGAAGCTGCTGCTGTGGGGCGCGGCGAGT 1024
Qy 61 GCCCTTTCCCTGGCCGGCGCCAGTCTGGTCCTGAGTCTGCTGCAGAGGGTGGCGAGCTAC 120
||||||||||||||||||||||||||||||||||| ||||||||||||||||||||||||
Db 1025 GCCCTTTCCCTGGCCGGCGCCAGTCTGGTCCTGAGCCTGCTGCAGAGGGTGGCGAGCTAC 1084
Qy 121 GCGCGGAAATGGCAGCAGATGCGGCCCATCCCCACGGTGGCCCGCGCCTACCCACTGGTG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1085 GCGCGGAAATGGCAGCAGATGCGGCCCATCCCCACGGTGGCCCGCGCCTACCCACTGGTG 1144
Qy 181 GGCCACGCGCTGCTGATGAAGCCGGACGGGCGAGAATTTTTTCAGCAGATCATTGAGTAC 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1145 GGCCACGCGCTGCTGATGAAGCCGGACGGGCGAGAATTTTTTCAGCAGATCATTGAGTAC 1204
Qy 241 ACAGAGGAATACCGCCACATGCCGCTGCTGAAGCTCTGGGTCGGGCCAGTGCCCATGGTG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1205 ACAGAGGAATACCGCCACATGCCGCTGCTGAAGCTCTGGGTCGGGCCAGTGCCCATGGTG 1264
Qy 301 GCCCTTTATAATGCAGAAAATGTGGAGGTAATTTTAACTAGTTCAAAGCAAATTGACAAA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1265 GCCCTTTATAATGCAGAAAATGTGGAGGTAATTTTAACTAGTTCAAAGCAAATTGACAAA 1324
Qy 361 TCCTCTATGTACAAGTTTTTAGAACCATGGCTTGGCCTAGGACTTCTTACAAGTACTGGA 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1325 TCCTCTATGTACAAGTTTTTAGAACCATGGCTTGGCCTAGGACTTCTTACAAGTACTGGA 1384
Qy 421 AACAAATGGCGCTCCAGGAGAAAGATGTTAACACCCACTTTCCATTTTACCATTCTGGAA 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1385 AACAAATGGCGCTCCAGGAGAAAGATGTTAACACCCACTTTCCATTTTACCATTCTGGAA 1444
Qy 481 GATTTCTTAGATATCATGAATGAACAAGCAAATATATTGGTTAAGAAACTTGAAAAACAC 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1445 GATTTCTTAGATATCATGAATGAACAAGCAAATATATTGGTTAAGAAACTTGAAAAACAC 1504
Qy 541 ATTAACCAAGAAGCATTTAACTGCTTTTTTTACATCACTCTTTGTGCCTTAGATATCATC 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1505 ATTAACCAAGAAGCATTTAACTGCTTTTTTTACATCACTCTTTGTGCCTTAGATATCATC 1564
Qy 601 TGTGAAACAGCTATGGGGAAGAATATTGGTGCTCAAAGTAATGATGATTCCGAGTATGTC 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1565 TGTGAAACAGCTATGGGGAAGAATATTGGTGCTCAAAGTAATGATGATTCCGAGTATGTC 1624
Qy 661 CGTGCAGTTTATAGAATGAGTGAGATGATATTTCGAAGAATAAAGATGCCCTGGCTTTGG 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1625 CGTGCAGTTTATAGAATGAGTGAGATGATATTTCGAAGAATAAAGATGCCCTGGCTTTGG 1684
Qy 721 CTTGATCTCTGGTACCTTATGTTTAAAGAAGGATGGGAACACAAAAAGAGCCTTCAGATC 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1685 CTTGATCTCTGGTACCTTATGTTTAAAGAAGGATGGGAACACAAAAAGAGCCTTCAGATC 1744
Qy 781 CTACATACTTTTACCAACAGTGTCATCGCGGAACGGGCCAATGAAATGAACGCCAATGAA 840
||||||||||||||||||||||||||||| ||||||||||||||||||||||||||||||
Db 1745 CTACATACTTTTACCAACAGTGTCATCGCTGAACGGGCCAATGAAATGAACGCCAATGAA 1804
Qy 841 GACTGTAGAGGTGATGGCAGGGGCTCTGCCCCCTCCAAAAATAAACGCAGGGCCTTTCTT 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1805 GACTGTAGAGGTGATGGCAGGGGCTCTGCCCCCTCCAAAAATAAACGCAGGGCCTTTCTT 1864
Qy 901 GACTTGCTTTTAAGTGTGACTGATGACGAAGGGAACAGGCTAAGTCATGAAGATATTCGA 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1865 GACTTGCTTTTAAGTGTGACTGATGACGAAGGGAACAGGCTAAGTCATGAAGATATTCGA 1924
Qy 961 GAAGAAGTTGACACCTTCATGTTTGAGGGGCACGATACAACTGCAGCTGCAATAAACTGG 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1925 GAAGAAGTTGACACCTTCATGTTTGAGGGGCACGATACAACTGCAGCTGCAATAAACTGG 1984
Qy 1021 TCCTTATACCTGTTGGGTTCTAACCCAGAAGTCCAGAAAAAAGTGGATCATGAATTGGAT 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1985 TCCTTATACCTGTTGGGTTCTAACCCAGAAGTCCAGAAAAAAGTGGATCATGAATTGGAT 2044
Qy 1081 GACGTGTTTGGGAAGTCTGACCGTCCCGCTACAGTAGAAGACCTGAAGAAACTTCGGTAT 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2045 GACGTGTTTGGGAAGTCTGACCGTCCCGCTACAGTAGAAGACCTGAAGAAACTTCGGTAT 2104
Qy 1141 CTGGAATGTGTTATTAAGGAGACCCTTCGCCTTTTTCCTTCTGTTCCTTTATTTGCCCGT 1200
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2105 CTGGAATGTGTTATTAAGGAGACCCTTCGCCTTTTTCCTTCTGTTCCTTTATTTGCCCGT 2164
Qy 1201 AGTGTTAGTGAAGATTGTGAAGTGGCAGGTTACAGAGTTCTAAAAGGCACTGAAGCCGTC 1260
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2165 AGTGTTAGTGAAGATTGTGAAGTGGCAGGTTACAGAGTTCTAAAAGGCACTGAAGCCGTC 2224
Qy 1261 ATCATTCCCTATGCATTGCACAGAGATCCGAGATACTTCCCCAACCCCGAGGAGTTCCAG 1320
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2225 ATCATTCCCTATGCATTGCACAGAGATCCGAGATACTTCCCCAACCCCGAGGAGTTCCAG 2284
Qy 1321 CCTGAGCGGTTCTTCCCCGAGAATGCACAAGGGCGCCATCCATATGCCTACGTGCCCTTC 1380
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2285 CCTGAGCGGTTCTTCCCCGAGAATGCACAAGGGCGCCATCCATATGCCTACGTGCCCTTC 2344
Qy 1381 TCTGCTGGCCCCAGGAACTGTATAGGTCAAAAGTTTGCTGTGATGGAAGAAAAGACCATT 1440
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2345 TCTGCTGGCCCCAGGAACTGTATAGGTCAAAAGTTTGCTGTGATGGAAGAAAAGACCATT 2404
Qy 1441 CTTTCGTGCATCCTGAGGCACTTTTGGATAGAATCCAACCAGAAAAGAGAAGAGCTTGGT 1500
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2405 CTTTCGTGCATCCTGAGGCACTTTTGGATAGAATCCAACCAGAAAAGAGAAGAGCTTGGT 2464
Qy 1501 CTAGAAGGACAGTTGATTCTTCGTCCAAGTAATGGCATCTGGATCAAGTTGAAGAGGAGA 1560
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2465 CTAGAAGGACAGTTGATTCTTCGTCCAAGTAATGGCATCTGGATCAAGTTGAAGAGGAGA 2524
Qy 1561 AATGCAGATGAACGC 1575
|||||||||||||||
Db 2525 AATGCAGATGAACGC 2539
SEQ ID NO:76 aligned with the translated SEQ ID NO:11 (US Pat. No. 12065663)
RESULT 1
AASEQ2_03102026_154711
Query Match 100.0%; Score 2775; DB 1; Length 525;
Best Local Similarity 100.0%;
Matches 525; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MAGLWLGLVWQKLLLWGAASALSLAGASLVLSLLQRVASYARKWQQMRPIPTVARAYPLV 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAGLWLGLVWQKLLLWGAASALSLAGASLVLSLLQRVASYARKWQQMRPIPTVARAYPLV 60
Qy 61 GHALLMKPDGREFFQQIIEYTEEYRHMPLLKLWVGPVPMVALYNAENVEVILTSSKQIDK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GHALLMKPDGREFFQQIIEYTEEYRHMPLLKLWVGPVPMVALYNAENVEVILTSSKQIDK 120
Qy 121 SSMYKFLEPWLGLGLLTSTGNKWRSRRKMLTPTFHFTILEDFLDIMNEQANILVKKLEKH 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SSMYKFLEPWLGLGLLTSTGNKWRSRRKMLTPTFHFTILEDFLDIMNEQANILVKKLEKH 180
Qy 181 INQEAFNCFFYITLCALDIICETAMGKNIGAQSNDDSEYVRAVYRMSEMIFRRIKMPWLW 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 INQEAFNCFFYITLCALDIICETAMGKNIGAQSNDDSEYVRAVYRMSEMIFRRIKMPWLW 240
Qy 241 LDLWYLMFKEGWEHKKSLQILHTFTNSVIAERANEMNANEDCRGDGRGSAPSKNKRRAFL 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 LDLWYLMFKEGWEHKKSLQILHTFTNSVIAERANEMNANEDCRGDGRGSAPSKNKRRAFL 300
Qy 301 DLLLSVTDDEGNRLSHEDIREEVDTFMFEGHDTTAAAINWSLYLLGSNPEVQKKVDHELD 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 DLLLSVTDDEGNRLSHEDIREEVDTFMFEGHDTTAAAINWSLYLLGSNPEVQKKVDHELD 360
Qy 361 DVFGKSDRPATVEDLKKLRYLECVIKETLRLFPSVPLFARSVSEDCEVAGYRVLKGTEAV 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 DVFGKSDRPATVEDLKKLRYLECVIKETLRLFPSVPLFARSVSEDCEVAGYRVLKGTEAV 420
Qy 421 IIPYALHRDPRYFPNPEEFQPERFFPENAQGRHPYAYVPFSAGPRNCIGQKFAVMEEKTI 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 IIPYALHRDPRYFPNPEEFQPERFFPENAQGRHPYAYVPFSAGPRNCIGQKFAVMEEKTI 480
Qy 481 LSCILRHFWIESNQKREELGLEGQLILRPSNGIWIKLKRRNADER 525
|||||||||||||||||||||||||||||||||||||||||||||
Db 481 LSCILRHFWIESNQKREELGLEGQLILRPSNGIWIKLKRRNADER 525
SEQ ID NO: 4 matched to SEQ ID NO:11 (US Pat. No. 12065663):
RESULT 2
US-17-812-425-11
Sequence 11, US/17812425
Patent No. 12065663
GENERAL INFORMATION
APPLICANT: CHIGENOVO CO.,LTD. (en)
TITLE OF INVENTION: VECTOR AND METHOD FOR TREATING BIETTI'S CRYSTALLINE DYSTROPHY (en)
FILE REFERENCE: FI220208US
CURRENT APPLICATION NUMBER: US/17/812,425
CURRENT FILING DATE: 2022-07-13
NUMBER OF SEQ ID NOS: 23
SEQ ID NO 11
LENGTH: 2943
TYPE: DNA
FEATURE:
NAME/KEY: source
LOCATION: 1..2943
QUALIFIERS: mol_type = other DNA
organism = synthetic construct
Query Match 100.0%; Score 937; Length 2943;
Best Local Similarity 100.0%;
Matches 937; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CCATTGACGTCAATAATGACGTATGTTCCCATAGTAACGCCAATAGGGACTTTCCATTGA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 CCATTGACGTCAATAATGACGTATGTTCCCATAGTAACGCCAATAGGGACTTTCCATTGA 60
Qy 61 CGTCAATGGGTGGAGTATTTACGGTAAACTGCCCACTTGGCAGTACATCAAGTGTATCAT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 CGTCAATGGGTGGAGTATTTACGGTAAACTGCCCACTTGGCAGTACATCAAGTGTATCAT 120
Qy 121 ATGCCAAGTACGCCCCCTATTGACGTCAATGACGGTAAATGGCCCGCCTGGCATTATGCC 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ATGCCAAGTACGCCCCCTATTGACGTCAATGACGGTAAATGGCCCGCCTGGCATTATGCC 180
Qy 181 CAGTACATGACCTTATGGGACTTTCCTACTTGGCAGTACATCTACGTATTAGTCATCGCT 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 CAGTACATGACCTTATGGGACTTTCCTACTTGGCAGTACATCTACGTATTAGTCATCGCT 240
Qy 241 ATTACCATGGTCGAGGTGAGCCCCACGTTCTGCTTCACTCTCCCCATCTCCCCCCCCTCC 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 ATTACCATGGTCGAGGTGAGCCCCACGTTCTGCTTCACTCTCCCCATCTCCCCCCCCTCC 300
Qy 301 CCACCCCCAATTTTGTATTTATTTATTTTTTAATTATTTTGTGCAGCGATGGGGGCGGGG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 CCACCCCCAATTTTGTATTTATTTATTTTTTAATTATTTTGTGCAGCGATGGGGGCGGGG 360
Qy 361 GGGGGGGGGGGGCGCGCGCCAGGCGGGGCGGGGCGGGGCGAGGGGCGGGGCGGGGCGAGG 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 GGGGGGGGGGGGCGCGCGCCAGGCGGGGCGGGGCGGGGCGAGGGGCGGGGCGGGGCGAGG 420
Qy 421 CGGAGAGGTGCGGCGGCAGCCAATCAGAGCGGCGCGCTCCGAAAGTTTCCTTTTATGGCG 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 CGGAGAGGTGCGGCGGCAGCCAATCAGAGCGGCGCGCTCCGAAAGTTTCCTTTTATGGCG 480
Qy 481 AGGCGGCGGCGGCGGCGGCCCTATAAAAAGCGAAGCGCGCGGCGGGCGGGAGTCGCTGCG 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 AGGCGGCGGCGGCGGCGGCCCTATAAAAAGCGAAGCGCGCGGCGGGCGGGAGTCGCTGCG 540
Qy 541 ACGCTGCCTTCGCCCCGTGCCCCGCTCCGCCGCCGCCTCGCGCCGCCCGCCCCGGCTCTG 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 ACGCTGCCTTCGCCCCGTGCCCCGCTCCGCCGCCGCCTCGCGCCGCCCGCCCCGGCTCTG 600
Qy 601 ACTGACCGCGTTACTCCCACAGGTGAGCGGGCGGGACGGCCCTTCTCCTCCGGGCTGTAA 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 ACTGACCGCGTTACTCCCACAGGTGAGCGGGCGGGACGGCCCTTCTCCTCCGGGCTGTAA 660
Qy 661 TTAGCGCTTGGTTTAATGACGGCTTGTTTCTTTTCTGTGGCTGCGTGAAAGCCTTGAGGG 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 TTAGCGCTTGGTTTAATGACGGCTTGTTTCTTTTCTGTGGCTGCGTGAAAGCCTTGAGGG 720
Qy 721 GCTCCGGGAGGGCCCTTTGTGCGGGGGGAGCGGCTCGGGGCTGTCCGCGGGGGGACGGCT 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 GCTCCGGGAGGGCCCTTTGTGCGGGGGGAGCGGCTCGGGGCTGTCCGCGGGGGGACGGCT 780
Qy 781 GCCTTCGGGGGGGACGGGGCAGGGCGGGGTTCGGCTTCTGGCGTGTGACCGGCGGCTCTA 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 GCCTTCGGGGGGGACGGGGCAGGGCGGGGTTCGGCTTCTGGCGTGTGACCGGCGGCTCTA 840
Qy 841 GAGCCTCTGCTAACCATGTTCATGCCTTCTTCTTTTTCCTACAGCTCCTGGGCAACGTGC 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 GAGCCTCTGCTAACCATGTTCATGCCTTCTTCTTTTTCCTACAGCTCCTGGGCAACGTGC 900
Qy 901 TGGTTATTGTGCTGTCTCATCATTTTGGCAAAGAATT 937
|||||||||||||||||||||||||||||||||||||
Db 901 TGGTTATTGTGCTGTCTCATCATTTTGGCAAAGAATT 937
SEQ ID NO: 17 is 100% identical to SEQ ID NO: 65 (Ahlers):
WO2019018383-A1.
XX
CC PD 24-JAN-2019.
XX
CC PF 17-JUL-2018; 2018WO-US042471.
XX
PR 18-JUL-2017; 2017US-0533719P.
PR 07-AUG-2017; 2017US-0541931P.
PR 06-APR-2018; 2018US-0653913P.
XX
CC PA (CALI-) CALIMMUNE INC.
CC PA (CALI-) CALIMMUNE AUSTRALIA PTY LTD.
XX
CC PI Ahlers J, Bartlett J, Lee C, Ringpis GE, Symonds GP, Yan M;
XX
DR WPI; 2019-096004/12.
XX
CC PT Vector comprises first expression control sequence linked to first
CC PT nucleic acid sequence, first nucleic acid sequence encoding RNAi to
CC PT knockdown hypoxanthine-guanine phosphoribosyltransferase and second
CC PT expression control sequence.
XX
CC PS Example 3; SEQ ID NO 65; 157pp; English.
Query Match 100.0%; Score 122; Length 128;
Best Local Similarity 100.0%;
Matches 122; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AACTTGTTTATTGCAGCTTATAATGGTTACAAATAAAGCAATAGCATCACAAATTTCACA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AACTTGTTTATTGCAGCTTATAATGGTTACAAATAAAGCAATAGCATCACAAATTTCACA 60
Qy 61 AATAAAGCATTTTTTTCACTGCATTCTAGTTGTGGTTTGTCCAAACTCATCAATGTATCT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AATAAAGCATTTTTTTCACTGCATTCTAGTTGTGGTTTGTCCAAACTCATCAATGTATCT 120
Qy 121 TA 122
||
Db 121 TA 122
Conclusion
15. Claims 1, 4, and 8-12 are rejected.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY DUNN whose telephone number is (571)272-5825. The examiner can normally be reached Monday-Friday 8-4:30.
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/LINDSAY DUNN/ Examiner, Art Unit 1642
/Laura B Goddard/ Primary Examiner, Art Unit 1642
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