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 .
DETAILED ACTION
1. Claims 1-12 are pending and under examination in the present office action.
Priority
2. The present application is a continuation application of 17/756,996 filed on 1/24/2023 which claims benefit of PCT/CN2020/102292 filed on 7/16/2020 and CN201911255192 filed on 12/9/2019. The present claims were reviewed and determined to be disclosed in the above application. Therefore, priority is grated to the above applications and the effective filing date of 12/9/2019 is granted.
Specification
3. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see page 33. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
4. The examiner’s broadest reasonable interpretation of the claims is set forth below.
Claim 2 recites:
“The vector according to claim 1, wherein the CAG promoter comprises a nucleotide sequence set forth in SEQ ID NO: 4.”
The phrase “comprises a nucleotide sequence set forth in SEQ ID NO: 4” are reasonably interpreted as a CAG promoter comprising any sequence in SEQ ID NO:4, as few as two consecutive nucleotide sequences long.
Claim 3 recites:
“The vector according to claim 1, wherein the CYP4V2 comprises an amino acid sequence set forth in any of SEQ ID NOs: 76-82.”
The phrase “comprises an amino acid sequence set forth in SEQ ID NOs: 76-82” are reasonably interpreted as CYP4V2 comprising any sequence in the listed sequences, as few as two consecutive amino acid sequences long.
Claim 4 recites:
“The vector according to claim 1, wherein the polynucleotide encoding CYP4V2 comprises a nucleic acid sequence set forth in SEQ ID NO: 62 or a nucleic acid sequence having at least 95% identity to the nucleic acid sequence set forth in SEQ ID NO: 62.”
The phrase “comprises a nucleic acid sequence set forth in SEQ ID NO: 62” are reasonably interpreted as a CYP4V2 comprising any sequence in SEQ ID NO:62, as few as two consecutive nucleotide sequences long.
Claim 5 recites:
“The vector according to claim 1, wherein the PolyA signal site comprises a nucleic acid sequence set forth in any of SEQ ID NOs: 17-21.”
The phrase “comprises a nucleic acid sequence set forth in any of SEQ ID NOs: 17-21” are reasonably interpreted as a PolyA signal site comprising any sequence in the listed sequences, as few as two consecutive nucleotide sequences long.
Claim Rejections - 35 USC § 112
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.
5. Claims 10-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating and alleviating a disease or disorder associated with RPE atrophy, does not reasonably provide enablement for preventing a disease or disorder associated with RPE atrophy. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The claims are drawn to a method for treating, alleviating, or preventing a disease or disorder associated with RPE atrophy, comprising administering to a subject an effective amount of the CAG promoter-CYP4V2-Poly A signal site vector or a cell encoded with the vector or a pharmaceutical composition comprising the vector or the cell.
The specification discloses the treatment or alleviation of BCD through the use of CYP4V2 expression vectors. The specification discloses the testing of expression vectors on BCD mice, as defined by the absence of the Cyp4v3 gene. Following administration of CYP4V2 expression vectors crystalline deposits are observed to decrease. (See Example 14, also Figs. 15-16). The specification further discloses the BCD mice who received administration of the CYP4V2 expression vectors all displayed significantly increased retinal function. (See Example 15, Figs. 20). Therefore, the specification provides evidence that BCD subjects can receive treatment or alleviation of symptoms through the administration of a CYP4V2 expression vector, but no evidence of the prevention of BCD disease.
Relevant art teaches Bietti’s crystalline dystrophy is a rare inherited disorder presenting between the teenage years into the fourth decade with no correlation between the age of onset and the severity of retinal damage. (See Garcia-Garcia, et al., pg. 1380, column 2, paragraph 4). The relevant art further teaches that BCD is difficult to diagnose due to affected individuals being asymptomatic during the early stages. (See Garcia-Garcia, pg. 1380, column 2, paragraph 5). Additionally, unrelated individuals harboring the same or similar mutations have displayed clinical variability with diet and environmental factors playing a role in the phenotypic characterization of the disease. (See Garcia-Garcia, pg. 1395, column 2, paragraph 3).
One cannot extrapolate the disclosure of the specification to the scope of the claims because prevention of retinal pigment epithelium atrophy is not enabled due to what is unknown in the art, the state of the art, the quantity of experimentation necessary, the breadth of the claims, lack of guidance in the specification, and the absence of working examples. The state of the art provides that the disease is rare and shows clinical variability with outside factors possibly affecting disease progression. Thus, the state of the art provides it would require significant experimentation to predict the potential development of the disease and the breadth of the claims provide for the prevention of the disease from the claimed present invention. Further, while the specification provides working examples of the treatment and alleviation of BCD symptoms in BCD mice, there is no evidence that it prevented the development of the disease. Treated BCD mice still displayed crystalline deposits showing disease progression existed prior to treatment. (See fig. 19).
Reasonable correlation must exist between the scope of the claims and scope of enablement set forth, and it cannot be reasonably predicted that CYP4V2 expression vectors will predictably function as claimed.
Therefore, in view of the novel nature of the invention, what is unknown in the art the state of the art, the quantity of experimentation necessary, the breadth of the claims, lack of guidance in the specification, and the absence of working examples, it would require undue experimentation for one skilled in the art to practice the invention as broadly claimed.
Examiner Suggestion: Amend claim 10 to remove “preventing.”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
6. Claim 8 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 8 is rejected under 35 U.S.C. 101 and AIA § 33(a) as being directed to or encompassing a human organism. The claims read on cells found in intact mammals, including humans that receive nucleic acids encoding the claimed vector. See also Animals -Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Examiner Suggestion: amending claim 8 to recite “an isolated cell” to overcome this rejection.
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.
7. Claims 1 and 3-12 are rejected 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 regard to claim 1, Yang discloses a vector including a nucleic acid molecule for a functional CYP4V2 protein operably linked to a regulatory sequence (See Yang, pg. 36, paragraph 4) where the regulatory sequence can be a promoter, including a CAG promoter (See Yang, pg. 39, paragraphs 2-3) and a PolyA signal site (See Yang, pg. 43, paragraph 4).
In regard to claims 3 and 5, Yang discloses an amino acid sequence of a CYP4V2 protein, SEQ ID NO:20, that is 100% identical to SEQ ID NO: 79. Yang also discloses a nucleotide sequence, SEQ ID NO:34, that is 100% identical to SEQ ID NO:18. See alignments below.
In regard to claims 6-12, Yang discloses using an AAV2 variant, including AAV2/8. (See Yang, pg. 41, paragraph 1). Additionally, Yang discloses using a cell to express the vector (See Yang, pg. 40, paragraph 2), in a composition along with a carrier (See Yang, pg. 40, paragraph 1), for treatment of a retinal disease including Bietti crystalline dystrophy (BCD) (See Yang, pg. 40, paragraph 5), in a human subject (See Yang, pg. 11, paragraph 4).
Yang does not disclose the sequential design of the promoter as being a promoter, a polynucleotide encoding CYP4V2, and a PolyA signal site in the 5’ to 3’ direction from claim 1.
Powell, et. al., teaches the sequential design of the promoter, gene, and polyA signal site are considered to be generic and essential for any AAV viral vector. (See Powell, Figure 1).
Further, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to combine the sequential design taught in Powell to the disclosed CYP4V2 vector of Yang. It would have been obvious because Powell teaches this design is generic and these components are considered essential for any AAV viral vector. Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to combine the sequential design for an AAV vector taught in Powell to the vector components disclosed in Yang with a reasonable expectation of success.
In regard to claim 4, Yang does not disclose a nucleotide sequence for CYP4V2 comprising SEQ ID NO: 62.
However, Yang does disclose an amino acid sequence encoding CYP4V2, SEQ ID NO:4 that is 100% matched to the protein encoded by the nucleotide sequence of instant SEQ ID NO:62. See Alignments below.
It would be obvious to a person of ordinary skill in the art prior to the effective date to use the CYP4V2 amino acid sequence of SEQ ID NO:4 to obtain a nucleotide sequence for the present claimed invention. It would be obvious because nucleotide sequences encoding for amino acids are finite and well established. Therefore, a person of ordinary skill in the art prior to the effective date would have been motivated to use an amino acid sequence to determine the nucleotide sequence encoding the CYP4V2 protein of SEQ ID NO:4, and arrived at the encoding polynucleotide of instant SEQ ID NO:62 with a reasonable expectation of success.
SEQ ID NO: 79 100% identical to SEQ ID NO: 20 (Yang)
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486
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447
455
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SEQ ID NO: 18 100% identical to SEQ ID NO: 34 (Yang)
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240
498
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247
478
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SEQ ID NO: 62 100% matched to SEQ ID NO: 4 (Yang)
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257
515
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606
471
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712
464
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9. Claim 2 is rejected 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, 3-12 above, and further in view of Liu (WO 2019/222569 A1, pub. 11/21/2019).
Yang and Powell disclose the limitations of claim 1 as discussed above.
Yang and Powell do not disclose the CAG promoter as comprising a nucleotide sequence set forth in SEQ ID NO:4.
Liu discloses the use of a CAG promoter, comprising the nucleotide sequence of SEQ ID NO:29 which is 100% identical to SEQ ID NO: 4, in an optogenetics based gene therapy vector. (See Liu, abstract). Further, Liu teaches that these sequences are generally known in the art. (See Liu, pg. 17, “Sequences”). See alignments below.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to combine the nucleotide sequence of the CAG promoter from Liu to the vector design of Yang and Powell to create the vector of the claimed invention. It would have been obvious because Liu teaches that the CAG promoter is generally known in the art and the promoter of Yang can easily be replaced by another known promoter for the same function in a vector system. Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective date to replace the promoter of the Yang and Powell vector for the promoter of Liu with a reasonable expectation of success.
SEQ ID NO:4 100% identical to SEQ ID NO:29 (Liu)
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226
475
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486
448
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272
441
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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.
10. Claims 1-2 and 4-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9, 13, and 17 of U.S. Patent No. 12065663. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both drawn to a vector comprising a polynucleotide encoding CYP4V2 and a promoter operably linked to the polynucleotide encoding CYP4V2.
Below, the table outlines the overlap between the claims. Sequence alignments follow after. It should be noted that while the claims in US Patent No. 12065663 do not explicitly claim the promoter region to be the CAG promoter, the only claimed sequence for the vector is SEQ ID NO: 11 which the presently claimed SEQ ID NO:4 is encoded within (see below for alignment). Therefore, the issued patent is claiming a CAG promoter.
US Pat. No. 12065663
Present Claims
Claim 1:
A vector comprising a polynucleotide encoding CYP4V2 and a promoter operably linked to the polynucleotide encoding CYP4V2;
wherein the vector comprises the entire nucleotide sequence set forth in SEQ ID NO: 11; and
[See alignment of SEQ ID NO:11 to both SEQ ID NO: 4, SEQ ID NO:76, and SEQ ID NO:62]
wherein the vector is a recombinant AAV2/8 vector.
Claim 1:
A vector sequentially comprising, in 5’ to 3’ direction: a promoter, a polynucleotide encoding CYP4V2 and a PolyA signal site, wherein the promoter is operably linked to the polynucleotide encoding CYP4V2, and the promoter is CAG promoter.
Claim 2:
The vector according to claim 1, wherein the CAG promoter comprises a nucleotide sequence set forth in SEQ ID NO: 4.
Claim 3:
The vector according to claim 1, wherein the CYP4V2 comprises an amino acid sequence set forth in any of SEQ ID NOs: 76-82.
Claim 4:
The vector according to claim 1, wherein the polynucleotide encoding CYP4V2 comprises a nucleic acid sequence set forth in SEQ ID NO: 62 or a nucleic acid sequence having at least 95% identity to the nucleic acid sequence set forth in SEQ ID NO: 62.
Claim 6:
The vector according to claim 1, wherein the vector is AAV2/2, AAV2/5, AAV2/8, or AAV2/9.
Claim 7:
The vector according to claim 6, wherein the vector is AAV2/8.
Claim 6:
The vector according to claim 1, wherein the vector further comprises a polyadenylation (PolyA) signal site located at 3' end of the polynucleotide encoding CYP4V2, wherein the polyadenylation (PolyA) signal site comprises an entire nucleotide sequence set forth in SEQ ID NO: 3; and/or the promoter is located at 5' end of the polynucleotide encoding CYP4V2.
[See alignment of SEQ ID NO:3 to both SEQ ID NO: 18]
Claim 1:
A vector sequentially comprising, in 5’ to 3’ direction: a promoter, a polynucleotide encoding CYP4V2 and a PolyA signal site, wherein the promoter is operably linked to the polynucleotide encoding CYP4V2, and the promoter is CAG promoter.
Claim 5:
The vector according to claim 1, wherein the PolyA signal site comprises a nucleic acid sequence set forth in any of SEQ ID NOs: 17-21.
Claim 9:
A cell comprising the vector according to claim 1.
Claim 8:
A cell comprising a vector according to claim 1.
Claim 10:
A pharmaceutical composition comprising: a) the vector according to claim 1, and b) a pharmaceutically acceptable adjuvant.
Claim 9:
A pharmaceutical composition comprising a vector according to claim 1 and/or a cell comprising the vector, and a pharmaceutically acceptable adjuvant.
Claim 13:
A method for treating or alleviating Bietti's crystalline dystrophy (BCD), comprising administrating the vector according to claim 1 to a subject in need thereof, wherein the administration is subretinal injection.
Claim 10:
A method for treating, alleviating, and/or preventing a disease or disorder associated with retinal pigment epithelium (RPE) atrophy, comprising administrating to a subject in need thereof an effective amount of a vector according to claim 1 and/or a cell comprising the vector or a pharmaceutical composition comprising the vector and/or the cell.
Claim 11:
The method according to claim 10, wherein the disease or disorder is Bietti’s crystalline dystrophy.
Claim 17:
The method according to claim 13, wherein the subject is human.
Claim 12:
The method according to claim 10, wherein the subject is human.
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:18 matches 100% to SEQ ID NO:3 (US Pat. No. 12065663):
PNG
media_image11.png
249
465
media_image11.png
Greyscale
11. Claims 1-12 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). 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: 76-82 and the nucleotide sequences of SEQ ID NO: 62 and a PolyA signal site.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
12. In summary, claims 1-12 are rejected.
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/LINDSAY DUNN/Examiner, Art Unit 1644
/Laura B Goddard/Primary Examiner, Art Unit 1642