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 .
Priority
Acknowledgement is made of Applicants’ claim for benefit to prior filed to Patent Application Number PCT/IB2020/001097, filed on 12/08/2020.
Information Disclosure Statement
The Information Disclosure Statements filed 06/05/2023 and 06/15/2023 have been considered by the Examiner.
Status of Claims
Claims 1-17 are under examination.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4-9, and 13-14 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang (WO 2019/025984).
Regarding claim 1, Yang teaches an expression cassette comprising (i) a GRK1 promoter (page 106, paragraph 2) and (ii) a nucleic acid sequence encoding LRIT3 (pages 143&183, line 30&table 4-line 19) that is operably linked regulatory sequence (page 82, paragraph 2) which can be a promoter (page 43, paragraph 2).
Regarding claim 3, Yang teaches an expression cassette which comprises a GRK1 promoter (page 106, paragraph 2).
Regarding claim 4, Yang teaches a recombinant expression vector (page 203, claim 7).
Regarding claim 5, Yang teaches a recombinant expression vector including an AAV capsid (page 203 claim 8) and an expression cassette.
Regarding claim 7, Yang teaches the AAV can contain a post-transcriptional regulatory element a woodchuck hepatitis virus post-transcriptional regulatory element, WPRE (page 107, paragraph 3) and polyA (page 205, claim 24).
Regarding claim 8, Yang teaches the AAV expresses LRIT3 in photoreceptor cells (page 206, claims 31&32).
Regarding claim 9, Yang teaches an AAV vector for use as a treatment for ocular disease (page 82, paragraph 3).
Regarding claims 13 and 14, Yang teaches composition which includes a vector (page 95, paragraph 2) and can be formulated for delivery with a pharmaceutically acceptable carrier (page 115, paragraph 4).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Yang (WO 2019/025984) as applied to claims 1 and 5 above.
Yang teaches an AAV expression cassette comprising a capsid, a GRK1 promoter (page 106, paragraph 2), and a nucleic acid sequence encoding LRIT3 (pages 143&183, line 30&table 4-line 19) that is operably linked to a promoter(page 82, paragraph 2).
Regarding claim 6, Yang does not specifically teach the AAV capsid is an AAV2.7m8. However, Yang teaches the capsid can be AAV2, AAV 7m8, a hybrid, a derivative, or variant thereof. Yang therefore makes obvious the AAV capsid variant is AAV2/7m8 (page 37, paragraph 2).
Claims 2, 10-12, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (WO 2019/025984) as applied to claims 1, 5, and 13 above, and further in view of Hoerr (US 2018/0126003 Al).
Yang teaches an AAV expression cassette comprising a capsid, a GRK1 promoter (page 106, paragraph 2), and a nucleic acid sequence encoding LRIT3 (pages 143&183, line 30&table 4-line 19) that is operably linked to a promoter(page 82, paragraph 2). Yang further teaches a composition which the includes the AAV expression cassette and a pharmaceutically acceptable carrier (pages 95&115, paragraphs 2&4).
Regarding claim 2, Yang teaches an expression cassette where the nucleic acid sequence encodes human LRIT3. Yang teaches variations of CYP4V2 protein for delivery, but does not further teach sequences for the other ocular disorders (page 37, paragraph 4). Yang does not teach the human LRIT3 has at least 90% identity with SEQ ID NO:1.
Hoerr teaches selection of a protein or peptide which relates to a particular disease and creating a polynucleotide encoding the protein or peptide for treatment of the disease (page 4, paragraph 0035). Hoerr teaches the disease or condition can be an ocular related disease, including congenital stationary night blindness (pages 539&1072, left column). Hoerr teaches administration of human LRIT3, SEQ ID NO: 260093 which is the same as SEQ ID NO:1 of the present application.
It would have been obvious to combine the AAV which comprises a nucleic acid sequence encoding LRIT3 of Yang with the LRIT3 sequence taught by Hoerr. The results would be predictable because delivery of the LRIT3 sequence is taught by Hoerr for treating an ocular disease (page 1084, left column).
Regarding claim 10, Yang teaches a recombinant AAV vector for use in treatment of inherited ocular disorders, but does not teach the specific treatment of congenital stationary night blindness (page 1084, left column).
Hoerr teaches delivery of LRIT3 sequence for treatment of congenital stationary night blindness.
One of ordinary skill in the art would have used the AAV vector to deliver LRIT3 of Yang for the treatment of congenital stationary night blindness of Hoerr. The results of this combination would have been predictable because Yang teaches delivery of LRIT3 for treatment of congenital stationary night blindness which is an ocular disease.
Regarding claim 11, Hoerr further teaches the congenital stationary night blindness is congenital stationary night blindness type 1F (CSNB1F) a form of complete congenital stationary night blindness
Regarding claim 12, Yang teaches a recombinant AAV vector for use in treatment of inherited ocular disorders. Yang further teaches a method to maximize therapeutic effect to different patients of the same genetic disease, in viral vector mediated gene therapy (page 121, paragraph 3). Yang teaches the subject treated is a mammal (page 216, claim 101). Yang does not teach the specific treatment of congenital stationary night blindness.
Hoerr teaches delivery of LRIT3 sequence for use in treatment of congenital stationary night blindness.
One of ordinary skill in the art would have used the AAV vector to deliver LRIT3 of Yang for the treatment of congenital stationary night blindness of Hoerr. The results of this combination would have been predictable because Yang teaches delivery of LRIT3 for treatment of congenital stationary night blindness which is an ocular disease.
Regarding claim 15, Yang teaches a pharmaceutical composition for treatment of inherited ocular disorders, but does not teach the specific treatment of congenital stationary night blindness.
Hoerr teaches delivery of LRIT3 sequence for use in treatment of congenital stationary night blindness.
One of ordinary skill in the art would have used the AAV vector to deliver LRIT3 of Yang for the treatment of congenital stationary night blindness of Hoerr. The results of this combination would have been predictable because Yang teaches delivery of LRIT3 for treatment of congenital stationary night blindness which is an ocular disease.
Regarding claim 16, Yang teaches the pharmaceutical composition can be delivered for intravitreal or subretinal administration (page 114, paragraph 3). Yang does not teach the specific treatment of congenital stationary night blindness.
Hoerr teaches delivery of LRIT3 sequence for use in treatment of congenital stationary night blindness.
One of ordinary skill in the art would have used the AAV vector to deliver LRIT3 of Yang for the treatment of congenital stationary night blindness of Hoerr. The results of this combination would have been predictable because Yang teaches delivery of LRIT3 for treatment of congenital stationary night blindness which is an ocular disease.
Regarding claim 17, Yang teaches a method of treating ocular diseases caused by one or more genetic mutations (page 82, paragraph 1).
Hoerr teaches delivery of LRIT3 sequence for use in treatment of congenital stationary night blindness.
One of ordinary skill in the art would have used the pharmaceutical composition to deliver LRIT3 of Yang for the treatment of congenital stationary night blindness of Hoerr. The results of this combination would have been predictable because Yang teaches delivery of LRIT3 for treatment of congenital stationary night blindness which is an ocular disease.
Conclusion
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/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635