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 .
Claims 93-119, of record 7/21/2025, are pending and subject to prosecution.
Priority
The instant application is a national stage entry of PCT/US2023/016871 (filed 3/30/2023), which claims benefit to provisional applications 63/325542, 63/325540, 63/325543, 63/325544, 63/325548, 63/325550, 63/325551, 63/325553, 63/325555, 63/325558, 63/325559, and 63/325562 (all filed 3/30/2022).
Claim Interpretation
Claim 1 recites the limitation “wherein the AAV capsid polypeptide comprises an amino acid sequence selected from any one of SEQ ID NOs: 2, 3, 4, or 5”. The broadest reasonable interpretation of “an amino acid sequence selected from any one of SEQ ID NOs: 2, 3, 4, or 5” is considered to be any two or more sequential residues from any of instant SEQ ID NOs 2-5.
Claim 114 recites the limitation “AAV vector”, which is not defined by the instant specification. The broadest reasonable interpretation is therefore considered to be any vehicle, such as a plasmid or virus, used to transfer AAV genes into a cell.
Claim 118 recites an “AAV particle produced using a mammalian cell comprising an AAV vector of claim 114”. The AAV particle is defined using product-by-process language. Product-by-process limitations are considered only in so far as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product as claimed is the same or obvious over a product of the prior art (i.e. is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. In the instant case, because the use of a mammalian cell is not indicated as imparting distinct characteristics to the AAV particle, the AAV particle is interpreted as encompassing any AAV particle comprising a capsid polypeptide comprising any two or more sequential residues from any of instant SEQ ID NOs 2-5.
Claim Objections
Claims 94-97, 99-100, 102-103, 105, 107, 112-113, and 118-119 are objected to because of the following informalities:
In claims 94-97, 99-100, 102-103, 105, 107, and 112-113, “AAV” should be inserted in front of each instance of “capsid”.
In claim 99, “acapsid” should be replaced with “the capsid” in line 2, and “mammalian” should be inserted in from of each instance of “retinal”.
In line 2 of claim 102, “a capsid” should be replaced with “the capsid”
In claims 107 and 119, “adeno-associated virus (AAV)” should be replaced with “AAV”.
In line 1 of claim 118, “an AAV vector” should be replaced with “the AAV vector”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 101 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 101 recites the limitation “the mammal” in line 1. Because parent claim 99 recites “a mammalian retinal cell” and does not actually require a mammal, there is insufficient antecedent basis for this limitation in the claim.
Claim 115 recites “the nucleic acid sequence encoding any one of SEQ ID NOs: 2-5”. There is insufficient antecedent basis for this limitation in the claim
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 111 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 111 recites the AAV particle of claim 107, wherein the amino acid sequence insert comprises any one of SEQ ID NOs 2-5. Claim 107 recites, in part, an amino acid sequence insert of Formula A, wherein Formula A is L1-EGSGRN (SEQ ID NO 2)-L2. Claim 111 improperly broadens parent claim 107, which requires that the insert is Formula A, which consists of (“…Formula A is…”) SEQ ID NO 2 flanked by two optional linkers.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 95, 114, 116, and 118 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretations.
Regarding claims 95, 114, and 118: Claim 93 is directed to an AAV capsid polypeptide, wherein the AAV capsid polypeptide comprises an amino acid sequence selected from any one of SEQ ID NOs: 2, 3, 4, or 5. Claim 114 is directed to an AAV vector comprising a polynucleotide encoding the AAV capsid polypeptide of claim 93. Claim 116 is directed to an AAV particle produced using a mammalian cell comprising an AAV vector of claim 114.
Claims 95, 114, and 118 appear to read on wt AAV2, which comprises a capsid having the sequence of SEQ ID NO 1 (See Schaffer et al., ¶0040, SEQ ID NO2, and alignment below).
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The underlined regions read on “an amino acid sequence selected from any one of SEQ ID NOs: 2, 3, 4, or 5”. Based on the claimed polypeptide, AAV vector, and AAV particle as reading on wt AAV2, the claims are analyzed as follows:
Step 1: The claims are to a composition, which is a statutory category of invention (Step 1: YES).
Step 2A, prong 1: For the reasons set forth above, the claims are considered to encompass wt AAV2. AAV2 is a nature-based product. There is no evidence that the composition as claimed, differs from AAV2 in nature. Thus, the claimed composition does not have markedly different characteristics from what occurs in nature and is a "product of nature" exception. Accordingly, the claim is directed to a judicial exception (Step 2A, prong 1: YES).
Step 2A, prong 2: The claims are directed to a product and do not recite any structure that serves to integrate the composition into a practical application (Step 2A, prong 2: NO).
Step 2B: There are no additional elements required by the claims. The claims do not qualify as eligible subject matter and are rejected under 35 U.S.C. 101.
Regarding claim 116: Following the discussion of claims 93, 114, and 118, Claim 116 is directed to a mammalian cell comprising the AAV vector of claim 114.
Claim 116 appears to read on a mammalian cell comprising wt AAV2. Based on this interpretation, the claim is analyzed as follows:
Step 1: The claim is to a composition, which is a statutory category of invention (Step 1: YES).
Step 2A, prong 1: The claim is considered to encompass a mammalian cell comprising wt AAV2. Mammalian cells and wt AAV2 are nature-based products. Schaffer et al. teach that wt AAV2 infects mammalian cells (See ¶0013, 0084, and 0105). There is no evidence that the composition as claimed, differs from mammalian cells infected with AAV2 in nature. Thus, the claimed composition does not have markedly different characteristics from what occurs in nature and is a "product of nature" exception. Accordingly, the claim is directed to a judicial exception (Step 2A, prong 1: YES).
Step 2A, prong 2: The claim is directed to a product and does not recite any structure that serves to integrate the composition into a practical application (Step 2A, prong 2: NO).
Step 2B: There are no additional elements required by the claim. The claim does not qualify as eligible subject matter and is rejected under 35 U.S.C. 101.
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 93 and 98 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sah et al. (US 20210277418 A1), of record in IDS dated 1/7/2026.
Regarding claims 93 and 98: Sah et al. teach AAV variants having enhanced tropism and their use in gene therapy (See Abstract and ¶0009). The viral genome can encode a payload (which reads on “exogenous nucleic acid”) such as a polypeptide or RNA (See ¶0014, 0145, and 0222). A peptide sequence can be inserted in the capsid protein, and the inserted sequence can be MEGSGRN (which reads on “an amino acid sequence selected from any one of SEQ ID NOs: 2, 3, 4, or 5”) (See ¶0119 and table 2, SEQ ID NO 6175, and alignment below), which anticipates the claimed invention.
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Claims 93, 114, 116, and 118 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Schaffer et al. (US 20160017295 A1).
Regarding claims 93, 114, and 118: Schaffer et al. teach recombinant AAV particles with variant capsid proteins (See Abstract). Schaffer et al. teach an amino acid sequence for the wt AAV2 capsid protein that is identical to instant SEQ ID NO 1 (See ¶0040, SEQ ID NO 2, and alignment below).
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The underlined regions read on “an amino acid sequence selected from any one of SEQ ID NOs: 2, 3, 4, or 5”. AAV2, comprising the AAV2 capsid sequence taught by Schaffer et al., therefore anticipates the claimed capsid polypeptide, AAV vector, and AAV particle.
Regarding claim 116: Following the discussion of claims 93, 114, and 118, Schaffer et al. teach that AAV2 infects mammalian cells (See ¶0013, 0084, and 0105), thereby anticipating a mammalian cell comprising the AAV vector.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 93, 98-99, 101-102, 104, 106, 114, and 116-118 are rejected under 35 U.S.C. 103 as being unpatentable over Sah et al. (US 20210277418 A1), of record.
The teachings of Sah et al. are set forth in the rejection above and are incorporated herein in their entirety.
Regarding claims 99, 101-102, 104, and 106: Following the discussion of claims 93 and 98, Sah et al. teach that the AAV can be used to treat a mammalian subject, including a human subject (See ¶0322) but do not expressly teach the use of their virus for delivering therapeutic payloads to retinal cells. However, Sah et al. teach that AAV can be used for treating eye diseases such as Leber’s congenital amaurosis (which reads on “LCA”) and inherited retinal diseases (See ¶0005). It therefore would have been obvious to infect retinal cells with the AAV of Sah et al. in order to treat eye diseases by expression of the viral payloads. Such a modification could be readily made, as Sah et al. teach that enhanced AAV capsids have been previously used for targeting retinal cells (See ¶0080).
Regarding claims 114 and 116-118: Following the discussion of claims 99, 101-102, 104, 106, and 119, Sah et al. teach that AAV particles can be generated by transfecting mammalian cells with a viral genome (which reads on “AAV vector” and “a second AAV vector”) encoding a payload (which reads on “an exogenous polynucleotide that encodes an RNA or a polypeptide”), a viral genome encoding replication and capsid genes (which reads on “AAV vector comprising a polynucleotide encoding the AAV capsid polypeptide of claim 93” and “a second AAV vector”), and a helper construct (See ¶0292). The production process therefore renders obvious the resulting AAV particle as well as a mammalian producer cell comprising the AAV particle.
Claims 93-94 and 96-119 are rejected under 35 U.S.C. 103 as being unpatentable over Sah et al. (US 20210277418 A1), of record, in view of Samulski et al. (US 20090191597 A1).
The teachings of Sah et al. are set forth in the rejections above and are incorporated herein in their entirety.
Regarding claims 94, 100, 103, 115, and 119: Following the discussion of claims 93, 98-99, 101-102, 104, 106, 114, and 116-118, Sah et al. teach that targeting peptides can be inserted between any of amino acids 586-592 or 586-589 of the AAV capsid VP1 and that the AAV can comprise an AAV2 capsid (See ¶0012, 0045, 0053, and 0139). Sah et al. do not expressly teach the capsid as having the amino acid sequence of instant SEQ ID NO 1 or 10.
Samulski et al. teach methods for producing recombinant AAV vectors (See ¶0003). Samulski et al. teach an AAV2 VP1 capsid protein sequence identical to the sequence of instant SEQ ID NO 1 (See ¶0013 and fig. 23, SEQ ID NO 12, and alignment below (first 120 aa displayed)).
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It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Sah et al. to substitute the sequence taught by Samulski et al. for the AAV capsid protein. Substitution of one known element for another known element is considered to be prima facie obvious, absent a showing that the substitution yields more than predictable results. See MPEP 2143(I)(B).
Sah et al. do not expressly teach an embodiment wherein a peptide comprising “EGSGRN” is inserted between amino acids 587-588, however, it would have been obvious to one of the ordinary skill in the art to combine the teachings of Sah et al. to yield a virus that reads on the claimed invention. One would have been motivated to make this modification because Sah et al. teach MEGSGRN as a peptide that can be used to enhance targeting of AAV to cells and between any of amino acids 586-592 or 586-589 as an appropriate site to place a targeting peptide within the AAV capsid (See ¶0012 and 0139).
Regarding claims 96-97: Following the discussion of claims 93, 98-99, 101-102, 104, 106, 114, and 116-118, Sah et al. teach that the targeting peptide can be used to replace a portion of loop VIII of the AAV capsid, rather than be inserted within loop VIII (See ¶0137). Instead of insertion between amino acids 588-589, replacement of the native amino acid sequence with the targeting peptide could encompass replacement of amino acids 586-592 or 585-591, which would read on “replacing amino acid residues corresponding to positions 585 to 590”.
Regarding claim 105: Following the discussion of claims 93, 98-99, 101-102, 104, 106, 114, and 116-118, Sah et al. teach that the targeting peptide inserted into the capsid can enhance tropism to and transduction of a desired tissue (See ¶0025, 0087, 0508, and 0558). One of ordinary skill in the art would understand enhanced tropism and transduction to be associated with higher expression of a transgene versus delivery using wt capsid proteins, due to the greater number of viruses infecting the cells.
Regarding claims 107-113: Following the discussion of claims 93, 98-99, 101-102, 104, 106, 114, and 116-118, Sah et al. teach an AAV capsid insertion peptide as MEGSGRN and do not expressly teach an insertion sequence of L1-EGSGRN-L2.
However, Sah et al. teach that the targeting peptide can be 3-12 amino acids in length, for example, 6 or 7 amino acids long, and that a particular region of the peptide, such as the central core or flanking regions, may be optimized (See ¶0092 and 0094). One of ordinary skill in the art therefore would have found it obvious to modify the peptide by truncation of a residue at either end in order to optimize targeting to a particular cell. The truncated targeting peptides would encompass EGSGRN, and because L1 and/or L2 are optional and/or absent, the teachings of Sah et al. render obvious the claimed AAV particle and capsid polypeptide.
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.
Claims 93-105, 107-110, 112-115, and 119 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-9, 11, 13, 18-19, 23, 34-36, and 50-84 of co-pending Application No. 19523534 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 93-98, 113-115, and 119: Co-pending claim 1 recites an adeno-associated virus (AAV) vector comprising an AAV capsid polypeptide, wherein said capsid polypeptide comprises the amino acid sequence of any one of SEQ ID NOs:2-5, 77-80, and 151-154. Co-pending claim 2 recites, in part, the vector of co-pending claim 1, wherein said capsid polypeptide comprises the amino acid sequence of SEQ ID NO:1 or SEQ ID NO: 10 except that said amino acid sequence of any one of SEQ ID NOs: 2-5, 77-80, and 151-154 is located between amino acid positions… 587 and 588. Co-pending claim 3 recites, in part, the vector of co-pending claim 1, wherein said capsid polypeptide comprises the amino acid sequence of SEQ ID NO:1 or SEQ ID NO:1 except that said amino acid sequence of SEQ ID NO:5, 80, or 154 is located between amino acid positions… 587 and 588. Co-pending claim 4 recites the vector of co-pending claim 1, wherein said capsid polypeptide comprises the amino acid sequence of SEQ ID NO:1 or SEQ ID NO:10 except that the amino acids from position 585 to 590 of SEQ ID NO:1 or SEQ ID NO:10 are replaced with said amino acid sequence of any one of SEQ ID NOs:2-5, 77-80, and 151-154. Co-pending claim 5 recites the vector of co-pending claim 1, wherein said capsid polypeptide comprises the amino acid sequence of SEQ ID NO:1 or SEQ ID NO:10 except that the amino acids from position 585 to 590 of SEQ ID NO:1 or SEQ ID NO:10 are replaced with said amino acid sequence of SEQ ID NO:2, 80, or 154. Co-pending claim 8 recites the vector of any one of co-pending claims 1-7, wherein said vector comprises an exogenous nucleic acid encoding an RNA or a polypeptide. Co-pending claim 9 recites the vector of co-pending claim 8, wherein said exogenous nucleic acid encodes an RNA. Co-pending claim 11 recites the vector of co-pending claim 8, wherein said exogenous nucleic acid encodes a polypeptide. The co-pending claims render obvious the instant claims.
Regarding claims 99, 101, and 103: Following the discussion of claims 93-98, 113-115, and 119, co-pending claim 18 recites, in part, a method for (a) delivering an exogenous nucleic acid sequence to a retinal cell within a mammal, (b) delivering an exogenous nucleic acid sequence to retinal cells within at least two different retinal regions of an eye of a mammal, or (c) delivering an exogenous nucleic acid sequence to a retinal ganglion cell within a mammal, wherein said method comprises: (a) contacting said retinal cell with an AAV vector comprising an AAV capsid polypeptide and said exogenous nucleic acid sequence, wherein said capsid polypeptide comprises the amino acid sequence of any one of SEQ ID NOs:2-5, wherein said AAV vector infects said retinal cell, thereby delivering said exogenous nucleic acid sequence to said retinal cell. Co-pending claim 23 recites the method of any one of co-pending claims 18-22, wherein said mammal is a human. The co-pending claims render obvious the instant claims.
Regarding claim 100: Following the discussion of claims 93-99, 101, 103, 113-115, and 119, co-pending claim 19 recites, in part, the method of co-pending claim 18, wherein said capsid polypeptide comprises: (a) the amino acid sequence of SEQ ID NO:1 or SEQ ID NO:10 except that said amino acid sequence of any one of SEQ ID NOs:2-5 is located between amino acid positions… 587 and 588. The co-pending claims render obvious the instant claim.
Regarding claims 102 and 104: Following the discussion of claims 93-98, 113-115, and 119, co-pending claim 34 recites, in part, a method for treating a retinal condition in a mammal in need thereof, wherein said method comprises: (a) contacting retinal cells of a mammal having said retinal condition with AAV vectors comprising an AAV capsid polypeptide and an exogenous nucleic acid sequence, wherein said capsid polypeptide comprises the amino acid sequence of any one of SEQ ID NOs:2-5, wherein said AAV vectors infect said retinal cells and drive expression of said exogenous nucleic acid sequence within said retinal cells, thereby treating said retinal condition. Co-pending claim 35 recites the method of claim 34, wherein said mammal is a human. Co-pending claim 36 recites, in part, the method of any one of claims 34-35, wherein: (a) said capsid polypeptide comprises the amino acid sequence of any one of SEQ ID NOs:2-5, and wherein said retinal condition is selected from the group consisting of LCA, OCA1, retinitis pigmentosa, rod/cone dystrophy, cone dystrophy, Stargardt Disease, Usher syndrome, XLRP, and XLRS. The co-pending claims render obvious the instant claims.
Regarding claim 105: Following the discussion of claims 93-98, 113-115, and 119, co-pending claim 13 recites, in part, the vector of any one of co-pending claims 1-12, wherein: (a) said capsid polypeptide comprises the amino acid sequence of any one of SEQ ID NOs:2-5, and wherein said vector expresses more nucleic acid in retinal cells than the level of expression from a comparable AAV vector comprising a capsid polypeptide consisting of the amino acid sequence set forth in SEQ ID NO:1. The co-pending claims render obvious the instant claim.
Regarding claims 107-110 and 112: Following the discussion of claims 93-98, 113-115, and 119, co-pending claim 50 recites, in part, a non-naturally occurring adeno-associated virus (AAV) vector comprising an AAV capsid polypeptide, wherein said capsid polypeptide comprises the amino acid sequence of SEQ ID NO:1 or SEQ ID NO: comprising an amino acid sequence insert of Formula A, Formula B. or Formula C located… between amino acid positions 587 and 588… wherein said Formula A is: -L1-EGSGRN (SEQ ID NO:2)-L2-, wherein said L1 and said L2 are each independently optional amino acid linkers having one, two, or three amino acids. Co-pending claims 51-84 recite linker options that render obvious the instant claims. The co-pending claims render obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Double Patenting: Warning
Applicant is advised that should claim 94 be found allowable, claim 119 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight change in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP 608.01(m).
Allowable Subject Matter
Claim 95 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form, including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
An AAV capsid polypeptide comprising the amino acid sequence of SEQ ID NO 5 inserted between amino acids 587-588 of SEQ ID NO 1 or 10 appears to be free of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER S SPENCE, whose telephone number is 571-272-8590. The examiner can normally be reached M-F 8:30-5:30.
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/JENNIFER S SPENCE/Examiner, Art Unit 1633
Prosecution Insights