DETAILED ACTION
Claims 1-2, 7, 10-11, 13-14, 16, 18, 21, 24, 32, 35, 38, 41, 48-49, 54, 57, 59-61, 63, 66-67, 69, 72, 75, 83, 88-89, 98-100, 1o4 112-113, and 115-117 are currently pending.
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 .
Election/Restrictions
Applicant’s election of Invention Group I (claims 1-2, 7, 10-11, 13-14, 16, 18, 21, 24, 32, 35, 38, 41 and 89) and Group I targeting moieties SEQ ID NO:4 and SEQ ID NO:799, in the reply filed on 7/16/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 48-49, 54, 57, 59-61, 63, 66-67, 69, 72, 75, 83, 88, 98-100, 1o4 112-113, and 115-117 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Acknowledgement is made of the instant application being a national stage entry under 35 USC 371 of international application PCT/US2022/076117, filed September 8, 2022, which claims the benefit of provisional application No. 63/242,008, filed September 8, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/7/2024, 1/17/2025, 3/18/2025, 11/5/2025, 11/20/2025 and 7/16/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: typographical.
Claim 1 recites the phrase “…(a) a skeletal muscle ell…”. It appears the term “ell” should be “cell”. Appropriate correction is required.
Claim Interpretation
The examiner notes that the term optional means that the limitations following the recitation are not required to be present. Therefore, the broadest reasonable interpretation of every claim that includes optional (optionally) is that the limitations following this term are not required to be present.
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.
Claims 2 and 24 are 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 2 is indefinite since the claim recites “(Tables 4-11)”, “(Table 4)”, “(Table 5)”, “(Table 6)”, “(Table 7)”, “(Table 8)”, “(Table 9)”, “(Table 10)”, and “(Table 11)”, and thus renders the claim indefinite because it is unclear whether the limitation(s) within the parentheses are part of the claimed invention, or are merely an example of the claimed sequences. The claim is unclear because the metes and bounds of the claim cannot be determined. See MPEP § 2173.05(d).
However, if Applicant means for the claim to identify each of the specific sequences from the Tables, the limitations of the tables should be included in the claims. Specifically, MPEP 2173.05(s) states, “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Claim 24 as currently written is vague and indefinite. Claim 24 depends from claim 21. Claim 21 refers to mutations in positions 267, 269, 504, 505 or 590. However, claims 24 (in the second to last clause, step (g)) refers to both 590 and 509. It isn’t clear if the claim fails to further limit (refers to mutation which is different than the claim from which it depends) or if it contains a typo wherein 509 is supposed to be 590.
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.
Claims 7 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 7 recites that the one or more inserts are each 3-25 or 3-15 amino acids in length. Claim 7 depends from claim 1 wherein the inserts comprising the P-motif are defined by specific sequence IDs, wherein m is 0-3 and n is 0-7; and the RGD motif is defined by a RGD motif that comprises or consists of XmRGDXn, wherein m is 0-4 amino acids and n is 0-15 amino acids. These sequences already have a particular length. Since the claim is not limiting the length of the targeting moiety but the inserts, the claim fails to further limit the claim from which it depends.
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 1-2, 7, 10-11, 14, 32, 35, 38, 41 and 89 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. This judicial exception is not integrated into a practical application and claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as explained below:
The rationale set forth below conforms to current Office practice for examination of claims under § 101.
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. All of the claims are directed to a statutory category, e.g., a composition (Step 1: YES).
The next part of the analysis involves whether the claimed invention recites or is directed to one or more judicial exceptions (Step 2A, prong one).
Claim 1 is directed to a composition comprising a targeting moiety. The targeting moiety is a peptide. As taught by Tripathi et al (previously cited), the draft genome sequence of Lampropedia cohaerens strain CT6T was isolated from arsenic rich microbial mats of a Himalayan hot water spring. As evidenced by GenBank KKW67875.1 (previously cited), the Lampropedia cohaerens (ABC transporter) has a sequence of 236 amino acids which contains a P-motif having 100% Sequence Identity to instant SEQ ID No: 1699 as shown below.
The P-motif of claim 1 comprises the amino acid sequence of XmPX1QGTX2RXn wherein X1, X2, Xm, and Xn are each independently selected from any amino acid, wherein m is 0, 1, 2, or 3, and wherein n is 0, 1, 2, 3, 4, 5, 6, or 7. Thus, when m =0 and n=0, the P-motif comprises the amino acid sequence PX1QGTX2R.
Tripahti’s Lampropedia cohaerens (ABC transporter) amino acid sequence at amino acids 71-77 has 100% identity to the claimed P-motif since X1 and X2 are selected from any amino acid.
None of claims 1-2, 7 and 10 require more than the peptide. Claim 11 further defines the targeting peptide comprises a viral protein, however this does not change the structure of the peptide but is merely a vessel for carrying the peptide. Claim 14 further defines the type of viral protein but does not change the structure of the peptide. Claims 35 and 38 are limiting the optional cargo but it is still optional and not required to be present. Claim 32 further defines the AAV capsid protein is an engineered viral particle, however this limitation this is directed to a product by process. Note MPEP 2113: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The MPEP also indicates that “the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). “In determining validity of a product-by-process claim, the focus is on the product and not the process of making it.” Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1369 (Fed.Cir.2009). The process of making is only relevant “if the process by which a product is made imparts ‘structural and functional differences’ distinguishing the claimed product from the prior art” Greenliant Systems, Inc. v. XicorLLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012). The rest of the claim recites “optionally”. Therefore, the BRI of claim 32 is that none of the limitations following optionally are present. Thus, the claim further defines the targeting peptide comprises a viral particle, however this does not change the structure of the peptide but is merely a vessel for carrying the peptide.
Claim 41 further defines the intended use recited in claim 35, however this does not change the structure of the peptide.
Claim 89 defines that the polypeptide is produced by the vector system of claim 48, however this does not change the structure of the peptide.
Therefore, the answer to step 2A prong 1 is yes. Thus, the claims do not qualify as eligible subject matter and are rejected under 35 U.S.C. 101.
The next part of the analysis involves whether the claimed invention recites additional elements that integrate the judicial exception into a practical application (Step 2A, prong two).
Given the claims are directed to a composition, the claims do not recite additional steps that integrate the judicial exception into a practical application (Step 2A, prong two: No).
The final part of the analysis involves whether the claimed invention, as a whole, recite something “significantly more” than the judicial exceptions (Step 2B).
In view of the above and considered as a whole, the claimed composition does not have markedly different characteristics from what occurs in nature and such elements discussed above are not significantly more than the indicated judicial exceptions. Thus, the claims do not qualify as eligible subject matter and are rejected under 35 U.S.C. 101 (Step 2B: NO).
As to claims 13, 16, 18, 21, and 24, the examiner notes that the additional claims which clearly recite that the targeting moiety is inserted between two amino acids of the viral protein (i.e. claim 13 and 16) or the viral protein has reduced or eliminated uptake in a non-CNS and/or non-muscle cell as compared to the corresponding wild-type (i.e., claims 18, 21 and 24) are deemed eligible subject matter as these claims rise to the level of a marked difference.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 7, 10, 35, 38, 41 and 89 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tripathi et al., (previously cited, IDS 11/20/2025), as evidenced by GenBank KKW67875.1 (May 8 2015, previously cited).
The instant application claims a composition comprising a targeting moiety effective to target a muscle cell or both a muscle cell and a central nervous system (CNS) cell, wherein the targeting moiety comprises one or more inserts each comprising one or more P-motifs that comprises or consist of the amino acid sequence defined as SEQ ID NO:1699 (claim 1), wherein X1, X2, Xm and Xn are each independently selected from any amino acid, wherein m is 0-3 and wherein n is 0-7; or the insert comprises one or more RGD motifs that comprises or consists of XmRGDXn, wherein m is 0-4 amino acids, wherein n is 0-15 amino acids, and optionally a cargo, wherein the cargo is coupled to or is otherwise associated with the targeting moiety, and optionally wherein the targeting moiety is effective target (a) a skeletal muscle, (b) a cardiac muscle cell, (c) a skeletal muscle cell and a CNS cell, or (d) a cardiac muscle cell and a CNS cell.
The examiner notes that the “optionally” limitations are interpreted as not required to be present. Regarding the claimed “effective to target a muscle cell or both a muscle cell and a central nervous system (CNS) cell” does not structurally distinguish SEQ ID No: 1699 or the RGD motif from a sequence comprising the same sequence alignment. The examiner notes that the claim recites “comprising” which is interpreted as allowing for additional amino acids to be present.
Tripathi et al. is directed to draft genome sequence of Lampropedia cohaerens strain CT6T isolated from arsenic rich microbial mats of a Himalayan hot water spring. As evidenced by GenBank the Lampropedia cohaerens (ABC transporter) has a sequence of 236 amino acids which contains 100% Sequence Identity to instant SEQ ID No: 1699 as shown below.
The P-motif of claim 1 comprises the amino acid sequence of XmPX1QGTX2RXn wherein X1, X2, Xm, and Xn are each independently selected from any amino acid, wherein m is 0, 1, 2, or 3, and wherein n is 0, 1, 2, 3, 4, 5, 6, or 7. Thus, when m =0 and n=0, the P-motif comprises the amino acid sequence PX1QGTX2R.
Tripahti’s Lampropedia cohaerens (ABC transporter) amino acid sequence at amino acids 68-84 (LDTPTQGTVRLAREDLF) has 100% identity to the claimed P-motif since X1, X2, Xm and Xn are selected from any amino acid and m is 0-3 amino acids and n is 0-7 amino acids.
Since instant claim 1 recites the transitional phrase “comprising”, the 236 amino acid sequence anticipates instantly claimed SEQ ID No: 1699.
Regarding claim 7, X1 is T and X2 is V.
Regarding claim 10, the Lampropedia cohaerens (ABC transporter) has a sequence of 236 amino acids which is a polypeptide.
Regarding claims 35, 38 and 41, the cargo is still recited as optional. Therefore, the limitations recited in claims 35, 38 and 41 are not further limiting.
Regarding claim 89, the claim is interpreted as being directed to just a polypeptide. While the claim recites “…encoded, produced or both…. produced by a vector system…”, this is directed to a product by process. Note MPEP 2113: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The MPEP also indicates that “the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). “In determining validity of a product-by-process claim, the focus is on the product and not the process of making it.” Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1369 (Fed.Cir.2009). The process of making is only relevant “if the process by which a product is made imparts ‘structural and functional differences’ distinguishing the claimed product from the prior art” Greenliant Systems, Inc. v. XicorLLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012). The rest of the claim recites “optionally”. Therefore, the BRI of claim 89 is that none of the limitations following optionally are present. Thus, the claim merely recites a polypeptide.
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 1, 7, 10-11, 13-14, 16, 32, 35, 38, 41 and 89 are rejected under 35 U.S.C. 103 as being unpatentable over Michalakis et al. (WO 2019/076856; IDS 11/20/2025) as evidenced by Purves et al. (Neuroscience, 2001; IDS 11/20/2025).
It is initially noted that the term optional means that the limitations following the recitation are not required to be present. Therefore, the BRI of every claim that includes optional (or optionally) is that the limitations following this term are not required to be present.
Regarding claim 1, Michalakis is directed to AAV vectors comprising an insertion of at least 6-8 amino acids (polypeptide) between the positions corresponding to position 87 and 588 of SEQ ID NO:1 (Abstract).
Michalakis, at page 4, teaches the insertion sequence has from the N-terminus to the C-terminus the formula I:
X1A-X1B-X2-X3-X4-X5-X6-X7 (formula I)
wherein X5 is selected from P (Pro), L (Leu) and V (Val);
wherein X7 is R (Arg);
wherein X1A, X1B, X2, X3, X4, X6 are independently any amino acid;
wherein X1A and/or X1B are independently optionally absent or present,
(page 4).
In a further limiting embodiment, X1A or X1B is selected from A, L, V, I, S, T, N, Q, C, P and G, preferably X1A or X1B is selected from G, P and N ([129]), and/or
X2 is selected from S, T, N, Q, A, L, V and I, preferably X2 is selected from N and L ([131]);
and/or wherein X3 is selected from A, L, V, I, S, T, N, Q, C, G and P, preferably X3 is selected from S, Q and P ([132]); and/or
wherein X4 is selected from K, R, H, D, E, S, T, N, Q, A, V, I, L, C, G and P, preferably X4 is selected from P, A and T ([133]); and/or
wherein X6 is selected from K, R, H, D, E, S, T, N, Q, A, C, G and P, preferably X6 is selected from T, P and S ([134]). AAV are adeno-associated virus (abstract, paragraph 2).
While Michalakis teaches a short chain amino acid sequence which can be inserted into an AAV, Michalakis does not expressly teach the instantly claimed sequence SEQ ID NO: 1699 (e.g., PTQGTVR).
Regarding the claimed sequence, Michalakis teaches both X1A and X1B can be present. X1A is selected from G, P and N. Selecting P from one of three choices would be obvious. X1B is selected from A, L, V, I, S, T, N, Q, C, P and G. Selecting T from one of 11 choices would be obvious. X2 is selected from S, T, N, Q, A, L, V and I. Selecting Q from one of 8 choices is obvious. X3 is selected from A, L, V, I, S, T, N, Q, C, G and P. Selecting G from one of 11 choices would be obvious. X4 is selected from K, R, H, D, E, S, T, N, Q, A, V, I, L, C, G and P. Selecting T from 16 choices would be obvious. X5 is selected from P, L or V. Selecting V from one of three choices would be obvious. X6 is selected from K, R, H, D, E, S, T, N, Q, A, C, G and P. Selecting V from one of 13 choices would be obvious.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose any of the specifically taught amino acids in Michalakis and form an insertion sequence comprising the sequence PTQGTVR, for example. Michalakis teaches the sequence length is 6 to 8 amino acids. As set forth above there are a finite number of choices for each of the positions in formula I. Therefore, one skilled in the art would have been motivated to make any sequence falling within the pattern set forth in Michalakis. Since the insertion sequence is narrowly defined there would be a reasonable expectation of success. The AAVs are taught as having the ability to target cells of the retina (Abstract). As evidenced by Purves, despite its peripheral location, the retina is part of the central nervous system (first paragraph).
Further regarding claim 1, since the cargo is optional, it is not required to be present. Likewise, the optional targeted cell types are not required. It is noted however that, Michalakis teaches the AAVs are useful as a cargo system for other molecules including DNA, RNA, peptides, proteins and chemical compound (paragraph 58).
Regarding claim 7, the inserts are 6-8 amino acids.
Regarding claim 10, the 6-8 amino acid inserts are a polypeptide.
Regarding claims 11 and 14 the insert is in an AAV which is a viral protein.
Regarding claim 32, AAV particles are taught (paragraph 6, 54, 67).
Regarding claims 35, 38 and 41, the cargo is still recited as optional. Therefore, the limitations recited in claims 35, 38 and 41 are not further limiting.
Regarding claim 89, the claim is interpreted as being directed to just a polypeptide. While the claim recites “…encoded, produced or both…. produced by a vector system…”, this is directed to a product by process. Note MPEP 2113: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The MPEP also indicates that “the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). “In determining validity of a product-by-process claim, the focus is on the product and not the process of making it.” Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1369 (Fed.Cir.2009). The process of making is only relevant “if the process by which a product is made imparts ‘structural and functional differences’ distinguishing the claimed product from the prior art” Greenliant Systems, Inc. v. XicorLLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012). The rest of the claim recites “optionally”. Therefore, the BRI of claim 89 is that none of the limitations following optionally are present. Thus, the claim merely recites a polypeptide.
Regarding claim 13 and 16, Michalakis teaches the insert is between two amino acids, specifically 587 and 588 (claim 1) which falls within the scope of claim 16.
Regarding claims 18 and 21, Michalakis teaches recombinant AAV vectors with a short AAV capsid peptide insertions for delivery to the CNS (Abstract and [60]-[64], [68]). Michalakis teaches the AAV variants comprising the insertions may have functional characteristics that are not present in the parental AAV (wild-type AAV), specifically the AAV variant may have a different cellular tropism, i.e., a different affinity (uptake) for infecting a particular cell type, such as increased affinity for uptake in retinal cells ([68]) which reads on reduced uptake in non-CNS cells as compared to wild-type AAV capsid polypeptide.
It is additionally noted that Michalakis teaches peptide inserts that are encompassed by the claimed P-motif (SEQ ID NO:1699). Thus, the fact that Michalakis employs the same insertion peptides as the instant application means that any properties exhibited by or benefits provided the composition are inherent and are not given patentable weight over the prior art. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties Applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not inherently possess the same properties as instantly claimed product.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Michalakis et al. (WO 2019/076856; IDS 11/20/2025) as evidenced by Purves et al. (Neuroscience, 2001; IDS 11/20/2025), as applied to claims 1, 7, 10-11, 13-14, 16, 32, 35, 38, 41 and 89 above, and further in view of Albright et al. (Molecular Therapy, 2018; IDS 11/20/2025).
The teaching of Michalakis, as evidenced by Purves, is set forth above.
Regarding claim 24, Michalakis teaches the AAV comprises AAV9 ([82]). Michalakis does not expressly teach a mutation in the AAV corresponding to those recited in claim 24, such as 269T. However, this deficiency is cured by Albright et al.
Albright is directed to mapping the structural determinants required for AAVrh.10 transport across the blood-brain barrier (BBB) and teaches that, to achieve CNS gene transfer, intravenously administered AAV vectors must first cross the blood-brain barrier (BBB) to gain entry into the brain (page 510, last paragraph). In the case of AAVs, the BBB prevents entry of most serotypes into the brain, with a few notable exceptions. Albright teaches that isolates AAV9, AAVrh.8, and AAVrh.10 have been shown, among others, to efficiently traverse the BBB in different animal models, as compared to AAV serotypes 1–6 and 8, which results in poor CNS transduction (page 511, left column first paragraph). The current study identified 262N, 263G, 264T, 265S, 267G, 268S, 269T, and 273T as key residues on the chimeric AAV1RX capsid, derived from AAVrh.10, that are essential for crossing the BBB (517, last paragraph; Fig. 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Michalakis and Albright and utilize an AAV with a 269T. Michalakis desires administration to the retina, part of the CNS. Albright teaches that key residues that are essential for crossing the BBB include 269T. Therefore, one skilled in the art would have been motivated to utilize an AAV capsid with this mutation for the purpose of achieving the desired delivery.
Allowable Subject Matter
Claim 2 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.
A sequence search was conducted regarding Applicant’s elected P-motif, SEQ ID NO:799, and RGD motif, SEQ ID NO:4. The elected sequences are free of prior art.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to E. YVONNE PYLA whose telephone number is (571)270-7366. The examiner can normally be reached M-F 9am - 6pm.
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
Prosecution Insights