DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to an amendment filed 8/7/2026.
Claims 1- 30 are pending.
The instant application is a continuation of U.S Patent Application No. 17/614,327 filed 11/24/2021, now U.S Patent No. 12,668,814, which is a National Phase Application under 35 U.S.C. § 371 of PCT/US2021/042812, filed July 22, 2021 which claims the benefit of and priority to U.S. Provisional Patent Application No. 63/055,265, filed on July 22, 2020, U.S. Provisional Patent Application No. 63/107,394, filed on October 29, 2020, and U.S. Provisional Patent Application No. 63/183,038, filed on May 2, 2021.
Election/Restrictions
Applicant’s election of Group I (Claims 1-10, 13, 15-24 and 27) in the reply filed on 8/7/2026 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 § 818.03(a)).
However, it is noted that applicants have stated that the groups were established due to lack of unity. To the contrary, the restriction requirement of 6/29/2026 was made under 35 USC 121 practice and it was established therein that there was a serious search burden and examination burden if restriction was not required.
Information Disclosure Statement
Information Disclosure Statements filed 10/10/2025, 11/19/2025, 1/16/2026, 1/22/2026, 2/4/2026, 2/24/2026, 3/12/2026, 4/24/2026, 4/30/2026, 5/13/2026, 6/3/2026, 6/5/2026, 8/7/2026 have been identified and the documents considered. The signed and initialed PTO Form 1449 has been mailed with this action.
It is noted that the IDS had multiple duplicate and incomplete references. As complete a record as possible was made of what was in the file and not duplicates. There are three notations on the IDS. First, if the document has been identified and considered, it is initialed. In the case that the documents were duplicates, could not be located or the listing lacks necessary details such as title, it has been crossed off of the IDS without initials. For those missing, a search of the prior references in copending applications as well as those submitted with this application were scanned and could not be found in the cases. These are marked as missing from the file, it would be remedial to include a copy and a new 1449 with their listing in the response. Third, for document listed as a Notifications, Communications, court cases, search reports and office actions, these have been considered as indicated by the initials but have been crossed off of the Form 1449.
Claim Objections
Claim 7 and 21 are objected to for minor informalities. Claims 7 and 21 have the same format wherein mutations in the capsid are claimed. Because the claims recite for each option a-h using and/or, the recitation in part (i) that the mutation is any combination of a-h is redundant. This can be remedied by reciting a or b or c or d or e or f or g or h. Alternatively, part (a) can be deleted.
Appropriate correction is required.
Claims 24 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 19. 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 difference 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). Claim 19 recites that the capsid is part of an engineered AAV with limiting definition of what AAV serotypes are intended. Claim 24 recites the same particle formation but does not limit the serotype. Hence, claim 24 does not embrace any additional limitations outside of claim 19.
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 4 and 18 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 4 is unclear by reciting that the RGDX1X2X3X4 part of the n-mer is inserted between two contiguous amino acids between amino acids 452 and 460 or 581-593 of an AAV9 capsid or equivalent in another serotype. Claim 3 from which claim 4 depends indicates that the first three amino acids of the n-mer replace one or more amino acids of the capsid. Hence, RGDX1X2X3X4 cannot be next to a native amino acid in the capsid but must be next to a replaced amino acid of the capsid. However, claim 4 requires that RGDX1X2X3X4 be inserted between native sequences. It is unclear if the RGDX1X2X3X4 is removed from the Xm3Xm2Xm1 portion or not. This is true of claim 18.
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 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.
Claims 1-10, 13, 15-24 and 27 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a modified AAV capsid polypeptide wherein the modification comprises an inserted targeting moiety that targets a muscle cell wherein the targeting moiety comprises the motif Xm3Xm2Xm1RGDX1X2X3X4 wherein X1 is R and/or X4 is L and it is inserted after AAV9 453, 587 and 588 or analogous sites in other AAV serotypes, does not reasonably provide enablement for any other embodiment. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the patent coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is required is not based on a single factor but is rather a conclusion reached by weighing many factors (See Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter, 1986) and In re Wands, 8USPQ2d 1400 (Fed. Cir. 1988); these factors include the following:
1) Nature of invention. The instant claims are drawn to a composition for targeting muscle cell wherein the targeting moiety is in an AAV capsid and comprises an amino acid sequence comprising n-mer comprising Xm3Xm2Xm1RGDX1X2X3X4 wherein X1 is R and/or X4 is L.
2) Scope of the invention. The n-mer motif comprises Xm3Xm2Xm1RGDX1X2X3X4 wherein X1 is R and/or X4 is L and wherein the remaining Xs are any amino acid. However as regards the capsid insertion site, the claims embrace a large number of such sites wherein due to the structure of the capsid of AAV, it has been found tolerant insertion sites are limited such that targeting can result.
3) Number of working examples and guidance. The specification is directed to use of AAV to transduce muscle cells. Applicants modify AAV9 to comprise an RGD targeting motif. Specifically, the disclosure is drawn to identifying AAV variants that bind to muscle cells with the conjecture that this method should work for other cell types.
AAV capsid protein engineering coupled with in vivo selection is a promising approach to enable potent gene delivery to a variety of tissues
In the experimental system, n-mer motifs RGD are inserted in place of 588, 589, 590 into the capsid. The listed targeting n-mer sequences are 5-15 amino acids amino acid sequences wherein Xm can b 1-4 and Xn is 1-9 (see Tables 2, 3 and figure 14F).
Generally, an AA V capsid library can be generated by expressing engineered capsid
vectors each containing an engineered AA V capsid polynucleotide previously described in an
appropriate AAV producer cell line. See e.g., FIG. 8. This can generate an AAV capsid library
that can contain one more desired cell-specific engineered AAV capsid variant. FIG. 7 shows
a schematic demonstrating embodiments of generating an AAV capsid variant library,
particularly insertion of a random n-mer (n=3-15 amino acids) into a wild-type AAV, e.g.,
AAV9. In this example, random 7-mers were inserted between aa588-589 of variable region
VIII of AA V9 viral protein and used to form the viral genome containing vectors with one variant per vector.
The identified sequences are all n-mer sequences that are 7 or 10 amino acids long, comprise RGD and have Xm 0-3 and Xn 4. Applicants teach (page 227-229).
Cross-comparison of muscle-enriched variant capsid sequences furthermore identified a common RGD motif among the top variants, and additional analyses uncovered a strong interaction with, and dependence on, target cell expression of RGD-binding integrin heterodimers.
FIG. 14F shows the sequence of the 7-mer insertion in the top highly expressed capsid variants in mouse muscles after the second round of transcript-based selection. Variants with the same color in each group are encoded by synonymous DNA codons. [0598] Strikingly, in the second round of selection, all 12 of the top capsid variants highly expressed in muscles from either the CK8 or MHCK7 libraries contained the same arginineglycine-aspartic acid (RGD) motif in the first 3 amino acid positions of the 7-mer insert.
As to site of insertion, applicants teach only use of AAV9 after amino acid 588 of the VP protein.
First, each variant included a random 7-mer peptide inserted between amino acids 588 and 589 in the hypervariable region VIII of the AA V9 capsid, a design that ensures exposure of the variable peptide sequence on the capsid surface ((DiMattia et al., 2012)
While the disclosure states that other sites can be used, there is only use of 588 as the insertion point which is consistent with the art.
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[0689] The AAV9-based capsid libraries that were designed for this study included several
key features to facilitate identification of muscle-directed vectors with high potency for in vivo
use. First, each variant included a random 7-mer peptide inserted between amino acids 588 and
589 in the hypervariable region VIII of the AAV9 capsid, a design that ensures exposure of the
variable peptide sequence on the capsid surface ((Bomer et al., 2020; DiMattia et al., 2012)),
4) State of the art. One of the main issues with gene delivery for therapy is the inability to target the disease or disordered site without secondary tissue affects. At the same time, the effect of direct or local administration was not sufficient for therapeutic methods. The delivery is complicated and if the disorder is wide-spread ineffective. This invention is designed to provide a targeting moiety that mediates muscle delivery. The moiety is developed in AAV which is a well-studied molecule used for gene delivery. The capsid of AAV has served as a target site for altering tropism by inserting peptides that are directive to a specific cell type.
The capsid comprises sequences that direct the virus to specific receptors. Modifications to redirect AAV by engineering the capsid protein are undertaken. Serious analysis and study of insert sites in the AAV capsid has been undertaken since the 1990s. These studies were initially in AAV2 as this was the first used and readily available AAV. It also showed success in therapies such as Leber’s congenital amaurosis, aromatic L-amino acid decarboxylase deficiency (AADC), and choroideremia. Since then, additional serotypes have been developed (see Buning and Srivastave, page 248). AAV9 has shown great promise in neurological conditions even with systemic administration. However, to develop this molecule further, the goal is to alter the tropism of AAV to reduce liver tropism (natural tropism) and increase muscle tropism. This method involves inserting peptide sequences into the capsid. However, to develop this molecule further, the goal is to alter the tropism of AAV to reduce liver tropism (natural tropism) and increase muscle tropism. This method involves inserting peptide sequences into the capsid.
5) Unpredictability of the art. Regarding the breadth of the targeting moiety, applicants claim a large breadth of such moieties but do not describe the full breadth that can mediate muscle transduction. The court and the Board have repeatedly held (Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.,18 USPQ2d 1016 (CA FC, 1991); Fiers v. Revel, 25 USPQ2d 1601 (CA FC 1993); Fiddes v. Baird, 30 USPQ2d 1481 (BPAI 1993) and Regents of the Univ. Calif. v. Eli Lilly & Co., 43 USPQ2d 1398 (CA FC, 1997)) that an adequate written description of a compound requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it, irrespective of the complexity or simplicity of the method; what is required is a description of the compound itself. It is not sufficient to define a product solely by its principal biological property, because disclosure of no more than that, as in the instant case, is simply a wish to know the identity of any peptide with muscle cell tropism with that biological property. Naming a type of material generically known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material. When one is unable to envision the detailed constitution of a complex chemical compound having a particular function, such as a biomolecule so as to distinguish it from other materials, as well as a method for obtaining it, conception has not been achieved until reduction to practice has occurred, i.e., until after the molecule has been isolated. Thus, claiming the capsid with the insert in any site is an attempt to preempt the future before it has arrived. Also, where a claim purports to cover all capsid insertion sites and the specification discloses but a single known to do work in the desired fashion, the situation is analogous to a single means claim and does not meet the enablement requirement under para. 1 ' of§112.
It has been found that insertion sites are limited due to the impact of the insertion on the structural integrity of the capsid. As well, the secondary structure does not naturally allow for any site within the capsid to be available. Analysis has demonstrated that the region of 587-590 of the AAV alone can tolerate insertion of peptides. Mattenberger demonstrate that at the time of filing, even structural analysis of lesser used capsids was at its inception (see e.g. abstract).
The capsids of non-enveloped viruses are highly multimeric and multifunctional protein assemblies that play key roles in viral biology and pathogenesis. Despite their importance, a comprehensive understanding of how mutations affect viral fitness across different structural and functional attributes of the capsid is lacking.
To date, systemic analysis has determined that only functional inserts can be made at 453, 587-588 in AAV2. Borner et al and Buning detail this.
(Buning) When Girod et al.48 reported the first successful capsid modification for re-targeting in 1999, no crystal structure for AAV capsids was available, and possible insertion sites were predicted based upon the crystal structure of canine parvovirus (CPV). Of the six candidate insertion sites (I) for AAV2 (I-261, I-381, I-447, I-534, I-573, and I-587; VP1 numbering), three sites turned out to be suitable for surface display of the b1 integrin-binding model ligand L14 (QAGTFALRGDNPQG) .48,49 Finally, however, only L14 peptide insertion at I-587, i.e., insertion between the amino acid residue asparagine (N) 587 and arginine (R) 588, allowed for target receptor- mediated cell transduction48
(Borner) Thus, the AAV2 I-587 insertion site allows genetic modifications of the capsid without interfering with capsid assembly or genome packaging, accepts peptides of up to a size of 34 amino acids, displays the foreign sequence in such a way that peptides can interact with target cell surface molecules, and enables vector re-targeting in a single step because the AAV2 primary receptor binding motif is modified upon insertion of the novel targeting ligand.55 These advantageous features are the likely reason why I-587 and the neighboring position I-588 have become the most frequently used positions for genetic cell surface targeting approaches employing AAV2 vectors (Tables 1 and 2).
To this date, promise has been held in other spots but no viable option other than this site has been used. This site translates to a number of other serotypes as shown below (see Borner et al, Table S1 and Buning, Table 4).
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Even as recently as 2020, these sites are limited in AAV (Li and Samulski, page 262).
Rational design can also be used to generate AAV capsids that can deliver genes to cells that are not usually permissible to AAV transduction. Here, specific cell-targeting peptides are selected from a bacteriophage display library and incorporated into the AAV capsid to make AAV mutants63,64. However, as this approach may alter the conformation of peptides in the virus capsid or prevent the peptide from efficiently binding to receptors on target cells, capsid variants with targeted tropism have also been selected from random AAV display peptide libraries17,65. Randomized nucleic acid sequences encoding a library of peptides, including those that bind to specific receptors on target cells, are inserted into permissible sites of the AAV capsid genome, such as residue 587 or 588 of AAV2 VP1
Hence, insertion sites are limited due to the impact of the insertion on the structural integrity of the capsid. As well, the secondary structure does not naturally allow for any site within the capsid to be available. Analysis has demonstrated that the region of 587-590 of the AAV alone can tolerate insertion of peptides. While there has been no indication of insertion sites other than 588 and surrounding amino acids in other AAV, applicants suggest others sites. This is nothing more than a wish list.
Regarding example 6 and the isolation of 5,000,000 starting variants, this does not establish that there are sites outside of 453, 587 and 588 that can tolerate insertion. The arguments that the n-mers are limited is not valid in the rejection. The issue is limited to the sites of insertion and neither the art nor the specification teach any other results. While it is routine to screen for variants comprising multiple substitutions/multiple modifications, the specific modifications that can be made with a reasonable expectation of success in obtained the desired activity are limited and the result of such modifications is unpredictable. Applicants support this on page 228,
Selection of variants based on mRNA expression yielded a select few functional capsids
compared to selection based on the presence of vector genome DNA (FIGS. 21B-21G),
suggesting that only a small fraction of capsid variants that physically enter target cells can
functionally transduce these cells to express their encoded transgene.
As demonstrated by applicants, predictability of which moieties inserted into which sites and have the desired activity requires a specific knowledge of and guidance with regard to which sites can be used and which sequences can have said claimed activity. It is this specific guidance that applicants do not provide.
6) Amount of Experimentation Required. As set forth above, the unpredictability of this art has demonstrated that one cannot use the claimed product without undue experimentation. Secondly, applicants’ guidance provides use for a single basic structure. Hence, applicants have only demonstrated how to make an AAV9 capsid protein that once part of an AAV can direct one to muscle cells. Neither the specification nor the art provide guidance on how to use the large genus of 1000s and 1000s of products embodied by any viral capsid with any of the almost 400 sequences wherein any combination can be used to meet the one or more component in any site in the capsid protein will be enabled for the disclosed use. "[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent's specification must enable a person skilled in the art to make and use the entire class.(Amgen, page 13)" The single disclosure are an attempt to "monopolize an entire class of things defined by their function (Amgen page 3)" wherein the specification does not provide a roadmap for obtaining the genus. “For if our cases teach anything, it is that the more a party claims, the broader the monopoly it demands, the more it must enable. That holds true whether the case involves telegraphs de-vised. (Amgen, page 20)”
MPEP 2164.05 teaches, “However, the examiner should carefully compare the steps, materials, and conditions used in the experiments of the declaration with those disclosed in the application to make sure that they are commensurate in scope; i.e., that the experiments used the guidance in the specification as filed and what was well known to one of skill in the art. Such a showing also must be commensurate with the scope of the claimed invention, i.e., must bear a reasonable correlation to the scope of the claimed invention. Given the unpredictability of the art, the poorly developed state of the art with regard to predicting the structural/ functional characteristics of n-mers as claimed, the lack of adequate working examples and the lack of guidance provided by applicants, the skilled artisan would have to have conducted undue, unpredictable experimentation to practice the claimed invention.” Consequently, the prior art (and post-filing art) when combined with the lack of a single experimental product and test of Applicant's hypothesis, shows that one of skill in the art at the time the invention was made would have had no basis to reasonably predict or conclude the claimed sequences could be identified given the lack of details necessary to identify those meeting the necessary functions. Though not controlling, the lack of working examples, is, nevertheless, a factor to be considered in a case involving both physiological activity and an undeveloped art. When a patent applicant chooses to forego exemplification and bases utility on broad terminology and general allegations, he runs the risk that unless one with ordinary skill in the art would accept the allegations as obviously valid and correct, the PTO may, properly, ask for evidence to substantiate them. Ex parte Sudilovsky, 21 USPQ2d 1702, 1705 (BPAI 1991); In re Novak, 134 USPA 335 (CCPA 1962); In re Fouche, 169 USPQ 429 (CCPA 1971).
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
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. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 2, 4-10, 13, 15-24 and 27 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-13 of U.S. Patent 12,668,814.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1-13 of U.S. Patent 12,668,814. That is, the cited claims of U.S. Patent 12,668,814 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, the claims are drawn to the same targeting motifs which are inserted into a capsid peptide. The two differ with respect to the site of insertion of the motif but recite overlapping locations.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the U.S. Patent 12,668,814, then two different assignees would hold a patent to the claimed invention of 12,668,814, and thus improperly there would be possible harassment by multiple assignees.
Claims 1, 2, 4-10, 13, 15-24 and 27 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-26 of U.S. Patent 11,920,150 from copending Application No. 17/707,940.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1-26 of U.S. Patent 11,920,150. That is, the cited claims of U.S. Patent 11,920,150 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, U.S. Patent 11,920,150 recites that the n-mer can be Xm3Xm2Xm1RGDX1X2X3X4 wherein Xm can be 0-4 this encompassing 3 and the instant claims allow for any amino acid in this position just as the copending claims so. As well Xn can be 1-15 encompassing the 4 provided for in the instant claims (see copending claim 2). The instant claims indicated that this situation can be X1X2X3X4 wherein X4 can be L (see ¶0229). Instant claim 3 recites that the first 3 amino acids are inserted into the capsid and hence replace the three amino acids therein. As well, the instant claims allow the first 3 amino acids to be any. Hence, SEQ ID NO:8471 RGDHSSL also inserted int the capsid meets the corresponding sequence requirements where the first 3 amino acids are any in the assertion site followed by RGD then X3 is S as recited in instant claim 2 and X4 is L. The remaining claims of U.S. Patent 11,920,150 are rejected as the applications are not divisionals of one another and therefore lack safe harbor.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the U.S. Patent 11,920,150, then two different assignees would hold a patent to the claimed invention of U.S. Patent 11,920,150, and thus improperly there would be possible harassment by multiple assignees.
Claims 1-10, 13, 15-24 and 27 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-28 of U.S. Patent 12,618,082.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1-28 of U.S. Patent 12,618,082. That is, the cited claims of U.S. Patent 12,618,082 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, U.S. Patent 12,618,082 recites that the n-mer can be Xm3Xm2Xm1RGDX1X2X3X4 wherein Xm can be 0-4 this encompassing 3 and the instant claims allow for any amino acid in this position just as the copending claims so. As well Xn can be 1-15 encompassing the 4 provided for in the instant claims (see copending claim 2). The instant claims indicated that this situation can be X1X2X3X4 wherein X4 can be L (see ¶0229). Instant claim 3 recites that the first 3 amino acids are inserted into the capsid and hence replace the three amino acids therein. As well, the instant claims allow the first 3 amino acids to copmrise any. Hence, SEQ ID NO:131 ADGRGDRSSL meets the corresponding sequence requirements where the first 3 amino acids are any in the assertion site followed by RGD then X3 is S as recited in instant claim 2 and X4 is L. The remaining claims of U.S. Patent 12,618,082 are rejected as the applications are not divisionals of one another and therefore lack safe harbor. Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the U.S. Patent 12,618,082, then two different assignees would hold a patent to the claimed invention of U.S. Patent 12,618,082, and thus improperly there would be possible harassment by multiple assignees.
Claims 1-10, 13, 15-24 and 27 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1, 2, 9, 12, 13, 1515, 21, 22, 24, 26, 27 and 29 of copending Application No. 18/915,615.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1, 2, 9, 12, 13, 1515, 21, 22, 24, 26, 27 and 29 of copending Application No. 18/915,615. That is, the cited claims of copending Application No 18/915,615 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, copending Application No. 18/915,615 recites an n-mer of the same formula and for the same construction in a capsid as the instant claims comprising Xm3Xm2Xm1RGDX1X2X3X4 wherein X4 is L and X2 is A. The remaining claims of the copending application are rejected as the applications are not divisionals of one another and therefore lack safe harbor.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the copending Application No. 18/915,615, then two different assignees would hold a patent to the claimed invention of copending Application No. 18/915,615, and thus improperly there would be possible harassment by multiple assignees.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1-10, 13, 15-24 and 27 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1, 2, 7, 10, 11, 13, 14, 16, 18 and 21 of copending Application No. 18/689,897.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1, 2, 7, 10, 11, 13, 14, 16, 18 and 21 of copending Application No. 18/689,897. Specifically, copending Application No. 18/689,897 recites that the n-mer can be Xm3Xm2Xm1RGDX1X2X3X4 wherein Xm can be 0-4 this encompassing 3 and the instant claims allow for any amino acid in this position just as the copending claims so. As well Xn can be 1-15 encompassing the 4 provided for in the instant claims. And specifically cites in copending Application No. 18/689,897 is SEQ ID NO:38, ENRRGDAQLL which meets claim 1 and 2 with X2 as Q. The remaining claims of the copending application are rejected as the applications are not divisionals of one another and therefore lack safe harbor.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the copending Application No. 18/689,897, then two different assignees would hold a patent to the claimed invention of copending Application No. 18/689,897, and thus improperly there would be possible harassment by multiple assignees.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1-10, 13, 15-24 and 27 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-3, 5, 6, 8, 9, 11, 13, 16, 19, 27, 30, 32, 34, 37, 44-46, 48, 50, 52, 57, 58, 60, 63, 66, 74, 77, 79-81, 91, 92, 93, 105 and 108 of copending Application No. 18/698,929.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1-3, 5, 6, 8, 9, 11, 13, 16, 19, 27, 30, 32, 34, 37, 44-46, 48, 50, 52, 57, 58, 60, 63, 66, 74, 77, 79-81, 91, 92, 93, 105 and 108 of copending Application No. 18/698,929. That is, the cited claims of copending Application No. 18/698,929 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, copending Application No. 18/689,897 recites that the n-mer can be Xm3Xm2Xm1RGDX1X2X3X4 wherein Xm can be 0-4 this encompassing 3 and the instant claims allow for any amino acid in this position just as the copending claims so. As well Xn can be 1-15 encompassing the 4 provided for in the instant claims. And specifically claimed in copending Application No. 18/689,897 is SEQ ID NO:708, ATARGDSREL which meets claim 1 and 2 with X3 as L. The remaining claims of the copending application are rejected as the applications are not divisionals of one another and therefore lack safe harbor.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the copending Application No. 18/698,929, then two different assignees would hold a patent to the claimed invention of copending Application No. 18/698,929, and thus improperly there would be possible harassment by multiple assignees.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1-10, 13, 15-24 and 27 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 2-37 of copending Application No. 19/390,032.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1-27 of copending Application No. 19/390,032. That is, the cited claims of copending Application No. 19/390,032 anticipate and fall entirely within the scope of the rejected claims of the instant application. Specifically, copending Application No. 19/390,032 claims XmRGDXn where Xm is 3 and Xn is 4. Also provided as SE ID NO:9125 wherein the amino acids are any without limitation (see ¶0229). The first amino acids can replace the amino acids in the capsid. The remaining claims of the copending application are rejected as the applications are not divisionals of one another and therefore lack safe harbor.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the copending Application No. 18/287,963, then two different assignees would hold a patent to the claimed invention of copending Application No. 18/287,963, and thus improperly there would be possible harassment by multiple assignees.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
AAV capsid modifications including insertion of RGD has been explored before the instant application see for example Sayroo, Gene Therapy, 2015, pages 18-25 (IDS filed 10/10/2025) and Buning, Molecular Therapy: Methods & Clinical Development Vol. 12 March 2019, pages 248-265 (IDS filed 10/10/2025).
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/MARIA MARVICH/
Primary Examiner, Art Unit 1633
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