Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claim status
Claims 1, 2, 6, 9, 14, 21, 22, 26, 27, 33, 39-43, 46 and 47 are pending
Claims 21, 22, 26, 27, 33, 39-43, 46 and 47 are withdrawn
Claims 1, 2, 6, 9, and 14 are under examination
Election/Restrictions
Applicant’s election of the following invention in the reply filed on 8/10/2026 is acknowledged.
Applicant's election with traverse is acknowledged. The traversal is on the ground(s) that the Examiner has mischaracterized the cited prior art of Gradinaru et al. (WO2020/210655).
This is not found persuasive because the examiner was able to provide art which satisfied the limitations of the product of group I, thereby demonstrating that the special technical feature lacks novelty. Therefore, a lack of unity exists between the restricted groups.
The requirement is still deemed proper and is therefore made FINAL.
Group I, claims 1, 2, 6, 9, and 14, drawn to a viral capsid comprising a targeting moiety.
Claims 21, 22, 26, 27, 33, 39-43, and 47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable linking claim.
Applicant’s election of the following species is acknowledged.
Applicant elects the targeting moiety comprising the amino acid sequence of SEQ ID NO:1 (NNSTRGG).
Rejoinder
The targeting moiety of SEQ ID NO:1 (NNSTRGG) is free of the prior art.
SEQ ID NO:282 (TNGTKPT) and SEQ ID NO: 333 (PNTIRNV) are rejoined.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/19/2024 and 3/29/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objections to the Specification
Hyperlink
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (p. 34, [0120], p. 35, [0120]. Applicant is required to amend or delete the embedded hyperlink and/or other form of browser-executable code. For example, “www” can be replaced with “world wide web” as the URL code. See MPEP § 608.01.
Color Figures
The disclosure is objected to because of the following informalities: p. 10, [0047] in reference to Figure 12A, p. 12, [0051] in reference to Figure 17D, describe elements in the figures with colors (e.g., red and blue). However, Applicant has not submitted drawings executed in color.
Furthermore, Applicant is reminded that color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 6 is objected to because of the following informalities: instant claim is directed to the n-mer motif of SEQ ID NOs: 1-3, and 6-1099. However, many of these SEQ ID NOs are duplicates. For example, SEQ ID NO:1 (NNSTRGG) is also SEQ ID NOs: 281, 639, 849 and 970, or SEQ ID NO: 333 (PNTIRNV) is also SEQ ID NOs: 679, 865, and 1022. These are just illustrative examples and are not intended to be a comprehensive list of all the duplicate SEQ ID NOs claimed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
(Written Description)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 6, 9, and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 1 encompasses a genus of compositions capable of increasing transduction of endothelial cells of the CNS comprising any targeting moiety comprising the claimed X1-N-X3-X4-K/R-X6-X7 motif, wherein when X5 is K, X1, X3, X4, X6 and X7 are independently selected from any amino acid, or wherein when X5 is R, X3 is R, N, D, C, E, Q, G, H, I, L, K, M, F, P, S, T, W, or V, and X1, X3, X4, X6 and X7 are independently selected from any amino acid, optionally, wherein the overall charge of the n-mer motif at neutral pH is between 0 and + 2, and wherein the targeting moiety is part of a viral capsid protein, while the specification discloses a limited number of such targeting motifs that achieve the claimed function and where the targeting moiety is inserted in specific locations of a AAV capsid.
Dependent claim 2, encompasses a genus of compositions wherein the X1, X3, X4, X6, and X7 positions of the targeting moiety are further limited to a subgenus of amino acids, while the specification discloses a limited number of such targeting motifs that achieve the claimed function and where the targeting moiety is inserted in specific locations of a AAV capsid.
Dependent claim 6, encompasses a genus of compositions wherein the targeting moiety are further limited to a subgenus of SEQ ID NOs:1-3, and 6-1099, while the specification discloses that the targeting moiety is inserted in specific locations of a AAV capsid in order to achieve the claimed function.
Dependent claim 9, encompasses a genus of compositions wherein the targeting moiety is further limited to being part of an AAV capsid, while the specification discloses a limited number of such targeting motifs that achieve the claimed function and where the targeting moiety is inserted in specific locations of a AAV capsid.
Dependent claim 14, encompasses a genus of compositions wherein the cargo that is coupled to or otherwise associated with the targeting moiety includes a genus of polynucleotides, polypeptides and ribonucleoprotein complexes, while the specification discloses that the targeting moiety is inserted in specific locations of a AAV capsid that carry a polynucleotide cargo in their genome.
Under the written description guidelines (see MPEP 2163) the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
ACTUAL REDUCTION TO PRACTICE
In regard to instant claims encompassing a genus of compositions capable of increasing transduction of endothelial cells of the CNS comprising any targeting moiety comprising the claimed X1-N-X3-X4-K/R-X6-X7 motif variants, at any position in any viral capsid, associated with any type of cargo, the specification discloses a limited number of such compositions that are capable of achieving the claimed function.
Specifically, Applicant has screened a capsid library of AAV9 variants comprising different 7-mer targeting moieties between positions 588 and 589 of the VP1 capsid protein in mice and marmosets in vivo and human brain endothelial cells in vitro, and characterized the AAV9 targeting moieties that were capable of increasing transduction of the brain endothelium (Example 1). Applicant discloses that targeting moieties corresponding to SEQ ID NOs:1-3, and 6-1099 were capable of increasing transduction of the brain endothelial cells (Tables 1-7). In regard to the cargo associated with the targeting moieties, Applicant discloses that AAV9-Express vector system was used that carry a polynucleotide encoding a GFP reporter in their genome.
Accordingly, Applicant did not demonstrate the full genus of compositions that would be capable of increasing transduction of endothelial cells of the CNS comprising 1) any targeting moiety comprising the claimed X1-N-X2-X3-X4-K/R-X6-X7 motif variants, 2) inserted anywhere in any viral capsid, and 3) could do so with the polypeptide or ribonucleoprotein complex cargo claimed, nor did Applicant adequately set forth in terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention (e.g., rational approach to making such substitutions in amino acid sequence of the targeting motifs) that are sufficiently detailed to show that Applicant was in possession of the claimed genus of compositions.
DISCLOSURE OF STRUCTURE
The Applicant has provided a limited genus of compositions comprising 1) a specific targeting moiety comprising the claimed X1-N-X2-X3-X4-K/R-X6-X7 motif variants according to SEQ ID NOs:1-3, and 6-1099, 2) inserted between positions 588 and 589 of an AAV9 VP1 viral capsid, and 3) carrying a polynucleotide cargo in their genome. Certainly, with the help of computer and viral expression system, a skilled artisan could begin to make the genus of compositions comprising an engineered 7-mer targeting motif, albeit the size of the claimed genus even with two fixed positions is 205th (i.e., about 3 million variants). However, the prior art is silent with respect to full genus of engineered targeting motifs comprising the claimed X1-N-X2-X3-X4-K/R-X6-X7 motif variants. Furthermore, neither the specification nor the art indicate a relationship between the structure of the claimed genus of compositions comprising engineered targeting motifs comprising the claimed X1-N-X2-X3-X4-K/R-X6-X7 motif variants and the ability to increase transduction of brain endothelial cells.
SUFFICIENT RELEVANT IDENTIFYING CHARACTERISTICS
As mentioned above, the prior art is silent to modifications that can be made in claimed X1-N-X2-X3-X4-K/R-X6-X7 motif variants and yet retain the ability to increase transduction of brain endothelial cells. Nevertheless, Applicant discloses that targeting moieties corresponding to SEQ ID NOs:1-3, and 6-1099 were capable of increasing transduction of the brain endothelial cells (Tables 1-7), and based on the sequence homology of the sequences Applicant has proposed a targeting motif of X1-N-X3-X4-K/R-X6-X7 (N2KR5). Applicant goes on to describe that the overall charge of the targeting moiety is 0 or +1, with a lesser number of variants with an overall charge change of +2 (Example 1, Fig. 2). Finally, Applicant limits the genus of positions for X1-X7 to a subgenus of about 9 or 10 amino acids each to as few as 2 amino acids each. It must be noted in regard to the later subgenus that none of the peptides claimed as having an X1 as K or R, and X2, X3, X4, and X7 as D or E were demonstrated by Applicant as having the claimed function.
The breadth of the claims encompass a genus of compositions claimed genus of compositions comprising that would be capable of increasing transduction of endothelial cells of the CNS comprising 1) any targeting moiety comprising the claimed X1-N-X2-X3-X4-K/R-X6-X7 motif variants, 2) inserted anywhere in any viral capsid, and 3) could do so with the polypeptide or ribonucleoprotein complex cargo claimed, yet the present specification provides no guidance nor description which modifications would result in the functional targeting moiety as broadly as claimed, therefore the skilled artisan would not know what rational approach to take to make the genus of engineered targeting moieties with any predictable outcome on function. Therefore, it is incumbent on the applicant to provide this nexus between structure and function, in order to be given credit for possession of the claimed genus of compositions.
An applicant may show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613.
STATE OF THE ART & QUANTITY OF EXPERIMENTATION
The method of making the claimed invention is not well established. Although the screening methods for targeting motifs in AAV vectors for the transduction of endothelial cells was known in the state of the art, one of skill in the art would neither expect nor predict an appropriate function of the genus of compositions as broadly as claimed.
For example, Zhang et al. (Human Gene Therapy, 2019, 30:1284-1296) teach that is was known to screen 7-mer targeting moieties inserted between positions 587 and 588 of the AAV2 VP1 capsid, however Zhang does not identify any targeting motifs according the claimed genus of X1-N-X2-X3-X4-K/R-X6-X7 motif variants. In fact Zhang arrives at an entirely different set of peptides that do not conform to the claimed motif (see Figure 2), and goes on to demonstrate that these positions are exquisitely sensitive to change, wherein the alteration of one or two amino acid position can eliminate endothelial cell transduction. Zhang warns that isolation of AAV variants form transduced endothelial cells may indicate successful viral cell entry; however, it does not indicate the ability of the mutants to reach the nucleus (p. 1289, 1st para.). Zhang also cautions that AAV efficiency is influenced not only by the specific peptide insertion, but also the cell surface receptor binding the engineered capsid (which Applicant has NOT disclosed), and/or the respective downstream signaling pathways activated on binding of this engineered capsid to the endothelial cell surface (p.1294, Discussion, 2nd para.).
Furthermore, the prior art of Gradinaru et al., (WO2020/210655, filed 4/10/2020, published 10/15/2020, now US Patent 12,644,131, see IDS filed 1/19/2024) teaches a targeting moiety that is encompassed by the claimed genus of X1-N-X2-X3-X4-K/R-X6-X7 motif variants, but does not increase transduction of brain endothelial cells. Specifically, Gradinaru teaches the 7-mer QNTKGV targeting moiety inserted between positions 588 to 589 of the VP1 capsid of AAV9 that does not increase the transduction of endothelium in the mouse brain (see Fig. 65 excerpt below, right panel). These data can be compared to Applicant’s Fig. 6, which demonstrates clear brain endothelial transduction with the 7-mer NNSTRGG (SEQ ID NO:1) targeting moiety inserted between positions 588 to 589 of the VP1 capsid of AAV9.
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Thus, the closest prior art provides no guidance as to which substitution could be made in the claimed genus of X1-N-X2-X3-X4-K/R-X6-X7 motif variants, but still is capable of increasing transduction of brain endothelial cells.
Finally, in regard to the genus of cargo as per claim 14, as state supra, there is no description of the targeting moiety in any type of viral capsid beyond an AAV capsid as being able to increase the transduction of an endothelial cell. Furthermore, although AAV capsids were well known to be indirectly associated with cargo such as polynucleotides, the transduction of polypeptides and ribnucleoprotein complexes have not been predictably described in state of the art. For example, the post-filing art of Hoffmann et al. (BioRxiv, posted 8/14/2024) reviews AAV particles as protein carriers, and discloses that although AAV is widely used for efficient delivery of DNA cargo, the delivery of protein (or ribonucleoprotein) payloads is unexplored. Hoffman evidences at the time of filing, there were limited means to incorporate a protein payload and it was not discovered until after the time of filing that “nanobodies” could be used to deliver some protein payload. However, these “nanobodies” red-direct the tropism of the AAV (p. 2 of Introduction). Thus, the state of the art at the time of filing for generating a genus of compositions comprising the claimed targeting moiety, even when incorporated into the claimed insertion sites of the AAV capsid was not well established for delivering a polypeptide or ribonucleoprotein cargo.
Applicant has claimed a genus of compositions capable of increasing transduction of endothelial cells of the CNS comprising 1) any targeting moiety comprising the claimed X1-N-X2-X3-X4-K/R-X6-X7 motif variant, 2) inserted anywhere in any viral capsid, and 4) could do so with the polypeptide or ribonucleoprotein complex cargo claimed, yet the specification has disclosed (1) a limited number of targeting moiety SEQ ID NOs, (2) that are inserted in specific positions in an AAV capsid, and are (3) associated with polynucleotide cargo, and has not set forth in terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention (e.g., structural studies through crystallography or molecular modeling) that are sufficiently detailed to show that Applicant was in possession of the claimed a genus of compositions comprising a targeting moiety that is capable of performing the claimed function. It is well known that there is limited tolerance to random amino acid changes in targeting moiety of AAV particles, and limited cargo they can predictably carry, therefore the state of the art indicated that making the claimed genus of targeting moieties was not well established with the claimed function for increasing transduction of endothelial cells of the CNS, and would require undue experimentation, and one of skill in the art would neither expect nor predict the claimed function and cargo according to the claimed a genus of compositions.
CONCLUSION
Therefore, the Examiner concludes that there is insufficient written description of the instantly claimed genus of compositions comprising that would be capable of increasing transduction of endothelial cells of the CNS comprising 1) any targeting moiety comprising the claimed X1-N-X2-X3-X4-K/R-X6-X7 motif variants, 2) inserted anywhere in any viral capsid, and 3) could do so with the polypeptide or ribonucleoprotein complex cargo claimed. Specifically, there is limited description of the structure-function relationship between the claimed genus of compositions and their ability to achieve the claimed function, and the Examiner further concludes a skilled artisan would find the specification inadequately describes the claimed genus of compositions.
Claim Rejections - 35 USC § 112(b)
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 1, 2, 6, 9, and 14 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 1 recites the limitation that the targeting moiety is effective at “increasing transduction” of endothelial cells. A claim may be rendered indefinite where a claim limitation is defined relative to an object whose characteristics are variable (see MPEP 2173.05(b), II). Specifically, the phrase “increasing transduction” is a relative term which renders the claim indefinite. The phrase "increasing transduction" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 2, 6, 9, and 14 are included in the basis of this rejection because they do not clarify what the increase is relative to.
Claim 2 recites the limitation that the X1, X3, X4, X6, and X7 positions of the targeting moiety are independently selected from a genus of groups in regard to Claim 1. There is insufficient antecedent basis for this limitation in the claim because Claim 1 is directed to a targeting moiety that splits the genus of X1, X3, X4, X6, and X7 positions in terms of the X5 position being K or R, thereby rendering Claim 2 indefinite as to the X1, X3, X4, X6, and X7 positions as being directed to the X5 position as being K or R.
Claim 9 recites the limitation "the targeting motif" in regard to Claim 1. There is insufficient antecedent basis for this limitation in the claim because Claim 1 is directed to a “targeting moiety” and “n-mer motif”, but not a “targeting motif” thereby rendering Claim 9 indefinite.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 6, 9, and 14 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Gradinaru et al., (WO2020/210655, filed 4/10/2020, published 10/15/2020, now US Patent 12,644,131, see IDS filed 1/19/2024)
Overcoming Rejection by Declaration under 37 CFR 1.130
Gradinaru et al., (WO2020/210655, filed 4/10/2020, published 10/15/2020) and instant application have a common inventor. Applicant may rely on the exception under 35 U.S.C. 102(b)(1)(A) to overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore not prior art under 35 U.S.C. 102(a)(1) . Alternatively, applicant may rely on the exception under 35 U.S.C. 102(b)(1)(B) by providing evidence of a prior public disclosure via an affidavit or declaration under 37 CFR 1.130(b).
In regard to claims 1, 2, 6, and 9, Gradinaru claims an AAV capsid comprising SEQ ID NO:10424 (PNTIRNV) inserted between amino acid positions 558 and 589 of AAV9 (i.e., SEQ ID NO: 1) (see Claim 1 of Gradinaru and p. 6 of Fig. 33), which is identical to SEQ ID NO:333 of instant claims. Although she is silent to this 7-mer increasing transduction of endothelial cells of the CNS, this is an inherent feature of the AAV particle of Gradinaru.
In regard to claim 14, Gradinaru claims the AAV capsid is to treat a disease or conditions of the CNS (see claim 14 of Gradinaru), and she goes on to explain this is done so by including a cargo associated with the AAV capsid and targeting moiety (i.e., transgene therapy), which is a polynucleotide encoding a therapeutic protein [0101, 0152-0156, 0206],
Accordingly, Gradinaru anticipates instant claims.
Claims 1, 2, 6, 9, and 14 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Sah et al., (WO2020/028751, filed 8/02/2019, published 2/06/2020)
In regard to claims 1, 2, 6, and 9, Sah claims an AAV capsid comprising SEQ ID NO:11888 (TNGTKPT) inserted between amino acid positions 558 and 589 of AAV9 VP1 (i.e., SEQ ID NO: 2) (see Claims 1 and 6 of Sah and p. 288 of Table 2), which is identical to SEQ ID NO:282 of instant claims. Although she is silent to this 7-mer increase transduction of endothelial cells of the CNS, this is an inherent feature of the AAV particle of Sah.
In regard to claim 14, Sah claims the AAV capsid is part of an AAV particle comprising a cargo associated with the AAV capsid and targeting moiety, which is an RNAi oligonucleotide (see Claims 9-12 of Sah).
Accordingly, Sah anticipates instant claims.
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 obviousness-type 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
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, 6, 9, and 14 are rejected on the grounds of nonstatutory double patenting over claims 1, 3-6, 8-12 of U.S. Patent No. 12,644,131 (Gradinaru et al., Patented 6/02/2026).
The subject matter claimed in the instant application is fully disclosed in the referenced patent as follows the AAV composition comprising the targeting moiety of SEQ ID NO:10424 (PNTIRNV) from Fig. 33 of cited patent anticipates the AAV comprising the targeting moiety of SEQ ID NO: 333 of instant application claims 1, 2, 6, and 9. In regard to claim 14, Gradinaru claims the AAV capsid is to treat a disease or conditions of the CNS (see claim 11 of Gradinaru), and she goes on to explain this is done so by including a cargo associated with the AAV capsid and targeting moiety (i.e., transgene therapy), which is a polynucleotide encoding a therapeutic protein. It is clear that all the elements of the cited patent claims are to be found in instant claims. The difference between the cited patent claims and the instant claims lies in the fact that the cited patent claims are much more specific. Thus the invention of said claims of the cited patent are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by over cited patent claims, said claims are not patentably distinct.
Provisional Double Patenting
Claims 1, 2, 6, 9, and 14 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 8, 10, 17 of copending Application No. 18/791,629. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the AAV composition comprising SEQ ID NO: 17 (ENHTRKD), SEQ ID NO: 18 (GNDTRST) and SEQ ID NO: 21 (VNTVREF) of cited application anticipates the composition of instant application claims. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
Claims 1, 2, 6, 9, and 14 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 20-34 of copending Application No. 19/288,927. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the AAV composition comprising SEQ ID NO: 1-3 of cited application anticipates the composition of instant application claims. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/ Examiner, Art Unit 1631
