DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s response of 01/23/2026, including replacement drawing sheets, has been received and entered into the application file.
Claims 1, 8, and 14 were amended in the claim set filed 01/23/2026.
Accordingly, claims 1, 3-4, 6-8, 11-14, 18-22, 24-25, and 28-29 are pending and under consideration.
Status of Prior Objections/Rejections
RE: Drawings
►Figures 19, 21, 23, and 25, were previously objected to for minor informalities.
The replacement drawing sheets received 01/23/2026 have obviated the basis of the prior objections. The objections of record are hereby withdrawn.
RE: Claim Objections
►Claim 8 was previously objected to for minor informalities.
The amendments to instant claim 8 have obviated the basis of the prior objection. The objection of record is hereby withdrawn.
RE: Claim Rejections - 35 USC § 112(a)
►Claims 1, 3-4, 6-8, 11-14, 18, 19-22, 24-25, and 28-29 were previously 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 amendments to instant claims 1 and 14 have obviated the basis of the prior rejection. The rejection of record is hereby withdrawn.
►Claim 8 was previously 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 amendments to instant claim 8 have obviated the basis of the prior rejection. The rejection of record is hereby withdrawn.
RE: Claim Rejections - 35 USC § 112(b)
►Claims 1, 3-4, 6-8, 11-14, 18, 19-22, 24-25, and 28-29 were previously 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.
The amendments to instant claims 1 and 14 have obviated the basis of the prior rejection. The rejection of record is hereby withdrawn.
►Claim 8 was previously 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.
The amendments to instant claim 8 have obviated the basis of the prior rejection. The rejection of record is hereby withdrawn.
New/Maintained Grounds of Objection/Rejection
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 4, 24, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 8, 11, and 18 of U.S. Patent No. 12,508,327 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
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Instant claim 1 recites “an isolated or modified nucleic acid encoding aspartoacylase (ASPA) comprising the nucleic acid sequence of SEQ ID NO: 2.”
In comparison, claims 1, 7, and 18 of patent ‘327 all recite “a nucleic acid encoding aspartoacylase (ASPA) or a functional fragment thereof, wherein the ASPA or functional fragment thereof comprises an amino acid sequence that is at least 75% identical to the sequence of SEQ ID NO: 1.” Claim 8 of patent ‘327 requires 100% identity to SEQ ID NO: 1. As shown in the alignment above, instant SEQ ID NO: 2 translates into a sequence that is 100% identical to SEQ ID NO: 1 of patent ‘327. Thus, the nucleic acid recited in patent ‘327 reads on the instantly claimed nucleic acid.
Furthermore claim 18 of patent ‘327 recites “a kit for increasing a level or activity of ASPA in a cell of a subject comprising a rAAV1 vector or a virus-like particle, wherein the virus or virus-like particle comprises a nucleic acid encoding ASPA or a functional fragment thereof, wherein the ASPA or functional fragment thereof comprises an amino acid sequence that is at least 75% identical to the sequence of SEQ ID NO: 1, and wherein the ASPA or functional fragment thereof has the enzymatic activity of aspartoacylase.” This kit is not patentably distinct from the kit recited at instant claim 29, which also requires a nucleic acid encoding ASPA or a functional fragment thereof that reads on the nucleic acid of patent ‘327, as set forth above. As set forth in MPEP § 2111.02(II), when a preamble only states a purpose or intended use for the invention, it is not considered to carry patentable weight. Thus, the kit of patent ‘327 is not patentably distinct from the kit recited at instant claim 29.
Instant claims 3 and 4 recite “a vector genome comprising the modified nucleic acid of claim 1,” and “a recombinant adeno-associated virus (rAAV) vector genome” comprising the modified nucleic acid of claim 1.
In comparison, claim 11 of patent ‘327 recites that the therapeutic “nucleic acid [encoding ASPA as set forth above] is carried on a recombinant adeno-associated virus (rAAV) vector,” which reads on the instantly claimed rAAV vector comprising a nucleic acid encoding ASPA. Thus, the rAAV vector recited in patent ‘327 reads on the instantly claimed rAAV vector as well as the broadly claimed vector genome.
Finally, with regard to instant claim 24, which recites “an isolated host cell comprising the isolated nucleic acid of claim 1” (see Examiner’s Amendment below), as set forth above, the nucleic acid of the instant application is not patentably distinct from that of patent ‘327. Therefore, given that the recited preamble of “an isolated cell” does not change the structure of the claimed product (i.e. an isolated nucleic acid) and is therefore also not patentably distinct from the nucleic acid of patent ‘327.
Therefore, instant claims 1, 3, 4, 24, and 29 are not patentably distinct from the subject matter claimed in patent ‘327.
Claims 1, 3, 4, 24, and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 10, 13, 15, and 19 of copending Application No. 19/396,542 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 1 recites “an isolated or modified nucleic acid encoding aspartoacylase (ASPA) comprising the nucleic acid sequence of SEQ ID NO: 2.”
In comparison, copending claims 1 and 13 both recite “a nucleic acid encoding aspartoacylase (ASAP) or a functional fragment thereof, wherein the ASPA or function fragment thereof…comprises an amino acid sequence at least 75% identical to the sequence of SEQ ID NO: 1.” Claims 3 and 15 require 100% identity to SEQ ID NO: 1. As shown in the alignment below, instant SEQ ID NO: 2 translates into a sequence that is 100% identical to copending SEQ ID NO: 1. Thus, the nucleic acid recited in copending application ‘542 reads on the instantly claimed nucleic acid.
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Instant claims 3 and 4 recite “a vector genome comprising the modified nucleic acid of claim 1,” and “a recombinant adeno-associated virus (rAAV) vector genome” comprising the modified nucleic acid of claim 1.
In comparison, copending claims 10 and 19 both recite that “the nucleic acid [encoding ASPA as set forth above” is carried on a recombinant adeno-associated virus (rAAV) vector,” which reads on the instantly claimed rAAV vector comprising a nucleic acid encoding ASPA. Thus, the rAAV vector recited in copending application ‘542 reads on the instantly claimed rAAV vector as well as the broadly claimed vector genome.
With regard to instant claims 24 and 29, which respectively recite “an isolated host cell comprising the isolated nucleic acid of claim 1” (see Examiner’s Amendment below) and “a kit for the treatment of Canavan disease (CD), comprising a therapeutically effective amount of an isolated nucleic acid of claim 1,” as set forth above, the nucleic acid of the instant application is not patentably distinct from that of the copending application. Therefore, given that the recited preamble of “an isolated cell” does not change the structure of the claimed product (i.e. an isolated nucleic acid) and is therefore also not patentably distinct from the nucleic acid of the copending application. Furthermore, as set forth in MPEP § 2111.02(II), when a preamble only states a purpose or intended use for the invention, it is not considered to carry patentable weight. Therefore, instant claim 29 is considered to be drawn to an isolated nucleic acid that is not patentably distinct from the nucleic acid of the copending application, as set forth above.
Therefore, instant claims 1, 3, 4, 24, and 29 are not patentably distinct from the subject matter claimed in copending application ‘542.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
EXAMINER'S AMENDMENT
An Examiner’s Amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
Authorization for this Examiner’s Amendment was given in an interview with Sarah Pollock on 03/04/2026. After leaving a voicemail message regarding amendments to instant claims 24, 25, and 28 to overcome a rejection under 35 U.S.C. § 101, Applicant’s representative left a voicemail message on 03/04/2026 authorizing an Examiner’s Amendment, as set forth below.
The application has been amended as follows:
24. (Currently Amended) An isolated host cell comprising the isolated nucleic acid of claim 1.
25. (Currently Amended) The isolated host cell of claim 24, wherein the cell is selected from the group consisting of VERO, WI38, MRC5, A549, HEK293, B-50 or any other HeLa cell, HepG2, Saos-2, HuH7, and HT1080.
28. (Currently Amended) The isolated host cell of claim 25, wherein the cell comprises at least one nucleic acid encoding at least one protein selected from the group consisting of an AAV rep protein, an AAV capsid (Cap) protein, an adenovirus (Ad) early region 1A (E1a) protein, an Ad E1b protein, an Ad E2a protein, an Ad E4 protein and a viral associated (VA) RNA.
Allowable Subject Matter
Claim 14 is allowed.
The following is an examiner’s statement of reasons for the indication of allowable subject matter:
As previously set forth, instant SEQ ID NO: 2 (recited at independent claims 1 and 14 and incorporated into all dependent claims) is free of the art, as determined by a thorough search of both the patent and non-patent literature. While further search and consideration necessitated the double patenting rejections set forth above regarding the instantly claimed nucleic acid sequence, the allowed claim requires an AAV vector that was not known in the art prior to the effective filing date of the claimed invention.
Accordingly, the claimed AAV vector comprising instant SEQ ID NO: 2 as defined at instant claim 14 is considered to be free of the art and is therefore allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 6-8, 11-13, 18, 19, 20-22, 25, and 28 are 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.
Claims 6-8, 11-13, 18, 19, 20-22, 25, and 28 all directly or indirectly depend from instant claim 1, which stands rejected under non-statutory double patenting, as set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sarah E Allen whose telephone number is (571)272-0408. The examiner can normally be reached M-Th 8-5, F 8-12.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at 571-272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH E ALLEN/Examiner, Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637