DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 142-161 are pending as amended 11/13/23, and are considered herein.
Formalities
The specification of 11/13/23 is accepted.
The drawings of 1/30/23 are accepted.
The IDS filings of 5/31/23 (2 IDS filings of same date) and references therein are considered herein, and a signed copy of each IDS is provided herewith.
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 142-161 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,566,263. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 142: Patent Claim 1 teaches treating a subject by contacting a retina with viral vectors encoding similar first and second gRNAs to first and second sides of the CEP290, the dosage is applied at a concentration of 1E11 to 9E13 vg/mL.
Claim 143: Claim 2 teaches the same Markush of concentrations added as presently claimed.
Claim 144: Claim 3 teaches LCA-10.
Claim 145: Claim 4 requires AAV vectors.
Claim 146: Claim 5 requires AAV5 vectors.
Claim 147: Claim 1 teaches the first being different from the second cellular nucleic acid sequence.
Claim 148: Claims 6-9 teach embodiments requiring a sequence of SEQ ID NO: 1-3 paired with a sequence of SEQ ID NO: 4-6.
Claim 149: Similar to the relation of present Claim 142 to Patent Claim 1, the present claim (Claim 149) is taught in Patent Claim 10.
Claim 150: Claim 11 teaches all the same embodiments of the Markush of concentrations of administered composition.
Claim 151: Claim 12 teaches the subretinal space.
Claim 152: Claim 13 teaches LCA-10.
Claim 153: Claim 14 teaches AAV vectors.
Claim 154: Claim 15 teaches AAV5 vectors.
Claim 155: Similar to the relation of present Claim 142 to Patent Claim 1, the present claim (Claim 155) is taught in Patent Claim 19.
Claim 156: Claim 20 teaches the same Markush of concentrations.
Claim 157: Claim 26 teaches LCA-10.
Claim 158: Claim 27 teaches AAV vectors.
Claim 159: Claim 28 teaches AAV5 vectors.
Claim 160: Claim 1 teaches for the same type of modifications, the sequences may be different.
Claim 161: Claims 22-25 teach pairings of a sequence of SEQ ID NO: 1-3 paired with a sequence of SEQ ID NO: 4-6.
Thus, in light of the patent, the invention is obvious. The Artisan would make the invention, and expect success, as it is claimed.
Claims 142-147 and 149-154 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-117 of U.S. Patent No. 11,667,603. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 142: Claim 1 teaches treating LCA in a subject by administration to the eye, an AAV comprising a first gRNA for a first domain on CEP290, a second gRNA to a second domain, and a Cas9 molecule. The AAV5 is administered at 6E11, 1E12, or 2E12 vg/mL concentration, and it alters a position in the gene. Necessarily the two gRNAs target a position on either side of a target position, and are different, because the gene does not copy itself in reverse with a PAM sequence so spaced to allow the cleavages.
Claim 143: 6E11, 1E12 and 2E2 are all taught (e.g., Claims 1 and 17-19).
Claim 144: Claim 1 teaches LCA-10.
Claim 145-146: Claim 1 teaches an AAV5 vector.
Claim 147: As addressed above, the gene is not known to repeat itself in reverse, with properly located PAM sites, so the sequences are different.
Claim 149: As shown above, Claim 1 teaches the same method, and the result of an altered retinal cell is thus, presumed. Claim 20 also parallels Claim 1, with an NHEJ alteration being made.
Claim 150: 6E11, 1E12 and 2E2 are all taught (e.g., Claims 1, 17-19 and 20).
Claim 151: Claims 4, 23, 42, and 60 teach retinal administration, in which the specification teaches subretinal administration as essential written description administration to a retina (e.g., paragraphs 4, 9, 11, 17, 19, 20, 1038, 1102, 1104, 1141-1145, 1273, 1281, and 1282).
Claim 152: e.g., Claim 1 teaches LCA10.
Claim 153: AAV vectors are taught (e.g., Claim 1).
Claim 154: AAV5 vectors are taught (e.g., Claim 1).
Thus, in light of the patent, the invention is obvious. The Artisan would make the invention, and expect success, as it is claimed.
Claim Rejections - 35 USC § 112
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 142-146, 148-159, and 161 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As seen by non-rejected Claims 147 and 160, the claims are necessarily generic for the first and second cellular nucleic acid sequences being the same sequence.
The specification does not teach a single embodiment where the gRNA sequences targeting the same sequence can be adapted to cleave on two different sides of a site.
In fact, to do so, the sequence would require an inverted repeat, as 3’-5’ remains for each gRNA. There are no known sequences in the art, where a PAM is spaced and intervening sequences are met, for the claimed Cas9 molecules, or for any CRISPR molecule.
Thus, the Artisan would not have understood Applicant to have been in possession of the invention as claimed.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638