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 amendment and response to restriction requirement of 7/14/26 is entered.
All previous claims are canceled, and Claims 9-27 are newly presented.
Formalities:
The specification as amended 6/27/24 is accepted.
The drawings as filed 6/27/24 are accepted.
The IDS filings of 8/7/24 (two filings) and references therein, have been considered. A signed copy of each is provided herewith.
Election/Restrictions
Claims 11 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/14/26.
Claims 9-10, 12-19, and 21-27 are considered with respect to the elected species (SEQ ID NO: 4). However, other species may be rejected, even though withdrawn, if realized by the Examiner, and in order to provide compact prosecution.
The drawings are objected to because Figures 2A and 5A contain sequences requiring sequence identifiers, and there are no identifiers, either in the drawing, or in the brief description thereto. See also: PTO-2301, provided herewith. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 9-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,793,861. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 9: Claim 1 of the patent teaches an AAV, comprising a DNA encoding, e.g., SEQ ID NO: 4. Further Claim 1 requires the genome to lack rep and cap genes. Claim 4 teaches the H1 promoter operably linked to the shRNA coding sequence.
Claim 10: Claim 1 teaches SEQ ID NO: 4.
Claim 11: Claim 1 teaches SEQ ID NO: 5.
Claim 12: Claim 4 teaches the H1 promoter.
Claim 13: Claim 4 teaches the H1 promoter, and Table 2 provides essential written description for the sequence comprising 966-1064 of SEQ ID NO: 20 as such promoter.
Claim 14: Claim 6 teaches a stuffer sequence (spelling error), and as part of the essential written description the stuffer sequence is placed 3’ to the promoter (e.g., Example 8).
Claim 15: Claim 6 teaches the stuffer sequence, and essential written description for such sequence is provided as SEQ ID NO: 22 (e.g., Example 8).
Claim 16: Claim 2 teaches the further presence of a pharmaceutically acceptable carrier.
Claims 17-18: Claim 3 teaches the inhibition of expression of a mutant SOD1 in a cell, by the same administration of the same composition. Claim 9 teaches similar administration of the AAV to a subject, in treating ALS, in a subject in need, the subject having mutant SOD1. The effect is necessarily present, as the steps occur.
Claim 19: Claim 9 teaches SEQ ID NO: 4.
Claim 20: Claim 9 teaches SEQ ID NO: 5.
Claim 21: Claim 4 teaches the use of the H1 promoter.
Claim 22: Claim 4 teaches the H1 promoter, and Table 2 provides essential written description for the sequence comprising 966-1064 of SEQ ID NO: 20 as such promoter.
Claim 23: Claim 6 teaches a stuffer sequence (spelling error), and as part of the essential written description the stuffer sequence is placed 3’ to the promoter (e.g., Example 8).
Claim 24: Claim 6 teaches the stuffer sequence, and essential written description for such sequence is provided as SEQ ID NO: 22 (e.g., Example 8).
Claim 25: Claim 11 teaches intrathecal administration.
Claim 26: Claim 12 teaches the administration of a contrast agent.
Claim 27: Claim 13 teaches the same specific contrast agents.
Thus, in light of the patent, the invention is obvious. The Artisan would do so, as it is claimed and/or provided as the essential written description for the claim limitations. The Artisan would expect success, as it is claimed and/or provided as the essential written description for the claim limitations.
Claims 9-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 12-29 of copending Application No. 18/028,018 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 9: Claim 1 teaches and AAV comprising a shRNA encoding DNA, the SOD1 encoding of any of SEQ ID NO: 1-14 and 16-19, the virus lacking rep and cap genes. Claim 14 teaches the H1 promoter so-operatively linked and thus must be in that order.
Claim 10: Claim 1 teaches SEQ ID NO: 4.
Claim 11: Claim 1 teaches SEQ ID NO: 5.
Claim 12: Claim 14 teaches the H1 promoter.
Claim 13: Claim 14 teaches the H1 promoter. And Table 2 teaches, as part of the essential written description for the H1 promoter, nucleotides 966-1064 of SEQ ID NO: 20.
Claim 14: Claim 15 teaches a stuffer sequence.
Claim 15: Claim 15 teaches a stuffer sequence, and as part of the essential written description the stuffer sequence is placed 3’ to the promoter (e.g., Example 8).
Claim 16: The AAV is taught for the use in the methods of delivering (e.g., Claim 18), and thus, must necessarily be in the presence of carriers including water and buffers.
Claim 17: Claim 18 teaches the delivery to subjects in need, and thus, the delivery must reduce expression of mutant SOD1 (e.g., in the essential written description as ALS being those in need).
Claim 18: Claim 24 teaches delivery to subjects with ALS, and thus, it must reduce mutant SOD1.
Claim 19: Claim 24 teaches SEQ ID NO: 4.
Claim 20: Claim 1 teaches the AAV encoding SEQ ID NO: 5, and as essential written descripotin, it is taught for treating ALS (e.g., TITLE), which necessarily then reduces mutant SOD1.
Claim 21: Claim 14 teaches the H1 promoter.
Claim 22: Claim 14 teaches the H1 promoter. And Table 2 teaches, as part of the essential written description for the H1 promoter, nucleotides 966-1064 of SEQ ID NO: 20.
Claim 23: Claim 15 teaches a stuffer sequence, and as part of the essential written description the stuffer sequence is placed 3’ to the promoter (e.g., Example 8).
Claim 24: Claim 15 teaches the stuffer sequence, and essential written description for such sequence is provided as SEQ ID NO: 22 (e.g., Example 8).
Claim 25: while administration is not specifically claimed as intrathecal, the essential written description includes intrathecal administration (e.g., Example 7).
Thus, in light of the patent, the invention is obvious. The Artisan would do so, as it is claimed and/or provided as the essential written description for the claim limitations. The Artisan would expect success, as it is claimed and/or provided as the essential written description for the claim limitations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 18-27 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.
The claims are generic for reducing SOD in a generic subject in need.
The specification only describes ALS as a subject that has mutant SOD and is in need of such treatment (e.g., TITLE, ABSTRACT, paragraphs 3, 5-10, 15-16, 37-39, 59). Antecedent basis is provided for a generic disease, but the only direct example is that of ALS (e.g., paragraph 28, 68, 76-78). In addition, the data are directed only treatment for ALS (paragraph 78 and examples in general).
The prior art only recognizes ALS as being caused by mutant SOD1 that needs to be downregulated (e.g., Kabashi, et al. (2007) “Oxidized/Misfolded Superoxide Dismutase-1: The Cause of All Amyotrophic Lateral Sclerosis?”, Annals of Neurology, 62: 553-59, ABSTRACT).
Given the great breadth of possible diseases that may be caused by SOD1 mutants, and single showing of ALS, along with a recognition in the Art of only ALS being caused by SOD1 mutants, the Artisan would not understood Applicant to have been possession of the invention as generically 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
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