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 argument of 2/3/26 are entered.
Claims 34 and 37-38 are amended.
Claims 39-56 are canceled.
Claims 57-62 are newly added.
Claims 34-38, and 57-62 are presently pending.
Claim Status, Canceled Claims
In light of the cancelation of Claims 39-56, all rejections/objections thereto, are withdrawn.
Election/Restrictions
Applicant has canceled all claims to non-elected inventions.
Claims 34-38 and 57-62 are considered with respect to the elected species: Farber disease, AAV9 capsids, and CAG promoter, herein.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(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.
In light of the amendments, the rejections of Claim(s) 34-39 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent No. 12,241,078 to Scaria, et al., are withdrawn.
To wit, the present claims require a CAG promoter that is 90% identical to SEQ ID NO: 9, and a human beta globin gene polyA that is 90% identical to SEQ ID NO: 2. While Scaria teaches to use a CAG promoter (e.g., paragraph 62), as well as poly A sequences, these particular sequences in combination with the rest, is not taught.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 34-38 and 57-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 12,241,078 to Scaria, et al.; Wu, et al. (2007) “Toward simpler and faster genome-wide mutagenesis in mice”, Nature Genetics, 39(7): 922-30; and Marotta, et al. (1974) “Nucleotide sequences of human globin messenger RNA”, Proceedings of National Academy of Science, USA, 71(6): 2300-04, as further evidenced by the attached “SEQ ID NO: 9 Comparison to Wu 2007, printed 3/2/26, and the attached “SEQ ID NO: 2 Comparison to Marotta 1974, printed 3/2/26, 6 pages long.
Claims 34-35: Scaria teaches delivering a rAAV to the CNS of a subject (e.g., Claim 1). The rAAV may encode Acid Ceramidase (e.g., Claim 8). The subject may have a Farber disease (e.g., Claim 23). Further, the specification specifically teaches the use of Acid Ceramidase with Farber disease (e.g., TABLE 1), and the Art has long recognized their linkage (Official Notice). Further, it is taught to utilize AAV2 ITRs (e.g., paragraphs 182 and 184).
Claim 36: It is taught to utilize AAV9 also: Summary of the Invention, Paragraph 5.
Claim 37-38: the coding sequence is taught to be under the control of, e.g., the CAG promoter (e.g., Claim 16).
Claim 57: Scaria teaches single stranded polynucleotides (e.g., paragraph 34).
Claims 58-59: absent reason to believe otherwise, when treating Farber disease, the effects are seen, as the structure is present.
Claim 60: IV administrations are taught (e.g., paragraph 255).
Claim 61: intrathecal injection is taught (e.g., paragraph 164).
Claim 62: several intracerebral administrations are taught (e.g., paragraph 164).
The CAG promoter is taught (e.g., Claim 16), however a CAG promoter of 90% identity to SEQ ID NO: 9 is not taught. And while the use of polyadenylation signals is recognized (e.g., Paragraph 175), the use of a BBH promoter of 90% identity to SEQ ID NO: 2 is not taught.. And the specification teaches the use of polyadenylation sequences (e.g., paragraph 107). For the record (official notice) the use of polyadenylation sequences is well known in the art.
On the other hand, the Artisan, interested in CAG promoters, would be aware of Wu for its teaching of a CAG promoter of 97.9% identity to SEQ ID NO: 9, as shown by the comparison given here by the “SEQ ID NO: 9 comparison to Wu 2007, printed 3/2/26, 4 pages long”. Further the Artisan would be aware of Marotta for its teachings of a polyA signal that is 100% identical to SEQ ID NO: 2, as shown by the comparison given here by the “SEQ ID NO: 2 Comparison to Marotta 1974, printed 3/2/26, 6 pages long.
Thus, at the time invention, it would have been obvious to utilize the sequences of Wu for the promoter and Marotta for the polyA signal. The Artisan would do so as they were known in the art as functional CAG and polyA signals. The Artisan would expect success, as the components are utilized for art-recognized purposes.
Response to Argument – 102, Scaria
Applicant’s argument of 2/3/26 is addressed, as it includes the Scaria reference.
Applicant argues that the combination of SEQ ID NO 9, SEQ ID NO: 2 (including sequences for both with 90% identity), is not taught in context with the ITRs of AAV2 and ASAHI1 ORF (p. 6).
Such is not persuasive. The structures were available in the art, for their functions required, as seen by the rejection for obviousness herein.
Applicant argues that the there is no teaching/expectation of success, for FD, and that their results show it produces greatly prolonged life expentancy and it is surprising that it would have an effect on blood cell composition and leads to stronger expression than with the PGK promoter (pp. 67, paragraph bridging).
Such is not persuasive. The examiner cannot question the validity of the patent. The patent teaches delivery of the composition (claim 1), and Farber disease (Claim 23). As such the treatment being taught, the results are obtained. As far as CAG being better than PGK, the patent claims use of the CAG promoter (Claim 16). Finally, as far as the effect on blood cell composition, and surprising results, applicant provides no evidence of surprising results, Applicant provides no evidence, but the specification states surprising that is particularly limited to the AAV9 vector, and its particular composition (p. 38, paragraph 2). Applicant has not so-limited their claims accordingly, and thus, it need not be considered at this time.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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