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 .
WITHDRAWN REJECTIONS
Claims 19-20 and 22-23 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 enablement requirement.
The rejection is withdrawn following claim cancellation of claims 19-20 and amendments to claims 22-23.
MAINTAINED REJECTIONS
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 6 and 8 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.
Claim 6 requires:
“The variant of claim 1, wherein the capsid protein comprises an amino acid sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 2
This claimed composition encompasses polypeptides comprising ≥95% identity to SEQ ID NO: 2.
Applicant’s claims do not provide support for all amino acids comprising ≥95% identity to SEQ ID NO: 2. The specification as filed does not provide sufficient evidence that Applicants were in possession of the full scope of the claimed invention at the time of filing of the instant invention. As such, >95% identity to a 736 amino acid polypeptide encompasses
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polypeptides, if only substitutions were considered. However, the claim wording encompasses deletions, insertion mutations as well. This amounts to enormous number of polynucleotides which do not have support in the specification. The specification also does not provide any guidance on how or where the amino acids need to be changed, to preserve function. The specification also did not provide sufficient guidance or predictive structure-function relationships to distinguish operative form in operative variants across full scope of the claims. It is clear that the vector of the invention was restricted to SEQ ID NO: 2. For example, see instant specification at [0043]-[0045].
Thus, Applicants were not in possession of the full scope of the claimed invention at the time of filing of the instant invention.
Similar rejection applied to claim 8 which encompasses twice number of polypeptides as position 178 is the wild card amino acid.
Response to Applicant arguments
Applicant argued that because claim 1 fixes the variable region motifs the claims encompass a substantially smaller genus than originally calculated. Applicant’s arguments have been considered but are not found persuasive.
It is acknowledged that incorporation of the limitations of claim 1 narrows the claim genus relative to capsid sequence having unrestricted variability across all amino acid positions. However, the written description inquiry is not resolved merely because the claimed genus is smaller. Rather the issue whether the specification reasonably conveys possession of the full scope of the claimed genus. Although the specification identifies specific VR motifs, it does not describe representative backbone variants comprising at least 95% identity to SEQ ID NO: 2, nor does it identify which backbone residues may be modified while maintaining the claimed properties of a capsid of AAV3B adenovirus. The specification contains no mutagenesis analysis, no conservative amino acid substitution guidance, no structure-function correlation for the non-VR residues, and no representative species spanning the claimed genus.
Applicant further argued that the AAV capsid backbone functions as a conserved structural scaffold and therefore backbone variation would not disrupt the functional properties attributable to the recited VR motifs. However, the specification does not disclose such a structure-function correlation or experimental evidence demonstrating that the variants throughout the claimed backbone retain the claimed properties.
Allowable Subject Matter
Claims 1-5, 7, 10, 12, 15-16, 18, 22-23, 25-26 appear to be directed to allowable subject matter. The following is a statement of reasons for the indication of allowable subject matter: from the sequence search, the sequences recited in claim 1 appear novel and unobvious over prior art.
THIS ACTION IS MADE FINAL. 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 JAGAMYA VIJAYARAGHAVAN whose telephone number is (703)756-5934. The examiner can normally be reached 9:00a-5:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher M. Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAGAMYA NMN VIJAYARAGHAVAN/ Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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