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 .
Status of Application/Amendment/Claims
This Office action is in response to the communications filed on April 23, 2026.
Currently, claims 73, 75-79, and 81-92 are pending in the instant application. Claims 91-92 are withdrawn from further consideration as being drawn to a nonelected invention, there being no allowable generic or linking claim. Accordingly, claims 73, 75-79, and 81-90 are under examination on the merits in the instant application.
The following rejections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Response to Arguments and Amendments
Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
Maintained Rejections
Claim Rejections - 35 USC § 112
Claims 73, 75-79, and 81-90 remain rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement for the reasons as set forth in the Office action mailed on February 13, 2026 and for the reasons stated below.
Applicant's arguments filed on April 23, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims as currently amended fully comply with the written description requirement. Contrary to applicant’s argument, the amendments introduced to each of claims 73 and 79 are not sufficient to address all of the written description issues raised in the last Office action. That is, the claims as amended do not address the reduced RPE65 protein expression in cells transfected with a vector comprising the codon-optimized sequence of SEQ ID NO:6 with hGHpA (see RPE002) compared to SEQ ID NO:1. Further, the claims as amended do not address how a vector comprising a CAG promoter operably linked to SEQ ID NO:6 and SV40pA (see RPE006 and RPE007) is representative of the structural variants having at least 98% sequence identity to SEQ ID NO:6 in view of the high level of variability/unpredictability as demonstrated in the instant application as explained in detail in the last Office action. Since the composition of claims 73, 75-79, and 81-90 is not a representative number of species within the claimed genus as currently amended, this rejection is maintained.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 86 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 86 recites that “the second polynucleotide comprises less than 300 CpG dinucleotides.” It is noted that claim 79 as currently amended require that the second polynucleotide has at least 98% sequence identity to SEQ ID NO:6, which has 10 CpG dinucleotides. Hence, the broader range of “less than 300 CpG dinucleotides” recited in claim 86 fails to further limit the subject matter of claim 79.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 86 is 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.
Claim 86 recites that the second polynucleotide that is at least 98% identical to SEQ ID NO:6 comprises “less than 300 CpG dinucleotides.” It is noted that a nucleotide sequence satisfying the at least 98% sequence identity level to SEQ ID NO:6 cannot have up to 299 CpG dinucleotides as recited in the claim. Hence, claim 86 recites structurally conflicting limitations, thereby rendering the claim indefinite.
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 DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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