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 .
Receipt and entry of the response dated 11/17/2025 is acknowledged.
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 1, 4-6, 8, 12, 16-20 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. This rejection is maintained for reasons made of record in the Office Action dated 6/18/2025 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive. Applicants essentially assert that: 1) the claims have been amended to recite the construct comprises integration signals; 2) the claims have been amended to recite a specific S/MAR element by a SEQ ID NO: and length, and the figures and examples provide the use of such in an expression vector.
Regarding 1), it is stipulated that specific integration signals, including those found in the instant specification, were known and characterized in the relevant prior art. However, this rejection is based on the combination of such signals with a generic S/MAR element in order to provide integration and increased expression as required by the claims.
Regarding 2), as best understood the claimed S/MAR element need only comprise 12 specific nucleotides in an element ranging from 100 to 200 residues; that is, SEQ ID NO: 1 is “ATTA” and only three such four-residue repeats need be present in the S/MAR element. The remaining 88-188 nucleotides can be any nucleotide. To put the situation in perspective, the number of possible nucleotide sequences of 88 residues in length is 488 (approx. 1052). Thus, even a simple analysis of the claimed SEQ ID NO: 1 repeat held to a consecutive repeat, “ATTAATTAATTA”, would represent a claimed genus including 1052 possible S/MAR elements. Although the specification discusses in generic, prophetic terms that the claimed S/MAR element need only comprise three repeats of SEQ ID NO: 1, it does not reduce any such specific sequence to practice, let alone a reasonable number of species to provide support for the claimed genus. The working examples and figures are of no help in this instance because these do not disclose the specific S/MAR element used in the working examples or figures, thus, it cannot be determined what the exact sequence of the functional S/MAR element might be. For example, it cannot even be determined if the functional S/MAR falls within the claimed genus of elements comprising the three repeats of SEQ ID NO: 1.
Conclusion
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.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638