DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to the communication filed 8-24-26.
Claims 208, 211-215, 217, 220-227 are pending in the instant application.
Response to Arguments and Amendments
Withdrawn Rejections/Objections
Any objections or rejections not repeated in this Office are hereby withdrawn.
New 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.
Claim 227 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the delivery and expression of circular RNA polynucleotides, does not reasonably provide enablement for the treatment and/or prevention of any diseases or conditions in a subject.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The following factors have been considered in determining that the specification does not enable the skilled artisan to make and/or use the invention over the broad scope claimed.
The breadth of the claim:
The claim is broadly drawn to a method of treating or preventing a disease, disorder or condition comprising administering an effective amount of a pharmaceutical composition to at least one eukaryotic cell of a patient in need thereof, which pharmaceutical composition comprises
a . a circular RNA polynucleotide comprising a 3' post-splicing intron sequence of a 3' group I intron fragment, (ii) an internal ribosome entry site (IRES), (iii) an expression sequence, and (iv) a 5' post-splicing intron sequence of a 5' group I intron fragment; and which expression sequence encodes a chimeric antigen receptor (CAR), and
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The teachings in the art and in the specification:
The instant specification teaches the delivery and expression of circular polynucleotides in various lipid formulations in various cells in vitro and in mice. The specification fails, however, to teach any methods of treatment or prevention for any diseases or conditions in any subject.
In light of the unpredictability associated with providing any treatments or prophylactic effects in any subject for any diseases or conditions, and since the specification fails to provide particular guidance whereby treatment or prophylactic effects are obtained in a subject, and since determination of the factors required for these are highly unpredictable, it would require undue experimentation to practice the invention over the full scope claimed. The examples provided in the specification are neither correlative nor representative of the ability to provide treatment or prophylactic effects in a subject.
For the reasons stated above, the instant rejection for lacking enablement over the full scope claimed is proper.
Allowable Subject Matter
Claims 208, 211-215, 217, 220-226 are allowed.
Conclusion
Certain papers related to this application may be submitted to Art Unit 1637 by facsimile transmission. The faxing of such papers must conform with the notices published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 C.F.R. ' 1.6(d)). The official fax telephone number for the Group is 571-273-8300. NOTE: If Applicant does submit a paper by fax, the original signed copy should be retained by applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jane Zara whose telephone number is (571) 272-0765. The examiner’s office hours are generally Monday-Friday, 10:30am - 7pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jennifer Dunston, can be reached on (571)-272-2916. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (703) 308-0196.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Jane Zara
10-1-26
/JANE J ZARA/Primary Examiner, Art Unit 1637
