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 .
Election/Restrictions
Applicant’s election without traverse of Group III (claim 10) in the reply filed on 09/03/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-8 and 10 are pending; Claims 1-8 are withdrawn from prosecution for being drawn to non-elected subject matter. Claim 10 is examined.
Drawings
The drawings are objected to because the text of the figures is barely readable, if at all. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosen et al. (U.S. Pub. No. 20050186664- cited by Applicant).
The reference discloses an albumin fusion protein, and the structure thereof is: R1-L-R2; or R2-L-R1; wherein R1 is a therapeutic protein, L is a peptide linker, R2 is albumin, and the therapeutic protein is IL-2 (see claims 1-5, and description, paragraphs 48, and table 2 in paragraphs 55, 56 and 59, and sequence listing), and the amino acid sequences thereof are respectively SEQ IN NOs: 242, 243, 258, 259 and 293. By comparison, positions 158-742 of SEQ ID NO: 242, positions 25-609 of SEQ ID NO: 243, positions 158-742 of SEQ ID NO: 258, positions 25-609 of SEQ ID NO: 259, and positions 154-738 of SEQ ID NO: 293 are 100% identical to SEQ ID NO: 9 of the present application; positions 25-157 of SEQ ID NO: 242, positions 610-742 of SEQ ID NO: 243, positions 25-157 of SEQ ID NO: 258, positions 610-742 of SEQ ID NO: 259, and positions 21-153 of SEQ ID NO: 293 are 100% identical to SEQ ID NO: 10 of the present application; positions 25-742 of SEQ ID NO: 259 are 100% identical to SEQ ID NO: 1 of the present application; and positions 25-742 of SEQ ID NO: 258 and positions 21-738 of SEQ ID NO: 293 are 100% identical to SEQ ID NO: 3 of the present application. The IL-2 mature peptide sequence can be fused directly to the N- or C-terminus of albumin. The reference further discloses composition comprising an albumin fusion protein and a pharmaceutically acceptable carrier, and discloses that diseases regulated by IL-2, i.e. cancers can be treated.
Thus claim 10 is anticipated by the instant reference.
Conclusion
The claim is not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647
