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 .
An amendment was filed on 09/03/2026.
Claim Status
Claims 1, 12, 15-30 are pending in the application.
Withdrawn Rejections
The rejections of claims 1,19, 21, 24-26 and 28 under 35 USC 103 over WO 2018/209155 (Yang et al) and 35 USC 102(a)(2) over US 2-18/0256497 (Johns Hopkins University) are withdrawn in view of applicant’s amendment to the claims on 09/03/2026.
Maintained Rejection
The rejection of claims 1, 12, and 15-30 under the judicially created doctrine of obviousness-type double patenting over the claims of US Patent No. 11,883,525 are maintained in this action.
Response to Arguments
Applicant's arguments concerning the obviousness-type double patenting rejection filed 09/03/2026 have been fully considered but they are not persuasive.
This application was filed on or after September 16, 2012. The person who signed the terminal disclaimer is not the applicant, the patentee or an attorney or agent of record. See 37 CFR 1.321(a) and (b).
Applicant’s terminal disclaimer was not approved. Applicant is advised that the power of attorney is missing with regard to the person signing the terminal disclaimer. The person who signed the terminal disclaimer is not the applicant, patentee, or an attorney of record (37 CFR 1.321(a) and (b). Please file a power of attorney to the attorney or agent who is signing the terminal disclaimer, along with another copy of the terminal disclaimer form, or file a terminal disclaimer signed by the applicant. No additional fee is required for the resubmission.
New Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 29 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 29 sets out a release rate of axitinib “for at least 6 months”. This sets out an impermissible extension to drug delivery to infinity instead of a defined time period. It is suggested that applicant use the widest timeframe set out at [0054), which is 1-12 months.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
