DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to filed provisions of the AIA .
2. Claims 1-8 and 10-11 are pending upon entry of amendment filed on 2/17/26.
Claims 10-11 stand withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claim 1-8 are under consideration in the instant application.
3. Applicant’s IDS filed on 12/6/22 has been acknowledged.
4. IN light of Applicant’s amendment to the claims fled on 2/17/26, the rejection under 35 U.S.C. 112(b) and 35 U.S.C. 103 (note sections 5-6 and 10-12 of the office action mailed on 8/18/25) have been withdrawn.
5. The following rejection remains.
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
7 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
8. Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by WO2011/080209 (IDS reference) for the reasons set forth in the office action mailed on 8/18/25.
The ‘209 publication teaches EGFR antibody formulations comprising histidine buffer, polysorbate, sucrose and amino acids including methionine at pH about 6 (claims). Given that the ‘209 publication teaches EGFR antibody includes nimotuzumab (p. 2) and meets the limitations of the claimed invention. The concentration of antibody includes 200mg/ml, buffering agent includes about 20mM, stabilizer of 200mM and readable upon claimed invention. The claims include lyophilized formulation of EGFR antibody formulation. In addition, the ‘209 publication teaches addition of methionine at about 25mM (p. 9) and the formulation may be lyophilized (p. 9-13). The formulation improves stability upon physical stress (p. 17).
Given that the claims are identical to the claimed invention, the claims inherently have a viscosity of less than 5cP and claim 8 is included in this rejection. Therefore, the reference teachings anticipate the claimed invention.
Applicant’s response filed on 2/17/26 has been fully considered but they were not persuasive.
Applicant has asserted that the currently amended limitations are not taught by the prior art and ‘209 publication fails to teach the viscosity of less than 5cP as required by claim 8 of the instant application.
Unlike Applicant’s assertion, the embodiment encompassed by the claims of the ‘209 publication does not comprise hyaluronidase enzyme. Given that the specific excipient concentrations and combinations are taught by the ‘209 publication are identical to the claimed formulation, the formulation would inherently have the viscosity of less than 5cP. As such, all the limitations are taught and the rejection is maintained.
9. No claims are allowable.
10. THIS ACTION IS MADE FINAL. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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, Misook Yu can be reached at 571-272-0839. 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.
Yunsoo Kim
Patent Examiner
Technology Center 1600
April 14, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
Prosecution Insights