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 6/16/22.
Applicant’s election of group I, claims 1-8 without traverse in the reply filed on 7/14/25 has been acknowledged. Accordingly, claims 10-11 are withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.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. The oath filed on 8/4/22 has been acknowledged.
5. 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.
6. Claims 1 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 pre-AIA the applicant regards as the invention.
The use of the term “optionally” in claim 1 renders the claim indefinite because it is unclear whether the limitations following such terms or phrases are part of the claimed invention. See MPEP 2173.05 (h).
7. 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.
8. 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.
9. Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by WO2011/080209 (IDS reference).
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.
10. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
11. Claims 1-8 are rejected under 35 U.S.C. 103(a) as being unpatentable over CN107898756 (IDS reference) in view of U.S. Pub 2006/0088523.
The ‘756 publication teaches nimotuzumab formulation comprising 15-150mg/ml antibody, 10-100mM buffer and 0.01-0.1% polysorbate (note abstract).
The disclosure of the ‘756 publication differs from the instant claimed invention in that it does not teach the use of 5-30mM of histidine buffer, 0.02-0.06% polysorbate, methionine at 30-150mM and sucrose 2-6% as in claim 1-8 of the instant application.
The ‘523 teaches the use of about 20mM of histidine at pH 6.5, polysorbate of about 0.02-0.06%, sucrose of about 250mM (claims) and use of methionine (note p. 34) stabilizes antibody and the antibody formulation includes various targets including EGFR antibody (p. 15, 21). The formulations comprising histidine, sucrose and polysorbate improve stability and reduces aggregates (p.7). Given that the combination of the references are identical to the claimed invention, the claims are expected to have a viscosity of less than 5cP and claim 8 is included in this rejection.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize formulations taught by the ‘523 publication into nimotuzumab composition taught by the ‘756 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of formulation comprising histidine, polysorbate and sucrose improve stability of antibody by reducing aggregates.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
12. Claims 1-8 are rejected under 35 U.S.C. 103(a) as being unpatentable over CN107898756 (IDS reference) in view of WO2011/080209 (IDS reference).
The ‘756 publication teaches nimotuzumab formulation comprising 15-150mg/ml antibody, 10-100mM buffer and 0.01-0.1% polysorbate (note abstract).
The disclosure of the ‘756 publication differs from the instant claimed invention in that it does not teach the use of 5-30mM of histidine buffer, 0.02-0.06% polysorbate, methionine at 30-150mM and sucrose 2-6% as in claim 1-8 of the instant application.
Teachings of the ‘209 publication have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize formulations taught by the ‘209 publication into nimotuzumab composition taught by the ‘756 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of formulation comprising histidine, polysorbate and sucrose improve stability of antibody by reducing aggregates upon physical stress.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
13. No claims are allowable.
14. 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
August 15, 2025
/YUNSOO KIM/Primary Examiner, Art Unit 1641