DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-18 are pending upon entry of amendment filed on 8/29/25.
Applicant’s election of group I, claims 1-11 and 15-18 without traverse in the reply filed on 9/25/25 has been acknowledged.
Accordingly, claims 12-14 are withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claim 1-11 and 15-18 are under consideration in the instant application.
3. Applicant’s IDS filed on 8/29/22 has been acknowledged.
The non-English foreign patent documents have been considered to its English abstract. English translation is required if further consideration is needed.
4. The oath filed on 8/29/22 has been entered.
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, 4, 6, 8, and 9 are 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 terms “fragment thereof” or “antibody fragment thereof”, renders the claim indefinite because the fragment or antibody fragment may include Fc that does specifically not bind to OX40-antagonist. As such, applicant is advised to amend to “antigen binding fragment thereof” for consistency.
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, 7, 11, 15-16 and 18 is/are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by WO2013/008171.
The ‘171 publication teaches anti-OX40 antagonist antibody pharmaceutical compositions in the presence of buffer comprising histidine, EDTA and/or polysorbate (p. 48). Further, the ‘171 publication teaches administration of antibody via intravenously, subcutaneously (p. 55) and the article of manufacture (p. 55). Claims 7, 16 and 18 are included in this rejection as the claim 1 including any tonicity agent or stabilizing agent would inherently exhibit stability set forth in claims 7 and 16 and the dosage ranges of 0.01-10mg/kg would include concentration ranges set forth in claim 18. Given that the administration method includes intravenous which require liquid pharmaceutical composition, it meets the limitation of claim 1 of the instant application (p. 48, sterile injectable solution). 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 1-11 and 15-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2013/008171 in view of U.S.Pub 2016/0355597.
The teachings of the ‘171 publication have been discussed, supra.
The disclosure of the ‘171 publication differs from the instant claimed invention in that it does not teach the specific concentration of histidine buffer, sucrose at about 2-6% and polysorbate at about 0.0005-0.05% at pH 5.5-6.5 as in claims 2-6 and concentration of antibody around 100-200mg/ml as in claim 9 of the instant application.
The ‘597 publication teaches the use of histidine, acetate buffer at 1-50mM, polysorbate about 0.02% and sucrose at about 200-300mM at pH 5-6 (p. 37-38) in OX40 antibody formulation to stabilize and the formulation is suitable for lyophilization. The reconstituted antibody would be upto 200mg/ml and the formulation improves stability (p. 39).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to the excipients and composition concentrations as set forth in ‘597 publication into the OX-40 antagonist compositions taught by the ‘171 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the excipient combination and the concentration of the antibody adds stability and reduce aggregates of the antibody formulation.
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. No claims are allowable.
13. 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.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
October 7, 2025
/YUNSOO KIM/Primary Examiner, Art Unit 1641