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 1-21 are pending upon entry of amendment filed on 9/29/23.
Applicant’s election of group I, claims 1-16 without traverse in the reply filed on 6/8/26 has been acknowledged.
Accordingly, claims 16-21 are withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claims 1-16 are under consideration in the instant application.
3. Applicant’s IDS filed on 7/31/24 has been acknowledged.
4. The oaths filed on 4/23/24 have been acknowledged.
5. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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 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.
8. Claims 1-16 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2019/085902 (IDS reference) in view of U.S. Pub. 2018/0028655 and U.S. Pat. 8,460,664.
The ‘902 publication teaches antibody formulations comprising antibody that binds CemX, histidine buffer, NaCl and polysorbate at pH 5-8 (claims 31-38). The concentration of antibody is about 20mg/ml, histidine buffer at about 20mM. The antibody includes FB825 (p.2-3) and kits comprising the formulation (p. 28-29). Given that the kits comprising the container and metered administration in single-unit dosage form (note p. 19-21, 28), claims 15-16 are included in this rejection.
The disclosure of the ‘902 publication differs from the instant claimed invention in that it does not teach the use of NaCl at 50-100mM, antibody concentration at 120-200mg/ml, arginine or threonine at 1-3% as in claims 1-7 and use of SEQ ID NO:2-5 and 8-12 as in claims 11-12 of the instant application, respectively.
The ‘655 publication teaches formulating antibody in 20-1500mg/ml of antibody in 5-50mM histidine buffer, 20-150mM sodium chloride, 20-200mM of amino acid including arginine, and 1-50um of polysorbate in the absence of polyol (p.2, [0020, 0119-121]). Further, the ‘655 publication teaches use of InjectEase and multiuse syringes ([0304-0308]). Given that the InjectEase require prefilled syringes, it meets the limitations of claims 15-16. In addition, the ‘655 publication teaches use of higher concentration of antibody for subcutaneous administration and the formulation is stable at 40oC for 2 weeks (p. 2, 8, claims).
Moreover, the ‘664 patent teaches the CemX antibody set forth in claimed SEQ ID NO:2-5 and 8-12 as seen SEQ ID NO:5, 7, 8, 11 and 12. The antibody that binds CemX is known in treatment of IgE mediated disorders (note claims).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize combination of excipients with known concentrations taught by the ‘655 publication and known humanized CemX antibody set forth in ‘664 patent into the CemX antibody compositions taught by the ‘902 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 known sequences of CemX improves therapeutic efficacy in treatment of IgE mediated disorders and the known excipient combination and concentrations improve stability in formulating higher concentration of antibody.
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.
9. No claims are allowable.
10. 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.
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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
July 15, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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