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, 5, 9, 15, 17, 18, 20-22, 24, 25, 27, 29, 30, 61-66 are pending upon entry of amendment filed on 11/7/25.
Applicant’s election of group I, claims 1, 5, 9, 15, 17, 18, 20-22, 24, 25, 27 and 63-66 without traverse in the reply filed on 11/7/25 has been acknowledged.
Accordingly, claims 29-30 and 61-62 are withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claim 1, 5, 9, 15, 17, 18, 20-22, 24, 25, 27 and 63-66 are under consideration in the instant application.
3. Applicant’s IDS filed on 11/29/22 and 10/20/25 have been acknowledged.
4. The oaths filed on 3/16/23 have been acknowledged.
5. The title of the invention is not descriptive. A new title is required that is clearly indicative of the inventio 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, 5, 9, 15, 17, 18, 20-22, 24, 25, 27 and 63-66 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2018/109588 (IDS reference) as evidenced by the U.S. Pat. 9,415,102 in view of WO2018/154320 (IDS reference) and U.S. Pub. 2003/124119.
The ‘588 publication teaches C5 antibody formulation (e.g. eculizumab) comprising 10-100mg of C5 antibody, 1-20mM of buffer at pH about 5 to 7.8 in the presence of sorbitol, arginine and polysorbate (claims, abstract).
As evidenced by the ‘102 patent teaches C5 antibody formulations comprising histidine, polyol and polysorbate at about pH 6-8 (col. 23) at antibody concentration of 100-200mg/ml. Further, the ‘102 patent teaches SEQ ID NO:12-14 that are identical to the claimed SEQ ID NO:10, 11 and 17, respectively and disclosed as ecrulizumab sequences (note col. 17). Given that prior art SEQ ID NO:12-14 are identical to the claimed SEQ ID NO:10, 11 and 17, the prior art SEQ ID NO:12-14 expect to comprise heavy and light chain CDRs set forth in claim 1 of the instant application.
IN addition, the ‘102 patent teaches 1-20mM of histidine, about 0.01% of polysorbate of 20 or 80, about 5% of mannitol and sorbitol (col. 21-23). Given that the identical antibody at different concentration is formulated in the same buffer, stabilizer concentration, the addition of other excipient may be applicable to ecrulizumab at broad concentration ranges.
The disclosure of the ‘588 publication differs from the claimed invention in that it does not teach the use of EDTA and acetate as in claims 1, 15, 17, 18, 20-22, 24, 25, 27 and 63-66 of the instant application.
The ‘320 publication teaches the use of 10-50mM of EDTA in the antibody formulation to reduce aggregates and improve stability with antibody at about 25mg/ml (p. 24-35).
Likewise, the ‘119 publication teaches the use of acetate buffer in the antibody formulation to reduce pain upon administration ([0094]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize EDTA and acetate buffer as taught by the ‘320 and 119 publications into the C5/ecrulizumab antibody formulation taught by the ‘588 publication evidenced by the ‘102 patent.
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 EDTA and acetate buffer improves stability and reduces pain upon administration.
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. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
10. Claims 1, 5, 9, 15, 17, 18, 20-22, 24, 25, 27 and 63-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Application No. 18/843,084.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘084 application recites a pharmaceutical composition comprising C5 antibody set forth in SEQ ID NO:10,11, and 17 in the presence of acetate buffer, EDTA and polysorbate in the presence of polyol.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
11. No claims are allowable.
12. 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
November 25, 2025
/YUNSOO KIM/Primary Examiner, Art Unit 1641