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 1-19 are pending upon entry of amendment filed on 1/21/26.
Claims 11, 13, 14 and 18 stand withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claims 1-10, 12, 15-17 and 19 are under consideration in the instant application.
3. In light of Applicant’s amendment to the claims filed on 1/21/26, the rejection under 35 U.S.C. 112(b) and 35 U.S.C. 102 (a)(1) and (a)(2)(see sections 5-6, 8-9 of the office action mailed on 9/22/25) has been withdrawn.
4. The following rejection remains.
5. 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.
6. 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.
7. Claims 1-10, 12, 15-17 and 19 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pat. 9,340,611 (of record) in view of U.S. Pat. 10,465,003 (of record) for the reasons set forth in the office action mailed on 9/22/25.
The ‘611 teaches pharmaceutical compositions comprising adalimumab antibody in the presence of histidine buffer at about 20mM, trehalose at about 220mM and about 0.02mg/ml of polysorbate at pH about 5.5 (col. 81-82, claims). In addition, the ‘611 patent allows further addition of glycine, methionine and/or arginine (claims) and prefilled device of the pharmaceutical compositions thereof (col. 69). The formulation is suitable to stabilize antibody at a higher temperature.
Further, the ‘611 patent teaches expression of the antibody and the same glycosylation profile with Humira (col. 11, 69) and meets the limitations of claim 15 and included in this rejection.
The disclosure of the ‘611 patent differs from the instant claimed invention in that it does not teach the use of the entire SEQ ID NO:1-2 as recited in claims 1 and 11 of the instant application.
The ‘003 patent teaches TNF-alpha antibody set forth in SEQ ID NO:36-37 that are identical to the claimed SEQ ID NO:1-2. The antibody is being filled in the prefilled syringes and the TNF-a antibody is capable of treating various disease and antibody is formulated in buffer, amino acid, surfactant and stabilizers (col 29-36).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize compositions taught by the ‘611 patent into the antibody taught by the ‘003 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the compositions comprising histidine, stabilizer and surfactant stabilize TNF alpha antibody that is therapeutically effective.
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.
Applicant’s response filed on 1/21/26 has been fully considered but they were not persuasive.
Applicant has asserted that the antibody disclosed in the ‘003 patent is golimumab that is different from the claimed antibody and the combination of the references does not result in the claimed invention. However, the sequence search reveals the following:
Query Match 100.0%; Score 2435; Length 456;
Best Local Similarity 100.0%;
Matches 456; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVESGGGVVQPGRSLRLSCAASGFIFSSYAMHWVRQAPGNGLEWVAFMSYDGSNKKY 60
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Db 1 QVQLVESGGGVVQPGRSLRLSCAASGFIFSSYAMHWVRQAPGNGLEWVAFMSYDGSNKKY 60
Qy 61 ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDRGIAAGGNYYYYGMDVWGQGT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARDRGIAAGGNYYYYGMDVWGQGT 120
Qy 121 TVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFP 180
Qy 181 AVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 AVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPA 240
Qy 241 PELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKP 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 PELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKP 300
Qy 301 REEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTL 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 REEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTL 360
Qy 361 PPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLT 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 PPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLT 420
Qy 421 VDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 456
||||||||||||||||||||||||||||||||||||
Db 421 VDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 456
Query Match 100.0%; Score 1121; Length 234;
Best Local Similarity 100.0%;
Matches 215; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EIVLTQSPATLSLSPGERATLSCRASQSVYSYLAWYQQKPGQAPRLLIYDASNRATGIPA 60
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Db 20 EIVLTQSPATLSLSPGERATLSCRASQSVYSYLAWYQQKPGQAPRLLIYDASNRATGIPA 79
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCQQRSNWPPFTFGPGTKVDIKRTVAAPSVFIFP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 80 RFSGSGSGTDFTLTISSLEPEDFAVYYCQQRSNWPPFTFGPGTKVDIKRTVAAPSVFIFP 139
Qy 121 PSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTL 180
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Db 140 PSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTL 199
Qy 181 TLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 215
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Db 200 TLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 234
As such, the antibody is deemed identical antibody as the claimed and the rejection is maintained.
8. No claims are allowable.
9. 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.
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.
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
February 24, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641