DETAILED ACTION
1. The present application is being examined under the pre-AIA first to invent provisions.
2. Claims 1, 4, 7, 8, 10-16, 18-20 and 22-33 are pending upon entry of amendment filed on 3/23/26.
Claims 1, 4, 7, 8, 10-16, 18-20 and 22-33 are under consideration in the instant application.
3. NO oath is of record.
4. Applicant’s submission of IDS filed on 3/23/26 has been considered.
5. Upon approval of the terminal disclaimer filed on 3/23/26, the double patenting rejections (in part) have been withdrawn (see sections 9 and 11 of the office action mailed on 9/23/25).
6. The following rejections remain.
7. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office Action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
8. Claims 1, 4, 7, 8, 10-16, 18-20 and 22-33 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO01/78779 (of record) in view of U.S. Pub. 2006/0088523 (of record) for the reasons set forth in the office action mailed on 9/23/25.
The ‘779 publication teaches antibody formulations comprising an antibody that binds integrin α4β7 with buffers (p. 24-25, Fig 5, note sequences of Fig 5 are claimed SEQ ID Nos: 8-13 of claim 1). Given that the human and humanized antibodies of integrin α4β7 are included (p. 20) as well as LDP-2, claims 23-28 reciting vedolizumab is included in this rejection as evidenced by p.40 of the instant application. In addition, the ‘779 publication teaches dosage of 1-5mg/kg (p. 16) and packaging into a container (p.24-25) including autoinjector. A dose of 60-170mg/ml of antibody as in claims 1 and 19 are included in this rejection as the general condition is known in the art and it is not inventive to discover optimum or workable ranges by routine experiment. See MPEP 2144.05
The disclosure of the ‘779 publication differs from the instant claimed invention in that it does not teach the use of specific buffer and excipient combinations of the instant application, respectively.
The ‘523 publication teaches addition of histidine buffer concentration of 10-40mM, 60-250mM of sucrose and polysorbate of 0.0001-1% at pH 5.5-6.5, in the presence of glycine or methionine (p.33-34) with antibody concentration of 1-250mg/ml (note claims). Further, the ‘523 publication teaches that the antibody formulation comprising buffer, amino acid, and polysorbate stabilizes antibody upon storage at 40oC for 3 months (p.7). Given that the formulations of the ‘523 publication is suitable for various antibody targets, the formulation comprising histidine, sucrose, polysorbate and amino acid would expect to stabilize vedolizumab.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize formulation comprising histidine, sucrose and polysorbate to stabilize antibody as taught by the ‘523 publication to the antibody formulation taught by the ‘779 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the addition of histidine, sucrose, surfactant and arginine improves antibody stability and reduces aggregates upon storage.
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 3/23/26 has been fully considered but they were not persuasive.
Applicant has asserted that the combination of the references fails to teach the currently amended limitations of “after two weeks at 40oC the stable liquid formulation has less than about 1.0% aggregate formation” and the Wang reference describes high concentration antibody formulation is greatest challenge. Applicant further adds the Wang reference describes that the formulation that is suitable for one antibody may not be suitable for another antibody. Applicant adds Daugherty reference to support this premise.
However, unlike Applicant’s assertion, the ‘523 publication teaches that the formulation comprising histidine, sucrose and polysorbate at pH 6 showed more than 99.4% of monomer content under SEC after 2 weeks storage at 40oC (note Table 3 in p.36). As such, having the currently amended property is expected and taught by the prior art.
In addition, Applicant uses Wang reference and Daugherty reference to support that there is no universal antibody that is suitable for any antibody. Applicant has asserted that the Avastin at 25mg/ml, Humira of 50mg/ml and Tysabri at 20mg/ml in Table 1 of Wang reference as to support that each antibody is formulated differently.
However, Applicant is reminded that that how broadly the claimed invention is recited. IN lack of specific excipient and/or buffer concentration combinations, the same Wang reference in Table 1 supports that the structurally distinct antibodies like Herceptin and Lucentis can be formulated in histidine, sugar and surfactant. Note the distinction relies at the concentration level. As such, the combination of the references remains obvious and the rejection is maintained.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
10. Claims 1, 3, 4, 7, 8, 10-16, 18-20 and 22-32 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim(s) 1-20 of copending Application No. 16/784052.
Although the conflicting claims are not identical, they are patentably distinct from each other because both claims recite antibody formulations comprising the SEQ ID Nos:2, 4, 5, 8-13 in the presence of buffer, antioxidants, chelator, buffer, surfactant and free amino acid such as arginine.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
As Applicant has requested that the double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the rejection is maintained.
10. Claim(s) 1, 3, 4, 7, 8, 10-16, 18-20 and 22-32 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim(s) 1-33 of U.S. Pat. 9,764,033.
Although the conflicting claims are not identical, they are patentably distinct from each other because both claims recite antibody formulations comprising the SEQ ID Nos:2, 4, 5, 8-13 in the presence of buffer, antioxidants, chelator, buffer, surfactant and free amino acid such as arginine.
Applicant’s response filed on 3/23/26 has been fully considered but they were not persuasive.
Applicant has asserted that the formulation of the ‘033 patent is lyophilized while the claimed invention is stable liquid.
However, the ‘033 patent encompasses reconstituted formulation that is liquid and the same formulation will inherently be stable and shows less than 1% aggregate after storage for 2 weeks at 40oC. The rejection is maintained.
11. No claims are allowable.
12. 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.
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 on Mon-Fri 8:30-5. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 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
April 16, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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