Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Application Status
Claims 1-24 are pending and examined on the merits herein.
Claim Rejections - 35 USC § 102
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.
Claims 1-5, 7-15, 17-21, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao (Clin Drug Investig 36, 889–902 (2016); PTO-892) as evidenced by Leung (WO 2020/078453 A9; IDS entered 04/16/2024).
Regarding claims 1-2, 4-5, 7-11, 13, and 24, Zhao teaches that SM03 injections, containing 10.00 mg/mL SM03, 7.25 mg/mL hydrogen phosphate disodium, 1.54 mg/mL sodium dihydrogen phosphate and 0.40 mg/mL polysorbate 80 (pH 7.2) (section 2.2, page 891). There is a typographical error in the manuscript of poly polysorbate 8, as there is no known polysorbate 8 nonionic surfactant it is presumed that this was intended to read polysorbate 80. Zhao further teaches that SM03 is a recombinant, human/mouse chimeric immunoglobulin (Ig) G1 monoclonal antibody directed against the CD22 antigen on human B lymphocytes (page 891, col 1, para 2). 1.54 mg/ml sodium dihydrogen phosphate calculates to 12.83 mM; 0.4mg/ml polysorbate 80 calculates to 0.04%. All of the necessary materials to produce a kit are already present in the formulation and printed instructions do not distinguish the claimed product (MPEP
2112.01 (III)).
Regarding claim 3, as the claim does not recite additional elements in the formulation composition and Zhao teaches all of the components of claim 1, it naturally flows that the formulation as taught by Zhao must also have an osmotic pressure within 50-100 mOsmol/kg.
Regarding claims 12 and 18, Zhao teaches eligible patients received multiple intravenous infusions of SM03 for 4 weeks (240 mg/m2, 600 or 900 mg, once weekly) (abstract). Regarding the isotonic agent as recited in claim 18, this could be a separate vial of the formulation which would by necessity of containing the same formulation be isotonic but be administered concomitantly to achieve a different final dosage for the patient.
Regarding claims 14-15, as evidenced by Leung, Suciraslimab (SM03) has a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 001 and a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 005 (page 3, last para -page 4, first para), SEQ ID NO: 1 has 100% sequence identity with instant claimed SEQ ID NO: 1-4 and SEQ ID NO: 5 has 100% sequence identity with instant claimed SEQ ID NO: 5-8.
Regarding claims 17 and 19-21, Zhao teaches that SM03 partly reduced the peripheral lymphocyte count (CD19+ B cells) in SLE patients and that this initial clinical efficacy and safety profile of SM03 supports its continued development for SLE treatment (conclusion).
Claim Rejections - 35 USC § 103
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, 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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao (Clin Drug Investig 36, 889–902 (2016); PTO-892) as evidenced by Leung (WO 2020/078453 A9; IDS entered 04/16/2024) as applied to claims 1-5, 7-15, 17-21, and 24 above, and further in view of Challener (BioPharm International 2017 30 (1) 32-35; PTO-892).
The teachings of Zhao regarding claims 1-5, 7-15, 17-21, and 24 are detailed above.
Zhao does not teach wherein the polysorbate is polysorbate 20.
Challener states there are a limited number of excipients that have been used in marketed protein biopharmaceuticals. Challener further states using a novel excipient that has no precedent requires additional safety data and the cost and risk associated with this path make it an undesirable first choice (page 34-35, bridging sentence). Thus, Challener indicates there is not a large laundry list wherein components are widely variable and wherein the function of the individual excipients is not recognized. The selection of excipients used is therefore limited. Challener further teaches that surfactants such as polysorbates 80 and 20 are used with large molecules that exhibit sensitivity to interfacial interactions (page 33, last col, last para). The use of sucrose, mannitol, citrate buffer and the surfactant polysorbate 20 have a long history of use in lyophilization formulations and have been primary choices for lyophilization.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use polysorbate 20 as the surfactant as taught by Challener in the formulation of CD22 antibody as taught by Zhao. The ordinary artisan would have been motivated to do so because Challener teaches that sucrose, mannitol, citrate buffer and the surfactant polysorbate 20 have a long history of use in lyophilization formulations and have been primary choices for lyophilization. Therefore, it would be beneficial to develop a stable antibody formulation for lyophilization for long term storage and shipment.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao (Clin Drug Investig 36, 889–902 (2016); PTO-892) as evidenced by Leung (WO 2020/078453 A9; IDS entered 04/16/2024) as applied to claims 1-5, 7-15, 17-21, and 24 above, and further in view of Jain (Sci Rep 11, 11332 (2021); PTO-892).
The teachings of Zhao regarding claims 1-5, 7-15, 17-21, and 24 are detailed above.
Zhao does not teach wherein said formulation is stable upon multiple cycles of freezing and thawing.
Jain teaches that physical instabilities of proteins in the form of protein aggregation continue to be a major challenge in the development of protein drug candidates and that aggregation can occur during different stages of product lifecycle such as freeze–thaw, manufacturing, shipping, and storage, and can potentially delay commercialization of candidates (abstract). Jain further teaches freezing and thawing are typical steps involved in the manufacturing of drug product and also teaches a process to identify optimal freeze thaw conditions including balancing different excipients to reduce or eliminate aggregation (abstract). Jain further teaches that proteins are commonly exposed to the freeze–thaw (F/T) events during bulk drug substance handling, manufacturing, and storage, as well as potential excursions during shipping (page 1, last para).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to test and optimize the antibody formulation to be stable through freeze thaw cycles as taught by Jain in the formulation of CD22 antibody as taught by Zhao. The ordinary artisan would have been motivated to do so because Jain teaches that freezing and thawing are typical steps involved in the manufacturing of drug product including substance handling, manufacturing, and storage, as well as potential excursions during shipping. Therefore, it would be beneficial to the patient and the pharmaceutical production to optimize the antibody formulation to be stable through multiple freeze thaw cycles through the manufacturing and shipping process.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (Clin Drug Investig 36, 889–902 (2016); PTO-892) as evidenced by Leung (WO 2020/078453 A9; IDS entered 04/16/2024) as applied to claims 1-5, 7-15, 17-21, and 24 above, and further in view of Leung (WO 2020/078453 A9; IDS entered 04/16/2024).
The teachings of Zhao regarding claims 1-5, 7-15, 17-21, and 24 are detailed above.
Zhao does not teach wherein the autoimmune disorder, or disease is rheumatoid arthritis.
Leung teaches a method of treating rheumatoid arthritis in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of an anti-CD22 antibody (claim 1), wherein the anti-CD22 antibody is selected from a group consisting of SM03 (claim 24). Leung further teaches that methods of employing Siglec specific antibodies that target CD22 epitopes to treat disorders in which overactive or uncontrolled immune (or autoimmune) activity is detrimental (including rheumatoid arthritis), by inhibiting or modifying B cell activity by intravenous administration of anti‐CD22 antibodies in multiple times in multiple cycles such that the disorder is treated (page 4, last para).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to treat rheumatoid arthritis as taught by Leung with the formulation of CD22 antibody as taught by Zhao. The ordinary artisan would have been motivated to do so because Leung teaches methods of employing specific antibodies that target CD22 epitopes to treat disorders in which overactive or uncontrolled immune (or autoimmune) activity is detrimental (including rheumatoid arthritis), by inhibiting or modifying B cell. Therefore, it would be beneficial to rheumatoid arthritis patients to treat the overactive or uncontrolled immune system with SM03 to inhibit B cells.
Conclusion
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/AMBER K FAUST/ Examiner, Art Unit 1643
/JULIE WU/ Supervisory Patent Examiner, Art Unit 1643
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