DETAILED ACTION
Notice of Pre-AIA or AIA Status
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 3-6 are pending. Claims 1-2 and 7-60 are canceled.
3. Claims 3-6 are under examination.
Priority
4. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/775,025, filed on 01/28/2020.
5. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 62/943,716, 62/931,014, 62/899,094, 62/861,954, 62/847,826 and 62/797,876 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim 3 is drawn to a liquid pharmaceutical formulation comprising (a) isatuximab at a concentration of 5-20 mg/ml;(b) a buffering agent selected from the group consisting of: histidine, acetate, and phosphate; (c) an excipient selected from the group consisting of: sucrose and mannitol, and (d) polysorbate 80 (PS80).
Claim 4 is drawn to the liquid pharmaceutical formulation of claim 3, wherein isatuximab is present at a concentration of 5 mg/ml, wherein the buffering agent is histidine and the histidine is at a concentration of 10 mM, wherein the excipient is sucrose and the sucrose is at a concentration of 10% (w/v), wherein the PS80 is present at a concentration of 0.005% (w/v), and wherein the pharmaceutical formulation has a pH of about 6.0 or about 6.5.
Claim 5 is drawn to the liquid pharmaceutical formulation of claim 4, wherein the pH is about 6.5.
Application Nos. 62/943,716, 62/931,014, 62/899,094, 62/861,954, 62/847,826 and 62/797,876 do not disclose a liquid pharmaceutical formulation comprising isatuximab at a concentration of 5-20 mg/ml or 5 mg/ml, and an acetate or phosphate buffer.
Therefore, claims 3-5 are not entitled to the benefit of the earlier filing dates of these provisional applications. The effective filing date of claims 3-5 is the filing date of US 16/775,025, i.e. 01/28/2020.
Information Disclosure Statement
6. The information disclosure statement (IDS) submitted on 4/25/2024 has been considered by the examiner.
Claim Rejections - 35 USC § 102/103
7. 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.
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.
8. Claim 3 is rejected under 35 U.S.C. 102 and/or 35 U.S.C. 103 as being unpatentable over Doshi et al. (WO 2016/187546A1, pub. date: 11/24/2016, IDS filed on 4/25/2024).
Regarding claim 3, Doshi et al teaches: “For administration, 20 mg/ml of the anti-CD38 antibody in 25 mM sodium acetate, 60 mM sodium chloride, 140 mM D-mannitol, 0.04% polysorbate 20, pH 5.5 may be mixed with rHuPH20, 1.0 mg/mL (75-150 kU/mL) in 10 mM L-Histidine, 130 mM NaCl, 10 mM L-Methionine, 0.02% Polysorbate 80, pH 6.5 prior to administration of the mixture to a subject.” (page 36, paragraph 1). The mixture (which can be interpreted as a formulation) would comprise an anti-CD38 antibody, an acetate buffer, L-histidine buffer, D-mannitol, and polysorbate 80. Doshi et al. teaches that the concentration of the anti-CD38 antibody in the pharmaceutical composition is about 20 mg/ml (page 34, line 6), and the anti-CD38 antibody can be isatuximab (page 17).
Therefore, Doshi teaches every limitation of claim 3 and/or renders claim 3 obvious.
Claim Rejections - 35 USC §103
9. 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.
10. Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Hann et al. (US 2014/0161819A1, pub. date: 6/12/2014), in view of Andya et al. (WO 2006/044908A2, pub. date: 4/27/2006) and Arch et al (US 2015/0132311A1, pub. date: 5/14/2015), and Better et al. (US 2005/0009097A1, pub. date 1/13/2005)
Hann et al teaches that hu38SB19 (also known as isatuximab) was provided in solution at 5 mg/ml, stored at 4°C ([0075]).
Hann et al does not teach a formulation comprising 5 mg/ml or 20 mg/ml of isatuximab, 10 mM or 20 mM histidine, 10% (w/v) sucrose, and 0.005% (w/v) or 0.02% (w/v) polysorbate 80 (PS80) with a pH about 6.0 to 6.5.
Andya et al teaches a stable pharmaceutical formulation comprising a full length IgG1 monoclonal antibody in an amount of 10 mg/ml to about 250 mg/ml or 20 mg/ml to 40 mg/ml, 10 mM or 20 mM histidine-acetate buffer or histidine-HCl buffer, pH 5.5 to 6.5 or 5.8-6.2, 10 mM-1M or 240 mM sucrose, and a surfactant, wherein the surfactant is polysorbate 20 (PS20) or polysorbate 80 (PS80) (claims, page 8, page 12, last line and Examples 3, 5 and 8). Andya et al teaches that their formulation reduces deamidation or aggregation of a therapeutic monoclonal antibody (page 8).
Arch et al teaches a formulation comprising an antibody (1D1 1.31), 20 mM histidine, 10% sucrose (which is about 292 mM), 0.02% polysorbate 80, pH 5.8 ([1049]).
Better et al teaches adding 0.005% polysorbate 80 as a stabilizer to a formulation comprising 5 mg/ml anti-Ep-CAM antibody and buffer ([0283]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made a formulation comprising 5 mg/ml or 20 mg/ml of isatuximab, 10 mM or 20 mM histidine, 10% (w/v) sucrose, and 0.005% or 0.02% (w/v) polysorbate 80 (PS80) with a pH about 6.0 to 6.5 in view of Andya, Arch and Better. One of ordinary skill in the art would have been motivated to do so because Andya et al teaches that their pharmaceutical stable formulation reduces deamidation or aggregation of a therapeutic monoclonal antibody (page 8). One of ordinary skill in the art would have had a reasonable expectation of success because Andya et al teaches a stable pharmaceutical formulation comprising a full length IgG1 monoclonal antibody in an amount of 10 mg/ml or 20 mg/ml, 10 mM or 20 mM histidine-acetate buffer or histidine-HCl buffer, pH 5.5 to 6.5 or 5.8-6.2, 240 mM sucrose, and a surfactant, wherein the surfactant is polysorbate 20 (PS20) or polysorbate 80 (PS80) (claims, page 8, page 12, last line and Examples 3, 5 and 8), Arch et al teaches an formulation comprising an antibody (1D1 1.31), 20 mM histidine, 10% sucrose (which is about 292 mM), 0.02% polysorbate 80, pH 5.8 ([1049]), and Better et al teach adding 0.005% polysorbate 80 as a stabilizer to a formulation comprising 5 mg/ml anti-Ep-CAM antibody and buffer ([0283]).
Conclusion
11. No claims are allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
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/HONG SANG/Primary Examiner, Art Unit 1646
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