DETAILED ACTION
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 .
The objection to the specification is withdrawn in view of amendments to the specification adding trademarks and generic terminology.
The rejection under section 112(a) is withdrawn in view amendments limiting the bioactive agents to antibodies and antigen-binding fragments thereof.
The rejection under section 112(b) is withdrawn in view of amendments clarifying bioactive agents and claimed ranges.
The rejections under sections 102 and 103 over WO 657 are withdrawn since the reference does not teach formulations with the required antibodies or antigen-binding fragments of antigens.
The following rejections under sections 102 and 103 are maintained below. Inclusion of new claims was necessitated by Applicant’s amendments.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 37 and 38 remain rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2020/097141 (WO 141).
WO 141 teaches a formulation of an anti-PD-1 antibody comprising:
(a) 75, 100 or 200 mg/ml to 250 mg/ml of an anti-human PD-I antibody
(b) 10 mM histidine buffer;
(c) 10 mM L-methionine;
(d) 7.0% w/v sucrose; and
(e) 0.005 % w/v to 0.60% w/v non-ionic surfactant, which is selected from the group consisting of: polysorbate 20, a poloxamer, vitamin E TPGS, polyethylene glycol tert-octylphenyl ether (TRITON™ X-100), OM, DOM, and DDAO, see pages 41 and 42.
In one embodiment, the non-ionic surfactant is vitamin E TPGS.
Regarding claims 40 and 41, Example 2 teaches pembrolizumab, a humanized monoclonal anti-PD-1 antibody, 10 mM histidine buffer (pH 5.5) and TPGS as surfactant.
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.
Claims 47-50, 60 and 68-71 remain rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/097141 (WO 141)
WO 141 teaches a formulation of an anti-PD-1 antibody comprising:
(a) 75, 100 or 200 mg/ml to 250 mg/ml of an anti-human PD-I antibody
(b) 10 mM histidine buffer;
(c) 10 mM L-methionine;
(d) 7.0% w/v sucrose; and
(e) 0.005 % w/v to 0.60% w/v non-ionic surfactant, which is selected from the group consisting of: polysorbate 20, a poloxamer, vitamin E TPGS, polyethylene glycol tert-octylphenyl ether (TRITON™ X-100), OM, DOM, and DDAO, see pages 41 and 42.
In one embodiment, the non-ionic surfactant is vitamin E TPGS.
Example 2 teaches pembrolizumab, a humanized monoclonal anti-PD-1 antibody, 10 mM histidine buffer (pH 5.5) and TPGS as surfactant.
The applied references may not specifically teach the recited particle size or that the recited particle sizes were formed (claim 60).
The applied references may not teach the recited stability over the recited time frames.
However, WO 141 and WO 657 teach the recited formulations with the required components. In this manner, those of ordinary skill would understand that any observed physical or chemical characteristics, including the recited particle sizes and stability, would also be necessary characteristics of the formulations described by WO 141 and WO 657, see MPEP 2112.01 (“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”).
Therefore, difference between the physical attributes of the claimed formulations and those described by the applied references is that the applied references do not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, since the applied references teach the same formulations as those covered by the claims, the applied references also teach the physical characteristics of particle size and stability of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the these elements of the claimed invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Applicant argues that WO 141 does not teach the recited amounts of TPGS. However, the reference teaches that “[i]n specific embodiments, the surfactant is about 0.01% to about 0.03% w/v vitamin E D-α-tocopherol polyethylene glycol succinate (TPGS) [emphasis applied].”), see page 3. As outlined above, any observed effect on particle size would have been an invariable result of this amount of TPGS. Therefore, the rejection is maintained.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch, can be reached at telephone number 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646
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