DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to filed provisions of the AIA .
2. Claims 121-143 are pending upon entry of amendment filed on 6/18/24.
3. Applicant’s IDS filed on 6/20/24 and 1/10/25 have been acknowledged.
4. The oath filed on 3/8/24 has been acknowledged.
5. The specification in p. 26 discloses mosunetuzumab is disclosed in WO2015/09539 and is incorporated by reference. The reference contains an error; WO requires 6-digit number for its publication number. Appropriate correction is required.
6. 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.
7. 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.
8. Claims 121-143 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub 2018/0134798 in view of U.S.Pub 2006/0088523 (IDS reference) and WO2014/141152 (IDS reference).
The ‘798 publication teaches CD3xCD20 bispecific antibodies in treatment of cancer (p. 2-4, 6) and the cancer includes NHL, DCBCL or CLL. The bispecific antibody reads on mosunetuzumab as the CD3xCD20 comprises SEQ ID NO:7, 8, 15 and 16 as evidenced in p. 42 (Table 1) of the specification of the instant application. Further, the ‘798 publication further teaches dissolving antibody in physiological saline ([205], p. 27) and claim 135 is included in this rejection.
The disclosure of the ‘798 publication differs from the instant claimed invention in that it does not teach the use of methionine, polysorbate, histidine, acetate and sucrose as in claims 121-143 of the instant application.
The ‘523 publication teaches stable antibody formulations comprising CD20 antibody at 1-200mg/ml, histidine-acetate buffer at about 10-40mM, polysorbate 20 at 0.0001%-0.01% and sucrose of 60-250mM at pH 5.5-6.5 (claims 1-79). The ‘523 publication further teaches intravenous administration, packaging in vial (claims 38-40) and the formulation being stable at 40oC for 4 weeks, at least year or more at 5-15oC ([0379]).
In addition, the ‘523 publication defines the term “stability” to retain activity, stable at 40oC for at least 2-4 weeks, 4oC for at least 1 year, [0092]) and stability is accessed by SEC-HPLC, CZE or IEX ( p. 36 and examples). Claims 12-18 are included in this rejection.
Likewise, the ‘152 publication teaches CD3 antibody formulation comprising 0.01-1mg/ml of antibody, 0.01-0.5% polysorbate 20, about 10mM of methionine (table 5) and 20mM histidine at about pH6. The ‘152 publication teaches % low molecular weight aggregates less than 5% (Table 1) and meets the claim limitations of claim 130.
Given that the combination of prior art formulation is identical to the claimed formulation for the claimed antibody composition comprising 1mg/ml mosunetuzumab, 10mM histidine-acetate, 10mM methionine, 240mM sucrose, about 0.06% polysorbate 20 at pH 6 as in claim 35, the prior art combination is expected to be stable about 2 weeks at 25oC, the conditions (a)-(f) of claims 127-130 are expected properties.
Further, instant specification discloses in p. 55 that 1mg/ml mosunetuzumab and 0.05% of polysorbate 20 having the molar ratio of 56, the combination of excipients addressed above reads on “less than 100” molar ratio of less than 100 and meets the limitation of claim 2.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize excipient of choice and concentrations taught by the ‘523 and 152 publications and into the CD3xCD20 bispecific antibody readable upon mosunetuzumab antibody formulation taught by the ‘798 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization excipient combination that is known to stabilize CD20 or CD3 antibody stabilizes bispecific antibody of CD3x CD20.
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.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
10. Claims 121-143 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 129-31, 33-36, 61-63 and 71-76 of U.S. Application No. 19/647,343.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘343 application recite methods of treating cancer comprising administering a pharmaceutical composition comprising mosunetuzumab antibody product in the presence of methionine, histidine-acetate buffer, polysorbate, sucrose at pH 5-6.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
11. Claims 121-143 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Pat 12,291,575 in view of U.S.Pub 2006/0088523 (IDS reference) and WO2014/141152 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘575 recite methods of treating cancer comprising administering a pharmaceutical composition comprising mosunetuzumab antibody product.
The claims of the ‘575 patent differ from the claimed invention in that they do not teach addition of histidine, sucrose, methionine and polysorbate.
The teachings of the ‘523 and 152 publications have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize excipient of choice and concentrations taught by the ‘523 and 152 publications and into the CD3xCD20 bispecific antibody readable upon mosunetuzumab antibody formulation taught by the ‘575 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization excipient combination that is known to stabilize CD20 or CD3 antibody stabilizes bispecific antibody of CD3x CD20.
12. No claims are allowable.
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-. 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
September 22, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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