DETAILED ACTION
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 103-106 and 111-157 are pending upon entry of amendment filed on 9/1/23.
Upon further consideration, the restriction requirement mailed on 12/17/25 has been withdrawn.
Claims 103-106 and 111-157 are under consideration in the instant application.
The instant application comprises 3 independent claims and the claimed invention relates method of treating proliferative disorder comprising intravenous administration of a liquid composition comprising 0.72-2.7mg/ml of anti-CD79b immunoconjugate, 0.36-1.35mM of sodium succinate, 0.51-16.24mM of sucrose, 0.0432-0.162mg/ml of polysorbate at pH 5-5.7 and the antibody set forth in SEQ ID NO:1-6 for heavy and light chain variable CDRs and SEQ ID NO:7-10 for heavy and light chain sequences.
3. Applicant’s IDS filed on 9/28/23 and 3/17/26 have been acknowledged.
4. The oath filed on 4/7/23 has been acknowledged.
5. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
6. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
7. Claims 103-106 and 111-157 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling method of treating diffuse large B-cell lymphoma (DLBCL) comprising intravenous administration of a liquid composition comprising 0.72-2.7mg/ml of anti-CD79b immunoconjugate, 0.36-1.35mM of sodium succinate, 0.51-16.24mM of sucrose, 0.0432-0.162mg/ml of polysorbate at pH 5-5.7 (or equivalent in claims 137 and 145) and the antibody set forth in SEQ ID NO:1-6 for heavy and light chain variable CDRs and SEQ ID NO:7-10 for heavy and light chain sequences, does not reasonably provide enablement for more.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use of the invention commensurate in scope with these claims.
The specification does not enable one of skill in the art to practice the invention as claimed without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention.
There is insufficient guidance in the specification as filed as to how the skilled artisan would use a liquid composition comprising 0.72-2.7mg/ml of anti-CD79b immunoconjugate, 0.36-1.35mM of sodium succinate, 0.51-16.24mM of sucrose, 0.0432-0.162mg/ml of polysorbate at pH 5-5.7 (or equivalent in claims 137 and 145) and the antibody set forth in SEQ ID NO:1-6 for heavy and light chain variable CDRs and SEQ ID NO:7-10 for heavy and light chain sequences in treatment of any proliferative disorders encompassed by the claimed invention.
Although Examples 1-3 of the instant application focused on the stability of the composition comprising 0.72-2.7mg/ml of anti-CD79b immunoconjugate, 0.36-1.35mM of sodium succinate, 0.51-16.24mM of sucrose, 0.0432-0.162mg/ml of polysorbate at pH 5-5.7 (or equivalent in claims 137 and 145) and the antibody set forth in SEQ ID NO:1-6 for heavy and light chain variable CDRs and SEQ ID NO:7-10 for heavy and light chain sequences in terms of aggregates and agitation stresses, no examples showed any treatment of proliferative disorders listed in p. 62-72 of the instant application.
As seen in Tilly et al (New England Journal of Medicine, vol.386:4, p.351-363, 2022) teach polatuzumab vedotin (e.g. CD79b-vc-MMAE immunoconjugate) is being used in treatment of diffuse large B-cell lymphoma (DLBCL) along with rituximab, cyclophosphamide, doxorubicin and predinisone (R-CHP). No treatment plan for DLBCL described for CD79b immunoconjugate alone. Further, the POLIVY product insert sheet (IDS reference) indicates polatuzumab vedotin (e.g. CD79b-vc-MMAE immunoconjugate) is used for DLBLC not otherwise specified or high-grade B-cell lymphoma at most.
As such, polatuzumab vedotin (e.g. CD79b-vc-MMAE immunoconjugate) has not been used in treatment of DLBCL alone as recited in claims, or any other proliferative disorder and this regimen cannot be extrapolated to any other proliferative disorders encompassed by the claimed invention.
The specification fails to provide sufficient guidance to direct a person of skilled in the art to achieve the intended use of the claimed invention without undue experimentation. It is unpredictable to develop antibody formulation and one exemplary formulation disclosed in the example cannot be extrapolated to various formulations encompassed by the claimed invention.
To summarize, reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view or the quantity of experimentation necessary, the limited working example, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breath of the claims, it would take undue trials and errors to practice the claimed invention.
8. No claims are allowed.
9. 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 Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 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 23, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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