DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-12 are pending and under consideration in this Office Action.
Title
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.
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 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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over WO2011134921 (11/03/2011; IDS filed 01/26/2025) in view of Bruhlmann et al. ("Tailoring recombinant protein quality by rational media design", vol. 31, no. 3, 29 April 2015 (2015-04-29), pages 615-629; IDS filed 01/26/2025), US20140273092 (09/18/2014; PTO 892).
WO2011134921 teaches a cell culture medium with high content of choline chloride and controlled concentration of amino acids which allows the production of recombinant polypeptides in CHO cells with higher quality especially in that the aggregation of the formed polypeptide is reduced. The total concentration of amino acids is specified, in particular the concentration of asparagine and aspartic acid. The basal medium can be a serum-free or a protein-free medium. The recombinant polypeptide produced can be a recombinant antibody. See entire publications and claims especially claims 1-10, Summary of the Invention section pages 6-9, pages 16-19, and Experimental setup section pages 27-33. The teachings of the reference differ from the claims in that the reference does not teach including the recited amounts of asparagine, aspartic acid, zinc, and/or phosphate in the cell culture medium.
Bruhlmann et al. teach tailoring recombinant protein quality by rational media design and about its potential to modulate quality attributes including aggregates formation. Bruhlmann et al. teach in particular on how to reduce aggregate formation and states that iron plays a major role in inhibiting the formation of aggregate forms, as shown in long-term drug substance stability studies, where the abundance of HMW species was significantly lower at low iron concentrations (0-4 ppm) in the presence of a chelator. See entire publication especially Aggregates section pages 622-23, Figs.1-2, and Tables 1-2.
US20140273092 teaches methods for producing an antibody such as infliximab, having a desired C-terminal lysine content, sialic acid content, galactose content and/or ratio of sialic acid to galactose, by controlling culture conditions, in particular zinc concentration, EDTA concentration and harvest time. The culture medium can comprise other ingredients in addition to zinc and/or EDTA. In some embodiments, the culture medium is a serum-free medium. Useful cell lines include, among others, those derived from Chinese Hamster Ovary (CHO) cells. US20140273092 teaches a method for controlling sialic acid content of an antibody having a sialic acid content of 1 % to 20% in a process for biosynthesizing the antibody in a culture medium, the method comprising monitoring a level of zinc in the culture medium during biosynthesis of the antibody and regulating the level of zinc in the culture medium during biosynthesis of the antibody. US20140273092 teaches a method for controlling galactose content of an antibody having a galactose content of 50% to 90% in a process for biosynthesizing the antibody in a culture medium, the method comprising monitoring a level of zinc in the culture medium during biosynthesis of the antibody and regulating the level of zinc in the culture medium during biosynthesis of the antibody. See entire publication and claims especially claims 1-6 and 32-40, paragraphs [0004]- [0024], and Examples 1-6.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify and/or combine the reference teachings to make the claimed invention by adding zinc, aspartic acid, and/or phosphate at the recited amounts to the CHO cell culture medium of WO2011134921 where the culture medium is chemically defined, is basal medium, is protein free, and/or does not contain added serum or hydrolysates, and maintained at the recited pH, temperature, amount of dissolved oxygen, amount of carbon dioxide. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this in order to obtain a simple and efficient method for increasing decreasing galactose content of a recombinant glycoprotein expressed in CHO cells including a recombinant antibody, antibody fragment or fusion protein. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success because increasing or decreasing the amounts of asparagine, aspartic acid, zinc and/or iron in the CHO cell culture medium are known in the art as shown by the reference teachings. Hence, the claimed invention as a whole is prima facie obvious.
Double Patenting
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-12 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11401509. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons. The claims and the specification of the patent teach a method of increasing galactose content of a recombinant glycoprotein expressed in Chinese Hamster Ovary (CHO) cells under suitable cell culture conditions. Thus, the reference teachings anticipate the claimed invention.
Claims 1-12 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11655457. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons. The claims and the specification of the patent teach a method of increasing galactose content of a recombinant glycoprotein expressed in Chinese Hamster Ovary (CHO) cells under suitable cell culture conditions. Thus, the reference teachings anticipate the claimed invention.
Claims 1-12 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12234483. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons. The claims and the specification of the patent teach a method of increasing galactose content of a recombinant glycoprotein expressed in Chinese Hamster Ovary (CHO) cells under suitable cell culture conditions. Thus, the reference teachings anticipate the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christian L Fronda whose telephone number is (571)272 0929. The examiner can normally be reached Monday-Thursday and alternate Fridays between 9:00AM-5:00PM.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652
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