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 .
Claim Status
Claims 1-13 are pending.
Claim Objections
Claims 1 is objected to because of the following informalities:
Claim 1 recites “ a composition of the fusion protein comprising of target % of monomer species”. Applicant should clarify to avoid possible ambiguity. Examiner suggests modifying the wording to “a composition of the fusion protein comprising a target % of monomer species”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 cites “supplementation of sulphur based additives”. It is unclear based on the claim language of what is being supplemented with the sulphur based additives. Claims 2, and 4-8 are linked to claim 1 and to the ambiguity of what is being supplemented with the sulphur based additives.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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)(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 1-13 are rejected under 35 U.S.C. 101 (a)(1) and 102(a)(2) as being anticipated by Leister et al (US Patent No. 10,851,150 B2; December 1, 2020) hereinafter referred to as Leister.
With respect to Claims 1-3, 6, 7, 11, and 12, Leister teaches “improved compositions and methods for producing CTLA4-Ig compositions” (Column 2, lines 15-16) “wherein greater than 95% of the molecules are CLTA4-Ig dimers” (Column 4, lines 57-59) and “less than 0.7% of the molecules are CLTA4-Ig monomers” (Column 5, lines 3-4). Leister also teaches “a method for producing a recombinant protein comprising: (a) expanding mammalian cells that secrete a recombinant protein, wherein the expanding is from a seed culture” and (b) “isolating the recombinant protein from the liquid culture” (Column 146, lines 1-8). Furthermore, Leister teaches “a method for producing a ratio of single chain:dimer form of a protein, such protein capable of existing in dimer as well as in single chain form” which comprises the steps of providing and/or maintaining “a liquid cell culture medium for the culture of cells expressing said protein, in which the concentration of an agent capable of reducing or inhibiting dimer formation (such as cysteine) is selected to provide said ratio” (Column 199, lines 25-35). Leister teaches that the protein “is a CTLA4-Ig protein” (a CLTA4-Ig fusion protein) (Column 10, lines 35-40). Leister also teaches that “supplementation of cysteine directly or cysteine containing media to cells secreting CTLA4-Ig” can “result in rapid formation of single chain and high molecular weight species” and that “the rate is proportional to the amount of cysteine added” (Column 83. Ines 50-54). Furthermore, Leister teaches that “the invention provides for a population of CTLA4-Ig molecules, wherein greater than 95% of the molecules are CTLA4-Ig dimers” (Column 4, lines 57-59). Leister also teaches a “lyophilized CTLA4-Ig mixture comprising at least 90%, 95%, 99%, or 99.5% CTLA4-Ig dimer” and “not more than 2%” CLTA4-Ig monomer (Column 156, lines 9-14). Leister teaches that “the population of CTLA4-Ig molecules can include predominately homodimers” (Column 123, lines 30-33). Additionally, Leister teaches that cell culture conditions can be developed to enhance protein production during the production phase of the cell culture for a period of time and that during the production phase, cells can be subjected to various shifts in temperature to enhance protein production (Column 135, lines 15-48). Furthermore, Leister teaches “a three-stage temperature control strategy is used” during a bioreactor step “to optimize cell growth and CTLA4-Ig production” (Column 270, lines 7-9) wherein the “temperature is lowered” (Column 270, lines 11-12). Leister teaches that the initial incubation temperature is at 37◦ C followed by incubation at two additional lowered temperatures (Column 270, lines 6-16). Leister also teaches that “sufficient levels of glucose and other nutrients” are added “to the culture to support the production of CTLA4-Ig protein” (Column 270, lines 25-29).
In regards to Claims 4,5, 9, and 10, Leister teaches that “during the production phase, cells can be subjected to various shifts in temperature to enhance protein production” and that “two or more temperature shifts comprising the cell culture process can result in an increased number of viable cells that survive in culture until the end of the process” (Column 135, lines 50-53). Furthermore, Leister teaches propagation of cell culture “at 35-39◦ C for 3-6 days until the cells reach a target seeding density” and that the culture medium is maintained at a second “temperature lower than the growth temperature (for example at or about 33-35◦ C for 3-4 days)”, and a third lower temperature shift “at or about 31-33◦ C for 6-8 days” for protein expression (Column 140, lines 2-15).
With respect to Claims 8 and 13, Leister teaches cell lines having an expression cassette that, when expressed in mammalian cells, including CHO cells, can result in proteins having amino acid sequence of SEQ ID NO: 2 wherein, the cell line “secretes CTLA4-Ig molecules” and “abatacept refers to SEQ ID NO:2 proteins” (Column 70, lines 55-65).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE T LOUNTOS whose telephone number is (571)272-0502. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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/GEORGE THEMISTOCLIS LOUNTOS/Examiner, Art Unit 1652
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652