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
This is a first action on the merits for this continuous application filed on 10/01/2024
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 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 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.
Claims 1-2, 5, 7, 9, 11, 14, 17, 27-28, 30-35, and 44-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lim et al. (US 2011/0190194 A1).
Regarding claim 1, Lim et al. discloses a method of producing [0021] a polypeptide [0005 and 0097] of interest, comprising:
(a) binding [0017] the polypeptide to a chromatography matrix, and
(b) washing the [0018-0019] polypeptide-bound chromatography matrix with a wash solution at a pH of lower than about 4.0 [0018], wherein the wash solution comprises a sufficient concentration of salt ([0019 and 0076]) to substantially reduce elution of the polypeptide during (b).
Regarding claim 2, Lim et al. discloses that the chromatography matrix [0018] is an affinity chromatography matrix [0069].
Regarding claim 5, Lim et al. discloses that the chromatography matrix is a mixed-mode anion-exchange chromatography matrix [0066].
Regarding claim 7, Lim et al. discloses that the elution of the polypeptide during (b) is reduced to less than 30% [0021 and 0018].
Regarding claim 9, Lim et al. discloses that the pH of the wash solution is about 2.5 to about 4.0 [0006].
Regarding claim 11, Lim et al. discloses that the concentration of the salt is greater than about 0.5 M [0018].
Regarding claim 17, Lim et al. discloses that the wash solution further comprises arginine [0093] and PEG [0093].
Regarding claim 27, Lim et al. discloses that the polypeptide is recombinantly produced [0005 and 0097] in a cell culture.
Regarding claim 28, Lim et al. discloses that the cell culture is a human cell culture [0097].
Regarding claim 30, Lim et al. disclose that prior to (a) and (b), the polypeptide is harvested after recombinant production in a cell culture [0097].
Regarding claim 31, Lim et al. discloses that the polypeptide is bound to the chromatography matrix at a pH from about 6.0 to about 8.0 [0080]
Regarding claim 32, Lim et al. discloses that the method further comprises eluting the polypeptide from the chromatography matrix with an elution solution [0065].
Regarding claim 33, Lim et al. discloses that at least about 70% of the polypeptide is recovered in the elution solution [0072].
Regarding claim 34, Lim et al. discloses that at least about 70% of the polypeptide is recovered in the elution solution [0072].
Regarding claim 35, Lim et al. discloses that the polypeptide comprises CH2/CH3 domains [0093] of an immunoglobin constant region.
Regarding Claim 44, Lim et al. discloses that the polypeptide comprises an antibody [0093] or an antibody fragment.
Regarding claim 45, Lim et al. discloses that the polypeptide comprises an antibody [0074]
Regarding claim 46, Lim et al. discloses that the antibody is a human antibody [0037, 0069].
Claim Rejections - 35 USC § 103
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.
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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (US 2011/0190194) as applied to claim 27, and further in view of Lozano Soto et al. (US 8,404,633 B2).
Lim et al. appears silent to disclose that the human cell is a Human Embryonic Kidney (HEK) 293 cell.
Lozano Soto et al. discloses pharmaceutical compositions for prevention and treatment of fungal infections (col.1, lines 26-30) that uses Human Embryonic Kidney (HEK) 293 cells since such cells provide stable expressing systems (col.9, Example 5). 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 to add Lozano Soto et al. Human Embryonic Kidney (HEK) 293 cells to the method of Lim et al. cells [0005] since such cells provide stable expressing systems in experiments related to treatment of human diseases.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONZER R CHORBAJI whose telephone number is (571)272-1271. The examiner can normally be reached M-F 5:30-12:00 and 6:00-9:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill J Warden can be reached at (571)272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MONZER R CHORBAJI/Primary Examiner, Art Unit 1799
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