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 .
Claims 1-13 are pending and have been considered on the merits.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 2 and 7 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 2 discloses that the amount of mannose being added is from about 1g/L to about 10g/L. It is not clear what the “L” or “liter” is referring to. Is it the volume of the culture medium in the bioreactor or the capacity or volume of the bioreactor. Clarification is required.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation of “at least 1%”, and the claim also recites “at least 2%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Furthermore, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 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.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al. (US 948190 B2; IDS ref.)
Regarding claims 1-2, 5, Huang et al. teach a method comprising culturing mammalian cells expressing a recombinant protein including antibody in a bioreactor and the culture medium contains at least 3, 6, 9 g/L mannose (col. 2, lines 1-17; col. 3, lines 15-20). Regarding the intended outcome disclosed in the preamble of claim 1, the limitation does not provide any active step to be carried out, and rather it is directed to the result of the claimed steps. As Huang et al. teach the identical steps as claimed, the identical results are expected.
Regarding claim 3, Huang et al. teach that the bioreactor has a capacity of at least 500 L (col. 3, lines 11-12).
Regarding claim 4, Huang et al. teach the antibody as a recombinant protein and the antibody includes monoclonal antibody (col. 13, lines 40-44) and exemplify various known mAb such as adalimumab, bevacizumab, etc. (col. 14, lines 29-42). These “mabs” are monoclonal IgGs.
Regarding claims 6-7, the wherein clause of these claims is directed to the results of the claimed method but does not require any active step to be performed. Thus, the limitation of the wherein clause does not provide any patentable weight in determining patentability of the claimed method. Furthermore, the same results are expected from the method of Huang et al. as they teach the identical method steps as the claimed method.
Regarding claim 8 directed to the fed-batch process, Huang et al. teach that the mammalian cells inoculated into the production bioreactor can be maintained as a batch culture using a fed-batch process (col. 7, lines 5-9).
Regarding claim 9 directed to the perfusion process, Huang et al. teach that for cultures maintained by perfusion, perfusion feeds can begin at any time, for example, perfusion feeds can begin on or about day 3 or 4 of the culture or a day or two earlier or later (col. 7, lines 16-19).
Regarding claim 10 directed to the method further comprising isolating step of the expressed antibody, Huang et al. teach a method further comprising a step of harvesting and purifying the recombinant protein produced by the cell culture (col. 22, claim 14).
Regarding claim 11, the method of claim 11 is interpreted the same as claim 1 because the active steps of claim 11 are identical to those of claim 1 because the intended purpose of the method to match the afucosylation of a recombinantly produced antibody to a previously obtained target afucosylation percentage for the same antibody does not provide any additional method steps to the steps of claim 1. Furthermore, the “previously obtained target afucosylation percentage for the same antibody” does not provide any standard and thus, the target afucosylation percentage is considered as any afucosylation percentage, and thus, the teachings of Huang et al. as discussed with regard to claim 1 would anticipate the subject matter of claim 11.
Regarding claim 12, the wherein clause of the claim is directed to the result obtainable , and it does not limit the steps for the claimed method. Thus, claim 12 is interpreted the same as claim 11. Huang et al. teach the method steps disclosed in claim 11 as discussed above.
Regarding claim 13 directed to the perfusion process, Huang et al. teach that for cultures maintained by perfusion, perfusion feeds can begin at any time, for example, perfusion feeds can begin on or about day 3 or 4 of the culture or a day or two earlier or later (col. 7, lines 16-19).
Thus, the reference anticipates the claimed invention.
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, 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 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.
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.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (supra).
Regarding claims 1-2, 5, Huang et al. teach a method comprising culturing mammalian cells expressing a recombinant protein including antibody in a bioreactor and the culture medium contains at least 3, 6, 9 g/L mannose (col. 2, lines 1-17; col. 3, lines 15-20). Regarding the intended outcome disclosed in the preamble of claim 1, the limitation does not provide any active step to be carried out, and rather it is directed to the result of the claimed steps. As Huang et al. teach the identical steps as claimed, the identical results are expected.
Regarding claim 3, Huang et al. teach that the bioreactor has a capacity of at least 500 L (col. 3, lines 11-12).
Regarding claim 4, Huang et al. teach the antibody as a recombinant protein and the antibody includes monoclonal antibody (col. 13, lines 40-44) and exemplify various known mAb such as adalimumab, bevacizumab, etc. (col. 14, lines 29-42). These “mabs” are monoclonal IgGs. Thus, it would have been obvious to a person skilled in the art to use the method of Huang et al. for producing monoclonal IgG with a reasonable expectation of success.
Regarding claims 6-7, the wherein clause of these claims is directed to the results of the claimed method but does not require any active step to be performed. Thus, the limitation of the wherein clause does not provide any patentable weight in determining patentability of the claimed method. Furthermore, the same results are expected from the method of Huang et al. as they teach the identical method steps as the claimed method.
Regarding claim 8 directed to the fed-batch process, Huang et al. teach that the mammalian cells inoculated into the production bioreactor can be maintained as a batch culture using a fed-batch process (col. 7, lines 5-9). Thus, it would have been obvious to a person skilled in the art to use the fed-batch process in order to produce a recombinant antibody using the method of Huang et al. with a reasonable expectation of success.
Regarding claim 9 directed to the perfusion process, Huang et al. teach that for cultures maintained by perfusion, perfusion feeds can begin at any time, for example, perfusion feeds can begin on or about day 3 or 4 of the culture or a day or two earlier or later (col. 7, lines 16-19). Thus, it would have been obvious to a person skilled in the art to use the perfusion process in order to produce a recombinant antibody using the method of Huang et al. with a reasonable expectation of success.
Regarding claim 10 directed to the method further comprising isolating step of the expressed antibody, Huang et al. teach a method further comprising a step of harvesting and purifying the recombinant protein produced by the cell culture (col. 22, claim 14). Thus, it would have been obvious to a person skilled in the art to harvest, isolate and purify the produced recombinant antibody using the method of Huang et al. in order to utilize the antibody for subsequent analysis and/or therapeutic application with a reasonable expectation of success.
Regarding claim 11, the method of claim 11 is interpreted the same as claim 1 because the active steps of claim 11 are identical to those of claim 1 because the intended purpose of the method to match the afucosylation of a recombinantly produced antibody to a previously obtained target afucosylation percentage for the same antibody does not provide any additional method steps to the steps of claim 1. Furthermore, the “previously obtained target afucosylation percentage for the same antibody” does not provide any standard and thus, the target afucosylation percentage is considered as any afucosylation percentage, and thus, the teachings of Huang et al. as discussed with regard to claim 1 would anticipate the subject matter of claim 11.
Regarding claim 12, the wherein clause of the claim is directed to the result obtainable , and it does not limit the steps for the claimed method. Thus, claim 12 is interpreted the same as claim 11. Huang et al. teach the method steps disclosed in claim 11 as discussed above.
Regarding claim 13 directed to the perfusion process, Huang et al. teach that for cultures maintained by perfusion, perfusion feeds can begin at any time, for example, perfusion feeds can begin on or about day 3 or 4 of the culture or a day or two earlier or later (col. 7, lines 16-19).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
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/TAEYOON KIM/ Primary Examiner, Art Unit 1631