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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/15/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 3 and 8 are objected to because of the following informalities:
In claim 3, it is recommended to use the phrase “the recirculating” rather than “the recirculation” to match the style of the prior claims.
In claim 8, it is recommended to use the phrase “the air overlay” rather than “the air overlay space” to match the style of the prior claims.
Appropriate correction is required.
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 1-18 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 recites the limitation "the air overlay" in line 3. There is insufficient antecedent basis for this limitation in the claim. The prior lines of the claim do not recite that the container has an air overlay nor is it taken that the container must inherently have an air overlay, and therefore antecedent basis is lacking.
Claim 4 recites the limitation "the liquid surface" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the interior wall" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims are rejected for the same reason(s) as the base claim(s) upon which they depend.
Claim Rejections - 35 USC § 102
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 1-4, 13, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mimitsuka et al. (US Patent Application Publication 2011/0177551).
Regarding claim 1, Mimitsuka et al. discloses a method for controlling the level of a dissolved oxygen (DO) in a solution (Abstract, para. 60) which comprises a recombinant protein (para. 104, 112, 177), comprising recirculating the solution by drawing the solution to an air overlay of the top of the container (para. 57-59, 63, 67, 110) (Fig. 1, sheet 1 of 20).
Regarding claim 2, Mimitsuka et al. discloses wherein the recirculating is through a tube (para. 63, 67, 71) (Fig. 1, sheet 1 of 20).
Regarding claim 3, Mimitsuka et al. discloses wherein the recirculation is driven by a pump (para. 63, 67, 71) (Fig. 1, sheet 1 of 20).
Regarding claim 4, Mimitsuka et al. discloses wherein the recirculated solution is directed to the liquid surface (para. 63, 67) (Fig. 1, sheet 1 of 20).
Regarding claim 13, Mimitsuka et al. discloses wherein the storage container is a tank (Abstract).
Regarding claim 18, Mimitsuka et al. discloses wherein the solution is a partially purified protein solution (para. 57, 61-63) (Fig. 1, sheet 1 of 20).
Claims 1-4 and 9-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (Very high cell density perfusion of CHO cells anchored in a non-woven matrix-based bioreactor).
Regarding claim 1, Zhang et al. discloses a method of controlling the level of dissolved oxygen (DO) in a solution which comprises a recombinant protein in a storage container (Abstract; Section 2.2, pp. 29-30) (Fig. 1, p. 30), comprising recirculating the solution by drawing the solution to an air overlay of the top of the container (see rotameter “pouring”, Section 3.1, p. 31) (Fig. 1, p. 30).
Regarding claim 2, Zhang et al. discloses wherein the recirculating is through a tube (Fig. 1, p. 30).
Regarding claim 3, Zhang et al. discloses wherein the recirculating is driven by a pump (Section 3.1, p. 31) (Fig. 1, p. 30).
Regarding claim 4, Zhang et al. discloses wherein the recirculated solution is directed to a liquid surface (Section 3.1, p. 31) (Fig. 1, p. 30).
Regarding claim 9, Zhang et al. discloses refreshing the air overlay with a new gas through inlet and outlet ports in the container (Section 2.2, pp. 29-30) (Fig. 1, p. 30).
Regarding claim 10, Zhang et al. discloses wherein the new gas is oxygen (Section 2.2, pp. 29-30) (Fig. 1, p. 30).
Regarding claim 11, Zhang et al. discloses wherein the new gas is nitrogen or carbon dioxide (Section 2.2, pp. 29-30) (Fig. 1, p. 30).
Regarding claim 12, Zhang et al. discloses wherein the new gas is nitrogen (Section 2.2, pp. 29-30) (Fig. 1, p. 30).
Regarding claim 13, Zhang et al. discloses wherein the storage container is a tank (Abstract; Section 2.2, pp. 29) (Fig. 1, p. 30).
Regarding claim 14, Zhang et al. discloses wherein the recombinant protein is recombinant IgG (Abstract) (reads on a disulfide-bond containing protein; all IgG antibodies comprise disulfide bonds).
Regarding claim 15, Zhang et al. discloses wherein the recombinant IgG (disulfide-bond containing protein) is a monoclonal antibody (Abstract).
Regarding claim 16, Zhang et al. discloses wherein the recombinant protein is monoclonal IgG antibody, as set forth above. IgG monoclonal antibodies bind SARS-CoV-2 spike protein (see Abstract and Results, p. 830, of Barnes et al. which is cited as an evidentiary reference). Therefore, Zhang et al. fulfils the claim.
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.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Mimitsuka et al. (US Patent Application Publication 2011/0177551) in view of Khan et al. (US Patent Application Publication 2017/0356022).
Regarding claim 5, Mimitsuka et al. discloses wherein the top end of the tube (comprising transfer line 15) recirculates the solution into the top of the container (para. 63, 67) (Fig. 1, sheet 1 of 20). Mimitsuka et al. further discloses oxygenating the solution to benefit culture processes (para. 60, 110).
Mimitsuka et al. is silent as to wherein the top end of the tube is connected to a nozzle.
Khan et al. discloses a method of culturing cells to produce a protein (Abstract) comprising flowing culture fluid into the top of a vessel via a J-tube, wherein the J-tube is configured to cascade the fluid down an interior vessel wall in contact with a vessel headspace in order to oxygenate the fluid (para. 211-212) (Figs. 8-9, sheets 9-11 of 11).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the top end of the tube disclosed by Mimitsuka et al. to be connected to a J-tube (reads on a nozzle, as the J-tube controls a direction of fluid flow, as discussed above), as Khan et al. discloses that it was known in the art to provide such a configuration to allow oxygenation of a fluid as it is introduced in the top of a vessel, and the skilled artisan would have been motivated to adopt a technique recognized in the art to allow for oxygenation of the solution to benefit culturing within the container.
Regarding claim 6, Mimitsuka et al. in view of Khan et al. teaches wherein the nozzle is a J-tube (reads on curved), as set forth above.
Regarding claim 7, Mimitsuka et al. in view of Khan et al. teaches wherein the nozzle is a J-tube (reads on a J nozzle), as set forth above.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mimitsuka et al. (US Patent Application Publication 2011/0177551) in view of Nienow et al. (Design and Performance of Single-Use, Stirred-Tank Bioreactors).
Regarding claim 8, Mimitsuka et al. discloses the air overlay space, as set forth above, and further discloses wherein the container is a cell culturing tank (Abstract).
Mimitsuka et al. does not expressly teach wherein the air overlay space comprises greater than 1% of the interior volume of the storage container, although Fig. 1 of Mimitsuka et al. is in accordance with this limitation.
Nienow et al. discloses that headspace volume typically comprises 20-30% of the interior volume of a cylindrical bioreactor (p. 8).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the method disclosed by Mimitsuka et al. such that the air overlay space comprises 20-30% of the interior volume of the storage container (falls within the claim range), based on the teachings of Nienow et al., as the skilled artisan would have been motivated to provide an air overlay volume recognized in the art to be suitable for bioprocessing.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (Very high cell density perfusion of CHO cells anchored in a non-woven matrix-based bioreactor) in view of Nienow et al. (Design and Performance of Single-Use, Stirred-Tank Bioreactors).
Regarding claim 8, Zhang et al. discloses the air overlay space, as set forth above, and further discloses wherein the container is a cell culturing tank (Abstract) (Fig. 1, p. 30).
Zhang et al. does not expressly teach wherein the air overlay space comprises greater than 1% of the interior volume of the storage container, although Fig. 1 of Zhang et al. is in accordance with this limitation.
Nienow et al. discloses that headspace volume typically comprises 20-30% of the interior volume of a cylindrical bioreactor (p. 8).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the method disclosed by Zhang et al. such that the air overlay space comprises 20-30% of the interior volume of the storage container (falls within the claim range), based on the teachings of Nienow et al., as the skilled artisan would have been motivated to provide an air overlay volume recognized in the art to be suitable for bioprocessing.
Claims 9-12, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mimitsuka et al. (US Patent Application Publication 2011/0177551) in view of Zhang et al. (Very high cell density perfusion of CHO cells anchored in a non-woven matrix-based bioreactor).
Regarding claim 9, Mimitsuka et al. discloses the air overlay, as set forth above, and further discloses adding gas to pressurize the inside of the storage container (para. 110).
Mimitsuka et al. is silent as to the method comprising refreshing the air overlay with new air or a new gas through inlet and outlet ports in the container.
Zhang et al. discloses a method for culturing cells in a storage container comprising recirculating culture solution through the container wherein an air overlay is provided at the top of the container (Section 2.2, pp. 29-30) (Fig. 1, p. 30). Zhang et al. further discloses refreshing the air overlay with a new gas through inlet and outlet ports in the container to pressurize the inside of the container for maintaining sterility (Section 2.2, pp. 29-30) (Fig. 1, p. 30).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the method disclosed by Mimitsuka et al. to comprise refreshing the air overlay with a new gas through inlet and outlet ports in the container, based on the teachings of Zhang et al., in order to maintain pressurization and promote sterility.
Regarding claim 10, Mimitsuka et al. in view of Zhang et al. teaches the new gas, as set forth above, wherein Zhang et al. teaches the new gas is oxygen (Section 2.2, pp. 29-30) (Fig. 1, p. 30). Therefore, the prior art combination arrives at the claimed subject matter.
Regarding claim 11, Mimitsuka et al. in view of Zhang et al. teaches the new gas, as set forth above, wherein Zhang et al. teaches the new gas is nitrogen or carbon dioxide (Section 2.2, pp. 29-30) (Fig. 1, p. 30). Therefore, the prior art combination arrives at the claimed subject matter.
Regarding claim 12, Mimitsuka et al. in view of Zhang et al. teaches the new gas, as set forth above, wherein Zhang et al. teaches the new gas is nitrogen (Section 2.2, pp. 29-30) (Fig. 1, p. 30). Therefore, the prior art combination arrives at the claimed subject matter.
Regarding claim 14, Mimitsuka et al. discloses the recombinant protein, as set forth above. Mimitsuka et al. further discloses that the solution is a cell culture solution and that the method is directed towards producing cell culture products (Abstract) wherein the products include recombinant proteins are “not particularly limited” (para. 112).
Mimitsuka et al. is silent as to wherein the recombinant protein is a recombinant disulfide-bond containing protein.
Zhang et al. discloses a method of producing recombinant IgG monoclonal antibody (reads on a disulfide-bond containing protein) comprising expressing the antibody by means of culturing CHO cells (Abstract). Zhang et al. further discloses that the IgG product is a biologic having pharmaceutical and research utility (Section 1, pp. 28-29; Section 5, pp. 39-49).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the recombinant protein disclosed by Mimitsuka et al. to comprise a recombinant IgG monoclonal antibody (reads on a disulfide-bond containing protein), based on the teachings of Zhang et al., in order to enhance the experimental and clinical utility of the method.
Regarding claim 16, Mimitsuka et al. in view of Zhang et al. teaches wherein the recombinant protein is monoclonal IgG antibody, as set forth above. IgG monoclonal antibodies bind SARS-CoV-2 spike protein (see Abstract and Results, p. 830, of Barnes et al. which is cited as an evidentiary reference). Therefore, Mimitsuka et al. in view of Zhang et al. fulfils the claim.
Claims 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mimitsuka et al. (US Patent Application Publication 2011/0177551) in view of Ren et al. (Recombinant SARS-CoV-2 spike S1-Fc fusion protein induced high levels of neutralizing responses in nonhuman primates).
Regarding claim 14, Mimitsuka et al. discloses the recombinant protein, as set forth above. Mimitsuka et al. further discloses that the solution is a cell culture solution and that the method is directed towards producing cell culture products (Abstract) wherein the products include recombinant proteins are “not particularly limited” (para. 112).
Mimitsuka et al. is silent as to wherein the recombinant protein is a recombinant disulfide-bond containing protein.
Ren et al. discloses a method of producing a SARS-CoV-2 S1-Fc recombinant protein comprising expressing the protein by means of culturing CHO cells (Abstract; Section 3.1, pp. 5654-5655). Specifically, the recombinant protein is a disulfide-bond containing protein (Abstract; Section 1, p. 5653; Section 4, pp. 5656-5657). Ren et al. further discloses wherein the SARS-CoV-2 S1-Fc recombinant protein has strong experimental and clinical utility for vaccine development against the COVID-19 pandemic (Abstract; Section 1, p. 5653-5654).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the recombinant protein disclosed by Mimitsuka et al. to comprise a SARS-CoV-2 S1-Fc recombinant protein (reads on a disulfide-bond containing protein), based on the teachings of Ren et al., in order to enhance the experimental and clinical utility of the method.
Regarding claim 17, Mimitsuka et al. in view of Ren et al. teaches wherein the recombinant disulfide-bond containing protein is an Fc-fusion protein, as set forth above.
Claim 17 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (Very high cell density perfusion of CHO cells anchored in a non-woven matrix-based bioreactor) in view of Ren et al. (Recombinant SARS-CoV-2 spike S1-Fc fusion protein induced high levels of neutralizing responses in nonhuman primates).
Regarding claim 17, Zhang et al. discloses wherein the recombinant disulfide-bond containing protein is IgG, as set forth above. Zhang et al. further discloses that the method is directed towards the production of biologics (Section 5, pp. 39-40).
Zhang et al. is silent as to wherein the recombinant disulfide-bond containing protein is a Fc-fusion protein.
Ren et al. discloses a method of producing a SARS-CoV-2 S1-Fc recombinant protein comprising expressing the protein by means of culturing CHO cells (Abstract; Section 3.1, pp. 5654-5655). Specifically, the recombinant protein is a disulfide-bond containing protein derived from IgG (Abstract; Section 1, p. 5653; Sections 3-4, pp. 5654-5657). Ren et al. further discloses wherein the SARS-CoV-2 S1-Fc recombinant protein has strong experimental and clinical utility for vaccine development against the COVID-19 pandemic (Abstract; Section 1, p. 5653-5654).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the recombinant protein disclosed by Zhang et al. to comprise a SARS-CoV-2 S1-Fc recombinant protein (reads on a Fc-fusion protein) based on the teachings of Ren et al., in order to enhance the experimental and clinical utility of the method.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Li et al. (US Patent Application Publication 2015/0031099) is directed to a method comprising recirculating a fermentation solution by drawing the solution to a headspace of a container by means of a nozzle.
Conclusion
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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