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 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.
Claims 4, 14, 17, 21 and 25 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 14 recites the limitation "the biocarriers" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 4, 17, 21 and 25, the phrases "such as" and “e.g.” render the claims indefinite because it is unclear whether the limitations following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
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, 8, 9, 13 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parameswaran (US 20170015968).
With respect to claim 1, Parameswaran discloses a bioreactor comprising a shell (Figure 4B:150) defined by one or more walls and a length and a plurality of porous hollow fiber membranes (Figure 4B:110) inside the shell. This taught in paragraphs [0032]-[0043]. Figure 4B shows that the porous hollow fiber membranes do not span the entire length of the shell.
With respect to claim 2, Parameswaran discloses the apparatus as described above. Parameswaran shows in Fig. 4B that approximately 50% of the length of the shell remains unoccupied by the plurality of porous hollow fiber membranes.
With respect to claims 3 and 4, Parameswaran discloses the apparatus as described above. Parameswaran shows in Figs. 3 and 4a show that the porous hollow fiber membranes 110 are incorporated into a module (Figure 3:170). A first end of each hollow fiber is potted at a first portion of the module, and a second end of each hollow fiber is potted at a second portion of the module. As previously discussed, Fig. 4B shows that the module and hollow fibers extend to the middle of the bioreactor shell 150. Paragraph [0045] states that the porous hollow fiber membranes may include polypropylene materials.
With respect to claims 8 and 9, Parameswaran discloses the apparatus as described above. Parameswaran depicts in Figs. 4B and %a-5C that the porous hollow fiber membranes are cylindrical tube bundles, and that the shell has the shape of a cylinder.
With respect to claim 13, Parameswaran discloses the apparatus as described above. Parameswaran states that microorganisms are grown on outer surfaces of the porous hollow fiber membranes. See paragraph [0018] (“a biofilm disposed on the outer surface of the hollow fiber membrane”).
With respect to claim 16, Parameswaran discloses the apparatus as described above. Parameswaran teaches a corresponding method for extracting compounds from a broth. Parameswaran states that microorganisms are cultured on outer surfaces of the hollow fiber membranes so that they are in direct contact with a shell side stream containing the broth.
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.
Claims 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Parameswaran (US 20170015968) as applied to claims 1 and 13, and further in view of Kasuto (US 20150232797).
Parameswaran discloses the apparatus as described above, however does not teach the use of biocarriers.
Kasuto discloses a bioreactor comprising a plurality of biocarriers (Figure 1A:10) comprising pores for supporting cell growth. See paragraph [0061] (“the material used to produce any of the devices describe herein can…have a hollow or porous interior”). Paragraph [0076] teaches that the biocarriers are configured to be utilized within hollow fiber bioreactors.
Before the effective filing date of the claimed invention, it would have been obvious to support microorganism growth within the pore spaces of a plurality of biocarriers disposed within the shell volume of the Parameswaran reactor. Kasuto teaches that this would increase the surface area for cell attachment and facilitate the formation of cell biofilms. Kasuto further states that the provision of biocarriers improves cell recovery and product purification, which enables commercial up-scaling.
Claims 17, 21-25 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Parameswaran (US 20170015968) as applied to claims 1 and 13, and further in view of Kipp (US 20120184759) and Angenent (US 20140322772).
With respect to claim 17, Parameswaran discloses the method described above. Parameswaran teaches that chemical fuel products and precursors (e.g., carboxylates) are purified from the shell side broth using an extraction process. Parameswaran, however, does not appear to teach that the shell side stream of broth flows in a cross-current or co-current pattern in relation to a solvent flowing axially through the plurality of porous hollow fiber membranes.
Kipp discloses a method of extracting one or more compounds from a broth (Figure 1:102). The broth containing microorganisms flows in a counter-current pattern relative to the flow of a solvent flowing axially through a plurality of porous hollow fiber membranes (Figure 1:104a-c). This is taught in paragraphs [0058]-[0063].
Angenent discloses a method of producing and extracting carboxylate from a fermentation broth. Angenent teaches that a hollow fiber separation device is configured to permit extraction of carboxylate products across a porous membrane using a mineral oil solvent comprising trioctylphosphine oxide. This is taught in paragraphs [0051], [0075], [0095] and [0100].
Before the effective filing date of the claimed invention, it would have been obvious to pass a solvent through the plurality of hollow fiber membranes taught by Parameswaran for the purpose of extracting a product from the culture broth. As evidenced by Kipp and Angenent, this is an effective way to obtain a purified compound of interest from a cell culture fluid that is particularly well suited for the recovery of carboxylates. Angenent teaches in paragraph [0051] that membrane-based liquid-liquid extraction using a mineral oil stripping solution is a well-known strategy characterized by a high degree of predictability. It is well within the ability of one of ordinary skill to select an art-recognized solution when determining how to extract product compounds from the Parameswaran broth.
With respect to claim 21, Parameswaran, Kipp and Angenent disclose the combination described above. As previously discussed, Angenent states in paragraphs [0051], [0075], [0095] and [0100] that the membrane separation device utilizes a mineral oil solvent comprising trioctylphosphine oxide.
With respect to claims 22-24, Parameswaran, Kipp and Angenent disclose the combination described above. Angenent teaches in paragraph [0051] that a stripping aqueous phase petraction solution is maintained “at pH greater of 8.0 or above” for removal of carboxylates from the solvent. See also paragraph [0095] (“The solvent, which wet the hydrophobic membranes, was pumped at the same rate on the shell side (outside the fibers) of the membrane, counter-flow to the bioreactor liquid. The solvent was constantly recirculated between contact with the bioreactor liquid and the shell side of a second membrane unit, where it contacted an aqueous phase buffered with a 0.5 M borate solution at pH 9. The pH 9 solution was continuously recirculated from a 5-L reservoir where a pH controller maintained the pH by automatic addition of 5M NaOH”).
With respect to claims 25, 27 and 28, Parameswaran, Kipp and Angenent disclose the combination described above. Parameswaran teaches in paragraph [0036] that temperature and pH within the bioreactor are maintained at optimum values based on the type of microorganism in the culture. The vessel is configured to control temperature and pH, and Parameswaran shows in Table 1 different microorganisms that require temperatures between about 25°C and 35°C and a pH between about 5 and 6. Parameswaran teaches that pH may be controlled through the recirculation of gases through the bioreactor. Paragraph [0094] of Angenent discloses an embodiment in which the bioreactor is maintained at a pH of about 5.5 and a temperature of about 30°C. Angenent states that biogas is recirculated through the reactor. Paragraph [0044] indicates that hydraulic retention time may be about 24 hours.
With respect to claim 29, Parameswaran, Kipp and Angenent disclose the combination described above. Angenent states in paragraph [0003] that medium chain carboxylic acids are produced.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Chauve (US 11060118), Kobayashi (US 20130280767) and Gonzalez (US 20120247008) references teach the state of the art regarding hollow fiber bioreactors.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799