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 .
Preliminary Remarks
The amendment filed on 09/08/2026 has been entered. Claims 2-7 and 9-13 were amended, claims 2, 8, and 20 have been canceled, claims 14-19 and 21-22 are withdrawn and amended by applicant. Therefore, claims 2-7, 9-19 and 21-22 remain pending in the application.
Claim Objections
Claims 3-13 have been amended to overcome the objection cited in the Office Action mailed on 06/26/2026. Therefore, the objection of said claims is withdrawn.
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.
Claims 2-7 and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO8605202A1-Dean et al. (hereafter, “Dean”).
Regarding claim 2, Dean discloses a reactor comprising a plurality of sections in sequential order (serial arrangement of individual reactors 100, page 5, paragraph 5, Fig. 4) in which a first section includes a gas input port (inlet 30, page 4, paragraph 1, Fig. 1) and a second section includes a gas output port (outlet 32, paragraph 4, Fig. 1). It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. It has been well established that it is fundamental that an apparatus claim defines the structure of the invention and not how the structure is used in a process, or what materials the structure houses in carry out the process. It is further noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. See MPEP §2144 and 2115.
“wherein each section of the plurality includes: a packing material”: Dean discloses biocatalyst beads 136 (page 5, paragraph 2, Fig. 4).
“a liquid recirculation circuit of the section including a fluid line that carries liquid from below the packing material to above the packing material;”: Dean discloses side loops 160 from each reactor (also, corresponds to 16 in Fig. 1, page 5, paragraph 5, Fig. 4), where Fig. 4 shows loops 160 carrying fluid from below beads 136 and to above beads 136 in each reactor 100.
“and a gas recirculation circuit of the section including a gas line that carries gas from above the packing material to below the packing material, the gas recirculation circuit including a blower or a fan configured to recirculate gas within the section;”: Figure 4 includes tubing on both sides of each reactor 100. Further, Dean discloses cooling fans (page 4, paragraph 7).
“wherein a flow rate in the gas line is in a range from 2x to 10x a volumetric flow of gas at the gas input port.”: Dean discloses the recirculation rate needed in any cell culture application is a function of many variables (page 8, paragraph 2). Also, Dean discloses valves of the system to control the rate (page 9, paragraph 2).
Regarding claim 3, Dean discloses the plurality of section of reactors 100 are oriented vertically (shown in Fig. 4).
Regarding claim 4, Dean discloses biocatalyst beads (136 page 5, paragraph 2), where Fig. 4 shows that due to the orientation of the reactors 100, liquid would occur under gravity feed.
Regarding claim 5, Dean discloses via Fig. 4 the biocatalyst beads 136, where the beads cab be arranged either structured or random.
Regarding claim 6, Dean discloses product stream passes through an in-line microporous filter 321 to remove cells and cell debris and is collected in storage vessel 318 (page 9, paragraph 7).
Regarding claim 7, Dean discloses the liquid is recirculated using pumps 235 to the fluidized bed through heat exchangers (page 7, paragraph 8).
Regarding claim 10, Dean discloses a duct where the reactors 100 are connected to each other via connectors 162 shown in Fig. 4.
Regarding claim 11, Dean discloses multiple sections of the device as shown in Fig. 4; where Fig. 4 depicts multiple reactors having sections of the reactors. Further, Dean discloses multiple control valves 161, shown Fig. 4 to control the flow rate of the recirculation loops 160.
Regarding claim 12, Dean discloses anaerobic processes are contemplated also (page 5, paragraph 8).
Regarding claim 13, Dean discloses control of the rate of medium and flow rate of the recirculating culture liquid (page 5, paragraph 5); also, Dean discloses multiple control valves 161 in Fig. 4.
Therefore, the reference of Dean meet the limitations of claims 2-7 and 10-13.
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 (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 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 9 is rejected under 35 U.S.C. 103 as being unpatentable over WO8605202A1-Dean et al. (hereafter, “Dean”).
Regarding claim 9, Dean discloses the invention discussed above in claim 1. Further, Dean discloses a recirculation circuit and a barrier, also discussed above. However, Dean does not explicitly disclose a gas port in the barrier.
For claim 9, a different embodiment of Dean discloses ports 262 in the reactors 200 (page 6, paragraph 6, Fig. 5).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to incorporate the ports 262 of another embodiment of Dean in order to allow removal of product removal from the reactor as taught by the other embodiment of Dean (page 6, paragraph 6, Fig. 5).
Response to Arguments
Applicant’s arguments with respect to claims 2-13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. More specifically, the current rejection above pertains to new reference(s) relied upon to address the newly amended claim limitations; the arguments filed rely on the reference or combination of references not currently being used in the present Office Action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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.
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/LENORA A ABEL/Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
