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 01/02/2026 has been entered. Claim 1 has been amended, and claim 6-11 are withdrawn from consideration. Therefore, claims 1-11 remain pending in the application.
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 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP2011211961A-Norihiko (all citations are made to the machine English translation attached).
Regarding claim 1, Norihiko discloses a sterilization filter system for a process of manufacturing an antibody pharmaceutical (para. [0001]; para. [0008]; and para. [0002]), comprising: a preparation tank for preparing one selected from a medium and a buffer (stock solution tank 2, para. [0020], line 2, liquid medium component, Fig. 1);
Norihiko discloses a storage tank for storing the medium or buffer received from the preparation tank (a certain amount of liquid medium is stored in the storage tank 4, the filter sterilization pump 47 is driven, the liquid medium is pumped to the sterilization filter 46, para. [0042], lines 1-2, Fig. 1);
Norihiko discloses a transfer pipeline configured to flow the medium or buffer stream discharged from the preparation tank into the storage tank (circulation pipe 19 and pipe line 21, para. [0023] and para. [0029], lines 1-2, Fig. 1);
Norihiko discloses a process liquid storage tank for storing a process liquid in the intermediate stage of purification and culture processes (post-process tank 52, para. [0033], lines 6-7, shown in Fig. 1);
Norihiko discloses a process liquid transfer pipeline (liquid supply pipe 45 configured to flow the process liquid into the process liquid storage tank (para. [0035], line 1, Fig. 1);
Norihiko discloses and a control unit (controlled filtration flow rate, para. [0041], line 3), wherein the sterilization filter cartridge comprises, for a washing and filter test process including one or more selected from filter sterilization, filter wetting, flushing, filter integrity test, air ballasting and barrier integrity testing (filter wetting—liquid medium is pumped to sterilization filter 46, para. [0042], line 2-3), a first pipeline entering the sterilization filter cartridge (Fig. 1 shows a pipe entering the left side of filter 46, which is connected to flow sensor 49), and a second pipeline exiting the sterilization filter cartridge (a second pipeline pipe 53 exits filter 46, as shown in Fig. 1); and wherein the first pipeline (Fig. 1 shows a pipe entering the left side of filter 46, which is connected to flow sensor 49) and the second pipeline (a second pipeline pipe 53 exits filter 46, as shown in Fig. 1) are separate from the transfer pipeline and the process liquid transfer pipeline (Fig. 1 shows a second pipeline pipe 53 exits filter 46 is separate from the transfer pipeline—pipe 21 and the process liquid transfer pipeline—liquid supply pipe 45).
Regarding claim 2, wherein an integrity tester is provided on the first pipeline entering the sterilization filter cartridge (Norihiko discloses a sensor 48 are confirmed to confirm there is no abnormality, para. [0042], lines 4-5).
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.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over JP2011211961A-Norihiko (all citations are made to the machine English translation attached) as applied to claim 1 above, and further in view of US 2013/0109086 A1-Kobayashi et al. (hereinafter Kobayashi).
Regarding claim 3, Norihiko teaches the invention discussed above in claim 1. Further, Norihiko teaches medium in a preparation tank and a storage tank; and a control mechanism, also discussed above. However, Norihiko does not explicitly teach a control unit automatically transfers a medium or buffer.
For claim 3, Kobayashi teaches an invention relating to a disposable set for cell culture, a cell culture device, and a cell preparation method for sequentially carrying out all of a step of separating useful cells, a step of culturing the useful cells separated, and a step of washing and concentrating the cultured cell (para. [0001]) and Kobayashi teaches a programmable controller (para. [0055], lines 1-2), where the controller opens and closes the flow path on-off valve (para. [0055], lines 1-2), which reads on the instant claim limitation of a control unit automatically transfers a medium or buffer.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of Norihiko and further include a control unit automatically transfers a medium or buffer as taught by Kobayashi. Further, Kobayashi teaches the controller controls flow path of the on-off valve via opening and closing said valve (para. [0037], lines 12-14).
Regarding claim 4, Norihiko teaches the invention discussed above in claim 1. Further, Norihiko teaches process liquid and a process liquid storage tank, also discussed above. However, Norihiko does not explicitly teach a control unit automatically transfer process liquid.
For claim 4, Kobayashi teaches an invention relating to a disposable set for cell culture, a cell culture device, and a cell preparation method for sequentially carrying out all of a step of separating useful cells, a step of culturing the useful cells separated, and a step of washing and concentrating the cultured cell (para. [0001]) and Kobayashi teaches a programmable controller (para. [0055], lines 1-2), where the controller opens and closes the flow path on-off valve (para. [0055], lines 1-2), which reads on the instant claim limitation of a control unit automatically transfer process liquid.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of Norihiko and further include a control unit automatically transfer process liquid as taught by Kobayashi. Further, Kobayashi teaches the controller controls flow path of the on-off valve via opening and closing said valve (para. [0037], lines 12-14).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over JP2011211961A-Norihiko (all citations are made to the machine English translation attached) as applied to claim 1 above, and further in view of WO2018080178A1-Park et al. (hereinafter Park).
Regarding claim 5, Norihiko teaches the invention discussed above in claim 1. Further, Norihiko teaches a sterilization system applied to transfer of a medium and a process liquid. However, Norihiko does not explicitly teach the process of manufacturing one or more antibody pharmaceuticals selected from the group consisting of abagovomab, abciximab, adalimumab, adecatumumab, alemtuzumab, altumomab, altumomab pentetate, anatumomab, anatumomab mafenatox, arcitumomab, atlizumab, basiliximab, bectumomab, ectumomab, belimumab, benralizumab, bevacizumab, brentuximab, canakinumab, capromab, capromab pendetide, catumaxomab, certolizumab, clivatuzumab tetraxetan, daclizumab, denosumab, eculizumab, edrecolomab, efalizumab, etaracizumab, ertumaxomab, fanolesomab, fontolizumab, gemtuzumab, girentuximab, golimumab, ibritumomab, igovomab, infliximab, ipilimumab, labetuzumab, mepolizumab, muromonab, muromonab-CD3, natalizumab, necitumumab, nimotuzumab, ofatumumab, omalizumab, oregovomab, palivizumab, panitumumab, ranibizumab, rituximab, satumomab, sulesomab, ibritumomab, ibritumomab tiuxetan, tocilizumab, tositumomab, trastuzumab, ustekinumab, visilizumab, votumumab, zalutumumab, brodalumab, anrukinzumab, bapineuzumab, dalotuzumab, demcizumab, ganitumab, inotuzumab, mavrilimumab, moxetumomab pasudotox, rilotumumab, sifalimumab, tanezumab, tralokinumab, tremelimumab, urelumab, adornase alfa, Rebif, becaplermin, alteplase, laronidase, alefacept, aflibercept, raxibacumab, darbepoetin alfa, becaplermin concentrate, interferon beta-lb, botulinum toxin type A, rasburicase, asparaginase, epoetin alfa, etanercept, agalsidase beta, interferon alfacon-1, interferon alfa-2a, anakinra, botulinum toxin type B, pegfilgrastim, oprelvekin, filgrastim, denileukin diftitox, peginterferon alfa-2a, aldesleukin, dornase alfa, interferon beta-la, becaplermin, reteplase, interferon alfa-2, tenecteplase, drotrecogin alfa, rilonacept, romiplostim, methoxypolyethylene glycol-epoetin beta, a C1 esterase inhibitor, idursulfase, alglucosidase alfa, abatacept, galsulfase, palifermin and interferon gamma-lb.
For claim 5, Park teaches a process for reducing undesired culture by-products in a glutamine-free cell culture medium, a culture process for producing a target protein related thereto, and a culture process for producing a target protein (page 1, paragraph 1, lines 1-2), and Park teaches a target protein abagovomab, which reads on the instant claim limitation of process of manufacturing one or more antibody pharmaceuticals selected from the group consisting of abagovomab.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of Norihiko and further include a process of manufacturing one or more antibody pharmaceuticals selected from the group consisting of abagovomab as taught by Park. Further, Park teaches abagovomab is a target protein and Park teaches the target protein refers to a protein to be obtained by culturing cells (page 2, paragraph 5, line 1). Also, Park teaches cells maintained under the process conditions may have increased viability (page 3, paragraph 3, line 1).
Response to Arguments
Applicant's arguments filed 01/02/2026 have been fully considered but they are not persuasive. On the top of page 6 of applicant’s remarks, applicant cites the status of the claims and the relied upon art. Applicant also discusses claim 1 was amended and no new matter has been entered via the amendment(s) submitted. Applicant’s arguments begin on the top of page 7 of their remarks submitted. Applicant asserts the Norihiko reference does not disclose or teach “wherein the sterilization filter cartridge comprises, for a washing and filter test process including one or more selected from filter sterilization, filter wetting, flushing, filter integrity test, air ballasting and barrier integrity testing, a first pipeline entering the sterilization filter cartridge, and a second pipeline exiting the sterilization filter cartridge, and wherein the first pipeline and the second pipeline are separate from the transfer pipeline and the process liquid transfer pipeline”. Further, applicant briefly discusses the claimed subject matter and provides an annotation of Figure 1 of the instant application.
On the bottom of page 7 and the top of page 8 of applicant’s remarks, applicant cites the relied upon reference, Norihiko, as cited in the Office Action mailed on 10/03/2025. Applicant asserts, the previously mentioned reference does not disclose or teach “wherein the sterilization filter cartridge comprises, for a washing and filter test process including one or more selected from filter sterilization, filter wetting, flushing, filter integrity test, air ballasting and barrier integrity testing, a first pipeline entering the sterilization filter cartridge, and a second pipeline exiting the sterilization filter cartridge, and wherein the first pipeline and the second pipeline are separate from the transfer pipeline and the process liquid transfer pipeline”. Applicant also asserts the filtration means 46 is only connected to the pipe connecting the storage tank 4 and the post-treatment tank 52, and does not disclose separate first and second pipelines.
In response, applicant’s latter argument is not found persuasive because as discussed above in the rejection, filter means 46 comprises a first pipe (Fig. 1 shows a pipe entering the left side of filter 46, which is connected to flow sensor 49) and a second pipe (a second pipeline pipe 53 exits filter 46; that is, on the right side of filter 46, as shown in Fig. 1). Additionally, Norihiko does disclose the previously mentioned first and second pipes are separate, as shown in Fig. 1. Further, the first pipe and second pipe previously discussed, are separated from the transfer pipeline (pipe 21, shown in Fig. 1) and the process liquid transfer pipeline (liquid supply pipe 45, also shown in Fig. 1). Moreover, the latter is shown below in annotated Fig. 1 of Norihiko.
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Therefore, for the reasons discussed above in this section, the claims stand rejected. Likewise, it does not appear applicant has provided support for the fourth pipeline claimed in independent 1, because based on applicant’s figure 1, there appears to be only 3 pipelines entering the filter cartridge, versus four, as claimed by applicant.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/L.A.A./ Examiner, Art Unit 1799
/MICHAEL L HOBBS/ Primary Examiner, Art Unit 1799