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 02/20/2026 has been entered. Claims 6-7 remain withdrawn from consideration, claims 1 and 4 have been amended, no claims have been canceled, and no claims have been added. Therefore, claims 1-7 remain pending in the application.
Drawings
Applicant has submitted replacement drawings to overcome the objection cited in the Office Action mailed on 11/20/2025. Therefore, the objection of the drawings previously cited is withdrawn.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 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP2011172533A-Kamada et al. (hereinafter Kamada, all citations are made to the machine English translation).
Regarding claim 1, Kamada discloses a microcarrier-based cell culture apparatus (cell culture carrier substrate useful for efficiently forming a high-density culture of cells and thereby forming a three-dimensional cell cluster (spheroid). The present invention also relates to a cell culture reactor, page 1, paragraph 1, lines 1-3; reactor (1), page 9, paragraph 3, line 1, shown in Fig. 1), comprising: a cell culture chamber (page 9, paragraph 3, line 2, Fig. 1); a cell culture medium accommodated in the chamber (liquid medium 7 corresponding to the fluid flows, page 9, paragraph 3, line 4); and microcarriers suspended in the cell culture medium to provide surfaces on which cells are grown (a PMMA carrier is suspended in the culture, page 5, lines 15-16), wherein the cell culture medium is introduced through a lower region of the cell culture chamber (fluid inlet 2, page 9, paragraph 3, line 2, Fig. 1, where Fig. 1 shows inlet 2 oriented on a lower region) and discharged through an upper region thereof (outlet 3, page 9, paragraph 3, line 2, Fig. 1, where Fig. 1 shows outlet 3 oriented on an upper region).
and wherein, as cells grow on surfaces of the microcarriers, a specific gravity of cell-microcarrier complexes each comprising a respective microcarrier and cells attached thereto increases such that the cell-microcarrier complexes sink toward a bottom region of the cell culture chamber, and a growth state of the cells is observed by confirming a change in location distribution within the cell culture chamber of the cell-microcarrier complexes (Kamada discloses there is an influence due to gravity, it seems that cells may gather at the bottom of the microcarrier having a good culture environment, page 14, paragraph 4, lines 4-5).
Regarding claim 3, Kamada discloses wherein, as cells proliferate (cell proliferation effect by suspension of culture carrier in culture medium and stirring of culture medium, page 13, paragraph 4, lines 1-3) on surfaces of the microcarriers, the microcarriers sink to a bottom of the cell culture chamber.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over JP2011172533A-Kamada et al. (hereinafter Kamada, all citations are made to the machine English translation) as applied to claim 1 above, and further in view of JP2004236553A-Ozawa et al. (hereinafter Ozawa, all citations are made to the machine English translation).
Regarding claim 2, Kamada teaches the invention discussed above in claim 1. Further, Kamada teaches a microcarrier-based cell culture apparatus and a cell culture medium, also discussed above. However, Kamada does not explicitly teach a specific gravity of the of the microcarriers is less than that of the cell culture medium.
For claim 2, Ozawa teaches an invention relating to a microcarrier used as a culture carrier for adhesion-dependent cells, a culture apparatus and a culture method using the same (page 1, lines 1-3) and Ozawa teaches the microcarrier has a specific gravity of 0.9, where the suspension culture has a specific gravity preferably about 1.0 (page 2, lines 46-47), which reads on the instant claim limitation of a specific gravity of the of the microcarriers is less than that of the cell culture medium.
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 invention of Kamada and further include a specific gravity of the of the microcarriers is less than that of the cell culture medium as taught by Ozawa. Further, Ozawa teaches when the specific gravity is smaller than that of the culture medium, the tendency of the microcarriers to rise from the culture medium increases, and it is necessary to stir vigorously (page 2, lines 49-50); and thus, Kamada suggests when the microcarriers sink to the bottom of the chamber, the microcarriers have a greater specific gravity. Also, Kamada teaches the specific gravity of the particular can be adjusted and therefore, the entire microcarrier, it may be desired by a conventionally known means such as selection of the introduction amount of the magnetic substance for specific gravity to be obtained (page 3, lines 52-53).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over JP2011172533A-Kamada et al. (hereinafter Kamada, all citations are made to the machine English translation) as applied to claim 1 above, and further in view of US 4,748,123A-Birch et al. (hereinafter Birch).
Regarding claim 4, Kamada teaches the invention discussed above in claim 1. Further, Kamada teaches a cell culture chamber. However, Kamada does not explicitly teach a turbulent eddy-breaker at a lower end thereof.
For claim 4, Birch teaches an invention relating to a continuous fermenter vessel for receiving an agitated suspension culture of cell (col. 1, lines 6-7) and Birch teaches a baffle means defining in combination with interior wall of the vessel (col. 2, lines 3-4), where Fig. 1 shows baffle 9 extending to a lower end of vessel 1, which reads on the instant claim limitation of a turbulent eddy-breaker.
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 invention of Kamada and further include a turbulent eddy-breaker (baffle 9) as taught by Birch. Further, Birch teaches the baffle means allow for circulation of a suspension culture (col. 2, lines 3-6).
Response to Arguments
Applicant's arguments filed 02/20/2026 have been fully considered but they are not persuasive. Applicant recites amended claim 1 on the top of page 6, and support thereof. Also, applicant discusses the objection of the drawings on the middle and bottom of page 6 of their remarks, and on the top of page 7 of their remarks. Applicant has submitted replacement sheet(s) for the objected drawings.
Applicant cites the status of the claims and the relied upon art noted in the previously mailed rejection on the middle and bottom of page 7 and the top of page 8 of applicant’s remarks. Applicant’s arguments begin on the bottom of page 8 of their remarks. Applicant asserts the relied upon references of Kamada, Ozawa and Birch either alone or in combination do not disclose or suggest the features of claim 1 of the instant application. Further, applicant briefly recites that Kamada related to cell culturing using microcarriers and asserts Kamada only describes observing cell adhesion and proliferation using a microscope. Applicant also asserts Kamada does not disclose a mechanism for observing cell growth by confirming changes in the location distribution of cell-microcarrier complexes, nor does it contain any inferences about such a mechanism.
In response, the latter argument is not found persuasive because applicant has acknowledged Kamada does disclose a microscope, where in the instant case, is a type of mechanism for observing cell growth, where the user of the microscope can observe changes in the location of the cell-microcarrier complexes as well. Further, Kamada discloses the formation state of the cell aggregate can be observed with the microscope (page 4, paragraph 3, line 6). That is, the microscope of Kamada has the capabilities for observing cell growth by confirming changes in the location distribution of cell-microcarrier complexes, as discussed above in this section.
On the top of page 9 of applicant’s remarks, applicant asserts, the Ozawa reference describes the specific gravity of microcarriers and the necessity of agitation. Applicant asserts Ozawa does not disclose a configuration for observing cell growth by confirming changes in the location distribution of cell-microcarrier complexes, nor does it contain any content that allows for inference of such a configuration. In response, the latter argument is not found persuasive firstly, because application does acknowledge Ozawa does teach s specific gravity of the microcarriers. Secondly, the specific gravity of the cell-microcarrier complexes has been disclosed by the Kamada reference as discussed above in the rejection. That is the attachment to the cells of the microcarriers of Kamada does allow for a specific gravity, because the cell-microcarrier complex does sink to the bottom of the device, as discussed above in the rejection. Thirdly, the Ozawa reference was relied upon for teach the limitation of “a specific gravity of the of the microcarriers is less than that of the cell culture medium.”
On the middle of page 9 of applicant’s remarks, applicant briefly states the additional reference, Birch, relates to a suspension culture device. Applicant also asserts here that Bird does not disclose a configuration for observing cell growth by confirming changes in the location distribution of cell-microcarrier complexes, nor does it contain any content that allows for inference of such a configuration. In response, the latter argument is not found persuasive because as discussed above in this section, as well as in the rejection above, the primary reference, Kamada, does teach this limitation. That is, applicant has acknowledged Kamada does disclose a microscope, where in the instant case, is a type of mechanism for observing cell growth, where the user of the microscope can observe changes in the location of the cell-microcarrier complexes as well. Further, Kamada discloses the formation state of the cell aggregate can be observed with the microscope (page 4, paragraph 3, line 6). Also, the microscope of Kamada has the capabilities for observing cell growth by confirming changes in the location distribution of cell-microcarrier complexes, as discussed above in this section.
On the bottom of page 9 and the top pf page 10 of applicant’s remarks, applicant asserts the references of “Kamada, Ozawa, and Birch do not disclose or suggest the claimed features in which the growth state of cells is observed through a change in the location distribution of cell-microcomplexes, as the specific gravity of cell cell-microcomplex increases as the cell grow, and the cell-microcomplexes settle to the bottom of the cell culture chamber as the specific gravity increases.” In response, the latter assertion by applicant is also not found persuasive for the reasons discussed above in this section as well as in the rejection above. That is, Kamada alone, discloses microcarriers and cells being attached to those microcarriers. Also, as discussed above, due to an influence of gravity, the cells gather to a bottom of the microcarrier having a good culture environment. Moreover, Kamada discloses an observation mechanism, a microscope, as acknowledged by applicant, which is capable of observing cell growth, where the user of the microscope can observe changes in the location of the cell-microcarrier complexes as well.
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