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 .
Status of the Claims
The amendment filed 5/1/2026 has been entered. Claims 30-56 remain pending in the application and claims 51-56 remain withdrawn. Applicant’s amendments to the claims have overcome each 112(b) rejection previously set forth in the Non-Final Office Action mailed 12/8/2025.
Response to Arguments
Applicant’s arguments filed 5/1/2026 have been considered but they are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Applicant added limitations to independent claim 30 for a membrane including endothelial cells and mesenchymal stromal cells. These new limitations do not distinguish the claimed invention over the prior art. The Examiner acknowledges that Cuiffi et al. does not explicitly teach culturing endothelial cells or mesenchymal stromal cells; however, Cuiffi et al. does disclose a permeable membrane for supporting multiple cell types (paras. 0008, 0081, 0084).
Though Cuiffi et al. does not explicitly disclose culturing endothelial cells or mesenchymal stromal cells, it would have been obvious to modify the device of Cuiffi et al. in view of Huh et al. (US 2020/0190456 A1), which discloses culturing these cells on a membrane. This will be discussed in further detail in the 35 USC § 103 section below.
Applicant’s arguments regarding the objection to claim 50 previously set forth in the Non-Final Office Action mailed 12/8/2025 are persuasive; and accordingly, the objection to claim 50 has been withdrawn.
Specification
The disclosure was objected to because it contained an embedded hyperlink and/or other form of browser-executable code (para. 00152). Amendments to the specification were received on 5/1/2026. Accordingly, the objection to the specification has been withdrawn.
Claim Objections
Claims 30 and 50 are objected to because of the following informalities: it is recommended that a comma be added after “tumor models” and before “the modular system” in line 2. Appropriate correction is required.
Claim 46 objected to because of the following informalities: it is recommended that "one or more sidewall" should read "one or more . Appropriate correction is required.
Claim 4 objected to because of the following informalities: it is recommended that "one or more sidewall" should read "one or more . Appropriate correction is required.
Claim 4 objected to because of the following informalities: it is recommended that "one or more sidewall" should read "one or more . Appropriate correction is required.
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.
Claims 30-32, 34-44, and 46-50 are rejected under 35 U.S.C. 103 as being unpatentable over Cuiffi et al. (US 2017/0137768 A1) (already of record) in view of Huh et al. (US 2020/0190456 A1).
Regarding claim 30, Cuiffi et al. teaches a modular system (para. 0003 “modular device”) for culturing systemic bioengineered tumor models (abstract “culturing and interconnecting of a plurality of tissue types”), the modular system including a permeable membrane (para. 0008 “membrane to support a plurality of cells”; paras. 0081, 0084 “permeable membrane”), and one or more tissues or cells (para. 0047 “the culture of multiple types of cells and/or tissue”), wherein the modular system comprises: a platform having a substantially planar body including a bottom surface and a top surface, the top surface defining at least one seat, and the bottom surface including a channel disposed along the platform body (204 fluid flow plate); and a portable tissue chamber releasably mounted to the seat of the platform (206 cell culture vessel), the portable tissue chamber including an internal compartment configured to hold a tissue culture (para. 0081 “cell culture vessels 206 are configured to house a specific cell type and/or cells from a particular organ type”), the internal compartment being defined by a bottom surface of the portable tissue chamber (Fig. 3A 206 cell culture vessel), a plurality of sidewalls of the portable tissue chamber extending from the bottom surface of the portable tissue chamber (Fig. 3A 206 cell culture vessel), and an open top of the portable tissue chamber defined by the plurality of sidewalls of the portable tissue chamber (Fig. 3A 206 cell culture vessel), the bottom surface of the portable tissue chamber being formed at least in part by the permeable membrane positioned proximate the channel of the platform (para. 0047 “cell culture vessels 206 are configured to include 3-dimensional cell culture scaffolds to support and culture the cells and/or tissues”; para. 0093 “the bottom surface of the cell culture insert includes a semi-permeable membrane”); wherein the platform includes a first coupling member extending from the platform body (308 screws), the portable tissue chamber includes a second coupling member releasably engaged to the first coupling member of the platform to secure the portable tissue chamber to the seat of the platform (Figs. 2-3 cell culture vessels 206 include indentation which accommodates screw 308 to attach the cell culture vessels to the fluid flow plate 204); the one or more tissues or cells are disposed within the portable tissue chambers (para. 0047).
Cuiffi et al. teaches a cell culture system for culturing multiple cell types (abstract “culturing and interconnecting of a plurality of tissue types”; para. 0008 “membrane to support a plurality of cells”), but does not explicitly teach culturing endothelial cells and mesenchymal stromal cells (MSCs). However, Huh et al. teaches that culturing endothelial cells and mesenchymal cells on a membrane is known in the art (para. 0034). Though Cuiffi et al. does not explicitly teach culturing endothelial cells and mesenchymal cells, it would have been obvious to a person of ordinary skill in the art to culture these cell types on a membrane because the substitution of one known element for another would have predictably resulted in a cell culture system that cultures endothelial cells and mesenchymal cells on a membrane, with reasonable expectation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of Cuiffi et al. with the teachings of Huh et al. to obtain the invention as specified in claim 30.
Regarding the limitation “one or more of the first coupling member of the platform and the second coupling member of the portable tissue chamber are pivotable with respect to the other”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by modified Cuiffi et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to reversibly couple components to a cell culture platform with clips, screws, vacuum, or adhesive (para. 0048) and would be structurally capable of having a coupling member that is pivotable absent clear evidence otherwise.
Regarding claim 31, Cuiffi et al. teaches a system wherein the channel is in communication with the portable tissue chamber (Fig. 2 culture vessel 206 sits on top of fluid flow plate 204).
Regarding claim 32, Cuiffi et al. teaches a system comprising an on-board pump disposed on the platform body (Fig. 1 fluid pump 114), wherein the on-board pump is operatively connected to a reservoir, and the reservoir is configured to hold media (Fig. 1 fluid reservoir 118).
Regarding claim 34, Cuiffi et al. teaches a system wherein the reservoir is disposed on the platform body and the platform body includes a media entrance port and a media exit port (para. 0046 “The cell culture platform 102 further includes a plurality of fluid and/or gas inlet/outlet ports 208. As illustrated, the ports 208 are components of the control plate 202. In other implementations, the control plate 202, fluid flow plate 204, and/or cell culture vessels 206(1)-206(n) each include one or more ports 208.”).
Regarding claim 35, Cuiffi et al. teaches a system wherein the channel of the platform body is in fluid connection with the permeable membrane of the portable tissue chamber (para. 0074 “fluid flow plate 204 acts as an interface between the control plate 202 and the cell culture vessels 206”).
Regarding claim 36, Cuiffi et al. teaches a system wherein the platform further comprises a media entrance port and a media exit port, each disposed on the top surface of the platform body (para. 0046 “The cell culture platform 102 further includes a plurality of fluid and/or gas inlet/outlet ports 208).
Regarding claim 37, Cuiffi et al. teaches a system including a plate disposed beneath the platform (Fig. 2 control plate 202).
Regarding claim 38, Cuiffi et al. teaches a system wherein the channel of the platform is configured to permit media flow through the system (para. 0045 “fluids include growth medium”).
Regarding claim 39, Cuiffi et al. teaches a system wherein the permeable membrane is selectively permeable to media flowing through the system (para. 0086 “semi-permeable membrane”).
Regarding claim 40, Cuiffi et al. teaches a system comprising a plurality of portable tissue chambers mounted to a corresponding seat defined by the top surface of the platform body (Figs. 2-3A multiple cell culture vessels 206 positioned on the fluid flow plate 204), wherein each portable tissue chamber contains a different tissue (para. 0047 “the culture of multiple types of cells and/or tissue from different organ systems”; para. 0105 “the first cell culture vessel can be configured to culture tissue from a first organ (e.g., lung tissue), and the second cell culture vessel can be configured to culture tissue from a second organ (e.g., liver tissue)”).
Regarding claim 41, Cuiffi et al. teaches a system comprising a plurality of portable tissue chambers mounted to a corresponding seat defined by the top surface of the platform body, wherein the plurality of modular tissue chambers includes at least a first portable tissue chamber, a second portable tissue chamber, a third portable tissue chamber, and a fourth portable tissue chamber (Fig. 3A eight cell culture vessels 206 positioned on the fluid flow plate 204).
Regarding claim 42, Cuiffi et al. teaches a system wherein the first portable tissue chamber contains liver tissue (para. 0113 “liver tissue”), the second portable tissue chamber is capable of containing heart tissue (para. 0047 “culture of multiple types of cells and/or tissue from different organ systems”), the third portable tissue chamber contains skin or lung tissue (para. 0113 “alveolar tissue”), and the fourth portable tissue chamber is capable of containing bone tissue (para. 0047 “culture of multiple types of cells and/or tissue from different organ systems”).
Regarding the limitations “heart tissue” and “bone tissue”, the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims (MPEP § 2115). Therefore, the apparatus disclosed by modified Cuiffi et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for culturing different types of tissue from different organ systems (para. 0047) and would be structurally capable of culturing heart and bone tissue absent clear evidence otherwise.
Regarding claim 43, Cuiffi et al. teaches a system comprising a plurality of portable tissue chambers mounted to a corresponding seat defined by the top surface of the platform body, wherein the plurality of portable tissue chambers includes at least a first portable tissue chamber and a second portable tissue chamber (Fig. 3A eight cell culture vessels 206 positioned on the fluid flow plate 204), and the first portable tissue chamber is capable of containing osteosarcoma cells and the second portable tissue chamber is capable of containing breast adenocarcinoma cells (para. 0047 “culture of multiple types of cells and/or tissue from different organ systems”).
Regarding the limitations “osteosarcoma cells” and “breast adenocarcinoma cells”, the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims (MPEP § 2115). Therefore, the apparatus disclosed by modified Cuiffi et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for culturing different types of cells and/or tissue from different organ systems (para. 0047) and would be structurally capable of culturing osteosarcoma cells and breast adenocarcinoma cells absent clear evidence otherwise.
Regarding claim 44, Cuiffi et al. teaches a system wherein the osteosarcoma and breast adenocarcinoma cells are capable of being derived from one patient (para. 0047 “ the culture of multiple types of cells and/or tissue from different organ systems”).
Regarding the limitation “the osteosarcoma and breast adenocarcinoma cells are derived from one patient”, the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims (MPEP § 2115). Therefore, the apparatus disclosed by modified Cuiffi et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for culturing different types of cells and/or tissue from different organ systems (para. 0047) and would be structurally capable of culturing osteosarcoma cells and breast adenocarcinoma cells derived from one patient absent clear evidence otherwise.
Regarding claim 46, Cuiffi et al. teaches a system wherein the second coupling member of the portable tissue chamber extends from one or more sidewalls of the plurality of sidewalls of the portable tissue chamber (Figs. 3A-3B screw 308 attaches a side wall of a cell culture vessel 206 to fluid flow plate 204).
Regarding claim 47, Cuiffi et al. teaches a system wherein the second coupling member of the portable tissue chamber extends from one or more sidewalls of the plurality of sidewalls that is proximate an outer edge of the platform (Figs. 3A-3B screw 308 attaches a side wall of a cell culture vessel 206 to an edge of the fluid flow plate 204).
Regarding claim 48, Cuiffi et al. teaches a system wherein the second coupling member of the portable tissue chamber is integrally formed on one or more sidewalls of the plurality of sidewalls (Figs. 3A-3B screw 308 attaches a side wall of a cell culture vessel 206 to fluid flow plate 204).
Regarding claim 49, Cuiffi et al. teaches a system wherein the coupling member of the portable tissue chamber is configured to pivot with respect to the first coupling member of the platform (Figs. 2-3 cell culture vessels 206 include indentation which accommodates screw 308 to attach the cell culture vessels to the fluid flow plate 204).
Regarding claim 50, Cuiffi et al. teaches a system comprising a modular system (para. 0003 “modular device”) for culturing systemic bioengineered tumor models (abstract “culturing and interconnecting of a plurality of tissue types”), the modular system including a permeable membrane (para. 0008 “membrane to support a plurality of cells”; paras. 0081, 0084 “permeable membrane”), and one or more tissues or cells (para. 0047 “the culture of multiple types of cells and/or tissue”), wherein the modular system comprises: a platform having a substantially planar body including a bottom surface and a top surface, the top surface defining at least one seat, and the bottom surface including a channel disposed along the platform body (204 fluid flow plate); and a portable tissue chamber configured to releasably mount to the seat of the platform (206 cell culture vessel), the portable tissue chamber including an internal compartment configured to hold a tissue culture (para. 0081 “cell culture vessels 206 are configured to house a specific cell type and/or cells from a particular organ type”), the internal compartment being defined by a bottom surface of the portable tissue chamber (Fig. 3A 206 cell culture vessel), a plurality of sidewalls of the portable tissue chamber extending from the bottom surface of the portable tissue chamber (Fig. 3A 206 cell culture vessel), and an open top of the portable tissue chamber defined by the plurality of sidewalls of the portable tissue chamber (Fig. 3A 206 cell culture vessel), the bottom surface of the portable tissue chamber being formed at least in part by the permeable membrane configured to be positioned proximate the channel of the platform when the platform is mounted to the seat of the platform (para. 0047 “cell culture vessels 206 are configured to include 3-dimensional cell culture scaffolds to support and culture the cells and/or tissues”; para. 0093 “the bottom surface of the cell culture insert includes a semi-permeable membrane”); wherein the platform includes a first coupling member extending from the platform body (308 screws), the portable tissue chamber includes a second coupling member extending from the portable tissue chamber (Figs. 2-3 cell culture vessels 206 include indentation which accommodates screw 308 to attach the cell culture vessels to the fluid flow plate 204), and the first coupling member of the platform is configured to releasably engage the second coupling member of the portable tissue chamber to secure the portable tissue chamber to the seat of the platform (Figs. 2-3 cell culture vessels 206 include indentation which accommodates screw 308 to attach the cell culture vessels to the fluid flow plate 204); the one or more tissues or cells are disposed within the portable tissue chambers (para. 0047).
Cuiffi et al. teaches a cell culture system for culturing multiple cell types (abstract “culturing and interconnecting of a plurality of tissue types”; para. 0008 “membrane to support a plurality of cells”), but does not explicitly teach culturing endothelial cells and mesenchymal stromal cells (MSCs). However, Huh et al. teaches that culturing endothelial cells and mesenchymal cells on a membrane is known in the art (para. 0034). Though Cuiffi et al. does not explicitly teach culturing endothelial cells and mesenchymal cells, it would have been obvious to a person of ordinary skill in the art to culture these cell types on a membrane because the substitution of one known element for another would have predictably resulted in a cell culture system that cultures endothelial cells and mesenchymal cells on a membrane, with reasonable expectation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of Cuiffi et al. with the teachings of Huh et al. to obtain the invention as specified in claim 50.
Regarding the limitation “one or more of the first coupling member of the platform and the second coupling member of the portable tissue chamber are configured to be pivotable with respect to the other”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by modified Cuiffi et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to reversibly couple components to a cell culture platform with clips, screws, vacuum, or adhesive (para. 0048) and would be structurally capable of having a coupling member that is pivotable absent clear evidence otherwise.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Cuiffi et al. (US 2017/0137768 A1) (already of record) in view of Huh et al. (US 2020/0190456 A1) as applied to claim 32 above, and further in view of Daniele et al. (US 2021/0008555 A1) (already of record).
Regarding claim 33, Cuiffi et al. teaches a system comprising pumping fluid through channels (para. 0057) and flow lines (para. 0037) and an exit port (para. 0046 “cell culture platform 102 further includes a plurality of fluid and/or gas inlet/outlet ports 208), but does not explicitly teach tubing connected to the pump. However, Daniele et al. teaches pump tubing that couples a fluid reservoir to a pump so the pump receives fluid from the reservoir (para. 0039).
Though Cuiffi et al. does not explicitly teach pump tubing, it would have been obvious to a person of ordinary skill in the art to use pump tubing because the substitution of one known element for another would have predictably resulted in a system couples a fluid reservoir to a pump so the pump receives fluid from the reservoir. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of Cuiffi et al. with the teachings of Daniele et al. to obtain the invention as specified in claim 33.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Cuiffi et al. (US 2017/0137768 A1) (already of record) in view of Huh et al. (US 2020/0190456 A1) as applied to claim 30 above, and further in view of Wikswo et al. (US 9,725,687) (already of record).
Regarding claim 45, Cuiffi et al. teaches a system wherein the media is capable of including one or more of tumor cells and immune cells (para. 0045 “fluids include… test agents, toxins”), but does not explicitly teach tumor cells or immune cells included in the media. However, Wikswo et al. teaches that adding immune cells helps study inflammatory response in a liver or gut model (Col. 8, lines 44-46).
Though Cuiffi et al. does not explicitly teach immune cells, it would have been obvious to a person of ordinary skill in the art to use immune cells because the substitution of one known element for another would have predictably resulted in a system that studies inflammatory response in a liver or gut model, with reasonable expectation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of Cuiffi et al. with the teachings of Wikswo et al. to obtain the invention as specified in claim 45.
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 ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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