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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/24/2025 has been entered.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-10, 12-19, 20-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilkes et al (US20070166817A1 published 07/19/2007; hereinafter Wilkes).
Regarding claim 1, Wilkes teaches a device for cell culture analysis (cell culture system 200 – Fig. 7), comprising:
a first component (a peripheral sealing member 230 – Fig. 7) comprising a receptacle with an insert aperture (opened top of the peripheral sealing member 230 is opened to receive a cell culture container 20 – Fig. 7) configured to receive a cell culture insert having an apical surface and a basal surface (the peripheral sealing member 230 receives a cell culture container 20 having an apical surface and a basal surface – Fig. 7) (the limitation “configured to receive a cell culture insert” does not positively recited “a cell culture insert”, thus the limitation “a cell culture insert” is deemed unclaimed);
a second component (plate well 10 – Fig. 7);
an inlet port disposed at at least one of the first and second components (a conduit 270 on the peripheral sealing member 230 – Fig. 7); and
an outlet port disposed at at least one of the first and second components (a sealed conduit 273 on the peripheral sealing member 230 – Fig. 7) (Sealed conduit 273 comprises a septum 272 that can be punctured if it is desired to open sealed conduit 273 – paragraph 49), the first component and second component being releasably couplable (peripheral sealing member 230 and plate well 10 are releasably couplable – Fig. 7) and configured to define a flow path for a consistent and controlled fluid flow (“for a consistent and controlled fluid flow” is interpreted as intended use and deemed to read on a flow path capable of being used for a consistent and controlled fluid flow) from the inlet port through the outlet port when in a coupled state (a flow path formed between conduit 270 and sealed conduit 273 when the peripheral sealing member 230 and the plate well 10 are coupled – Fig. 8 and 11) (the flow path capable of being used for a consistent and controlled fluid flow – Fig. 8 and 11), the flow path at least partially defined by a surface of the second component (bottom of the flow path is defined by the plate well 10 – Fig. 8), the flow path having a geometry (the flow path has a geometry relative to the basal surface of the cell culture container 20 – Fig. 7), relative to the basal surface, that provides for the consistent and controlled fluid flow in the flow path at the insert aperture (the geometry of the flow path is capable of allowing a consistent and controlled fluid flow from a pump 67 to the conduit 270 and the sealed conduit 273 located at the opened top of the peripheral sealing member 230 – Fig. 10 and paragraphs 36, 49), the first component configured to expose the basal surface of the cell culture insert to the flow path at the insert aperture (the peripheral sealing member 230 is capable of exposing the basal surface of the cell culture container 20 to the flow path between conduit 270 and sealed conduit 273 at the opened top of the peripheral sealing member 230 when system is disassembled – Fig. 7).
Regarding claim 2, Wilkes teaches the device of claim 1, further comprising a third component configured to engage with the first component to enclose the cell culture insert in the receptacle (an insert sealing member 254 engages with the peripheral sealing member 230 holds the cell culture container 20 – Fig. 8).
Regarding claim 3, Wilkes teaches the device of claim 1, wherein the surface of the second component and a complementary surface of the first component define a channel that at least partially defines the flow path (bottom of the peripheral sealing member 230 and top surface of the plate well 10 defines a portion of the flow path – Fig. 9).
Regarding claim 4, Wilkes teaches the device of claim 3, wherein one of the first and second components comprises at least one channel support member configured to engage a complementary structure at the other of the first and second components to maintain a height of the channel when pressure is applied to the device (rim of the peripheral sealing member 230 with tabs 232 and 234 engages the rim of the plate well 10 – Fig. 8).
Regarding claim 5, Wilkes teaches the device of claim 4, wherein the at least one channel support member (tabs 232 and 234 – Fig. 8) comprises at least two channel support members, the at least two channel support members disposed at opposing ends of the channel (tabs 232 and 234 are at opposite sides – Fig. 8).
Regarding claim 6, Wilkes teaches the device of claim 5, wherein one of the at least two channel support members is disposed adjacent to the inlet port and the other of the at least two channel support members is disposed adjacent to the outlet port (tabs 232 and 234 are disposed adjacent to conduit 270 and sealed conduit 273 respectively – Fig. 8).
Regarding claim 7, Wilkes teaches the device of claim 3, wherein the channel is a millifluidic channel (the space between the peripheral sealing member 230 and the plate well 10 is capable of handling volumes in the mL range – Fig. 8 and paragraph 44).
Regarding claim 8, Wilkes teaches the device of claim 1, wherein the receptacle comprises an alignment structure configured to maintain a position of the basal surface of the cell culture insert with respect to the flow path (the peripheral sealing member 230 comprises notches 236 are configured to align with tabs 26 extending from cell culture container 20 – Fig 11 and paragraph 49).
Regarding claim 9, Wilkes teaches the device of claim 1, wherein one of the first and second components comprises at least one alignment member configured to engage a complementary structure at the other of the first and second components to align the first and second components for coupling (peripheral sealing member 230 comprises indicia 229 provide guidance for alignment during assembly – Fig 11 and paragraph 49).
Regarding claim 10, Wilkes teaches the device of claim 9, wherein the at least one alignment member is further configured to be a channel support member (indicia 229 provide guidance for alignment located tabs 232 and is capable of supporting the peripheral sealing member 230 – Fig. 8).
Regarding claim 12, Wilkes teaches the device of claim 1, wherein first and second components are reusable, sterilizable, autoclavable, or a combination thereof (the peripheral sealing member 230 and plate well 10 are capable of being reused, sterilized, autoclaved – Fig. 7 and paragraph 58).
Regarding claim 13, Wilkes teaches the device of claim 1, wherein the device further comprises at least one sealing member disposed between the first and second components and configured to maintain a pressure of the flow channel (rim of the peripheral sealing member 230 with tabs 232 and 234 engages the rim of the plate well 10 and capable of maintaining a pressure between the peripheral sealing member 230 and the plate well 10 – Fig. 8).
Regarding claim 14, Wilkes teaches the device of claim 1, wherein the cell culture insert is a hanging cell culture insert (the cell culture container 20 hangs on the peripheral sealing member 230 – Fig. 7).
Regarding claim 15, Wilkes teaches the device of claim 1, wherein the first component comprises a plurality of receptacles, each receptacle configured to receive a cell culture insert (multiple cell culture systems 200 each with a peripheral sealing member 230 to receive a cell culture container 20 – Fig. 7 and paragraph 53).
Regarding claim 16, Wilkes teaches the device of claim 15, wherein the surface of the second component and a complementary surface of the first component define at least two channels that at least partially define a flow path (bottom of the peripheral sealing member 230 and top surface of the plate well 10 defines a flow path between the conduit 270 and the conduit 262 – Fig. 9).
Regarding claim 17, Wilkes teaches a system for cell culture analysis, comprising:
a device comprising (a cell culture system – paragraph 5):
a first component comprising a receptacle with an insert aperture configured to receive a cell culture insert having an apical surface and a basal surface (opened top of the peripheral sealing member 230 receives a cell culture container 20 – Fig. 7),
a second component (plate well 10 – Fig. 7),
an inlet port disposed at at least one of the first and second components (a conduit 270 on the peripheral sealing member 230 – Fig. 7), and
an outlet port disposed at at least one of the first and second components (a sealed conduit 273 on the peripheral sealing member 230 – Fig. 7) (Sealed conduit 273 comprises a septum 272 that can be punctured if it is desired to open sealed conduit 273 – paragraph 49), the first component and second component being releasably couplable (peripheral sealing member 230 and plate well 10 are releasably couplable – Fig. 7) and configured to define a flow path for a consistent and controlled fluid flow (“for a consistent and controlled fluid flow” is interpreted as intended use and deemed to read on a flow path capable of being used for a consistent and controlled fluid flow) from the inlet port through the outlet port when in a coupled state (a flow path between conduit 270 and sealed conduit 273 when the peripheral sealing member 230 and the plate well 10 are coupled – Fig. 8 and 11), the flow path at least partially defined by a surface of the second component (bottom of the flow path is defined by the plate well 10 – Fig. 8), the flow path having a geometry (the flow path between conduit 270 and sealed conduit 273 has a geometry relative to the basal surface of the cell culture container 20 – Fig. 7), relative to the basal surface, that provides for the consistent and controlled fluid flow in the flow path at the insert aperture (the geometry of the flow path is capable of allowing consistent and controlled fluid flow from a pump 67 to the conduit 270 and the sealed conduit 273 located at the opened top of the peripheral sealing member 230 – Fig. 10 and paragraphs 36, 49), the first component configured to expose the basal surface of the cell culture insert to the flow path at the insert aperture (the peripheral sealing member 230 is capable of exposing the basal surface of the cell culture container 20 to the flow path between conduit 270 and sealed conduit 273 at the opened top of the peripheral sealing member 230 when system is disassembled – Fig. 7); and
at least one pump in fluidic communication with the inlet port (a media supply system 66 comprising a vacuum pump 65 in communication with the conduit 270 – paragraphs 39, 47 and Fig. 9).
Regarding claim 18, Wilkes teaches the system of claim 17, wherein the pump is configured to supply the consistent and controlled fluid flow to the fluid path from the inlet port through the outlet port at a flow rate that induces shear stress of cells disposed at the basal surface (vacuum pump 65 capable of supplying a fluid flow because the cell matrix 40 is porous enough to allow media culture 71 to flow through it at a flow rate that induces shear stress – paragraph 44).
Regarding claim 19, Wilkes teaches the system of claim 18, wherein the flow rate is about 0.1 ml/min to about 120 ml/min (vacuum pump 65 is capable of a flow rate 0.1 ml/min to about 120 ml/min by adjusting the pressure differential created across permeable membrane 22 – paragraph 40).
Regarding claim 20, Wilkes teaches the device of claim 1, wherein the flow path is of a substantially rectangular geometry (the geometry of a cross section of the flow path has a rectangular shape – Fig. 8).
Regarding claim 21, Wilkes teaches the device of claim 1, wherein the consistent and controlled fluid flow is a fluid flow of a substantially constant velocity at the insert aperture (the vacuum pump 65 is capable of being used to maintain a substantially constant flow velocity at the at the opened top of the peripheral sealing member 230 – paragraphs 39, 47 and Fig. 9).
Regarding claim 22, Wilkes teaches the device of claim 1, wherein the insert aperture is disposed substantially centered with respect to both a length and a width of the flow path geometry (the opened top of the peripheral sealing member 230 is disposed substantially centered with respect both a length and a width to the conduit 270 and sealed conduit 273 – paragraphs 39, 47 and Fig. 9).
Regarding claim 23, Wilkes teaches the device of claim 1, wherein the insert aperture is disposed such that the consistent and controlled fluid flow at the insert aperture is undisturbed by a boundary of the geometry of the flow path (the vacuum pump 65 is capable of being used to flow reagent the opened top of the peripheral sealing member 230 undisturbed by a boundary of the geometry of the flow path – paragraphs 39, 47 and Fig. 8-9).
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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wilkes in view of Lianides et al (US20170145373A1 published 05/25/2017; hereinafter Lianides).
Regarding claim 11, Wilkes teaches the device of claim 1.
However, Wilkes does not teach wherein the first and second components comprise a transparent material.
Lianides teaches an automated cell culture system comprising a culture insert carrying plate 80 and a top plate 44 wherein the first and second components comprise a transparent material (the culture insert carrying plate 80 and the top plate 44 are transparent or semi-transparent polycarbonate -paragraph 36 and Fig. 36). Lianides teaches to use a transparent material to take photos of the culture within the cassette 42 (paragraph 42).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cell culture system 200, as taught by Wilkes, to use a transparent or semi-transparent polycarbonate, taught by Lianides, to take photos of the culture within the system. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Wilkes and Lianides teach cell culture systems with well plates and inserts.
Response to Arguments
Applicant's arguments filed 09/24/2025 have been fully considered but they are not persuasive.
Point 1: The applicant argues that “the "flow path", as recited in Applicant's independent Claim 1, as currently amended, provides for a "consistent and controlled fluid flow from the inlet port through the outlet port" is not persuasive.
The examiner points out that the limitation “for a consistent and controlled fluid flow” is an intended use of the flow path. Furthermore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Point 2: The applicant argues that “Wilkes do not include an "outlet port" as claimed … in claim 1” because “an optional secondary inlet port for additional culture media, and would not function as an outlet port” is not persuasive.
The examiner points out that “outlet port” in claim 1 is respect to the manner in which a claimed apparatus is intended to be employed. However, this does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (see MPEP 2114 II). In this case, Wilkes teaches the sealed conduit 273 with an optional secondary inlet port that is capable of being used with the conduit 270 to establish a flow path.
Point 3: The applicant argues that in claim 20 “the "substantially rectangular geometry" refers to what should be understood as a substantially rectangular prism geometry” is not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “a substantially rectangular prism geometry”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
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/T.C.S./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796