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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on 6/12/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 103
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.
Claims 17 and 20-30 are rejected under 35 U.S.C. 103 as being unpatentable over Wegener (EP 3591377 From IDS) and further in view of Harouaka et al. (US 11,885,793).
Regarding claim 17 Wegener discloses a device for detecting water transport through at least one layer of biological cells, the device having (See Wegener Abstract wherein the device detects transport of materials through a layer of cells.)
at least one detection chamber which (a) comprises at least one first container for receiving liquid; and (b) comprises at least one second container for receiving liquid which is arranged at least partially within the first container; (See Wegener Fig. 2b wherein a first container 12 has a first fluid and a second container 13 may receive a second fluid with second container received in the first container.)
wherein a base of the at least one second container consists at least in some regions of a planar substrate, wherein the surface of the substrate is suitable for allowing biological cells to grow, (See Wegener Abstract Fig. 2b and 14 wherein the second container 13 has planar porous substrate 16 on which cells grow.)
and the at least one second container is arranged in the at least one first container in such a way that a lower compartment is created in the at least one first container and an upper compartment is created in the at least one second container; (See Wegener Fig. 2b wherein the second container is arranged in the first container to form a lower and upper compartments in respected containers.)
wherein a base of the at least one first container has at least one electrode pair, the electrodes of the at least one electrode pair each having an electrical connection which leads into a space outside the first container. (See Wegener [0063]-[0064]) wherein electrode pair 102 and 104 are located in the base, i.e. bottom, of the first chamber and have connections which lead outside the container to a measurement device 106.)
Wegener does not disclose the specific porosity of the substrate, i.e. it being water permeable.
Harouska et al. discloses a device for measuring transport across cell layers by measuring electrical properties thereof wherein the cell layers are placed on a porous membrane having pores having a size of 1nm to 250 microns and formed of materials allowing water to pass therethrough. (See Harouska Abstract Col. 7 Lines 40-65 wherein a porous substrate allows fluid communication, i.e. water permeable.)
It would have been obvious to one of ordinary skill in the art at the time of invention to provide a substrate being formed form materials and having the porosity/permeability of Harouska in the device of Wegemem because such a substrate provides a biocompatible substrate capable of holding cell layers and measuring electrical properties thereof as would be desirable in the device of Wegener and one would have a reasonable expectation of success in utilizing such a substrate in Wegener.
Regarding claim 20 Wegener discloses all the claim limitations as set forth above as well as the device wherein the base of the at least one first container has at least two electrode pairs, the electrodes of the respective electrode pairs each having an electrical connection that leads into a space outside the first container. (See Wegener [0090]- [0093] wherein there are at least two electrode pairs in the first container. Each electrode pair must have a connection to the outside space of the first container to allow electrical connection and measurement thereof.)
Regarding claim 21 Wegener discloses all the claim limitations as set forth above as well as the device the lower compartment has a further electrode, and the upper compartment has a further electrode. (See Wegener [0090]- [0093] wherein another electrode may be placed in the upper compartment.)
Regarding claim 22-23 Wegener discloses all the claim limitations as set forth above as well as the device wherein the at least one first container (ii) comprises plastic and/or glass. (See Wegener [0042] wherein the first container is glass)
Regarding claim 24 Wegener discloses all the claim limitations as set forth above as well as the device wherein the at least one electrode pair on the base of the first container comprises two film electrodes. (See Wegener Fig. 2B wherein the electrodes are flat and planar metal, i.e. films.)
Even assuming arguendo with respect to the electrodes being shaped as a film it is noted that such a modification would have required a mere change in shape of the electrodes which would have been obvious to one of ordinary skill in the art to reduce electrode size and because the change in configuration of shape of a device is obvious absent persuasive evidence that the particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 25 Wegener discloses all the claim limitations as set forth above as well as the device wherein the two film electrodes (i) are coplanar; (See Wegener Fig. 2b wherein the electrodes are coplanar.)
Regarding claim 26 Wegener discloses all the claim limitations as set forth above as well as the device wherein the at least one electrode pair on the base of the first container (iii) comprises a material selected from the group consisting of metal, electrically conductive metal compound, carbon, electrically conductive plastic and combinations thereof. (See Wegener [0043] wherein the electrodes are metal)
Regarding claim 27 Wegener discloses all the claim limitations as set forth above as well as the device, wherein the electrical connection of the electrodes of the at least one electrode pair (iii) comprises a material selected from the group consisting of metal, electrically conductive metal compound, carbon, electrically conductive plastic and combinations thereof; (See Wegener [0088] wherein the electrical connection comprises wires, i.e. metal.)
Regarding claim 28 Wegener discloses all the claim limitations as set forth above as well as the device wherein the water-permeable substrate of the second container (i) comprises plastic and/or glass; (See Wegemer [0047] wherein the membrane is a polymer, i.e. plastic.)
Regarding claim 29 Wegener discloses all the claim limitations as set forth above as well as the device wherein the planar water-permeable substrate of the second container has at least one layer of biological cells on a side facing away from the first compartment and/or on a side facing the first compartment. (See Wegener Fig. 2b and 14 wherein a layer of biological cells is on a side facing away from the first compartment.)
Regarding claim 30 Wegener discloses all the claim limitations as set forth above as well as the device the at least one layer of biological cells (ii) is an individual layer of biological cells or consists of a plurality of layers, arranged one above the other, of biological cells; (See Wegener [0026] wherein the biological cells is an individual, i.e. single, layer.)
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wegener (EP 3591377 From IDS) in view of Harouaka et al. (US 11,885,793) as applied to claims above, and further in view of Petrini et al. (US 2022/0073857)
Regarding claims 18-19 Wegener discloses all the claim limitations as set forth above but does not specifically disclose a least 2-96 detection chamber arranged next to each other on a plate.
Petrini discloses a device for growing cells and transport across cell layers comprising a detection chamber having first and second containers with a second container placed in said first container and wherein there are at least 96 containers in a plate arranged next to each other. (See Petrini Abstract [0062], [0115])
It would have been obvious to one of ordinary skill in the art at the time of invention to provide at least 96 detection chambers of Wegener arranged next to one another on a plate as described by Petrini because such an arrangement allows the simultaneous testing of multiple samples increasing testing throughput as would be desirable in the device of Wegener.
It is noted that when multiple detection chambers of Wegener are provided the electrical connections of respective electrode pairs lead outside the plate to measurement devices.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Wegener (EP 3591377 From IDS) in view of Harouaka et al. (US 11,885,793) as applied to claims above, and further in view of El-Sayed (US 2012/0211373 From IDS).
Regarding claim 31 Wegener discloses all the claim limitations as set forth above but does not disclose a temperature-control unit which is configured to keep the temperature of the device constant.
El-Sayed discloses a device for measuring transport across a cell layer wherein the device for measuring transport includes an incubator configured to keep the temperature of the device constant at 37 degrees C. (See El-Sayed Abstract and [0078])
It would have been obvious to one of ordinary skill in the art to provide a temperature control unit of El-Sayed in the device of Wegener because such a temperature control unit allows the device to be kept under steady and optimal conditions for cell preservation and accurate measurement as would be desirable in the device of Wegener.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 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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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799
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