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 without traverse of Group I, 2, 6, 9, 11, 18, 20, and 24 in the reply filed on 30 January 2026 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 29 April 2023 and 30 January 2026 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1, 2, 9, 11, 18, 20, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Noh et al (US 20130236972 A1) in view of McCarthy et al (US 20160089673 A1, provided on the 892 submitted 04 December 2025) and further in view of Reumers et al (US 20170115201 A1, provided on the 892 submitted 04 December 2025).
With regards to claim 1, Noh et al teaches;
The claimed “A microfluidic device” has been read on the taught ([0013], “Liver sinusoid model 100 is an in vitro microfluidic model…”);
The claimed “a first microchannel fluidly connected to a port on an exterior of said device, and having a length, a first end, and a second end” has been read on the taught ([0014], “Top microchannel 112 also includes a top inlet passage 115 at a first end 112a of top microchannel 112 and a top outlet passage 116 and a second end 112b of top microchannel 112.”);
The claimed “an ultrathin membrane having nanopores, mesopores, micropores, or a combination of two or more of these, said ultrathin membrane having a first side and a second side, wherein said first side of said membrane is fluidly connected through said first microchannel to said port on said exterior of said device” and “a second microfluidic channel, which second microfluidic channel faces said ultrathin membrane and is fluidly connected to receive any fluid coming through nanopores, mesopores, micropores, or combinations thereof of said ultrathin membrane” have been read on the taught ([0015], “A microporous membrane 120 is placed over the top of bottom substrate 106 so that membrane 120 covers microchannel 114. […] It is desired that the pores are sufficiently large enough to allow liquids and proteins to pass through from one side of membrane 120 to opposing side of membrane 120… second microchannel 114 is generally parallel to first microchannel 112, with microchannels 112, 114 being separated from each other by membrane 120.”; Bottom microchannel 114 reads on a second microfluidic channel.);
However, Noh et al does not explicitly disclose wherein a sensor is integrated into the microfluidic device including ultrathin membranes.
In the analogous art of microfluidic cell culture devices, McCarthy et al teaches;
The claimed “a microfluidic device” has been read on the taught ([0055], “…self-contained microfluidic drive module 24 for the single cell flexing device 2 that would provide actuation for one single well 8 in the baseplate 12.”; A microfluidic drive module for the device reads on a microfluidic device);
“Two channels separated by an ultrathin porous membrane” has been read on the taught ([0066], “The flexible membrane 34 is cut to fit within an upper recess 92 in the upper structure 94 of the flexing chamber 6. The flexible membrane 34 (silicone or other flexible material, including tissue specific cell matrix components,) would be preferably either a solid surface or perforated with micropores (between 5-30 μm), the latter membrane 34 could be used in studies requiring co-culture of cells above and below the plane of the silicone membrane 34, with cells below the plane of silicone in a lower recess 96 in the lower structure 98.”; Upper structure 94 reads on a first channel. Lower structure 98 reads on a second channel. Flexible membrane 34 which is perforated with micropores reads on an ultrathin porous membrane).
“A sensing device disposed in said first microchannel or in said second microchannel, which said sensor is functionalized to detect the presence of a first analyte of interest in fluid in said first microchannel or said second microchannel, respectively” has been read on the taught ([0081], “..a microwell plate 130 format flexing chamber 6 that facilitates imaging of cell response to stretch using an upright microscope format… An optional addition to the flexing chamber 6 would permit the placement within one well 8 from each row of a pressure/strain or other sensor to provide real-time readout to the host computer 38 of the mechanical strain occurring during the flex cycle for each row.”; Permitting the imaging of a cell response supports a device which can be combined with optical methods. A sensor to provide real-time readout supports a device which allows sensors to be disposed within the microchannel.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microfluidic device as taught by Noh et al with the sensing components as taught by McCarthy et al, for the predictable benefit of allowing direct, in-vivo data collection of cell responses to the conditions within the microfluidic device (McCarthy et al, [0009], “This allows for the direct in vivo imaging of biosensor activation in response to a single displacement force.”).
However, Noh et al in view of McCarthy et al does not explicitly disclose wherein the sensor is a photonic integrated sensor.
In the analogous art of cell sensing methods, Reumers et al teaches;
The claimed “a first photonic integrated circuit sensor […] functionalized to detect the presence of a first analyte of interest in fluid” has been read on the taught ([0039], “The device is capable of simultaneously recording optical and electrophysiological signals of cell… A light source is positioned and configured to illuminate cells present on the substrate with a light wave.”; [0041], “…the light source may be a photonic integrated circuit… Such a photonic integrated circuit comprises an optical waveguide and one or more light couplers coupled to the optical waveguide, for coupling light out of the optical waveguide towards the biological material under test.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cell culturing device which allows for sensing as taught by Noh et al in view of McCarthy et al with the photonic integrated circuit as taught by Reumers et al, for the predicable benefit of allowing simultaneous optical detection and bio-signal sensing (Reumers et al, [0038], “It is an advantage of embodiments of the invention that a sensing device is provided for optically detecting cells and simultaneously recording bio-signals from those cells…”).
With regards to claim 2, the device of claim 1 is obvious over Noh et al in view of McCarthy et al and further in view of Reumers et al.
Noh et al additionally teaches;
The claimed “wherein said ultrathin membrane is a nanoporous membrane, a mesoporous, a microporous membrane, has a combination of any two pore sizes selected from nanopores, mesopores, and micropores, or has nanopores, mesopores, and micropores” has been read on the taught ([0015], “A microporous membrane 120 is placed over the top of bottom substrate 106 so that membrane 120 covers microchannel 114.”).
With regards to claim 9, the device of claim 1 is obvious over Noh et al in view of McCarthy et al and further in view of Reumers et al.
The limitation of “a second PIC sensor, which second PIC sensor is disposed in said first microchannel or in said second microchannel, and is functionalized to detect the presence of a second analyte of interest in fluid in said first microchannel or said second microchannel, respectively” is drawn exclusively to the duplication of parts.
According to MPEP 2144.04(VI)(B), “mere duplication of parts has no patentable significance unless a new and unexpected result is produced.”—see In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microfluidic device including a PIC sensor as taught by Noh et al in view of NAME and further in view of NAME with a second PIC sensor, for the predictable advantages of allowing quality control redundancy or the concurrent measurement of a second analyte.
With regards to claim 11, the device of claim 1 is obvious over Noh et al in view of McCarthy et al and further in view of Reumers et al.
Noh et al additionally teaches;
The claimed “an outlet in said second microchannel to allow fluids in said second microchannel to exit the device” has been read on the taught ([0015], “Bottom microchannel 112 also includes […] a bottom outlet passage 118 at a second end 114b of bottom microchannel 114.”).
With regards to claim 18, the device of claim 1 is obvious over Noh et al in view of McCarthy et al and further in view of Reumers et al.
The limitation of a device “configured to allow said first PIC sensor to be exchanged by sliding said first PIC sensor out and sliding a fresh PIC sensor in” is drawn exclusively to making parts separable.
According to MPEP 2144.04(V)(C), making parts separable is prima facie obvious, provided that is desirable for any reason to access the part; see In reDulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). In the case of the instant invention, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device with a separable PIC sensor, for the predictable advantage of allowing broken sensor components to be replaced.
With regards to claim 20, the device of claim 1 is obvious over Noh et al in view of McCarthy et al and further in view of Reumers et al.
Noh et al additionally teaches;
The claimed “wherein cells of a first type are disposed on said first side of said ultrathin membrane” has been read on the taught ([0016], “A plurality of liver cells 130 are disposed on membrane 120 in first microchannel 112.”; See also figure 10.).
With regards to claim 24, the device of claim 20 is obvious over Noh et al in view of McCarthy et al and further in view of Reumers et al.
The limitation “wherein said cells of a first cell type disposed on said first side of said ultrathin membrane are tendon fibroblasts” and “configured to provide uniaxial stress to said tendon fibroblasts describe the material being worked upon by the apparatus. The positively recited structural limitations are met by Noh et al in view of McCarthy et al and further in view of Reumers et al. As discussed in the rejection of claim 20, the device of Noh et al is suitable for culturing cells. No expressed or implied structure is added by the specified “tendon fibroblasts.” Accordingly, this limitation does not render claim 24 patentably distinct over the combination of Noh et al in view of McCarthy et al and further in view of Reumers et al; Please see MPEP 2115.
However, neither Noh et al nor Reumers et al address the limitation wherein “said device is configured to provide uniaxial stress…”
McCarthy et al further teaches;
The claimed “wherein said device is configured to provide uniaxial stress” has been read on the taught (Abstract, “A hydraulic cell stretching device comprising a source of variable pressured hydraulic fluid hydraulically coupled to a flexing chamber.”; [0006], “Once attached to the flexible substratum, the cells can be subjected to cyclic stretching in either direction (e.g., positive or negative stretch)…”; Stretching reads on providing uniaxial stress to cultured cells.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Noh et al in view of McCarthy et al in view of Reumers et al with the hydraulic membrane stretching as taught by McCarthy et al, for the benefit of creating a device which allows cellular response to stress to be tested (McCarthy et al, [0084], “At face value, the disclosed device 2 could be used for exploring basic research questions with regard to the effects of cyclic stretch of cells (similar to what occurs in vivo in blood vessels).”)
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Noh et al (US 20130236972 A1) in view of McCarthy et al (US 20160089673 A1) in view of Reumers et al (US 20170115201 A1) as applied to claim 1 above, and further in view of DesOrmeaux et al (DesOrmeaux, et al., "Nanoporous silicon nitride membranes fabricated from porous nanocrystalline silicon templates", Nanoscale, 2014. 6(18): p. 10798-10805; Cited on the IDS provided 30 January 2026).
With regards to claim 6, the device of claim 1 is obvious over Noh et al in view of McCarthy et al and further in view of Reumers et al.
However, this combination does not explicitly disclose wherein the ultrathin membrane is of silicon nitride.
In the analogous art of ultrathin membranes, DesOrmeaux et al teaches;
The claimed “wherein said ultrathin membrane is of silicon nitride” has been read on the taught (Abstract, “Here we present a facile, wafer-scale method to produce nanoporous silicon nitride (NPN) membranes…”; Page 2 paragraph 2, “The mechanical strength of SiN has enabled free-standing thin films including microporous and nanoporous membranes.”).
It would have been obvious to one of ordinary skill in the art to modify the device of Noh et al in view of McCarthy et al and further in view of Reumers et al with the ultrathin membrane made of silicon nitride as taught by DesOrmeaux et al, for the predictable benefit of enabling excellent flow through a stronger and more chemically stable membrane (DesOrmeaux, Page 2 paragraph 4, “NPN membranes share the excellent flow and separation characteristics of pnc-Si while being markedly stronger and more chemically stable.”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ingber et al (US 20110250585 A1) teaches a microfluidic device which cyclically stretches tendon fibroblasts.
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/ALISON CLAIRE GERHARD/ Examiner, Art Unit 1797 /LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797