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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/1/24 is being considered by the examiner.
Claim Status
Claims 1-25 are pending and are examined. Claims 26-50 are cancelled.
Claim Rejections - 35 USC § 102
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 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bennet (“Airway-On-A-Chip: Designs and Applications for Lung Repair and Disease”. Cells. 2021.).
Regarding Claim 1, Bennet teaches an apparatus for simulating an airway (Fig. 3B, lung-on-a chip platform), comprising:
an air channel having a central portion with an air inlet at a first end and an air outlet at a second end opposite the first end (Fig. 3B, upper (air) channel); and
a vascular channel adjacent to the central portion of the air channel (Fig. 3B, lower (blood) channel),
the vascular channel being separated from an interior of the central portion of the air channel by a porous membrane (Fig. 3B - see porous membrane),
the air channel being configured to conduct air from the air inlet through the central portion such that air moves adjacent to the porous membrane.
Regarding Claim 15, Bennet teaches the apparatus of claim 1, further comprising an in-line humidifier coupled to the air channel (4.3 Dynamic Air-Liquid Interface (ALI) Exposures, Last paragraph, Perfusion with clean, humidified air between exposure might enable mucociliary clearance out of the lung-on-chip, while regular replacement of downstream tubing and connections may prevent blockages and eliminate the need to perfuse with liquid, preserving an ALI.).
Claims 1, 2, 13, 14, 16, 17, 18, 20, 21, 22, 23, 24, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nawroth (US Pub 2021/0062129).
Regarding Claim 1, Nawroth teaches an apparatus for simulating an airway ([0158] a stem cell-based Lung-on-Chip is described. This in vitro microfluidic system can be used for modeling differentiation of cells on-chip into lung cells, e.g., a lung (Lung-On-Chip), bronchial (Airway-On-Chip; small-Airway-On-Chip), alveolar sac (Alveolar-On-Chip), etc., for use in modeling disease states of derived tissue, i.e. as healthy, pre-disease and diseased tissues.), comprising:
an air channel having a central portion with an air inlet at a first end and an air outlet at a second end opposite the first end; and a vascular channel adjacent to the central portion of the air channel, the vascular channel being separated from an interior of the central portion of the air channel by a porous membrane, the air channel being configured to conduct air from the air inlet through the central portion such that air moves adjacent to the porous membrane ([0077] FIG. 1C shows cells in relation to device parts in a closed top chip, e.g. upper and lower channels and optional vacuum chamber. 1. Air channel; 2. Vascular channel (lower); 3. Lung tissue (e.g. epithelial cells); 4. Capillaries (e.g. endothelial cells); 5. Membrane; and 6. Vacuum Channels.).
Regarding Claim 2, Nawroth teaches the apparatus of claim 1, wherein the air channel comprises a flexible material ([0196] One embodiment of a microfluidic device is composed of a flexible poly(dimethylsiloxane) (PDMS) elastomer and contains two opposed, parallel microchannels).
Regarding Claim 13, Nawroth teaches the apparatus of claim 1, further comprising a liquid pump coupled to the vascular channel, wherein the liquid pump is configured to deliver cell culture media to the vascular channel ([0580] peristaltic pump (Cole-Palmer GmbH, Germany) to supply the culture media or the receiver solution to each unit.).
Regarding Claim 14, Nawroth teaches the apparatus of claim 13, wherein the pump comprises a peristaltic pump ([0580] peristaltic pump (Cole-Palmer GmbH, Germany) to supply the culture media or the receiver solution to each unit.).
Regarding Claim 16, Nawrith teaches the apparatus of claim 1, wherein the central portion of the air channel comprises a nasal portion of the air channel,wherein the vascular channel comprises a nasal vascular channel, and wherein the porous membrane comprises a nasal porous membrane, wherein the apparatus further comprises: a lung portion coupled to the air outlet at the second end of the air channel, a lung vascular channel adjacent to the lung portion, wherein the lung vascular channel is separated from an interior of the lung portion by a lung porous membrane, and wherein the air channel is configured to conduct air from the air inlet through the nasal portion to the lung portion ([0077] FIG. 1C shows cells in relation to device parts in a closed top chip, e.g. upper and lower channels and optional vacuum chamber. 1. Air channel; 2. Vascular channel (lower); 3. Lung tissue (e.g. epithelial cells); 4. Capillaries (e.g. endothelial cells); 5. Membrane; and 6. Vacuum Channels. The examiner notes that the terms “nasal portion” and “lung portion” refer broadly to any “portion” rather than to a lung or a nose since a lung or a nose are not part of the claimed invention.).
Regarding Claim 17, Nawroth teaches the apparatus of claim 16, wherein the lung portion of the air channel comprises at least one branched passageway for air flow, and wherein the lung vascular channel and the lung porous membrane each comprise at least one branched portion complementary to the at least one branched passageway of the lung portion of the air channel ([0508] The device in FIG. 1A can comprise a plurality of access ports 205. In addition, the branched configuration 203 can comprise a tissue-tissue interface simulation region or regions (such as a region on the membrane 208 in FIG. 1B) where cell behavior and/or passage of gases, chemicals, molecules, particulates and cells are monitored.).
Regarding Claim 18, Nawroth teaches the apparatus of claim 17, wherein the lung portion of the air channel comprises a flexible material ([0196] One embodiment of a microfluidic device is composed of a flexible poly(dimethylsiloxane) (PDMS) elastomer and contains two opposed, parallel microchannels).
Regarding Claim 20, Nawroth teaches the apparatus of claim 16, wherein the lung vascular channel comprises an inlet and an outlet for flow of cell culture media (in FIG. 1B, the first outer body portion or first structure 204 includes one or more inlet fluid ports 210 in communication with one or more corresponding inlet apertures 211 located on an outer surface of the first structure 204. The device 200 can be connected to a fluid source via the inlet aperture 211 in which fluid travels from the fluid source into the device 200 through the inlet fluid port 210. [0511] Additionally, the first outer body portion or first structure 204 can include one or more outlet fluid ports 212 in communication with one or more corresponding outlet apertures 215 on the outer surface of the first structure 204. In some embodiments, a fluid passing through the device 200 can exit the device to a fluid collector or other appropriate component via the corresponding outlet aperture 215. It should be noted that the device 200 can be set up such that the fluid port 210 is an outlet and fluid port 212 is an inlet. [0512] In some embodiments, as shown in FIG. 1B, the device 200 can comprise an inlet channel 225 connecting an inlet fluid port 210 to the first chamber 204. The inlet channels and inlet ports can be used to introduce cells, agents (e.g., but not limited to, stimulants, drug candidate, particulates), airflow, and/or cell culture media into the first chamber 204.).
Regarding Claim 21, Nawroth teaches the apparatus of claim 16, wherein the lung porous membrane comprises a nano-porous membrane ([0515] The membrane separating the first chamber and the second chamber in the devices described herein can be porous (e.g., permeable or selectively permeable). The membrane 208 can have a porosity of about 0% to about 99%. As used herein, the term “porosity” is a measure of total void space (e.g., through-holes, openings, interstitial spaces, and/or hollow conduits) in a material, and is a fraction of volume of total voids over the total volume, as a percentage between 0 and 100% (or between 0 and 1)).
Regarding Claim 22, Nawroth teaches the apparatus of claim 16, wherein the lung porous membrane comprises a micro-porous membrane ([0515] The membrane separating the first chamber and the second chamber in the devices described herein can be porous (e.g., permeable or selectively permeable). The membrane 208 can have a porosity of about 0% to about 99%. As used herein, the term “porosity” is a measure of total void space (e.g., through-holes, openings, interstitial spaces, and/or hollow conduits) in a material, and is a fraction of volume of total voids over the total volume, as a percentage between 0 and 100% (or between 0 and 1)).
Regarding Claim 23, Nawroth teaches the apparatus of claim 16, wherein the lung porous membrane comprises a polycarbonate membrane ([0489] plastic polymer (polyethylene, polycarbonate).
Regarding Claim 24, Nawroth teaches the apparatus of claim 16, wherein a first side of the lung porous membrane facing the air channel comprises at least one of bronchial or tracheal epithelial cells growing thereon, and wherein a second side of the lung porous membrane opposite the first side and facing the lung vascular channel comprises microvascular endothelial cells growing thereon ([0088] FIG. 3A Overview of Epithelial surface (upper channel) showing exemplary primary adult human alveolar epithelial cells seeded on ECM made of Collagen IV, Fibronectin and Laminin. [0089] FIG. 3B Overview of Vascular compartment (lower channel) showing exemplary primary adult microvascular endothelial cells are seeded on ECM made of Collagen IV and Fibronectin.).
Regarding Claim 25, Nawroth teaches the apparatus of claim 16, further comprising fibroblasts growing on the lung porous membrane ([0197] In preferred embodiments, a stroma compartment (area) is filled with collagen I hydrogel (and/or other different lung ECM components) where primary lung fibroblasts are embedded (recreated or artificial or simulated lung stroma) (FIGS. 2H and 2I).).
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 3, 4, 5, 6, 7, 8, 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nawroth (US Pub 2021/0062129) as applied to claims 2 and 16 above.
Regarding Claim 3, Nawroth teaches the apparatus of claim 2.
Nawroth is silent to a central portion of the air channel is enlarged and wherein the first end tapers down from the central portion to the air inlet and wherein the second end tapers down from the central portion to the air outlet.
Regarding “a central portion of the air channel is enlarged”, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04 IVA.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have enlarged the central portion of the air channel in the device of Nawroth to allow for bubbles to be trapped and to prevent clogging.
Regarding “the first end tapers down from the central portion to the air inlet and wherein the second end tapers down from the central portion to the air outlet”, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). See MPEP 2144.04IVB.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the configuration of the air channel by tapering the first end from the central portion to the air inlet and by tapering the second end from the central portion to the air outlet, in the device of Nawroth, to allow for a device to be suitable for fitting the nasal and airway passages.
Regarding Claim 4, Nawroth teaches the apparatus of claim 3, wherein the vascular channel comprises an inlet and an outlet for flow of cell culture media (in FIG. 1B, the first outer body portion or first structure 204 includes one or more inlet fluid ports 210 in communication with one or more corresponding inlet apertures 211 located on an outer surface of the first structure 204. The device 200 can be connected to a fluid source via the inlet aperture 211 in which fluid travels from the fluid source into the device 200 through the inlet fluid port 210. [0511] Additionally, the first outer body portion or first structure 204 can include one or more outlet fluid ports 212 in communication with one or more corresponding outlet apertures 215 on the outer surface of the first structure 204. In some embodiments, a fluid passing through the device 200 can exit the device to a fluid collector or other appropriate component via the corresponding outlet aperture 215. It should be noted that the device 200 can be set up such that the fluid port 210 is an outlet and fluid port 212 is an inlet. [0512] In some embodiments, as shown in FIG. 1B, the device 200 can comprise an inlet channel 225 connecting an inlet fluid port 210 to the first chamber 204. The inlet channels and inlet ports can be used to introduce cells, agents (e.g., but not limited to, stimulants, drug candidate, particulates), airflow, and/or cell culture media into the first chamber 204.).
Regarding Claim 5, Nawroth teaches the apparatus of claim 4, wherein the porous membrane comprises a nano-porous membrane ([0515] The membrane separating the first chamber and the second chamber in the devices described herein can be porous (e.g., permeable or selectively permeable). The membrane 208 can have a porosity of about 0% to about 99%. As used herein, the term “porosity” is a measure of total void space (e.g., through-holes, openings, interstitial spaces, and/or hollow conduits) in a material, and is a fraction of volume of total voids over the total volume, as a percentage between 0 and 100% (or between 0 and 1)).
Regarding Claim 6, Nawroth teaches the apparatus of claim 5, wherein the porous membrane comprises a micro-porous membrane ([0515] The membrane separating the first chamber and the second chamber in the devices described herein can be porous (e.g., permeable or selectively permeable). The membrane 208 can have a porosity of about 0% to about 99%. As used herein, the term “porosity” is a measure of total void space (e.g., through-holes, openings, interstitial spaces, and/or hollow conduits) in a material, and is a fraction of volume of total voids over the total volume, as a percentage between 0 and 100% (or between 0 and 1)).
Regarding Claim 7, Nawroth teaches the apparatus of claim 6, wherein the porous membrane comprises a polycarbonate membrane ([0489] plastic polymer (polyethylene, polycarbonate).
Regarding Claim 8, Nawroth teaches the apparatus of claim 7, wherein a first side of the porous membrane facing the air channel comprises epithelial cells growing thereon, and wherein a second side of the porous membrane opposite the first side and facing the vascular channel comprises microvascular endothelial cells growing thereon ([0088] FIG. 3A Overview of Epithelial surface (upper channel) showing exemplary primary adult human alveolar epithelial cells seeded on ECM made of Collagen IV, Fibronectin and Laminin. [0089] FIG. 3B Overview of Vascular compartment (lower channel) showing exemplary primary adult microvascular endothelial cells are seeded on ECM made of Collagen IV and Fibronectin.).
Regarding Claim 9, Nawroth teaches the apparatus of claim 8, further comprising fibroblasts growing on the porous membrane ([0197] In preferred embodiments, a stroma compartment (area) is filled with collagen I hydrogel (and/or other different lung ECM components) where primary lung fibroblasts are embedded (recreated or artificial or simulated lung stroma) (FIGS. 2H and 2I).).
Regarding Claim 19, Nawroth teaches the apparatus of claim 16.
Nawroth is silent to a central portion of the nasal portion of the air channel is enlarged and wherein the first end tapers down from the central portion to the air inlet and wherein the second end tapers down from the central portion to the lung portion.
Regarding “a central portion of the air channel is enlarged”, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04 IVA.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have enlarged the central portion of the air channel in the device of Nawroth to allow for bubbles to be trapped and to prevent clogging.
Regarding “the first end tapers down from the central portion to the air inlet and wherein the second end tapers down from the central portion to the air outlet”, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). See MPEP 2144.04IVB.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the configuration of the air channel by tapering the first end from the central portion to the air inlet and tapering the second end from the central portion to the lung portion, in the device of Nawroth, to allow for a device to be suitable for fitting the nasal and airway passages.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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