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 December 20, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 5 is objected to because of the following informalities: “through cyclic application of vacuum” should read “through cyclic application of a vacuum”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: “wherein the body is a polymer material” should read “wherein the body is made of a polymer material”. Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities:
In para. [0004] line 10 of the specification: The acronyms SLA, MSLA, and DLP are not defined previously in the specification.
The use of the term RatCol® Advanced Biomatrix in para. [0039], line 2 of the specification, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
The use of the term Next Dent Ortho Flex® in para. [0051], line 9 of the specification, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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 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, 3, 6, 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nath et al. (US 20170299578 A1) (Referenced in 892).
Regarding Claim 1, Nath et al. teaches a lung microphysiological system (para. [0005-0006]), comprising:
a body (See annotated Figure 1, housing 10);
a first microfluidic feature comprising one or more vacuum channels (top channel 12) extending into the body from a vacuum inlet (port 46) to a terminal portion within the body;
a second microfluidic feature comprising a circulation channel (bottom chamber 14) extending into the body (housing 10) from a circulation inlet (inlet 34) and exiting the body at a circulation outlet (outlet 36), wherein at least one or more vacuum channels (top channel 12) is separated from the circulation channel by a flexible barrier (membrane 20).
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Regarding Claim 3, Nath et al. teaches the system of claim 1. Nath et al additionally shows in the embodiment of Figure 1 wherein the vacuum inlet (port 46) is the only inlet of the first microfluidic feature.
Regarding Claim 6, Nath et al. teaches the system of claim 1, wherein the second microfluidic feature is configured to provide flow of an incompressible medium (“A source of liquid such as liquid cell culture medium can be coupled to the at least one inlet and a pump can be coupled to the at least one outlet. The apparatus comprises an upstream to downstream liquid flow path from the source of liquid downstream to the at least one inlet, through the bottom chamber to the at least one outlet and from the at least one outlet to the pump” para. [0018]) across cells disposed in the circulation channel (“A population of cells can be provided on at least a portion of at least one of the first and second side surfaces of the membrane and the bottom chamber can contain a liquid cell culture medium for nurturing the cell population” para. [0017]).
Regarding Claim 17, Nath et al. teaches the system of claim 1. Nath et al. also teaches a specific example where the flexible barrier is 35 μm in thickness (para. [0064]). It has been held that in the case where a specific example in the prior art which is within the claimed range, a prima facie case of anticipation exists (MPEP § 2131.03).
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.
Claims 2, 4, 5, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Nath et al. in view of Ingber et al. (WO-2010009307-A3) (Cited in 892).
Regarding Claim 2, Nath et al. teaches the system of claim 1. Nath et al. fails to teach that the body and the flexible barrier are integrally formed as a single, contiguous material. Ingber et al. teaches a body (body 202) and flexible barriers (microchannel walls 234’, 244’), within the body, as integrally formed as a single, contiguous material. Ingber et al. also teaches that “The body 202 is preferably made of a flexible biocompatible polymer” (para. [0076]). Ingber et al. also teaches that the difference in pressure caused by the suction force against the microchannel walls (234, 244) causes the walls to stretch toward the sides of the device, mimicking the mechanical forces experienced in a lung’s tissue-tissue interface. (see Annotated Figure 3B)” (para. [0096]).
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It would have been obvious of one of ordinary skill in the art to use Ingber et al.’s configuration in Nath et al. because having a single, contiguous material allows for stretching of the microchannel walls and mimicking the lung’s tissue-tissue interface. This method of improving Nath et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ingber et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nath et al. and Ingber et al. to obtain the invention as specified in claim 2.
Regarding Claim 4, Nath et al. teaches the system of claim 1. Nath et al. also teaches a first microfluidic feature comprising a vacuum channel separated from the circulation channel by a flexible barrier (feature 20). Nath et al. fails to teach multiple vacuum channels with each separated from the circulation channel by a flexible barrier. Ingber et al. teaches multiple vacuum channels (operating microchannels 252), each separated from the circulation channel (250A, 250B) by a flexible barrier (feature 244). Ingber et al. also teaches that through applying negative pressure through multiple microchannels (feature 252), continuous expansion and contraction of a membrane (feature 208) is achieved (para. [0098]), as this mimics the mechanical forces experienced by a tissue-tissue interface in the lung alveolus during breathing (para. [0097]).
It would have been obvious of one of ordinary skill in the art to use Ingber et al.’s configuration in Nath et al.’s because multiple vacuum chambers would faciliate expansion and contraction of a membrane, which mimics the mechanical forces experienced in the lung during breathing. This method of improving Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Ingber et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nath et al. and Ingber et al. to obtain the invention as specified in claim 4.
Regarding Claim 5, Nath et al. teaches the system of claim 1. Nath et al. fails to explicitly teach that the first microfluidic feature is configured to provide cyclic strain to cells disposed in the circulation channel through cyclic application of vacuum to the vacuum channel, thereby causing cyclic deflection of the flexible barrier which transfers cyclic flexing to the cells. Ingber et al. teaches:
a microfluidic feature configured to provide cyclic strain to cells disposed in the circulation channel (“the membrane 208 may be subjected to physiological mechanical strain generated by cyclic stretching of the membrane 208” (para. [00111]);
through cyclic application of vacuum to the vacuum channel (“a negative pressure (i.e. suction or vacuum) may be applied to one or more of the operating channels 252” (para. [0098]);
thereby causing cyclic deflection of the flexible barrier, which transfers cyclic flexing to the cells (“dynamic mechanical stretching of an adjacent monolayers of lung epithelial or endothelial cells grown on the membrane at the same time” (para. [00111]).
Ingber et al. also teaches that the membrane may be exposed to mechanical strain through cyclic stretching of the membrane (feature 208) to recapitulate the native microenvironment of the alveoli and underlying pulmonary capillaries (para. [00111]).
It would have been obvious of one of ordinary skill in the art to use Ingber et al.’s configuration in Nath et al. because cyclical stretching through mechanical strain can model the microenvironment of the alveoli and underlying pulmonary capillaries. This method of improving Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Ingber et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nath et al. and Ingber et al. to obtain the invention as specified in claim 5.
Regarding Claim 7, Nath et al. teaches the system of claim 6. Nath et al. does not explicitly teach that the flow of an incompressible medium through the circulation channel mimics blood flow. Ingber et al. teaches the flow of an incompressible medium through the circulation channel (feature 250B), which mimics blood flow (“human blood flowing or medium containing circulating immune cells in the second section 250B” (para. [00116]). Ingber et al. also teaches the flow allows in vitro simulation of inflammatory responses and allows study of how immune cells migrate from the blood, through the endothelium and into the alveolar compartment (para. [00116]).
It would have been obvious of one of ordinary skill in the art to use Ingber et al.’s configuration in Nath et al. because the flow allows study of inflammatory and immune responses. This method of improving Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Ingber et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nath et al. and Ingber et al. to obtain the invention as specified in claim 7.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Nath et al. (already referenced) in view of Karalis et al. (US 20210054323 A1) (referenced in 892).
Regarding claim 8, Nath et al. teaches the system of claim 1. Nath et al. does not explicitly teach that the body is made of a polymer material. Karalis et al. teaches a microfluidic system with a body (feature 204, 206) made of a polymer material. “The material used to make the first structure and/or second structure or at least the portion of the first structure 204 and/or second structure 206 that is in contact with a gaseous and/or liquid fluid can comprise a biocompatible polymer or polymer blend” (para. [0242]). Karalis et al. also teaches that the biocompatible polymer does not deteriorate appreciably and does not induce a significant immune response or deleterious tissue reaction (para. [0242]).
It would have been obvious of one of ordinary skill in the art to use Karalis et al.’s configuration in Nath et al. because polymer materials are biocompatible, preventing deterioration and immune responses when in contact with liquid or gaseous fluids. This method of improving Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Karalis et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nath et al. and Karalis et al. to obtain the invention as specified in claim 8.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nath et al. (already referenced) in view of Vulto et al. (EP3472301B1) (referenced in 892).
Regarding claim 9, Nath et al. teaches the system of claim 1. Nath et al. fails to teach that the body includes an aperture disposed above the circulation channel. Vulto et al. teaches an aperture (100) disposed above a circulation channel (microfluidic channel 102) in Figure 1. Vulto et al. also teaches that apertures allow for fluid communication between the microfluidic channel of the microfluidic layer and other components of the microfluidic network disposed thereon (para. [0047]).
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It would have been obvious of one of ordinary skill in the art to use Vulto et al.’s configuration in Nath et al. because the apertures would enable fluid communication between the channel and other components in the device. This method of improving Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Vulto et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nath et al. and Vulto et al. to obtain the invention as specified in claim 9.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Nath et al. (already referenced) and Vulto et al. (already referenced) as applied to claim 9 above, and in further view of Leduc et al. (WO2004094586 A2) (referenced in 892).
Regarding Claim 10, modified Nath et al. teaches the system of claim 9, but fails to teach that one or more of the vacuum channels are not disposed directly beneath the aperture. Leduc et al. teaches a device (feature 200) wherein the one vacuum channel (tube 270) is not disposed directly beneath an aperture (See annotated Figure 2A), as base plate (feature 230) separates the aperture from the channel. Leduc et al. also teaches that when applying the vacuum (feature 290), the elastomeric membrane (feature 260) flexes towards the base plate (230) (Page 14). Leduc et al. also teaches that cell propagation can be improved by applying mechanical stress (flexing) to cells. (Page 2)
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It would have been obvious of one of ordinary skill in the art to use Leduc et al.’s configuration in modified Nath et al. because the vacuum channel allows the membrane to flex towards the base plate, thereby improving cell propagation. This method of improving Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Leduc et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nath et al. and Leduc et al. to obtain the invention as specified in claim 10.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Nath et al. (already referenced) and Vulto et al. (already referenced) as applied to claim 9 above, and in further view of Banes (US 4822741 A) (referenced in 892).
Regarding Claim 11, modified Nath et al. teaches the system of claim 9, but fails to teach that a culturing membrane is disposed over the aperture. Banes teaches a culturing membrane (See annotated Figure 6, elastomeric membrane 26) disposed over an aperture (apertures 52). Banes teaches also that as a vacuum is induced, the elastomeric membrane is elongated downwardly in the direction of the aperture (Col 7, Line 25-35). Additionally, Banes teaches that this elongation simulates the physical deformation in the environment of the lung (Col 2, Line 1-4).
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It would have been obvious of one of ordinary skill in the art to use Banes’ configuration in modified Nath et al. because placing the membrane over the aperture allows the vacuum to flex the culturing membrane, improving cell propagation. This method of improving Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Banes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nath et al. and Banes to obtain the invention as specified in claim 11.
Claims 12, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nath et al. (already referenced), Vulto et al. (already referenced) and Banes (already referenced) as applied to claim 11 above, and in further view of Ingber et al. (already referenced).
Regarding claim 12, modified Nath et al. teaches the system of claim 11, but fails to explicitly state that the culturing membrane comprises an extracellular matrix (ECM) to form an ECM membrane. Ingber et al. teaches of a culturing membrane comprising of an ECM to form an ECM membrane (para. [00121]). Ingber et al. teaches that the membrane (feature 208) may be optimized under extracellular matrix (ECM) coating to maintain morphological and functional characteristics of the co-cultured cells and permit their direct cellular interaction across the membrane (para. [00111]).
It would have been obvious of one of ordinary skill in the art to use Ingber et al.’s ECM configuration in modified Nath et al. to maintain morphological and functional characteristics of the co-cultured cells and permit their direct cellular interaction across the membrane. This method of improving Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Ingber et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nath et al. and Ingber et al. to obtain the invention as specified in claim 12.
Regarding claims 14 and 15, modified Nath et al. teaches the system of claim 12, but fails to teach endothelial cells disposed on a lower side of the ECM membrane and are thereby exposed to the circulation channel (Claim 14). Modified Nath et al. also fails to teach epithelial cells are disposed on an upper side of the ECM membrane (Claim 15). Ingber et al. teaches of endothelial cells disposed on a lower side of the ECM membrane (“lung microvascular endothelial cells are cultured on the opposite side of the membrane 208 facing the second section 250B (circulation channel) (hereinafter bottom side of membrane)” (para. [00112]). Ingber et al. also teaches of epithelial cells disposed on an upper side of the ECM membrane (“type I alveolar epithelial cells to the side of the membrane 208 facing the first section 250A”) (para. [00112]). Ingber et al. also teaches that the endothelial and epithelial cells are utilized in membrane 208 to simulate the tissue-tissue interface between the alveolar epithelium and pulmonary endothelium in the lung (para. [00112]).
It would have been obvious of one of ordinary skill in the art to use Ingber et al.’s configuration in modified Nath et al. to simulate the tissue-tissue interface between the alveolar epithelium and pulmonary endothelium in the lung. This method of improving Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Ingber et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Nath et al. and Ingber et al. to obtain the invention as specified in claims 14 and 15.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over of Nath et al. (already referenced), Vulto et al. (already referenced), Banes (already referenced) and Ingber et al. (already referenced) as applied to claim 12 above, and in further view of Zamprogno et al (doi:10.1038/s42003-021-01695-0).
Regarding claim 13, modified Nath et al. teaches the system of claim 12. Modified Nath et al. fails to teach that the ECM membrane comprises collagen and elastin. Zamprogno et al. teaches a lung-on-a -chip with a lung ECM comprised of collagen and elastin. Zamprogno et al. also teaches that these proteins enable the membrane to be biodegradable and stretchable (Introduction, para. 0004).
It would have been obvious of one of ordinary skill in the art to use Zamprogno et al.’s configuration in modified Nath et al. because the collagen and elastin would allow the ECM membrane to be biodegradable and stretchable. This method of improving modified Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Zamprogno et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Nath et al. and Zamprogno et al. to obtain the invention as specified in claim 13.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Nath et al. (already referenced), Vulto et al. (already referenced), Banes (already referenced) and Ingber et al. (already referenced) as applied to claim 12 above, and in further view of Vulto et al. (WO 2020109421 A1).
Modified Nath et al. teaches the system of claim 12, but fails to teach that the membrane is held in position via weak bonding to the body and/or surface tension, without an adhesive. Vulto et al. discloses an elastomeric membrane that can be attached to the upper surface of the base or lower surface of the base using standard bonding techniques including surface tension (Page 15). Vulto et al. also teaches that sandwiching the sheet of elastomer between the sub-layers with apertures forms a diaphragm (Page 14).
It would have been obvious of one of ordinary skill in the art to use Vulto et al.’s configuration in modified Nath et al. because using standard bonding techniques like surface tension would allow a diaphragm to be formed between the membrane and body. This method of improving modified Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Vulto et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Nath et al. and Vulto et al. to obtain the invention as specified in claim 16.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nath et al. (already referenced) and in further view of Pranzo et al. (doi: 10.3390/mi9080374).
Nath et al. teaches the system of claim 1. Nath et al. also teaches that the thin flexible barriers (membrane 20) can be made of poly-L-lactic acid, polycaprolactone (PCL), PLLA-PCL copolymer, polyester, polycarbonate, or a combination thereof (para. 0063). Nath et al. fails to teach that the flexible barrier can be formed via a 3D-printing polymer. Pranzo et al. teaches that thermoplastic 3D-printed filaments like poly-L-lactic acid (PLA) are used in microfluidics (Section 2.1). Pranzo et al. teaches that PLA offers advantages of being biodegradable, nontoxic, and inexpensive (Section 2.1).
It would have been obvious of one of ordinary skill in the art to use Pranzo et al.’s teaching in Nath et al. because 3D printed polymers are inexpensive, nontoxic, biodegradable, and used across the art. This method of improving Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Pranzo et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nath et al. and Pranzo et al. to obtain the invention as specified in claim 18.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over of Nath et al. (already referenced), Ingber et al. (already referenced), and Vulto et al. (EP3472301B1).
Nath et al. teaches:
a body (See annotated Figure 1 below, housing 10);
a first microfluidic feature comprising a vacuum inlet, the only inlet of the first microfluidic feature (Figure 1, port 46);
a second microfluidic feature comprising a circulation channel (Figure 1, 14) extending into the body from a circulation inlet (inlet 34) and exiting the body at a circulation outlet (outlet 36);
a set of flexible barriers (membrane 20), each flexible barrier disposed to separate a respective vacuum (top channel 12) from the circulation channel (Figure 1, 14).
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Nath et al. fails to teach the following limitations:
multiple vacuum channels extending into the body from a vacuum inlet
an aperture disposed above the circulation channel
the body and the flexible barriers are integrally formed as a single continuous material
Regarding limitation 1, Ingber et al. teaches multiple vacuum channels (operating microchannels 252), each separated from the circulation channel (250A, 250B) by a flexible barrier. Ingber et al. also teaches that through applying a vacuum through the two microchannels 252, expansion and contraction of a membrane (208) is achieved (para. [0098]), as this mimics the mechanical forces experienced by a tissue-tissue interface in the lung alveolus during breathing (para. [0097]).
It would have been obvious of one of ordinary skill in the art to use Ingber et al.’s configuration in Nath et al.’s because multiple vacuum chambers would allow expansion and contraction of the membrane to be achieved, mimicking the mechanical forces experienced during breathing. This method of improving Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Ingber et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nath et al. and Ingber et al to obtain the invention as specified in claim 19.
Regarding limitation 2, Vulto et al. teaches an aperture (100) disposed above a circulation channel (microfluidic channel 102). Vulto et al. also teaches that apertures allow for fluid communication between the microfluidic channel of the microfluidic layer and other components of the microfluidic network disposed thereon (para. [0047]).
It would have been obvious of one of ordinary skill in the art to use Vulto et al.’s configuration in Nath et al. because the apertures would enable fluid communication between the channel and other components in the device. This method of improving Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Vulto et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nath et al. and Vulto et al. to obtain the invention as specified in claim 19.
Regarding limitation 3, Ingber et al. teaches a body (body 202) and flexible barriers (microchannel walls 234’, 244’), within the body, as integrally formed as a single, contiguous material. Ingber et al. also teaches that “The body 202 is preferably made of a flexible biocompatible polymer” (para. [0076]). Ingber et al. also teaches that the difference in pressure caused by the suction force against the microchannel walls (234, 244) causes the walls to stretch toward the sides of the device, mimicking the mechanical forces experienced in a lung’s tissue-tissue interface (para. [0096]).
It would have been obvious of one of ordinary skill in the art to use Ingber et al.’s configuration in Nath et al. because having a single, contiguous material allows for stretching of the microchannel walls and mimicking the lung’s tissue-tissue interface. This method of improving Nath et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ingber et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Nath et al. and Ingber et al. to obtain the invention as specified in claim 19.
Claim 20 is rejected under 35 U.S.C. 103 in view of Nath et al. (already referenced), Ingber et al. (already referenced) and Vulto et al. (EP3472301B1) as applied to claim 19 above, and in further view of Leduc et al. (already referenced).
Regarding Claim 20, Modified Nath et al. teaches the system of claim 19, but fails to teach that one or more of the vacuum channels are not disposed directly beneath the aperture. Leduc et al. teaches a device (feature 200) wherein the one vacuum channel (tube 270) is not disposed directly beneath an aperture, as base plate (230) separates the aperture from the channel. Leduc et al. also teaches that when applying the vacuum (feature 290), the elastomeric membrane (feature 260) flexes towards the base plate (230) (Page 14). Leduc et al. also teaches that cell propagation can be improved by applying mechanical stress (flexing) to cells (Page 2).
It would have been obvious of one of ordinary skill in the art to use Leduc et al.’s configuration in modified Nath et al. because the vacuum channel allows the membrane to flex towards the base plate, which improves cell propagation. This method of improving Nath et al. device was within the ability of one of ordinary skill in the art based on the teachings of Leduc et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Nath et al. and Leduc et al. to obtain the invention as specified in claim 20.
Conclusion
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/JULIUS FRANCIS YOH/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799