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 a plurality of temperature sensors as Species A, and analyte capture sensors as Species B, and optical sensors as Species C, in the reply filed on 7/8/26 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)).
Examiner notes that Applicant elected temperature sensors as Species A, but indicated that claims 10, 13, 15, 17 and 21 read on this species. However, claims 10, 13, 15, 17 and 21 read on the non-elected species of pH sensors, and therefore are considered withdrawn. Examiner notes that upon allowance of a generic claim, the species to the generic claim would be rejoined.
Claim Objections
Claim 22 is objected to because of the following informalities: “for insert the fluid” should be –for inserting the fluid--. Appropriate correction is required.
Examiner also notes that while claim 1 recites in line 6 “a microchannel network for fluid flow” and thus provides some antecedent basis for “the fluid in claim 22. The claim would be more clear if more sufficient antecedent basis was provided for “the fluid” in claim 22.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 in line 2 recites “preferably a spiral”. It is not clear whether “spiral” is required or not. The claim would be more clear if this limitation was deleted.
Claim 24 recites in line 2 “the pressure and flow”. The claim lacks sufficient antecedent basis for this limitation.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 4, 7, 22-30, 33 and 36 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 20110086382 Marx.
Applicant’s claim 1 recites the following.
A device for the production of an organoid cell culture or cultures, comprising:
a base layer for support;
a transducer layer arranged on the base layer;
and an intermediate layer, arranged on the transducer layer, comprising a plurality of
openings to form cavities for organoid cell growth and a microchannel network
for fluid flow;
wherein the transducer layer comprises a heating device and at least a plurality of
sensors in each cavity for cell parameter control and growth,
wherein each sensor is located for measuring an organoid cell growth parameter in the
interior of each cavity,
wherein the heating device is located in the interior of each cavity,
wherein the heating device and the plurality of sensors are in direct contact with the
organoid cell culture or cultures and configured to provide real-time monitoring
of physiological parameters of the organoid cell culture or cultures in furtherance of the production of the organoid cell culture or cultures,
and wherein the plurality of sensors is selected from temperature sensor, pH sensor or
combinations thereof.
Marx discloses the following, which are relevant to Applicant’s claims, as will be discussed in details further below.
Marx discloses a self-contained organ-on-a-chip device (1) comprising (a) at least one organ growth section (3) comprising at least one organ cavity (4, 4a, 4b), and (b) wherein the at least one organ cavity (4, 4a, 4b) comprises and/or is connected to at least one sensor (8, 8a, 8b). Para. 0017.
In a further aspect the present invention relates to the use of the self-contained organ-on-a-chip device (1) of the present invention comprising one or more tissues, organs and/or organoids for testing the effects of one or more test compounds on the tissues, organs or organoids or for examining organ or organoid functions. Para. 0023.
FIG. 1 shows a top-down view of an embodiment of a section of a partly assembled self-contained organ-on-a-chip device (1) comprising the upper closing layer (14) and the organ cavity layer (15)…This section comprises six individual organ growth sections (3), each comprising three organ cavities (4, 4a, 4b). To reveal the features comprised therein the parts are drawn translucent. However, in some embodiments the material used to produce the upper closing layer (14) and/or the organ cavity layer (15) is partially or entirely translucent. The medium fed from the upper medium layer (12) (not shown) flows through the microfluidic feed channel (6), for example, to the centre of an organ growth section (3) to allow even distribution of the medium to the organ cavities (4, 4a, 4b) comprised in one organ growth section (3). The medium is, for example, fed into the organ growth section from an outlet (10) positioned opposite to the stem cell cavity (9), which is located in the organ cavity layer (15). Thus, stem cells may flow with the fresh medium into the adjacent organ cavities (4, 4a, 4b) to replenish/regenerate the cell populations constituting the respective organ and/or organoid. The organ cavities (4, 4a, 4b) of one organ growth section (3) are, for example, populated by different cell populations forming different tissues, organs and/or organoids, which allows, e.g. the testing of the effect of one compound on more than one organ or organoid simultaneously. The organ cavities (4, 4a, 4b) are, for example, microstructured to support the organization of the cell population into the respectively desired organ and/or organoid. Some tissues, organs and/or organoids will require a particular microenvironment, e.g. changing pressure, secondary flow of medium within the organ cavity, special additional medium etc., to form and/or to be maintained. Organ cavity (4) is structured to provide several separate microcavities, which supports the establishment and/or maintenance of, e.g. neurons. Organ cavity (4a) is structured to provide a pressurized environment, which supports the establishment and/or maintenance of, e.g. bone and/or cartilage structures. Organ cavity (4b) is structured to provide a secondary flow within the organ cavity, which supports the establishment and/or maintenance of, e.g. vascularised skin. The organ cavity (4, 4a, 4b) is, for example, delimited at the upper end by the upper closing layer (14) and at the lower end by the lower closing layer (16), while the sides of the cavity are formed in the organ cavity layer (15). Thus, microstructures required for organ growth and/or maintenance may also be provided by the upper and/or lower end of the organ cavity (4, 4a, 4b). The outlet allowing medium to flow into the microfluidic waste channel (7, 7a, 7b) is, for example, located at a position opposite to the outlet (10) of the microfluidic feed channel (6) in a way that any medium flowing from inlet (10) into the organ cavity (4, 4a, 4b) can, for example, flow through the entire organ cavity (4, 4a, 4b) before it flows out of the organ cavity through the inlet of the waste channels (7, 7a, b)… Para. 0024.
FIG. 2B is a top-down view of the upper side of the lower closing layer (16). Depicted are heating means (11), which can, for example, be made of indium tin oxide (ITO), a temperature sensor (23), which can, for example, be a meander structure made of platinum, and electric connectors (19), which can, for example, be made of gold. Similarly the conductive paths can be made of gold. The lower closing layer (16) can, for example, be made of glass and translucent at least in the regions of the organ growth sections (3) to allow transmission microscopy. The lower closing layer (16) can, for example, be provided with temperature sensors to control the temperature within the organ growth sections (3). Para. 0026.
FIG. 4A shows a top-down view on a section of an embodiment of the organ cavity layer (15) comprising an organ growth section (3) comprising three differently structured organ cavities (4, 4a, 4b). The medium flow within the organ growth section (3) into the organ cavities (4, 4a, 4b) starts from the outlet (10) of the microfluidic feed channel (not shown, since it is located on the upper closing layer in this embodiment), which is juxtaposed to the stem cell cavity (9), into the organ cavities (4, 4a, 4b) and out through three separate microfluidic waste channels (7, 7a, 7b). The direction of the fluid flow is depicted by straight white arrows. The flow within the organ cavities can, for example, be radially outward from the medium outlet in the middle of the growth section towards the inlets of the waste channels (7, 7a, 7b) at the periphery of the growth section. In growth cavity (4b), which provides an environment for establishment/maintenance of vascularised skin, a secondary fluid flow (21) can be effected by pressurizing means or pumps located in the side chambers of organ cavity (4b). Para. 0028.
FIG. 4B shows a three dimensional view of part of an organ growth section (3) comprising three organ cavities (4, 4a, 4b), wherein an embodiment of an adult stem cell cavity (9) is positioned in the center of three organ cavities (4, 4a, 4b). Para. 0029.
An "organ-on-a-chip device" refers to an assembly, which can, for example, be made from multiple individually structured and microstructured layers, that are in fluid-tight connection with each other and can, for example, be capable to provide a fluid-tight environment and, thus, for example, a sterile environment… Para. 0055.
In an embodiment, materials can comprise SiO.sub.2, glass, and synthetic polymers. Synthetic polymers can, for example, comprise polystyrol (PS), polycarbonate (PC), polyamide (PA), polyimide (PI), polyetheretherketone (PEEK), polyphenylenesulfide (PPSE), epoxide resin (EP), unsaturated polyester (UP), phenol resin (PF), polysiloxane, e.g. polydimethylsiloxane (PDMS), melamine resin (MF), cyanate ester (CA), polytetrafluoroethylene (PTFE) and mixtures thereof. The synthetic polymers are optically transparent and can include, for example, polystyrol (PS), polycarbonate (PC), and polysiloxane, e.g. polydimethylsiloxane (PDMS). Para. 0056.
As set out above, an organ growth section (3) comprises a cavity termed "organ cavity" which holds the majority of the cells, for example, at least 80%, for example, 85%, 90%, 95%, 98% or more of the cells comprised in the organ growth section. The organ cavity (4, 4a, 4b) can, for example, have the proper dimension, shape and nutrition for each specific organ and provides access to introduce additionally necessary elements of micro-architecture and micro-environment as well as to load the organ-on-a-chip device with the cell suspension, cell clusters and/or tissue slices, as the case may be, and is coated with the appropriate materials to attract/maintain cells of a particular type as outlined in more detail below. Additionally the organ cavity, which in fact may be subdivided to form several "sub-cavities", which may be required to simulate the correct environment for a particular tissue or organ type, may be equipped with sensors, microactuators etc. as explained in more detail below. Each organ cavity within one growth section can, for example, provide the appropriate microenvironment for a different organ and/or organoid, e.g. for neurons, heart tissue, cartilage, bone and/or vascularised skin. In this way it is possible to assess the effect of one particular compound on several tissues, organoids and/or organs simultaneously. Alternatively, one organ growth section can comprise two or more organ cavities of the same type, which will allow measuring the effect of a given compound with a higher statistical significance by averaging the results obtained from two, three, four or more organ cavities in parallel… Para. 0058.
The organ cavity can, for example, be substructured by subdivision into two, three, four or more cavities comprising or consisting of a main cavity and one or two side cavities, which are all in fluidic connection. It can, for example, comprise a structured internal surface providing ridges, channels, funnels, with the aim to delimit an environment suitable for supporting growth and maintenance of the respectively desired organoid, and/or organ. Thus, organ cavities (4, 4a, 4b) within an organ growth section (3) provide space for self-assembly, maintenance and/or re-assembly of the smallest functionally self-reliant structural unit of a specific organ (e.g. alveoli of lung, epidermis and dermis of skin, gut mucosa, liver lobulus, or nephron of kidney) or a specific system (e.g. microvasculature of blood system, grey matter of nerve system)… Para. 0059.
Depending on the type of cells, tissues, organoids or organs to be established and/or to be maintained in the organ growth section (3) one type of medium will be sufficient to support differentiation and/or maintenance of all cells, tissues, organoids or organs or it may be required to provide different media to different organ growth sections (3) and/or different media to different organ cavities (4, 4a, 4b) within one organ growth section (3). It may also be required to provide two or more different media at different points in time, e.g. during differentiation and maintenance, respectively. Thus, the organ-on-a-chip device (1) may comprise in certain embodiments 2, 3, 4, 5, 6, 7, or more different medium feed reservoirs (2), which are in fluidic communication with an organ growth section through a microfluidic feed channel (6). As some cells, tissues, organoids or organs may require a second medium one medium feed reservoir (2) may be in fluidic communication with only one organ cavity (4, 4a, 4b) within a given organ growth section (3), which is designed to provide a microenvironment for a cell type requiring such a second medium. Para. 0066.
At least one microfluidic feed channel (6) fluidically connects the medium feed reservoir (2) with, for example, the one or more organ growth sections (3)…Para. 0067.
To control the flow of medium and/or supplements to each organ growth section it is possible to provide a flow control means in the flow path from the medium feed reservoir (2) to the organ growth sections (3). Such control of flow can, for example, be implemented by external pressure sources, external mechanical pumps, integrated mechanical micropumps, or by electrokinetic mechanisms. Process monitoring capabilities in continuous-flow systems can be achieved with highly sensitive microfluidic flow sensors based on, e.g. MEMS technology, which offer resolutions down to the nanoliter range. Thus, such devices may also be present in the flow path either to the organ growth section and/or from the organ growth section. Para. 0068.
The organ-on-a-chip device (1) according to an aspect of the present invention comprises, for example, at least one medium feed reservoir (2), wherein the medium feed reservoir (2) is connected to the at least one organ growth section (3) by a microfluidic feed channel (6). Again in this context the terms "medium feed reservoir (2)" and "microfluidic feed channel (6)" have the same meaning and preferred meanings outlined above. Para. 0080.
The properties of the cells, tissues, organoids and/or organs established and/or maintained in the organ growth section and organ cavities, respectively, can be monitored in the medium flow through drained from the organ growth section (3) and organ cavities (4, 4a, 4b), respectively, or within the organ cavity (4, 4a, 4b). Such properties may comprise secreted or released substances, modified substrates, change of impedance, electric pulses, mechanical forces etc. To detect these properties, in either aspect of the organ-on-a-chip device (1) of the present invention, at least one sensor (8, 8a, 8b) can, for example, be arranged between the at least one organ cavity (4, 4a, 4b) and at least one medium waste reservoir (5) and/or within the at least one organ cavity. Such sensors (8, 8a, 8b) are known in the art and are, for example, selected from the group consisting of pH sensor; pO.sub.2 sensor; analyte capture sensor; surface acoustic wave sensor (SAW), sensor; plasmon resonance sensor; temperature sensor; CO.sub.2 sensor; NO sensor; chemotaxis sensor; cytokine sensor; ion sensor; potentiometric sensor; amperometric sensor; flow-through-sensor; fill sensor; impedance sensor; conductivity sensor; tension sensors, electromagnetic field sensor; and metabolic sensor. ..Alternatively or additionally two or more, e.g. two, three, four, or five different sensors are provided within the flow path either to provide a system with an increased flexibility or to monitor two or more properties simultaneously… In an embodiment, the self-contained organ-on-a-chip device further comprises a temperature sensor arranged to determine the temperature in the at least one medium feed reservoir (2) and/or the at least one organ cavity (4, 4a, 4b). Para. 0082.
Alternatively or additionally sensing substances, e.g. pH sensory substances to the medium and flow with the medium. Such sensory substances may, for example, already be comprised in the medium feed reservoir (2), may be comprised in a separate reservoir and may be added continuously, at predetermined intervals or when required to carry out certain measurements or may be added through the membrane or flexible sheet directly into the organ growth section (3), preferably directly to the organ cavity (4, 4a, 4b). Typically, such sensing substances alter a chemical and/or physical property in response to a change in the environment, e.g. pH, pO.sub.2, salt concentration, temperature, presence or absence of an analyte etc. Such an alteration of a physical property may be, e.g. a change in absorption or emission property, e.g. fluorescence, or change of redox-potential of the sensing substance. In some embodiments, such sensing substances may be immobilized within an organ cavity (4, 4a, 4b) or may be immobilized on or within a microbead or nanobead… Para. 0083.
Actuating means are provided, for example, within the organ cavity (4, 4a, 4b) to more completely simulate the natural environment, which in addition to chemical cues will also provide physical cues that are required for establishment and maintenance of specific tissues, organoids and/or organs. Thus, such actuating means comprise means that change the physical state of the cells by exerting pressure on the cell mass as required, e.g. for bone and cartilage formation, pump fluids back and forth in parts of the organ cavity to simulate capillary blood flow or a tissue interface as found in the gut, provide heat or electric stimulation. Such actuating means comprise, for example, at least one pulsative pressurizing means located in a separate sub cavity of a given organ cavity for providing a secondary flow through the organ cavity, one or more electrodes, electromagnetic field forces, or micropumps, including piezo elements, elastic membranes that swing back and forth, elastic hollow spheres seeded with pacemaker cells/cardiomyocytes that twitch termed "microheart", surface acoustic wave engines (SAW) or magnetic pistons that act on membranes within the organ cavities. Para. 0087.
To allow an efficient manufacturing of the self-contained organ-on-a-chip device (1) of the present invention, it is, for example, assembled of two, three, four, five, six, seven or more separately manufactured layers, depending on the required complexity of the microstructures. These layers can be manufactured by a variety of methods comprising machining from solid blocks of material, by e.g. milling, or laser ablation; casting, or optical lithography techniques as commonly used in the field of semi-conductors. Structures that are on the surface of one layer may become an internal closed structure once a second layer with corresponding microstructures is connected with the first layer in a fluid-tight manner… Para. 0099.
In an embodiment, the organ growth section layer (13) comprises or consists of an upper closing layer (14), an organ cavity layer (15) and a lower closing layer (16). The three layers together delimit the organ growth section (3), wherein the upper layer delimits the upper end of the organ growth section (3) and the organ cavities (4, 4a, 4b), respectively, the organ cavity layer provides the sides of the organ cavities and the lower closing layer delimits the lower end of the organ growth section (3) and the organ cavities (4, 4a, 4b), respectively. Para. 0102.
The organ cavity layer (15) comprises one or more organ cavities (4, 4a, 4b) and/or stem cell cavities (9) and optionally micro-fluidic channels. …The material of the organ growth layer (15) can, for example be SiO.sub.2 or glass. Para. 0104.
The lower closing layer (16) fluidically separates the microfluidic channels and/or openings in the organ cavity layer (15) from the outside environment; for example, it does not have an opening. The material of the lower closing layer can, for example, be SiO.sub.2 or glass. The lower closing layer (16) can, for example, comprise one or more of the following: heating means (11), sensor means, temperature sensing means, or electric connectors for connecting the device to corresponding electric connectors (19) of a holding means (18). Para. 0105.
The organ-on-a-chip device may also comprise a source of energy, e.g. a battery to provide certain functions, e.g. micropumping, sensor functions…Para. 0108.
The organ-on a chip device can, for example, be placed into a specially adapted supply unit (17) for holding the self-contained organ-on-a-chip device (l) during operation. This supply unit (17) comprises:
holding means (18) for releasably engaging the self-contained organ-on-a-chip device (l), and (b) electric connectors (19) for connecting to corresponding connectors on the self-contained organ-on-a-chip device (1) with the supply unit (17). Para. 0109.
Thus, regarding Applicant’s claim 1, Marx discloses a device for the production of an organoid cell culture or cultures [paras. 0017, 0023, 0024 disclosing an organ-on-a-chip; para. 0028, disclosing an organ growth section 3 that flows into organ cavities 4; para. 0029 disclosing an adult stem cell cavity 9) in the center of organ cavities], comprising:
a base layer for support [see para. 0109 disclosing holding means (18) for releasably engaging the organon-on-a-chip device; the holding means (18) is equivalent to Applicant’s base layer; see Fig. 6] [alternatively, see para. 0099 wherein the bottom-most layer of the multiple layers, such as seven or more layers of the chip device is equivalent to Applicant’s base layer];
a transducer layer [paras. 0026, 0102 and 0105 disclosing lower closing layer (16) which is equivalent to Applicant’s transducer layer; see in particular para. 0026 disclosing electric connectors in layer 16] arranged on the base layer [holding means (18); see para. 0102 disclosing that organ growth section layer (13) includes organ cavity layer (15) and lower closing layer (16); and see Fig. 6 showing (13) to be on top of a lower portion of (18)];
and an intermediate layer [para. 0024 and 0102 disclosing organ cavity layer (15), which is equivalent to Applicant’s intermediate layer], arranged on the transducer layer, comprising a plurality of openings to form cavities [para. 0024, disclosing organ cavities 4, 4a, 4b)] for organoid cell growth and a microchannel network for fluid flow [see para. 0024 disclosing microfluidic feed channel 6 distributing a medium to the organ cavities (4, 4a, 4b) in growth section (3) from outlet (10)];
wherein the transducer layer [i.e., Marx’s layer (16)] comprises a heating device [see
para. 0026, disclosing heating means (11) in layer (16)] and at least a plurality of sensors [see
para. 0026 disclosing temperature sensors in layer (16)] in each cavity for cell parameter control
and growth,
wherein each sensor is located for measuring an organoid cell growth parameter in the
interior of each cavity [temperature sensors disclosed by Marx in para. 0026 meets this
limitations, given that Applicant discloses and recites that the sensors include temperature
sensors (see Applicant’s claim 3)],
wherein the heating device is located in the interior of each cavity [see para. 0026 and Fig. 2B disclosing lower closing layer (16) being provided with heating device (23); and see para. 0099 disclosing that structures that are on the surface of one layer may become an internal closed structure once a second layer with corresponding microstructures is connected with the first layer in a fluid-tight manner; see also Fig. 2A showing layer (15) to be connected to layer (16), and thus Examiner notes that the heating device in layer (16) is understood to be in the interior of the cavity in layer (15)],
wherein the heating device and the plurality of sensors are in direct contact with the
organoid cell culture or cultures and configured to provide real-time monitoring
of physiological parameters of the organoid cell culture or cultures in furtherance of the production of the organoid cell culture or cultures [see paras. 0026, 0099, and 0105 and Fig. 2A regarding the heating device; and see paras. 0026, 0058, 0082-0083 and -105 regarding the sensors]
and wherein the plurality of sensors is selected from temperature sensor, pH sensor or
combinations thereof [see, for example, paras. 0026 and 0105 disclosing temperature sensors].
As to claim 3, see paragraphs 0026 and 0105 disclosing temperature sensors.
As to claim 4, see paragraph 0026 disclosing a meander structure of the temperature sensor (23).
As to claim 7, the configuration of the heating device (11) is considered to be a meander (see para. 0026 and 2B). [Alternatively, the configuration of the heating device being a meander, spiral, or coil configuration would have been an obvious design choice since it would have resulted in a predictable outcome of providing a heat source to the cavity that would have achieved the purposes disclosed by Marx.]
As to claim 22, see paragraph 0066 of Marx disclosing medium feed reservoirs (s) which are in fluidic communication with an organ growth section through a microfluidic feed channel (6). See also paragraph 0080 disclosing at least one medium feed reservoir connected to at least one organ growth section (3) by a feed channel (6). See also paragraph 0024 regarding the microfluidic feed (6).
As to claim 23, see paragraph 0099 disclosing multiple layers (e.g., seven layers) that form an internal closed structure. [Examiner notes that the topmost layer(s) is/are equivalent to Applicant’s “sealing layer”].
As to claim 24, see paragraph 0087 disclosing micropumps and other pressuring means for providing flow through the organ cavities. Thus Examiner notes that the channel (6) and outlet (10) and cavities form a plurality of tubes and connectors for regulation of the pressure and flow of the microfluidic system of the intermediate layer.
As to claim 25, ee Marx in figure 2A, showing 6 cavities.
As to claim 26, see paragraph 0066 of Marx disclosing medium feed reservoirs (s) which are in fluidic communication with an organ growth section through a microfluidic feed channel (6). See also paragraph 0080 disclosing at least one medium feed reservoir connected to at least one organ growth section (3) by a feed channel (6). See also paragraph 0024 regarding the microfluidic feed (6). Thus it is understood that the layer with the cavities [equivalent to Applicant’s intermediate layer] has micro-inlet and micro-outlet as recited.
As to claim 27, see Marx in paragraph 0082 additionally disclosing two or more different sensors, including pH sensor, analyte capture sensor, temperature sensor, NO sensor, plasmon resonance sensor, etc.
As to claim 28, see Marx in paragraph 0082 disclosing plasmon resonance sensor, which Examiner notes is an optical sensor. See also paragraph 0083 disclosing fluorescence sensing.
Applicant’s claim 29 recites that the intermediate layer [Marx’s organ cavity layer (15)] comprises glass or silicon. See March in paragraph 0105 disclosing the organ cavity layer (15) being SiO2 or glass.
As to claim 30, the layer forming the cavity [equivalent to Applicant’s intermediate layer] can be made from synthetic polymer such as polyimide or polyamide or polyetheretherketone (PEEK), polyphenylenesulfide (see Marc, para. 0056.).Marx also discloses that synthetic polymers are optically transparent and can include, for example, polystyrol (PS), polycarbonate (PC), and polysiloxane, e.g. polydimethylsiloxane (PDMS). Para. 0056.
As to claim 33, the base layer [the bottom-most layer of the multiple layers of the chip device
(para. 0099) is equivalent to Applicant’s base layer]
and transducer layer [i.e., Marx’s lower closing layer (16) which is equivalent to Applicant’s transducer layer (para. 0102, 0105)]
are fused or laminated to define a single layer [see para. 0099 and 0102 dislcosing tha the layers form a fluid-tight structure].
As to claim 36, the device defines a multiorgan-on-a-chip. See paragraphs 0017, 0023, 0024 disclosing an organ-on-a-chip; para. 0028, disclosing an organ growth section (3) that flows into organ cavities (4); para. 0029 disclosing an adult stem cell cavity (9) in the center of organ cavities. See paragraph 0023 disclosing that the organ-on-a-chip device comprises one or more organs for testing compounds.
Conclusion
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/Ann Montgomery/Primary Examiner, Art Unit 1678
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