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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/18/2025 has been entered.
Remarks
This office action fully acknowledges Applicant’s remarks and amendments in the reply filed on 22 May 2025.
Claims 1, 3-6, 8, 10, and 36-47 are pending.
Claims 2, 7, 9, and 11-35 are cancelled.
No claims are withdrawn.
Claims 44-47 are newly added.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-6, 8, and 44-47 are rejected under 35 U.S.C. 103 as being unpatentable over Bergkvisit et al. (US 2014/0038221 A1), hereinafter “Bergkvisit”, in view of Wikswo et al. (US 2018/0326417 A1), hereinafter “Wikswo”, and Ingber et al. (US PAT 8,647,861 B2), hereinafter “Ingber”, and as evidenced through WuDunn (Darrell WuDunn, Mechanobiology of trabecular meshwork cells, Experimental Eye Research, Volume 88, Issue 4, 2009, Pages 718-723, ISSN 0014-4835.), hereinafter “WuDunn”.
Regarding Claim 1, Bergkvisit teaches a modular microfluidic device (Fig. 6A shows modules 710a/710b and 711.) for simulating physiological conditions of a biological system ([0075]), the device comprising:
a first channel member 710a having a first perfusion chamber formed therein (Fig 6B shows the modular microfluidic device as having an upper perfusion chamber fed by the inflow channel 716 and separated from the cells 713 via a first membrane 712.),
the first perfusion chamber having a first inlet and a first outlet (Fig. 6B shows the upper perfusion chamber having an inlet 716 for delivering growth media, and an outlet formed as the opening directly above the first membrane 712 – see the annotated Fig. 6A below.);
a second channel member 710b having a second perfusion chamber formed therein (Fig 6B shows the modular microfluidic device as having a lower perfusion chamber that mirrors the upper perfusion chamber.),
the second perfusion chamber having a second inlet and a second outlet (Fig. 6B shows the lower perfusion chamber having an inlet formed as the opening directly below the second membrane 715 – see the annotated Fig. 6A below, and an outlet 717.);
a central member 711 disposed between the first and second channels members 710a/710b (Figs. 6A and 6B, and [0036-0037]);
the central member 711 comprising:
at least one well ([0023]: “…a multi-channel perfusion array including a scaffold holder with, a first element including a multi-well, microtiter plate designed as an insert to hold the 3-D micro- and nano-structured scaffolds…” – [0036]: “711 is the scaffold holder.” – See also para. [0166].);
wherein a 3D structure of cultured biological cells is disposed in each of the at least one wells of the central member, wherein the 3D structure comprises at least 10 cells across in all three spatial dimensions ([0091]: “HTM cells (for example 4×105 cell/scaffold) were seeded on HTM biocompatible coated scaffolds” – [0181]: “Three-dimensional confocal reconstruction by z-stacking of F-actin demonstrated that HTM cells grew on top of the SU-8 3-D micro- and nanostructured scaffolds as dense multilayers, forming a 3-D meshwork approximately 20 μm thick.” – The quantity of cells disclosed more than accounts for the “at least 10 cells across in all three spatial dimensions” given that HTM cells are generally as low as 1 μm in thickness when flattened, as evidenced through WuDunn. – Further, mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). Herein, one skilled in the art would find it obvious that providing additional cells to form an at least 10x10x10 cell structure would yield the predictable result of a higher throughput culture for chemical production, or a more workable structure of cells for forming into more complex structures.)
a first porous membrane 712 disposed between the first perfusion chamber and the at least one well; and a second porous membrane 715 disposed between the second perfusion chamber and the at least one well (Fig. 6B shows the first and second membranes 712/715 separating the wells formed in the central member 711 from the first and second perfusion chambers respectively.),
wherein a first layer of a first type of living cells is disposed on a surface of the first porous membrane; wherein a second layer of a second type of living cells is disposed on a surface of the second porous membrane (Para. [0176] discusses growth of the HTM cells directly on the membrane surfaces – see also Figs. 1 and 3A-C.),
as in Claim 1.
Further regarding Claim 1, Bergkvisit does not specifically teach the device discussed above wherein: the first inlet port and the first outlet port are longitudinally aligned with respect to each other; and the second inlet port and the second outlet port are longitudinally aligned with respect to each other, as in Claim 1.
However, Wikswo teaches a respective bioreactor cell culture device (Fig. 1E) wherein the inlets and outlets of channels 106 and 107 are longitudinally aligned, and the inlets and outlets of channels 126 and 127 are additionally longitudinally aligned, so as to provide an apical flow 123 and a basal flow 113 for cells 118 and 138 on either side of the membrane 136, thereby allowing different compositions of the apical and basal fluid for culture of cells optimized for the same ([0131-0133]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Bergkvisit wherein: the first inlet port and the first outlet port are longitudinally aligned with respect to each other; and the second inlet port and the second outlet port are longitudinally aligned with respect to each other, such as suggested by Wikswo, so as to provide independent apical and basal flows for cell lines requiring the same, as contemplated by Bergkvisit ([0181]).
Further regarding Claim 1, Bergkvisit does not specifically teach the device discussed above wherein: the first type of living cells is different from the second type of living cells, as in Claim 1.
However, Ingber teaches a respective cell/organoid culture device comprising three parallel microchannels separated by two porous membranes, wherein cancer cells are placed in the inner channel on both membranes, capillary endothelial cells are placed on the opposite side of one membrane, and lymphatic endothelial cells are placed on the opposite side of the other membrane (Fig. 7C). Therein, this structure allows for the recreation of complex microstructures (such as a tumor structure as exemplified above) to enable the study of complex processes such as oxygen transport, nutrient transport, tumor metastasis, etc. as discussed by Ingber (col. 4, line 6).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Bergkvisit wherein a first layer of a first type of living cells is disposed on a surface of the first porous membrane; wherein a second layer of a second type of living cells is disposed on a surface of the second porous membrane, and wherein the first type of living cells is different from the second type of living cells, such as suggested by Ingber, so as to enable the study of complex processes such as oxygen transport, nutrient transport, tumor metastasis, etc. as discussed by Ingber (col. 4, line 6).
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit teaches the device discussed above wherein the at least one well includes a first orifice in fluid communication with the first perfusion chamber via the first porous membrane 712, and a second orifice in fluid communication with the second perfusion chamber via the second porous membrane 715 (Fig. 6B shows a central arrow representing the flow of media through the device, wherein the flow passes through the central member 711. Fig. 6B further shows upper first orifices forming the openings of the wells, and para. [0065] discusses filter elements contained within the wells of the central member 711, wherein a second orifice must inherently be present to permit the flow shown in Fig. 6B through the filter elements contained therein. Further, as shown in Fig. 6B, these orifices lie between the membranes 712/715, thereby communicating with the first/second perfusion chambers via the two membranes as claimed.), as in Claim 3.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit teaches the device discussed above comprising an array of wells formed in the central member 711 (Fig. 6A shows an array of wells formed in the central member 711. – [0023]: “a multi-channel perfusion array”), as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 4 as discussed above. Further, Bergkvisit teaches the device discussed above wherein each well of the array includes a first orifice in fluid communication with the first perfusion chamber via the first porous membrane 712, and a second orifice in fluid communication with the second perfusion chamber via the second porous membrane 715 (Fig. 6B shows a central arrow representing the flow of media through the device, wherein the flow passes through the central member 711. Fig. 6B further shows upper first orifices forming the openings of the wells, and para. [0065] discusses filter elements contained within the wells of the central member 711, wherein a second orifice must inherently be present to permit the flow shown in Fig. 6B through the filter elements contained therein. Further, as shown in Fig. 6B, these orifices lie between the membranes 712/715, thereby communicating with the first/second perfusion chambers via the two membranes as claimed.), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 4 as discussed above. Further, Bergkvisit teaches the device discussed above wherein the central member 711 includes a well access passage (The open passage which passes through the open upper orifice of each well.) for each well, as in Claim 6.
Regarding Claim 8, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit teaches the device discussed above wherein the first type of living cells comprises endothelial cells ([0051]: “Choices of HTM cells may include…endothelial cells…”), as in Claim 8.
Regarding Claim 44, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit does not specifically teach the device discussed above wherein the 3D structure of cultured biological cells comprises a spheroid, and/or an organoid, as in Claim 44.
However, Ingber teaches a respective culture device wherein the 3D structure of cultured biological cells comprises an organoid of multiple cell types (Fig. 7C) thereby enabling the study of complex processes such as oxygen transport, nutrient transport, tumor metastasis, etc. as discussed by Ingber (col. 4, line 6).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Bergkvisit wherein the 3D structure of cultured biological cells comprises a spheroid, and/or an organoid, such as suggested by Ingber, so as to enable the study of complex processes such as oxygen transport, nutrient transport, tumor metastasis, etc. as discussed by Ingber (col. 4, line 6).
Regarding Claim 45, the prior art meets the limitations of Claim 44 as discussed above. Further, as discussed above regarding Claim 44, one skilled in the art would find it obvious to provide the culture device of Bergkvisit with the organoid of Ingber so as to enable the study of complex processes. Therein Ingber, the organoid comprises cancer/organ/tissue cells (col. 4, lines 1-9).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying the culture device of Bergkvisit with the organoid of Ingber, to provide the 3D structure of cultured biological cells comprising cancer cells, tissue cells, and/or organ cells, so as to appropriately provide the organoid of Ingber.
Regarding Claim 46, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit does not specifically teach the device discussed above wherein the at least one well of the central member is provided in a 96-well plate format, as in Claim 46.
However, mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). Here3in, one skilled in the art would find it obvious to merely duplicate the wells so as to increase the throughput device, thereby representing an obvious and expected result to the variable of the number of wells.
Regarding Claim 47, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit teaches the device discussed above wherein the at least one well is configured to facilitate growth of biological cells along all three dimensional axes into one or more 3D structures of cultured biological cells and/or maintain one or more 3D structures of biological cells in all three-dimensional axes ([0030, 0057-0064]), as in Claim 47.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bergkvisit in view of Wilkswo and Ingber, as applied to Claims 1, 3-6, 8, and 44-47 above, and in further view of Zudaire et al. (US 2010/0255528 A1), hereinafter “Zudaire”.
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit/Wilkswo/Ingber does not specifically teach the device discussed above wherein the second type of living cells comprises one or more cell types selected from the group consisting of: fibroblast cells, mesenchymal cells and adipocyte cells, as in Claim 10.
However, Zudaire teaches a respective 3-D cell culture apparatus wherein a base layer comprises a neutral polysaccharide polymer gel, a first cell layer comprises endothelial cells, and a second cell layer comprises at least one additional mammalian cell type, such as fibroblast and/or adipocyte cells ([0148]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Bergkvisit/Wilkswo/Ingber to include a second type of cells comprising fibroblast and/or adipocyte cells, such as suggested by Zudaire, given that Bergkvisit teaches a layered arrangement of different cell types wherein fibroblast and/or adipocyte cells represent obvious alternative cell types known in the art that are applied to an endothelial base layer; and would have a reasonable expectation of success therein.
Claims 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Bergkvisit in view of Wilkswo and Ingber, as applied to Claims 1, 3-6, 8, and 44-47 above, and in further view of Handique et al. (US 2019/0064168 A1), hereinafter “Handique”.
Regarding Claim 36, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit/Wilkswo/Ingber does not specifically teach the device discussed above wherein the central member comprises a translucent material, as in Claim 36.
However, Handique teaches a respective cell culture device wherein cells are housed within wells 120 of a multi-well substrate 110 (Fig. 1), wherein the multi-well substrate 110 is transparent or translucent so as to permit observation of the contents of the multi-well array using a microscope or equivalent imaging system so as to determine properties of the cells ([0095]: “The imaging subsystem 194 is preferably positioned beneath the substrate and oriented to image the contents of the set of wells through the transparent (or translucent) material of the substrate”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Bergkvisit/Wilkswo/Ingber to include a central member comprised of a translucent material, such as suggested by Handique, so as to provide a structure capable of allowing cells contained within the wells to be viewed using a microscope or equivalent imaging system to monitor and determine properties of the cells contained therein; and would have a reasonable expectation of success therein.
Regarding Claim 37, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit/Wilkswo/Ingber does not specifically teach the device discussed above wherein the central member comprises an optically transparent material, as in Claim 36.
However, Handique teaches a respective cell culture device wherein cells are housed within wells 120 of a multi-well substrate 110 (Fig. 1), wherein the multi-well substrate 110 is transparent or translucent so as to permit observation of the contents of the multi-well array using a microscope or equivalent imaging system so as to determine properties of the cells ([0095]: “The imaging subsystem 194 is preferably positioned beneath the substrate and oriented to image the contents of the set of wells through the transparent (or translucent) material of the substrate”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Bergkvisit/Wilkswo/Ingber to include a central member comprised of an optically transparent material, such as suggested by Handique, so as to provide a structure capable of allowing cells contained within the wells to be viewed using a microscope or equivalent imaging system to monitor and determine properties of the cells contained therein; and would have a reasonable expectation of success therein.
Claims 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Bergkvisit in view of Wilkswo and Ingber, as applied to Claims 1, 3-6, 8, and 44-47 above, and in further view of McDevitt et al. (US 2014/0363838 A1), hereinafter “McDevitt”.
Regarding Claim 38, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit/Wilkswo/Ingber does not specifically teach the device discussed above wherein the first and second channel members comprise a white material, as in Claim 38.
However, McDevitt teaches a respective cell culture apparatus wherein cell-housing components of the device are fabricated from white material so as to provide the benefit of allowing for luminescence applications ([0034]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the channel members of Bergkvisit/Wilkswo/Ingber to be fabricated from a white material, such as suggested by McDevitt, so as to provide a structure capable of being used with luminescence applications; and would have a reasonable expectation of success therein.
Regarding Claim 39, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit/Wilkswo/Ingber does not specifically teach the device discussed above wherein the first and second channel members comprise a black material, as in Claim 39.
However, McDevitt teaches a respective cell culture apparatus wherein cell-housing components of the device are fabricated from black material so as to provide the benefit of allowing for fluorescence applications ([0034]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the channel members of Bergkvisit/Wilkswo/Ingber to be fabricated from a black material, such as suggested by McDevitt, so as to provide a structure capable of being used with fluorescence applications; and would have a reasonable expectation of success therein.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Bergkvisit in view of Wilkswo and Ingber, as applied to Claims 1, 3-6, 8, and 44-47 above, and in further view of Handique, and further as evidenced through Ramazani et al. (Ahmad Ramazani S.A., et al., “Polycarbonate surface cell's adhesion examination after Nd:YAG laser irradiation”, Materials Science and Engineering: C, Volume 29, Issue 4, 2009, Pages 1491-1497), referred to hereinafter as “Ramazani”.
Regarding Claim 40, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit/Wilkswo/Ingber does not specifically teach the device discussed above wherein the central member comprises polycarbonate, as in Claim 40.
However, Handique teaches a respective cell culture device wherein cells are housed within wells 120 of a multi-well substrate 110 (Fig. 1), wherein the multi-well substrate 110 is composed of polycarbonate ([0050]: “…the substrate 110 can be composed of any one or more of: glass, ceramic, a silicone-based material (e.g., polydimethylsiloxane (PDMS)), a polymer (e.g., agarose, polyacrylamide, polystyrene, polycarbonate, poly-methyl methacrylate (PMMA), polyethylene glycol, etc.)…”). Polycarbonate is commonly utilized in the art of cell culture apparatus as the material is inherently biocompatible, as evidenced through Ramazani (“On the basis of years of laboratory experimentation, polycarbonate is biocompatible…”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the central multi-well member of Bergkvisit/Wilkswo/Ingber as comprising polycarbonate, such as suggested by Handique, so as to provide a suitable biocompatible material for cell culture, as evidenced through Ramazani; and would have a reasonable expectation of success therein.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Bergkvisit in view of Wilkswo and Ingber, as applied to Claims 1, 3-6, 8, and 44-47 above, and in further view of Patel (US 2018/0163172 A1), hereinafter “Patel”.
Regarding Claim 41, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit/Wilkswo/Ingber does not specifically teach the device discussed above wherein the first and second porous membranes comprise track-etched polycarbonate, and optionally one or both membranes are coated with an adhesion-promoting material such as proteins or peptides, as in Claim 41.
However, Patel teaches a respective cell culture apparatus comprising filter membranes comprising track-etched polycarbonate ([0035]: “…the filter membrane can be made of…polycarbonate track etched (PCTE)…”). Patel further describes the benefit of this material as being biocompatible with cells ([0035]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the first and second membranes of Bergkvisit/Wilkswo/Ingber as comprising track-etched polycarbonate material, such as suggested by Patel, so as to provide a structure that is biocompatible with cells; and would have a reasonable expectation of success therein.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Bergkvisit in view of Wilkswo and Ingber, as applied to Claims 1, 3-6, 8, and 44-47 above, and in further view of Hase et al. (US 2011/0151565 A1), hereinafter “Hase”.
Regarding Claim 42, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit/Wilkswo/Ingber does not specifically teach the device discussed above wherein the first porous membrane is surrounded by a first membrane frame, and the second porous membrane is surrounded by a second membrane frame, as in Claim 42.
However, Hase teaches a respective cell culture apparatus comprising a membrane, wherein the membrane is supported by a membrane frame for the purpose of immobilizing the membrane and maintaining its dimensions (Fig. 1a and abstract: “…a support-held culture membrane comprising an organic thin film having cell adhesion properties and biodegradability and a frame-like support fixed on the periphery of the organic thin film for maintaining the dimensions of the organic thin film…”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the first and second membranes of Bergkvisit/Wilkswo/Ingber to include first and second membrane frames, such as suggested by Hase, so as to immobilize the membrane and maintain its dimensions; and would have a reasonable expectation of success therein.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Bergkvisit in view of Wilkswo and Ingber, as applied to Claims 1, 3-6, 8, and 44-47 above, and in further view of Griffith et al. (US 2017/0227525 A1), hereinafter “Griffith”.
Regarding Claim 43, the prior art meets the limitations of Claim 1 as discussed above. Further, Bergkvisit teaches the device discussed above wherein the first channel member 710a comprises one or more alignment pins and the second channel member 710b comprises one or more alignment holes configured to receive the alignment pins (Fig. 6A shows alignment pins and holes for snapping together the modular components of the device via snap fit.), as in Claim 43.
Further regarding Claim 43, Bergkvisit/Wilkswo/Ingber does not specifically teach the device discussed above wherein the central member comprises at least one alignment groove configured to pass the at least one alignment pin therethrough, as in Claim 43.
However, Griffith teaches a respective organoid culture device wherein layers of the device are assembled by threading a base pin through alignment holes of additional layers ([0030, 0093, 0195]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Bergkvisit/Wilkswo/Ingber wherein the central member comprises at least one alignment groove configured to pass the at least one alignment pin therethrough, such as suggested by Griffith, so as to provide an alternative fastening mechanism for the layers of the device, as the arrangement of Griffith represents a mere alternative arrangement achieving the identical function of fastening layers of an organoid culture device.
Response to Arguments
35 USC 102
Applicant’s arguments are on the grounds that Bergkvisit does not specifically teach the amendments to Claim 1 requiring the microfluidic device having the first inlet port and the first outlet port are longitudinally aligned with respect to each other; and the second inlet port and the second outlet port are longitudinally aligned with respect to each other; and wherein a 3D structure of cultured biological cells is disposed in each of the at least one wells of the central member, wherein the 3D structure comprises at least 10 cells across in all three spatial dimensions; wherein a first layer of a first type of living cells is disposed on a surface of the first porous membrane; wherein a second layer of a second type of living cells is disposed on a surface of the second porous membrane; and wherein the first type of living cells is different from the second type of living cells. Applicant notes the configuration of Bergkvisit having two different cell types on opposite sides of a same membrane, whereas the instant claims require different cell types on two separate membranes.
Applicant’s arguments are not persuasive because Bergkvisit teaches a structure having two separate membranes, wherein the deficiency in Bergkvisit of two different cell types on opposite sides of the two separate membranes is cured by obvious combination with Ingber teaching a flow-monitoring device wherein two distinct cell types are placed on opposite sides of separate membranes, and wherein a central member containing cells separates the two membranes. Therein, one skilled in the art would find it obvious to provide this arrangement of cells to the device of Bergkvisit so as to provide different complex cellular systems for analysis.
Applicant further argues that any combination with Bergkvisit having a 3D structure of multiple cell types would render the device of Bergkvisit inoperable for its purpose of modeling the physiology of outflow pathways. However, this is not persuasive because the device of Bergkvisit remains capable of modeling flow pathways, as similarly performed in Ingber. One skilled in the art would recognize the multi-membrane configuration of Bergkvisit, similar to that of Ingber (Fig. 7C) as useful for modeling a variety of flow systems given its intended purpose of flow modeling. Further, the mere adding of additional cell lines would not render the device of Bergkvisit inoperable for analyzing HTM cells, as HTM cells may be grown along with other cells on the sides of the membranes as in Ingber.
Regarding Applicant’s arguments regarding the ports and longitudinal alignment thereof as in the amendments to Claim 1, the additional reference of Wilkswo is provided herein. As discussed above in the body of the action, one skilled in the art would find it obvious to provide the additional inlet/outlet ports of Wilkswo, being longitudinally aligned, as to provide a structure capable of providing independent flow pathways for both apical and basal flow so as to further achieve the flow analysis contemplated by Bergkvisit as inspired by the system of Wilkswo. Examiner additionally notes that this modification would not render the device of Bergkvisit inoperable for flow analysis, and the device of Bergkvisit would remain functional for the growth and analysis of HTM cells.
Applicant’s arguments are further on the grounds that Bergkvisit relies on a single scaffold of a single component system. However, Fig. 6A shows the multi-component, modular system of Bergkvisit, not a single component system. Further, para. [0024] discusses a plurality of 3D micro and nano-structured scaffolds inserted into the wells of a microtiter plate, thereby providing a plurality of scaffolds, not a single scaffold – see also Fig. 6B.
35 USC 103
Applicant’s arguments are on the grounds that the additional references of Zudaire, Handique, McDevitt, Ramazani, Patel, and Hase do not remedy the alleged deficiencies of Claim 1 addressed in the response to arguments above.
Applicant’s arguments are not persuasive because, as discussed above, the alleged deficiencies of Claim 1 are cured through obvious modification of Bergkvisit with the port arrangement of Wilkswo providing independently controllable apical and basal flow pathways, and with the layered cellular arrangement of Ingber providing a biological structure for analyzing complex multi-cell-type systems. These references of Wilkswo and Ingber being newly cited herein solely as necessitated by Applicant’s amendments to Claim 1.
Regarding Handique, Applicant further argues there is no motivation to combine the device of Bergkviusit with the optically transparent material of Handique. This is not found persuasive because, as discussed in the body of the action regarding Claims 36-37, the optically transparent/translucent permits interrogation of the cellular sample by optical analysis, as is similarly contemplated by Bergkvisit in para. [0174] representing a clear motivation for providing an optically transparent/translucent material as suggested by Handique.
Examiner further notes, regarding Claim 43, the reference of Griffith is added herein, as necessitated by Applicant’s amendments, so as to provide the claimed layered structure connected by a through-pin.
New Claims
Claims 44-47 are newly added herein. As discussed above in the body of the action, new Claims 44-47 are rejected under 35 USC 103 as unpatentable over Bergkvisit in view of Wilkswo and Ingber.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798