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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments in the reply filed on 28 April 2026.
Claims 1, 3-6, 8, 10, 36-43, and 45-49 are pending.
Claims 2, 7, 9, 11-35, and 44 are cancelled.
No claims are withdrawn.
Claims 48-49 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 45-49 are rejected under 35 U.S.C. 103 as being unpatentable over Masuhara et al. (WO 2019/049944 A1), hereinafter “Masuhara”, in view of Ingber et al. (US PAT 8,647,861 B2), hereinafter “Ingber”, and Shoval et al. (Shoval, H., Karsch-Bluman, A., Brill-Karniely, Y. et al. Tumor cells and their crosstalk with endothelial cells in 3D spheroids. Sci Rep 7, 10428 (2017).), hereinafter “Shoval”.
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Regarding Claim 1, Masuhara teaches a modular microfluidic device 2200 (Fig. 22 reproduced above – See further “Specifically, the particle capturing chamber according to the embodiment of the present disclosure can be stacked materials including a plurality of layers.”) for simulating physiological conditions of a biological system (“As described above, in the case where the target to be captured is a cell, examples of the buffer liquid include RPMI1640 and DMEM that are culture media. For example, FBS may be added to RPMI1640 and DMEM.”), the device comprising:
a first channel member 2440 (Fig. 24 and “The first fluid supply channel unit 2203 of the particle capturing chamber 2200 is formed by the hole 2481 of the cover plate 2480, the hole 2472, the channel 2470, and the hole 2464 of the channel forming layer 2460, the hole 2454 of the matrix layer 2450, the hole 2444 of the chamber forming layer 2440, the through hole 2303 of the chip 2300, and the hole 2424 and the channel 2422 of the one-layer channel sheet 2420.”) having a first perfusion chamber 2210 formed therein (Fig. 22 and “a second fluid supply channel unit 2231 connected to a space 2210”), the first perfusion chamber having a first inlet port and a first outlet port (See the annotated Fig. 22 reproduced above.);
a second channel member 2420 (Fig. 24 and “one-layer channel sheet 2420”) having a second perfusion chamber 2209 formed therein (Fig. 22 and “a first fluid supply channel unit 2203 connected to a space 2209 on the side on which the particle settles”), the second perfusion chamber 2209 having a second inlet port and a second outlet port (See the annotated Fig. 22 reproduced 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 (See the annotated Fig. 22 which shows the first inlet/outlet ports and the second inlet/outlet ports being longitudinally aligned (a horizontal axis passing perpendicularly through each of their center openings) commensurately as claimed.);
a central member 2201 (Held on chip 2300 as seen in Fig. 24.) disposed between the first and second channel members 2440/2420 (“A particle capturing chamber 2200 shown in Fig. 22 includes a particle capturing unit 2201”); the central member 2201 comprising:
at least one well (See the annotated Fig. 22 above and “Particle capturing using the particle capturing chamber 2200 shown in Fig. 22 may be performed by supplying fluid containing particles from the first fluid supply channel unit 2203 and performing suction via the particle capturing channel unit 2202 with the valves 2235 and 2234 closed. As a result of the particle capturing, particles 2230 are captured in the wells.”),
as in Claim 1.
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Further regarding Claim 1, Masuhara does not specifically teach the device discussed above further comprising a first porous membrane disposed between the first perfusion chamber and the at least one well; wherein a first layer of a first type of living cells is disposed on a surface of the first porous membrane; a second porous membrane disposed between the second perfusion chamber and the at least one well; wherein a second layer of a second type of living cells is disposed on a surface of the second porous membrane, wherein the first type of living cells is different from the second type of living cells wherein a 3D structure of cultured biological cells is disposed in the central channel, wherein the 3D structure of cultured biological cells comprises a third type of living cells and the third type of living cells are each different from the first/second, as in Claim 1.
However, Ingber teaches a respective culture device comprising a first porous membrane 806A disposed between a first perfusion chamber 8-4A and a central channel 804B; wherein a first layer of a first type of living cells is disposed on a surface of the first porous membrane 806A (“In particular, membrane 806A is coated with a lymphatic endothelium on its upper surface 805A”); a second porous membrane 806B disposed between a second perfusion chamber and the central channel 804B; wherein a second layer of a second type of living cells is disposed on a surface 805C of the second porous membrane 806B, wherein the first type of living cells is different from the second type of living cells (“the second porous membrane 805B [has] a vascular endothelium on its bottom surface 805C” – vascular epithelial cells are different from lymphatic endothelium) wherein a 3D structure of cultured biological cells is disposed in the central channel 804B, wherein the 3D structure of cultured biological cells comprises a third type of living cells and the third type of living cells are each different from the first/second (“Tumor cells are placed in the central microchannel surrounded on top and bottom by layers of stromal cells on the surfaces of the upper and lower membranes in section 804B.”) – See the annotated Fig. 7C above. Therein, this arrangement is useful for “accurately modeling biological tissue-tissue interfaces found in other physiological systems such as the blood-brain barrier, intestine, bone marrow, glomerulus, and cancerous tumor microenvironment”.
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 Masuhara with a first porous membrane disposed between the first perfusion chamber and the at least one well; wherein a first layer of a first type of living cells is disposed on a surface of the first porous membrane; a second porous membrane disposed between the second perfusion chamber and the at least one well; wherein a second layer of a second type of living cells is disposed on a surface of the second porous membrane, wherein the first type of living cells is different from the second type of living cells wherein a 3D structure of cultured biological cells is disposed in the central channel, wherein the 3D structure of cultured biological cells comprises a third type of living cells and the third type of living cells are each different from the first/second, such as suggested by Ingber, so as to more accurately replicate particular tissue microenvironments and their effects on the captured particles/cells (or tumor cells growing on top of or across the central member surface seeded by captured tumor seed cells) in Masuhara.
Further regarding Claim 1, Masuhara/Ingber does not specifically teach the device discussed above wherein the 3D structure comprises at least 10 cells across in all three spatial dimensions; wherein the 3D structure of cultured biological cells comprises a discrete spheroid and/or a discrete organoid confined within a respective one of each of the at least one wells of the central member; and wherein the 3D structure of cultured biological cells has a diameter of at least 0.5 mm, as in Claim 1.
However, Shoval teaches a respective spheroid culture device wherein discrete spheroids are confined within respective discrete wells of the device (Fig. 1B) wherein the wells are separated from an endothelial media by a filter/membrane (Fig. 5B). In Shoval, the 3D structure/spheroid comprises at least 10 cells across in all three spatial dimensions (Fig. 1 caption: “Spheroids were made of 5,000 cells per spheroid.”), wherein the 3D structure of cultured biological cells has a diameter of at least 0.5 mm (“larger spheroids, which can reach up to 400–500 µm in diameter” – Further, one would find it obvious to optimize the spheroid diameter for its particular application and/or progression of growth/size as tumors continuously grow unabated.). Therein, this arrangement allows for “the imaging of multiple spheroids in a single imaging field” (See the “Results” section.).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide discrete spheroids within each of the discrete wells of Masuhara/Ingber so as to allow for the imaging of multiple spheroids in a single imaging field, thereby increasing throughput of the device, and wherein the specific cellular dimensions and diameter of the spheroid are merely drawn to routinely optimized variables which are further specifically disclosed by Shoval.
Examiner additionally notes that Masuhara specifically teaches the optimization of well size for the particular application at hand (“In the present disclosure, the entrance of the hole can have a dimension that prevents the particle to be captured from passing through the hole by suction to reach the particle capturing channel unit. For example, the minimum dimension of the entrance of the hole is less than the dimension of the particle. For example, in the case where the shape of the entrance of the hole is a rectangle, the short side or the long side of the rectangle, particularly the short side of the rectangle can have a dimension smaller than the dimension (diameter of the particle or the like) of the particle to be captured. For example, the length of the short side of the rectangle can be, for example, not more than 0.9 times, particularly not more than 0.8 times, more particularly not more than 0.7 times, even more particularly not more than 0.6 times the dimension (e.g., diameter of the particle) of the particle to be captured.”), and even further teaches microorganisms as particles to be captured (“Examples of the particles include, but not limited to, biological microparticles such as cells, microorganisms...”), wherein such microorganisms would be expected to be at least 10 cells across in all three spatial dimensions. Thus, one skilled in the art would find it obvious to optimize the well size in Masuhara to accommodate the spheroids of Shoval, as suggested and affirmed by Masuhara.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Masuhara teaches the device discussed above wherein wherein the at least one well includes a first orifice in fluid communication with the first perfusion chamber, and a second orifice in fluid communication with the second perfusion chamber (See the annotated Fig. 22 above.), as in Claim 3.
Further, as discussed above, Masuhara is modified in view of Ingber wherein the central channel and member are flanked by dual membranes, the apical and basal flows of the inlets/outlets being supplied on the exterior sides of the membranes away from the central channel/member. Thus, when in combination with Ingber, the first orifice of Masuhara is in fluid communication with the first perfusion chamber via the first membrane, and the second orifice is in fluid communication with the second perfusion chamber via the second membrane.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Masuhara teaches the device discussed above comprising an array of wells formed in the central member (See Fig. 22 showing multiple wells in the central member.), as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 4 as discussed above. Further, Masuhara 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, and a second orifice in fluid communication with the second perfusion chamber via the second porous membrane (See the above discussion of Claim 3, which is true for each well of the array of wells.), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 4 as discussed above. Further, Masuhara teaches the device discussed above wherein the central member 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, Masuhara modified in view of Ingber provides the device discussed above wherein the first type of living cells comprises endothelial cells (See the above discussion regarding Ingber in Claim 1 and the cited passage “In particular, membrane 806A is coated with a lymphatic endothelium on its upper surface 805A”), as in Claim 8.
Regarding Claim 45, the prior art meets the limitations of Claim 44 as discussed above. Further, Masuhara modified in view of Ingber provides the device discussed above wherein the third type of livinqcells comprises a first type of cancer cells, a first type of tissue cells, and/OR a first type of organ cells (“Tumor cells are placed in the central microchannel surrounded on top and bottom by layers of stromal cells on the surfaces of the upper and lower membranes in section 804B.”), as in Claim 45.
Regarding Claim 46, the prior art meets the limitations of Claim 1 as discussed above. Further, Masuhara 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). Herein, 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, Masuhara 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 (As the wells of Masuhara comprise an open, 3-dimensional volume capable of receiving culture media, the wells are thereby configured to “facilitate” (“help bring about”) growth of biological cells along all three dimensional axes into one or more 3D structures of cultured biological cells.), as in Claim 47.
Regarding Claim 48, the prior art meets the limitations of Claim 1 as discussed above. Further, as discussed above regarding Claim 1, Masuhara/Ingber is modified in view of Shoval so as to provide for discrete organoids/spheroids within each of the wells. Further, Shoval teaches different types of spheroids contained within wells of the device (See the Spheroid formation using Petri Dish well array section: “Master 3D Petri Dish® 35-well array (Microtissues Inc., RI, USA) was used to create 2% agarose hydrogel micro-wells. Micro-wells were then incubated with 1 ml of the appropriate medium for 60 minutes, followed by seeding of different cells. Cells used in this assay were PANC1, BxPC3, A375 and MDA-MB-231, and two patient-derived cells: BR-58 and M21.”) wherein this arrangement allows for multiplexed analysis of varying spheroids.
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 Masuhara/Ingber with the discrete well-contained spheroids of Shoval, to provide a second (or more) 3D structure of cultured biological cells having a fourth type of living cells is disposed in the second well, and wherein the third type of living cells is different from the fourth type of living cells, such as suggested by Shoval, to allow for multiplexed analysis of different spheroid types within a single run of the device.
Regarding Claim 49, the prior art meets the limitations of Claim 48 as discussed above. Further, as discussed above regarding Claim 48, Shoval provides for at least a second spheroid of a fourth type of cells. Further, Shoval teaches the fourth (and additional) cell type(s) as a second type of cancer cells (the cells listed by Shoval discussed in Claim 48 are cancer cells) so as to provide for multiplexed study of various tumor structures in response to a same stimulus/environment.
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 Masuhara/Ingber in view of Shoval, to provide the fourth cell type as being cancer cells so as to provide for a multiplexed tumor analysis system.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Masuhara in view of Ingber and Shoval, as applied to Claims 1, 3-6, 8, and 45-49 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, Masuhara/Ingber/Shoval 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 Masuhara/Ingber/Shoval to include a second type of cells comprising fibroblast and/or adipocyte cells, such as suggested by Zudaire, given that Ingber 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 Masuhara in view of Ingber and Shoval, as applied to Claims 1, 3-6, 8, and 45-49 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, Masuhara/Ingber/Shoval 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 Masuhara/Ingber/Shoval 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, Masuhara/Ingber/Shoval 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 Masuhara/Ingber/Shoval 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 Masuhara in view of Ingber and Shoval, as applied to Claims 1, 3-6, 8, and 45-49 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, Masuhara/Ingber/Shoval 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 Masuhara/Ingber/Shoval 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, Masuhara/Ingber/Shoval 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 Masuhara/Ingber/Shoval 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 Masuhara in view of Ingber and Shoval, as applied to Claims 1, 3-6, 8, and 45-49 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, Masuhara/Ingber/Shoval 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 Masuhara/Ingber/Shoval 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 Masuhara in view of Ingber and Shoval, as applied to Claims 1, 3-6, 8, and 45-49 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, Masuhara/Ingber/Shoval 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 Masuhara/Ingber/Shoval 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 Masuhara in view of Ingber and Shoval, as applied to Claims 1, 3-6, 8, and 45-49 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, Masuhara/Ingber/Shoval 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 Masuhara/Ingber/Shoval 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 Masuhara in view of Ingber and Shoval, as applied to Claims 1, 3-6, 8, and 45-49 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, Masuhara/Ingber/Shoval does not specifically teach the device discussed above wherein the first channel member comprises one or more alignment pins and the second channel member comprises one or more alignment holes configured to receive the alignment pins and 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 Masuhara/Ingber/Shoval wherein the first channel member comprises one or more alignment pins and the second channel member comprises one or more alignment holes configured to receive the alignment pins and wherein the central member comprises at least one alignment groove configured to pass the at least one alignment pin therethrough, so as to ensure proper alignment of the layers of the device, thereby reducing operator error relating to incorrect assembly.
Response to Arguments
35 USC 103
Applicant’s arguments are drawn to alleged deficiencies of the previously applied prior art of Bergksvisit in teaching the limitations of Claim 1 and its dependents. However, Bergksvisit is no longer relied upon herein for teaching any aspect of the instant claims. As such, Applicant’s arguments against Bergksvisit are moot.
Bergksvisit was removed as the primary reference as necessitated by Applicant’s amendments specifying the “at least 0.5 mm” diameter of the spheroids to be contained within the wells of the device. The wells (membrane pores) of Bergksvisit are not large enough to accommodate such sized spheroids, and Bergksvisit further does not provide guidance for optimizing well size. The prior art of Masuhara is instead newly added and relied upon herein for its teaching of specific architectural elements of the device, as well as teachings of optimizing the well size respective to the particular cell/particle/organism being captured therein, as discussed above in the body of the action.
Applicant’s additional amendments requiring a discrete organoid in each of the wells necessitated the addition of the prior art of Shoval, teaching a multiwell-plate-type arrangement housing individual spheroids within each respective well.
New Claims
Claims 48-49 are newly added herein. As discussed above in the body of the action, new Claims 48-49 are rejected under 35 USC 103 as unpatentable over Masuhara in view of Ingber and Shoval.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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