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 .
Claim Objections
Claims 13 and 17 are objected to because of the following informalities: The Examiner suggests amending the claims to specify the unit for ‘150’ in claim 13 and ‘50’ in claim 17. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-7 and 10-16 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Kim et al. (US 2018/0066299).
Regarding claim 1, Kim et al. teach:
1. A cell assay device comprising
a substrate (see e.g., culture dish/PDMS well in Fig. 1B; see also 96 well plates in Fig. 11A) having an upper surface supporting a plurality of arrays (see i.e., patterns on the upper surface of the culture dish in Figs. 1B & on the well surface in 11A for example), wherein each array comprises a plurality of spots comprising an adhesion-promoting material (e.g., cell adhesion region);
a membrane (e.g., nanopatterned substrate ¶ 0041-0042; see also cell matrix, e.g., MATRIGEL or other cell culture scaffold ¶ 0222; basement membrane ¶ 0120, Table 2 ¶ 0197) having top and bottom surfaces and positioned adjacent to the upper surface of the substrate and defining a plurality of chambers within the membrane between the top surface and the bottom surface of the membrane (see i.e., A cell chamber wall/barrier can be attached or affixed to the surface of the substrate to generate a multi-well plate, or alternatively, the nanopatterning and micropatterning can be performed on the surface of a coverslip and placed in individual wells of a multi-well plate, or a directly on the culture surfaces of a multi-well plate. ¶ 0124 & Fig. 10; see also ¶ 0041-0042, 0222, 0120 for example), wherein the membrane comprises at a plurality of openings in the top surface of the membrane, wherein at least two openings of the plurality of openings provide access to each chamber of the plurality of chambers (see Figs. 1B and 11A for example); and
wherein each chamber in the membrane is aligned with a respective one of the arrays (see Figs. 8A-8D and 9 for example); and
a frame (i.e., body of the culture dish/PDMS well; and 96 well plate) positioned on the top surface of the membrane, sandwiching the membrane between the frame and the substrate, wherein the frame defines a series of open-ended compartments, one compartment for each of the chambers within the membrane, wherein the compartments are in fluid communication with the chambers via the plurality of openings in the membrane (see Figs. 1B and 11A for example).
Regarding claims 2-7, 10-16, Kim et al. teach:
2. The device of claim 1, wherein the substrate comprises glass, plastic, or silicon (see i.e., Figs. 1A-1B & ¶ 0042+).
3. The device of claim 1, wherein the plurality of spots are circular, oval, or toroidal in shape (¶ 0182), and wherein the adhesion-promoting material comprises one or more of poly-L-lysine, polyacrylamide, a cationic polymer, and a cell adhesion molecule (¶ 0188-0214).
4. The device of claim 1,wherein the substrate is substantially planar (see i.e., Figs. 1A-1B).
5. The device of claim 1, wherein the plurality of chambers are formed into the bottom surface of the membrane (see Figs. 1B, 8A-8D for example).
6. The device of claim 1, wherein the membrane comprises a polymer (¶ 0042+).
7. The device of claim 6, wherein the polymer comprises one or more of a polydimethylsiloxane, a plastic, or a hydrogel (¶ 0042+).
10. The device of claim 1, wherein the membrane is semi-permeable (this limitation is sufficiently broad to have read on the dimensions taught in ¶ 0020+, 0039-0046; and a cell impermeable barrier in ¶ 0064).
11. The device of claim 1, wherein the membrane is capable of being permeable for molecules and particles having a diameter of from about 1 nm to about 100 µm (see the dimensions larger than about 1 nm to about 100 µm in ¶ 0020+, 0039-0046).
12. The device of claim 1, wherein the membrane has a thickness of about 1.5 mm (¶ 0500).
13. The device of claim 1, wherein the plurality of spots are between about 150 and about 200 µm in diameter (¶ 0184-0185).
14. The device of claim 1, wherein the total number of the plurality of spots is between about 1 and about 3,000 (¶ 0025+).
15. The device of claim 1, wherein the distance between adjacent spots of the plurality of spots of each array is at least about 35 µm (see Figs. 8-9 for example).
16. The device of claim 1, wherein the number of the one or more spots of each array is between about 4 and about 100 (see Figs. 8-9 for example).
With regard to limitations in claim 11 (e.g., the membrane is permeable for molecules and particles having a diameter of from about 1 nm to about 100 µm), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2018/0066299) in view of Chen et al. (US 2014/0030788).
Regarding claim 17, Kim et al. do not explicitly teach: 17. The device of claim 1, wherein the height of the chamber is between about 50 to about 150 µm.
Chen et al. teach: A cell assay device comprising
a substrate (e.g., 152) having an upper surface supporting a plurality of arrays of spots comprising an adhesion-promoting material (i.e., the nanostructures that form the obstacles can be attached, e.g., adhered or chemically bonded (e.g., ionically or covalently bonded) ¶ 0133);
a membrane (e.g., catalyst film ¶ 0216-0217) having top and bottom surfaces and positioned adjacent to the upper surface of the substrate and defining a plurality of chambers (i.e., etched/removed surfaces ¶ 0176, 0216) within the membrane between the top surface and the bottom surface of the membrane, wherein the membrane comprises at least two openings (i.e., hollow obstacles ¶ 0010+) in the top surface of the membrane (see Fig. 23 for example); and
wherein each chamber in the membrane is aligned with a respective one of the arrays of spots on the substrate (see Figs. 10, 23 for example); and
a frame (see i.e., frame of the PDMS channel in Fig. 2) positioned on the top surface of the membrane, sandwiching the membrane between the frame and the substrate, wherein the frame defines a series of open-ended compartments, one compartment for each of the chambers within the membrane, wherein the compartments are in fluid communication with the chambers (see Figs. 1-2 & ¶ 0010+ for example).
wherein the substrate comprises glass, plastic, or silicon (see ¶ 0238 for example).
wherein the plurality of spots are circular, oval, or toroidal in shape (see Figs. 1A, 45B & ¶ 0144 for example), and wherein the adhesion-promoting material comprises one or more of poly-L-lysine, polyacrylamide, a cationic polymer, and a cell adhesion molecule (¶ 0237,0243).
wherein the substrate is substantially planar (see Fig. 1 for example).
wherein the plurality of chambers are formed into the bottom surface of the membrane (i.e., etched/removed surfaces ¶ 0176, 0216).
wherein the membrane comprises a polymer (see ¶ 0181 for example).
wherein the polymer comprises one or more of a polydimethylsiloxane, a plastic, or a hydrogel (see ¶ 0004, ¶ 0238 for example).
wherein the membrane is semi-permeable (e.g., selectively permeable ¶ 0066+).
wherein the membrane is capable of being permeable for molecules and particles having a diameter of from about 1 nm to about 100 μm (¶ 0176, 0197-0198).
wherein the plurality of spots are between about 150 and about 200 µm in diameter (¶ 0176).
wherein the total number of the plurality of spots is between about 1 and about 3,000 (¶ 0131+).
wherein the distance between adjacent spots of the plurality of spots of each array is at least about 35 µm (see ¶ 0176 & Fig. 10B for example).
wherein the number of the one or more spots of each array is between about 4 and about 100 (this limitation is sufficiently broad to have read on Chen et al. ¶ 0131+).
wherein the height of the chamber is between about 50 to about 150 μm (see ¶ 0176 & Fig. 10B for example).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify chamber geometries of Kim et al. with the teachings of Chen et al., since a change in geometries of an element involves only routine skill in the art. The motivation for doing so would be to provide favorable chamber geometries for the intended use of the device (i.e., migration properties, or different samples, etc.).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2018/0066299).
Regarding claim 18, although Kim et al. teach a PDMS well of 14x12x8 mm (¶ 0501). However, Kim et al. do not explicitly teach: 18. The device of claim 1, wherein the width and depth of the chamber are about 6.4 mm. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify chamber geometries of Kim et al., since a change in geometries of an element involves only routine skill in the art. The motivation for doing so would be to provide favorable chamber geometries for the intended use of the device (i.e., migration properties, or different samples, etc.).
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground(s) of rejection. Applicant is thanked for their thoughtful amendments to the claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798