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 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) 1-5, 7-11, 14-16, 18, 22-24 and 29 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Toner (US 2011/0294187 A1).
Regarding claim 1, Toner teaches:
1. A microfluidic chip, the chip comprising:
a first layer (e.g., 105);
a second layer (e.g., 110); and
a fluid flow region (i.e., the inner surfaces of the walls of the channel/micro-channel/microchannel 115) between the first layer and the second layer, wherein the chip capable of accepting flow of a cell suspension into the fluid flow region (see i.e., flowing particles suspended in the fluid through the inner surfaces of the walls of the micro-channel, ¶ 0030, 0048+ & Fig. 2),
a plurality of support pillars (e.g., side walls 120, 125) within the fluid flow region (see Figs. 1, 2A, 2B for example), the plurality of support pillars connecting the first layer and the second layer (see i.e., the micro-channel 115 can have a rectangular cross-section including two side walls 120 and 125, ¶ 0050 & Fig. 1 for example),
the first layer comprises a protrusion (e.g., grooves 135, 140, V-shaped protrusions ¶ 0049) extending toward the second layer to form a constriction between the protrusion and the second layer (¶ 0049+),
wherein the protrusion extends away from an inner surface of the first layer in a height direction perpendicular to the inner surface of the first layer and comprises a distal end of the protrusion that forms the constriction between the distal end of the protrusion and an inner surface of the second layer (see Fig. 1 for example), wherein a height of the constriction between the distal end of the protrusion and the inner surface of the second layer, as measured in the height direction, ranges from about 1 micron to about 8 microns (see i.e., a ratio between groove height and channel height can be less than one, for example, in a range between 0.1 to 0.6. In some implementations, the ratio can be equal to one (e.g., the groove height can be equal to the channel height), or can be greater than one [...]. ¶ 0058; hg ranges between 3 μm and 70 μm ¶ 0054), and
wherein an opening to the fluid flow region between the first layer and the second layer is greater in the height direction compared to the height of the constriction (see i.e., a ratio between groove height and channel height can be greater than one (e.g., the groove height, for example, 60 μm, can be greater than the channel height, for example, 50 μm). ¶ 0058).
With regard to limitations in claim 1 (e.g., wherein the constriction perturbs a cell membrane when a cell of the cell suspension passes through the constriction), 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)).
Regarding claims 2-5, 7-11, 14-16, 18, 22-24 & 29, Toner teaches:
2. The microfluidic chip of claim 1, wherein the first layer comprises silicon and/or the second layer comprises glass (¶ 0059).
3. The microfluidic chip of claim 1, wherein the second layer comprises glass (¶ 0060).
4. The microfluidic chip of claim 1, wherein the protrusion extends away from the inner surface of the first layer in a height direction perpendicular to the inner surface of the first layer and comprises a proximal end that is adjacent to the inner surface of the first layer (see Fig. 1 for example).
5. The microfluidic chip of claim 1, wherein the height of the constriction between the distal end of the protrusion and the inner surface of the second layer, as measured in the height direction, is less than or equal to 5 microns (see i.e., a ratio between groove height and channel height can be less than one, [...]. In some implementations, the ratio can be equal to one (e.g., the groove height can be equal to the channel height), or can be greater than one [...]. ¶ 0058; hg ranges between 3 μm [...] ¶ 0054).
7. The microfluidic chip of claim 1, wherein the microfluidic chip comprises an inlet and an outlet, wherein the inlet is positioned at a first end of the chip and the outlet is positioned at a second end of the chip opposite the first end, wherein a distance between the inlet and the outlet extends in a direction perpendicular to the inner surface of the first layer (see ¶ 0005 & Figs. 1, 7 for example).
8. The microfluidic chip of claim 4, wherein the proximal end of the protrusion has a thickness extending perpendicular to the height direction and extending from an upstream side of the protrusion to a downstream side of the protrusion, wherein the thickness of the proximal end of the protrusion is greater than or equal to 10 microns (see i.e., a ratio between groove height and channel height can be less than one, [...]. In some implementations, the ratio can be equal to one (e.g., the groove height can be equal to the channel height), or can be greater than one [...]. ¶ 0058; hg ranges between 3 μm and 70 μm ¶ 0054).
9. The microfluidic chip of claim 5, wherein the distal end of the protrusion has a thickness extending perpendicular to the height direction and extending from an upstream side of the constriction to a downstream side of the constriction, wherein the thickness of the distal end of the protrusion is greater than or equal to 5 microns (see i.e., hg ranges between 3 μm and 70 μm ¶ 0054).
10. The microfluidic chip of claim 4, wherein the protrusion has a length extending perpendicular to the height direction and extending along an interface between an upstream side of the constriction and a downstream side of the constriction, wherein the length is greater than or equal to 0.5 cm (see Figs. 1, 7 for example).
11. The microfluidic chip of claim 10, wherein the interface between the upstream side of the constriction and the downstream side of the constriction; a)_comprises one or more of a curve and an angle; and/or b) forms a serpentine path (see Figs. 1, 7 & ¶ 0054, 0058, 0065 for example).
14. The microfluidic chip of claim 11, wherein the serpentine path comprises one or more right angles (see Figs. 3A, 7 & ¶ 0054 for example).
15. The microfluidic chip of claim 1, wherein a first dimension of the microfluidic chip extending perpendicular to a height direction that is perpendicular to a planar surface of one or both of the first and second layers is 18 mm to 24 mm (see ¶ 0065 for example).
16. The microfluidic chip of claim 1, wherein a second dimension of the microfluidic chip extending perpendicular to a height direction that is perpendicular to a planar surface of one or both of the first and second layers is 8 mm to 15 mm (see ¶ 0065 for example).
18. The microfluidic chip of claim 1, wherein the second layer contacts the first layer at the plurality of support pillars, wherein each support pillar of the plurality of support pillars extends from the inner surface of the first layer to the second layer (see Fig. 1 for example).
22. The microfluidic chip of claim 1, wherein an uppermost surface of the protrusion comprises; a) a planar surface parallel to the inner surface of the first layer and perpendicular to the height direction in which the protrusion extends from the inner surface of the first layer; and/or b) a planar surface parallel to the inner surface of the second layer and perpendicular to the height direction in which the protrusion extends from the inner surface of the first layer (see Fig. 1 for example).
23. The microfluidic chip of claim 1, wherein an uppermost surface of the protrusion comprises a planar surface parallel to the inner surface of the second layer and perpendicular to a height direction in which the protrusion extends from the inner surface of the first layer (see Fig. 1 for example).
24. The microfluidic chip of claim 1, wherein a side surface of an upstream side of the protrusion extends upwards and away from the inner surface of the first layer at an angle (see i.e., a side surface (i.e., 150) of an upstream side of the protrusion extends upwards and away from the inner surface of the first layer at an angle (i.e., hg), see Figs. 3A-3C for example).
29. The microfluidic chip of claim 1, wherein a quotient of a cross-sectional area of the constriction to a perimeter of the constriction is greater than or equal to 0.5 microns (see ¶ 0054 for example).
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.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toner (US 2011/0294187 A1).
Regarding claim 25, Toner teaches wherein the side surface of the protrusion is angled between 10° and 170° (¶ 0054), and the inner surface of the first layer can be one of several shapes including but not limited to triangle, trapezoid, half-moon, and the like (¶ 0050). However, Toner does not explicitly teach: 25. The microfluidic chip of claim 24, wherein the side surface of the protrusion is angled at 50-60 degrees from the inner surface of the first layer.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the protrusion of Toner, oriented at 50-60 degrees from the inner surface of the first layer, to achieve a desired fluid flow (¶ 0001). The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141. Therefore, although the claimed angle may not have been explicitly taught, selecting appropriate angle for the design of the device would have been obvious to one of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed 08/04/2026 have been fully considered but they are not persuasive.
Objections to claims 15-17, 19 and 20 have been withdrawn.
Based on the claim amendments, 35 USC § 112 rejections have been withdrawn.
In response to the Applicant's argument that Toner does not teach a plurality of support pillars within the fluid flow region, Examiner disagrees.
Toner teaches, among other things, a plurality of support pillars (e.g., side walls 120, 125) within the fluid flow region (see Figs. 1, 2A, 2B for example).
In response to the Applicant's argument that Toner does not teach an opening to the fluid flow region between the first layer and the second layer is greater in the height direction compared to the height of the constriction, Examiner disagrees.
Toner teaches, among other things, wherein an opening to the fluid flow region between the first layer and the second layer is greater in the height direction compared to the height of the constriction (see i.e., a ratio between groove height and channel height can be greater than one (e.g., the groove height, for example, 60 μm, can be greater than the channel height, for example, 50 μm). ¶ 0058).
In response to the Applicant's argument to the amended claim 24, Toner teaches, among other things, wherein a side surface of an upstream side of the protrusion extends upwards and away from the inner surface of the first layer at an angle (see i.e., a side surface (i.e., 150) of an upstream side of the protrusion extends upwards and away from the inner surface of the first layer at an angle (i.e., hg), see Figs. 3A-3C for example).
In response to the Applicant's argument to claim 25, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the protrusion of Toner, oriented at 50-60 degrees from the inner surface of the first layer, to achieve a desired fluid flow (¶ 0001). The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141. Therefore, although the claimed angle may not have been explicitly taught, selecting appropriate angle for the design of the device would have been obvious to one of ordinary skill in the art. Regarding the Applicant's argument to the ratio, Toner also teaches a ratio between groove height and channel height can be greater than one (e.g., the groove height, for example, 60 μm, can be greater than the channel height, for example, 50 μm). ¶ 0058. In addition, as noted by the Court, "When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art." Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001).
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
THIS ACTION IS MADE FINAL. 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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/DEAN KWAK/Primary Examiner, Art Unit 1795
DEAN KWAK
Primary Examiner
Art Unit 1795
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