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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/05/2025 (RCE 12/12/2025) has been entered.
Claim Objections
Claim 15 is objected to because of the following informalities: Examiner suggests amending “[...] -24 mm” in L3 to read “[...] to 24 mm”.
Claim 16 is objected to because of the following informalities: Examiner suggests amending “[...] -15 mm” in L3 to read “[...] to 15 mm”.
Claim 17 is objected to because of the following informalities: Examiner suggests amending “[...] -1500 microns” in L3 to read “[...] to 1500 microns”.
Claim 19 is objected to because of the following informalities: Examiner suggests amending “[...] -750 microns” in L1 to read “[...] to 750 microns”.
Claim 20 is objected to because of the following informalities: Examiner suggests amending “[...] -650 microns” in L2 to read “[...] to 650 microns”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 15-17, 19 & 20 are rejected under 35U.S.C. 112(b) or 35U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35U.S.C. 112, the applicant), regards as the invention.
Claims 15-17, 19 & 20 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired. The claims are vague and unclear reciting “18-24 mm” (claim 15), “8-15 mm” (claim 16), “1000-1500 microns” (claim 17), “500-750 microns” (claim 19) and “450-650 microns” (claim 20) because the units for ‘18’, ‘8’, ‘1000’, ‘500’, and ‘450’ are not specified.
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, 7-12, 14-16, 18, 22-24, 29 & 45 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) in the fluid flow region 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 chip is capable of operating at a pressure (¶ 0059),
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).
With regard to limitations in claim 1 (e.g., wherein the chip accepts flow of a cell suspension into the fluid flow region, [...] wherein the constriction perturbs a cell membrane when a cell of the cell suspension passes through the constriction, wherein the chip operates at a pressure of greater than or equal to 10 psi), 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, 7-12, 14-16, 18, 22-24, 29 & 45, Toner teaches:
2. The microfluidic chip of claim 1, wherein the first layer comprises silicon (¶ 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 comprises one or more of a curve and an angle (see Figs. 1, 7 & ¶ 0054, 0058 for example).
12. The microfluidic chip of claim 1, wherein the interface between the upstream side of the constriction and the downstream side of the constriction forms a serpentine path (see Figs. 1, 7 for example).
14. The microfluidic chip of claim 12, 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 18-24 mm (¶ 0065).
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 8-15 mm (¶ 0065).
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 planar surface parallel to the inner surface of the first 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).
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 the protrusion extends upwards and away from the inner surface of the first layer at an angle (see Figs. 1, 2B, 2D, 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).
45. The microfluidic chip of claim 1, wherein a height of the plurality of support pillars is greater than a height of the protrusion, in a height direction perpendicular to the inner surface of the first layer (see Fig. 1 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) 17, 19-21, 25, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toner (US 2011/0294187 A1).
Regarding claims 17 & 19-21, Toner does not explicitly teach: 17. The microfluidic chip of claim 1, wherein a height dimension of the microfluidic chip extending in a height direction that is perpendicular to a planar surface of one or both of the first and second layers is 1000-1500 microns. 19. The microfluidic chip of claim 1, wherein the first layer has a total height of 500-750 microns as measured in a height direction that is perpendicular to a planar surface of the first layer. 20. The microfluidic chip of claim 1, wherein the first layer has a minimum height of 450-650 microns, wherein the minimum thickness is measured in a height direction that is perpendicular to the inner surface of the first layer and wherein the minimum thickness is measured from an outer surface of the first layer to a nearest inner surface of the first layer that interfaces with the fluid flow region. 21. The microfluidic chip of claim 1, wherein the second layer has a thickness of 450-800 microns as measured in a height direction that is perpendicular to a planar surface of one or both of the first and second layers.
However, Toner teaches the dimension of the microfluidic chip can vary. See i.e., In general, the choice of groove heights can depend on factors including channel dimensions, particle properties including size, density, and the like, and particle suspension flow rates. Although deeper grooves offer more disruption, other factors can impose limits on groove heights. For example, up to a certain limit, the groove height can be increased in proportion with the channel height. The channel height, and consequently the groove height, can depend upon the particle to micro-channel 115 surface contact area. An increase in channel dimensions can cause a decrease in particle-micro-channel 115 interactions as surface contact area available for the particles to interact decreases relative to the cross-sectional flow area. Also, a lower limit on the channel height, and consequently the groove height, can be imposed to prevent clogging. ¶ 0058. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to change the height/thickness of the microfluidic chip layers of Toner as based upon its suitability of intended use. A change in dimension is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955).
Regarding claims 25-26, 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. 26. The microfluidic chip of claim 24, wherein the side surface of the protrusion is angled at 54.7 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, or 54.7 degrees from the inner surface of the first layer, such that the fluid flows towards the protrusion (¶ 0005). 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 12/05/2025 have been fully considered but they are not persuasive.
In response to the Applicant's argument that Toner fails to teach: “a plurality of support pillars in the fluid flow region connecting the first layer and the second layer,” Examiner disagrees.
Toner teaches, among other things, 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) in the fluid flow region 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).
In response to the Applicant's argument that “the groove height is disclosed to range between 3 μm and 70 μm the channel height must equal 100 μm [...], Examiner notes that Toner further teaches 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.
In response to the Applicant's argument to claim 24, Toner teaches the limitations in Figs. 1, 2B, 2D, 3A, 3C for example.
In response to the Applicant's arguments to the 35 USC § 103 rejections, Applicant’s remarks that the “Applicant has cancelled claims 17 and 19-21, rendering moot the rejection of these claims” is unclear as the claims do not appear as canceled.
Regarding claims 25-26, 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. 26. The microfluidic chip of claim 24, wherein the side surface of the protrusion is angled at 54.7 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, or 54.7 degrees from the inner surface of the first layer, such that the fluid flows towards the protrusion (¶ 0005). 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.
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
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
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