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 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 02/19/2026 has been entered.
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 1, 2, 4-8, 10, 12, 13, 16-17 are rejected under 35 U.S.C. 112(b) or 35 U.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 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is not clear with respect to what applicant is claiming. The claim does not clearly set forth the metes and bounds of the patent protection desired. Claim 1 is unclear reciting “A fluid-tight flow system comprising: a feeder channel in fluid communication with the inlet port, an exit channel in fluid communication with the outlet port, and a capture bed comprising a plurality of isolation channels, wherein the feeder channel intersects with the plurality of isolation channels and the exit channel intersects with the plurality of isolation channels; a microfluidic chip comprising an inlet port in fluid communication with an outlet port, and one or more microchannels in fluid communication with the inlet port and the outlet port, wherein the one or more microchannels do not have an open side apart from the opening at the inlet port and the opening at the output port; a first automated pipette comprising a first pump, and a first pipette tip containing a liquid sample and directly coupled to the inlet port via a friction fit; a second automated pipette comprising a second pump, and a second pipette tip directly coupled to the outlet port via a friction fit simultaneously with the first pipette tip directly coupled to the inlet port, wherein the first pipette tip directly coupled to the inlet port and the second pipette tip directly coupled to the output port provides a fluid-tight seal [...].” It is unclear if the inlet port in fluid communication with the feeder channel is the same as the inlet port of the microfluidic chip; and if the outlet port in fluid communication with the exit channel is the same as the outlet port in fluid communication with the inlet port of the microfluidic chip. Since the microfluidic chip has no other ‘open side apart from the opening at the inlet port and the opening at the output port’, it is unclear how the microfluidic chip and the first and second automated pipettes are connected to the feeder channel and the exit channel of the capture bed. In addition, it is unclear which inlet port is directly coupled to the first pipette tip, and which outlet port is directly coupled to the second pipette tip. Further, the “[...] first pipette tip containing a liquid sample and directly coupled to the inlet port via a friction fit” is unclear. It is clear that the first pipette tip is directly coupled to the inlet port. However, the limitation introduces additional element “friction fit” with a preposition “via”, making the limitation unclear because it would have to be that the first pipette tip is directly coupled to the friction fit, and the friction fit is directly coupled to the inlet port. In addition, it is unclear if the friction fit is a separate element, part of the first pipette tip, or part of the inlet port, making the claim further indefinite. It is further unclear because the friction fit has not been positively claimed. The “second pipette tip directly coupled to the outlet port via a friction fit” is similarly unclear. For these reasons, the scope of the claim is unascertainable.
Claim 1 recites the limitation "the inlet port" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the outlet port" in L3. There is insufficient antecedent basis for this limitation in the claim.
Claims 1, 6, 16, 17 are unclear because the claims interchangeably use a liquid sample, the sample liquid, the liquid sample.
Claim 16 recites the limitation "the command" in L2/L4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the command" in L2/L4-5. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 2, 4-8, 10, 12, 13, 16 & 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu (US 2006/0257290) in view of Soper et al. (US 2012/0100521).
Regarding claim 1, Shimizu teaches:
1. A fluid-tight flow system (i.e., “the present invention relates to a fluid dispenser, fluid dispensing method in which leakage of fluid can be prevented, [...]” ¶ 0002+) comprising:
a microfluidic chip (see e.g., sensor unit 12 in Fig. 3, annotated Figs. 1A, 4 & ¶ 0098, 0104-0105+) comprising an inlet port (see i.e., a cross shaped slit 43b, a suitable hole in a double sided adhesive tape 44 associated with a passage aperture 42b formed in the sealing mechanism 42, the passage aperture 42b connected the first orifice 16a forming an inlet port as annotated in Figs. 1A, 3-4) in fluid communication with an outlet port (see i.e., a cross shaped slit 43b, a suitable hole in a double sided adhesive tape 44 associated with a passage aperture 42b formed in the sealing mechanism 42, the passage aperture 42b connected the second orifice 16b forming an outlet port as annotated in Figs. 1A, 3-4), and one or more microchannels (e.g., flow channels 16, see i.e., “A horizontal width or diameter of the flow channels 16 is approximately 1 mm” ¶ 0074. The term micro is sufficiently broad to have properly read on Shimizu since the instant specification lack dimensional description of the claimed microfluidic chip comprising one or more microchannels. Further, the claim does not recite specific dimension of the microfluidic chip or the one or more microchannels, and Shimizu teaches a flow channel width or diameter of approximately 1mm is a very small (micro) channel. Examiner further notes that the term micro is different from micrometer or micron, i.e., a unit of length. However, even if considering the term micro as a unit of length, 1mm, which equals to 1,000 µm reads on the limitation as the claim broadly presents.) in fluid communication with the inlet port and the outlet port (see Fig. 1A for example), wherein the one or more microchannels do not have an open side apart from the opening at the inlet port and the opening at the output port (see i.e., “The flow channels 16 are in the U shape.” ¶ 0073 & annotated Figs. 1A, 3-4; see also flow channel 245 Figs. 13-14);
a first automated pipette (e.g., first pipette device 19a ¶ 0076) comprising a first pump (see e.g., pumps 52 ¶ 0107 & annotated Fig. 4; see also first pump motor 227C in Fig. 15), and a first pipette tip (e.g., pipette tips 50 ¶ 0107) containing a liquid sample (¶ 0076+) and directly coupled to the inlet port (see Figs. 1A-1B, 4, 7, 8, 15, 21 and i.e., “[...] a sensor unit including a flow channel having plural orifices, [...]. The fluid dispenser comprises a pipette device group, having plural pipette devices for accessing respectively the orifices. [...] Preferably, the pipette devices are firmly connected with the orifices.” ¶ 0015-0016 & annotated Fig. 4 for example) capable of providing a friction fit (see discussion below);
a second automated pipette (e.g., second pipette device 19b ¶ 0076) comprising a second pump (see e.g., pumps 52 ¶ 0107 & annotated Fig. 4 see also second pump motor 228C in Fig. 15), and a second pipette tip (e.g., pipette tips 50 ¶ 0107) directly coupled to the outlet port (see Figs. 1A-1B, 4, 7, 8, 15, 21 & ¶ 0077 for example) capable of providing a friction fit (see discussion below) simultaneously with the first pipette tip directly coupled to the inlet port (see Figs. 1A-1B, 4, 7, 8, 15, 21 and i.e., “[...] a sensor unit including a flow channel having plural orifices, [...]. The fluid dispenser comprises a pipette device group, having plural pipette devices for accessing respectively the orifices. [...] Preferably, the pipette devices are firmly connected with the orifices.” ¶ 0015-0016 & annotated Fig. 4 for example), wherein the first pipette tip directly coupled to the inlet port and the second pipette tip directly coupled to the output port provides a fluid-tight seal (see discussion below); and
a controller (55) comprising a non-transitory computer readable medium in communication with the first pump and the second pump (¶ 0044-0045+), and programmed to command to the first pump of the first automated pipette and the second pump of the second automated pipette, wherein:
commands to the first pump of the first automated pipette comprises a command to pull, push, or neither pull or push the sample liquid (see i.e., “the controller 55 actuates the pumps 52 for dispensation through the first pipette device 19a and aspiration through the second pipette device 19b. The first pipette device 19a dispenses activation liquid kept in the pipette tips 50, and introduces the same into the flow channel 16. The second pipette device 19b aspirates and sucks air or other liquid such as washing liquid from the flow channel 16 for removal.” ¶ 0117; “the controller 55 stops the pump driver 53 from driving the pumps 52, for interrupt process to interrupt the flow of fluid to the flow channel 16 as treatment.” ¶ 0119; “The sample immobilizing apparatus 100 inserts the multiple pipette assemblies 19 to the flow channels 16 in the sensor unit 12, for simultaneous flow for sample immobilization.” ¶ 0125; and “In the step S35, the apparatus waits to stand until lapse of predetermined time for delivery of analyte fluid YA of a predetermined amount. Upon the lapse of predetermined time, the dispensing and aspirating pumps 227 and 228 are stopped in the step S36.” ¶ 0174 for example), and
commands to the second pump of the second automated pipette comprises a command to pull, push, or neither pull or push the sample liquid simultaneously with commands to the first pump of the first automated pipette comprises a command to pull, push, or neither pull or push the sample liquid (see i.e., “the controller 55 actuates the pumps 52 for dispensation through the first pipette device 19a and aspiration through the second pipette device 19b. The first pipette device 19a dispenses activation liquid kept in the pipette tips 50, and introduces the same into the flow channel 16. The second pipette device 19b aspirates and sucks air or other liquid such as washing liquid from the flow channel 16 for removal.” ¶ 0117; “the controller 55 stops the pump driver 53 from driving the pumps 52, for interrupt process to interrupt the flow of fluid to the flow channel 16 as treatment.” ¶ 0119; “The sample immobilizing apparatus 100 inserts the multiple pipette assemblies 19 to the flow channels 16 in the sensor unit 12, for simultaneous flow for sample immobilization.” ¶ 0125 for example), and
wherein the command controls a flow rate (¶ 0046+) of the liquid sample through the microfluidic chip (see Fig. 5 & ¶ 0111, 0115-0117, 0162+ for example).
Regarding the “synchronize commands” limitation, Shimizu teaches i.e., “A syringe pump is associated with each one of the pipette devices, and includes a cylinder and a piston. The piston is so controlled with in a synchronized manner that a first one of the pipette devices at the flow channel is driven for aspiration and a second one of the pipette devices at the flow channel is driven for dispensation simultaneously.” ¶ 0012).
Regarding “the first pipette tip directly coupled to the inlet port and the second pipette tip directly coupled to the output port is a fluid-tight seal”, Shimizu teaches: wherein the first pipette tip (pipette tip 50 of the pipette device 19a in Fig. 4) directly coupled to the inlet port (i.e., a cross shaped slit 43b, a suitable hole in a double sided adhesive tape 44 associated with a passage aperture 42b formed in the sealing mechanism 42, the passage aperture 42b connected the first orifice 16a forming an inlet port; see Figs. 1A-1B, 4, 7, 8, 15, 21), and the second pipette tip (pipette tip 50 of the pipette device 19b in Fig. 4) directly coupled to the outlet port (i.e., a cross shaped slit 43b, a suitable hole in a double sided adhesive tape 44 associated with a passage aperture 42b formed in the sealing mechanism 42, the passage aperture 42b connected the second orifice 16b forming an outlet port; see Figs. 1A-1B, 4, 7, 8, 15, 21) are
a fluid-tight seal:
“The sensor unit includes a flow channel having first and second orifices, and the sensing surface, positioned in the flow channel, for detecting the reaction of the sample. First and second pipette devices access the orifices. First and second pumps are connected with respectively the pipette devices, for pressurization to dispense the sample fluid through the pipette devices, or for decompression to aspirate the sample fluid through the pipette devices.” (Abstract);
“More particularly, the present invention relates to a fluid dispenser, fluid dispensing method in which leakage of fluid can be prevented, [...]” ¶ 0002;
“an object of the present invention is to provide a fluid dispenser, fluid dispensing method in which leakage of fluid can be prevented, [...]” ¶ 0014;
“[...] it is possible according to the invention to prevent leakage of fluid in the immobilization and assay.” ¶ 0047;
“The controller 55 drives the shifting mechanism 54 in keeping the decompressed state, and pulls and removes the pipette devices 19a and 19b from the flow channel 16. As force of suction or aspiration is exerted in the pipette devices 19a and 19b, it is possible to prevent leakage of liquid through the ends of the pipette devices 19a and 19b. Also, a liquid surface of the liquid in the flow channel 16 is depressed by air when the state of the flow channel 16 comes back from the depression to the normal pressure of the atmosphere.” ¶ 0121;
“A passage aperture 42b is formed in the sealing mechanism 42, and positioned at each of the first and second orifices 16a and 16b of the flow channel 16, for entry of an end of each of the pipette devices 19a and 19b, and pipette devices 26a and 26b. The passage aperture 42b has a funnel shape with a decreasing diameter for introducing liquid ejected by the pipette toward the first orifice 16a. A lower face of the passage aperture 42b is connectable with each of the first and second orifices 16a and 16b of the flow channel 16 for flow of fluid with the sealing mechanism 42.” ¶ 0103;
“Note that suitable holes are formed in the double sided adhesive tape 44, and associated with the passage aperture 42b and the bosses 42c.” ¶ 0104; and
via a friction fit [...] providing a fluid-tight seal:
“The flow cell lid 43 covers the passage aperture 42b communicating to the flow channel 16, and prevents evaporation of liquid in the flow channel 16. The flow cell lid 43 is formed from rubber, elastomer, resin or other elastic material. A cross shaped slit 43b is formed in the flow cell lid 43 and positioned respectively at the passage aperture 42b. The flow cell lid 43 is required to cover the passage aperture 42b in order to prevent liquid in the flow channel 16 from evaporation. However, no pipette can enter the passage aperture 42b if covering of the flow cell lid 43 is complete. So the cross shaped slit 43b is formed to enable insertion of pipettes, and to close the passage aperture 42b while no pipette is inserted. If a pipette is forcibly pressed into the cross shaped slit 43b, its edges are elastically deformed, to allow receipt of the pipette by becoming open. See FIGS. 1A and 1B. When the pipette is externally pulled out, the cross shaped slit 43b elastically closes the passage aperture 42b again by returning to its initial state.” ¶ 0105.
Shimizu clearly teaches that the sensor unit is pressurized (i.e., fluid-tight seal) in order to dispense and aspirate a fluid by the use of the first and second pumps connected to respective first and second pipette devices that are directly coupled with the first and second orifices (part of inlet and outlet ports), see for example “The sensor unit includes a flow channel having first and second orifices, [...]. First and second pipette devices access the orifices. First and second pumps are connected with respectively the pipette devices, for pressurization to dispense the sample fluid through the pipette devices, or for decompression to aspirate the sample fluid through the pipette devices.” (Abstract); see also the controller drives the shifting mechanism keeping the decompressed state, [...] force of suction or aspiration is exerted in the pipette devices 19a and 19b, it is possible to prevent leakage of liquid through the ends of the pipette devices 19a and 19b (¶ 0121 i.e., pressurized and fluid-tight seal exists) via a friction fit (i.e., cross shaped slit 43b) “The flow cell lid 43 covers the passage aperture 42b communicating to the flow channel 16, and prevents evaporation of liquid in the flow channel 16. The flow cell lid 43 is formed from rubber, elastomer, resin or other elastic material. A cross shaped slit 43b is formed in the flow cell lid 43 and positioned respectively at the passage aperture 42b. The flow cell lid 43 is required to cover the passage aperture 42b in order to prevent liquid in the flow channel 16 from evaporation. However, no pipette can enter the passage aperture 42b if covering of the flow cell lid 43 is complete. So the cross shaped slit 43b is formed to enable insertion of pipettes, and to close the passage aperture 42b while no pipette is inserted. If a pipette is forcibly pressed into the cross shaped slit 43b, its edges are elastically deformed, to allow receipt of the pipette by becoming open. [...]” ¶ 0105. Therefore, the fluid-tight seal & [...] via a friction fit [...] providing a fluid-tight seal limitations are taught.
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Regarding claim 1, Shimizu further teaches: a feeder channel (i.e., channel downstream of 16a, 122a, 245a) in fluid communication with the inlet port, an exit channel (i.e., channel upstream of 16b, 122c, 245b) in fluid communication with the outlet port (see ¶ 0081 & Fig. 4 for example), and a capture bed (22, 127) comprising a plurality of isolation channels (see Figs. 8, 21 & ¶ 0148 for example). However, Shimizu does not explicitly teach: wherein the feeder channel intersects with the plurality of isolation channels and the exit channel intersects with the plurality of isolation channels.
Soper et al. teach: a feeder channel in fluid communication with an inlet port (e.g., input), an exit channel in fluid communication with an outlet port (e.g., output), and a capture bed406 comprising a plurality of isolation channels (see Fig. 1 for example), wherein the feeder channel intersects with the plurality of isolation channels and the exit channel intersects with the plurality of isolation channels (see i.e., a system to efficiently, accurately, and rapidly isolate and enumerate rare cells, such as circulating tumor cells, from liquids such as whole blood. ¶ 0019; multiple parallel channels are preferred to enhance throughput; a very high capture efficiency is obtained ¶ 0020-0023+).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the Shimizu with a capture bed comprising a plurality of isolation channels, wherein the feeder channel intersects with the plurality of isolation channels and the exit channel intersects with the plurality of isolation channels of Soper et al. for the purpose of efficiently, accurately, and rapidly isolating cells of interest (Soper et al. ¶ 0019-0023+).
Regarding claims 2, 4-6, 8, 16 & 17, modified Shimizu teaches:
2. The fluid-tight flow system of claim 1, wherein the first pump comprises a plunger and a pipetting drive motor (¶ 0138).
4. The fluid-tight flow system of claim 1, wherein the system further comprises closed-loop feedback control wherein: the first automated pipette further comprises a first pressure sensor (65); the second automated pipette further comprises a second pressure sensor (65); and the non-transitory computer readable medium is further in communication with the first pressure sensor and second pressure sensor; wherein said non-transitory computer readable medium is further programmed to receive data from the first pressure sensor in real-time (¶ 0112-0113) and data from the second pressure sensor in real-time, and adjust command of at least the first pump of the first automated pipette or the second pump of the second automated pipette to adjust flow through the microfluidic chip using real-time feedback based on said data from the first pressure sensor and the second pressure sensor (¶ 0111, 0118+).
5. The fluid-tight flow system of claim 4, wherein the real-time feedback, based on said data from the first pressure sensor and the second pressure sensor, comprises detection above a pressure threshold (¶ 0112).
6. The fluid-tight flow system of claim 1, wherein the liquid sample is a bodily fluid (¶ 0080).
8. The fluid-tight flow system of claim 1, wherein the microfluidic chip (e.g., 12) further comprises a cell selection module (13a/13b), the cell selection module comprising the capture bed (see above), a plasma isolation module (Soper et al. ¶ 0081), or a solid-phase extraction module (Soper et al. ¶ 0010-0011, 0023+) in fluid communication with the inlet port and the outlet port (see Figs. 3 & 7).
16. The fluid-tight flow system of claim 1, wherein the command to the first pump of the first automated pipette comprises a command to push the sample liquid, and the command to the second pump of the second automated pipette comprises a command to pull the sample liquid simultaneously with the command to the first pump of the first automated pipette to push the sample liquid (see i.e., “the controller 55 actuates the pumps 52 for dispensation through the first pipette device 19a and aspiration through the second pipette device 19b. The first pipette device 19a dispenses activation liquid kept in the pipette tips 50, and introduces the same into the flow channel 16. The second pipette device 19b aspirates and sucks air or other liquid such as washing liquid from the flow channel 16 for removal.” ¶ 0117 for example).
17. The fluid-tight flow system of claim 1, wherein the command to the first pump of the first automated pipette comprises a command to pull the sample liquid, and the command to the second pump of the second automated pipette comprises a command to push the sample liquid simultaneously with the command to the first pump of the first automated pipette to pull the sample liquid (see i.e., “A first one of the pipette devices aspirates to draw and remove the liquid or air from the flow channel. A second one of the pipette devices dispenses the liquid. Thus, the liquid in the flow channel is exchanged.” ¶ 0011 for example).
Regarding claim 7, Shimizu does not explicitly teach: 7. The fluid-tight flow system of claim 6, wherein the bodily fluid is blood, saliva, lymphatic fluid, cells suspended in fluid, synovial fluid, semen, urine, cerebrospinal fluid, or amniotic fluid.
Soper et al. teach, wherein the bodily fluid is blood, saliva, lymphatic fluid, cells suspended in fluid, synovial fluid, semen, urine, cerebrospinal fluid, or amniotic fluid (entire reference).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use blood in the flow system, as taught by Soper et al. for the purpose of efficiently, accurately, and rapidly isolating cells of interest (Soper et al. ¶ 0019-0023+).
Regarding claims 10, 12 & 13, Shimizu does not explicitly teach: 10. The fluid-tight flow system of claim 8, wherein the capture bed further comprises solid supports configured to bind to biomarker cells, or a filter substrate configured as a size-based separator for biomarker cells. 12. The fluid-tight flow system of claim 10, wherein the solid supports are pillars, beads, or resins. 13. The fluid-tight flow system of claim 8, wherein the plurality of isolation channels are configured to isolate circulating tumor cells or circulating leukemic cells.
Soper et al. teach:
wherein the capture bed further comprises solid supports (¶ 0010-0011, 0023+) configured to bind to biomarker cells, or a filter substrate configured as a size-based separator for biomarker cells (¶ 0010-0012, 0018, 0023, 0057, 0078-0079, Claims 1).
wherein the solid supports are pillars, beads, or resins (¶ 0007, 0010-0011, 0047, 0060+).
wherein the plurality of isolation channels are configured to isolate circulating tumor cells or circulating leukemic cells (entire reference).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to further modify the device of Shimizu, with the teachings of Soper et al. for the purpose of efficiently, accurately, and rapidly isolating cells of interest (Soper et al. ¶ 0019-0023+), such as circulating tumor cells or circulating leukemic cells (Soper et al. entire reference). It is noted that the Court stated that if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Id. at ___, 82 USPQ2d at 1396.
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground(s) of rejection.
The amendments have been considered and have been addressed within the above art rejection and an additional piece of art has been included in the pertinent prior art section below should Applicant disagree with any of the Examiner’s rejections above.
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fulton et al. (US 2011/0020919) teach a pipette tip coupled to an inlet port via a friction fit (e.g., friction fit/seal/contact) forming a fluid-tight connection between the pipette tip and a capture bed (e.g., packed bed), see ¶ 0022-0031+ & Figs. 25-26.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798