/LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797 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 .
Response to Arguments
Applicant’s arguments, see Remarks page 7, filed 07 January 2026, with respect to the rejections of the claims under 35 U.S.C 112(b) have been fully considered and are persuasive in light of the amendments. The rejections of claims 1 – 7, 9, 10, 12, 14, and 18 have been withdrawn.
Applicant’s arguments, see Remarks page 9, filed 07 January 2026, with respect to the objections to the drawings have been fully considered and are persuasive in light of the amendments. The objections to the drawings have been withdrawn.
Applicant's arguments, see Remarks page 7, filed 07 January 2026, with respect to the rejections of claims 16 and 17 under 35 U.S.C. 102 have been fully considered but they are not persuasive. The claimed wash manifold has been read on the washing station (152) of Steinert, which is translated along the path defined by the rotor (108) in the second embodiment. The rotor rotates in the X-Y plane, which is perpendicular to the longitudinal axis of the probe (the Z axis). During washing, the probe is located within the wash manifold, and is separated by the walls of the wash manifold from the container. Thus, the probe is not in fluid communicated with the container. Accordingly, the 102 rejection of the claims has been maintained.
Applicant's arguments, see Remarks page 8, filed 07 January 2026, with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not entirely persuasive. During washing, the probe taught is separated from the sample container by the walls of the wash manifold, and so is interrupted from fluid communication with the sample container. The added limitation of wherein “the first wash manifold position is a standby position” is functional language describing the intended use of the device; moreover, any stage of rotation of the rotor in Steinert where the wash manifold is not in line with the sample probe reads on a standby position.
However; while the wash manifold position of Steinert is “away from the sample probe,” it cannot be said to be “away from […] the sample container holder,” as both components are located on the same rotor. Accordingly, the rejection of independent claim 1 has been updated in view of Hofmann et al, which was made of record in the previous office action and which teaches a probe washer which moves independently, and which is arranged to avoid intersecting other components of the fluid handling system.
Status of Claims
Applicant's amendments to the claims filed 07 January 2026 have been entered. Applicant's remarks filed 07 January 2026 are acknowledged.
Claims 1, 7, and 16 – 18 are in status “Currently Amended.” Claims 2 – 6, 9, 10, 12, and 14 are in status “Original” or “Previously Prevented.” Claims 19 and 21 – 25 are withdrawn as due to non-elected subject matter. Claims 8, 11, 13, 15, 20, and 26 – 30 are canceled.
Claim Rejections - 35 USC § 102
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 16 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steinert (EP 3153864 A1, cited on the IDS submitted 07 December 2022).
With regards to claim 16, Steinert teaches;
The claimed "a fluid sample handling system" has been read on the taught ([0003], "The present invention is intended for apparatus which operate with liquids reagents…");
The claimed "a sample container region" has been read on the taught ([0013], "The apparatus comprises […] a rotor comprising at least a first compartment for receiving the first vessel from the first input…"; The first compartment of the rotor reads on a sample container region.);
The claimed "a probe configured for aspiration of a fluid sample from a sample container located at the sample container region" has been read on the taught ([0013], "The apparatus comprises […] a pipetting device at least adapted to pipette a sample from the first vessel and/or the second vessel. The rotor is rotatable at least between a first processing position […] and a third processing position, at which the sample of the first vessel and/or the second vessel is aspiratable by the pipetting device.");
The claimed "a wash manifold" has been read on the taught ([0042], "In the present embodiment, the processing station 148 comprises three mixing chambers 150 and a washing station 152 for washing the pipetting needle 138."; Washing station 152 reads on a wash manifold.);
The claimed fluid sample handling system being convertible between "a sampling state in which the probe is in a sampling position and the sample container region is in a sampling position such that the probe is in fluid communication with a container located at the sample container region" has been read on the taught ([0013], " The rotor is rotatable at least between […] a third processing position, at which the sample of the first vessel and/or the second vessel is aspiratable by the pipetting device."; A third processing position reads on a sampling state.);
The claimed fluid sample handling system being convertible between "a washing state in which the probe is in a washing position and the wash manifold is in a washing position, the wash manifold being translated along a path oriented perpendicular to a longitudinal axis of the probe into the washing position, such that the probe is in fluid communication with the wash manifold and the probe is free of fluid communication with a container located at the sample container region" has been read on the taught ([0054], "In the processing station 148, the pipetting device 112 is moved downwards along the second axis 140 so as to insert the pipetting needle 138 into the washing station 152."; The pipetting device being located in processing station 148, with access to the washing station 153 reads on a washing state. See annotated figure below, showing the perpendicular path of the wash manifold);
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With regards to claim 17, the system of claim 16 is anticipated by Steinert.
Steinert additionally teaches;
The claimed "wherein in the loading state, the probe is in a loading position such that the probe is free of fluid communication with a container located at the sample container region when the sample container region is in its loading position" has been read on the taught (Figures 1 and 4 show the probe located upwards and out of the way of the system. See also [0054] as cited in claim 16, which teaches that the probe needs to be moved to the processing station after the rack is loaded).
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, 4 – 7, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Steinert (EP 3153864 A1, cited on the IDS submitted 07 December 2022) in view Hofmann et al (US 20210025910 A1).
With regards to claim 1, Steinert teaches;
The claimed "a fluid sample handling system" has been read on the taught ([0003], "The present invention is intended for apparatus which operate with liquids reagents…");
The claimed "a sample container holder configured to receive a sample container" has been read on the taught ([0013], "The apparatus comprises […] a rotor comprising at least a first compartment for receiving the first vessel from the first input…"; The first compartment of the rotor reads on a sample container holder. The first vessel reads on a sample container.);
The claimed "the sample container holder being moveable between at least (1) a first sample holder position and (2) a second sample holder position" has been read on the taught ([0013], "The rotor is rotatable at least between a first processing position, at which the first vessel is transportable to the first compartment of the rotor by the gripping device,[…], and a third processing position, at which the sample of the first vessel and/or the second vessel is aspiratable by the pipetting device."; The first processing position and third processing position accessible to the first vessel read on a first sample holder position and a second sample holder position.);
The claimed "a sample probe, the sample probe defining a proximal end configured for fluid communication with the sample container, the sample probe configured to communicate therethrough, in a first direction, fluid aspirated from the sample container" has been read on the taught ([0045], "The pipetting device 112 is at least adapted to pipette a sample from the first vessel 114 and/or the second vessel 116. …the pipetting device 112 comprises a pipetting needle 138."; Pipetting needle 138 reads on the sample probe defining a proximal end-- see also Figure 1. The pipetting device being adapted to pipette a sample reads on the sample probe being configured to communicate fluid aspirated from the sample container.);
The claimed "the sample probe defining a sample probe axis along which the sample probe is moveable between at least (1) a first sample probe position for aspirating fluid from the sample container when the sample holder is located at the first sample holder position and (2) a second sample probe position for washing" has been read on the taught ([0045], "More particularly, the pipetting device 112 is moveable upwards and downwards along the second axis 140… More particularly, the second frame 144 is moveable to the leftwards and rightwards along the third axis 142. Thus, the pipetting device 112 may be moved within a plane defined by the second axis 140 and the third axis 142."; The third axis reads on a sample probe axis.);
The claimed "a wash manifold" has been read on the taught ([0042], "In the present embodiment, the processing station 148 comprises three mixing chambers 150 and a washing station 152 for washing the pipetting needle 138."; Washing station 152 reads on a wash manifold.).
In a second embodiment of the device, Steinert teaches;
The claimed "the wash manifold being moveable along a wash manifold path" has been read on the taught ([0060], "Further, the processing station 148 is arranged on the rotor 108.");
The claimed "a first wash manifold position and a second wash manifold position, the second wash manifold position being such that when the wash manifold is located at the second position, the wash manifold receives fluid communicated from the proximal end of the sample probe when the sample probe is located at the second probe position and the wash manifold interrupts fluid communication between the proximal end of the sample probe and a sample container received by the sample holder" has been read on the taught ([0063], "Then, the rotor 108 is rotated into the third processing position such that the first vessel 114 is located in the operating range of the pipetting device 112. [….] The pipetting device 112 aspirates the first sample. […] The rotor 108 is rotated such that the processing station 148 is move into the operating range of the pipetting device 112. …the rotor 108 is rotated further step by step so as to move the washing station 152 and the mixing chambers 150 into the operating range of the pipetting device 112 as the washing station 152 and the mixing chambers 150 are arranged on a circular path around the rotational axis 122 on the rotor 108."; As is made clear by the description and by Figure 14, the processing position and the washing station are both located on the rotor. The third processing position reads on a first wash manifold position. As shown in Figure 15, when the rotor is moved such that the probe is engaged with the sample, the probe is not in fluid communication with the wash manifold. Likewise, when the probe is engaged with the wash manifold, it is not in fluid communication with the sample.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Steinert including the sample probe moveable along a sample probe axis with the second embodiment of Steinert, including the wash manifold moveable along a wash manifold path. According to MPEP 2143(I)(C), use of a known device to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, Steinert teaches a "base" device in the first embodiment featuring a fixed wash manifold, upon which the claimed invention can be seen as an improvement. Steinert teaches a "comparable" device in the second embodiment featuring a moveable wash manifold, which is not the same as the base device and which has been improved in the same way as the claimed invention. One of ordinary skill in the art could have applied the improvement of a moveable wash manifold in the same way to the base device, for the predictable result of generating a fluid handling system with a greater range of configurations regarding the locations of the probe and wash manifold.
However, Steinert does not explicitly wherein a first wash manifold position is away from the sample probe and the sample container holder, wherein the first wash manifold position is a standby position, and the wash manifold path is perpendicular to the sample probe axis.
In the analogous art of probe washing devices, Hofmann et al teaches;
A wash manifold that is moveable along a wash manifold path between at least a first wash manifold position away from the sample probe and the sample container holder, wherein the first wash manifold position is a standby position, and the wash manifold is perpendicular to the probe axis has been read on the taught ([0054], “…the probe washer 30 is positioned at a deployed position pw2, intersects the probe path 300 when the probe washer 30 is positioned at the deployed position pw2 (shown in dashed line), and clears the probe path 300 when the probe washer 30 is positioned at a stowed position pw1. The probe washer actuator 20 moves the probe washer 30 between the deployed position pw2 and the stowed position pw1. The probe washer actuator 20 actuates the probe washer 30 relative to the frame 16.”; Actuating the probe washer relative to the frame reads on the wash manifold being perpendicular to the probe axis.);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the probe washing system as taught by Steinert with the independently moveable wash manifold as taught by Hofmann. According to MPEP 2143(I)(C), use of a known device to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, Steinert teaches a "base" device including a wash manifold. Hofmann et al teaches a "comparable" device of a probe washer which is independently mobile, which is not the same as the base device and which has been improved in the same way as the claimed invention. One of ordinary skill in the art could have applied the improvement of an independently moveable wash manifold for the predictable result of creating a fluid handling system which allows the wash manifold to be stored away from the sample container when not in use.
Regarding Hofmann et al, [0053] further states that the probe washer may be actuated relative to another portion of the component. Hofmann’s teaching in [0054] that the probe washer should clear the probe supports an interpretation of the first manifold position being away from the sample probe and the sample container holder. Furthermore, MPEP 2144.04(VI)(C) teaches that rearrangement of parts may be prima facie obvious. In particular, In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) teaches that the particular placement of components may be an obvious matter of design choice. Accordingly, given the teachings of a moveable probe, a moveable sample container, and a moveable wash manifold that clears the probe, the arrangement of these parts would be obvious to one of ordinary skill in the art.
With regards to claim 4, the system of claim 1 is obvious over Steinert.
Steinert additionally teaches;
The claimed system further comprising "a linear motion stage configured to effect motion of the sample probe between the first sample holder position and the second sample holder position" has been read on the taught ([0022], "The pipetting device may be moveable along a second axis and along a third axis, wherein the third axis is different from the second axis. Thus, by means of a movement within a single plane, the pipetting device may process the samples from the respective vessels.").
With regards to claim 5, the system of claim 1 is obvious over Steinert.
Steinert additionally teaches;
The claimed "a motion stage configured to effect motion of the wash manifold between the first wash manifold position and the second wash manifold position" has been read on the taught ([0060], "Further, the processing station 148 is arranged on the rotor 108."; Rotor 108 reads on a motion stage.).
With regards to claim 6, the system of claim 1 is obvious over Steinert.
Steinert additionally teaches;
The claimed "wherein the sample container holder is manually moveable between the first sample holder position and the second sample holder position" has been read on the taught ([0045], "More particularly, the pipetting device 112 is moveable upwards and downwards along the second axis 140… More particularly, the second frame 144 is moveable to the leftwards and rightwards along the third axis 142. Thus, the pipetting device 112 may be moved within a plane defined by the second axis 140 and the third axis 142."; The third axis reads on a sample probe axis.).
With regards to claim 7, the system of claim 1 is obvious over Steinert.
Steinert additionally teaches;
The claimed "a housing" has been read on the taught ([0031], "The processing chamber may comprise a closure, wherein the closure is adapted to selectively expose or block the second input."; The closure reads on a housing.).
However, Steinert does not explicitly disclose the housing being configured such that the sample container holder is visible to a user and the wash manifold is separated from the user, wherein the housing is optionally configured so as to separate the probe from the user when the probe is in the second sample probe position.
In the analogous art of probe washing devices, Hofmann et al teaches;
The claimed “a housing, the housing being configured such that the sample container holder is visible to a user and the wash manifold is separated from the user, wherein the housing is optionally configured so as to separate the probe from the user when probe is in the second sample position” has been read on the taught ([0115], “The depicted probe washer 500 further includes a housing 530.”; [0014], “In certain embodiments, the probe washer includes a housing that includes the inlet and/or the drain, and the housing may further include a wall that blocks (i.e., intersects) the probe path when the probe washer is at the second position.”; As shown in Figures 17 and 18, housing 530 is specific to the wash unit, and does not cover the sample vessels.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the probe washing system as taught by Steinert with the washing housing as taught by Hofmann. According to MPEP 2143(I)(C), use of a known device to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, Steinert teaches a "base" device including a wash manifold, and a housing which covers all components. Hofmann et al teaches a "comparable" device of a probe washer including a housing, which is not the same as the base device and which has been improved in the same way as the claimed invention. One of ordinary skill in the art could have applied the improvement of a housing separating the wash manifold in the same way to the base device, for the predictable result of generating a fluid handling system which allows sample containers to be added by a user but which prevents splashes from exiting the wash manifold.
With regards to claim 14, the fluid sample system of claim 1 is obvious over Steinert.
Steinert additionally teaches;
The claimed "A method, comprising operating a fluid sample system of claim 1 so as to aspirate a fluid from a sample container into the sample probe" has been read on the taught ([0061], "…the pipetting device 112 may aspirate a sample from the first vessel 114 being loaded into the first compartment 124.").
With regards to claim 18, the system of claim 16 is anticipated by Steinert.
Steinert additionally teaches;
The claimed "a housing" has been read on the taught ([0031], "The processing chamber may comprise a closure, wherein the closure is adapted to selectively expose or block the second input."; The closure reads on a housing.).
However, Steinert does not explicitly disclose the housing being configured such that the sample container holder is visible to a user and the wash manifold is separated from the user, wherein the housing is optionally configured so as to separate the probe from the user when the probe is in the second sample probe position.
In the analogous art of probe washing devices, Hofmann et al teaches;
The claimed “a housing, the housing being configured such that the sample container holder is visible to a user and the wash manifold is separated from the user, wherein the housing is optionally configured so as to separate the probe from the user when probe is in the second sample position” has been read on the taught ([0115], “The depicted probe washer 500 further includes a housing 530.”; [0014], “In certain embodiments, the probe washer includes a housing that includes the inlet and/or the drain, and the housing may further include a wall that blocks (i.e., intersects) the probe path when the probe washer is at the second position.”; As shown in Figures 17 and 18, housing 530 is specific to the wash unit, and does not cover the sample vessels.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the probe washing system as taught by Steinert with the washing housing as taught by Hofmann. According to MPEP 2143(I)(C), use of a known device to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, Steinert teaches a "base" device including a wash manifold, and a housing which covers all components. Hofmann et al teaches a "comparable" device of a probe washer including a housing, which is not the same as the base device and which has been improved in the same way as the claimed invention. One of ordinary skill in the art could have applied the improvement of a housing separating the wash manifold in the same way to the base device, for the predictable result of generating a fluid handling system which allows sample containers to be added by a user but which prevents splashes from exiting the wash manifold.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Steinert (EP 3153864 A1, cited on the IDS submitted 07 December 2022) in view of Hofmann et al (US 20210025910 A1) as applied to claim 1, and further in view Dunfee (US 20050074363 A1).
With regards to claim 2, the system of claim 1 is obvious over Steinert in view of Hofmann et al.
However, Steinert does not explicitly disclose wherein the system further comprises a source of rinse fluid, the source of rinse fluid configured for communication of rinse fluid through the sample probe.
In the analogous art of automated probe cleaning devices, Dunfee teaches;
The claimed “a source of rinse fluid, the source of rinse fluid configured for communication of rinse fluid through the sample probe” has been read on the taught ([0049], “Cleansing solution source 99 is operated to maintain the internal reservoir 80R of second open cleansing body 80 filled with a bleach-like cleansing solution…”; [0017], “The interior of the sample fluid probe is cleaned by aspirating and discharging the cleaning solution.”; Cleaning solution source reads on a source of rinse fluid. Aspirating and discharging the cleaning solution reads on the rinse fluid being configured for communication of the rinse fluid through the sample probe.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system including a wash manifold as taught by Steinert with the source of rinse fluid as taught by Dunfee, for the benefit of minimizing residual carryover when performing sample operations (Dunfee, [0017], “In this manner the volume of residual carryover on the exterior surface or the interior of the sample fluid probe is minimized. As a practical matter, cleaning of both the sample fluid probe and cleaning resource is required to preserve proper operation.”).
With regards to claim 3, the system of claim 1 is obvious over Steinert in view of Hofmann et al.
However, Steinert does not explicitly disclose wherein the system further comprises a vacuum source configured to effect motion of fluid received by the wash manifold.
In the analogous art of automated probe cleaning devices, Dunfee teaches;
The claimed “a vacuum source configured to effect motion of fluid received by the wash manifold” has been read on the taught ([0049], “Cleansing solution source 99 is operated to maintain the internal reservoir 80R of second open cleansing body 80 filled with a bleach-like cleansing solution with the excess bleach-like cleansing solution drawn away by vacuum source 86.”; [0053], “The cleaning solution and rinse water mixture is removed from cleansing chamber 100 through vacuum tube 103 by vacuum into waste reservoir 102.”).
Claims 9, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Steinert (EP 3153864 A1, cited on the IDS submitted 07 December 2022) in view of Hofmann et al (US 20210025910 A1) as applied to claim 1, and further in view of Davis et al (US 10890596 B2, effectively filed 03 March 2011, cited on the IDS submitted 07 December 2022).
With regards to claim 9, the system of claim 1 is obvious over Steinert.
However, Steinert does not explicitly disclose the system further comprising a restorative spring, the restorative spring being configured to oppose the motion of the sample probe toward an obstacle.
In the analogous art of sample probe design, Davis et al teaches;
The claimed “a restorative spring, the restorative spring being configured to oppose the motion of the sample probe toward an obstacle” has been read on the taught (Abstract, “The probe includes an elongated portion and a restorative spring inserted onto the elongated portion of the probe.”; Column 9, line 10, “The properties of the Hall effect sensor 1904 and the restorative spring […] may be selected to allow the restorative spring […] to provide a restorative force allowing sensing of an obstacle and stopping without damaging a tip of the sampling probe 1900.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the probe washing system as taught by Steinert with the restorative spring as taught by Davis et al, for the benefit of increasing probe durability and accuracy (Column 1, line 49, “…there is provided a sample probe with a built-in obstacle detection mechanism that may reduce costs and increase time savings by reducing both instrument downtime and increasing probe position accuracy and durability.”).
With regards to claim 10, the system of claim 9 is obvious over Steinert in view of Davis et al.
Steinert does not explicitly disclose wherein the restorative spring comprises a metal spring, a magnet, or any combination thereof.
Davis et al additionally teaches;
The claimed “wherein the restorative spring comprises a metal spring, a magnet, or any combination thereof” has been read on the taught (Column 1, line 65, “…the restorative spring may include a single magnet, three magnets, or a metal spring, for example.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the probe washing system as taught by Steinert with the restorative spring as taught by Davis et al, for the benefit of increasing probe durability and accuracy (Column 1, line 49, “…there is provided a sample probe with a built-in obstacle detection mechanism that may reduce costs and increase time savings by reducing both instrument downtime and increasing probe position accuracy and durability.”).
With regards to claim 12, the system of claim 1 is obvious over Steinert.
Steinert does not explicitly disclose the system further comprising a sensor configured to detect a location of the sample probe, and wherein the fluid sample handling system is configured to stop a motion of the probe in response to a signal associated with a location of the probe.
In the analogous art of sample probe design, Davis et al teaches;
The claimed system further comprising “a sensor configured to detect a location of the sample probe, and wherein the fluid sample handling system is configured to stop a motion of the probe in response to a signal associated with a location of the probe” has been read on the taught (Column 8, line 23, “…the probe 1908 may be magnet-based and may use a Hall effect sensor 1904, which may improve reliability and sealing. Although the sensor may be a Hall effect sensor 1904 that uses a magnetic field for detection, to sense, react, and stop in the event of unexpected contact, any sensor that can sense the displacement of the probe once in contact with a surface could also be used.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the probe washing system as taught by Steinert with the restorative spring as taught by Davis et al, for the benefit of increasing probe durability and accuracy (Column 1, line 49, “…there is provided a sample probe with a built-in obstacle detection mechanism that may reduce costs and increase time savings by reducing both instrument downtime and increasing probe position accuracy and durability.”).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON CLAIRE GERHARD whose telephone number is (571)270-0945. The examiner can normally be reached M-F, 9:00 - 5:30pm EST.
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/ALISON CLAIRE GERHARD/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797