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 .
Notice of Amendment
In response to the amendment filed on 7/10/2026, amended claims 1, 4-7, 9, and 24 and cancelled claims 3, 8, 10, 15-16, 18-19, and 23 are acknowledged. Claims 1-2, 4-7, 9, 11-14, 17, 20-22, and 24 remain pending, with claims 14 and 17 withdrawn from further consideration. The following new and reiterated grounds of rejection are set forth:
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) 1-2, 4-5, 9, 12, 20, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zerfas et al. (US Publication No. 2013/0131445 A1) (previously cited), further in view of Ghani et al. (US Publication No. 2022/0218367 A1) (previously cited) and Campisi (US Patent No. 10,660,510 B2) (cited by Applicant) (previously cited).
Regarding claim 1, Zerfas et al. discloses a ureteroscope device (see [0025] – “Embodiments of the present disclosure can be used for a variety of therapeutic procedures, including ureteroscopy, hysteroscopy, and cystoscopy, for example”) comprising:
a) an insertion tube (102) comprising a proximal end and a distal end (106), wherein the distal end of the insertion tube comprises an insertion tip (see Figure 1 and [0026] – “Retrieval device 100 may include a tube 102 having a proximal end 104 and a distal end 106, and a handle 108 coupled to proximal end 104. Tube 102 may include two or more internal channels 110 having proximal and distal end openings 112, 114, respectively, to receive, e.g., one or more medical devices. The channels may be used for, among other things, providing irrigation, suction, and/or insufflation”);
i) an aspiration channel (302d) having an outlet at the insertion tip and configured for removal of a stone particle or fragment thereof (see Figure 3A and [0025] – “For example, the retrieval device may be utilized to remove tissue or bladder stones” and [0043] – “return channel 302d may induce a suction force using a suction device 308”), wherein the aspiration channel extends linearly from the distal end to the proximal end of the insertion tube such that no sharp angles are formed within the aspiration channel (see [0044] – “In general, channels 302 may be defined as elongate hollow lumens that extend, at least partially, between proximal end 104 and distal end 106 of tube 102” and [0047] – “In addition, although the depicted embodiments illustrate that channels 302 include substantially uniform cross-sectional configurations and dimensions, the cross-sectional dimensions and/or configurations of any of channels 302 may vary as desired”);
ii) a lumen comprising two workin channels (110, 302c) disposed in the insertion tube, each having an outlet at the insertion tip (see Figure 3A and [0040] – “Tube 102 may include multiple channels 110 to slidingly receive two or more devices, either independently or simultaneously” and [0042] – “working channels 302c”); and
d) an image sensor (306) and a light source (304) disposed at the insertion tip (see Figure 3A and [0043] – “illumination channels 302a may be connected to a light source 304; visualization channel 302b may accommodate a visualization device 306”).
It is noted Zerfas et al. does not specifically teach a divider disposed longitudinally within the insertion tube such that an interior space of the insertion tube is divided into the aspiration channel and the lumen comprising the working channels, or wherein at least a portion of the aspiration channel extends distally beyond the distal end of the insertion tube, or a blocking bar disposed at the outlet of the aspiration channel, wherein the blocking bar splits the outlet of the aspiration channel into two openings. However, Ghani et al. teaches at least a portion of the aspiration channel extends distally beyond the distal end of the insertion tube (see Figure 1D and [0060] – “FIG. 1D shows an exemplary device similar to FIG. 1A where the suction port is presented on a protrusion 7 comprising suction port 2 and anti-clog inlet 3. Placing the suction port on a protrusion aids in isolating the suction port from the camera and reduces the risk of a stone obstructing the view of the camera. In some embodiments, protrusion 7 is constructed of a compliant material. The protrusion 7 may be of any shape or length that accommodates the inlet 3”) and a blocking bar (16) disposed at the outlet of the aspiration channel (11), wherein the blocking bar splits the outlet of the aspiration channel into two openings (2, 3) (see Figure 2A and [0015] – “In some embodiments, the suction port comprises one or more anti-clog elements (e.g., including but not limited to, one or more of the port or channel in operable communication with the port comprising a smaller inner diameter than suction tubing in operable communication with the port, a mesh material that covers the opening, a bar or beam that covers the opening, and/or one or more protrusions or depressions adjacent to the opening). In some embodiments, the anti-clog elements prevent occlusion of the suction port, working channel or suction channel by a kidney stone or fragments thereof” and [0062] – “Still referring to FIG. 2A, suction port 2 and anti-clog inlet 3 are shown as separate openings separated by a bar 16 that lead to suction channel 11 (not shown)”). 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 ureteroscope device of Zerfas et al. to include at least one blocking bar disposed at the outlet of the aspiration channel, wherein the at least one blocking bar splits the outlet of the aspiration channel into multiple openings, as disclosed in Ghani et al., so as to prevent occlusion of the suction port, working channel, or suction channel by a kidney stone or fragments thereof (see Ghani et al.: [0015]).
Campisi teaches a divider (5) disposed longitudinally within the insertion tube such that an interior space of the insertion tube is divided into the aspiration channel and the working channel (see Figure 5 and col. 6, line 66-col. 7, line 5 – “In the variant according to FIGS. 4 and 5, the region internal to the tube 2 is divided up by a single longitudinal partition wall 5 into a first region or chamber 7, within which the imaging devices 11 and 12 and the connecting cables thereof are positioned, and a second region or chamber 8 acting as a conduit for the flow of the aspirated fatty material”).
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 ureteroscope device of Zerfas et al. to include at least a portion of the aspiration channel extends distally beyond the distal end of the insertion tube, or a blocking bar disposed at the outlet of the aspiration channel, wherein the blocking bar splits the outlet of the aspiration channel into two openings, as disclosed in Ghani et al., so as to aid in isolating the suction port from the camera and reduce the risk of the stone obstructing the view of the camera (see Ghani et al.: [0060]).
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 ureteroscope device of Zerfas et al. and Ghani et al. to include a divider disposed longitudinally within the insertion tube such that an interior space of the insertion tube is divided into the aspiration channel and the lumen comprising the working channels, as disclosed in Campisi, so as to hermetically separate the aspiration channel from the other lumen, in order to guarantee sterile conditions within the aspiration channel (see Campisi: col. 5, lines 33-37).
Regarding claim 2, Zerfas et al. teaches the outlet of the aspiration channel occupies at least half of a space on the insertion tip, wherein the outlets of the working channels, image sensor, and light source occupies the remaining space on the insertion tip (see Figure 3A).
Regarding claim 4, Ghani et al. teaches the blocking bar splits the outlet of the aspiration channel equally (see Figure 2A).
Regarding claim 5, Ghani et al. teaches the blocking bar is centrally disposed at the outlet of the aspiration channel at a 90° angle (see Figure 2A).
Regarding claim 9, Zerfas et al. teaches the plurality of two working channels each are selected from the group consisting of an irrigation port (312), a basket port, and a laser port (310) (see Figures 3A and 4 and [0043] – “the working channel may accommodate a morcellating device 310, an irrigation system 312, or any other suitable devices, depending on the surgical procedure”).
Regarding claim 12, Zerfas et al. teaches the light source comprises an LED (light-emitting diode) or a fiber optic (see [0050] – “Alternatively, illumination channel 302a may itself be an optical fiber directly connected to light source 304”). Ghani et al. also teaches the light source comprises an LED (light-emitting diode) or a fiber optic (see [0052] – “In some embodiments, commercially available lights are utilized, including, for example, one or more LED lights or fiber optic filaments”).
Regarding claim 20, Ghani et al. teaches a handle disposed at the proximal end of the insertion tube (see [0138] – “An exemplary system is shown in FIG. 11. Referring to FIG. 11, shown is a system comprising ureteroscope tip 17, temperature and/or pressure sensor 12, ureteroscope handle 13, suction port distal end 14, and working channel distal end 15”).
Regarding claim 22, Ghani et al. discloses the aspiration channel exits a proximal end of the handle to avoid narrowing the aspiration channel, thereby maximizing its aspiration capabilities (see [0020] – “In some embodiments, the endoscopic device comprises an outer housing (e.g., outer housing and/or outer jacket) surrounding an interstitial space, wherein the distal end or distal portion of the endoscopic device comprises one or more interstitial flow openings in fluid communication with the interstitial space, wherein the interstitial flow openings are configured to deliver fluids or suction through such interstitial space; and a fluid port and/or suction component (e.g. located at the proximal end of the endoscopic device (e.g., in the handle) or another location)”).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zerfas et al., Ghani et al., and Campisi, further in view of Weitzner et al. (US Publication No. 2008/0188890 A1) (previously cited).
Regarding claim 6, it is noted none of Zerfas et al., Ghani et al. or Campisi specifically teach the blocking bar splits the outlet of the aspiration channel unequally. However, Weitzner et al. teaches the blocking bar splits the outlet of the aspiration channel unequally (see Figure 2B and [0143] – “Alternatively, as illustrated in FIG. 2B, at least one of channels 42, 44a, 44b, can be defined by a divider that extend along at least a portion of guide tube 26. For example, all three channels 42, 44a, 44b can share a common sheath or outer jacket 54. One skilled in the art will appreciate that the divider can be defined by a portion of the guide tube and/or by a separate element that is mated with the guide tube and/or instruments (an example of which is described in more detail with respect to FIGS. 7A through 7C)”; see also [0174]-[0178]). 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 ureteroscope device of Zerfas et al., Ghani et al., and Campisi to include the blocking bar splits the outlet of the aspiration channel unequally, as disclosed in Weitzner et al., so as to define channels of different sizes for receiving differently sized instruments.
Regarding claim 7, Weitzner et al. teaches the blocking bar disposed at the outlet of the aspiration channel at a 60°or 30° angle (see Figure 2B).
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zerfas et al., Ghani et al., and Campisi, further in view of Walak et al. (US Publication No. 2023/0042812 A1) (previously cited).
Regarding claim 11, it is noted none of Zerfas et al., Ghani et al. or Campisi specifically teach the image sensor comprises a complementary metal-oxide-semiconductor (CMOS) sensor or a charge-coupled device (CCD). However, Walak et al. teaches the image sensor comprises a complementary metal-oxide-semiconductor (CMOS) sensor or a charge-coupled device (CCD) (see [0039] – “Imaging device 100 may be one or more light emitting devices (e.g. LEDs), one or more imaging devices (e.g., cameras, including CMOS or CCD imagers), or a combination thereof. While only one imaging device 100 is shown, there may be more than one imaging device 100, e.g., multiple imaging devices, multiple light emitting devices, and/or one or more of each of imaging devices and light emitting devices”). 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 ureteroscope device of Zerfas et al., Ghani et al., and Campisi to include the image sensor comprises a complementary metal-oxide-semiconductor (CMOS) sensor or a charge-coupled device (CCD), as disclosed in Walak et al., because CMOS sensors and CCDs are well-known and commonly used in the endoscope arts.
Regarding claim 13, it is noted none of Zerfas et al., Ghani et al. or Campisi specifically teach the image sensor and the light source are combined and comprise a combined light-emitting diode (LED) complementary metal-oxide-semiconductor (CMOS) sensor. However, Walak et al. teaches the image sensor and the light source are combined and comprise a combined light-emitting diode (LED) complementary metal-oxide-semiconductor (CMOS) sensor (see [0039] – “Imaging device 100 may be one or more light emitting devices (e.g. LEDs), one or more imaging devices (e.g., cameras, including CMOS or CCD imagers), or a combination thereof. While only one imaging device 100 is shown, there may be more than one imaging device 100, e.g., multiple imaging devices, multiple light emitting devices, and/or one or more of each of imaging devices and light emitting devices”). 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 ureteroscope device of Zerfas et al., Ghani et al., and Campisi to include the image sensor and the light source are combined and comprise a combined light-emitting diode (LED) complementary metal-oxide-semiconductor (CMOS) sensor, as disclosed in Walak et al., because CMOS sensors and LEDs are well-known and commonly used in the endoscope arts.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zerfas et al., Ghani et al., and Campisi, further in view of Yurek (US Patent No. 11,324,526 B2) (previously cited).
Regarding claim 21, it is noted none of Zerfas et al., Ghani et al., or Campisi specifically teach the handle comprising control buttons configured to selectively activate and deactivate aspiration and irrigation. However, Yurek teaches the handle comprising control buttons configured to selectively activate and deactivate aspiration and irrigation (see col. 3, lines 11-16 – “The catheter may have a handle configured to be positioned outside the body of the patient. The handle may have a control for a user to stop and/or start the suctioning. The handle may have a control for a user to stop and/or start the irrigation. The handle may have a control for a user to stop and/or start the suction and the irrigation” and col. 25, lines 26-40 – “In some embodiments, the finger port may comprise a pressable button. The pressable button may allow air flow through the finger port 228 and prevent suction when left unpressed and may either occlude (e.g., pinch) the irrigation passage when pressed or cause a valve to open within the irrigation passage when pressed. Other various mechanical arrangements are possible to suit any desired configuration of control over aspiration and irrigation. In some implementations, actuation of the finger port 228 or other control may not start and stop suction and/or irrigation but may modulate the level of suction and/or irrigation. For instance, a basal level of suction and/or irrigation may be provided and the level may be transiently increased (e.g., pulsed) or transiently decreased (e.g., dampened) by actuation of the finger port 228”). 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 ureteroscope device of Zerfas et al., Ghani et al., and Campisi to include the handle comprising control buttons configured to selectively activate and deactivate aspiration and irrigation, as disclosed in Yurek, so as to allow air flow through the finger port and prevent suction when left unpressed and may either occlude (e.g., pinch) the irrigation passage when pressed or cause a valve to open within the irrigation passage when pressed (see Yurek et al.: col. 25, lines 27-31).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zerfas et al. and Ghani et al., further in view of Yurek.
Regarding claim 24, Zerfas et al. discloses a ureteroscope device (see [0025] – “Embodiments of the present disclosure can be used for a variety of therapeutic procedures, including ureteroscopy, hysteroscopy, and cystoscopy, for example”) comprising:
a) an insertion tube (102) comprising a proximal end and a distal end (106), wherein the distal end of the insertion tube comprises an insertion tip (see Figure 1 and [0026] – “Retrieval device 100 may include a tube 102 having a proximal end 104 and a distal end 106, and a handle 108 coupled to proximal end 104. Tube 102 may include two or more internal channels 110 having proximal and distal end openings 112, 114, respectively, to receive, e.g., one or more medical devices. The channels may be used for, among other things, providing irrigation, suction, and/or insufflation”);
b) an aspiration channel (302d) disposed in the insertion tube, the aspiration channel having an outlet at the insertion tip (see Figure 3A and [0043] – “return channel 302d may induce a suction force using a suction device 308”), wherein the aspiration channel extends linearly from the distal end to the proximal end of the insertion tube (see [0044] – “In general, channels 302 may be defined as elongate hollow lumens that extend, at least partially, between proximal end 104 and distal end 106 of tube 102” and [0047] – “In addition, although the depicted embodiments illustrate that channels 302 include substantially uniform cross-sectional configurations and dimensions, the cross-sectional dimensions and/or configurations of any of channels 302 may vary as desired”);
d) a plurality of working channels (110, 302c) disposed in the insertion tube, each having an outlet at the insertion tip (see Figure 3A and [0040] – “Tube 102 may include multiple channels 110 to slidingly receive two or more devices, either independently or simultaneously” and [0042] – “working channels 302c”); and
e) an image sensor (306) and a light source (304) disposed at the insertion tip (see Figure 3A and [0043] – “illumination channels 302a may be connected to a light source 304; visualization channel 302b may accommodate a visualization device 306”).
It is noted Zerfas et al. does not specifically teach blocking bar disposed at the outlet of the aspiration channel, wherein the blocking bar splits the outlet of the aspiration channel into two openings or a handle disposed at the proximal end of the insertion tube, the handle comprising control buttons configured to selectively activate and deactivate aspiration and irrigation, wherein the aspiration channel exits a proximal end of the handle as a male connector to avoid narrowing the aspiration channel, wherein suction tubing is configured to be positioned over the male connector. However, Ghani et al. teaches a blocking bar (16) disposed at the outlet of the aspiration channel (11), wherein the blocking bar splits the outlet of the aspiration channel into two openings (2, 3) (see Figure 2A and [0015] – “In some embodiments, the suction port comprises one or more anti-clog elements (e.g., including but not limited to, one or more of the port or channel in operable communication with the port comprising a smaller inner diameter than suction tubing in operable communication with the port, a mesh material that covers the opening, a bar or beam that covers the opening, and/or one or more protrusions or depressions adjacent to the opening). In some embodiments, the anti-clog elements prevent occlusion of the suction port, working channel or suction channel by a kidney stone or fragments thereof” and [0062] – “Still referring to FIG. 2A, suction port 2 and anti-clog inlet 3 are shown as separate openings separated by a bar 16 that lead to suction channel 11 (not shown)”) and a handle disposed at the proximal end of the insertion tube (see [0138] – “An exemplary system is shown in FIG. 11. Referring to FIG. 11, shown is a system comprising ureteroscope tip 17, temperature and/or pressure sensor 12, ureteroscope handle 13, suction port distal end 14, and working channel distal end 15”), wherein the aspiration channel exits a proximal end of the handle to avoid narrowing the aspiration channel (see [0020] – “In some embodiments, the endoscopic device comprises an outer housing (e.g., outer housing and/or outer jacket) surrounding an interstitial space, wherein the distal end or distal portion of the endoscopic device comprises one or more interstitial flow openings in fluid communication with the interstitial space, wherein the interstitial flow openings are configured to deliver fluids or suction through such interstitial space; and a fluid port and/or suction component (e.g. located at the proximal end of the endoscopic device (e.g., in the handle) or another location)”).
Yurek teaches a handle disposed at the proximal end of the insertion tube, the handle comprising control buttons configured to selectively activate and deactivate aspiration and irrigation (see col. 3, lines 11-16 – “The catheter may have a handle configured to be positioned outside the body of the patient. The handle may have a control for a user to stop and/or start the suctioning. The handle may have a control for a user to stop and/or start the irrigation. The handle may have a control for a user to stop and/or start the suction and the irrigation” and col. 25, lines 26-40 – “In some embodiments, the finger port may comprise a pressable button. The pressable button may allow air flow through the finger port 228 and prevent suction when left unpressed and may either occlude (e.g., pinch) the irrigation passage when pressed or cause a valve to open within the irrigation passage when pressed. Other various mechanical arrangements are possible to suit any desired configuration of control over aspiration and irrigation. In some implementations, actuation of the finger port 228 or other control may not start and stop suction and/or irrigation but may modulate the level of suction and/or irrigation. For instance, a basal level of suction and/or irrigation may be provided and the level may be transiently increased (e.g., pulsed) or transiently decreased (e.g., dampened) by actuation of the finger port 228”), wherein the aspiration channel exits a proximal end of the handle as a male connector (222) to avoid narrowing the aspiration channel, wherein suction tubing is configured to be positioned over the male connector (see Figures 8A-B and col. 17, lines 11-21 – “In some embodiments, the inner diameter of the vacuum lumen increases continually from the distal end to the proximal end. In some embodiments, the inner diameter of a vacuum lumen within a handle to which the vacuum lumen is coupled also increases from distal to proximal within the handle. Thus, in some embodiments, the inner diameter of the combined catheter and handle vacuum lumens continuously increases from distal to proximal such that the minimum inner diameter is at the distal tip of the catheter, and the maximum inner diameter is at a fluid port on the handle, which is to be coupled to a vacuum source” and col. 24, lines 6-14 – “In some embodiments, the vacuum lumen within the handle extends substantially straight from a distal portion of the handle 202 to the proximal end of the handle 202, for example from the coupling to the catheter vacuum tube 110 to the proximal end of the handle. In some embodiments, the inner diameter of the vacuum lumen within the handle tapers from proximal to distal, such that the inner diameter at the proximal end fluid port 222 is greater than the inner diameter at the coupling to the catheter vacuum tube 110”).
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 ureteroscope device of Zerfas et al. to include a blocking bar disposed at the outlet of the aspiration channel, wherein the blocking bar splits the outlet of the aspiration channel into two openings and a handle disposed at the proximal end of the insertion tube, wherein the aspiration channel exits a proximal end of the handle to avoid narrowing the aspiration channel, as disclosed in Ghani et al., so as to prevent occlusion of the suction port, working channel, or suction channel by a kidney stone or fragments thereof (see Ghani et al.: [0015]).
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 ureteroscope device of Zerfas et al. and Ghani et al. to include the handle comprising control buttons configured to selectively activate and deactivate aspiration and irrigation, wherein the aspiration channel exits a proximal end of the handle as a male connector to avoid narrowing the aspiration channel, wherein suction tubing is configured to be positioned over the male connector, as disclosed in Yurek, so as to reduce clogging of the vacuum lumen with debris (see Yurek: col. 17, lines 1-4).
Response to Arguments
Applicant's arguments filed 7/10/2026 have been fully considered but they are not persuasive.
Applicant argues the cited references do not suggest the feature of a portion of the aspiration tube extending beyond the distal end of the insertion tube. However, Figure 1D of Ghani shows the suction port (2) and anti-clog inlet (3) being presented on a protrusion (7) that extends beyond the distal portion of the insertion tube where the working channel (4), camera (5), and light (1) are located. Such a configuration aids in isolating the suction port from the camera and reduces the risk of a stone obstructing the view of the camera (see [0060]).
Applicant argues the cited references do not suggest the feature of an aspiration channel exits a proximal end of the handle as a male connector to avoid narrowing of the aspiration channel. However, Figures 8A-B of Yurek show the aspiration channel exiting the proximal end (118) of the handle (202) as a male connector (222), and further describes that the vacuum lumen extends substantially straight from a distal portion of the handle to the proximal end of the handle and tapers from proximal to distal along an entire length of the vacuum lumen, such that the inner diameter at the fluid port (222) is greater than the inner diameter at the vacuum tube (110), which reduces clogging of the vacuum lumen with debris (see col. 16, line 62-col. 17, line 4 and col. 24, lines 6-14).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Intintoli et al. (US 2019/0298321 A1) describes a biopsy endoscope with suction tubing attached to a proximal portion of the handle at a male connector to provide a linear removal pathway.
Harrah et al. (US 2017/0215899 A1) describes a uretoscope having an aspiration channel that extends distally beyond a distal end of an insertion tube.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791