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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/16/2026 has been entered.
Notice of Amendment
In response to the amendment filed on 2/16/2026, amended claims 1 and 14, cancelled claims 3, 10, 15-16, and 18-19, and new claims 20-24 are acknowledged. Claims 1-2, 4-9, 11-14, 17, and 20-24 are currently pending with claims 14 and 17 withdrawn from consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 23 is 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 23 recites the limitation “wherein a portion of the insertion tip at the distal end of the insertion tube opposite of the aspiration channel is recessed into the insertion tip”, which renders the claim indefinite because it is unclear how the insertion tip can be recessed into itself.
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 22-23 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).
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”);
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 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”);
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 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. However, Ghani et al. teaches at least one blocking bar (16) disposed at the outlet of the aspiration channel (11), wherein the at least one blocking bar splits the outlet of the aspiration channel into multiple 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]).
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 at least one blocking bar splits the outlet of the aspiration channel equally (see Figure 2A).
Regarding claim 5, Ghani et al. teaches the at least one 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 working channels comprises an irrigation port (312), a basket port, a laser port (310), or a combination thereof (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)”).
Regarding claim 23 as best understood, Ghani et al. discloses a portion of the insertion tip at the distal end of the insertion tube opposite of the aspiration channel (2, 11) is recessed into the insertion tip (see Figures 2A and 7A and [0081] – “In the view shown in FIG. 7A, the light is shown as recessed below the working channels 4 and camera 5, although other configurations of light 1 are specifically contemplated”).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zerfas et al. and Ghani et al., further in view of Weitzner et al. (US Publication No. 2008/0188890 A1) (previously cited).
Regarding claim 6, it is noted neither Zerfas et al. nor Ghani et al. specifically teach the at least one blocking bar splits the outlet of the aspiration channel unequally. However, Weitzner et al. teaches the at least one 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. and Ghani et al. to include the at least one 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 at least one blocking bar disposed at the outlet of the aspiration channel at a 60°or 30° angle (see Figure 2B).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zerfas et al. and Ghani et al., further in view of Campisi (US Patent No. 10,660,510 B2) (cited by Applicant) (previously cited).
Regarding claim 8, it is noted neither Zerfas et al. nor Ghani et al. specifically teach the insertion tube further comprises a divider disposed longitudinally within the insertion tube such that an interior space of the insertion tube is divided into two lumens, wherein one of the lumens forms the aspiration channel and the other lumen contains the plurality of working channels, the image sensor, and the light source. However, Campisi teaches the insertion tube further comprises a divider (5) disposed longitudinally within the insertion tube such that an interior space of the insertion tube is divided into two lumens (7, 8), wherein one of the lumens forms the aspiration channel (8) and the other lumen (7) contains the plurality of working channels, the image sensor (11), and the light source (12) (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. and Ghani et al. to include the insertion tube further comprises a divider disposed longitudinally within the insertion tube such that an interior space of the insertion tube is divided into two lumens, wherein one of the lumens forms the aspiration channel and the other lumen contains the plurality of working channels, the image sensor, and the light source, 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).
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zerfas et al. and Ghani et al., further in view of Walak et al. (US Publication No. 2023/0042812 A1) (previously cited).
Regarding claim 11, it is noted neither Zerfas et al. nor Ghani et al. 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. and Ghani et al. 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 neither Zerfas et al. nor Ghani et al. 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. and Ghani et al. 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 and 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 (US Patent No. 11,324,526 B2)
Regarding claim 21, it is noted neither Zerfas et al. nor Ghani et al. 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. and Ghani et al. 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).
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 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 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 to avoid narrowing the aspiration channel. However, Ghani et al. teaches at least one blocking bar (16) disposed at the outlet of the aspiration channel (11), wherein the at least one blocking bar splits the outlet of the aspiration channel into multiple 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”).
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 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, 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).
Response to Arguments
Applicant's arguments filed 2/16/2026 have been fully considered but they are not persuasive.
Applicant argues the combination of Zerfas and Ghani fails to teach or suggest the feature of an aspiration channel extending linearly from the distal end to the proximal end of the insertion tube. The Examiner respectfully disagrees and notes that Zerfas explicitly states “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” (see [0044]). Moreover, Zerfas notes that the channels can include substantially uniform cross-sectional configurations and dimensions (see [0047]), which, in conjunction with other cited portions of Zerfas, reasonably maps to the claim limitation “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”.
Conclusion
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791