DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/26/2025 has been entered.
Response to Amendment
As of the reply filed 12/26/2025, claims 1-33 are pending. Claim 33 is new, and claims 30-31 have been amended.
Response to Arguments
Applicant’s amendments to claims 30-31 have overcome the previously filed rejections under 35 U.S.C. 112(b), therefore these rejections are withdrawn.
Applicant's arguments filed 12/26/2025 have been considered but are not persuasive.
Applicant argues that “the Office Action has not identified any particular motivation for applying a sterile drape to the drive mechanism 118 of Au” (see pages 7-12 of Remarks), but the Examiner respectfully disagrees. The Office Action filed 9/25/2025 states that “One of ordinary skill in the art would have been motivated to perform this modification in order to “maintain a sterile field… [and] controllably hold the drape portion to the indicator section and the manipulator” (PP [0050]). The Applicant argues that this “merely restates the use of the magnet in the specific system of Devengenzo, and does not provide a reason to modify Au to include the proposed modifications”, but the Examiner counters that the Devengenzo et al. reference generally teaches the incorporation of a sterile field to shield a drive mechanism (see Fig. 10) from a sterile field during surgery. The Applicant argues that positioning a sterile drape “between a surgical tool and a manipulator assembly that tool is coupled to in Devengenzo is not a reason to position a sterile drape on a drive mechanism 118 having drive wheels that rolls along a track or ramp as in Au” (see page 11 of Remarks), but the Examiner disagrees. The modification as proposed would yield the drive unit of Au et al. including the magnet of Devengenzo et al. (noting that independent claim 1 does not include a sterile drape, and the only recitation of a sterile drape is in the functional language of claim 29) which is configured to couple to a sterile drape which can be manipulated or adjusted by the user as necessary. The device of Au et al. including a ramp and drive wheels does not change that Devengenzo et al. also teaches a magnet (97 in Fig. 10) placed onto a drive mechanism (see Figs. 5-6) to provide a sterile barrier between the drive housing of a surgical device and the surgical field and that this feature could be used to improve the device of Au et al. in the same way. Maintaining a sterile field in general does not relate solely to the specific structures as proposed.
Applicant further argues that “The Office has not found that there is a recognized problem or need in the art for providing a magnet on a drive mechanism such as drive mechanism 118 of Au” (see pages 12-13 of Remarks), however the Examiner respectfully disagrees. In the present case, the “recognized problem or need” is the issue of placement with respect to the magnet of the proposed combination. The Examiner maintains that one of ordinary skill in the art would find it obvious to place the at least one magnet on the first surface of the hub, alongside the one rotatable roller, particularly since the Applicant does not specifically recite the meaning or placement of “first surface”.
Applicant further argues that “one of ordinary skill in the art would have no reasonable expectation of success at attaching a magnet and sterile drape to the drive mechanism 118” (see Remarks page 14), however the Examiner respectfully disagrees. Independent claim 1 does not positively recite a sterile drape as argued by the Applicant, and dependent claim 29 only references a sterile drape as the object of functional language. The Applicant argues that “the Office Action has not indicated what the sterile drape is intended to separate in the proposed modifications”, but the sterile drape is not required by the claim, only a magnet disposed upon the surface of the drive unit 118 (analogous to the magnet 97 in Fig. 10 of Devengenzo et al. located on the drive unit shown there) configured to attach to a sterile drape. The combination as proposed, and claim 1 as presently written, simply requires a magnet disposed on an exterior of the hub, and does not specifically require its placement between the hub and the track, therefore the Applicant’s arguments against the combination as proposed are unpersuasive as they rely on a narrower interpretation of the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims (see In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993)).
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 following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10, 15-20, and 29-33 are rejected under 35 U.S.C. 103 as being unpatentable over Au (US PGPub 2017/0281288 A1) in view of Devengenzo et al. (US PGPub 2007/0142824 A1).
With respect to claim 1, Au discloses a robotically driven interventional device (100 in Fig. 1), comprising:
an elongate, flexible body (110) comprising a proximal end and a distal end (proximal end 116, distal end 112);
a hub (118) being positioned on the proximal end (118 is connected to 116);
at least one rotatable roller (154) being on a first surface of the hub (118) and disposed to roll along a drive surface (152) so that the elongate flexible body (110) and hub (118) are axially movable along the drive surface (PP [0018]: “insertion drive system 150 includes a track or ramp 152 and drive wheels 154 that engage track 152”).
However, Au fails to disclose at least one magnet on the first surface of the hub.
In the same field of robotic surgical devices (abstract), Devengenzo et al. teaches a robotically driven interventional device (see Fig. 5) comprising a hub (52 in Fig. 5 and 24 in Fig. 3). Devengenzo et al. further discloses a magnet (97 in Fig. 10) on a surface of the hub (see Fig. 10 with 97 on unmarked 20 of 52, see also Fig. 5).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Au disclosure to incorporate the teachings of Devengenzo et al. to include at least one magnet on the first surface of the hub. One of ordinary skill in the art would have been motivated to perform this modification in order to “maintain a sterile field… [and] controllably hold the drape portion to the indicator section and the manipulator” (PP [0050] Devengenzo et al.), and additionally because incorporating the magnet on the first surface of the hub, specifically, would have been obvious to try, as there are a limited number of surfaces on the hub of the Au device to connect a magnet to, which one of ordinary skill in the art could have explored with a reasonable expectation of success.
Regarding claim 2, Au as modified by Devengenzo et al. further discloses wherein the at least one rotatable roller (154 in Fig. 1 of Au) extends further away from the first surface than the at least one magnet (97 in Fig. 10 of Devengenzo et al., the combination as proposed would include the roller extending more than the magnet because otherwise the magnet would impede the roller 154 and the track 152).
Regarding claim 3, Au as modified by Devengenzo et al. further discloses at least a second roller (see other unmarked 154 in Fig. 1 of Au).
Regarding claim 4, Au as modified by Devengenzo et al. further discloses a rotational drive (320 in Fig. 3 of Au) within the hub (118 in Fig. 1, PP [0024]: “FIG. 3 schematically illustrates one specific implementation of a catheter system 300 that may operate as described above”), for rotating the elongate, flexible body (110 in Fig. 1) with respect to the hub (118, PP [0029]: “steering drive mechanism 320 may be used to control other movement of catheter 310 such as rotation or roll of the proximal end of catheter 310”).
Regarding claim 5, Au as modified by Devengenzo et al. further discloses a retraction mechanism (330 in Fig. 3 of Au) in the hub (118 in Fig. 1), for proximally retracting a pull element (430 in Fig. 4) extending through the elongate, flexible body (PP [0029]: “Steering drive mechanism 320 of FIG. 3, which pulls on tendons 430 to actuate distal steerable segment 316, includes a mechanical system or transmission 324 that converts the movement of actuators 322, e.g., electric motors, into movements of (or tensions in) tendons 430 that run through catheter 310 and connect to distal steerable segment 316”).
Regarding claim 6, Au as modified by Devengenzo et al. further discloses wherein the pull element (430 in Fig. 4 of Au) comprises a pull wire (PP [0028]: “Tendons 430 can be wires, cables, Bowden cables, hypotubes, or any other structures that are able to transfer force from steering drive mechanism 320 to distal tip 415 and limit bending of proximal section 312 when steering drive mechanism 320 pulls on tendons 430”).
Regarding claim 7, Au as modified by Devengenzo et al. further discloses wherein the pull element (430 in Fig. 4 of Au) comprises a pull tube (PP [0028]: “Tendons 430 can be wires, cables, Bowden cables, hypotubes, or any other structures that are able to transfer force from steering drive mechanism 320 to distal tip 415 and limit bending of proximal section 312 when steering drive mechanism 320 pulls on tendons 430”).
Regarding claim 8, Au as modified by Devengenzo et al. further discloses wherein a shape of a portion of the elongate, flexible body (110 in Fig. 1 of Au, see also 316 in Fig. 4 analogous to 116) changes in response to proximal retraction of the pull element (PP [0029]: “Steering drive mechanism 320 of FIG. 3, which pulls on tendons 430 to actuate distal steerable segment 316, includes a mechanical system or transmission 324 that converts the movement of actuators 322, e.g., electric motors, into movements of (or tensions in) tendons 430 that run through catheter 310 and connect to distal steerable segment 316”).
Regarding claim 9, Au as modified by Devengenzo et al. further discloses wherein a stiffness characteristic of a portion of the elongate, flexible body (110 in Fig. 1 of Au, see also 316 in Fig. 4 analogous to 116) changes in response to proximal retraction of the pull element (PP [0029]: “Control of the actuator force applied to tendons 430 can also control the effective stiffness or resistance to movement of steerable segment 316”).
Regarding claim 10, Au as modified by Devengenzo et al. further discloses a sensor (see 360 in Fig. 3 of Au, PP [0025]: “catheter 310 may include smaller lumens for pull wires and sensor lines”) on the elongate, flexible body (110 in Fig. 1, see also 316 in Fig. 4 analogous to 116).
Regarding claim 15, Au as modified by Devengenzo et al. further discloses wherein the sensor (see 360 in Fig. 3 of Au, PP [0025]: “catheter 310 may include smaller lumens for pull wires and sensor lines”) comprises a catheter shape sensor (PP [0028]: “defines smaller lumens, for example, for actuating tendons 430 and a shape sensor”).
Regarding claim 16, Au as modified by Devengenzo et al. further discloses wherein the sensor (see 360 in Fig. 3 of Au, PP [0025]: “catheter 310 may include smaller lumens for pull wires and sensor lines”) comprises a catheter position sensor (PP [0020]: “a display of sensor information indicating the position of distal tip 112”).
Regarding claim 17, Au as modified by Devengenzo et al. further discloses wherein the elongate, flexible body (110 in Fig. 1 of Au) comprises a guide catheter (PP [0025]: “Catheter 310 is generally flexible and has one or more lumens including a main lumen that can accommodate interchangeable probes such as a biopsy needle or a vision system”, any catheter can be a guide catheter, see MPEP 2112.01).
Regarding claim 18, Au as modified by Devengenzo et al. further discloses wherein the elongate, flexible body (110 in Fig. 1 of Au) comprises a guidewire (see MPEP 2112.01, 110 is thin and flexible and capable of being used as a guidewire).
Regarding claim 19, Au as modified by Devengenzo et al. further discloses wherein the elongate, flexible body (110 in Fig. 1 of Au) comprises an access catheter (PP [0025]: “Catheter 310 is generally flexible and has one or more lumens including a main lumen that can accommodate interchangeable probes such as a biopsy needle or a vision system”, any catheter can be an access catheter, see MPEP 2112.01).
Regarding claim 20, Au as modified by Devengenzo et al. further discloses wherein the elongate, flexible body (110 in Fig. 1 of Au) comprises an aspiration catheter (PP [0025]: “Catheter 310 is generally flexible and has one or more lumens including a main lumen that can accommodate interchangeable probes such as a biopsy needle or a vision system”, any catheter can be an aspiration catheter if it is connected to a suction source, see MPEP 2112.01).
Regarding claim 29, Au as modified by Devengenzo et al. further discloses wherein the at least one magnet (97 in Fig. 10 of Devengenzo et al.) is a first magnet disposed to magnetically couple to a second magnet separated from the first magnet by a sterile barrier (the claim language only requires a first magnet “disposed to” couple to a second magnet and does not positively recite the second magnet or the sterile barrier, 97 is configured to connect to a second magnet such that it is separated from it by a sterile barrier, PP [0050]: “Magnet 97 operably couples to metal strip 98 to controllably hold the drape portion to the indicator section and the manipulator, thereby allowing for management of drape material (in particular for keeping excess drape material from obstructing instrument engagements)”).
Regarding claim 30, Au as modified by Devengenzo et al. further discloses wherein the first magnet (97 in Fig. 10 of Devengenzo et al.) is configured to be spaced from the second magnet (97 is configured to connect to a second magnet such that it is separated from it by a sterile barrier, PP [0050]: “Magnet 97 operably couples to metal strip 98 to controllably hold the drape portion to the indicator section and the manipulator, thereby allowing for management of drape material (in particular for keeping excess drape material from obstructing instrument engagements)”) by no more than 0.15 inches (see MPEP 2112.01, this is a functional limitation, magnet 97 is able to be disposed at this distance since it is a separate component from the second magnet and can be held at no more than 0.15 inches apart from it, furthermore the sterile drape being disposed between the magnets would separate them by no more than 0.15 inches depending on the width of the sterile drape).
Regarding claim 31, Au as modified by Devengenzo et al. further discloses wherein the first magnet and the second magnet (97 in Fig. 10 of Devengenzo et al., PP [0050]: “Magnet 97 operably couples to metal strip 98 to controllably hold the drape portion to the indicator section and the manipulator, thereby allowing for management of drape material (in particular for keeping excess drape material from obstructing instrument engagements)”) are configured to face the sterile barrier (97 and 98 are configured to hold the drape, therefore the first and second magnet face the sterile barrier, see MPEP 2112.01).
Regarding claim 32, Au as modified by Devengenzo et al. further discloses wherein the at least one rotatable roller comprises a plurality of rotatable rollers (154 in Fig. 1 of Au et al., PP [0018]: “insertion drive system 150 includes a track or ramp 152 and drive wheels 154 that engage track 152”), but fails to explicitly disclose wherein the at least one magnet is positioned between the plurality of rotatable rollers.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Au et al. and Devengenzo et al. combination such that the at least one magnet is positioned between the plurality of rotatable rollers. Positioning the at least one magnet (97 in Fig. 10 of Devengenzo et al.) on the first surface (see Fig. 1 of Au et al., note that claim 1 does not define the boundaries of the first surface and the entire exterior of the Au et al. device can be considered to be a first surface) such that the at least one magnet is positioned longitudinally between the rollers (a magnet placed on the sides or top part of the device of Au et al. can still be considered to be between the rollers if it is located at a longitudinal position that is between the two rollers) would have been obvious to one of ordinary skill in the art because it has been held that a simple rearrangement of parts is an obvious matter of design choice (see MPEP 2144.04 VI. C., In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)).
Regarding claim 33, Au as modified by Devengenzo et al. further discloses wherein the at least one magnet (97 in Fig. 10 of Devengenzo et al., placed on 118 in Fig. 1 of Au et al.) is a driven magnet (any magnet can be a driven magnet if it is configured to move along with a drive magnet) disposed to magnetically couple to a drive magnet separated from the driven magnet by the drive surface (see MPEP 2112.01, “disposed to” is functional language, the drive magnet is not positively recited, a magnet on 118 in Fig. 1 of Au et al. could be considered to be a driven magnet separated from a drive magnet by the drive surface depending on the strength of the functional drive magnet since a magnet on 118 in Fig. 1 would be on rollers and configured to move).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Au (US PGPub 2017/0281288 A1) in view of Devengenzo et al. (US PGPub 2007/0142824 A1) as applied to claim 1 above, and further in view of Wenderow et al. (US PGPub 2013/0231678 A1).
Regarding claim 11, Au as modified by Devengenzo et al. fails to disclose wherein the sensor comprises an axial force sensor.
In the same field of robotic catheters (abstract), Wenderow et al. teaches a robotic surgical assembly (see Fig. 1), wherein the sensor comprises an axial force sensor (PP [0099]: “a sensor configured to determine the amount of axial force applied to guide wire 301 by guide wire axial drive motor 602 as guide wire axial drive mechanism 350 advances and retracts the guide wire”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the Au and Devengenzo et al. combination to include the axial force sensor as taught by the Wenderow et al. reference. One of ordinary skill in the art would have been motivated to perform this modification because it is a simple substitution of sensors that would have yielded predictable results, since Au is generally concerned with “control[ling] the insertion force” (PP [0018]) and includes a sensor system (360 in Fig. 3, PP [0025]: “catheter 310 may include smaller lumens for pull wires and sensor lines”).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Au (US PGPub 2017/0281288 A1) in view of Devengenzo et al. (US PGPub 2007/0142824 A1) and Wenderow et al. (US PGPub 2013/0231678 A1) as applied to claim 11 above, and further in view of Danitz et al. (PGPub US 2005/0107667 A1).
Regarding claim 12, the combination of Au, Devengenzo et al., and Wenderow et al. fails to disclose wherein a distal portion of the elongate, flexible body includes at least a first electrical conductor spaced axially apart from and insulated from a second electrical conductor.
In the same field of articulating instruments for remote manipulation (abstract), Danitz et al. teaches an elongate flexible body (see Fig. 12A) comprising a distal portion (141) wherein the distal portion (141) includes at least a first electrical conductor (129) spaced axially apart from and insulated from (127) a second electrical conductor (PP [0135]: “Other antenna or wire geometries, including helical coils…”, multiple coils are contemplated therefore a second electrical conductor coil is contemplated).
It would have been prima facie obvious before the effective filing date for one of ordinary skill in the art to have modified the combination of Au, Devengenzo et al., and Wenderow et al. to include the conductive elements as taught by Danitz et al. because Au is generally concerned with “an instrument such as a lung catheter, a bronchoscope, a biopsy instrument, or other similar medical device through airways or other branching or convoluted natural lumens” (PP [0003]). Incorporating the conductor arrangement of Danitz et al. therefore would have been a simple substitution of distal ends that would have yielded predictable results, since an ablation catheter is within the scope contemplated by the Au reference.
Regarding claim 13, Au as modified by Devengenzo et al., Wenderow et al. and Danitz et al. further discloses wherein first electrical conductor (129 in Fig. 12A of Danitz et al.) and second electrical conductor (unmarked, see rejection above) are adjacent helical windings of conductive wire (PP [0135]: “Other antenna or wire geometries, including helical coils…”, 129 is stated to be a wire in PP [0135]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Au (US PGPub 2017/0281288 A1) in view of Devengenzo et al. (US PGPub 2007/0142824 A1) as applied to claim 10 above, and further in view of Romo et al. (PGPub US 2016/0184032 A1).
Regarding claim 14, the combination of Au and Devengenzo et al. fails to disclose wherein the sensor comprises an oxygen sensor.
In the same field of robotic catheters (abstract), Romo et al. teaches an ablation catheter (PP [0280]: “the laser tool 3307 may be directed to operative site 3306 to emit laser radiation 3308 for purposes of tissue ablation, drilling, cutting, piercing, debriding, cutting or accessing non-superficial tissue”) including a sensor, wherein the sensor comprises an oxygen sensor (PP [0270]: “Imaging tools such as fluorescence imaging, near infrared imaging, oxygen sensors, molecular biomarker images, and contrast dye imaging may help pinpoint the exact coordinates of the lesion”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of Au and Devengenzo et al. to include the oxygen sensor of the Romo et al. disclosure. One of ordinary skill in the art would have been motivated to perform this modification because Romo et al. teaches that “real-time imaging based on different imaging modalities [can] further enhance navigation” (PP [0270]) by providing a precise location of the target tissue during a procedure.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Au (US PGPub 2017/0281288 A1) in view of Devengenzo et al. (US PGPub 2007/0142824 A1) as applied to claim 1 above, and further in view of Wallace et al. (PGPub US 2013/0035537 A1).
Regarding claim 21, Au as modified by Devengenzo et al. fails to further disclose a fiber bragg grating sensor.
In the same field of robotically actuated manipulation members (abstract), Wallace et al. teaches a flexible body (26 in Fig. 3) comprising a sensor, wherein the sensor comprises a fiber bragg grating sensor (PP [0118]: “a fiber optic Bragg sensing fiber may be placed inside the lumen of the elongate member 26 to sense position, shape and temperature”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Au and Devengenzo et al. combination to incorporate the teachings of Wallace et al. and include a fiber bragg grating sensor. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have been an incorporation of a known technique (application of a fiber optic Bragg sensing fiber to a catheter) with a known device (a catheter) to yield predictable results and improve localization of the device while it is deployed. Furthermore, Au already contemplates shape sensors for localization (PP [0028]: “defines smaller lumens, for example, for actuating tendons 430 and a shape sensor”), therefore performing this modification would be a simple substitution of sensors which would yield predictable results.
Claims 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Au (US PGPub 2017/0281288 A1) in view of Devengenzo et al. (US PGPub 2007/0142824 A1), as applied to claim 1 above, and further in view of Quick (PGPub US 2019/0231373 A1).
Regarding claim 22, Au as modified by Devengenzo et al. fails to disclose a clot filter in fluid communication with the hub.
In the same field of catheter intervention systems (abstract), Quick teaches a catheter (206 in Fig. 1A) and a hub (100) and further teaches a clot filter (321 in Fig. 3A, inside of 306 in Fig. 1A) in fluid communication with the hub (100, see Fig. 1A, they are in fluid communication via tubing 314 and 316).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Au and Devengenzo et al. combination to include the clot filter as taught by Quick because Au is generally concerned with “an instrument such as a lung catheter, a bronchoscope, a biopsy instrument, or other similar medical device through airways or other branching or convoluted natural lumens” (PP [0003]), including aspiration catheters. One of ordinary skill in the art would have been motivated to perform this modification because “the filter 321 inhibits clot material from passing into the check valve assembly 335, which could inhibit function of the check valve assembly 335 and/or macerate the clot material and make it indistinguishable from or difficult to distinguish from other fluids (e.g., blood) aspirated and/or removed from the patient” (PP [0047]).
Regarding claim 23, Au as modified by Devengenzo et al. and Quick further discloses wherein the clot filter (321 in Fig. 3A of Quick) is carried by the hub (100 in Fig. 1A, if the hub were to be supported alone it in turn would “carry” and support the clot filter 321 within 306 since they are connected via tubing 314 and 316, see also hub 118 in Fig. 1 of Au).
Regarding claim 24, Au as modified by Devengenzo et al. and Quick further discloses wherein the clot filter (321 in Fig. 3A of Quick) has a transparent side wall (322) to permit visual inspection of captured clot (PP [0047]: “the housing 322 may be made of a transparent material that permits the operator to visualize material within the housing 322”).
Claims 25-28 are rejected under 35 U.S.C. 103 as being unpatentable Au (US PGPub 2017/0281288 A1) in view of Devengenzo et al. (US PGPub 2007/0142824 A1), as applied to claim 1 above, and further in view of Seip et al. (PGPub US 2018/0161001 A1).
Regarding claim 25, Au as modified by Devengenzo et al. fails to disclose a bubble detector in fluid communication with a flow path through the hub.
In the related field of robotic surgical systems (abstract), Seip et al. teaches a device comprising a bubble detector in fluid communication with a flow path through a hub (PP [0071]: “debubbling can be monitored using ultrasound-based or optical bubble detectors attached to the fluid path line(s)”, PP [0116]: “wherein a gas bubble flowing through the first tube disrupts a flow of light from the light source to the detector, thereby indicating to the computer system the presence of at least one gas bubble in the fluid circulated in at least one of the bolus assemblies and the transducer assembly”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of Au an Devengenzo et al. to incorporate the teachings of Seip et al. and include the bubble detection and removal system as taught by Seip et al. because Seip et al. teaches that the presence of dissolved gases/gas bubbles within flow paths can disrupt surgical procedures (PP [0006]). Since Au discloses a catheter assembly which may be prone to bubbles entering through the lumen and disrupting the flow path, the Au device would also benefit from a way to remove these bubbles.
Regarding claim 26, Au as modified by Devengenzo et al. and Seip et al. further discloses wherein the bubble detector is carried by the hub (Seip et al. PP [0115]: “a detector positioned on or near an opposing side of the first tube”, the detector would be on the proximal end of the flexible body, it would be close to and connected to the hub therefore it is carried by the hub).
Regarding claim 27, Au as modified by Devengenzo et al. and Seip et al. further discloses a valve in the flow path (Seip et al. PP [0068]: “one or more circulating fluid pumps of the fluid management system 22′ can be turned “ON.” Next, the bolus assembly 18 and/or the transducer assembly can be tapped or connected to another structure to dislodge or begin to disclose gases or bubbles. The bolus assembly and/or the transducer assembly can be oriented so that the fluid outlet port is located at a top of the bolus assembly and/or the transducer assembly, thereby allowing dislodged bubbles to float up close to the outlet port and be removed by the circulating fluid pump(s)”, a pump would include a valve), and a processor configured to adjust the valve in response to detection of bubbles in the flow path (PP [0116]: “wherein a gas bubble flowing through the first tube disrupts a flow of light from the light source to the detector, thereby indicating to the computer system the presence of at least one gas bubble in the fluid circulated in at least one of the bolus assemblies and the transducer assembly”, the fluid pumps/valves are actuated via the computer system when gas bubbles are detected).
Regarding claim 28, Au as modified by Devengenzo et al. and Seip et al. further discloses wherein bubbles are diverted out of the flow path in response to adjustment of the valve (Seip et al. PP [0068]: “one or more circulating fluid pumps of the fluid management system 22′ can be turned “ON.” Next, the bolus assembly 18 and/or the transducer assembly can be tapped or connected to another structure to dislodge or begin to disclose gases or bubbles. The bolus assembly and/or the transducer assembly can be oriented so that the fluid outlet port is located at a top of the bolus assembly and/or the transducer assembly, thereby allowing dislodged bubbles to float up close to the outlet port and be removed by the circulating fluid pump(s)”, the bubbles are removed therefore they are diverted out of the flow path as the pumps/valves are adjusted).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771