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 .
Status of Claims
This office action is responsive to the amendment filed 10 November 2022.
Claims 1-21 are canceled.
Claims 40 and 41 are added.
Claims 22, 27, 36, and 39 are amended.
Claims 22-41 are presently pending in this application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitations recites sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitations are:
“attachment means” in claim 22, further claiming sufficient structure of “a clip” in claim 23.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 22 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Truckai (US Patent Publication No. 20200329953 A1).
Regarding claim 22, Truckai teaches an accessory device (Truckai: Fig. 19B, comprising image sensor 816 and elastomeric body 815) for assisting insertion of a catheter (Fig. 19B, tool shaft 872 can be any particular tool, such as a catheter), wherein the accessory device (Fig. 19B, comprising image sensor 816 and elastomeric body 815) comprises: a handle (elastomeric body 815 is capable of being held) comprising an attachment means (Fig. 19B, working channel 860) for releasably coupling a catheter to the handle (elastomeric body 815 can be stretched over a tool, such as a catheter, and temporarily be used; para. 0107), and a camera (Fig. 19B, image sensor 816) for capturing one or more images (image sensor 816 allows a physician to observe images captured; para. 0047 and 0110); and a monitor (Fig. 1, display 112) in communication with the camera (display 112 is connected to image sensor; para. 0047), the monitor (Fig. 1, display 112) comprising a display (Fig. 1, display 112 is a display) configured to display the one or more images (images are viewed on display 112; para. 0047); wherein the attachment means (Fig. 19B, working channel 860) is configured for fixating the catheter (Fig. 19B, tool shaft 872) along a first catheter axis (Fig. 19B, longitudinal axis 810) and positioning a tip of the catheter (Fig. 19B, tool shaft 872 can be any particular tool, such as a catheter) at a predetermined distance from a lens of the camera (the working channel 860 can be positioned on any particular position on the tool shaft 872 prior to use; para. 0107 and 0111), and the camera (Fig. 19B, image sensor 816) comprises a first optical axis (Fig. 19B, optical axis 875) defining a viewing direction, and wherein the first optical axis (Fig. 19B, optical axis 875) intersects the first catheter axis (Fig. 19B, the intersecting viewing angle is optimized for viewing the working end of a tool, such as a catheter; para. 0111).
Claim Rejections - 35 USC § 103
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.
Claims 22, 23, 26, 27, 29-31, 40, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Bendory et al. (US Patent No. 10492670 B1), hereinafter Bendory, in view of Truckai (US Patent Publication No. 20200329953 A1).
Regarding claim 22, Bendory discloses an accessory device (Bendory: Fig. 2 and 4, comprising coupler 212 and endoscope 102) for assisting insertion of a catheter (Fig. 6, the coupler is held during insertion, guiding the insertion of the device, therefore the coupler is assisting in insertion. The device can assist insertion of any particular tool, including a catheter; col 8, ln 46-59), wherein the accessory device (Fig. 2 and 4, comprising coupler 212 and endoscope 102) comprises: an attachment means (Fig. 4, tool attachment portion 216) for releasably coupling a catheter to the accessory device (Fig. 4, tool attachment portion 216 allows a tool, including a catheter, to be releasably coupled to the coupler 212; col 10, ln 47-67), and a camera (Fig. 2, endoscope 102 has camera located at tip 111 and image sensor 140) for capturing one or more images (col 9, ln 25-38); and a monitor (Fig 2, monitor 126) in communication with the camera (Fig. 2, monitor 126 is connected to the processor 122, which is in communication with the endoscope 102 via cable 124; col 9, ln 25-53), the monitor (Fig 2, monitor 126) comprising a display (monitor 126 comprises a display; col 8, ln 10-18) configured to display the one or more images (monitor 126 displays images captures by endoscope 102; col 8, ln 10-18); wherein the attachment means (Fig. 4, tool attachment portion 216) is configured for fixating the catheter along a first catheter axis (Fig. 4, if a tool, such as a catheter, were coupled to tool attachment portion 216, it would be fixed along a first longitudinal axis; col 10, ln 47-67), and the camera (Fig. 2, endoscope 102) comprises a first optical axis (Fig. 4, if endoscope 102 is coupled to the coupler 212, it would be fixed along a longitudinal axis; col 10, ln 47-67) defining a viewing direction (endoscope 102 longitudinal direction defines a viewing direction; col 9, ln 25-38).
Bendory does not expressly disclose a handle.
An alternative embodiment of Bendory teaches that the accessory device (Fig. 9A and 9B, comprising handle 304 and couplers 307a and 307b; col 14, ln 9-30) comprises a handle (Fig. 9A, handle 304).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the accessory device of Bendory such that it comprises a handle as taught by the alternative embodiment of Bendory in order to allow a physician to hold the device easily (Bendory: col 14, ln 9-30).
Bendory does not expressly disclose the first optical axis intersects the first catheter axis and positioning a tip of the catheter at a predetermined distance from a lens of the camera .
Truckai teaches an accessory device (Truckai: Fig. 19B, comprising image sensor 816 and elastomeric body 815) comprising a camera (Fig. 19B, image sensor 816) mounted to a tool shaft (Fig. 19B, tool shaft 872), wherein a first optical axis (Fig. 19B, optical axis 875) of the camera (Fig. 19B, image sensor 816) intersects a first tool axis (Fig. 19B, longitudinal axis 810) of a catheter shaft (Fig. 19B, tool shaft 872. The tool is fully capable of being a catheter) and positioning a tip of the catheter (Fig. 19B, tool shaft 872 can be any particular tool, such as a catheter) at a predetermined distance from a lens of the camera (the working channel 860 can be positioned on any particular position on the tool shaft 872 prior to use; para. 0107 and 0111).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the accessory device of Bendory such that the first optical axis intersects the first catheter axis and positioning a tip of the catheter at a predetermined distance from a lens of the camera and positioning the proximal end of the catheter at a predetermined distance from a lens of the camera as taught by Truckai in order to allow for viewing the working end of the tool during use (Truckai: para. 0111) and positioning of the camera prior to use (para. 0107).
Regarding claim 23, Bendory in view of Truckai discloses the device above, wherein the attachment means (Bendory: Fig. 4, tool attachment portion 216) comprises a clip (Fig. 4, top opening 250 is a clip; col 10, ln 47-67) for releasably coupling a connector of a tool (Fig. 4, top opening 250 allows a tool to be releasably coupled to the coupler 212. Any particular tool, including a catheter, can be used with tool attachment portion 216; col 8, ln 46-59 and col 10, ln 47-67) to the handle (Bendory: Fig. 9A, alternate embodiment of a coupler comprising handle 304).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the accessory device of Bendory such that it comprises a handle as taught by the alternative embodiment of Bendory in order to allow a physician to hold the device easily (Bendory: col 14, ln 9-30).
Regarding claim 26, Bendory in view of Truckai discloses the device above.
Bendory in view of Truckai does not expressly disclose that the camera is fixated in the handle relative to the attachment means.
The alternative embodiment of Bendory teaches a camera (Fig. 9A and 9B, endoscope 302) that is fixated in a handle (Bendory: Fig. 9A, alternate embodiment of a coupler comprising handle 304) relative to an attachment means (Fig. 9A and 9B, endoscope 302 is fixed by one of the couplers 307a and 307b; col 14, ln 9-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Bendory in view of Truckai such that the camera is fixated in the handle relative to the attachment means as taught by the alternative embodiment of Bendory in order to allow a physician to hold the device easily (Bendory: col 14, ln 9-30).
Regarding claim 27, Bendory in view of Truckai discloses the device above.
Bendory does not expressly disclose that the predetermined distance is between 55 mm and 200 mm between the tip of the catheter and the lens of the camera.
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Truckai teaches a predetermined distance between 55 mm and 200 mm between a tip of a catheter (the working channel 860 can be positioned on any particular position on the tool shaft 872 prior to use; para. 0107 and 0111) and the lens (Fig. 19B, lens 824) of the camera (Fig. 19B shown above, based on the calculated distance between the lens 824 and the theorized intersection point of longitudinal axis 810 and viewing angle VA, the distance can be between 7.46 mm to a hypothetically infinite distance based on the chosen VA and shaft length. The image sensor 816 is optimized to view the working end of a tool during use, therefore, the intersection point is interpreted to be the tip of the catheter; para. 0111).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the camera of Bendory such that the first optical axis intersects the first catheter axis at a distance between 55 mm and 200 mm from a lens of the camera as taught by Truckai in order to allow for viewing the working end of the catheter during use (Truckai: para. 0111). Additionally, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 29, Bendory in view of Truckai discloses the device above, wherein the accessory device (Bendory: Fig. 2 and 4, comprising coupler 212 and endoscope 102) further comprises a light source (Fig. 3, endoscope shaft 106 comprises light sources 142).
Regarding claim 30, Bendory in view of Truckai discloses the device above, wherein the light source (Bendory: Fig. 3, light sources 142) is arranged circularly about the camera (Fig. 3, light sources 142 are arranged circumferentially around image sensor 140. There can be any number of light sources arranged around the image sensor 140; col 10, ln 32-46).
Regarding claim 31, Bendory in view of Truckai discloses the device above, wherein the light source (Bendory: Fig. 3, light sources 142) is configured to generate a light beam being substantially parallel to the first optical axis (endoscope 102 longitudinal direction defines a viewing direction; col 9, ln 25-38) of the camera (Fig. 3, light sources 142 are arranged circumferentially around image sensor 140 and, therefore, point in the same direction as the sensor 140. It would be expected that the light sources would generate a light beam parallel to the image sensor optical axis).
Regarding claim 34, Bendory in view of Truckai discloses the device above, wherein the monitor (Bendory: Fig. 2, video monitor 126) is in communication with the camera (Fig. 2, endoscope 102) through a wired connection (Fig. 2, endoscope 102 is connected to processor 122 via cable 124, processor 122 is connected to monitor 126).
Regarding claim 40, Bendory in view of Truckai discloses the device above, wherein the attachment means (Bendory: Fig. 4, tool attachment portion 216) comprises a slit (Fig. 4, top opening 250) that extends along the first catheter axis (Fig. 4, top opening 250 extends along longitudinal axis where the tool, such as a catheter, would be inserted; col 10, ln 47-67) and is sized to permit at least a part of the catheter to pass therethrough (col 10, ln 47-67).
Regarding claim 41, Bendory in view of Truckai discloses the device above.
Bendory does not expressly disclose the first optical axis intersects the first catheter axis at the predetermined distance.
Truckai teaches a first optical axis (Fig. 19B, optical axis 875) intersects the first catheter axis (Fig. 19B, longitudinal axis 810) at the predetermined distance (the working channel 860 can be positioned on any particular position on the tool shaft 872 prior to use; para. 0107 and 0111).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Bendory such that the first optical axis intersects the first catheter axis at the predetermined distance as taught by Truckai in order to allow for viewing the working end of the tool during use (Truckai: para. 0111) and positioning of the camera prior to use (para. 0107).
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Bendory in view of Truckai, in further view of Bimbo et al. (US Patent Publication No. 20140027327 A1), hereinafter Bimbo.
Regarding claim 24, Bendory in view of Truckai discloses the device above.
Bendory in view of Truckai does not expressly disclose that the clip is configured for fixating a connector of a catheter by means of friction.
Bimbo teaches a clip (Bimbo: Fig. 6 and 7, base 22) that is configured for fixating a connector (Fig. 2 and 11, neck 12 is fixed by base 22) of a tube by means of friction (para. 0008).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the clip of Bendory in view of Truckai such that the clip that is configured for fixating a connector of a catheter by means of friction as taught by Bimbo in order to prevent the tube from disengaging with the clip (Bimbo: para. 0008).
Regarding claim 25, Bendory in view of Truckai and Bimbo discloses the device above.
Bendory in view of Truckai does not expressly disclose the clip comprises a conical inner shape configured to receive and fixate a connector of a catheter.
Bimbo teaches a clip (Bimbo: Fig. 6 and 7, base 22) comprising a conical inner shape (Fig. 7, opening 22e has a reverse taper, resulting in a conical inner shape; para. 0034) configured to receive and fixate a connector (Fig. 2 and 11, neck 12 is fixed by base 22) of a tube (para. 0008).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the clip of Bendory in view of Truckai such that the clip comprises a conical inner shape configured to receive and fixate a connector of a catheter as taught by Bimbo in order to prevent the tube from disengaging with the clip (Bimbo: para. 0008).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Bendory in view of Truckai, in further view of Wei et al. (US Patent Publication No. 20180063387 A1), hereinafter Wei.
Regarding claim 28, Bendory in view of Truckai discloses the device above.
Bendory in view of Truckai does not expressly disclose that the camera has a depth of field of at least 60 mm.
Wei teaches a camera (Wei: Fig. 5A, image sensor 110) that has a depth of field of at least 60 mm (depth of field may be 2-200 mm; para. 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the camera of Bendory in view of Truckai such that the camera has a depth of field of at least 60 mm as taught by Wei in order to derive images captured by the image sensor (Wei: para. 0047).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Bendory in view of Truckai, in further view of Jamal (US Patent Publication No. 20210008281 A1).
Regarding claim 32, Bendory in view of Truckai and Bimbo discloses the device above.
Bendory in view of Truckai does not expressly disclose the monitor comprises a strap for securing the monitor to an object.
Jamal teaches a monitor (Jamal: Fig. 16, display 55) comprising a strap (Fig. 16, monitor strap 86) for securing a monitor (Fig. 16, display 55) to an object (Fig. 16, display 55 is secured to an arm of a patient 89 via strap 86).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the monitor of Bendory in view of Truckai such that the monitor comprises a strap for securing the monitor to an object as taught by Jamal in order to secure the display to limb of a user (para. 0011).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Bendory in view of Truckai, in further view of Coon et al. (US Patent Publication No. 20190216307 A1), hereinafter Coon.
Regarding claim 33, Bendory in view of Truckai and Bimbo discloses the device above.
Bendory in view of Truckai does not expressly disclose the monitor comprises a coupling mechanism for releasably coupling the handle to the monitor.
Coon teaches a monitor (Coon: Fig. 18 and 19, a smart device comprising an adapter 500; para. 0211) comprising a coupling mechanism (Fig. 18 and 19, cylindrically shaped projection 520 coupled to proximal end handle portion 558) for releasably coupling a handle (Fig. 18, handle portion 558) to the monitor (Fig. 18 and 19, cylindrically shaped projection 520 allows for the adapter 500 to be releasably coupled to handle portion 558; para. 0211).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the monitor of Bendory in view of Truckai such that the monitor comprises a coupling mechanism for releasably coupling the handle to the monitor as taught by Coon in order to allow for the monitor to be easily and quickly attached to the handle in seconds (Coon: para. 0213).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Bendory in view of Truckai, in further view of Harris et al. (US Patent Publication No. 20220331529 A1), hereinafter Harris.
Regarding claim 35, Bendory in view of Truckai and Bimbo discloses the device above.
Bendory in view of Truckai does not expressly disclose the accessory device has a liquid ingress protection rating of at least IPX4 according to the IEC standard 60529.
Harris teaches a device (Harris: Fig. 1, autoinjector 100) that has a liquid ingress protection rating of at least IPX4 according to the IEC standard 60529 (housing configured to be water resistant to IPX4 or more; para. 0117).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the accessory device of Bendory in view of Truckai such that the accessory device has a liquid ingress protection rating of at least IPX4 according to the IEC standard 60529 as taught by Harris in order to achieve the required amount of water resistance during use (Harris: para. 0117).
Claims 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over McWeeney et al (US Patent No. 11064869 B2), hereinafter McWeeney, in view of Bendory et al. (US Patent No. 10492670 B1), hereinafter Bendory, in further view of Truckai (US Patent Publication No. 20200329953 A1).
Regarding claim 36, McWeeney teaches a catheter system (Fig. 1, catheter system 8) for assisting insertion of a catheter (Fig. 1, catheter 10 insertion is assisted by handle 30), the catheter system comprising: an accessory device (Fig. 1, hub 20), and a catheter (Fig. 1, catheter 10) comprising an insertable portion (Fig. 1, distal end 18 of distal portion 44 is designed for insertion; col 7, ln 43-59) and a connector (hub 20 consists of connectors; col 7, ln 8-26), the insertable portion (Fig. 1, distal portion 44) having a proximal end (Fig. 1, distal end 18).
McWeeney does not expressly disclose the accessory device comprises: a handle comprising an attachment means for releasably coupling the catheter to the handle, and a camera for capturing one or more images, and a monitor in communication with the camera, the monitor comprising a display configured to display the one or more images; wherein the attachment means is configured for fixating the catheter along a first catheter axis, and the camera comprises a first optical axis defining a viewing direction.
Bendory discloses an accessory device (Bendory: Fig. 2 and 4, comprising coupler 212 and endoscope 102) for assisting insertion of a tool (Fig. 6, the coupler is held during insertion, guiding the insertion of the device, therefore the coupler is assisting in insertion. The device can assist insertion of any particular tool; col 8, ln 46-59), wherein the accessory device (Fig. 2 and 4, comprising coupler 212 and endoscope 102) comprises: an attachment means (Fig. 4, tool attachment portion 216) for releasably coupling a tool to the accessory device (Fig. 4, tool attachment portion 216 allows a tool to be releasably coupled to the coupler 212; col 10, ln 47-67), and a camera (Fig. 2, endoscope 102) for capturing one or more images (col 9, ln 25-38); and a monitor (Fig 2, monitor 126) in communication with the camera (Fig. 2, monitor 126 is connected to the processor 122, which is in communication with the endoscope 102 via cable 124; col 9, ln 25-53), the monitor (Fig 2, monitor 126) comprising a display (monitor 126 comprises a display; col 8, ln 10-18) configured to display the one or more images (monitor 126 displays images captures by endoscope 102; col 8, ln 10-18); wherein the attachment means (Fig. 4, tool attachment portion 216) is configured for fixating the tool along a first tool axis (Fig. 4, if a tool were coupled to tool attachment portion 216, it would be fixed along a first longitudinal axis; col 10, ln 47-67), and the camera (Fig. 2, endoscope 102) comprises a first optical axis (Fig. 4, if endoscope 102 is coupled to the coupler 212, it would be fixed along a longitudinal axis; col 10, ln 47-67) defining a viewing direction (endoscope 102 longitudinal direction defines a viewing direction; col 9, ln 25-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the accessory device of McWeeney such that the accessory device comprises: a handle comprising an attachment means for releasably coupling the catheter to the handle, and a camera for capturing one or more images, and a monitor in communication with the camera, the monitor comprising a display configured to display the one or more images; wherein the attachment means is configured for fixating the catheter along a first catheter axis, and the camera comprises a first optical axis defining a viewing direction as taught by Bendory in order to allow a catheter to be coupled to the visualization component (Bendory: col 2, ln 10-23).
McWeeney in view of Bendory does not expressly disclose the accessory device comprising a handle.
An alternative embodiment of Bendory teaches that the accessory device (Bendory: Fig. 9A and 9B, comprising handle 304 and couplers 307a and 307b; col 14, ln 9-30) comprises a handle (Fig. 9A, handle 304).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the accessory device of McWeeney in view of Bendory such that it comprises a handle as taught by the alternative embodiment of Bendory in order to allow a physician to be held easily (Bendory: col 14, ln 9-30).
McWeeney in view of Bendory does not expressly disclose the first optical axis intersects the first catheter axis and positioning the proximal end of the catheter at a predetermined distance from a lens of the camera.
Truckai teaches a camera (Truckai: Fig. 19B, image sensor 816) mounted to a tool shaft (Fig. 19B, tool shaft 872), wherein a first optical axis (Fig. 19B, optical axis 875) of the camera (Fig. 19B, image sensor 816) intersects a first tool axis (Fig. 19B, longitudinal axis 810) of a tool shaft (Fig. 19B, tool shaft 872) and positioning the proximal end of the catheter (Fig. 19B, tool shaft 872 can be any particular tool, such as a catheter) at a predetermined distance from a lens of the camera (the working channel 860 can be positioned on any particular position on the tool shaft 872 prior to use; para. 0107 and 0111).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the accessory device of Bendory such that the first optical axis intersects the first catheter axis as taught by Truckai in order to allow for viewing the working end of the tool during use (Truckai: para. 0111) and positioning of the camera prior to use (para. 0107).
Regarding claim 37, McWeeney in view of Bendory and Truckai discloses the device catheter system above.
McWeeney in view of Bendory does not expressly disclose that the camera is configured to focus on the proximal end of the catheter.
Truckai teaches a camera (Truckai: Fig. 19B, image sensor 816) that is configured to focus on the proximal end of a tool (the viewing angle VA of sensor 816 is optimized for viewing the working end of a tool during use; para. 0111).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the camera of McWeeney in view of Bendory such that the camera is configured to focus on the proximal end of the catheter as taught by Truckai in order to allow the working end of a tool to be viewed during use (Truckai: para. 0111).
Regarding claim 38, McWeeney in view of Bendory and Truckai discloses the device catheter system above, wherein the catheter (McWeeney: Fig. 1, catheter 10) is an intermittent urinary catheter (catheter 10 is meant for use with urological procedures. Examiner interprets that catheter 10 could be used as an intermittent urinary catheter; col 1, ln 40-54 and col 7, ln 43-59).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over McWeeney in view of Bendory, in further view of Truckai and Coon et al. (US Patent Publication No. 20190216307 A1), hereinafter Coon.
Regarding claim 39, McWeeney in view of Bendory and Truckai discloses the catheter system above, wherein a method of using the catheter system comprises: observing images (user can view images captured by endoscope; col 15, ln 4-13), as captured by the camera (Fig. 1, handle 30 is an endoscope; col 15, ln 4-13), on a display of a monitor (images can be viewed on a display connected to handle endoscope 30; col 14, ln 14-16) to locate the meatal area and the meatus, and guiding the catheter (Fig. 1, catheter 10) into close proximity of the meatus (endoscope handle 30 is intended to assist in guiding and locating a tract of a desired location, such as a urinary tract. This would require location and guiding the catheter into the meatus; col 7, ln 43-59).
McWeeney does not expressly disclose using the attachment means to couple the catheter to the handle.
Bendory teaches using an attachment means (Bendory: Fig. 9A and 9B, couplers 307a and 307b; col 14, ln 9-30) to couple a handle (Fig. 9A and 9B, the alternate embodiment of the accessory device comprising handle 304 and couplers 307a and 307b; col 14, ln 9-30) to a tool (Fig. 9A and 9B, couplers 307a and 307b couple any tool to the handle 304; col 14, ln 9-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of McWeeney such that it included using the attachment means to couple a handle to a catheter as taught by Bendory in order to allow the catheter to be coupled to a visualization component (Bendory: col 14, ln 9-30 and col 2, ln 10-23).
McWeeney in view of Bendory does not expressly disclose fixating the proximal end of the catheter at the predetermined distance from the lens of the camera.
Truckai teaches fixating a proximal end of a catheter (Fig. 19B, tool shaft 872 can be any particular tool, such as a catheter) at a predetermined distance from a lens of a camera (the working channel 860 can be positioned on any particular position on the tool shaft 872 prior to use; para. 0107 and 0111).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of McWeeney in view of Bendory such that it including fixating a proximal end of a catheter at a predetermined distance from a lens of a camera as taught by Truckai in order to allow for viewing the working end of the tool during use (Truckai: para. 0111) and positioning of the camera prior to use (para. 0107).
McWeeney in view of Bendory and Truckai does not expressly disclose optionally decoupling the handle from the monitor.
Coon teaches optionally decoupling a handle (Fig. 18, handle portion 558) from a monitor (Fig. 18 and 19, cylindrically shaped projection 520 allows for the adapter 500, which can be coupled to a smart device, to be releasably coupled to handle portion 558; para. 0211).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of McWeeney in view of Bendory and Truckai such that it included optionally decoupling the handle from the monitor as taught by Coon in order to allow for the monitor to be easily and quickly attached to the handle in seconds (Coon: para. 0213).
Response to Arguments
Applicant’s arguments, see page 8, filed 24 November 2025, with respect to the objections to the drawings have been fully considered and are persuasive. The objections of the drawings has been withdrawn.
Applicant's arguments, see page 7-9 filed 24 November 2025, with respect to the rejections of claims 22-41 have been fully considered but they are not persuasive.
Applicant argues:
“Even so, Truckai fails to anticipate an "attachment means" that specifically fixates the catheter to "position[] a tip of the catheter at a predetermined distance from a lens of the camera."
Rather, Truckai even explicitly contemplates "re-positioning the sensor housing" and allowing "for expansion of the working channel-portion 860 in the elastomeric body 815 as a tool shaft 872 . . . is introduced through the working channel 848." Truckai, para. [0107]; see also Truckai, para. [0111], detailing different optical axis angles as a result of the displacement that occurs when the shaft is passed through the working channel.”
Truckai teaches fixating a proximal end of a catheter (Fig. 19B, tool shaft 872 can be any particular tool, such as a catheter) at a predetermined distance from a lens of a camera (the working channel 860 can be positioned on any particular position on the tool shaft 872 prior to use; para. 0107 and 0111). The limitation “predetermined” is does not limit movement of the optical angle nor the tip of the shaft. The broadest reasonable interpretation of the word “predetermined” would define it as a position that is determined prior to use, which the invention of Truckai is capable of. Therefore, the rejection is maintained.
Conclusion
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.
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783