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, 33, and 41 are canceled.
Claims 42 and 43 are added.
Claims 22, 32, 36, and 39 are amended.
Claims 22-32, 34-40, and 42-43 are presently pending in this application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 November 2022 has been entered.
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.
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: 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), the camera (Fig. 19B, image sensor 816) having a lens (Fig. 19B, lens 824) and a first optical axis (Fig. 19B, optical axis 875) extending in a field of view of the camera (Fig. 19B, image sensor 816); and 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) along a first catheter axis (Fig. 19B, longitudinal axis 810), thereby restricting a tip of the catheter (Fig. 19B, tool shaft 872) to an intersection point of the first optical axis (Fig. 19B, optical axis 875) and the first catheter axis (Fig. 19B, longitudinal axis 810) within a field of view of the camera (Fig. 19B, sensor 816) at a predetermined distance from the lens (the working channel 860 can be positioned on any particular position on the tool shaft 872 prior to use. The image sensor 816 is optimized to view the working end of a tool during use; para. 0107 and 0111); 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 43 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: 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), the camera (Fig. 2, endoscope 102) having a lens (camera 30 comprises a lens array; col 11, ln 41-59) and 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) extending in a field of view of the camera (endoscope 102 longitudinal direction extends in a field of view of the camera; col 9, ln 25-38); 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) along a first catheter axis, thereby restricting a tip of the catheter (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 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).
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 restricting a tip of the catheter to an intersection point of the first optical axis and the first catheter axis within a field of view of the camera at a predetermined distance from the lens.
Truckai teaches a camera (Fig. 19B, image sensor 816)having a lens (Fig. 19B, lens 824) and a first optical axis (Fig. 19B, optical axis 875) extending in a field of view of the camera (Fig. 19B, image sensor 816); and 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) along a first catheter axis (Fig. 19B, longitudinal axis 810), thereby restricting a tip of the catheter (Fig. 19B, tool shaft 872) to an intersection point of the first optical axis (Fig. 19B, optical axis 875) and the first catheter axis (Fig. 19B, longitudinal axis 810) within a field of view of the camera (Fig. 19B, sensor 816) at a predetermined distance from the lens (the working channel 860 can be positioned on any particular position on the tool shaft 872 prior to use. The image sensor 816 is optimized to view the working end of a tool during 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 it comprised restricting a tip of the catheter to an intersection point of the first optical axis and the first catheter axis within a field of view of the camera at a predetermined distance from the lens 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 43, Bendory in view of Truckai discloses the device above.
Bendory does not expressly disclose the tip of the catheter is restricted to a center of the field of view of the camera.
Truckai teaches a tip of the catheter (Truckai: Fig. 19B, tool shaft 872 can be any particular tool, such as a catheter) is restricted to a center of the field of view 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 device of Bendory such that the tip of the catheter is restricted to a center of the field of view 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).
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) and Coon et al. (US Patent Publication No. 20190216307 A1), hereinafter Coon.
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).
Bendory in view of Truckai and Jamal 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 and Jamal 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: 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), the camera (Fig. 2, endoscope 102) having a lens (camera 30 comprises a lens array; col 11, ln 41-59) and 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) extending in a field of view of the camera (endoscope 102 longitudinal direction extends in a field of view of the camera; col 9, ln 25-38); 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) along a first catheter axis, thereby restricting a tip of the catheter (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 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).
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).
McWeeny in view of Bendory does not expressly disclose restricting a tip of the catheter to an intersection point of the first optical axis and the first catheter axis within a field of view of the camera at a predetermined distance from the lens.
Truckai teaches a camera (Fig. 19B, image sensor 816) having a lens (Fig. 19B, lens 824) and a first optical axis (Fig. 19B, optical axis 875) extending in a field of view of the camera (Fig. 19B, image sensor 816); and 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) along a first catheter axis (Fig. 19B, longitudinal axis 810), thereby restricting a tip of the catheter (Fig. 19B, tool shaft 872) to an intersection point of the first optical axis (Fig. 19B, optical axis 875) and the first catheter axis (Fig. 19B, longitudinal axis 810) within a field of view of the camera (Fig. 19B, sensor 816) at a predetermined distance from the lens (the working channel 860 can be positioned on any particular position on the tool shaft 872 prior to use. The image sensor 816 is optimized to view the working end of a tool during 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 McWeeny in view of Bendory such that it comprised restricting a tip of the catheter to an intersection point of the first optical axis and the first catheter axis within a field of view of the camera at a predetermined distance from the lens 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 restricting a proximal end of a catheter (Fig. 19B, tool shaft 872 can be any particular tool, such as a catheter) within a field of view of a camera (Fig. 19B, image sensor 816) 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).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Bendory in view of Truckai, in further view of Langell et al. (US Patent Publication No. 20190320879 A1), hereinafter Langell.
Regarding claim 42, Bendory in view of Truckai discloses the device above.
Bendory does not expressly disclose an intersection point at a predetermined distance from the lens.
Truckai teaches an intersection point at a predetermined distance from the lens (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 it comprised an intersection point at a predetermined distance from the lens 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).
Bendory in view of Truckai does not expressly disclose the camera has a fixed focus distance corresponding to a point, thereby causing a subject to be in focus when fixated at the intersection point.
Langell teaches a camera (Langell: Borescope; para. 0016) that has a fixed focus distance corresponding to a point (pre-focused; para. 0016), thereby causing a subject to be in focus when fixated at the intersection point (para. 0016).
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 fixed focus distance corresponding to a point, thereby causing a subject to be in focus when fixated at the intersection point as taught by Langell in order to allow for optimal focusing of a subject with minimal technical assistance or adjustments (Langell: para. 0016).
Response to Arguments
Applicant's arguments filed 24 April 2026 have been fully considered but they are not persuasive.
Applicant argues that Truckai is silent to the amended claim language “thereby restricting a tip of the catheter to an intersection point of the first optical axis at a predetermined distance”.
Truckai, as explained above, teaches restricting a tip of the catheter to an intersection point of the optical axis at a predetermined distance. The broadest reasonable interpretation of the word “restrict”, in this instance, is that the tip of the catheter can be held in place in some way, which, as explained above, Truckai teaches. Furthermore, the broadest reasonable interpretation of the word “predetermined” need only require a chosen distance prior to use, which Truckai teaches. Therefore, the rejection is maintained.
Conclusion
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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