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 .
Response to Amendment
Applicant’s submission filed 02/20/2026 has been entered. Currently claims 1-20 are pending.
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.
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.
Claims 1-4, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Dayton et al., (US20210196106A1) in view of Alaswad et al., (US 11,779,362 B1).
Regarding claim 1, Dayton teaches a locator system (Abstract “medical device locator”) comprising:
a housing (fig. 3B location device 300 [0055]) formed as an extrusion having a proximal end, a distal end, and a hollow interior ([0057] the internal space 308 between the walls may be filled with gas, therefore making it have a hollow interior, and has a proximal and distal end) and defining with a guide lumen (fig. 3B the location device 300 includes a lumen that the elongate member 305 is inserted through [0055]; this lumen contains the elongate member 305 that contains the guidewire [0055]) extending longitudinally therethrough (fig. 3B the lumen containing the elongate member 305 extends through the location device 300), said guide lumen configured to advance said housing over a flexible elongate delivery device ([0055] a guidewire contained within elongate member 305; fig. 3B [0055] location device 300 is adhered to elongate member 305, and elongate member 305 can slide along the guidewire to the target, therefore as the elongate member 305 slides along the guidewire to the target, the location device 300 would slide with it) to a target site within a patient's body ([0020] the endoscope may be advanced through the stomach into a small bowel of the body) wherein the said housing has a wall defining the hollow interior (fig. 3B walls 304, 302, and 306) with a window defined laterally through said wall and forming a lateral access to the hollow interior ([0058] LEDs 310 are positioned within the internal space, and emit light through sidewall 302. Accordingly, side wall 302 includes a light transmitting window region that would provide lateral optical access to the hollow interior); and
a beacon element (fig. 3B LED 310 [0057]) positioned within the hollow interior of said housing (fig. 3B the LEDs are in the location device 300 [0057]) and said beacon element configured to be imaged by an imaging system remote from the target site ([0071]–[0072] a medical professional may visualize the cavity with a camera by using the LEDs 310); and
a sleeve around a portion of the housing including the window to hold said beacon element within said housing, said sleeve allowing imaging of said beacon element therethrough ([0060] a covering can cover all the walls, and can cover all or parts of the LED, and is transparent or semi-transparent so that the light may shine through.).
However, the Dayton is still silent regarding a housing defining a guide lumen and a power lumen extending longitudinally; the power lumen having power connections located therein for powering said element.
In the same intraluminal imaging field of endeavor, Alaswad teaches a housing defining a guide lumen and a power lumen extending longitudinally (fig. 6C the catheter housing includes a central lumen 134 for a guide wire 132 (col. 7 lin17-21) and a separate lumen for electric cable 610 (col. 8 lines 62-65)); and the power lumen having power connections located therein for powering said element (col. 8 lines 53-62 the electric cable are used to power the imaging device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the known technique of a dual lumen system with a power and guide lumen as taught by Alaswad to the base system of modified Dayton, as both inventions relate to intraluminal imaging devices, and would yield the predictable result of the housing of Dayton with a dual lumen of a power and a guide lumen to one of ordinary skill. One of ordinary skill would be able to perform such an application, and the results of modified Dayton with a dual lumen system are reasonable predictable. This dual lumen system would be an improvement as it would prevent mechanical interference between components. One of ordinary skill would understand that this application of a power lumen would apply to the beacon elements of Dayton, and would therefore read upon the limitation of a beacon element in communication with the power lumen for coupling with power connection for powering said beacon element.
Regarding claim 2, modified Dayton teaches the system of claim 1, wherein Dayton further teaches said beacon element is positioned within said housing to be located through the window to allow visualization of a beacon generating portion of said beacon element to be visible through the window (fig. 3B the LEDs 310 within the housing can be located through the window region of the sidewall 302 that would allow the visualization of the light coming from the LEDs [0058]-[0061]).
Regarding claim 3, modified Dayton teaches the system of claim 2, wherein Dayton further teaches wherein said beacon element emits a signal through the window radially outwardly with respect to said locator system (fig. 3B LEDs 310 may be emitted from internal space 308 of location device 300 via sidewall 302, which may be transparent or semitransparent [0058]; the LEDs 310 would radiate outward since it radiates through the sidewall 302 ).
Regarding claim 4, modified Dayton teaches the system of claim 2, wherein Dayton further teaches wherein said sleeve is positioned over the window to hold said beacon element within said housing and in place with respect to the window and (fig. 3B a covering such as an electrically insulating heat shrink may be placed over the sidewall 302, distal end wall 304, and proximal end wall 306, and may be transparent and would hold the LEDs to the elongate member [0060]) to present a smooth atraumatic surface to tissue ([0060] the covering would be capable of providing a smooth atraumatic surface to tissue), said sleeve being formed of a transparent material allowing imaging of said beacon element therethrough ([0060] “The covering may be transparent or semi-transparent such that light from LEDs 310 may be transmitted therethrough”).
Regarding claim 9, modified Dayton teaches the system of claim 1, wherein Dayton further teaches wherein said housing has a cross-sectional area and said beacon is positioned within the cross-sectional area of said housing (fig. 3B the LEDs 310 are within the walls 302 that would be the boundaries of the cross section area of the location device 300 [0058]).
Regarding claim 11, modified Dayton teaches the system of claim 1, wherein Dayton further teaches wherein said beacon element is a light (fig. 3B the LEDs 310 are lights [0057]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Dayton in view of Alaswad as applied to claim 1 above, and further in view of Webster (US5431168A).
Regarding claim 10, modified Dayton teaches the system of claim 1, wherein Dayton further teaches said sleeve extends from the proximal end to the distal end of the housing ([0060] the covering can be placed over the proximal and distal end walls) but fails to explicitly disclose wherein said housing is formed as a tubular extrusion.
However in the same catheter field of endeavor, Webster teaches said housing is formed as a tubular extrusion (col. 3 line 39- 42 the catheter body may be an elongated tubular extrusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the technique of a tubular extrusion as taught by Webster to a known base device of a intraluminal locator system of modified Dayton, as both inventions relate to intraluminal devices and would yield the predictable result of a locator system with a tubular extrusion as a housing to one of ordinary skill in the art. One of ordinary skill would be able to perform such an application, and the results of modified Dayton having a tubular extrusion for its housing are reasonably predictable.
Claims 12, 8, 13-15, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable by Dayton in view of Farr et al., (US20080045800A2)
Regarding claim 12, Dayton teaches a locator system (Abstract “medical device locator”) comprising:
a housing (fig. 3B location device 300 [0055]) having a proximal end a distal end and defining (see annotated fig. 3B) a guide lumen (fig. 3B the location device 300 includes a lumen that the elongate member 305 is inserted through [0055]; this lumen contains the elongate member 305 that contains the guidewire [0055]) extending therethrough between the proximal end and the distal end (fig. 3B the lumen containing the elongate member 305 extends through the location device 300); a distally extending beacon support (fig. 14 board 1404 holds LEDs 1412 [0094]); and at least one beacon element configured to be located by an imaging system remote from the target site (fig. 14 board 1404 hold LEDs 1412 on each side so that the LEDS can be viewed on both sides[0094]; [0091] the beacon can be viewed external to the lumen); and
a sleeve around a portion of the housing including around said beacon support (fig. 14 coating 1424 covers the beacon support 1404) and the beacon element to hold said beacon element with respect to the housing ([0060] a covering can cover all the walls, and can cover all or parts of the LED, and is transparent or semi-transparent so that the light may shine through.).
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However, Dayton is silent regarding a distally extending beacon support mounted on the distal end of said housing to extend distally from the distal end of said housing; and at least one beacon element mounted on said distally-extending beacon support and configured to be located by an imaging system remote from the target site.
In the same intraluminal imaging field of endeavor, Farr teaches a distally extending beacon support mounted on the distal end of said housing to extend distally from the distal end of said housing (fig. 16A LEDs 241a disposed on hinge portion 242 extend distally from the distal end 230 [0084]); and at least one beacon element mounted on said distally-extending beacon support (fig. 16A LEDs 241a disposed on hinge portion 242 extend distally from the distal end 230 [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Dayton with the hinge portions of Farr, as this would allow for illumination light sources at close proximity to the targets inside the body and eliminate any losses of the transmission of light (see Farr [0088]).
Regarding claim 8, modified Dayton teaches the system of claim 12, wherein Dayton further teaches wherein said distally- extending beacon support comprises a distally-extending platform on which said beacon element is mounted, said distally-extending platform having a rounded distal shape forming an atraumatic end facilitating navigating of said locator system into a patient's body with said distally-extending beacon support at a distal end of said locator system (fig. 14 board 1404 comprises a platform that distally extends, and has a rounded edge that forms an atraumatic end and would allow navigating of the system into the patient’s body [0094]).
Regarding claim 13, Dayton teaches the system of claim 12, wherein Dayton further teaches said at least one beacon element mounted on said distally-extending beacon support comprises a beacon element mounted on each side of said distally-extending beacon support element (fig. 14 LEDs 1412 and 1410 are on each side of the board 1404 that is extending distally [0094]).
Regarding claim 14, Dayton teaches the system of claim 12, wherein Dayton further teaches comprising a flexible elongate delivery device slidably insertable into a guide lumen extending through said housing (fig. 3B elongate member 305 extends through device 300), said housing slidable over said flexible elongate delivery device to be advanced independently of said flexible elongate delivery device to a target site within a patient's body ([0055] a guidewire may be placed into elongate member 305 and elongate member 305 may slide along guidewire, thereby the housing is also independently sliding with respect to the guidewire).
Regarding claim 15, Dayton teaches the system of claim 12, wherein Dayton further teaches wherein said housing has a cross-sectional area and said distally extending beacon support is positioned within the cross-sectional area of said housing (fig. 14 board 1404 is within the housing 1424 [0094]).
Regarding claim 16 Dayton teaches a method of locating a target site in a patient's body from a location remote from the target site (Abstract “the disclosure relates to medical device and/or anatomy locating devices” ;[0071]–[0072] a medical professional may visualize the cavity with a camera by using the LEDs 310), said method comprising:
advancing a distal end of a flexible elongate delivery device ([0055] a guidewire that is located within the elongate member 305) to the target site (fig. 3B the distal most end of the guidewire is positioned in the bowel or jejunum [0055]);
advancing a main housing (fig. 3B location device 300 [0055]) with a beacon element (fig. 3B LEDs 310 [0058]) positioned within a cross-sectional area of the main housing (fig. 3B the beacon element is positioned within a cross section of the main housing) and maintained with respect to the main housing by a sleeve positioned therearound ([0060] covering covers the main housing of the walls) over the flexible elongate delivery device (fig. 3B [0055] the guidewire included in the elongate member 30) and to the distal end of the flexible elongate delivery device positioned at the target site (fig. 3B [0055] location device 300 is adhered to elongate member 305, and elongate member 305 can slide along the guidewire to the target, therefore as the elongate member 305 slides along the guidewire to the target, the location device 300 would slide with it); with the beacon element to be advanced into the patient’s body and to the target site distal to the distal end of the main housing ([0026] the medical device may be advanced to the target position, and the target position would be distal to the distal end of the housing when advancing into the patient’s body) and
imaging the beacon element from a location different from the target site ([0091] the beacon can be viewed external to the lumen).
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However Dayton is silent regarding a beacon element mounted on a beacon support extending distally from a distal end of the main housing, with the beacon element extending distal to the distal end of the main housing.
In the same imaging field of endeavor, Farr teaches a beacon element mounted on a beacon support extending distally from a distal end of the main housing (fig. 16a LED 241a on hinge portion 242 and extends distally from the distal end 230), with the beacon element extending distal to the distal end of the main housing (fig. 16a LED 241a on hinge portion 242 and extends distally from the distal end 230).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Dayton with the hinge portions of Farr, as this would allow for illumination light sources at close proximity to the targets inside the body and eliminate any losses of the transmission of light (see Farr [0088]).
Regarding claim 17, modified Dayton teaches the method of claim 16, wherein Dayton further teaches emitting a light signal from the beacon element radially outwardly with respect to the housing (fig. 3B LEDs 310 may be emitted from internal space 308 of location device 300 via sidewall 302, which may be transparent or semitransparent [0058]; the LEDs 310 would radiate outward from the location device 300 since it radiates through the sidewall 302 ).
Regarding claim 18, modified Dayton teaches the method of claim 16, wherein Dayton further teaches emitting a light signal from the beacon element in more than one direction radially outwardly with respect to the housing ([0058] the LEDs 310 may be arranged to face different directions outwardly).
Regarding claim 19, modified Dayton teaches the method of claim 16, wherein Dayton further teaches wherein said the beacon support includes a platform beacon (fig. 14 board 1404), the platform having a rounded distal shape forming an atraumatic end facilitating said advancing of the beacon element into the patient’s body (fig. 14 board 1404 comprises a platform that distally extends, and has a rounded edge that forms an atraumatic end and would allow navigating of the system into the patient’s body [0094]) distal to the main housing([0026] the medical device may be advanced to the target position, and the target position would be distal to the distal end of the housing when advancing into the patient’s body)
Regarding claim 20 modified Dayton teaches the method of claim 16, wherein Dayton further teaches imaging the distal end of the flexible elongate delivery device and the housing (fig. 3B the LEDs 310 of the location device 300 that is located on the distal end of the elongate member 305 may be imaged by a camera [0072]), and advancing the housing to the distal end of the flexible elongate delivery device at the target site based on the imaging(fig. 3B the distal most end of the elongate member 305 that contains the guidewire and of which the location device 300 is located on is positioned in the bowel or jejunum [0055]; [0071] use of an imaging device to determine position).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Dayton and Farr as applied to claim 12 above, and further in view of Griffin (US10136803B1).
Regarding claim 6, modified Dayton teaches the system of claim 12, wherein Dayton teaches the housing (fig. 3B device 300)but is silent regarding wherein said distally extending beacon support comprises an end cap mounted on the distal end of said housing.
However in the same surgical field of endeavor, Griffin teaches wherein said distally extending beacon support comprises an end cap mounted on the distal end of said housing (fig. 3 details the beacon support, which comprises support 101 and lens 201 and array 301 which acts as an endcap and is on the distal end col. 6 line 13-46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the distal end of modified Dayton to include the end part of Griffin, as this would allow for more compact design while providing superior illumination and visualization (see Griffin col. 2 line 26-29)
Regarding claim 7, the modified Dayton teaches the system of claim 12, wherein Dayton teaches the housing (fig. 3B device 300)but is silent regarding wherein distally-extending beacon support further comprises a collar configured to mount said distally-extending beacon support with respect to said housing.
However in the same surgical field of endeavor, Griffin teaches wherein distally-extending beacon support further comprises a collar configured to mount said distally-extending beacon support with respect to said housing. (fig. 3 details the beacon support, which comprises support 101 and lens 201 and array 301 which acts as a collar and is on the distal end col. 6 line 13-46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the distal end of modified Dayton to include the end part of Griffin, as this would allow for more compact design while providing superior illumination and visualization (see Griffin col. 2 line 26-29).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Dayton in view of Alaswad as applied to claim 1 above, and further in view of Clerc et al., (US20070225559A1).
Regarding claim 5, modified Dayton teaches the system of claim 2, but is silent regarding power connections therethrough from a power source to said beacon element.
However in the same catheter field of endeavor, Clerc teaches a power lumen extends through said housing configured for passage of power connections therethrough from a power source to said beacon element (fig. 3C “The illumination source(s) are positioned in corresponding illumination ports 46 and 47 on the distal face 40 of the catheter 10c and generally comprise one or more light emitting diodes (LEDs) disposed on a substrate that are powered via wires that extend through a lumen to a power source at the proximal end of the catheter” [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Dayton with a lumen that includes wires for powering the LEDs, as this would provide a smaller diameter visualization catheter, and therefore improve access to remote locations in the body (see Clerc [0005]).
Response to Arguments
Applicant’s arguments regarding Inoue are moot as Inoue has not been used for any rejections.
In addition, regarding claim 1, Applicant argues that Dayton does not teach the housing with a wall defining a hollow interior and a window defined laterally through the housing and forming a lateral access to the hollow interior.
Examiner disagrees, as in the Broadest reasonable interpretation of the claims, since the sidewall of Dayton may be transparent, the parts of the side wall used to allow light through would constitute an wall, and thereby allowing lateral access of light to the hollow interior.
Applicant further argues that there is no reasonably manner of combining Alaswad’s catheter Lumens with Dayton’s locator device to obtain the claimed housing with guide lumen and power lumen.
Examiner disagrees. Applicant does not identify any structural incompatibility that would prevent the incorporation of Alaswad’s known dual-lumen arrangement into Dayton’s intraluminal locator device. Both references are directed to intraluminal medical devices having electrical components and elongated bodies. As such, one ordinary skill in the art would find that the application of the technique of the dual lumen as taught by Alaswad to the base device of the beacon device of Dayton would have yielded predictable results and resulted in an improved system by preventing mechanical interference between components (see MPEP 2143 for exemplary rationales). As such, one of ordinary skill would have been found it obvious to modify Dayton with Alaswad.
Applicant has also argued that it would been obvious to combine Webster with Dayton to arrive at the limitations of claim 10.
Examiner disagrees, as Webster teaches the tubular extrusion, and Dayton teaches the covering/sleeve that extends from a proximal to a distal end.
Regarding claim 12, Applicant has argued that it would not have been obvious to modify Farr with the sleeve since they are on a movable hinge. Examiner disagrees, as the claim does not require prevention of movement or rigid fixation, and as such a sleeve would still be able to maintain a component with respect to the housing while still permitting movement. Applicant is importing limitations from Farr’s embodiment. In response to applicant's argument that “the LED’s 241 in Farr must be moved into their ‘on’ position), the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Regarding claim 16, Applicant has argued that it would not have been obvious to modify Farr with the sleeve since they are on a movable hinge. Examiner disagrees, as the claim does not require prevention of movement or rigid fixation, and as such a sleeve would still be able to maintain a component with respect to the housing while still permitting movement. Applicant is importing limitations from Farr’s embodiment. In response to applicant's argument that “the LED’s 241 in Farr must be moved into their ‘on’ position), the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Regarding claim 5, Applicant has argued that Clerc fails to teach the sleeve limitation.
Examiner disagrees with this argument, as Dayton has been used to teach limitation.
The remaining claims are rejected for substantially the same reasons as above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL Y FANG whose telephone number is (571)272-0952. The examiner can normally be reached Mon - Friday 9:30 am - 6:00pm.
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/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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