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 .
This Office Action is in response to the amendments dated July 3, 2025.
Claims 21-25, 27-38, and 40-42 are pending.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”).
With respect to Claim 21, Barbagli discloses:
A medical system (Barbagli FIG. 1, teleoperational medical system 100), comprising:
a medical device (Barbagli FIG. 1, teleoperational manipulator assembly 102 and medical instrument system 104) including:
an imaging device (Barbagli FIG. 4A, visualization system 231) configured to capture images of a target site (Barbagli paragraph [0024], “visualization system (e.g., visualization system 231 of FIG. 4A) may include a viewing scope assembly that records a concurrent or real-time image of the surgical site”), wherein a location of the target site is determined based on the images (Barbagli paragraph [0077], “video images of the respiratory tract that may assist the clinician in navigating the distal end 218 towards a target location”; Examiner is interpreting Barbagli’s “visualization system 231” are requiring an electronic image sensor in order to provide for the function of capturing and recording images); and
a light source configured to direct a light onto the location of the target site (Barbagli paragraph [0034], “teleoperational medical system 100 may further include optional operation and support systems (not shown) such as illumination systems”); and
a processor (Barbagli FIG. 1, control system 112) and non-transitory computer readable medium storing instructions (Barbagli paragraph [0030], “control system 112 includes at least one memory and at least one computer processor (not shown), and typically a plurality of processors, for effecting control between the medical instrument system 104”),
wherein the medical device is configured to receive the instructions (Barbagli FIG. 1, control system 112; Barbagli paragraph [0024], “processors of the control system 112 may execute instructions corresponding to processes disclosed herein”),
wherein the medical device is configured to, upon a sensor detecting the light from the light source at the target site, move the medical device toward the target site (Barbagli paragraph [0077], “video images of the respiratory tract that may assist the clinician in navigating the distal end 218 towards a target location”; an “image sensor” detects light in order to capture/record images. Thus, capturing the video images of a target site is equivalent to the detection of light at the target site.).
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.
One or more of the rejections presented herein refer to Examiner-annotated FIG. 3 of Shimada et al. (US PGPUB 2009/0187288 – “Shimada”), referred to herein as Examiner-annotated Shimada FIG. 3 or simply Shimada FIG. 3:
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Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”) in view of Shimada et al. (US PGPUB 2009/0187288 – “Shimada”).
Regarding Claim 22, Barbagli discloses the features of Claim 21, as described above.
Barbagli does not explicitly disclose:
wherein the instructions stored in the non-transitory computer readable medium cause the processor to:
detect a change in location of the imaging device relative to the target site; and
determine the location of the target site relative to the imaging device,
wherein, in response to detecting a change in location of the imaging device relative to the target site and determining the location of the target site relative to the imaging device, the light is redirected to the location of the target site.
Shimada teaches:
wherein the instructions stored in the non-transitory computer readable medium cause the processor (Shimada FIG. 1, controller 15) to:
detect a change in location of the imaging device (Shimada FIG. 3, imaging device 12) relative to the target site (Shimada FIG. 3 and FIG. 4, showing target point moving from point P0 to point D, relative to surgical tool 11 and imaging device 12; Shimada paragraph [0064], “controller 15 detects the difference in the position on the screen between the specified target point and the tip of the surgical tool 11”); and
determine the location of the target site relative to the imaging device (Shimada paragraph [0064], “controller 15 detects the difference in the position on the screen between the specified target point and the tip of the surgical tool 11”),
wherein, in response to detecting a change in location of the imaging device relative to the target site and determining the location of the target site relative to the imaging device, the light is redirected to the location of the target site (Shimada FIG. 1, driver 13; Shimada paragraph [0064]; see also Shimada paragraph [0040], “spot light emitted from the tip of the manipulation tool (surgical tool)”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Shimada’s processor-controlled driver with the system disclosed by Barbagli. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a medical system that tracks a moving target within a patient such that a surgical tool is positioned at the current target location.
Regarding Claim 23, Barbagli in view of Shimada teach the features of Claim 22, as described above.
Shimada further teaches:
wherein the processor is configured to detect the change in location of the imaging device relative to the target site based on images periodically captured by the imaging device (Shimada FIG. 4; Shimada paragraph [0031], “an external display unit for displaying an image taken by the imaging device”); and
wherein the processor is configured to compare the location of the target site to an original location of the target site to determine a positional variance (Shimada paragraph [0063, “The images taken by the imaging device are converted into signals by the imaging section 14 and sent to the controller 15. The controller 15 displays, on the external display unit 16, the images taken by the imaging device 12. Meanwhile, based on the instructions provided through the input unit 17 by the practitioner, the controller operates the driver 13 to control the motion of and treatment by the surgical tool 11.”)
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”) in view of Shimada et al. (US PGPUB 2009/0187288 – “Shimada”) and Ho et al. (US PGPUB 2018/0344288 – “Ho”).
Regarding Claim 24, Barbagli in view of Shimada teach the features of Claim 23, as described above.
Barbagli in view of Shimada do not explicitly teach:
wherein the processor is configured to determine whether the positional variance exceeds a preprogrammed threshold,
wherein when the positional variance exceeds the preprogrammed threshold the processor at least obtains image data of the target site with the imaging device and analyzes the location of a target site.
Ho teaches wherein the processor is configured to determine whether the positional variance (Ho FIGs. 22a-22f, showing marker 360 moving between frames) exceeds a preprogrammed threshold (Ho FIG. 32, block 512; see Ho paragraph [0139]),
wherein when the positional variance exceeds the preprogrammed threshold the processor at least obtains image data of the target site with the imaging device and analyzes the location of a target site (Ho FIG. 32, block 514, showing the step of updating a marker position, as shown in Ho FIG. 22j; Ho paragraph [0107], “Each of the frames illustrated in FIGS. 22a-22k are spaced apart by an equal amount of time or number of frames”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Ho’s positional variance threshold with the medical system taught by Barbagli in view of Shimada. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of displaying a new location of a marker by analyzing the amount of temporal-spatial distance between a marker/target at different times, in order to determine the velocity of movement of the marker/target at different times.
Regarding Claim 25 , Barbagli in view of Shimada and Ho teach the features of Claim 24, as described above.
Shimada further teaches wherein the light source includes a source to generate a laser beam (Shimada paragraph [0076], “a laser pointer (laser emitter) is attached to the tip of the tool 11”).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”) in view of Ho et al. (US PGPUB 2018/0344288 – “Ho”).
Regarding Claim 27, Barbagli discloses the features of Claim 21, as described above.
Barbagli does not explicitly disclose wherein the processor is configured to generate a visual identifier along the images captured by the imaging device indicative of the location of the target site.
Ho teaches wherein the processor is configured to generate a visual identifier (Ho FIGs. 21a-21k, marker 350) along the images captured by the imaging device indicative of the location of the target site (see movement of marker 350 in Ho FIGs. 21a-21k).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Ho’s marker with the medical system disclosed by Barbagli. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a medical system that highlights a target for ease of user recognition.
Claims 28 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”) in view of Jung et al. (US Patent 6,239,868 – “Jung”).
Regarding Claim 28, Barbagli discloses:
A medical system (Barbagli FIG. 1, teleoperational medical system 100) comprising:
a medical device (Barbagli FIG. 1, teleoperational manipulator assembly 102 and flexible body catheter 216) including:
an imaging device (Barbagli FIG. 4A, visualization system 231) configured to capture images of a target site (Barbagli paragraph [0024], “visualization system (e.g., visualization system 231 of FIG. 4A) may include a viewing scope assembly that records a concurrent or real-time image of the surgical site”);
a light source configured to direct a light onto the target site (Barbagli paragraph [0034], “teleoperational medical system 100 may further include optional operation and support systems (not shown) such as illumination systems”); and
a medical instrument movably disposed within a working channel of the medical device, wherein the medical instrument is movable relative to the medical device, the medical instrument including a sensor configured to detect the light from the light source on the target site (Barbagli paragraph [0040], “flexible catheter body 216 includes a channel 221 sized and shaped to receive a medical instrument 226. Medical instruments may include, for example, image capture probes”),
wherein, upon the sensor detecting the light from the light source at the target site, the medical instrument is configured to move toward the target site (Barbagli paragraph [0077], “video images of the respiratory tract that may assist the clinician in navigating the distal end 218 towards a target location”; Examiner interprets this teaching of Barbagli as the medical instrument being movable toward the target in response to the user viewing the video images).
Barbagli does not explicitly disclose a mirror configured to reflect the light generated by the light source toward the target site.
Jung teaches a mirror configured to reflect the light generated by the light source toward the target site (Jung FIG. 1, mirror 6; Jung col. 9, lines 12-15, “light from light source 11 reflects from cold mirror 6 and into source fiber optic 5. Source fiber optic 5 passes through to the forward end of probe tip 1”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Jung’s mirror with the medical system disclosed by Barbagli. A person having ordinary skill in the art would be motivated to make the combination in order to “reduce the amount of infra-red light produced by light source 11 before the light is introduced into source fiber optic 5” (see col. 9, lines 18-20 of Jung).
Regarding Claim 31, Barbagli in view of Jung teach the features of Claim 28, as described above.
Barbagli further discloses a processor configured to detect movement of the medical device relative to the target site based on images captured by the imaging device; and wherein the light source is configured to redirect the light based on the detected movement of the medical device (Barbagli paragraph [0077], “video images of the respiratory tract that may assist the clinician in navigating the distal end 218 towards a target location”; Examiner interprets the movement of the medical device described above for Barbagli as teaching movement of the light associated with the teleoperational manipulator assembly 102 as described above).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”) in view of Jung et al. (US Patent 6,239,868 – “Jung”) and Liu et al. (US PGPUB 2013/0023760 – “Liu”).
Regarding Claim 29, Barbagli in view of Jung teach the features of Claim 28, as described above.
Barbagli in view of Jung do not explicitly teach wherein the mirror includes a micro- mirror (MEMs mirror) configured to reflect the light along two axes.
Liu teaches wherein the mirror includes a micro-mirror (MEMs mirror) configured to reflect the light along two axes (Liu, FIG. 2B, micro-mirror 22 reflecting light beam emitted from optical fiber 50).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Liu’s micro-mirror for Jung’s light mirror in the medical system taught by Barbagli in view of Jung. A person having ordinary skill in the art would be motivated to make this substitution in order to reduce optical aberration of the image captured by the image sensor (see paragraph [0005] of Liu, “The use of the micro-mirror minimizes optical aberration (no aberration theoretically).”)
Claims 30 and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”) in view of Jung et al. (US Patent 6,239,868 – “Jung”) and Rovegno (US PGPUB 2005/0240077 – “Rovegno”).
Regarding Claim 30, Barbagli in view of Jung teach the features of Claim 28, as described above.
Jung further teaches wherein the mirror is positioned adjacent to the light source on the medical device (Jung FIG. 1, showing mirror 6 adjacent light source 11).
Barbagli in view of Jung do not explicitly teach wherein the light source is disposed on a distal end of the medical device, and wherein the light source includes a source to generate a laser beam.
Rovegno teaches wherein the light source is disposed on a distal end of the medical device, and wherein the light source includes a source to generate a laser beam (Rovegno FIG. 3, laser diode 3 at distal end of a videoendoscopic probe).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to Rovegno’s laser diode with the medical system taught by Barbagli in view of Jung. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a medical system that measures the size of a target (see paragraph [0129] of Rovegno).
Regarding Claim 32, Barbagli in view of Jung teach the features of Claim 28, as described above.
Barbagli in view of Jung do not explicitly teach wherein the sensor includes at least one of a photodetector, a photodiode, and a charged coupled device (CCD), wherein the sensor is configured to generate a photodiode signal in response to detecting the light at the target site.
Rovegno teaches wherein the sensor includes at least one of a photodetector, a photodiode, and a charged coupled device (CCD), wherein the sensor is configured to generate a photodiode signal in response to detecting the light at the target site (Rovegno FIG. 3, CCD sensor 4; Rovegno paragraph [0113], “CCD sensor 4 connected to a video processor 8”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Rovegno’s CCD with the medical system taught by Barbagli in view of Jung. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a medical system capable of detecting images or spots of light reflected from a target for measuring the size of a target (see paragraph [0129] of Rovegno).
Regarding Claim 33, Barbagli in view of Jung and Rovegno teach the features of Claim 32, as described above.
Jung further teaches:
wherein a strength of the photodiode signal generated by the sensor includes a greater intensity when the sensor is positioned at a first distance from the light, and includes a smaller intensity when the sensor is positioned at a second distance from the light; and
wherein the first distance is less than the second distance (Jung col. 33, lines 41-42, “as the probe is moved closer to the surface, the received light intensity will increase”).
Claims 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”) in view of Kosmecki et al. (US PGPUB 2014/0218366 – “Kosmecki”) and Shimada et al. (US PGPUB 2009/0187288 – “Shimada”).
Regarding Claim 34, Barbagli discloses:
A method of moving a medical instrument toward a target site, the method comprising:
delivering a medical instrument (Barbagli FIG. 3, catheter system 200/202) having a sensor (Barbagli FIG. 4A, volatile organic compound (VOC) sensor 620) to a target site (Barbagli FIG. 3, mass/tumor 510);
capturing images of the target site with an imaging device (Barbagli paragraph [0024], “visualization system (e.g., visualization system 231 of FIG. 4A) may include a viewing scope assembly that records a concurrent or real-time image of the surgical site”);
using a light source at a distal end of the medical instrument (Barbagli FIG. 4B, medical tool 628 at distal tip 218 of catheter 202; Barbagli paragraph [0044], “Medical tool(s) 628 for …illumination…can be deployed through the channel 221 of the flexible body 216 and used at a target location within the anatomy”).
Barbagli does not explicitly disclose:
marking a location of the target site based on the images;
detecting light from the light source at the location by the sensor.
Kosmecki teaches:
marking a location of the target site based on the images (Kosmecki FIG. 2, endoscopy image 7 of tissue 4 marked by a cross on sub-region of interest; Kosmecki paragraph [0068], “light spots can be generated on the tissue 4 by a laser of the distance determining device, wherein said light spots mark the sub-region. In FIGS. 2 and 3 the position of the light spot is characterized by a cross”);
detecting light from the light source at the location by the sensor (Kosmecki FIG. 1, camera 22 on endoscopy device 2).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Kosmecki’s marking method with the method disclosed by Barbagli. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that to create a coordinate system for regions of interest being examined (see paragraph [0019] of Barbagli).
Barbagli in view of Kosmecki do not explicitly teach automatically moving the medical instrument toward the target site based on the sensor detecting the light at the location.
Shimada teaches automatically moving the medical instrument toward the target site based on the sensor detecting the light at the location (Shimada paragraph [0063, “The images taken by the imaging device are converted into signals by the imaging section 14 and sent to the controller 15. The controller 15 displays, on the external display unit 16, the images taken by the imaging device 12. Meanwhile, based on the instructions provided through the input unit 17 by the practitioner, the controller operates the driver 13 to control the motion of and treatment by the surgical tool 11.”; Examiner interprets the images captured by the imaging device 12 to also read on the light being detected by the sensor at the location. Thus, once the target site is identified by Kosmecki as described above, then it would be obvious for Shimada’s controller/driver to move the medical instrument to the identified target site).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Shimada’s method of moving the medical instrument toward the target site with the method described by Barbagli in view of Kosmecki. A person having ordinary skill in the art would be motivated to combine these
prior art elements according to known methods to yield the predictable result of a method that uses a controller to move a medical instrument to a target site, thus providing precision not normally achieved by a manual operation.
Regarding Claim 35, Barbagli in view of Kosmecki and Shimada teach the features of Claim 34, as described above.
Shimada further teaches wherein in response to detecting movement of the medical instrument toward the target site (Shimada FIG. 4, showing surgical tool 11 moving toward new target site D), the method further comprises:
capturing images of the target site with the imaging device to determine a second location of the target site (Shimada FIG. 4, image captured by imaging device 12 showing target site moving from P0 to D);
redirecting the light from the light source to the second location (Shimada paragraph [0040], “spot light emitted from the tip of the manipulation tool (surgical tool)”; Examiner interprets Shimada’s spot light as pointing towards the second location).; and
automatically moving the medical instrument toward the target site based on the sensor detecting the light at the second location (Shimada paragraph [0063, “The images taken by the imaging device are converted into signals by the imaging section 14 and sent to the controller 15. The controller 15 displays, on the external display unit 16, the images taken by the imaging device 12. Meanwhile, based on the instructions provided through the input unit 17 by the practitioner, the controller operates the driver 13 to control the motion of and treatment by the surgical tool 11.”; Examiner interprets the images captured by the imaging device 12 to read on the light being detected at the second location. Thus, once the target site is identified by Kosmecki as described above, then it would be obvious for Shimada’s controller/driver to move the medical instrument to the identified target site).
Regarding Claim 36, Barbagli in view of Kosmecki and Shimada teach the features of Claim 34, as described above.
Shimada further teaches wherein in response to moving the medical instrument toward the target site, the method further comprises: locking onto the target site with the sensor and automatically steering a distal end of the medical instrument toward the target site (Shimada paragraph [0064], “controller 15 detects the difference in the position on the screen between the specified target point and the tip of the surgical tool 11, and computationally determines what motion of the surgical tool 11 is required to bring the tip of the surgical tool 11 closer to the target point. The computed result is sent to the driver 13, which accordingly controls the motion of the surgical tool 11. This control process brings the tip of the surgical tool 11 closer to the target point”. Thus, once the target site is identified by Kosmecki as described above, then it would be obvious for Shimada’s controller/driver to automatically steer the distal end of the medical instrument toward the identified target site).
Regarding Claim 37, Barbagli in view of Kosmecki and Shimada teach the features of Claim 34, as described above.
Barbagli further discloses wherein in response to capturing images of the target site with an imaging device, the method further comprises:
using target identification logic to mark a location of a target site (Barbagli paragraph [0050], “the disclosed system and method can include identifying and detecting the volatile metabolomics signature of VOCs emitted by the target mass and navigating along anatomical passageways based on a change in strength of the volatile metabolomics signature detected.”).
Shimada further teaches wherein the imaging device executes the target identification logic to automatically redirect the medical instrument when the medical device has moved relative to the target site by periodically capturing images for comparison to image data within the imaging device (Shimada FIGs. 4a, 4b, and 4c; Shimada paragraph [0063], “controller 15 displays, on the external display unit 16, the images taken by the imaging device 12. Meanwhile…the controller operates the driver 13 to control the motion of and treatment by the surgical tool 11”) .
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”) in view of Kosmecki et al. (US PGPUB 2014/0218366 – “Kosmecki”), Shimada et al. (US PGPUB 2009/0187288 – “Shimada”), and Rovegno (US PGPUB 2005/0240077 – “Rovegno”).
Regarding Claim 38, Barbagli in view of Kosmecki and Shimada teach the features of Claim 34, as described above.
Barbagli in view of Kosmecki and Shimada do not explicitly teach wherein the sensor includes at least one of a photodetector, a photodiode, and a charged coupled device (CCD), wherein the sensor is configured to generate a photodiode signal in response to detecting the light at the target site.
Rovegno teaches wherein the sensor includes at least one of a photodetector, a photodiode, and a charged coupled device (CCD), wherein the sensor is configured to generate a photodiode signal in response to detecting the light at the target site (Rovegno FIG. 3, CCD sensor 4; Rovegno paragraph [0113], “CCD sensor 4 connected to a video processor 8”; Examiner interprets the output of a CCD as being a photodiode signal).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Rovegno’s CCD with the medical system taught by Barbagli in view of Kosmecki and Shimada. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a medical system capable of detecting images or spots of light reflected from a target for measuring the size of a target (see paragraph [0129] of Rovegno).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”) in view of Kosmecki et al. (US PGPUB 2014/0218366 – “Kosmecki”), Shimada et al. (US PGPUB 2009/0187288 – “Shimada”), Rovegno (US PGPUB 2005/0240077 – “Rovegno”), and Jung et al. (US Patent 6,239,868 – “Jung”).
Regarding Claim 40, Barbagli in view of Kosmecki, Shimada, and Rovegno teaches the features of Claim 38, as described above.
Barbagli in view of Kosmecki, Shimada, and Rovegno do not explicitly teach wherein a strength of the photodiode signal generated by the sensor includes a greater intensity when the medical instrument is positioned at a first distance from the light, and includes a smaller intensity when the medical instrument is positioned at a second distance from the light; and wherein the first distance is less than the second distance.
Jung teaches wherein a strength of the photodiode signal generated by the sensor includes a greater intensity when the medical instrument is positioned at a first distance from the light, and includes a smaller intensity when the medical instrument is positioned at a second distance from the light; and wherein the first distance is less than the second distance (Jung col. 33, lines 41-42, “as the probe is moved closer to the surface, the received light intensity will increase”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Jung’s method of using light intensity to measure distance with the method taught by Barbagli in view of Kosmecki, Shimada, and Rovegno. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that is able to determine the distance between a probe and an area of interest, in order to prevent the probe from contacting/damaging the area of interest.
Claims 41 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”) in view of Jung et al. (US Patent 6,239,868 – “Jung”) and Sargeant et al. (US PGPUB 2012/0108901 – “Sargeant”).
Regarding Claim 41, Barbagli in view of Jung teach the features of Claim 31, as described above.
As described above, Barbagli discloses a processor (Barbagli FIG. 1, control system 112) and non-transitory computer readable medium storing instructions (Barbagli paragraph [0030], “control system 112 includes at least one memory and at least one computer processor (not shown), and typically a plurality of processors, for effecting control between the medical instrument system 104”).
Sargeant teaches wherein the instructions stored in the non-transitory computer readable medium cause the processor to (Sargeant paragraph [0043], “The control member (not shown) may be used to mechanically and/or electrically manipulate the position of mirror 130 with respect to the longitudinal axis”):
detect a change in location of the imaging device relative to the target site (Sargeant FIG. 5, tubular member 12 of arthroscope 10; Sargeant paragraph [0041], “Once distal end 16 of arthroscope 10 is positioned within the joint space, as shown in FIGS. 5-6, the internal components of arthroscope 10, e.g., the fiber optic bundle, or LED and camera, may be activated to provide a video image of the joint space”;
determine the location of the target site relative to the imaging device (Sargeant paragraph [0041], “the field of view of arthroscope 10 is limited to the illuminated area extending distally from arthroscope 10 along longitudinal axis”); and
actuate the mirror to redirect the light to the location of the target site (Sargeant FIGs. 1-5, mirror assembly 100 composes of arm 120 and mirror 130; Sargeant paragraph [0042], “the mirror assembly 100 may be moved to the extended position to re-direct light 42 emitted from distal end 16 of arthroscope 10”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Sargeant’s light-directing mirror with the medical system taught by Barbagli in view of Jung. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a medical arthroscopic system having a retractable mirror for directing light from an arthroscope (see Sargeant paragraph [0032]) such that the mirror is not exposed while the arthroscope is being inserted into the patient.
Regarding Claim 42, Barbagli in view of Jung teach the features of Claim 31, as described above.
Sargeant teaches wherein the mirror (Sargeant FIG. 5, mirror 130) is configured to move to redirect the light toward the location of the target site in response to the processor detecting the change in location of the imaging device relative to the target site (Sargeant FIG. 5, tubular member 12 of arthroscope 10; Sargeant paragraph [0041], “Once distal end 16 of arthroscope 10 is positioned within the joint space, as shown in FIGS. 5-6, the internal components of arthroscope 10, e.g., the fiber optic bundle, or LED and camera, may be activated to provide a video image of the joint space”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Sargeant’s light-directing mirror with the medical system taught by Barbagli in view of Jung. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a medical arthroscopic system having a retractable mirror for directing light from an arthroscope (see Sargeant paragraph [0032]) such that the mirror is not exposed while the arthroscope is being inserted into the patient.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”) in view of Mizuno (US PGPUB 2004/0147810 – “Mizuno”) and Caplan (US PGPUB 2015/0253111 – “Caplan”).
With respect to Claim 21, Barbagli discloses:
A medical system (Barbagli FIG. 1, teleoperational medical system 100), comprising:
a medical device (Barbagli FIG. 1, teleoperational manipulator assembly 102 and medical instrument system 104) including:
an imaging device (Barbagli FIG. 4A, visualization system 231) configured to capture images of a target site (Barbagli paragraph [0024], “visualization system (e.g., visualization system 231 of FIG. 4A) may include a viewing scope assembly that records a concurrent or real-time image of the surgical site”), wherein a location of the target site is determined based on the images (Barbagli paragraph [0077], “video images of the respiratory tract that may assist the clinician in navigating the distal end 218 towards a target location”; Examiner is interpreting Barbagli’s “visualization system 231” are requiring an electronic image sensor in order to provide for the function of capturing and recording images); and
a light source configured to direct a light onto the location of the target site (Barbagli paragraph [0034], “teleoperational medical system 100 may further include optional operation and support systems (not shown) such as illumination systems”); and
a processor (Barbagli FIG. 1, control system 112) and non-transitory computer readable medium storing instructions (Barbagli paragraph [0030], “control system 112 includes at least one memory and at least one computer processor (not shown), and typically a plurality of processors, for effecting control between the medical instrument system 104”),
wherein the medical device is configured to receive the instructions (Barbagli FIG. 1, control system 112; Barbagli paragraph [0024], “processors of the control system 112 may execute instructions corresponding to processes disclosed herein”).
Mizuno teaches wherein the medical device (Mizuno FIG. 1, endoscope 100) includes a sensor (Mizuno FIG. 1, CCD 180) detecting light from the light source (Mizuno FIG. 1, laser array 110) at the target site (Mizuno FIG. 1, target tissue 200; Mizuno paragraph [0050], “laser beams reflected by the target tissue 200 are converged by the second micro focusing lens array plate 170 on respective ones of the light receiving elements of the CCD 180”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Mizuno’s laser designator of a tissue target with the medical system disclosed by Barbagli. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope capable of marking for identification a region of interest on a tissue target.
It is well known to those skilled in the art of device guidance to use laser-guidance to move a device toward a target site. For example, Caplan teaches in Caplan FIG. 1 a weapon 18 having a sensing system 18 that detects laser light from a laser target designator 12 reflected from a target 14, in order to guide the weapon 18 onto the target (see Caplan paragraph [0019]). Caplan is analogous art to Barbagli since they are reasonably pertinent to the problem faced by the inventor of guiding a device towards a target.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the laser tracking system of Caplan with the system taught by Barbagli in view of Mizuno. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a system that can guide an instrument towards a target for utilization thereof (see Caplan paragraph [0019]).
Response to Arguments
Applicant’s arguments, see page 8, filed July 3, 2025, with respect to the objection to the drawings and the rejection of Claim 21 under 35 U.S.C. 112(a) have been fully considered and are persuasive in view of the amendments to Claim 21. The objection to the drawings and the rejection of Claim 21 under 35 U.S.C. 112(a) have been withdrawn.
Applicant's arguments filed July 3, 2025, with respect to the rejection of Claim 21 under 35 U.S.C. 102(a)(1) have been fully considered but they are not persuasive. Applicant asserts that moving a medical device toward the target site based on an image is not the same as moving a medical device toward the target site based on a non-image light. Claim 21 does not claim feature. As stated above in the rejection of Claim 21 under 35 U.S.C. 102(a)(1), Examiner asserts that capturing the video images of a target site is equivalent to the detection of light at the target site. Thus, the rejection of Claim 21 under 35 U.S.C. 102(a)(1) is maintained. Examiner notes further that Claim 21 is also rejected under 35 U.S.C. 103 using new prior art (Mizuno and Caplan).
Applicant's arguments filed on July 3, 2025 regarding the rejection of Claim 28 under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant appears to be asserting that there is no teaching/motivation/suggestion (TSM) in Jung to combine Barbagli with Jung. Applicant is reminded that TSM is no longer required under KSR Int’l Co. v. Teleflex Inc. (see MPEP 2141(III)). Nonetheless, as stated above, Jung provides the motivation to combine Barbagli with Jung, since a person having ordinary skill in the art would be motivated to make the combination in order to “reduce the amount of infra-red light produced by light source 11 before the light is introduced into source fiber optic 5” (see col. 9, lines 18-20 of Jung). Thus, the rejection of Claim 28 under 35 U.S.C. 103 is maintained.
Applicant's arguments filed on July 3, 2025 regarding the rejection of Claim 34 under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant reiterates the argument presented against the rejection of Claim 21, which are addressed by Examiner. Applicant also argues that there is no automatic movement of the instrument based on light detection. Examiner respectfully disagrees. As stated above in the rejection of Claim 34, once the target site is identified by Kosmecki as described above, then it would be obvious for Shimada’s controller/driver to move the medical instrument to the identified target site. For reasons stated above, the rejection of Claim 34 under 35 U.S.C. 103 is maintained.
Applicant’s arguments with respect to 41-42 have been considered but are moot because the new ground of rejection does not rely on any reference (Sargeant) applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
THIS ACTION IS MADE FINAL. 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 JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
12/8/25