Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 10, 2026 has been entered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the medical instrument configured to automatically move toward the target site, as claimed in Claims 28, 34-35, and 43, must be shown or the feature(s) canceled from the claim(s). That is, exemplary FIG. 1 of the present patent application shows actuators 114 on a handle of an endoscope/medical device 110. FIG. 1 also shows a handle 141 on a medical instrument 140. However, actuator 114 is only described in the figures and the specification as being manually operated by the user. (See paragraph [0030].) Although paragraph [0049] states “the medical instrument 140 may be moved toward the target site in response to sensor 146 detecting the light/laser beam 132. The handle 141 of the medical instrument 140 may be actuated to automatically translate the longitudinal body 142 through a working lumen of the shaft 120 to position the distal end 144 adjacent to the target site”, there is nothing in the figures that depict a mechanism/actuator that causes the handle 141 to automatically/autonomously move. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 28, 34-35, and 43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Specifically, Claims 28, 34-35, and 43 claim a medical instrument configured to automatically move toward the target site. Exemplary FIG. 1 of the present patent application shows actuators 114 on a handle of an endoscope/medical device 110. FIG. 1 also shows a handle 141 on a medical instrument 140. However, actuator 114 is only described in the figures and the specification as being manually operated by the user. (See paragraph [0030].) Although paragraph [0049] states “the medical instrument 140 may be moved toward the target site in response to sensor 146 detecting the light/laser beam 132. The handle 141 of the medical instrument 140 may be actuated to automatically translate the longitudinal body 142 through a working lumen of the shaft 120 to position the distal end 144 adjacent to the target site”, there is nothing in the figures that depict a mechanism/actuator for the handle 141 to automatically/autonomously move, nor does the written description describe how such autonomous movement is effected. As such, the claimed feature of “a medical instrument configured to automatically move toward the target site” is not enabled in the specification.
Appropriate correction by Applicant is required.
For purposes of examination, Examiner interprets a medical instrument that automatically moves toward the target site based on the sensor detecting the light at the target site as “a medical instrument that moves toward the target site based on the sensor detecting the light at the target site”.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, Claim 21 claims “wherein, upon the sensor detecting the light from the light source at the target site, the medical instrument is configured to move, relative to the medical device, toward the target site”. It is unclear what this phrase means. That is, it is unclear how the medical instrument configured to move toward the target site when light reflected from the target site is detected. The claims provides no explanation of how it is to be configured (by being connected to an actuator, or being manually moved by a user, etc.), nor is such an explanation found in the written specification or figures. Even more specifically, it is unclear what “configured to move” means. It is unclear if this phrase means that the medical instrument’s components are rearranged or modified, or the medical instrument is connected to another device, or the medical instrument somehow becomes unrestricted, etc.
Appropriate correction by Applicant is required.
For purposes of examination, Examiner interprets “wherein, upon the sensor detecting the light from the light source at the target site, the medical instrument is configured to move, relative to the medical device, toward the target site” as “the medical instrument is movable toward the target site”.
Claims 28, 34-35, and 43 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, Claims 28, 34-35, and 43 claim a medical instrument configured to automatically move toward the target site. Exemplary FIG. 1 of the present patent application shows actuators 114 on a handle of an endoscope/medical device 110. FIG. 1 also shows a handle 141 on a medical instrument 140. However, actuator 114 is only described in the figures and the specification as being manually operated by the user. (See paragraph [0030].) Although paragraph [0049] states “the medical instrument 140 may be moved toward the target site in response to sensor 146 detecting the light/laser beam 132. The handle 141 of the medical instrument 140 may be actuated to automatically translate the longitudinal body 142 through a working lumen of the shaft 120 to position the distal end 144 adjacent to the target site”, there is nothing in the figures that depict a mechanism/actuator for the handle 141 to automatically/autonomously move, nor do the claims or written description describe such a mechanism. As such, the claimed feature of “a medical instrument configured to automatically move toward the target site” is unclear/indefinite. Examiner recognizes that breadth alone is not indefinite. However, the claim must nonetheless describe the metes and bound of the claim. MPEP 2173.04.
Appropriate correction by Applicant is required.
For purposes of examination, Examiner interprets a medical instrument that automatically moves toward the target site based on the sensor detecting the light at the target site as “a medical instrument that moves toward the target site based on the sensor detecting the light at the target site”.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 42 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Specifically, Claim 42, claims “the mirror 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”. Claim 42 depends on Claim 31, which claims “wherein the processor is configured to provide instructions to automatically move the mirror to redirect the light toward a location of the target site in response to the processor detecting a change in location of the imaging device relative to the target site.” As such, Claim 42 fails to further limit the subject matter of Claim 31. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 21 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”) in view of Hiraoka (US PGPUB 2015/0173711 – “Hiraoka”).
Regarding 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 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”), 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”; 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”);
a medical instrument (Barbagli FIG. 4A, medical instrument 226) having a sensor, wherein the sensor is configured to detect the light from the light source at 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”; Barbagli paragraph [0041], “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 that movement of the medical instrument is relative to the medical device.
Hiraoka teaches movement of the medical instrument (Hiraoka FIG. 6, treatment instrument TD1 within channel CH1 of channel tube 71a) is relative to the medical device (Hiraoka FIG. 1, forceps port 25b; Hiraoka paragraph [0086], “the treatment instrument TD1 such as a cannula is inserted into the channel CH1 from the forceps port 25b, the distal end portion of the treatment instrument TD1 passes through the channel CH1 and comes out of the opening portion 31a”).
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 Hiraoka’s instrument, which moves through the forceps port and through the instrument channel, 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 in which movement of a medical instrument is through an insertion portion of the medical system, in order to afford movement of the medical instrument that it at least partially unrestricted by the insertion portion, in order to allow finer movement of the medical instrument.
Regarding Claim 43, Barbagli in view of Hiraoka teaches the features of Claim 21, as described above.
Barbagli further teaches a user moving the medical instrument toward the target site based on the sensor detecting the light at 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”; Barbagli paragraph [0041], “Examiner interprets this teaching of Barbagli as the medical instrument being movable toward the target in response to the user viewing the video images).
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 Hiraoka (US PGPUB 2015/0173711 – “Hiraoka”), Shimada et al. (US PGPUB 2009/0187288 – “Shimada”), and Liu et al. (US PGPUB 2013/0023760 – “Liu”).
Regarding Claim 22, Barbagli in view of Hiraoka teaches discloses the features of Claim 21, as described above.
Barbagli further discloses a processor and a non-transitory computer readable medium, wherein the non-transitory computer readable medium stores instructions (Barbagli FIG. 1, control system 112; 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, the operator input system 106, the sensor system 108, and the display system 110. The control system 112 also includes programmed instructions (e.g., a computer-readable medium storing the instructions) to implement some or all of the methods described”).
Barbagli in view of Hiraoka does not explicitly teach executing instructions that 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, to redirect light to the target site.
Shimada teaches executing instructions that cause the processor (Shimada FIG. 1, controller 15) to:
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detect a change in location of the imaging device (Examiner-annotated Shimada FIG. 3 shown above, 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, to redirect light to the target site (Shimada FIG. 1, driver 13; Shimada paragraph [0064]; see also Shimada paragraph [0040], “the controller performs a control operation…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 taught by Barbagli in view of Hiraoka. 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.
Barbagli in view of Hiraoka and Shimada does not explicitly teach actuating a mirror to redirect light to the target site.
Liu teaches actuating a mirror to redirect light to the target site (Liu, FIG. 2B, micro-mirror 22 reflecting light beam emitted from optical fiber 50; Liu paragraph [0005], “The micro-mirror has an inclined surface at an angle…to reflect the light from…the longitudinal direction to a lateral or radial direction outwardly from the longitudinal axis of the rotary part”).
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 Liu’s micro-mirror for with Flanagan’s instrument/light in the medical system taught by Barbagli in view of Hiraoka and Shimada. 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).”)
Regarding Claim 23, Barbagli in view of Shimada, Shimada, and Liu teaches 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 Hiraoka (US PGPUB 2015/0173711 – “Hiraoka”), Shimada et al. (US PGPUB 2009/0187288 – “Shimada”), Liu et al. (US PGPUB 2013/0023760 – “Liu”), and Ho et al. (US PGPUB 2018/0344288 – “Ho”).
Regarding Claim 24, Barbagli in view of Shimada, Shimada, and Liu teaches the features of Claim 23, as described above.
Barbagli in view of Hiraoka, Shimada, and Liu does 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 Hiraoka, Shimada, and Liu. 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 Hiraoka, Shimada, Liu, and Ho teaches the features of Claim 24, as described above.
Shimada further teaches wherein the light source is a first light source, wherein the first 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”).
Hiraoka further teaches wherein the medical device (Hiraoka FIG. 1, endoscope 2) includes a second light source (Hiraoka FIG. 1, light source apparatus 3) configured to illuminate an environment around the medical device (Hiraoka FIG. 5, content group 31d; Hiraoka paragraph [0052], “content group 31d such as…an illumination light guide”), and wherein the first light source and the second light source emit different types of light (Examiner interprets Shimada’s laser pointer as being a different type of light than Hiraoka’s illumination light).
Claim 28 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”).
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).
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 teaches the features of Claim 28, as described above.
Barbagli in view of Jung does 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 teaches 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 does 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 teaches the features of Claim 28, as described above.
Barbagli in view of Jung does 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 teaches 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”).
Claim 31 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 Schnitzer et al. (US Patent 7,307,774 – “Schnitzer”).
Regarding Claim 31, Barbagli in view of Jung teaches 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 (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).
Barbagli in view of Jung does not explicitly teach and wherein the processor is configured to provide instructions to automatically move the mirror to redirect the light toward a location of the target site in response to the processor detecting a change in location of the imaging device relative to the target site.
Schnitzer teaches wherein the processor (Schnitzer FIG. 1A, MEMS controller 42) is configured to provide instructions to automatically move the mirror to redirect the light toward a location of the target site in response to the processor detecting a change in location of the imaging device relative to the target site (Schnitzer FIG. 1A, MEMS mirror arrangement 40; Schnitzer col. 2, lines 34-38, “The light direction arrangement includes a micro-mirror, an actuator for controllably moving the micro-mirror to direct light from the light source to different target locations of the sample”).
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 Schnitzer’s micro-mirror (MEMS) illumination system 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 is able to keep an illumination source aimed at a target that is moving relative to a medical device (see Schnitzer col. 4 lines 39-42, “Using an actuator or actuators, the micro-mirror is controllably moved to direct light from the light source to different target locations on the sample.”).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Kronman et al. (US PGPUB 2019/0231167 – “Kronman”) in view of Hunter et al. (US PGPUB 2015/0305650 – “Hunter”).
Regarding Claim 34, Kronman discloses:
A method of moving a medical instrument toward a target site, the method comprising:
delivering a medical instrument (Kronman FIG. 1, endoscope 102) having a sensor to a target site (Kronman FIG. 1, endoscope's 102 tip section 108; Kronman paragraph [0058], “endoscope's 102 tip section 108, such as for the tip section's viewing elements and illuminators”) to a target site (Kronman paragraph [0053], “FIG. 1 illustrates a multi-viewing element endoscopy system in which the method and system for repositioning a region of interest (ROI) from a first location to a second location such as the center of a display or as the focal point of images being captured by the viewing elements of an endoscope during an endoscopic procedure”);
capturing images of the target site with an imaging device of a medical device through which the medical instrument is inserted (Kronman FIG. 1, working channel opening 112; Kronman paragraph [0054], “working channel openings 112 through which surgical tools may be inserted”);
using a light source at a distal end of the medical device to mark a location of the target sited based on the images (Kronman paragraph [0067], “The ROI is detected and marked by matching various neighboring pixels contained in that specific area of the image”);
using the sensor to detect light source at the location (Kronman paragraph [0067], “the ROI may be detected by using one or more sensors incorporated in the insertion tube of the endoscope”); and
without receiving any movement instructions from a user, automatically moving the medical instrument toward the target site (Kronman paragraph [0019], “automatically moving the tip section of the insertion portion of the endoscope for positioning the region of interest in a target area of the display screen”) based on the sensor detecting the light at the location.
Although Kronman teaches a working channel opening through which an instrument can be inserted (Kronman FIG. 1, working channel opening 112), Kronman does not explicitly disclose that instrument being an imaging device of a medical device.
Hunter teaches an imaging device (Hunter FIG. 12A, bronchoscopic video camera 630) of a medical device (Hunter FIG. 12A, showing distal end portion 606 of a steerable catheter 600) through which the medical instrument is inserted.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Hunter’s steerable catheter 600 having bronchoscopic video camera 630 with the method disclosed by Kronman. 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 for using an endoscope to provide gross movement of a catheter/camera towards a region of interest.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Kronman et al. (US PGPUB 2019/0231167 – “Kronman”) in view of Hunter et al. (US PGPUB 2015/0305650 – “Hunter”), Shimada et al. (US PGPUB 2009/0187288 – “Shimada”), and Schnitzer et al. (US Patent 7,307,774 – “Schnitzer”).
Regarding Claim 35, Kronman in view of Hunter teaches the features of Claim 34, as described above.
Kronman in view of Hunter does not explicitly teach
in response to detecting movement of the medical instrument toward the target site, the method further comprises:
capturing images of the target site with the imaging device to determine a second location of the target site; and
moving the medical instrument toward the target site based on the sensor detecting the light at the second location.
Shimada 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);
and
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).
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 method taught by Kronman in view of Hunter. 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 surgical method that tracks a moving target within a patient such that a surgical tool is positioned at the current target location.
Kronman in view of Hunter and Shimada does not explicitly teach without receiving any redirecting instructions from a user, automatically redirecting the light from the light source to the second location;
Schnitzer teaches a processor (Schnitzer FIG. 1A, MEMS controller 42) that is configured to provide instructions to, without receiving any redirecting instructions from a user, automatically redirect the light from the light source to the second location (Schnitzer FIG. 1A, MEMS mirror arrangement 40; Schnitzer col. 2, lines 34-38, “The light direction arrangement includes a micro-mirror, an actuator for controllably moving the micro-mirror to direct light from the light source to different target locations of the sample”).
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 use of Schnitzer’s micro-mirror (MEMS) illumination system with the surgical method taught by Kronman in view of Hunter 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 that is able to keep an illumination source aimed at a target that is moving relative to a medical device (see Schnitzer col. 4 lines 39-42, “Using an actuator or actuators, the micro-mirror is controllably moved to direct light from the light source to different target locations on the sample.”).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Kronman et al. (US PGPUB 2019/0231167 – “Kronman”) in view of Hunter et al. (US PGPUB 2015/0305650 – “Hunter”) and Gunn (US PGPUB 2011/0169605 – “Gunn”).
Regarding Claim 37, Kronman in view of Hunter teaches the features of Claim 34, as described above.
Kronman in view of Hunter does not explicitly teach:
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,
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.
Gunn is analogous art in the area of tracking objects in captured images that teaches:
wherein in response to capturing images of the target site with an imaging device (Gunn FIG. 3, camera 308; Gunn paragraph [0047], “images captured by the camera 308 is displayed at least partially on the display screen “), the method further comprises:
using target identification logic (Gunn FIG. 3, laser projector 10 emitting laser beam 306) to mark a location of a target site (Gunn FIG. 3, luminous indicator 302; Gunn paragraph [0065], “the direction of the projected beam 306 (e.g. laser beam) is known for a specific piece of the luminous indicator 302”,
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 (Gunn FIG. 3, camera 308; Gunn FIG. 4, control software module 400 and tracking software module 404; Gunn paragraph [0072], “the module then transforms the map to an absolute coordinate system to determine the position of the luminous indicator 302 within the image captured and thereby providing an uniform coordinate for the camera 308 and the projector 10 to locate the indicator 302, and thereby allowing the indicator 302 to be tracked and controlled by the tracking module.”).
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 Gunn’s laser-based tracking method with the method taught by Kronman in view of Hunter. 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 tracks relative movement of a target during an endoscopic operation, in order to maintain a clear observation/record of regions of interest during the endoscopic operation.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Kronman et al. (US PGPUB 2019/0231167 – “Kronman”) in view of Hunter et al. (US PGPUB 2015/0305650 – “Hunter”) and Rovegno (US PGPUB 2005/0240077 – “Rovegno”).
Regarding Claim 38, Kronman in view of Hunter teaches the features of Claim 34, as described above.
Kronman in view of Hunter does 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 use of Rovegno’s CCD with the method taught by Kronman in view of Hunter. 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 Kronman et al. (US PGPUB 2019/0231167 – “Kronman”) in view of Hunter et al. (US PGPUB 2015/0305650 – “Hunter”), Gunn (US PGPUB 2011/0169605 – “Gunn”), and Jung et al. (US Patent 6,239,868 – “Jung”).
Regarding Claim 40, Kronman in view of Hunter and Gunn teaches the features of Claim 38, as described above.
Kronman in view of Hunter and Gunn does 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 Kronman in view of Hunter and Gunn. 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 41-42 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”), Schnitzer et al. (US Patent 7,307,774 – “Schnitzer”), and Sargeant et al. (US PGPUB 2012/0108901 – “Sargeant”).
Regarding Claim 41, Barbagli in view of Jung and Schnitzer teaches 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”).
However, Barbagli in view of Jung and Schnitzer does not explicitly teach:
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;
determine the location of the target site relative to the imaging device; and
actuate the mirror to redirect the light to the location of the target site.
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 and Schnitzer. 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 and Schnitzer teaches the features of Claim 31, as described above.
Barbagli in view of Jung and Schnitzer does not explicitly teach wherein the mirror 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 further 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 and Schnitzer. 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 44 is rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”) in view of Hiraoka (US PGPUB 2015/0173711 – “Hiraoka”) and Prinzhausen et al. (US PGPUB 2003/0002054 – “Prinzhausen”).
Regarding Claim 44, Barbagli in view of Hiraoka teaches the features of Claim 21, as described above.
Barbagli in view of Hiraoka does not explicitly teach wherein the sensor includes a four-quadrant photodiode configured to convert light into an electrical current.
Prinzhausen teaches wherein the sensor includes a four-quadrant photodiode configured to convert light into an electrical current (Prinzhausen paragraph [0024], “for a precise measurement of the object surface…the receiver surface is a four-quadrant photo diode”).
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 Prinzhausen’s four-quadrant photo diode with the medical system taught by Barbagli in view of Hiraoka. 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 having an imaging device having “an areal arrangement of image recording elements…for a focal plane situated in the observed surface area…a balanced intensity distribution result” (see Prinzhausen paragraph [0024]).
Response to Arguments
Applicant’s arguments, see page 10, filed March 10, 2026, with respect to the rejection(s) of Claim 21 under 35 U.S.C. 102 in view of Barbagli et al. (US PGPUB 2020/0179058 – “Barbagli”), have been fully considered and are persuasive in view of the present amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. 103 in view of Barbagli in view of Hiraoka (US PGPUB 2015/0173711 – “Hiraoka”), as described in the 103 rejection of Claim 21 presented above.
Applicant’s arguments, see pages 10-12, filed March 10, 2026, with respect to the rejection(s) of Claim 21 under 35 U.S.C. 103 in view of Barbagli in view of Mizuno (US PGPUB 2004/0147810 – “Mizuno”) and Caplan (US PGPUB 2015/0253111 – “Caplan”), have been fully considered and are persuasive in view of the present amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. 103 in view of Barbagli in view of Hiraoka, as described in the 103 rejection of Claim 21 presented above. That is, Examiner no longer relies on or cites Mizuno or Caplan in the 103 rejection of Claim 21 presented above.
Applicant’s arguments on page 13, filed March 10, 2026, with respect to the rejection of Claim 28 under 35 U.S.C. 103 in view of Barbagli in view of Jung et al. (US Patent 6,239,868 – “Jung”) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. More specifically, Applicant’s arguments relate to the newly-added feature to Claim 28 of “the medical instrument is configured to automatically move toward the target site”. This automatically feature is the basis of the objection to the figures presented above, as well as the rejection of Claim 28 under 35 U.S.C. 102a/b presented above.
Applicant’s arguments on page 13, filed March 10, 2026, with respect to the rejection of Claim 34 under 35 U.S.C. 103 in view of Barbagli in view of Kosmecki et al. (US PGPUB 2014/0218366 – “Kosmecki”) and Shimada et al. (US PGPUB 2009/0187288 – “Shimada”) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. More specifically, Applicant’s arguments relate to the newly-added feature to Claim 34 of “without receiving any movement instructions from a user, automatically moving the medical instrument toward the target site based on the sensor detecting the light at the location.” This without receiving any movement instructions from a user feature is the basis of the objection to the figures presented above, as well as the rejection of Claim 34 under 35 U.S.C. 102a/b presented above. Examiner further notes that the rejection of Claim 34 under 35 U.S.C. 103 no longer relies on Barbagli, Kosmecki, or Shimada. Rather, Claim 34 is now rejected under 35 U.S.C. 103 in view of Kronman et al. (US PGPUB 2019/0231167 – “Kronman”) in view of Hunter et al. (US PGPUB 2015/0305650 – “Hunter”), as presented above.
Furthermore, Applicant is reminded that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art. (See In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958 and MPEP 2144.04(III).) As such, the newly-claimed features of moving a medical instrument automatically accomplishes the same result as moving the medical instrument, and thus does not distinguish over the prior art.
As such, the rejections of Claims 21-25, 28-35, 37-38, and 40-44 are maintained.
Conclusion
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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
4/9/26
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