DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/21/2026 has been entered.
Disposition of Claims
Claims 1-6, 9-10, 12-17, and 20-21 are pending.
Claims 7-8, 11, 18-19, and 22 are cancelled.
Response to Arguments
Applicant’s arguments, see Pages 5-11, filed on 7/21/2026, with respect to the rejections under 35 U.S.C. § 103 of Claims 1 and 12 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.
Claim Objections
Claims 1 and 12 are objected to because of the following informalities:
In claim 1, line 3, “wires, , and” should read “wires, and”
In claim 12, line 5, “wherein the articulatable elongate member robotically controlled by” should read “wherein the articulatable elongate member is robotically controlled by”
Appropriate correction is required.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1, 3-4, 9, 12, 14-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2023/0084030 A1 to Samadani et al. (“Samadani”) in view of U.S. Patent Appl. Publ. No. 2022/0362518 A1 to Gu et al. (“Gu”) and U.S. Patent Appl. Publ. No. 2019/0175005 A1 to Tanaka (“Tanaka”).
Regarding claim 1, Samadani discloses a medical device (system 100 for endoscopy; Fig. 1, paragraph 0024) comprising:
an articulatable elongate member (the endoscope 250 includes a tube 252; Fig. 2B, paragraph 0033), and wherein an imaging sensor is located at a distal end of the articulatable elongate member (the endoscope 250 includes a tube 252 housing two cameras 254 placed side by side along a diameter of the tube 252; Fig. 2B, paragraphs 0025 and 0033);
one or more laser light sources (the light source 212 includes one or more light emitters 214, such as lasers (e.g., diode lasers); Fig. 2A, paragraph 0031), wherein the one or more laser light sources generate light transmitted through one or more optic fibers (the illumination system 200 further includes, at the proximal end 210 of the optical fiber 204, a light source 212 (constituting an example of light source 108) configured to generate and couple light into the optical fiber 204; Fig. 2A, paragraph 0031); and
one or more optical elements located at the distal end of the articulatable elongate member and configured to receive the light via the one or more optic fibers (Figs. 5C-5E illustrate examples of illumination beam sources that include movable or otherwise adjustable refractive, reflective, or diffractive optics at the distal fiber end 208 that control the direction of the illumination beam 224; Fig. 5C-E, paragraph 0053), wherein the one or more optical elements comprise a first diffractive optical element (DOE) controlled to adjust a distribution of the light for illuminating a target scene to match a field of view of the imaging sensor or adjust the distribution of the light based on a reflectivity of the target scene (the beam divergence is automatically adjusted as the user zooms in or out within a field of view of an endoscopeiborescope camera to match the field of illumination to the zoom level, or the beam is automatically steered as the user moves a zoomed-in region across the field of view to move the illuminating beam along with that region; Fig. 5C-E, paragraphs 0008 and 0034).
However, Samadani does not explicitly disclose an articulatable elongate member robotically controlled by an instrument driving mechanism via one or more pull wires and one or more laser light sources located at a handle portion or the instrument driving mechanism, wherein the handle portion is releasably coupled to the instrument driving mechanism and coupled to the articulatable elongate member.
Gu teaches an articulatable elongate member (the endoscope 110 includes … an elongate shaft 114 extending distally from the handle 112; Fig. 1, paragraph 0052) robotically controlled by an instrument driving mechanism (the motor control assembly 140 may include at least one motor; Fig. 1, paragraph 0055-0056) via one or more pull wires (the one or more first cables, wires, or filaments may be engaged with and/or connected to the distal tip 116, such that tension applied to the one or more first cables, wires, or filaments by the first pulley defects and/or articulates the distal tip 116 in the first plane; Fig. 5, paragraph 0053) and a handle portion releasably coupled to the instrument driving mechanism (the endoscopic system 100 may include a motor control assembly 140 including a motor control housing 142 configured to detachably interface with the handle 112 of the endoscope 110; Fig. 10, paragraph 0054) and coupled to the articulatable elongate member (the endoscope 110 includes a handle 112 and an elongate shaft 114 extending distally from the handle 112; Fig. 1, paragraph 0052). Gu teaches that the robotically controlled instrument driving mechanism helps to reduce and/or eliminate physician fatigue resulting from a procedure (paragraph 0051).
Gu is considered to be analogous to the claimed invention because it is in the same field of endoscopes with controlled defection of the insertion portion. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscope of Samadani to incorporate the teachings of Gu by adding a robotically controlled instrument driving mechanism. Doing so would help reduce and/or eliminate physician fatigue resulting from a procedure, as recognized by Gu.
Tanaka teaches one or more laser light sources located at a handle portion or the instrument driving mechanism (the light source portion 70 is mounted inside the operation portion 23; Fig. 2, paragraph 0044).
Tanaka is considered to be analogous to the claimed invention because it is in the same field of endoscopes with light source in the proximal component. It would have been obvious to one having ordinary skill in the art at the time the invention was made to move the light source to the handle, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70.
Regarding claim 3, Samadani, as previously modified by Gu and Tanaka, discloses the medical device according to claim 1. Samadani further discloses wherein the articulatable elongate member is disposable (tube 252 is capable of being disposable; Fig. 2B).
Regarding claim 4, Samadani, as previously modified by Gu and Tanaka, discloses the medical device according to claim 1. Samadani, as previously modified by Tanaka, further discloses further comprising a laser speckle reducer located at the handle portion (laser speckle can be diminished with a laser speckle reducer 430 placed at the Fourier transform plane 402 between the collimating and focusing optics 216, 218; Fig. 4B, paragraph 0044).
Regarding claim 9, Samadani, as previously modified by Gu and Tanaka, discloses the medical device according to claim 1. Samadani further discloses wherein the imaging sensor is embedded in the distal end of the articulable elongate member (the cameras 110 and illumination beam source 104 may be located side by side at the distal end of the device 112; Fig. 1, paragraph 0025).
Regarding claim 12, Samadani discloses an illumination system for a medical device (system 100 for endoscopy; Fig. 1, paragraph 0024) comprising:
one or more laser light sources (the light source 212 includes one or more light emitters 214, such as lasers (e.g., diode lasers); Fig. 2A, paragraph 0031), and wherein an imaging sensor is located at a distal end of the articulatable elongate member (the endoscope 250 includes a tube 252 housing two cameras 254 placed side by side along a diameter of the tube 252; Fig. 2B, paragraphs 0025 and 0033);
one or more optic fibers for transmitting light generated by the one or more laser light sources to the distal end of the articulatable elongate member; and
one or more optical elements located at the distal end of the articulatable elongate member, wherein the one or more optical elements are configured to receive the light via the one or more optic fibers (Figs. 5C-5E illustrate examples of illumination beam sources that include movable or otherwise adjustable refractive, reflective, or diffractive optics at the distal fiber end 208 that control the direction of the illumination beam 224; Fig. 5C-E, paragraph 0053) and comprise a first diffractive optical element (DOE) that is controlled to adjust a distribution of the light for illuminating a target scene to match a field of view of the imaging sensor or adjust the distribution of the light based on a reflectivity of the target scene (the beam divergence is automatically adjusted as the user zooms in or out within a field of view of an endoscopeiborescope camera to match the field of illumination to the zoom level, or the beam is automatically steered as the user moves a zoomed-in region across the field of view to move the illuminating beam along with that region; Fig. 5C-E, paragraphs 0008 and 0034).
However, Samadani does not explicitly disclose one or more laser light sources located at a handle portion or an instrument driving mechanism of the medical device, wherein the handle portion is coupled to an articulatable elongate member of the medical device and releasably coupled to the instrument driving mechanism, wherein the articulatable elongate member robotically controlled by the instrument driving mechanism via one or more pull wires.
Gu teaches a handle portion is coupled to an articulatable elongate member of the medical device (the endoscope 110 includes a handle 112 and an elongate shaft 114 extending distally from the handle 112; Fig. 1, paragraph 0052) and releasably coupled to the instrument driving mechanism (the endoscopic system 100 may include a motor control assembly 140 including a motor control housing 142 configured to detachably interface with the handle 112 of the endoscope 110; Fig. 10, paragraph 0054), wherein the articulatable elongate member robotically controlled by the instrument driving mechanism (the motor control assembly 140 may include at least one motor; Fig. 1, paragraph 0055-0056) via one or more pull wires (the one or more first cables, wires, or filaments may be engaged with and/or connected to the distal tip 116, such that tension applied to the one or more first cables, wires, or filaments by the first pulley defects and/or articulates the distal tip 116 in the first plane; Fig. 5, paragraph 0053). Gu teaches that the robotically controlled instrument driving mechanism helps to reduce and/or eliminate physician fatigue resulting from a procedure (paragraph 0051).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscope of Samadani to incorporate the teachings of Gu by adding a robotically controlled instrument driving mechanism. Doing so would help reduce and/or eliminate physician fatigue resulting from a procedure, as recognized by Gu.
Tanaka teaches one or more laser light sources located at a handle portion or the instrument driving mechanism (the light source portion 70 is mounted inside the operation portion 23; Fig. 2, paragraph 0044).
Tanaka is considered to be analogous to the claimed invention because it is in the same field of endoscopes with light source in the proximal component. It would have been obvious to one having ordinary skill in the art at the time the invention was made to move the light source to the handle, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70.
Regarding claim 14, Samadani, as previously modified by Gu and Tanaka, discloses the illumination system according to claim 12. Samadani further discloses wherein the articulatable elongate member is disposable (tube 252 is capable of being disposable; Fig. 2B).
Regarding claim 15, Samadani, as previously modified by Gu and Tanaka, discloses the illumination system according to claim 12. Samadani, as previously modified by Tanaka, further discloses further comprising a laser speckle reducer located at the handle portion (laser speckle can be diminished with a laser speckle reducer 430 placed at the Fourier transform plane 402 between the collimating and focusing optics 216, 218; Fig. 4B, paragraph 0044).
Regarding claim 20, Samadani, as previously modified by Gu and Tanaka, discloses the illumination system according to claim 12. Samadani further discloses wherein the imaging sensor is embedded in the distal end of the articulable elongate member (the cameras 110 and illumination beam source 104 may be located side by side at the distal end of the device 112; Fig. 1, paragraph 0025).
Claims 2 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Samadani in view of Gu and Tanaka as applied to claims 1 and 12 above, and further in view of U.S. Patent Appl. Publ. No. 2020/0107706 A1 to Kamee et al. (“Kamee”).
Regarding claim 2, Samadani, as previously modified by Gu and Tanaka, discloses the medical device according to claim 1. However, Samadani, as modified by Gu and Tanaka, does not explicitly disclose comprising a coupler to mix the light from the one or more laser light sources into white light.
Kamee teaches a coupler to mix the light from the one or more laser light sources into white light (the laser light L1 is a blue laser light having a center wavelength of 445 nm, the laser light L2 is green laser light having a center wavelength of 532 nm, and the laser light L3 is red laser light having a center wavelength of 635 nm. For this reason, the laser light emitted from the light combiner LC is white laser light; Fig. 2, paragraph 0064 and 0053).
Kamee is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a proximal laser light source. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a coupler for combining multiple laser light sources in the light source device of Samadani, as taught by Kamee, to increase the functionality of the endoscope system of Tatsuta by enabling the endoscope to output tunable white light to enhance specific tissue contrasts improving visibility during endoscopic procedures.
Regarding claim 13, Samadani, as previously modified by Gu and Tanaka, discloses the illumination system according to claim 12. However, Samadani, as modified by Gu and Tanaka, does not explicitly disclose comprising a coupler to mix the light from the one or more laser light sources into white light.
Samadani teaches a coupler to mix the light from the one or more laser light sources into white light (the laser light L1 is a blue laser light having a center wavelength of 445 nm, the laser light L2 is green laser light having a center wavelength of 532 nm, and the laser light L3 is red laser light having a center wavelength of 635 nm. For this reason, the laser light emitted from the light combiner LC is white laser light; Fig. 2, paragraph 0064 and 0053).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a coupler for combining multiple laser light sources in the light source device of Samadani, as taught by Kamee, to increase the functionality of the endoscope system of Samadani by enabling the endoscope to output tunable white light to enhance specific tissue contrasts improving visibility during endoscopic procedures.
Claims 5-6, 10, 16-17, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Samadani in view of Gu and Tanaka as applied to claims 1 and 12 above, and further in view of U.S. Patent Appl. Publ. No. 2022/0313070 A1 to Tatsuta et al. (“Tatsuta”).
Regarding claim 5, Samadani, as previously modified by Gu and Tanaka, discloses the medical device according to claim 1. However, Samadani, as modified by Gu and Tanaka, does not explicitly disclose wherein the one or more laser light sources comprise at least a red laser diode, a green laser diode, and a blue laser diode.
Tatsuta teaches wherein the one or more laser light sources comprise at least a red laser diode, a green laser diode, and a blue laser diode (red (the color of beam light) laser light having a wavelength of 600 nm or more and 650 nm or less is used as the light emitted from the light source 23a in this embodiment, but light having a wavelength in other ranges, for example, green light having a wavelength of 495 nm or more and 570 nm or less or blue light may be used; paragraph 0087). Tatsuta teaches the use of a light source that emits blue narrow band light for emphasizing superficial information about superficial blood vessels (paragraph 0076).
Tatsuta is considered to be analogous to the claimed invention because it is in the same field of endoscopes systems with light sources. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscope of Samadani to incorporate the teachings of Tatsuta by including one or more laser light sources that include a red laser diode, a green laser diode, and a blue laser diode. Doing so would increase the functionality of the endoscope system as different wavelengths of light can be used to examine different tissue types, as recognized by Tatsuta.
Regarding claim 6, Samadani, as previously modified by Gu, Tanaka, and Tatsuta, discloses the medical device according to claims 1 and 5. Samdani, as modified by Tasuta, further teaches wherein the one or more optical elements are selected based at least in part on an operating wavelength of the light received via a respective optic fiber (the DOE 23b converts the light, which is emitted from the light source; Fig. 7, paragraph 0087). As the beam light-emitting unit was design to be operational with red, blue, and green laser diodes, it is known that the one or more optical elements were selected based at least in part on the operating wavelength of the light.
Regarding claim 10, Samadani, as previously modified by Gu and Tanaka, discloses the medical device according to claim 1. However, Samadani, as modified by Gu and Tanaka, does not explicitly disclose wherein the one or more optical elements comprise a second DOE configured for generating structured light that is used for creating a depth map.
Tatsuta teaches wherein the one or more optical elements comprise a second DOE configured for generating structured light that is used for creating a depth map (the DOE 23b converts the light, which is emitted from the light source, into the measurement light used to obtain measurement information; Fig. 9, paragraphs 0087-0091)(a subject is irradiated with measurement light by the beam light-emitting unit. It is possible to recognize the position of a spot from a subject image, and to measure an observation distance to an object to be observed, the size of the objected to be observed, and the like; abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a second DOE configured for generating structured light that is used for creating a depth map in the endoscope of Samadani, as taught by Tatsuta, to increase the functionality of the endoscope system of Samadani by enabling the endoscope system to measure the size of the object to be observed.
Regarding claim 16, Samadani, as previously modified by Gu and Tanaka, discloses the illumination system according to claim 1. However, Samadani, as modified by Gu and Tanaka, does not explicitly disclose wherein the one or more laser light sources comprise at least a red laser diode, a green laser diode, and a blue laser diode.
Tatsuta teaches wherein the one or more laser light sources comprise at least a red laser diode, a green laser diode, and a blue laser diode (red (the color of beam light) laser light having a wavelength of 600 nm or more and 650 nm or less is used as the light emitted from the light source 23a in this embodiment, but light having a wavelength in other ranges, for example, green light having a wavelength of 495 nm or more and 570 nm or less or blue light may be used; paragraph 0087). Tatsuta teaches the use of a light source that emits blue narrow band light for emphasizing superficial information about superficial blood vessels (paragraph 0076).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endoscope of Samadani to incorporate the teachings of Tatsuta by including one or more laser light sources that include a red laser diode, a green laser diode, and a blue laser diode. Doing so would increase the functionality of the endoscope system as different wavelengths of light can be used to examine different tissue types, as recognized by Tatsuta.
Regarding claim 17, Samadani, as previously modified by Gu, Tanaka, and Tatsuta, discloses the illumination system according to claims 12 and 16. Samdani, as modified by Tasuta, further teaches wherein the one or more optical elements are selected based at least in part on an operating wavelength of the light received via a respective optic fiber (the DOE 23b converts the light, which is emitted from the light source; Fig. 7, paragraph 0087). As the beam light-emitting unit was design to be operational with red, blue, and green laser diodes, it is known that the one or more optical elements were selected based at least in part on the operating wavelength of the light.
Regarding claim 21, Samadani, as previously modified by Gu and Tanaka, discloses the illumination system according to claim 12. However, Samadani, as modified by Gu and Tanaka, does not explicitly disclose wherein the one or more optical elements comprise a second DOE configured for generating structured light that is used for creating a depth map.
Tatsuta teaches wherein the one or more optical elements comprise a second DOE configured for generating structured light that is used for creating a depth map (the DOE 23b converts the light, which is emitted from the light source, into the measurement light used to obtain measurement information; Fig. 9, paragraphs 0087-0091)(a subject is irradiated with measurement light by the beam light-emitting unit. It is possible to recognize the position of a spot from a subject image, and to measure an observation distance to an object to be observed, the size of the objected to be observed, and the like; abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a second DOE configured for generating structured light that is used for creating a depth map in the endoscope of Samadani, as taught by Tatsuta, to increase the functionality of the endoscope system of Samadani by enabling the endoscope system to measure the size of the object to be observed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Appl. Publ. No. 2021/0267443 A1 to Baumann et al. teaches a deformable lens with an adjustment mechanism such a piezo-motor as described in the descriptive text.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET.
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/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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