DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-2, 4-5, 7-10, 14-17, 19, 23-24, and 26-27 are pending, claims 3, 6, 11-13, 18, 20-22, 25, and 28-42 have been cancelled, and claims 1-2, 4-5, 7-10, 14-17, 19, 23-24, and 26-27 are currently under consideration for patentability under 37 CFR 1.104. Previous claim objection and 35 USC 112 Rejections have been withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2, 4-5, 7-10, 14-17, 19, 23-24, and 26-27 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 14 and 17 are objected to because of the following informalities:
Regarding claim 14, on line 25, change “an image brightness” to “the image brightness” (i.e., previously recited).
Regarding claim 17, on line 3, change “an image sensor” to “the image sensor” (i.e., previously recited).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 16 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.
Regarding claim 16, the limitation “the imaging unit comprises a distal end of the laparoscopic system” is unclear. It is unclear how an imaging unit would be able to include a distal end of the laparoscopic system, especially with respect to how the imaging unit is recited in claim 14.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4-5, and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over McKinley (US 2014/0107417), in view of Saito (US 2014/0036051) and Nishio (US 2019/0110663) and Ashida (US 2012/0035419) and Murakita (US 2017/0196443).
Regarding claim 1, McKinley discloses a cannula assembly (see 100, figure 1) comprising: a tube (110, figure 1) having a distal end portion (116, figure 1) configured for insertion into a patient (for insertion [0034]) and housing an imaging unit including an image sensor (CCD or CMOS [0037] | 304, figure 3), a light source (illumination component 305 [0040]). McKinley is silent regarding a temperature sensor; and a processor integrated into and positioned within the cannula assembly, wherein the processor is operable to: receive temperature information from the temperature sensor; determine, based on the temperature information, whether a temperature of the image sensor is within a predetermined temperature range having a predetermined high threshold and a predetermined low threshold; and maintain the temperature of the image sensor within the predetermined temperature range not to exceed the high threshold or go below the low threshold by modifying an illumination level of the imaging unit; wherein the processor is operable to control a gain of the image sensor in response to a change in the illumination level to maintain an image brightness at a predefined brightness range or predefined brightness level; wherein in response to a temperature of the image sensor exceeding the high threshold the controller reduces the illumination level of the light source and in response to a temperature of the image sensor being below the low threshold, the controller increases the illumination level of the light source until the temperature is equal to or greater than the low threshold; and wherein the processor is operable to control an exposure of images generated by the image sensor in response to changes in the illumination level adjusted in response to the temperature of the image sensor to maintain the image brightness at the predefined brightness range or the predefined brightness level.
Saito teaches an endoscope system (1, figure 1) with an endoscope (2, figure 1), a processing device (3, figure 1), and a light source device (4, figure 1). The endoscope has a temperature detector (244d, figure 2) that detects a temperature of the image pickup device (244, figure 2) in the distal end portion of the endoscope ([0020]). The temperature information is sent to the processing device (see temperature information in figure 2), where the process controller (309, figure 2) controls the image pickup device based on the temperature information ([0051]). The process controller compares the temperature with a temperature upper limit, where when the temperature is not lower than the upper limit temperature, the process controller performs control of lowering the output light quantity output from the light source device ([0061]). Further, the process controller performs control of raising a gain of the image signal input from the image pickup device ([0062]). If the temperature is lower than the upper limit temperature and is in the low temperature mode, the process controller performs control raising the output light quantity output from the light source device (figure 4; [0065]). The process controller lowers a gain of the image signal input from the image pickup device ([0066]). The brightness detector (303, figure 2) calculates a gain adjustment value and a light irradiation amount based on the detected brightness level, outputs the gain adjustment value to the gain adjustment unit (302c, figure 2), and outputs the light irradiation amount to the light adjustment unit (304, figure 2; [0045]).
Nishio teaches an endoscope system (100, figure 2) with an insertion module (11, figure 1), an operation module (12, figure 1), and a universal cord (13, figure 1) that connects to a central part (2, figure 1). The operation module (12, figure 2) has a light source (12a, figure 2) and a temperature sensor (12c, figure 2) that detects the temperature of the light source ([0037]). The operation module also contains a corrector (12d, figure 2) and a light source controller (12b, figure 2). The temperature detected by the temperature sensor is given to the corrector, where the corrector generates the correction value for addressing a change in the relationship between a current applied to the light source and the optical output of the light source ([0038]). The light source may be any type as long as it is adapted to emit primary light ([0032]).
Ashida teaches an electronic endoscope (11, figure 1) and a processing apparatus (13, figure 2). A DSP (32, figure 2) has a temperature converter (38, figure 2) for detecting a temperature of a CMOS sensor (21, figure 2). A CPU (43, figure 2) sets a upper limit to the light quantity of the illumination light outputted from the light source (41, figure 2) in accordance with the temperature of the CMOS sensor ([0058]). High and low threshold values Ta and Tb are set relative to the temperature of the CMOS sensor and high and low upper limits La and Lb to the light quantity of the illumination light are previously set ([0059]; see figure 7). When the temperature of the CMOs sensor exceeds the high threshold value Ta, the CPU sets the low upper limit LB as the upper limit ([0059]). The automatic light control (ALC) is performed such that the light quantity of the illumination light is within a range not exceeding the low upper limit Lb ([0059]). When the temperature of the CMOS sensor is at or below the low threshold value Tb, the CPU sets the high upper limit La as the upper limit, and performs the automatic light control such that the light quantity of the illumination light is within a range not exceeding the high upper limit La ([0059]).
Murakita teaches an endoscope (11, figure 1), where an image signal is transmitted to the CCU (13, figure 1). The CCU senses the brightness in the image and based on the acquired detection value, controls the exposure of the imaging section ([0042]). The shutter speed of the imaging section can be controlled and/or the gain applied to the captured image signal can be controlled ([0042]; [0044]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the cannula assembly with the temperature detector (244d, figure 2) and processing device (3, figure 2 | specifically 309, figure 2) as taught by Saito. Doing so would prevent the deterioration of image quality with temperature ([0006]). Also, it would have been obvious to modify the processor to be integrated into the cannula assembly to be near the light source as taught by Nishio (see 12b in operation module 12, figures 1-2). Doing so would alternatively provide a processor closer to the light source to control it (see figure 2; Nishio | [0047]). Further, it would have been obvious to modify the processor of McKinley and Saito and Nishio to use a low temperature threshold value Tb and high light quantity upper limit La, where automatic light control is performed such that the light quantity of the illumination light is within a range not exceeding the high light quantity upper limit La as taught by Ashida ([0059]). Doing so would ensure the temperature of the CMOS sensor are in a range for normal operation ([0060]). Additionally, it would have been obvious to modify the processor to also control the exposure of the imaging section as taught by Murakita ([0042]). Doing so would allow the brightness of the image to become a more preferable state and reach a correct exposure ([0042]). The modified assembly would have a temperature sensor (244d, figure 2; temperature detector…temperature in the image pickup device [0022]; Saito); and a processor (3 and 309, figure 2; Saito) integrated into and positioned within the cannula assembly (see 12b, figure 2; Nishio | any type of light source [0032], the Examiner interpreted the modified processor can be located in other parts of the assembly depending on the type of light source), wherein the processor is operable to: receive temperature information from the temperature sensor (see temperature information output to the process controller 309, figure 2; [0036]; Saito); determine, based on the temperature information, whether a temperature of the image sensor is within a predetermined temperature range (s102, figure 4; Saito) having a predetermined high threshold (s103, figure 4; Saito) and a predetermined low threshold (low threshold value Tb…[0059]; figure 9; Ashida); and maintain the temperature of the image sensor within the predetermined temperature range not to exceed the high threshold (see 103-105, figure 4; Saito) or go below the low threshold (at or below the low threshold value Tb…performs automatic light control…[0059]; Ashida) by modifying an illumination level of the imaging unit (s104, figure 4; Saito | performs automatic light control…illumination light is within a range not exceeding the high upper limit La [0059]; Ashida); wherein the processor is operable to control a gain of the image sensor in response to a change in the illumination level (s105 or s109, figure 4; Saito) to maintain an image brightness at a predefined brightness range or predefined brightness level (brightness detector…gain adjustment value…[0045] | interpreted there to be a predefined brightness level that is being used as a reference; Saito); wherein in response to a temperature of the image sensor exceeding the high threshold the controller reduces the illumination level of the light source (s104, figure 4; Saito) and in response to a temperature of the image sensor being below the low threshold, the controller increases the illumination level of the light source until the temperature is equal to or greater than the low threshold (performs automatic light control…illumination light is within a range not exceeding the high upper limit La [0059]; Ashida); and wherein the processor is operable to control an exposure of images (controls the shutter speed…exposure [0042]; Murakita) generated by the image sensor in response to changes in the illumination level adjusted in response to the temperature of the image sensor (detection result for the brightness…exposure [0042]; Murakita | brightness changes due to the change in illumination level, which is in response to the temperature of the image sensor) to maintain the image brightness at the predefined brightness range or the predefined brightness level (brightness of the image…preferable state [0042]; Murakita).
Regarding claim 2, McKinley further discloses the distal end portion further comprises a tip operable to create an incision (tip…puncturing the patient’s skin [0035]; McKinley).
Regarding claim 4, Murakita further teaches the processor is operable to increase the exposure of images generated by the image sensor in response to decreasing the illumination level (detects the brightness…controls the exposure…becomes a more preferable state/correct exposure [0042]; Murakita).
Regarding claim 5, Saito further teaches the processor is operable to increase the gain of the image sensor in response to decreasing the illumination level (raise gain s105, figure 4; Saito).
Regarding claim 7, Murakita further teaches the processor is operable to decrease the exposure of images generated by the image sensor in response to increasing the illumination level (detects the brightness…controls the exposure…becomes a more preferable state/correct exposure [0042]; Murakita).
Regarding claim 8, Saito and Ashida further teach the processor is operable to decrease the gain of the image sensor (s109, figure 4; Saito) in response to increasing the illumination level (performs ALC such that the light quantity…not exceeding the high upper limit La [0059]; figure 9 of Ashida | the light quantity can be raised, as La is a higher upper limit to light quantity, see figure 9).
Regarding claim 9, McKinley further discloses the image sensor includes a camera (CCD camera [0037]; McKinley) with a lens (window 510, figure 5a; [0052]).
Regarding claim 10, McKinley further discloses a deployable housing (see 204, figure 2; McKinley) rotatably coupled to the tube between a closed position (figure 1) and one or more open positions (figure 2), wherein the image sensor (304, figure 3) and the processor is housed within the deployable housing (see figure 3; McKinley | see 12b near 12a, figure 2 of Nishio; the modified assembly can have the processor be located in the deployable housing to be near the light source 305, figure 3 of McKinley), wherein the imaging unit is configured to provide a longitudinal view when the deployable housing is in the closed position (see figures 5; McKinley) and a transverse view relative to a longitudinal axis of the tube when the housing is in the one or more open positions (see figure 4).
Claim(s) 14-16, 23-24, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Saito (US 2014/0036051), in view of Nishio (US 2019/0110663) and Ashida (US 2012/0035419) and Murakita (US 2017/0196443).
Regarding claim 14, Saito discloses a system (figure 1) comprising: a surgical device (2, figure 1) used in a laparoscopic system (a body cavity [0017]), wherein the surgical device includes: a processor (3, figure 1); and a computer-readable data storage device (308, figure 2; [0050]) comprising program instructions (various programs…[0050]) that, when executed by the processor, control the system to: receive temperature information from a temperature sensor (244d, figure 2) of an imaging unit (light guide 24a and/or light source 41, CMOS image sensor 244, AFE unit 244b, temperature sensor 244d, figure 2); determine, based on the temperature information, whether a temperature of the imaging unit is within a predetermined temperature range (s102, figure 4) having a predetermined high threshold (s103, figure 4); and maintain the temperature of the imaging unit within the predetermined temperature range not to exceed the high threshold (see 103-105, figure 4) by modifying an illumination level of a light source of the imaging unit (s104, figure 4); wherein the processor is operable to control a gain of an image sensor (CMOS image sensor 244, figure 2) in response to a change in the illumination level (s105 and s109, figure 4) to maintain an image brightness at a predefined brightness range or predefined brightness level (brightness detector…gain adjustment value…[0045] | interpreted there to be a predefined brightness level that is being used as a reference); wherein in response to a temperature of the image sensor exceeding the high threshold the controller reduces the illumination level of the light source (s104, figure 4). Saito is silent regarding the processor integrated into and positioned within the surgical device, a predetermined low threshold; maintain the temperature of the imaging unit within the predetermined temperature range not to go below the low threshold by modifying the illumination level of the light source of the imaging unit in response to a temperature of the image sensor being below the low threshold, the controller increases the illumination level of the light source until the temperature is equal to or greater than the low threshold; and wherein the processor is operable to control an exposure of images generated by the image sensor in response to changes in the illumination level adjusted in response to the temperature of the image sensor to maintain an image brightness at the predefined brightness range or the predefined brightness.
Nishio teaches an endoscope system (100, figure 2) with an insertion module (11, figure 1), an operation module (12, figure 1), and a universal cord (13, figure 1) that connects to a central part (2, figure 1). The operation module (12, figure 2) has a light source (12a, figure 2) and a temperature sensor (12c, figure 2) that detects the temperature of the light source ([0037]). The operation module also contains a corrector (12d, figure 2) and a light source controller (12b, figure 2). The temperature detected by the temperature sensor is given to the corrector, where the corrector generates the correction value for addressing a change in the relationship between a current applied to the light source and the optical output of the light source ([0038]). The light source may be any type as long as it is adapted to emit primary light ([0032]).
Ashida teaches an electronic endoscope (11, figure 1) and a processing apparatus (13, figure 2). A DSP (32, figure 2) has a temperature converter (38, figure 2) for detecting a temperature of a CMOS sensor (21, figure 2). A CPU (43, figure 2) sets a upper limit to the light quantity of the illumination light outputted from the light source (41, figure 2) in accordance with the temperature of the CMOS sensor ([0058]). High and low threshold values Ta and Tb are set relative to the temperature of the CMOS sensor and high and low upper limits La and Lb to the light quantity of the illumination light are previously set ([0059]; see figure 7). When the temperature of the CMOs sensor exceeds the high threshold value Ta, the CPU sets the low upper limit LB as the upper limit ([0059]). The automatic light control (ALC) is performed such that the light quantity of the illumination light is within a range not exceeding the low upper limit Lb ([0059]). When the temperature of the CMOS sensor is at or below the low threshold value Tb, the CPU sets the high upper limit La as the upper limit, and performs the automatic light control such that the light quantity of the illumination light is within a range not exceeding the high upper limit La ([0059]).
Murakita teaches an endoscope (11, figure 1), where an image signal is transmitted to the CCU (13, figure 1). The CCU senses the brightness in the image and based on the acquired detection value, controls the exposure of the imaging section ([0042]). The shutter speed of the imaging section can be controlled and/or the gain applied to the captured image signal can be controlled ([0042]; [0044]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the processor of Saito to be integrated into the surgical device to be between an imaging unit and image processor as taught by Nishio (see 12b in operation module 12 between 11c and 2a, figures 1-2). Doing so would alternatively provide a processor closer the imaging unit (see figure 2; Nishio | [0033]). Also, it would have been obvious to modify the processor of Saito and Nishio to use a low temperature threshold value Tb and high light quantity upper limit La, where automatic light control is performed such that the light quantity of the illumination light is within a range not exceeding the high light quantity upper limit La as taught by Ashida ([0059]). Doing so would ensure the temperature of the CMOS sensor are in a range for normal operation ([0060]). Additionally, it would have been obvious to modify the processor to also control the exposure of the imaging section as taught by Murakita ([0042]). Doing so would allow the brightness of the image to become a more preferable state and reach a correct exposure ([0042]). The modified system would have the processor integrated into and positioned within the surgical device (see location of 12b in 12, figures 1-2; Nishio), a predetermined low threshold (low threshold value Tb…[0059]; figure 9; Ashida); maintain the temperature of the imaging unit within the predetermined temperature range not to go below the low threshold (at or below the low threshold value Tb…performs automatic light control…[0059]; Ashida) by modifying the illumination level of the light source of the imaging unit (performs automatic light control…illumination light is within a range not exceeding the high upper limit La [0059]; Ashida); in response to a temperature of the image sensor being below the low threshold (low threshold value Tb…[0059]; Ashida), the controller increases the illumination level of the light source until the temperature is equal to or greater than the low threshold (performs automatic light control…illumination light is within a range not exceeding the high upper limit La [0059] | the light quantity can be raised, as La is a higher upper limit to light quantity, see figure 9 of Ashida); and wherein the processor is operable to control an exposure of images (controls the shutter speed…exposure [0042]; Murakita) generated by the image sensor in response to changes in the illumination level adjusted in response to the temperature of the image sensor (detection result for the brightness…exposure [0042]; Murakita | brightness changes due to the change in illumination level, which is in response to the temperature of the image sensor) to maintain an image brightness at the predefined brightness range or the predefined brightness (brightness of the image…preferable state [0042]; Murakita).
Regarding claim 15, Saito further discloses the system is operable to: receive images from the image sensor of the imaging unit (244, figure 2; Saito); and normalize the images based on the modifying of the illumination level of the light source (s105 and s109, figure 4).
Regarding claim 16, Saito further discloses the system comprises the imaging unit (244, figure 2) comprises a distal end of the laparoscopic system (see 24, figures 1-2).
Regarding claim 23, Murakita further teaches the system is operable to increase the exposure of images generated by the image sensor in response to decreasing the illumination level (detects the brightness…controls the exposure…becomes a more preferable state/correct exposure [0042]; Murakita).
Regarding claim 24, Saito further discloses the system is operable to increase a gain of the image sensor in response to decreasing the illumination level (raise gain s105, figure 4; Saito).
Regarding claim 26, Murakita further teaches the system is operable to decrease the exposure of images generated by the image sensor in response to increasing the illumination level (detects the brightness…controls the exposure…becomes a more preferable state/correct exposure [0042]; Murakita).
Regarding claim 27, Saito and Ashida further discloses the system is operable to decrease the gain of the image sensor (lower gain s109, figure 4; Saito) in response to increasing the illumination level (performs ALC such that the light quantity…not exceeding the high upper limit La [0059]; figure 9 of Ashida | the light quantity can be raised, as La is a higher upper limit to light quantity, see figure 9).
Claim(s) 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Saito (US 2014/0036051) and Nishio (US 2019/0110663) and Ashida (US 2012/0035419) and Murakita (US 2017/0196443) as applied to claim 14 above, and further in view of McKinley (US 2014/0107417).
Regarding claim 17, Saito and Nishio and Ashida and Murakita disclose all of the features in the current invention as shown above in claim 14. They are silent regarding the surgical device comprises a cannula assembly including the processor and the imaging unit, the imaging unit including an image sensor, wherein the cannula assembly comprises a tube with a distal end configured for insertion into a patient and a housing on the tube for housing the image sensor.
McKinley teaches a cannula assembly (100, figure 1) with a tubular element (110, figure 1) and a deployable portion (204, figure 2). The deployable portion houses electronic components, which is at least partially disposed in the lumen when in the closed position ([0036]). The electronic components may be image transmission components (304, figure 3) and an illumination component (305, figure 3), which can be one or more light sources (306, figure 3) and their ancillary electronic drivers (310, figure 3). The deployable portion has an adjustable angle of deployment based on the operation of the opening adjustment means (see figures 1-2; [0036]). The pointed tip of the cannula assembly can puncture the patient’s skin ([0035]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the system, specifically the processing device and temperature feedback of Saito, Ashida, and Murakita to be used with the cannula assembly (100, figure 1) of McKinley. Doing so would minimize the number of openings for a minimally invasive procedure ([0003]) by combining a trocar cannula with imaging and illumination capabilities ([0008]). The modified system would have the surgical device comprises a cannula assembly (100, figure 1; McKinley) including the processor (see 12b in operation module 12 between 11c and 2a, figures 1-2; Nishio) and the imaging unit (244, figure 2; Saito), the imaging unit including an image sensor (CCD or CMOS [0037]; McKinley | 244, figure 2; Saito), wherein the cannula assembly comprises a tube (110, figure 1; McKinley) with a distal end configured for insertion into a patient (for insertion [0034]) and a housing on the tube for housing the image sensor (see 204, figure 2 | see 304, figure 3).
Regarding claim 19, McKinley further teaches the housing is rotatably coupled to the tube between a closed position (see figure 1; McKinley) and one or more open positions (see figure 2).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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PAMELA F. WU
Examiner
Art Unit 3795
April 17, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
Prosecution Insights