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 46-65 are pending, claims 1-45 have been cancelled, and claims 46-65 are currently under consideration for patentability under 37 CFR 1.104.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/24/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 46-65 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 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) 46-50 and 58-61 are rejected under 35 U.S.C. 103 as being unpatentable over Litscher (US 2006/0276689), in view of Banik (US 2005/0222499) and Ouyang (US 2010/0286477).
Regarding claim 46, Litscher discloses an imaging endoscopy kit (see figure 1; [0041]) for assembling an imaging endoscopy system (see figure 1) for use in gastroscopy or colonoscopy ([0002]), the imaging endoscopy system assembled from the kit comprising: a base unit (122, figure 1); a hand controller (116, figure 1); an umbilical section (114, figure 1) releasably connecting the base unit and the hand controller (114…connected to 122, figure 1; [0043]); an insertion section (118, figure 1) having a proximal end connected to the hand controller (118…connected…116 [0040]) and a distal end (see 120, figure 1) for insertion into a subject (advancing into a patient’s body [0040]), the distal end having a steering section (steer the endoscope distal tip 120 [0081]) and a distal tip (120, figure 1), wherein: the hand controller includes two rotational drive wheels (see plurality of rotary knobs 614, figure 6) for controlling bending of the steering section; the distal tip includes an imaging chip (image sensor…distal tip [0044]) for imaging a region of tissue of interest; the insertion section further including an electrical conductor for conducting electrical signals from the imaging chip to the proximal end of the insertion section (imaging electronics…transfer images…to the video display [0046]); the insertion section further including lumens (lumens…[0044]) adapted to: deliver insufflation gas to the distal tip (activating air [0074]); deliver irrigation liquid to the distal tip (activating water [0074]); provide suction at the distal tip (activating suction [0074]); provide a conduit (see 616, figure 6) for at least one surgical tool to be inserted along the insertion section to the distal tip (instrument into the working channel [0074]); wherein the imaging endoscopy kit comprises: the base unit (reusable control cabinet [0041]; see operator console 122, figure 1; reusable console 820 [0081]); and a plurality of sealed containers (imaging endoscope 110…manufacture…single-use, disposable item… sterile instrument [0041]), together containing: a plurality of said hand controllers, in sterile condition (110 includes…116 [0040]; 110…single-use, disposable item [0041]); a plurality of said umbilical sections, in sterile condition (110 includes…114 [0040]; 110…single-use, disposable item [0041]); and a plurality of said insertion sections, in sterile condition (110 includes…118 [0040]; 110…single-use, disposable item [0041]), wherein, when the umbilical section is detached from the base unit and the hand controller and insertion section (endoscope proximal shaft 112 that is electrically, mechanically, and fluidly connected…at an opposite end, to an inlet port of a handheld manual controller 116 [0040]) are immersed in water at room temperature and pressure, the hand controller and/or the insertion section is water permeable to permit ingress of water into the steering channels in the insertion section (inlet port is open, water can enter into the controller 116; see figure 6), the umbilical section, hand controller and insertion section being single use (single-use [0041]). Litscher is silent regarding the insertion section includes four steering wires connecting the rotational drive wheels of the hand controller and the steering section, the steering wires passing along steering channels in the insertion section, the steering section having two axes of bending; wherein the plurality of sealed containers includes one or more sealed containers each containing only a single one of: a hand controller, an umbilical section, or an insertion section, and sealing of the steering channels being unnecessary due to the umbilical section, hand controller and insertion section being single use.
Banik teaches a video endoscope system (10, figure 1a) with an endoscope (20, figure 1a) and a distal tip (22, figure 1a). The distal tip (400, figure 6a) has a distal cap (450, figure 6e). The distal cap can be precision molded out of ABS or other bio-compatible material ([0145]). The distal tip (400, figure 6a) has windows (460 and 462, figure 6b) to cover illumination sources, a lens port (458, figure 6b), a flush cap (456, figure 6b), a working channel (452, figure 6b), and an opening (454, figure 6b) for a low pressure lavage. The distal tip (600, figure 7) has a number of counter bored holes (602, figure 7) to receive the ends of the control cables to orient the distal tip ([0162]). The control cables may extend through guides within the wall of the articulation joint (654, figure 8; [0164]).
Ouyang teaches a visualization sensor component (100, figure 1) that has a distal end CMOS visualization sensor (110, figure 1) that includes a lens housing component (115, figure 1). The sub-components of the lens housing/light source component (115, figure 1) are operatively coupled to a flexible cable (130, figure 1) which provides for operative connection of the CMOS visualization sensor at the distal end of the device via the handle (140, figure 1). The flexible cable (130, figure 1) in the handle (140, figure 1) operatively connects to a cable (152, figure 1), which connects to video processing sub-system (150, figure 1). Each of the components of the device may individually be single-use, of limited reusability, or indefinitely reusable, resulting in an overall device or system comprised of components having differing usability parameters ([0039]). The components of the system may be packaged as desired, e.g., together or separately ([0056]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the insertion section to have control cables/steering wires ([0162]), an articulation joint (654, figure 8), and a distal tip (400, figure 6a and 600, figure 7) as taught by Banik. Doing so would provide steering/orient the distal tip ([0162]). It would have been obvious to modify the kit to have the hand controllers, umbilical sections, and insertion section be separately packaged ([0056]) with individual usability parameters ([0039]) as taught by Ouyang. Doing so would provide individual components with its own usability parameter ([0039]) that can be packaged as desired ([0056]). The modified kit would have the insertion section includes four steering wires (see 4 counter bored holes 602, figure 7; Banik) connecting the rotational drive wheels of the hand controller and the steering section (see knobs 614, figure 6 of Litscher | the modified insertion section would connect the knobs of Litscher to the steering wires of Banik), the steering wires passing along steering channels in the insertion section (extends through guides within the wall of the articulation joint [0164]), the steering section having two axes of bending (see the two knobs 614, figure 6 of Litscher | interpreted there to be 2 axes of bending); wherein the plurality of sealed containers includes one or more sealed containers each containing only a single one (modified kit can have various components separately packaged [0056]; Ouyang) of: a hand controller, an umbilical section, or an insertion section (114, 116, 118 [0040]; 110…single-use, disposable item [0041]; Litscher), and sealing of the steering channels being unnecessary due to the umbilical section, hand controller and insertion section being single use (single-use [0041]; Litscher).
Regarding claim 47, Litscher further discloses each sealed container (imaging endoscope 110…manufacture…single-use, disposable item… sterile instrument [0041]; Litscher) contains one hand controller, one umbilical section and one insertion section (110 includes…connector 114…controller 116…distal shaft 118 [0040]; 110…single-use, disposable item [0041]).
Regarding claim 48, Litscher further discloses the hand controller has an imaging operation switch (612…taking a picture [0074]; Litscher), adapted to control the system to record at least one of moving images and still images (image sensor…video capture [0046]; interpreted video capture to mean record).
Regarding claim 49, Litscher further discloses the distal tip includes a light source (illumination mechanism…distal tip [0044]; Litscher) for illumination of the region of tissue of interest.
Regarding claim 50, Litscher further discloses at least one electrical conductor (electrically…connected….endoscope distal shaft…[0040]; Litscher) for providing electrical power to the light source.
Regarding claim 58, Litscher discloses a method for assembling an imaging endoscopy system (see figure 1) for use in gastroscopy or colonoscopy ([0002]), the imaging endoscopy system comprising: a base unit (122, figure 1); a hand controller (116, figure 1); an umbilical section (114, figure 1) releasably connecting the base unit and the hand controller (114…connected to 122, figure 1; [0043]); an insertion section (118, figure 1) having a proximal end connected to the hand controller (118…connected…116 [0040]) and a distal end (see 120, figure 1) for insertion into a subject (advancing into a patient’s body [0040]), the distal end having a steering section (steer the endoscope distal tip 120 [0081]) and a distal tip (see 120, figure 1), wherein the hand controller includes two rotational drive wheels (see plurality of rotary knobs 614, figure 6) for controlling bending of the steering section; the distal tip includes an imaging chip (image sensor…distal tip [0044]) for imaging a region of tissue of interest; the insertion section further including an electrical conductor for conducting electrical signals from the imaging chip to the proximal end of the insertion section (imaging electronics…transfer images…to the video display [0046]); the insertion section further including lumens (lumens…[0044]) adapted to: deliver insufflation gas to the distal tip (activating air [0074]); deliver irrigation liquid to the distal tip (activating water [0074]); provide suction at the distal tip (activating suction [0074]); provide a conduit (see 616, figure 6) for at least one surgical tool to be inserted along the insertion section to the distal tip (instrument into the working channel [0074]); wherein, when the umbilical section is detached from the base unit and the hand controller and insertion section (endoscope proximal shaft 112 that is electrically, mechanically, and fluidly connected…at an opposite end, to an inlet port of a handheld manual controller 116 [0040]) are immersed in water at room temperature and pressure, the hand controller and/or the insertion section is water permeable to permit ingress of water into the steering channels in the insertion section (inlet port is open, water can enter into the controller 116; see figure 6), the umbilical section, hand controller and insertion section being single use (single-use [0041]), wherein the method comprises: disconnecting a used umbilical section (110 includes…114 [0040]; 110…single-use, disposable item [0041]) from the base unit (reusable control cabinet [0041]; see operator console 122, figure 1; reusable console 820 [0081]) and disposing of said used umbilical section, along with a connected used hand controller and insertion section (single-use, disposable item [0041]); opening two or more sealed containers (manufacture…single-use, disposable item… sterile instrument [0041]) containing: a hand controller, in sterile condition (110 includes…116 [0040]; 110…single-use, disposable item [0041]); an umbilical section, in sterile condition (110 includes…114 [0040]; 110…single-use, disposable item [0041]); and an insertion section, in sterile condition (110 includes…118 [0040]; 110…single-use, disposable item [0041]), and connecting the sterile umbilical section to the base unit (reusable control cabinet [0041]; see operator console 122, figure 1; reusable console 820 [0081] | sterile instrument for each use [0041]) to provide an imaging endoscopy system ready for use. Litscher is silent regarding the insertion section includes four steering wires connecting the rotational drive wheels of the hand controller and the steering section, the steering wires passing along steering channels in the insertion section, the steering section having two axes of bending; wherein the two or more sealed containers includes one or more sealed containers each containing only a single one of: a hand controller, an umbilical section, or an insertion section, and sealing of the steering channels being unnecessary due to the umbilical section, hand controller and insertion section being single use.
Banik teaches a video endoscope system (10, figure 1a) with an endoscope (20, figure 1a) and a distal tip (22, figure 1a). The distal tip (400, figure 6a) has a distal cap (450, figure 6e). The distal cap can be precision molded out of ABS or other bio-compatible material ([0145]). The distal tip (400, figure 6a) has windows (460 and 462, figure 6b) to cover illumination sources, a lens port (458, figure 6b), a flush cap (456, figure 6b), a working channel (452, figure 6b), and an opening (454, figure 6b) for a low pressure lavage. The distal tip (600, figure 7) has a number of counter bored holes (602, figure 7) to receive the ends of the control cables to orient the distal tip ([0162]). The control cables may extend through guides within the wall of the articulation joint (654, figure 8; [0164]).
Ouyang teaches a visualization sensor component (100, figure 1) that has a distal end CMOS visualization sensor (110, figure 1) that includes a lens housing component (115, figure 1). The sub-components of the lens housing/light source component (115, figure 1) are operatively coupled to a flexible cable (130, figure 1) which provides for operative connection of the CMOS visualization sensor at the distal end of the device via the handle (140, figure 1). The flexible cable (130, figure 1) in the handle (140, figure 1) operatively connects to a cable (152, figure 1), which connects to video processing sub-system (150, figure 1). Each of the components of the device may individually be single-use, of limited reusability, or indefinitely reusable, resulting in an overall device or system comprised of components having differing usability parameters ([0039]). The components of the system may be packaged as desired, e.g., together or separately ([0056]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the method to comprise the insertion section to have control cables/steering wires ([0162]), an articulation joint (654, figure 8), and a distal tip (400, figure 6a and 600, figure 7) as taught by Banik. Doing so would provide steering/orient the distal tip ([0162]). It would have been obvious to modify the method to have the hand controllers, umbilical sections, and insertion section be separately packaged ([0056]) with individual usability parameters ([0039]) as taught by Ouyang. Doing so would provide individual components with its own usability parameter ([0039]) that can be packaged as desired ([0056]). The modified method would comprise the insertion section includes four steering wires (see 4 counter bored holes 602, figure 7; Banik) connecting the rotational drive wheels of the hand controller and the steering section (see knobs 614, figure 6 of Litscher | the modified insertion section would connect the knobs of Litscher to the steering wires of Banik), the steering wires passing along steering channels in the insertion section (extends through guides within the wall of the articulation joint [0164]), the steering section having two axes of bending (see the two knobs 614, figure 6 of Litscher | interpreted there to be 2 axes of bending); wherein the two or more sealed containers includes one or more sealed containers each containing only a single one (modified kit can have various components separately packaged [0056]; Ouyang) of: a hand controller, an umbilical section, or an insertion section (114, 116, 118 [0040]; 110…single-use, disposable item [0041]; Litscher), and sealing of the steering channels being unnecessary due to the umbilical section, hand controller and insertion section being single use (single-use [0041]; Litscher).
Regarding claim 59, Litscher further discloses operating an imaging operation switch (612…taking a picture [0074]; Litscher) at the hand controller to record at least one of moving images and still images (image sensor…video capture [0046]; interpreted video capture to mean record).
Regarding claim 60, Litscher further discloses the distal tip includes a light source (illumination mechanism…distal tip [0044]; Litscher) for illumination of the region of tissue of interest.
Regarding claim 61, Litscher further discloses at least one electrical conductor (electrically…connected….endoscope distal shaft…[0040]; Litscher) for providing electrical power to the light source.
Claim(s) 51-57 and 62-65 are rejected under 35 U.S.C. 103 as being unpatentable over Litscher (US 2006/0276689) and Banik (US 2005/0222499) and Ouyang (US 2010/0286477) as applied to claims 46 and 58 above, and further in view of Seifert (US 2007/0249899).
Regarding claim 51, Litscher and Banik and Ouyang disclose all of the features in the current invention as shown above in claim 46. They are silent regarding the distal tip includes a distal tip housing which is integrally formed from light-transmissive material.
Seifert teaches a video arthroscope (see figure 1) with a CCD and four-way angulations ([0025]). The tip of the arthroscope can be provided with a distal window (20, figure 2) made of a polycarbonate or acrylic ([0025]) with very high light transmission properties (abstract).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the kit to have a distal tip housing that is integrally form of polycarbonate or acrylic ([0025]) as taught by Seifert. Doing so would provide a distal tip housing that has very high light transmission properties (abstract). The modified kit would have the distal tip includes a distal tip housing (see 450, figure 6c; Banik) which is integrally formed (precision molded [0145]; Banik) from light-transmissive material (modified to be made of polycarbonate or acrylic [0025]; Seifert).
Regarding claim 52, Banik further teaches the distal tip housing is integrally formed (precision molded [0145]; Banik) from plastics material (ABS [0145]; ABS or Acrylonitrile butadiene styrene is a specific type of plastic | see ABS plastic [0159] of Banik).
Regarding claim 53, Seifert further teaches in operation, the distal tip housing diffuses illumination light from a light source (very high light transmission properties; abstract of Seifert | LEDs…endoscope distal tip [0048]; Litscher).
Regarding claim 54, Banik further teaches the distal tip housing has a collar portion (see proximal end of 450, figure 6E; Banik) extending proximally of a distal end face (see distal end face of 450, figure 6c), the collar portion adapted to fit over a distal end of the steering section (see figure 6d).
Regarding claim 55, Banik further teaches the distal tip housing has at least one lumen extension portion (see the lumens extending proximally in figure 6e; Banik), adapted to engage with a corresponding lumen extending along a core part of the insertion section (see location of 470, figure 63 | working channel 452, low pressure lavage 454, and flush cap 456, figure 6b | interpreted these channels/lumens to connect with corresponding lumen of the insertion section), the lumen extension portion opening to a distal end face of the distal tip housing (see figures 6).
Regarding claim 56, Banik further teaches the distal tip housing has at least two lumen extension portions (see lumens extended proximally in figure 6e; Banik), adapted to engage with respective corresponding lumens extending along a core part of the insertion section (see location of 470, figure 63 | working channel 452, low pressure lavage 454, and flush cap 456, figure 6b | interpreted these channels/lumens to connect with corresponding lumen of the insertion section), the lumen extension portions being substantially equiangularly spaced around the distal tip housing when viewed in plan view (best seen in figure 6e).
Regarding claim 57, Banik further teaches the distal tip housing has a cleaning nozzle (456, figure 6b; Banik) arranged at a distal end face, to direct irrigation liquid to clean a lens of the imaging chip (see 458, figure 6b).
Regarding claim 62, Litscher and Banik and Ouyang disclose all of the features in the current invention as shown above in claim 58. They are silent regarding the distal tip includes a distal tip housing which is integrally formed from light-transmissive material.
Seifert teaches a video arthroscope (see figure 1) with a CCD and four-way angulations ([0025]). The tip of the arthroscope can be provided with a distal window (20, figure 2) made of a polycarbonate or acrylic ([0025]) with very high light transmission properties (abstract).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the method to use to have a distal tip housing that is integrally form of polycarbonate or acrylic ([0025]) as taught by Seifert. Doing so would provide a distal tip housing that has very high light transmission properties (abstract). The modified method would comprise the distal tip includes a distal tip housing (see 450, figure 6c; Banik) which is integrally formed (precision molded [0145]; Banik) from light-transmissive material (modified to be made of polycarbonate or acrylic [0025]; Seifert).
Regarding claim 63, Banik further teaches the distal tip housing is integrally formed (precision molded [0145]; Banik) from plastics material (ABS [0145]; ABS or Acrylonitrile butadiene styrene is a specific type of plastic | see ABS plastic [0159] of Banik).
Regarding claim 64, Banik further teaches the distal tip housing has a collar portion (see proximal end of 450, figure 6E; Banik) extending proximally of a distal end face (see distal end face of 450, figure 6c), the collar portion adapted to fit over a distal end of the steering section (see figure 6d).
Regarding claim 65, Banik further teaches the distal tip housing has a cleaning nozzle (456, figure 6b; Banik) arranged at a distal end face, to direct irrigation liquid to clean a lens of the imaging chip (see 458, figure 6b).
Conclusion
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
September 18, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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