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 .
Election/Restrictions
The office action is a response to Applicant’s election filed on 04/24/2023 without traverse of Invention I drawn to modular endoscopy system. Applicant’s election of Invention I without traverse is acknowledged.
Response to Amendment
The amendment filed 11/17/2025 has been entered. Claims 1-3, 7-15, 17, 19-20, 44-45, and 65-69 are currently pending in the application and examined below. Claims 4-6, 16, 18, 21-43, and 46-64 have been canceled. Claims 1-3, and 68-69 are amended.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because a new ground of rejection is necessitated by Applicant’s amendments to the independent claims 1, 68, and 69.
Such newly added limitations change the scope of the claims substantially, and require the new grounds of rejection. As such, the previous grounds of rejections are withdrawn and a new ground of rejections are presented below.
Please see sections 35 U.S.C §103 below for further explanation.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
First attachment mechanism in claim 1 which has structural support illustrated in Fig. 8A-C, 9A-D, 10A-B, 11A-B, and 12A-B, and in the specification stating in paragraph:
[0023] “…the attachment mechanism comprising a retention band,”
[0027] “…the attachment mechanism comprising a retention clip system,”
[0031] “…the attachment mechanism comprising a hinged basket,”
[0033] “…the attachment mechanism comprising an expandable sleeve,”
[0035] “…the attachment mechanism comprising a screw-on holder,”
[0079] “Camera module 150 can be attached to insertion section module 104 of FIG. 5 using any of the attachment mechanisms described herein, such as those shown in FIGS. 8A - 12B.”
[0091] “In various examples, the disclosed attachment mechanisms can attach to camera module 150 via groove 154 or another attachment feature, such as a hole, socket, channel and the like.”
Second attachment mechanism in claim 1, which has structural support in the specification in paragraph [0148-0157] stating, “Example 10 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 9 to optionally include an attachment mechanism that comprises a socket for coupling angulation wires.”
attachment mechanism in claims 2, 68 and 69, which has structural support in the specification in paragraph [0148-0157] stating, “Example 10 can include, or can optionally be combined with the subject matter of one or any combination of Examples 1 through 9 to optionally include an attachment mechanism that comprises a socket for coupling angulation wires.”
Imaging and illumination module in claim 1, which has structural support in the specification stating:
[0022] FIG. 6B is schematic illustration of the camera module of FIG. 6A comprising a communication circuit, a rechargeable power source, an imaging unit and an illumination unit.
[0023] FIG. 7 is a schematic illustration of the modular camera of FIGS. 6A and 6B connected to a wireless imaging and control system according to an example.
[0063] Both side-viewing endoscope camera module 50 of FIG. 3A and 3B and end-viewing endoscope camera module 70 of FIGS. 4A and 4B have several elements in common. In particular, endoscope camera modules 50 and 70 can include optical components (e.g., objective lenses 60 and 80,prism 66, imaging units 67 and 87, wiring 68 and 88) for collection of image signals, lighting components (e.g., illumination lenses 58 and 78, light transmitters 64 and 84) for transmission or generation of light. Endoscope camera modules 50 and 70 can also include a photosensitive element, such as a charge-coupled device ("CCD" sensor) or a complementary metal-oxide semiconductor ("CMOS") sensor. In either example, imaging units 67 and 87 can be coupled (e.g., via wired or wireless connections) to image processing unit 42 (FIG. 2) to transmit signals from the photosensitive element representing images (e.g., video signals) to image processing unit 42, in turn to be displayed on a display such as output unit 18.
[0081]Camera module 150 can be "self-contained." For instance, detachable camera module 150 can include wireless communication circuit 162,rechargeable power source 164, imaging unit 166 and illumination unit 168 in operative communication with one another, as schematically illustrated in FIG. 7. As such, camera module 150 can be capable of powering itself, capturing images with imaging unit 166, generating light with illumination unit 168, and transmitting captures images to external devices with wireless communication circuit 162 without the aid or intervention of an external device or system.
[0083] Illumination unit 168 can include one or more lamps e.g., LED, as illustrated in FIGS. 6B and 7, or other suitable light sources in a desired spectrum to permit imaging of patient anatomy, for instance according to Olympus Corporation's Narrow Band Imaging or other technologies.
[0084] Imaging unit 166 can include one or more of a CCD or CMOS photosensitive element.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-3, 9, 65, 66, 67, and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Yamaya et al. (US2004/0106850) hereinafter Yamaya, in view of Wood et al. (US2007/0265499) hereinafter Wood, in view of Calabrese et al. (US2018/0214015) hereinafter Calabrese.
Regarding Claim 1, Yamaya discloses a modular endoscopy system (Yamaya - Fig. 19 apparatus 500), comprising:
a handle (Yamaya - Fig. 19 operating portion 506) comprising control and navigation functionality (Yamaya – [0176-0177 and 0185]);
a patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1) having a proximal end section (Yamaya – Fig. 19 near bending preventing portion 516) and a distal end section (Yamaya – Fig. 19 near reference numeral 15) ,the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1) comprising:
a working channel (Yamaya – Fig. 2 first channel 34) extending through the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1); and
a window (Fig. 1 opening portion 17 and illustrated by an arrow in Fig. 19 near base 31) located on a side (Yamaya – Fig. 2 near reference numeral 2) of the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1) proximally of the distal end section (Yamaya – Fig. 19 near reference numeral 15) and configured to allow one or more therapeutic tools (Yamaya – Fig. 2 first treatment tool 37) to extend from the working channel out of the side (Yamaya – Fig. 2 near reference numeral 2) of the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1) ; and
an imaging and illumination module (Yamaya – Fig. 1 observation optical system 21 and illumination optical system 22,23),
wherein the handle (Yamaya - Fig. 19 operating portion 506) is positionable at the proximal end section (Yamaya – Fig. 19 bending preventing portion 516) of the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1) and is user-detachable (Yamya – [0215] “…the oscillating base operating portion 517 which is arranged to the operating portion 506, is detachable to the endoscope inserting portion 1 side of the grip portion 520…”) with the proximal end section (Yamaya – Fig. 19 near bending preventing portion 516) of the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1) via a second attachment mechanism (Fig. 21 area near screw portion 516a, Examiner’s Note: As identified above, in the claim interpretation section, the second attachment mechanism is being interpreted as comprising a socket figuration. Here, Yamaya discloses the inserting portion 1 being connected to the operating portion 506 within a socket figuration in paragraph [0187] stating, “Thus, referring to FIG. 21, the bending preventing portion 516 is screwed to a cylindrical structure 554 of the operating portion arranged in the grip portion 520 by a screw portion 516 a.”); and
wherein the handle (Yamaya - Fig. 19 operating portion 506), using the control and navigation functionality (Yamaya – [0176-0177 and 0185]), is configured to steer and bend a portion (Yamaya – Fig. 19 first bending portion 514 and second bending portion 513) of the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1) through the second attachment mechanism (Fig. 21 area near screw portion 516a [0187]) and to operate (Fig. 19, via image recording button 525, [0259] the imaging and illumination module (Yamaya – Fig. 1 observation optical system 21 and illumination optical system 22,23).
Yamaya is silent as to whether the imaging and illumination module configured in a side-viewing arrangement to view radially outward of the patient insertable working shaft and being user- detachable with the insertion tube patient insertable working shaft via a first attachment mechanism so that the imaging and illumination module is located distally of the window and the distal end section.
However Wood, in the same field of endeavor, teaches the imaging and illumination module (Wood - Figs. 6a-6b, 8A-8C operation window 32 including the illumination window 57 and visualization window 58) configured in a side-viewing arrangement to view radially outward of the patient insertable working shaft (Wood - Figs. 1, 6a-b, 8a-c tube 12’) and being user- detachable with the insertion tube patient insertable working shaft ( Wood - Figs. 1, 6a-b, 8a-c tube 12’) via a first attachment mechanism ([Wood – Fig. 8a, [0055 – 0064] Examiner’s note: As stated above, first attachment mechanism is being interpreted as hole an socket. Here Wood teaches a hole and socket attachment mechanism in Figs. 8a-8c.
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Yamaya in view of Wood to include the imaging and illumination module configured in a side-viewing arrangement to view radially outward of the patient insertable working shaft and being user- detachable with the insertion tube patient insertable working shaft via a first attachment mechanism for the benefit of viewing and accessing a position within a body cavity that is on a side of a patient insertable working shaft without the need for “…repeated manipulation and rotation of the entire endoscope within the patient’s body portion” (Wood – [0046]).
Although Yamaya and wood both individually illustrated and teach a window located on the side of the patient insertable working shaft they are both silent as to further explaining whether the imaging and illumination module is located distally of the window and the distal end section.
However Calabrese, in the same field of endeavor, teaches the imaging and illumination module (Calabrese – Figs 1-3, 5 image sensor 22 and light source 24) is located distally of the window (Calabrese – Figs. 1-3, 5 indentation 36) and the distal end section (Figs. 1-5 distal end section of elongate, flexible, tubular shaft proximal to the distal tip 4, [0020]).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Yamaya in view of Wood in view of Calabrese to include the imaging and illumination module is located distally of the window and the distal end section for the benefit of the window being configured to securely hold a medical device in place on a side of a patient insertable tube while the operator does additional maneuvers (Calabrese – [0003-0004, 0025-0030]).
Regarding Claim 2, Yamaya in view of Wood in view of Calabrese teach the modular endoscopy system of claim 1, further comprising an elevator mechanism (Yamaya – Fig. 1 first treatment-tool oscillating base 31) pivotably connected to the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1), the elevator mechanism (Yamaya – Fig. 1 first treatment-tool oscillating base 31) configured to orient and support the one or more therapeutic tools (Yamaya – Fig. 2 first treatment tool 37) to extend out (Yamaya – [0058]) the window (Fig. 1 opening portion 17 and illustrated by an arrow in Fig. 19 near base 31) via a user input (Yamaya – [0183] via operator input of movement of operation knob 532) at the handle (Yamaya - Fig. 19 operating portion 506),
Yamaya is silent as to further comprise an attachment mechanism configured to attached the imaging and illumination module to a distal end of the patient insertable working shaft distal of the elevator mechanism.
However Wood, in the same field of endeavor, teaches an attachment mechanism (Wood – Figs. 2-6B flexible drive shaft 40 with force transfer region 38, Examiner’s Note: As previously stated above, attachment mechanism may be interpreted as a device similar to a socket mechanism. Here Wood teaches a socket mechanism with a the shaft 40 and region 38 in Figs. 2-3) configured to attached the imaging and illumination module (Wood - Figs. 6a-6b, 8A-8C operation window 32 including the illumination window 57 and visualization window 58) to a distal end of the patient insertable working shaft ( Wood - Figs. 1, 6a-b, 8a-c distal end of tube 12’ proximal to rotating portion 24) distal of the elevator mechanism (Wood – Fig 6a elevator [0036] “ For example, endoscope 10′ may include pull wires for effectuating deflection during positioning and an elevator device for altering the angle at which a treatment instrument exits the endoscope 10′.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Yamaya in view of Wood in view of Calabrese with the teachings of Wood to include an attachment mechanism configured to attached the imaging and illumination module to a distal end of the patient insertable working shaft distal of the elevator mechanism for the benefit of allowing rotation of the distal tip of the patient insertable working shaft about the longitudinal axis of the patient insertable working shaft without maneuvering the entire shaft (Wood – [0040-0042].)
Regarding Claim 3, Yamaya in view of Wood in view of Calabrese teach the modular endoscopy system of claim 1, wherein the imaging and illumination module (Wood - Figs. 6a-6b, 8A-8C operation window 32 including the illumination window 57 and visualization window 58) comprises a housing (Wood – Figs. 6a-8C housing of rotating portion 24) containing a light source and a camera (Wood - Figs. 6a-6b, 8A-8C operation window 32 including the illumination window 57 and visualization window 58) , the housing (Wood – Figs. 6a-8C housing of rotating portion 24) being user-detachable (Wood – Figs. 8a-8c) with the distal end section of the patient insertable working shaft ( Wood - Figs. 1, 6a-b, 8a-c distal end of tube 12’ proximal to rotating portion 24);
the patient insertable working shaft ( Wood - Figs. 1, 6a-b, 8a-c distal end of tube 12’ proximal to rotating portion 24) comprises a fluid passage extending therein ([0056]); and
the housing (Wood – Figs. 6a-8C housing of rotating portion 24) comprises a fluid passages configured to receive fluid form the fluid passage of the patient insertable working shaft when the imaging and illumination module is attached to the patient insertable working shaft via the attachment mechanism (Wood – [0056] “FIGS. 8A-8C, an internal surface of proximal portion 26′ may include an internal helical groove 106 extending therein. In a final configuration, the rotating portion 24′ is received within the proximal portion in a fluid tight manner, but one that still allows rotation of rotating portion 24′ relative to proximal portion 26′. A fluid tight arrangement can be provided through the use of sealing projections (not shown) along reduced diameter portion 102, or within the hollow proximal portion 26′. Additionally, or alternatively, a fluid tight arrangement can be provided through the use of a gasket or o-ring element.”) , the attachment mechanism (Wood – Figs. 2-6B flexible drive shaft 40 with force transfer region 38, Examiner’s Note: As previously stated above, attachment mechanism may be interpreted as a device similar to a socket mechanism. Here Wood teaches a socket mechanism with a the shaft 40 and region 38 in Figs. 2-3) comprising a coupling the brings the housing (Wood – Figs. 6a-8C housing of rotating portion 24) into contact with a distal end face of the patient insertable working shaft ( Wood - Figs. 1, 6a-b, 8a-c distal end face of tube 12’ proximal to rotating portion 24) to allow fluid to pass from the fluid passage, through the attachment mechanism (Wood – Figs. 2-6B flexible drive shaft 40 with force transfer region 38, Examiner’s Note: As previously stated above, attachment mechanism may be interpreted as a device similar to a socket mechanism. Here Wood teaches a socket mechanism with a the shaft 40 and region 38 in Figs. 2-3) and into the housing (Wood – Figs. 6a-8C housing of rotating portion 24) .
Regarding Claim 9, Yamaya in view of Wood in view of Calabrese teach the modular endoscopy system of claim 1, wherein, when attached, the handle (Yamaya - Fig. 19 operating portion 506) and the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1) are generally co-axially positioned along a longitudinal axis of the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1).
Regarding Claim 65, Yamaya in view of Wood in view of Calabrese teach the modular endoscopy system of claim 1, further comprising an auxiliary instrument (Yamaya – Fig. 2 first treatment tool 37) insertable into the working channel (Yamaya – Fig. 2 first channel 34) of the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1), the auxiliary instrument (Yamaya – Fig. 2 first treatment tool 37) having a functional capability, wherein the handle (Yamaya - Fig. 19 operating portion 506) is configured to operate the functional capability of the auxiliary instrument (Yamaya – Fig. 2 first treatment tool 37).
Regarding Claim 66, Yamaya in view of Wood in view of Calabrese teach the modular endoscopy system of claim 1, further comprising: a plurality of insertion tubes (Yamaya – Figs. 2, 19, tube of first bending portion 514, tube of second bending portion 513, tube of flexible portion 513) having different capabilities, each of the plurality of insertion tubes (Yamaya – Figs. 2, 19, tube of first bending portion 514, tube of second bending portion 513, tube of flexible portion 513) being independently connectable to the handle (Yamaya - Fig. 19 operating portion 506) and the imaging and illumination module (Yamaya – Fig. 1 observation optical system 21 and illumination optical system 22,23) as alternatives to each other to function as an outer sheath for the modular endoscopy system; and a plurality of imaging and illumination modules (Yamaya – Fig. 1 observation optical system 21 and illumination optical system 22,23) having different capabilities, each of the imaging and illumination modules (Yamaya – Fig. 1 observation optical system 21 and illumination optical system 22,23) including a light source (Yamaya – Fig. 1 illumination optical system 22,23) ; wherein the handle (Yamaya - Fig. 19 operating portion 506) is capable of operating each insertion tube of the plurality of insertion tubes (Yamaya – Figs. 2, 19, tube of first bending portion 514, tube of second bending portion 513, tube of flexible portion 513) and each imaging and illumination module of the plurality of imaging and illumination modules (Yamaya – Fig. 1 observation optical system 21 and illumination optical system 22,23).
Regarding Claim 67, Yamaya in view of Wood in view of Calabrese teach the modular endoscopy system of claim 66, wherein each of the plurality of insertion tubes(Yamaya – Figs. 2, 19, tube of first bending portion 514, tube of second bending portion 513, tube of flexible portion 513) includes an internal lumen (Yamaya – Figs. 2, 19, internal lumen of tube of first bending portion 514, internal lumen of tube of second bending portion 513, internal lumen of tube of flexible portion 513) to guide an auxiliary instrument (Yamaya – Fig. 2 first treatment tool 37) to the window (Fig. 1 opening portion 17 and illustrated by an arrow in Fig. 19 near base 31.
Regarding Claim 68, Yamaya discloses a modular endoscopy system (Yamaya - Fig. 19 apparatus 500), comprising:
a handle (Yamaya - Fig. 19 operating portion 506) comprising control and navigation functionality (Yamaya – [0177]);
a patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1) having a proximal end section (Yamaya – Fig. 19 bending preventing portion 516) user-detachable with the handle (Yamaya - Fig. 19 operating portion 506) via a first attachment mechanism (Fig. 21 area near screw portion 516a, Examiner’s Note: As identified above, in the claim interpretation section, the attachment mechanism is being interpreted as comprising a socket figuration. Here, Yamaya discloses the inserting portion 1 being connected to the operating portion 506 within a socket figuration in paragraph [0187] stating, “Thus, referring to FIG. 21, the bending preventing portion 516 is screwed to a cylindrical structure 554 of the operating portion arranged in the grip portion 520 by a screw portion 516 a.”) and a distal end section (Yamaya – Fig. 19 near reference numeral 15); and
an elevator mechanism (Yamaya – Fig. 1 first treatment-tool oscillating base 31) pivotably connected to the distal end section (Yamaya – Fig. 19 near reference numeral 15) of the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1) and configured to orient and support one or more therapeutic tools (Yamaya – Fig. 2 first treatment tool 37) extended from the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1);
an internal working channel (Yamaya – Fig. 2 first channel 34) extending from the elevator mechanism (Yamaya – Fig. 1 first treatment-tool oscillating base 31) to a port (Yamaya – Fig. 19 first hole 521) located at a distal end portion (Yamaya – Fig. 19 grip portion 520) of the handle (Yamaya - Fig. 19 operating portion 506);
a fluid passage (Yamaya – fluid passages that connect to the air and water feed nozzle 14 and front water-feed port 15) extending within the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1);
an imaging and illumination module (Yamaya – Fig. 1 observation optical system 21 and illumination optical system 22,23),
wherein the handle (Yamaya - Fig. 19 operating portion 506) is positionable at the proximal end section of the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1) via the first attachment mechanism (Fig. 21 area near screw portion 516a, Examiner’s Note: As identified above, in the claim interpretation section, the attachment mechanism is being interpreted as comprising a socket figuration. Here, Yamaya discloses the inserting portion 1 being connected to the operating portion 506 within a socket figuration in paragraph [0187] stating, “Thus, referring to FIG. 21, the bending preventing portion 516 is screwed to a cylindrical structure 554 of the operating portion arranged in the grip portion 520 by a screw portion 516 a.”) to control operation of the elevator mechanism through the first attachment mechanism and control flow through the fluid passage ([0182] “Water and air is fed to the air and water feed nozzle 14 by operating a button 523 for controlling the feed of air and water, which will be described later, arranged to the operating portion 506. The front water-feed port 15 is connected to a front water-feed cap (not shown) arranged to a connector (not shown) at one end of the universal code 507, and the water is fed by a syringe or a water feed pump from the front water feed cap.”); and
wherein the imaging and illumination module (Yamaya – Fig. 1 observation optical system 21 and illumination optical system 22,23) is operatively connectable to a distal portion of the patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1).
Yamaya is silent as to whether the imaging and illumination module configured in a side -viewing arrangement to view radially outward of the patient insertable working shaft, the imaging and illumination module being user- detachable with the patient insertable working shaft via a second attachment mechanism, the imaging and illumination module further configured to receive fluid from the fluid passage through the second attachment mechanism wherein the imaging and illumination module is operatively connectable to a distal portion of the patient insertable working shaft distal of the elevator mechanism via the second attachment mechanism.
However Wood, in the same field of endeavor, teaches the imaging and illumination module (Wood - Figs. 6a-6b, 8A-8C operation window 32 including the illumination window 57 and visualization window 58) configured in a side-viewing arrangement to view radially outward of the patient insertable working shaft (Wood - Figs. 1, 6a-b, 8a-c tube 12’) and being user- detachable with the insertion tube patient insertable working shaft ( Wood - Figs. 1, 6a-b, 8a-c tube 12’) via a second attachment mechanism ([Wood – Fig. 8a, [0055 – 0064] Examiner’s note: As stated above, first attachment mechanism is being interpreted as hole an socket. Here Wood teaches a hole and socket attachment mechanism in Figs. 8a-8c.) , the imaging and illumination module (Wood - Figs. 6a-6b, 8A-8C operation window 32 including the illumination window 57 and visualization window 58) further configured to receive fluid from the fluid passage through (wood – [0056] “FIGS. 8A-8C, an internal surface of proximal portion 26′ may include an internal helical groove 106 extending therein. In a final configuration, the rotating portion 24′ is received within the proximal portion in a fluid tight manner, but one that still allows rotation of rotating portion 24′ relative to proximal portion 26′. A fluid tight arrangement can be provided through the use of sealing projections (not shown) along reduced diameter portion 102, or within the hollow proximal portion 26′. Additionally, or alternatively, a fluid tight arrangement can be provided through the use of a gasket or o-ring element.”) the second attachment mechanism ([Wood – Fig. 8a, [0055 – 0064] Examiner’s note: As stated above, first attachment mechanism is being interpreted as hole an socket. Here Wood teaches a hole and socket attachment mechanism in Figs. 8a-8c.) wherein the imaging and illumination module (Wood - Figs. 6a-6b, 8A-8C operation window 32 including the illumination window 57 and visualization window 58) is operatively connectable to a distal portion of the patient insertable working shaft ( Wood - Figs. 1, 6a-b, 8a-c distal portion of tube 12’) distal of the elevator mechanism (Wood - [0036] “ For example, endoscope 10′ may include pull wires for effectuating deflection during positioning and an elevator device for altering the angle at which a treatment instrument exits the endoscope 10′.”) via the second attachment mechanism ([Wood – Fig. 8a, [0055 – 0064] Examiner’s note: As stated above, first attachment mechanism is being interpreted as hole an socket. Here Wood teaches a hole and socket attachment mechanism in Figs. 8a-8c.)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Yamaya in view of Wood to include the imaging and illumination module configured in a side -viewing arrangement to view radially outward of the patient insertable working shaft, the imaging and illumination module being user- detachable with the patient insertable working shaft via a second attachment mechanism, the imaging and illumination module further configured to receive fluid from the fluid passage through the second attachment mechanism wherein the imaging and illumination module is operatively connectable to a distal portion of the patient insertable working shaft for the benefit of viewing and accessing a position within a body cavity that is on a side of a patient insertable working shaft without the need for “…repeated manipulation and rotation of the entire endoscope within the patient’s body portion” (Wood – [0046]).
While Yamaya in view of Wood are silent at explicitly teaching whether the imaging and illumination module is distal of the elevator mechanism, Calabrese explicitly teaches the imaging and illumination module (Calabrese – Figs 1-3, 5 image sensor 22 and light source 24) is distal of the elevator mechanism (Calabrese – Figs 1-3, 5 elevator or tubular member 6).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Yamaya in view of Wood with the teachings of Calabrese to include the imaging and illumination module is distal of the elevator mechanism for the benefit of securely hold a medical device in place on a side of a patient insertable tube while the operator does additional maneuvers (Calabrese – [0003-0004, 0025-0030]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yamaya et al. (US2004/0106850) hereinafter Yamaya, in view of Wood et al. (US2007/0265499) hereinafter Wood, in view of Calabrese et al. (US2018/0214015) hereinafter Calabrese in view of Bayer et al. (US2007/0177008) hereinafter Bayer.
Regarding Claim 8, Yamaya in view of Wood in view of Calabrese teach the modular endoscopy system of claim 1, but is silent whether the handle further comprises a first wireless communication circuit; and the imaging and illumination module further comprises a second wireless communication circuit; wherein the first wireless communication circuit and the second wireless communication circuit are configured to send or receive data or instructions between each other and an imaging and control system.
However Bayer, in the same field of endeavor teaches the handle further comprising a first wireless communication device (Bayer – control box within handle [0081]); the imaging and illumination module (Bayer - Figs. 1-4 imaging catheter assembly 20) comprises: a second wireless communication device (Bayer –wireless transceiver within the auxiliary image device 42 within imaging catheter assembly 20, [0081]) ; and wherein the first wireless communication device the second wireless communication circuit are configured to send or receive data or instructions between each other and an imaging and control system (Bayer – [0081-0083] “the auxiliary imaging device includes a wireless transceiver, associated circuitry and a battery. The wireless transceiver is configured to receive video signals from the imaging unit of the auxiliary imaging device and to transmit them wirelessly to a control box. Alternatively, the wireless circuit may be implemented in a flexible PCB or the handle of the imaging catheter assembly. The control box may also include a wireless transceiver. This wireless transceiver enables the control box to receive wireless video signals from the imaging device and transmit control commands to the imaging device. The wireless signal transmission and the use of batteries eliminate the need for electrical conductors within the tubular body 36. This reduces the restrictions imposed by electrical conductors to the physician's movements of the endoscope. Additionally, reducing the number of electrical conductors in the catheter and the flex-PCB allows for a larger diameter channel to be included in the catheter.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Yamaya in view of Wood in view of Calabrese with the teachings of Bayer to the handle further comprising a first wireless communication device; the imaging and illumination module comprises: a second wireless communication device; and wherein the first wireless communication device the second wireless communication circuit are configured to send or receive data or instructions between each other and an imaging and control system for the benefit of “…eliminate[ing] the need for electrical conductors within the tubular body …” (Bayer – [0082])
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Yamaya et al. (US2004/0106850) hereinafter Yamaya, in view of Bayer et al. (US2007/0177008) hereinafter Bayer.
Regarding Claim 69, Yamaya discloses a modular endoscopy system (Yamaya – Fig. 19 apparatus 500) , comprising:
a handle (Yamaya - Fig. 19 operating portion 506) comprising control and navigation functionality (Yamaya – [0177]),;
a patient insertable working shaft (Yamaya – Fig. 19 inserting portion 1) having a proximal end section (Yamaya – Fig. 19 bending preventing portion 516) user-detachable (Yamya – [0215] “…the oscillating base operating portion 517 which is arranged to the operating portion 506, is detachable to the endoscope inserting portion 1 side of the grip portion 520…”) with the handle (Yamaya - Fig. 19 operating portion 506) via a first attachment mechanism (Fig. 21 area near screw portion 516a, Examiner’s Note: As identified above, in the claim interpretation section, the attachment mechanism is being interpreted as comprising a socket figuration. Here, Yamaya discloses the inserting portion 1 being connected to the operating portion 506 within a socket figuration in paragraph [0187] stating, “Thus, referring to FIG. 21, the bending preventing portion 516 is screwed to a cylindrical structure 554 of the operating portion arranged in the grip portion 520 by a screw portion 516 a.”) and a distal end section (Yamaya – Fig. 19 near reference numeral 15);
an imaging and illumination module (Yamaya – Fig. 1 observation optical system 21 and illumination optical system 22,23), , wherein the imaging and illumination module (Yamaya – Fig. 1 observation optical system 21 and illumination optical system 22,23) comprises: a light source (Yamaya – Figs. And 19 illumination optical system 22, 23) and a video camera (Yamaya – Figs. 1 and 19 observation optical system 21),
Yamaya is silent to further disclose whether the imaging and illumination module being user- detachable to the distal end section of the patient insertable working shaft via a second attachment mechanism to hold the imaging and illumination module in a side-viewing orientation; the handle further comprising a first wireless communication device; the imaging and illumination module comprises: a sealed housing containing a second wireless communication device; and wherein the first wireless communication device is configured to transmit instructions for controlling the imaging and illumination module to the second wireless communication device; and wherein the second wireless communication device is configured to transmit an imaging signal to the first wireless communication device.
However Bayer, in the same field of endeavor, teaches the imaging and illumination module (Bayer - Figs. 1-4 imaging catheter assembly 20) being user- detachable (Bayer –, [0062] “…the hollow tubular end 72 of the flexible link 44 may be attached to the distal end 46 of the tubular body 36 by concentrically mating with the channel 48 of the tubular body 36.”) to the distal end section of the patient insertable working shaft (Bayer – Fig. 2 distal end section of the tubular body 36) via a second attachment mechanism (Bayer – [0062], Examiner’s Note: As stated above, Examiner is interpreting second attachment mechanism to a mechanism similar to a socket arrangement. Here Bayer teaches such arrangement with the hollow tubular end 72 mating with the channel 48 in a socket arrangement.) to hold the imaging and illumination module (Bayer - Figs. 1-4 imaging catheter assembly 20) in a side-viewing orientation (Bayer – [0060] “…the auxiliary imaging device 42 could be oriented in other directions to provide other views…”); the handle further comprising a first wireless communication device (Bayer – control box within handle [0081]); the imaging and illumination module (Bayer - Figs. 1-4 imaging catheter assembly 20) comprises: a sealed housing (Bayer – Fig. 4 housing 56a,56b [0055] “The housing 56 a, 56 b includes two parts 56 a, 56 b that are sealingly joined to form the housing 56 a, 56 b. The housing 56 a, 56 b may be made from any suitable material such as stainless steel or a plastic material.”) containing a second wireless communication device (Bayer –wireless transceiver within the auxiliary image device 42 within imaging catheter assembly 20, [0081]) ; and wherein the first wireless communication device is configured to transmit instructions for controlling the imaging and illumination module to the second wireless communication device; and wherein the second wireless communication device is configured to transmit an imaging signal to the first wireless communication device (Bayer – [0081-0083] “the auxiliary imaging device includes a wireless transceiver, associated circuitry and a battery. The wireless transceiver is configured to receive video signals from the imaging unit of the auxiliary imaging device and to transmit them wirelessly to a control box. Alternatively, the wireless circuit may be implemented in a flexible PCB or the handle of the imaging catheter assembly. The control box may also include a wireless transceiver. This wireless transceiver enables the control box to receive wireless video signals from the imaging device and transmit control commands to the imaging device. The wireless signal transmission and the use of batteries eliminate the need for electrical conductors within the tubular body 36. This reduces the restrictions imposed by electrical conductors to the physician's movements of the endoscope. Additionally, reducing the number of electrical conductors in the catheter and the flex-PCB allows for a larger diameter channel to be included in the catheter.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Yamaya with the teachings of Bayer to include the imaging and illumination module being user- detachable with the patient insertable working shaft for the benefit of allowing alternate viewing areas within the body cavity and minimize damage to the adjacent health tissue surrounding the distal end of and endoscope (Bayer – [0009-0010]).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Yamaya with the teachings of Bayer to the handle further comprising a first wireless communication device; the imaging and illumination module comprises: a sealed housing containing a second wireless communication device; and wherein the first wireless communication device is configured to transmit instructions for controlling the imaging and illumination module to the second wireless communication device; and wherein the second wireless communication device is configured to transmit an imaging signal to the first wireless communication device for the benefit of “…eliminate[ing] the need for electrical conductors within the tubular body …” (Bayer – [0082])
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Yamaya in view of Wood in view of Calabrese in view of Marc Levinson (US11445890) hereinafter Levinson.
Regarding Claim 10, Yamaya in view of Wood in view of Calabrese teach the modular endoscopy system of claim 1, wherein: the handle (Yamaya - Fig. 19 operating portion 506) comprises an actuation mechanism (Yamaya – Fig. 19 bending knob portion 526, 528) and first and second angulation wires connected to the actuation mechanism (Yamaya – [0228] “…first and second bending mechanisms (not shown) of the first bending knob portion 526 and the second bending knob portion 528 and the bending wires arranged to the first bending portion 514 and the second bending portion 513 are exposed and the loosing of the bending wires is removed and is adjusted.”); and
the second attachment mechanism (Fig. 21 area near screw portion 516a, Examiner’s Note: As identified above, in the claim interpretation section, the second attachment mechanism is being interpreted as comprising a socket figuration. Here, Yamaya discloses the inserting portion 1 being connected to the operating portion 506 within a socket figuration in paragraph [0187] stating, “Thus, referring to FIG. 21, the bending preventing portion 516 is screwed to a cylindrical structure 554 of the operating portion arranged in the grip portion 520 by a screw portion 516 a.”)
Yamaya alone or in view of Wood in view of Calabrese is silent whether further comprising a first socket and a second socket connected to the first and second angulation wires, respectively, where each of the first socket and the second socket is configured to receive an angulation wire of the patient insertable working shaft; wherein the first socket is independent of the second socket such that operation of the actuation mechanism can move the first socket relative to the second socket.
However Levinson, in the same field of endeavor, teaches the handle (Fig. 1 handle 17) comprises an actuation mechanism (Figs. 1, 7a coupling mechanism of the connection point between the handle 17 and sheath 1) and first and second angulation wires (Fig. 7a wires 27 a, b) connected to the actuation mechanism (Figs. 1, 7a coupling mechanism of the connection point between the handle 17 and sheath 1); and the attachment mechanism (Figs. 1, 7a coupling mechanism of the connection point between the handle 17 and sheath 1) comprises a first and second sockets (Fig. 7a [col. 3 line 62- col. 4 line 12] “In FIG. 7a , a ball 32 is joined to a socket 34. The ball and socket placement is arbitrary, and could be switched from handle or sheath side.”) connected to the first and second angulation wires (Fig. 7a wires 27 a, b), respectively, where each of the first and second sockets (Fig. 7a [col. 3 line 62- col. 4 line 12]) is configured to receive an angulation wire (wires 27b) of the insertion tube (Fig. 1 tube of sheath 1) wherein the first socket is independent of the second socket such that operation of the actuation mechanism can move the first socket relative to the second socket (Fig. 7a [col. 3 line 62- col. 4 line 12]).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Yamaya in view of Wood in view of Calabrese with the teachings of Levinson, as taught above, for the added benefit of coupling and uncoupling a sheath with a handle that simplifies sterility, is reliable, and has a cost reduction [col. 1 lines 40-67].
Claims 7, 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Yamaya in view of Wood in view of Calabrese in view of Sniffin et al. (US2012/0253116) hereinafter Sniffin.
Regarding Claim 7, Yamaya in view of Wood in view of Calabrese teach the modular endoscopy system of claim 1 but are silent as to whether the handle further comprises a rechargeable power source configured to provide power to the navigation and control functionality.
However Sniffin, in the same field of endeavor, teach the handle (Fig. 1 powered reusable handle assembly 110) further comprises a rechargeable power source (Fig. 2A battery pack 210) configured to provide power to the navigation and control functionality ([0031]).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Yamaya in view of Wood in view of Calabrese to include the handle comprises a rechargeable power source configured to provide power to the navigation and control functionality, as taught by Sniffin for the benefit of “…enabling flow of electrosurgical energy between the battery pack and the motor” (Sniffin - [0031]).
Regarding Claim 11, Yamaya in view of Wood in view of Calabrese teach the modular endoscopy system of claim 1, but is silent as to whether the handle comprises a joystick.
However Sniffin, in the same field of endeavor, teaches he handle (Sniffin – Fig. 1 powered reuseable handle assembly 110) comprises a joystick (Sniffin – Figs. 1 and 4c joystick controller 112).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Yamaya in view of Wood in view of Calabrese with the teachings of Sniffin to include the handle comprising a joystick for the benefit of “…gain[ing] precise movement [of an endoscope] in and around the target surgical site” (Sniffin – [0019]).
Regarding Claim 12, Yamaya in view of Wood in view of Calabrese in view of Sniffin teach the modular endoscopy system of claim 11, wherein the joystick (Sniffin – Figs. 1 and 4c joystick controller 112) is configured to manipulate angulation wires (Sniffin – cables 310, [0023] “The controller 112 of the powered reusable handle assembly 110 may be a joystick mechanism configured to steer a plurality of articulation linkages 128, which are distally disposed on the reusable cannula assembly 120, as described below.” and [0035] “The proximal end 124 of the reusable cannula assembly 120 may be referred to as the articulation assembly 124. The articulation assembly 124 includes racks 320 that attach to cables 310 to steer the articulation linkages 128, distally disposed.”).
Regarding Claim 13, Yamaya in view of Wood in view of Calabrese in view of Sniffin teach the modular endoscopy system of claim 12, wherein the joystick (Sniffin – Figs. 1 and 4c joystick controller 112) comprises one or more lock buttons (Sniffin – Fig. 1 switch 115) to inhibit movement of the angulation wires (Sniffin – cables 310, [0022] “The powered reusable handle assembly 110 also includes a switch 115 for activating an initial offset bend of the reusable cannula assembly 120.”).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Yamaya in view of Wood in view of Calabrese in view of Sniffin in view of Jasperson et al. (US Pub. No.: US2016/0135664) hereinafter Jasperson.
Regarding claim 14, Yamaya in view of Wood in view of Calabrese in view of Sniffin teach the modular endoscopy system of claim 12, but are silent as to whether the joystick further comprises one more programable buttons.
However Jasperson, in the same field of endeavor, teaches wherein the joystick (Jasperson - Fig. 4 directional control 132 [0038] “The directional control 132 is a joystick…”) further comprises one or more programable buttons (Jasperson - [0038] “The direction control 132 may be depressible to choose options on the display 81 similar to the selection control 114 of the remote interface 110 detailed above. The direction control 132 may provide tactile and/or haptic feedback to the clinician when the direction control 132 is depressed.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Yamaya in view of Wood in view of Calabrese in view of Sniffin teach the with the teachings of Jasperson to include the joystick further comprise one or more programable buttons to have the benefit of “enable[ing a] section of one or more options presented in the one or more field on the display by the software” [0011].
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Yamaya in view of Wood in view of Calabrese in view of Sniffin in view of Jasperson in view of Choi et al. (US 2011/0257661) hereinafter Choi.
Regarding claim 15, Yamaya in view of Wood in view of Calabrese in view of Sniffin teach the modular endoscopy system of claim 12, Sniffin continues to disclose, wherein the handle (Sniffin- Fig. 1 powered reusable handle assembly 110) further comprises a force sensor for sensing force applied to an angulation wire (Sniffin - [0039] “…the reusable handle assembly 110 may include at least one sensor positioned thereon or therewith. For example, electrical contacts, proximity sensors, optical sensors, photo diodes, and/or mechanical or metallic sensors may be used to control and/or record information concerning the end effector assembly 132 or the articulation linkages 128 distally disposed or the coupling relationships established between the components of the surgical system 100.”) but Sniffin alone or in combination with Yamaya in view of Wood in view of Calabrese are silent as to further disclosing a haptic feedback device configured to vibrate the joystick based on feedback from the force sensor when the sensed force exceeds a threshold force in the angulation wires.
However Jasperson, in the same field of endeavor, teaches a haptic feedback device configured to vibrate the joystick based on feedback from the force sensor (Jasperson - [0038] “The direction control 132 may be depressible to choose options on the display 81 similar to the selection control 114 of the remote interface 110 detailed above. The direction control 132 may provide tactile and/or haptic feedback to the clinician when the direction control 132 is depressed.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Yamaya in view of Wood in view of Calabrese in view of Sniffin teach the with the teachings of Jasperson to include , a haptic feedback device configured to vibrate the joystick based on feedback from the force sensor to have the benefit of providing feedback to the clinician [0038].
Yamaya in view of Wood in view of Calabrese in view of Sniffin teach in view of Jasperson are silent as to whether the haptic feedback device configured to vibrate the joystick based on feedback from the force sensor when the sensed force exceed a threshold force in the angulation wires
However Choi, in the same field of endeavor teaches, the vibration of the joystick is based on feedback from the force sensor when the sensed force exceeds a threshold force in the angulation wires (Choi - [0084] “A user manipulation unit can be connected to a surgical robot according to this embodiment, in which case the surgeon can control the robot arm 20 to move forward, backward, left, right, up, and down using a 3-dimensional joystick, etc., installed on the user manipulation unit. If the front end portion of the cannula 30 touches skin or muscle instead of fat when the surgeon is manipulating the robot, the haptic sensor 38 may sense this, and a suitable alarm signal, such as a warning sound, etc., may be supplied at the user manipulation unit in accordance to a signal from the haptic sensor 38, so as not to further advance the cannula 30.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Yamaya in view of Wood in view of Calabrese in view of Sniffin in view of Jasperson with the teachings of Choi to have the benefit of the haptic sensor acting as a waring sound to the surgeon if the instrument touches a wrong body part and to not further advance the medical instrument [0084].
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Yamaya in view of Wood in view of Calabrese in in view of Levinson in view of Hershel E. Francher (US Pub. No.: US2019/0313881) hereinafter Francher.
Regarding claim 17, Yamaya in view of Wood in view of Calabrese in view of Levinson teaches the modular endoscopy system of claim 10, but are silent as to whether the handle comprises a computer device comprising a touch screen display.
However Francher, in the same field of endeavor, teaches wherein the handle (Francher - Figs. 10-13 reusable hand-piece 502) comprises a computing device (Francher - communication module 590) comprising a touchscreen display (Francher - Figs. 10-13 display 540, [0103] “The display can be a touchscreen display.”) wherein the computing device (Francher - communication module 590) comprises a wireless communication device ([0108]).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Yamaya in view of Wood in view of Calabrese in view of Levinson with the teachings of Francher to include a computing device comprising a touch screen display and further comprise a wireless communication device to have the benefit of being “…prepared for a new procedure by simply using a wipe and antiseptic solution to clean the exterior surfaces of the reusable hand-piece and connecting a new disposable shaft assembly” [0029] and “transmitting image data to an external storage device” [0033].
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Yamaya in view of Wood in view of Calabrese in view of Levinson in view of Francher in view of Price et al. (US Pub No.: US2013/0324999) hereinafter Price.
Regarding claim 19, Yamaya in view of Wood in view of Calabrese in view of Levinson in view of Francher teaches the modular endoscopy system of claim 17, but are silent as to whether the computing device comprises non-transitory memory having instructions stored therein for gesture control of movement of the patient insertable working shaft.
However Price, in the same field of endeavor teaches, the computing device (Price - module 590, [0057]) comprises non-transitory memory (Price - [0057]) having instructions stored therein for gesture control of movement of the patient insertable working shaft. (Price - [0057] “In the present example, module (590) comprises a non-volatile solid state memory module that is operable to store one or more configuration datas. For example, module (590) may contain a configuration data having one or more gesture profiles to be used by a control module, such as control module (40) described in reference to FIG. 1, of surgical instrument (500) to compare the user's movement of instrument (500) with the expected gesture profiles defined by the configuration data. Such a comparison may be used to give feedback to the user as the procedure is progressing and/or to adjust settings of instrument (500)…”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Yamaya in view of Wood in view of Calabrese in view of Levinson in view of Francher with the teachings of Price to include the computing device include non-transitory memory having instructions stored therein for gesture control of an endoscope to have the benefit of comparison data, which can “be used to give feedback to the user as the procedure is progressing and/or to adjust settings of [the] instrument…” [0057].
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Yamaya in view of Wood in view of Calabrese in view of Shelton, IV et al. (US Pub. No.: US2017/0202591) hereinafter Shelton.
Regarding claim 20, Yamaya in view of Wood in view of Calabrese teaches the modular endoscopy system of claim 1, but are silent as to teach whether the handle comprises a first near-field communication device and the patient insertable working shaft comprises a second near-field communication device and memory having stored therein one or more of manufacturer information, model number information and serial number information; wherein near field communication can be established between the handle and the patient insertable working shaft.
However Shelton, the same field of endeavor teaches wherein
the handle (Shelton - Figs. 30-33 handle assembly via transducer/RF generator assembly 504) comprises first near-field communication device ([0236] “…the ultrasonic transducer/ RF generator assembly 504, 604 may include an amplification stage in the ultrasonic transducer and/or RF electronic circuits within the housing 548, 648 and different ratios of amplification based on the energy modality associated with the particular energy mode.”) ; and
the patient insertable working shaft (Figs. 30-33 shaft assembly 510) comprises a second near-field communication device (Fig. 30-33 ultrasonic blade 516) and memory having stored therein one or more of manufacturer information, model number information and serial number information ([0336-0339] “FIGS. 62-70 describe various circuits that are configured to operate with any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described in connections with FIGS. 1-61. … a processor 1302 coupled to a volatile memory 1304, one or more sensors 1306, a nonvolatile memory 1308 and a battery 1310.. The volatile memory 1304, such as a random-access memory (RAM), temporarily stores selected control programs or other software modules….among other features that are readily available for the product datasheet.”);
wherein near-field communication can be established between the handle and the patient insertable working shaft ([0230] “… first switch 520 a energizes the RF circuit to drive high-frequency current through the tissue to form a seal and the second switch 520 b energizes the ultrasonic transducer 530 to vibrate the ultrasonic blade 516 and cut the tissue.”.
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Yamaya in view of Wood in view of Calabrese with the teachings of Shelton, as taught above, to have the benefit of having a near-field communication in the first modular section and in the second modular section to have the benefit of “minimize[ing] the weight size and cost the electronics…” while also “…allow[ing] the electronics to be divided in such a way as the high wear high duty cycles elements could be only connectedly attached to the primary electronics enabling it to be more serviceable and repairable since the system is designed for high repeated use before disposal” [0236] in addition to having such featured information readily available for the surgeon [0336-0339].
Claim 44, and 45 is rejected under 35 U.S.C. 103 as being unpatentable over Yamaya in view of Wood in view of Calabrese in view of Sniffin in view of Choi.
Regarding claim 44, Yamaya in view of Wood in view of Calabrese in view of Sniffin teaches the modular endoscopy system of claim 12, but are silent as to teach whether the handle further comprises a proximity sensor for sensing force proximity of the patient insertable working shaft to an anatomic structure.
However Choi, in the same field of endeavor teaches the handle further comprises a proximity sensor for sensing force proximity of the patient insertable working shaft to an anatomic structure. ([0084] “A user manipulation unit can be connected to a surgical robot according to this embodiment, in which case the surgeon can control the robot arm 20 to move forward, backward, left, right, up, and down using a 3-dimensional joystick, etc., installed on the user manipulation unit. If the front end portion of the cannula 30 touches skin or muscle instead of fat when the surgeon is manipulating the robot, the haptic sensor 38 may sense this, and a suitable alarm signal, such as a warning sound, etc., may be supplied at the user manipulation unit in accordance to a signal from the haptic sensor 38, so as not to further advance the cannula 30.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Yamaya in view of Wood in view of Calabrese in view of Sniffin with the teachings of Choi, as taught above, to have the benefit of the haptic sensor acting as a waring sound to the surgeon if the instrument touches a wrong body part and to not further advance the medical instrument [0084].
Regarding claim 45, Yamaya in view of Wood in view of Calabrese in view of Sniffin in view of Choi teaches the modular endoscopy system of claim 44, further comprising a feedback device configured to vibrate the joystick based on feedback from the proximity sensor when the patient insertable working shaft is below a threshold proximity to the anatomic structure (Choi- [0084] “A user manipulation unit can be connected to a surgical robot according to this embodiment, in which case the surgeon can control the robot arm 20 to move forward, backward, left, right, up, and down using a 3-dimensional joystick, etc., installed on the user manipulation unit. If the front end portion of the cannula 30 touches skin or muscle instead of fat when the surgeon is manipulating the robot, the haptic sensor 38 may sense this, and a suitable alarm signal, such as a warning sound, etc., may be supplied at the user manipulation unit in accordance to a signal from the haptic sensor 38, so as not to further advance the cannula 30.”)
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.
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/MEGAN ELIZABETH MONAHAN/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795