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 .
Response to Amendment
The amendment filed on 7/23/2026 has been entered. Claims 1-3 and 5-21 remain pending in the application.
On page 8 of applicant’s arguments, filed on 7/23/2026, Applicant asserts that the specification has been amended to address the informalities presented in the objection set forth in the Non-Final Office Action mailed 4/23/2026. However, Applicant’s Specification, in the amendment filed on 7/23/2026, does not reflect this. The examiner believes the discrepancy is due to possible oversight. Accordingly, the objection to specification set forth in the Non-Final Office Action mailed 4/23/2026 stands. Please see section Specification below for further explanation.
With the exception of the aforementioned objection, Applicant’s amendments to the Claims and Specification have overcome each and every objection and 112b rejection previously set forth in the Non-Final Office Action mailed 4/23/2026. The claim interpretation under 112(f) presented in the Non-Final Office Action mailed 4/23/2026 of “the assembly” in claim 1 has been withdrawn in light of the Applicant’s amendments.
Response to Arguments
Applicant’s arguments, see pages 9-10, filed 7/23/2026, with respect to the rejection under 35 USC § 102 of Claim 1, have been fully considered and are persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 102 rejections identified in the Non-Final Office Action dated 4/23/2026 moot, and require a new ground of rejection.
Therefore, the 102 rejections previously identified in the non-final action dated 4/23/2026 have been withdrawn.
However, upon further search and consideration, a new ground of rejection is made. Please see section 35 USC § 103 below for further explanation.
Applicant’s arguments, see page 11, filed 7/23/2026, with respect to the rejection under 35 USC § 102 of Claim 16, have been fully considered and are persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 102 rejections identified in the Non-Final Office Action dated 4/23/2026 moot, and require a new ground of rejection.
Therefore, the 102 rejections previously identified in the non-final action dated 4/23/2026 have been withdrawn.
However, upon further search and consideration, a new ground of rejection is made. Please see section 35 USC § 103 below for further explanation.
Applicant’s arguments, see pages 11-12, filed 7/23/2026, with respect to the rejection under 35 USC § 103 of Claim 19, have been fully considered and are not persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 103 rejections identified in the Non-Final Office Action dated 4/23/2026 moot, and require a new ground of rejection.
Therefore, the 103 rejections previously identified in the non-final action dated 4/23/2026 have been withdrawn.
However, upon further search and consideration, a new ground of rejection is made. Applicant’s arguments are on the grounds that the light source is disposed on a first lateral side portion of the pivotable body and the imaging device and elevator are disposed on a second lateral side portion of the pivotable body. While Examiner does agree that the Applicant’s interpretation is accurate, the pivotable body can be interpreted as divided into numerous configurations of first and second lateral side portions including one in which the light source and imaging device are disposed on a first lateral side portion of the pivotable body and the elevator is disposed on a second lateral side portion of the pivotable body.
Please see section 35 USC § 103 below for further explanation.
Specification
The disclosure is objected to because of the following informalities:
Incorrect numbering of elements. In paragraph 0023 of the specification, “port 40” should read “port 140.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 6-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3 and 6 recite “a housing of the distal tip” in l. 2 of Claim 3 and l. 2 of Claim 6. It is unclear if applicant is referring to the “housing of the distal tip” previously recited in line 8 of Claim 1, or separate, different housing of the distal tip. For the purposes of examination, “a housing of the distal tip” is being interpreted as “the housing of the distal tip.”
Claims 7-8 are rejected as being dependent upon claims previously rejected under 35 USC § 112(b).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1-3, 5, 9, and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 3,896,793 A1 to Mitsui et al. (“Mitsui”) in view of WO 2018/154375 to Viebach Thomas (“Thomas”).
Regarding claim 1, Mitsui discloses a medical device (endoscope; Fig. 1, col. 4, paragraph 2) comprising:
a shaft (flexible tube section 2 connected at one end to said distal end section 1; Fig. 1, col. 4, paragraph 2) comprising a working channel (the forceps insertion channel 20 is extended also into the interior of the flexible tube section 2, and is extended up to the control unit 3 though not shown; Fig. 8, col. 6, paragraph 3); and
a distal tip (distal end section 1; Fig. 1, col. 4, paragraph 2), wherein the distal tip includes an assembly comprising:
an imaging device mounted on a body of the assembly (a movable member 8 is mounted onto the forward end portion 7a of the fiber bundle 7 as an image guide; Fig. 11, col. 4, paragraph 6); and
an elevator (the movable member 8 is formed at its entire upper surface with a recess 18 having a semicircular arcuate cross section; Fig. 11, col. 8, paragraph 5);
wherein the assembly is movable, relative to a housing of the distal tip, from a lowered configuration to an angled configuration to move the imaging device and the elevator from the lowered configuration to the angled configuration (the condition in which the movable member 8 is rocked is shown by two dots-and-dash lines. The view field 16a heretofore given to the image guide bundle 7 is altered to a different view field 16b by said rocking of the movable member 8; Fig. 6, col. 5, paragraph 3).
However, Mitsui does not explicitly disclose a distal tip comprising an irrigation opening fluidly coupled to an irrigation tube, wherein the irrigation opening is formed in the body, wherein the assembly is movable, relative to a housing of the distal tip, from a lowered configuration to an angled configuration to move the irrigation opening from the lowered configuration to the angled configuration.
Thomas teaches a medical device (endoscope; Fig. 1, [0035]) comprising:
a shaft (the insertion portion is a long tube-like member; [0037]) comprising a working channel (working channel 11; Fig. 1, [0036] and [0042]); and
a distal tip (endoscope head 1; Fig. 1, [0036]), wherein the distal tip includes an assembly comprising:
an imaging device (camera 18; Fig. 1, [0048]) mounted on a body of the assembly (the pivot lever 2 forms the distal end of the endoscope head … the camera 18 [is] arranged at this working area; Fig. 1, [0048];
an elevator (the output 111 of the working channel 11; Fig. 1, [0048]); and
an irrigation opening (water spray hole 16 and an air/water spray nozzle 19; Fig. 3, [0051]) fluidly coupled to an irrigation tube (water hose 140 and an air hose 150; Fig. 1, [0040]), wherein the irrigation opening is formed in the body (at the working portion of the swing lever 2, a water spray hole 16 and an air/water spray nozzle 19 are provided; Fig. 1, [0051]),
wherein the assembly is movable, relative to a housing of the distal tip, from a lowered configuration to an angled configuration to move the imaging device, the elevator, and the irrigation opening from the lowered configuration to the angled configuration (by pivoting the pivot lever 2, the camera 18 and the distal outlet 111 of the working channel 11 are thus pivoted, as a result of which the lateral orientation of microtools (e.g. a guide wire or a biopsy forceps) guided in the working channel can be changed; Figs. 1-6, [0048-0049]. Thomas teaches that the water nozzle helps to clean the lens of the camera ([0051]).
Thomas is considered to be analogous to the claimed invention because it is in the same field of endoscope systems with an elevator configured to deflect instruments advanced through a working channel of the endoscope. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal tip of Mitsui to incorporate the teachings of Thomas by incorporating an irrigation opening to the assembly such that the irrigation opening is movable between the lowered and angled configurations. Doing so would help to clean the lens of the camera, as recognized by Thomas.
Regarding claim 2, Mitsui, as previously modified by Thomas, discloses a medical device according to claim 1. Mitsui further discloses wherein the body is movable from the lowered configuration to the angled configuration via a hinge (a pivot pin 13 is secured to each of said paired ear portions 10 of the movable member 8. These pivot pins 13 act as support means for rockably supporting the movable member 8 to the base frame 5 within the space 6; Figs. 5 and 11, col. 5, paragraph 1).
Regarding claim 3, Mitsui, as previously modified by Thomas, discloses a medical device according to claim 1. Mitsui further discloses wherein the assembly is housed within a recessed portion of a housing of the distal tip (a movable member 8 similar to that described in the preceding embodiments is disposed within the space 6 of the distal end section 1; Fig. 10, col. 8, paragraph 4).
Regarding claim 5, Mitsui, as previously modified by Thomas, discloses a medical device according to claim 1. Mitsui further discloses wherein the imaging device is on a first lateral side of the distal tip, and wherein the elevator is on a second lateral side of the distal tip. (the imaging device and the elevator are located on two opposite lateral sides of the distal tip as indicated in annotated Fig. 5 seen below; Fig. 5).
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Regarding claim 9, Mitsui, as previously modified by Thomas, discloses a medical device according to claim 1. Mitsui further discloses wherein, in the angled configuration, a longitudinal axis of the assembly forms an angle between 0° to 90° relative a longitudinal axis of the shaft (the view field 16a heretofore given to the image guide bundle 7 is altered to a different view field 16b by said rocking of the movable member 8; Fig. 6, col. 5, paragraph 3). As seen in Fig. 6, when the movable element is positioned with field of view 16b, the movable member forms an angle between 0° to 90° relative a longitudinal axis of the shaft.
Regarding claim 11, Mitsui, as previously modified by Thomas, discloses a medical device according to claim 1. Mitsui further discloses wherein the imaging device faces at least partially radially outward in the angled configuration (the image of the view field 16b is observed via a fiber bundle 7 by a viewer of camera-photographed; Fig. 6, col. 5, paragraph 3).
Regarding claim 12, Mitsui, as previously modified by Thomas, discloses a medical device according to claim 1. Mitsui further discloses wherein the elevator is positioned within a groove of the body (a forceps 19 is received on said recess 18; Fig. 10-11, col. 6, paragraphs 2-3).
Regarding claim 13, Mitsui, as previously modified by Thomas, discloses a medical device according to claim 1. Mitsui further discloses wherein when the assembly is in the angled configuration, the imaging device and the elevator are angled in approximately a same direction (the forceps 19 is also moved together with said guides 7 and 70 by means of the recess 18; Fig. 4 and 10, col. 8, paragraph 6).
Regarding claim 14, Mitsui, as previously modified by Thomas, discloses a medical device according to claim 1. Mitsui further discloses wherein the assembly further comprises one or more lighting sources mounted on the body (the forward end portion of the illumination light guide bundle 70 is fully inserted into the rectangular through hole 110 and fixed; Fig. 10-11, col. 8, paragraph 4).
Regarding claim 15, Mitsui, as previously modified by Thomas, discloses a medical device according to claims 1 and 14. Mitsui further discloses wherein the one or more lighting sources are movable from the lowered configuration to the angled configuration (when the image guide bundle 7 is moved from the position for observing one view field to the position for observing another, the illumination light guide 70 is so moved as to permit an illumination light to be irradiated from said one view to said another; Fig. 10-11, col. 8, paragraph 6).
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Mitsui in view of U.S. Patent Appl. Publ. No. 2008/0287961 A1 to Miyamoto et al. (“Miyamoto”).
Regarding claim 16, Mitsui discloses a medical device (endoscope; Fig. 1, col. 4, paragraph 2), comprising:
a shaft (flexible tube section 2 connected at one end to said distal end section 1; Fig. 1, col. 4, paragraph 2); and
a distal tip (distal end section 1; Fig. 1, col. 4, paragraph 2), wherein the distal tip includes:
a housing (base frame 5; Fig. 8, col. 4, paragraph 5); and
a body pivotably coupled to the housing (these pivot pins 13 act as support means for rockably supporting the movable member 8 to the base frame 5 within the space 6; Fig. 8, col. 5, paragraph 1), wherein the body includes an imaging device (a movable member 8 is mounted onto the forward end portion 7a of the fiver bundle 7 as an image guide; Fig. 11, col. 4, paragraph 6) and an elevator (the movable member 8 is formed at its entire upper surface with a recess 18 having a semicircular arcuate cross section; Fig. 11, col. 8, paragraph 5), and wherein pivoting the body relative to the housing causes an orientation of the elevator and the imaging device to change (the condition in which the movable member 8 is rocked is shown by two dots-and-dash lines. The view field 16a heretofore given to the image guide bundle 7 is altered to a different view field 16b by said rocking of the movable member 8; Fig. 6, col. 5, paragraph 3), and wherein the imaging device faces at least partially radially outward in a second, angled configuration of the body (the image of the view field 16b is observed via a fiber bundle 7 by a viewer of camera-photographed; Fig. 6, col. 5, paragraph 3).
However, Mitsui does not explicitly disclose wherein the imaging device faces distally along a longitudinal axis of the shaft in a first, lowered configuration of the body.
Miyamoto teaches a medical device (lateral vision endoscope 70; Fig. 1, [0090]), comprising:
a shaft (an elongated insertion portion 72; Fig. 1, [0090]); and
a distal tip (a distal end portion 75; Fig. 1, [0091]), wherein the distal tip includes:
a housing (a distal end portion 75 that s formed of a rigid member; Fig. 1, [0091]); and
a body pivotably coupled to the housing (raising table 20; Fig. 21-22, [0129]), wherein the body includes an elevator (raising table 20; Fig. 21-22, [0131]), and wherein pivoting the body relative to the housing causes an orientation of the elevator to change (the facing direction of the side straight varying surface 20a of the raising table 20 is changed by about 90 degrees of the side surface direction of FIG. 22 from the distal end direction of the distal end portion 5 of FIG. 21; Fig. 21-22, [0138]), wherein the imaging device faces distally along a longitudinal axis of the shaft in a first, lowered configuration of the body (the direction in which the distal end surface 11 of the image catheter 2 faces (the view direction) is in the same direction as the longitudinal direction of the insertion portion 3; Fig. 21, [0140]), and wherein the imaging device faces at least partially radially outward in a second, angled configuration of the body (on the other hand, in the state shown in FIG. 22, the turning operation is performed so that the side straight varying surface 20a of the raising table 20 is changed by about 90 degrees, the direction in which the distal end surface 11 of the image catheter faces (the view direction) is substantially perpendicular to the axis of the longitudinal direction of the insertion portion 3; Fig. 22, [0140]). Miyamoto teaches that by positioning the imaging device to face distally along a longitudinal axis of the shaft, the operator can visually check the insert direction of the insertion portion through an image of the imaging device ([0143]).
Miyamoto is considered to be analogous to the claimed invention because it is in the same field of endoscope systems with an elevator configured to deflect instruments advanced through a working channel of the endoscope. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal tip of Mitsui to incorporate the teachings of Miyamoto by configuring the assembly such that the imaging device faces distally along a longitudinal axis of the shaft in a first, lowered configuration of the body. Doing so would allow the operator to visually check the insert direction of the insertion portion through an image of the imaging device, as recognized by Miyamoto.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mitsui in view of U.S. Patent Appl. Publ. No. 2021/0204800 A1 to Magno et al. (“Magno”).
Regarding claim 19, Mitsui discloses a medical device (endoscope; Fig. 1, col. 4, paragraph 2), comprising:
a shaft (flexible tube section 2 connected at one end to said distal end section 1; Fig. 1, col. 4, paragraph 2); and
a distal tip (distal end section 1; Fig. 1, col. 4, paragraph 2), wherein the distal tip includes a pivotable body having an elevator (the movable member 8 is formed at its entire upper surface with a recess 18 having a semicircular arcuate cross section; Fig. 11, col. 8, paragraph 5) and an imaging device (a movable member 8 is mounted onto the forward end portion 7a of the fiber bundle 7 as an image guide; Fig. 11, col. 4, paragraph 6), wherein the imaging device and one or more lighting sources are disposed on a first lateral side portion of the pivotable body (the imaging device 7 and the lighting source 70 are on a first lateral side of the pivotable body as seen in annotated Fig. 11 below; Fig. 11), wherein the elevator is disposed on a second lateral side portion of the pivotable body opposite the first lateral side portion (the elevator 18 is disposed on a second lateral side portion of the pivotable body as seen in annotated Fig. 11 below; Fig. 11), wherein the pivotable body is pivotable relative to a housing of the distal tip (the condition in which the movable member 8 is rocked is shown by two dots-and-dash lines. The view field 16a heretofore given to the image guide bundle 7 is altered to a different view field 16b by said rocking of the movable member 8; Fig. 6, col. 5, paragraph 3), and wherein a control wire is coupled to the pivotable body (to the upper surface of said member 8 is firmly secured on end of an actuating wire 14 functioning as movable member actuating means; Fig. 11, col. 5, paragraph 1).
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However, Mitsui does not explicitly disclose wherein a control wire is coupled to the pivotable body between the elevator and the imaging device.
Magno teaches multiple arrangements of the imaging device, light source, and tool elevator, demonstrating that relative positioning of these components is a known design consideration (Figs. 3, 6A, 7A, and 10-11).
Mango is considered to be analogous to the claimed invention because it is in the same field of endoscope systems with varying instrument tool fields. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal tip of Mitsui to incorporate the teachings of Magno by rearranging the imaging device and the light source such that the control wire is coupled to the pivotable body between the elevator and the imaging device. It would have been obvious to apply one of these known configurations, as taught by Magno, to Mitsui, as doing so merely involves the use of a known technique to achieve the predictable result of providing imaging, illumination, and tool actuation. Applying a known technique to a known device ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.). Additionally, it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70.
Regarding claim 20, Mitsui, as previously modified by Magno, discloses the medical device according to claim 19. Mitsui further discloses wherein movement of the control wire is configured to rotate the elevator and the imaging device about a hinge (when, in the endoscope having the aforesaid construction, the knob 3b provided for the control unit 3 is turned by a viewer or operator, the actuating wire 14 is pulled to slide toward the right side of Fig. 2 by passing through a channel 15a. As the result, the movable member 8 is rocked clockwise about the pivot pin 13 by actuating wire 14 to raise the forward end portion 7a of the fiber bundle 7; Fig. 2, col. 5, paragraph 3).
Claims 6-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mitsui, in view of Thomas as applied to claim 1 above, and further in view of Miyamoto.
Regarding claim 6, Mitsui, as previously modified by Thomas, discloses a medical device according to claim 1. However, Mitsui, as modified by Thomas, does not explicitly disclose wherein a bottom surface of the body contacts an inner surface of a housing of the distal tip in the lowered configuration.
Miyamoto teaches wherein a bottom surface of the body contacts an inner surface of a housing of the distal tip in the lowered configuration (the distal end portion 5 has a concave portion 34 for accommodating a gate 35; Fig. 26, paragraph 0150 and 0153). Miyamoto teaches that when the bottom surface of the gate contacts an inner surface of the distal tip, the view direction of the imaging device can be in a straight vision state of the longitudinal axis direction of the insertion portion of the endoscope (paragraph 0153).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal tip of Mitsui, as modified by Thomas, to incorporate the teachings of Miyamoto by having a bottom surface of the assembly contact an inner surface of a housing of the distal tip in the lowered configuration. Doing so would allow the view direction of the imaging device to be in a straight vision state of the longitudinal axis direction of the insertion portion of the endoscope, as recognized by Miyamoto.
Regarding claim 7, Mitsui, as previously modified by Thomas and Miyamoto, discloses a medical device according to claims 1 and 6. Mitsui further discloses wherein the assembly is coupled to a control wire (to the upper surface of said member 8 is firmly secured on end of an actuating wire 14 functioning as movable member actuating means; Fig. 11, col. 5, paragraph 1), wherein distal movement of the control wire moves the assembly towards the inner surface of the housing, and wherein proximal movement of the control wire moves the assembly away from the inner surface of the housing (when, in the endoscope having the aforesaid construction, the knob 3b provided for the control unit 3 is turned by a viewer or operator, the actuating wire 14 is pulled to slide toward the right side of Fig. 2 by passing through a channel 15a. As the result, the movable member 8 is rocked clockwise about the pivot pin 13 by actuating wire 14 to raise the forward end portion 7a of the fiber bundle 7; Fig. 2, col. 5, paragraph 3).
Regarding claim 10, Mitsui, as previously modified by Thomas, discloses a medical device according to claim 1. However, Mitsui, as modified by Thomas, does not explicitly disclose wherein the imaging device faces distally along a longitudinal axis of the shaft in the lowered configuration.
Miyamoto teaches a body pivotably coupled to the housing (raising table 20; Fig. 21-22, [0129]), wherein the body includes an elevator (raising table 20; Fig. 21-22, [0131]), and wherein pivoting the body relative to the housing causes an orientation of the elevator to change (the facing direction of the side straight varying surface 20a of the raising table 20 is changed by about 90 degrees of the side surface direction of FIG. 22 from the distal end direction of the distal end portion 5 of FIG. 21; Fig. 21-22, [0138]), wherein the imaging device faces distally along a longitudinal axis of the shaft in a first, lowered configuration of the body (the direction in which the distal end surface 11 of the image catheter 2 faces (the view direction) is in the same direction as the longitudinal direction of the insertion portion 3; Fig. 21, [0140]), and wherein the imaging device faces at least partially radially outward in a second, angled configuration of the body (on the other hand, in the state shown in FIG. 22, the turning operation is performed so that the side straight varying surface 20a of the raising table 20 is changed by about 90 degrees, the direction in which the distal end surface 11 of the image catheter faces (the view direction) is substantially perpendicular to the axis of the longitudinal direction of the insertion portion 3; Fig. 22, [0140]). Miyamoto teaches that by positioning the imaging device to face distally along a longitudinal axis of the shaft, the operator can visually check the insert direction of the insertion portion through an image of the imaging device ([0143]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal tip of Mitsui, as modified by Thomas, to incorporate the teachings of Miyamoto by configuring the assembly such that the imaging device faces distally along a longitudinal axis of the shaft in a first, lowered configuration of the body. Doing so would allow the operator to visually check the insert direction of the insertion portion through an image of the imaging device, as recognized by Miyamoto.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Mitsui in view of Miyamoto, as applied to claim 16 above, and further in view of Thomas.
Regarding claim 17, Mitsui, as previously modified by Miyamoto, discloses the medical device according to claim 16. Mitsui further discloses wherein the body further includes one or more lighting sources (the forward end portion of the illumination light guide bundle 70 is fully inserted into the rectangular through hole 110 and fixed; Fig. 10-11, col. 8, paragraph 4). However, Mitsui, as modified by Miyamoto, does not explicitly disclose wherein the body further includes an irrigation opening.
Thomas teaches wherein the body further includes an irrigation opening (at the working portion of the swing lever 2, a water spray hole 16 and an air/water spray nozzle 19 are provided; Fig. 1, [0051]). Thomas teaches that the water nozzle helps to clean the lens of the camera ([0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal tip of Mitsui, as modified by Miyamoto, to incorporate the teachings of Thomas by incorporating an irrigation opening into the body. Doing so would help to clean the lens of the camera, as recognized by Thomas.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Mitsui, in view of Miyamoto as applied to claim 16 above, and further in view of Magno.
Regarding claim 18, Mitsui, as previously modified by Miyamoto, discloses the medical device according to claim 16. Mitsui further discloses wherein a control wire is coupled to the body (to the upper surface of said member 8 is firmly secured on end of an actuating wire 14 functioning as movable member actuating means; Fig. 11, col. 5, paragraph 1), wherein movement of the control wire is configured to pivot the body relative to the housing (when, in the endoscope having the aforesaid construction, the knob 3b provided for the control unit 3 is turned by a viewer or operator, the actuating wire 14 is pulled to slide toward the right side of Fig. 2 by passing through a channel 15a. As the result, the movable member 8 is rocked clockwise about the pivot pin 13 by actuating wire 14 to raise the forward end portion 7a of the fiber bundle 7; Fig. 2, col. 5, paragraph 3). However, Mitsui, as modified by Miyamoto, does not explicitly disclose wherein a control wire is coupled to the body between the elevator and the imaging device.
Magno teaches multiple arrangements of the imaging device, light source, and tool elevator, demonstrating that relative positioning of these components is a known design consideration (Figs. 3, 6A, 7A, and 10-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal tip of Mitsui to incorporate the teachings of Magno by rearranging the imaging device and the light source such that the control wire is coupled to the body between the elevator and the imaging device. It would have been obvious to apply one of these known configurations, as taught by Magno, to Mitsui, as doing so merely involves the use of a known technique to achieve the predictable result of providing imaging, illumination, and tool actuation. Applying a known technique to a known device ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.). Additionally, it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Mitsui, in view of Magno as applied to claim 16 above, and further in view of Thomas.
Regarding claim 21, Mitsui, as previously modified by Magno, discloses the medical device according to claim 19. However, Mitsui, as modified by Magno, does not explicitly disclose wherein an irrigation opening is formed in the pivotable body and is fluidly coupled to an irrigation tube.
Thomas teaches an irrigation opening is formed in the pivotable body (at the working portion of the swing lever 2, a water spray hole 16 and an air/water spray nozzle 19 are provided; Fig. 1, [0051]) and is fluidly coupled to an irrigation tube (water hose 140 and an air hose 150; Fig. 1, [0040]). Thomas teaches that the water nozzle helps to clean the lens of the camera ([0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal tip of Mitsui to incorporate the teachings of Thomas by incorporating an irrigation opening to the assembly such that the irrigation opening is movable between the lowered and angled configurations. Doing so would help to clean the lens of the camera, as recognized by Thomas.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mitsui in view of Thomas and Miyamoto as applied to claims 1 and 6-7 above, and further in view of Magno.
Regarding claim 8, Mitsui, as previously modified by Thomas and Miyamoto, discloses the medical device according to claims 1 and 6-7. However, Mitsui, as modified by Thomas and Miyamoto, fails to explicitly disclose wherein the elevator is disposed on a first side portion of the assembly, wherein the imaging device is coupled to a second side portion of the assembly, wherein the control wire is coupled to a medial portion of the assembly, and wherein the medial portion is between the first side portion and the second side portion.
Magno teaches multiple arrangements of the imaging device, light source, and tool elevator, demonstrating that relative positioning of these components is a known design consideration (Figs. 3, 6A, 7A, and 10-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal tip of Mitsui, as modified by Thomas and Miyamoto, to incorporate the teachings of Magno by rearranging the imaging device and the light source such that the control wire is coupled to the pivotable body between the elevator and the imaging device. It would have been obvious to apply one of these known configurations, as taught by Magno, to Mitsui, as doing so merely involves the use of a known technique to achieve the predictable result of providing imaging, illumination, and tool actuation. Applying a known technique to a known device ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.). Additionally, it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET.
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/OLIVIA GRACE STARKEY/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
