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 .
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 1-11 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. Claim 1 recites, in pertinent part, a tubular fixation frame in which the distal end cover is fixed on a distal end side thereof. It is not clear how the distal end cover (31) is fixed in the tubular fixation frame (32). The drawings illustrate the distal end cover (31) being fixed on, not in, the tubular fixation frame (32; see Figs. 5 and 6). Accordingly, the claims are rendered indefinite. For purposes of examination, the limitation is interpreted as a tubular fixation frame on which the distal end cover is fixed on a distal end side thereof (emphasis added).
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.
Claim(s) 1-2 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe et al. (WO 2021/070634 A1) in view of Kienzle et al. (US 2019/0321077 A1).
Regarding claim 1, Watanabe discloses an endoscope (Fig. 1) comprising: a tubular distal end cover (26; Figs. 1-2; pg. 2 - an annular light distribution lens 26) disposed at a distal end of an insertion portion (2; Fig. 1); a tubular fixation frame (24; Figs. 1-2; pg. 2 - a tubular housing 24) in which the distal end cover (26) is fixed on a distal end side thereof; and a tubular illumination frame (see A of inserted Fig. 2 of Watanabe below) fixed to an inner peripheral surface of the fixation frame (24; Fig. 2) and holding a light source (71/72; Figs. 2-3; pg. 3 - a first LED 71 and a second LED 72 mounted on one surface of the substrate 70 that faces the light distribution lens 26) at a distal end thereof, wherein a predetermined gap (Fig. 2 – open space between the inner surface of 26 and surfaces of the illumination and 71/72) is provided between an inner surface of the distal end cover (26) and surfaces of the illumination frame (see B of inserted Fig. 2 of Watanabe below) and the light source (71/72).
However, Watanabe does not specifically disclose that the tubular distal end cover is translucent. Kienzle teaches an analogous endoscope wherein the distal cover is a diffusion element and is fabricated from a translucent material in order to provide uniform illumination of the target site (par. [0093]). It would have been obvious to one having ordinary skill in the art to make the tubular distal end cover of Watanabe out of a translucent material in order to provide uniform illumination of the target site, as taught by Kienzle.
Regarding claim 2, Watanabe in view of Kienzle disclose the endoscope according to claim 1, further comprising an observation window (25; Fig. 2; pg. 2 - a central observation window 25) protruding from the distal end cover (26), wherein the distal end cover (26) includes an illumination lens unit (Fig. 2 – air gap) that transmits illumination light emitted from the light source (71/72) and illuminates a visual field direction of the observation window (25; Fig. 2).
Regarding claim 3, Watanabe in view of Kienzle disclose the endoscope according to claim 2, wherein the distal end cover (26) includes a planar portion (see C of inserted Fig. 2 of Watanabe below) between the illumination lens unit (Fig. 2 – air gap) and the observation window (25), and a gap between the planar portion (see C of inserted Fig. 2 of Watanabe below) and a surface of the light source (distal most surface of 71/72). Watanabe does not specifically disclose that the gap is 50 micrometers or greater and 250 micrometers or less. However, "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (see MPEP §2144.05). It would have been obvious to one having ordinary skill in the art to discover the optimum ranges of the gap between the planar portion and a surface of the light source in order to achieve the desired light distribution of the illumination light from the distal end of the endoscope.
Regarding claim 5, Watanabe in view of Kienzle disclose the endoscope according to claim 1, wherein the light source (71/72) includes a light-emitting element (71/72; Figs. 2-3; pg. 3 - a first LED 71 and a second LED 72 mounted on one surface of the substrate 70 that faces the light distribution lens 26) and a phosphor (pg. 3 - covering the light emitting surface of a blue LED chip that emits blue light with a yellow phosphor) covering the light-emitting element, and a light source substrate (70; Figs. 2-3; pg. 3 - a first LED 71 and a second LED 72 mounted on one surface of the substrate 70 that faces the light distribution lens 26) on which the light-emitting element (71/72) is mounted is held on a distal end surface of the illumination frame (Fig. 2).
Regarding claim 6, Watanabe in view of Kienzle disclose the endoscope according to claim 5, wherein the light source substrate (70; Fig. 3) is in an annular shape, and a gap (Fig. 2) between the inner peripheral surface of the distal end cover (26) and an outer peripheral surface of the light source substrate (70; Fig. 2). Watanabe does not specifically disclose that the gap is 50 micrometers or greater and 250 micrometers or less. However, "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (see MPEP §2144.05). It would have been obvious to one having ordinary skill in the art to discover the optimum ranges of the gap between the planar portion and a surface of the light source in order to achieve the desired light distribution of the illumination light from the distal end of the endoscope.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe in view of Kienzle as applied to claim 1 above, and further in view of Makiyama et al. (WO 2012/017861 A1).
Regarding claim 4, Watanabe in view of Kienzle disclose the endoscope according to claim 1, but does not specifically disclose wherein a gap between the inner peripheral surface of the distal end cover and an outer peripheral surface of the illumination frame is 50 micrometers or greater and 250 micrometers or less.
Makiyama teaches an analogous endoscope having various gaps (a1, a2, and a3) between components of the imaging system (Figs. 3-4). Makiyama teaches that when an impact force is applied to the distal end of the endoscope, the gaps prevent components from being damaged (pg. 8 - when an impact force is unexpectedly applied from the side to the distal end portion 3, the force applied to the cover member 15 is the first gap. Since it is not directly transmitted to the front lens frame 31 by a1, it is possible to prevent the observation window 41a from being damaged). It would have been obvious to one having ordinary skill in the art to provide a gap between the inner peripheral surface of the distal end cover and an outer peripheral surface of the illumination frame in order to prevent damage to the components due to an impact force, as taught by Makiyama. Watanabe does not specifically disclose that the gap is 50 micrometers or greater and 250 micrometers or less. However, "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (see MPEP §2144.05). It would have been obvious to one having ordinary skill in the art to discover the optimum ranges of the gap between the planar portion and a surface of the light source in order to achieve the desired light distribution of the illumination light from the distal end of the endoscope.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe in view of Kienzle as applied to claim 1 above, and further in view of Usui et al. (US 2015/0014726 A1).
Regarding claim 7, Watanabe in view of Kienzle disclose the endoscope according to claim 5. Although Watanabe disclose the light-emitting element emits narrow band light including a green wavelength (pg. 3 - The first LED 71 emits narrow band light including a purple and green wavelength range), it does not specifically disclose wherein the light-emitting element emits violet light, and the phosphor is excited by light emitted from the light-emitting element to emit the green light. Usui teaches an analogous light-emitting element that emits green light wherein the light-emitting element emits violet light, and the phosphor is excited by light emitted from the light-emitting element to emit the green light (par. [0093]). Usui teaches that this configuration provides a light-emitting element with high luminous efficiency (par. [0020]) thereby effectively converting energy into visible light. It would have been obvious to one having ordinary skill in the art to provide the light-emitting element of Watanabe with the configuration of Usui in order to have a light-emitting device that effectively converts energy into green light, as taught by Usui.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe in view of Kienzle as applied to claim 1 above, and further in view of Balog et al. (US 2014/0356802 A1) in view of Benning et al. (US 2013/0131447 A1).
Regarding claim 8, Watanabe in view of Kienzle disclose the endoscope according to claim 1, but does not specifically disclose wherein the distal end cover is made of a material having a higher water absorption rate than a material constituting the fixation frame. Balog teaches an analogous light-emitting element (34; par. [0034]) that emits light through a translucent member (28; par. [0034]). Balog teaches that the translucent member may be made out a variety of materials including polycarbonate or nylon (par. [0049]). It would have been obvious to one having ordinary skill in the art to select either nylon or polycarbonate as the material for the distal end cover as the selection of a known material based on its suitability for its intended purpose (see MPEP §2144.07). Benning teaches an analogous endoscope wherein the translucent distal end cover (par. [0029]) disposed on the distal end of a fixation frame (24; Fig. 2). Benning teaches that the fixation frame may be made from a variety of biocompatible materials such as stainless steel or metal alloys (par. [0030]). It would have been obvious to one having ordinary skill in the art to select stainless steel as the material for the fixation frame as the selection of a known material based on its suitability for its intended purpose (see MPEP §2144.07). Such modification of Watanabe provides a configuration wherein the distal end cover (26) is made of a material (Balog - nylon) having a higher water absorption rate than a material constituting the fixation frame (Benning – stainless steel).
Regarding claim 9, Watanabe in view of Kienzle disclose the endoscope according to claim 1, but does not specifically disclose wherein the distal end cover is made of a material having a higher linear expansion coefficient than a material constituting the fixation frame. Balog teaches an analogous light-emitting element (34; par. [0034]) that emits light through a translucent member (28; par. [0034]). Balog teaches that the translucent member may be made out a variety of materials including polycarbonate or nylon (par. [0049]). It would have been obvious to one having ordinary skill in the art to select either nylon or polycarbonate as the material for the distal end cover as the selection of a known material based on its suitability for its intended purpose (see MPEP §2144.07). Benning teaches an analogous endoscope wherein the translucent distal end cover (par. [0029]) disposed on the distal end of a fixation frame (24; Fig. 2). Benning teaches that the fixation frame may be made from a variety of biocompatible materials such as stainless steel or metal alloys (par. [0030]). It would have been obvious to one having ordinary skill in the art to select stainless steel as the material for the fixation frame as the selection of a known material based on its suitability for its intended purpose (see MPEP §2144.07). Such modification of Watanabe provides a configuration wherein the distal end cover (26) is made of a material (Balog - nylon) having a higher linear expansion coefficient than a material constituting the fixation frame (Benning – stainless steel).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe in view of Kienzle as applied to claim 1 above, and further in view of Balog et al. (US 2014/0356802 A1).
Regarding claim 10, Watanabe in view of Kienzle disclose the endoscope according to claim 1, but does not specifically disclose wherein the distal end cover is made of polyamide, polycarbonate, copolyester, or a cyclo-olefin polymer. Balog teaches an analogous light-emitting element (34; par. [0034]) that emits light through a translucent member (28; par. [0034]). Balog teaches that the translucent member may be made out a variety of materials including polycarbonate or nylon (par. [0049]). It would have been obvious to one having ordinary skill in the art to select either nylon or polycarbonate as the material for the distal end cover as the selection of a known material based on its suitability for its intended purpose (see MPEP §2144.07).
Regarding claim 11, Watanabe in view of Kienzle disclose the endoscope according to claim 1, but does not specifically disclose wherein the distal end cover is made of Grilamid (registered trademark), Rilsan (registered trademark), TROGAMID (registered trademark), or UNITIKA Nylon 6. Balog teaches an analogous light-emitting element (34; par. [0034]) that emits light through a translucent member (28; par. [0034]). Balog teaches that the translucent member may be made out a variety of materials including polycarbonate or nylon (par. [0049]). It would have been obvious to one having ordinary skill in the art to select either nylon or polycarbonate as the material for the distal end cover as the selection of a known material based on its suitability for its intended purpose (see MPEP §2144.07). Grilamid, Rilsan, TROGAMID, and UNITIKA Nylon 6 are all nylon materials. Thus, it would have been obvious to one having ordinary skill in the art to select one of them as the material for the distal end cover as the selection of a known material based on its suitability for its intended purpose (see MPEP §2144.07).
Inserted Figure 2 of Watanabe et al.
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Conclusion
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 2/9/26