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
This office action is responsive to the amendment filed on 9/2/2025. As directed by the amendment, the status of the claim(s) are:
Claim(s) 1-2, 4-6, 8-15 has/have been amended;
Claim(s) 7 is/are cancelled;
Claim(s) 16-17 is/are new;
Claim(s) 1-6, 8-17 is/are presently pending.
Response to Arguments
Applicant argues on p. 8-9 that Arai does not teach illumination light and that it would not be obvious to modify with Makowski since Arai only takes into consideration the resection of an area surrounding a lateral lesion while Mankowski only takes into consideration the possibility of lateral viewing using a reusable optical unit that allows direction vision. After review, this is not persuasive. Both Arai and Mankowski are within the same field of endeavor of endoscopy and it would have yielded predictable results to a person of ordinary skill in the art to combine Arai’s teaching of treatment irradiation light with Mankowski’s teaching of illumination light for visualization with mirror structure at distal end to control direction of light(s).
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) 1-4, 6, 8-9, 11, 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arai (US 20030009085 A1; 1/9/2003; cited in previous office action) in view of Mankowski (US 20200154981 A1; 5/21/2020; cited in previous office action).
Regarding claim 1, Arai teaches a therapeutic light irradiation device for irradiating therapeutic light onto a tumor in which photosensitive drugs have accumulated (For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.), comprising:
a therapeutic light irradiation section configured to emit the therapeutic light in a first direction (Fig. 1A; Fig. 41; [0015]; [0309]; [0314]).
Arai does not teach an illumination light irradiation section configured to emit illumination light in the first direction;
an objective optical system configured to receive observation light from an object in the first direction.
Note that Arai does teach endoscopes ([0003]; [0058]) and so illumination light source would be inherent and/or at least understood to be commonly used in the field of endoscopy. However, Mankowski teaches in the same field of endeavor (Abstract) an illumination light irradiation section configured to emit illumination light in the first direction ([0079]; Fig. 30; [0106]);
an objective optical system configured to receive observation light from an object in the first direction (Fig. 30, 12a3; [0010] “lenses”; [0076] “lenses”).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Arai to include these features as taught by Mankowski because this enables providing light for imaging ([0079]; [0106]).
The combination of Arai and Mankowski teaches an irradiation direction switching section disposed on a front side of the therapeutic light irradiation section, the illumination light irradiation section, and the objective optical system (Arai Fig. 41; [0309]; Mankowski Fig. 30; [0106]), and
configured to switch an irradiation direction of both the illumination light and the therapeutic light, and a light receiving direction of the objective optical system to a second direction different from the first direction (Arai Fig. 41; [0309]; Mankowski Fig. 30; [0106]).
Regarding claim 2, the combination of Arai and Mankowski teaches a rotation mechanism configured to rotate a reflecting surface about an axis of rotation between a first position where the reflecting surface is disposed on a path of the therapeutic light emitted in the first direction and a second position where the reflecting surface is not disposed on the path of the therapeutic light emitted in the first direction (Arai Fig. 41; [0309]; Mankowski Fig. 30; [0106]).
Regarding claim 3, the combination of Arai and Mankowski teaches an operation member configured to operate the rotation mechanism to rotate the reflecting surface about the axis of rotation (Arai Fig. 41; [0309]; Mankowski Fig. 30; [0106]).
Regarding claim 4, the combination of Arai and Mankowski teaches wherein the operation member comprises a wire configured to transmit a force along an insertion section to operate the rotation mechanism to rotate the reflecting surface about the axis of rotation (Arai Fig. 41; [0309]; Mankowski Fig. 30; [0106]).
Regarding claim 6, the combination of Arai and Mankowski teaches wherein a connector is configured to be detachably connected to an insertion section at different positions to change a relative position of a reflecting surface relative to the insertion section (Arai [0309] “adjusted…with fingers”; Mankowski Fig. 1, 1a and 1b; Fig. 5; Fig. 14; [0072]-[0073] [0091]; [0106]; the bellows and/or bending section allows for changing of relative position).
Regarding claim 8, in the combination of Arai and Mankowski, Arai teaches a rotation mechanism configured to rotate a reflecting surface about an axis of rotation between a first position where the reflecting surface is disposed on a path of light emitted in the first direction and a second position where the reflecting surface is not disposed on the path of the light emitted in the first direction (Fig. 41; [0309]).
Regarding claim 9, in the combination of Arai and Mankowski, Arai teaches a wire configured to transmit a force along an insertion section to operate the rotation mechanism to rotate the reflecting surface about the axis of rotation ([0309]).
Regarding claim 11, Arai teaches an endoscope comprising:
a channel capable of inserting a therapeutic light irradiation section that is configured to irradiate therapeutic light in a first direction onto a tumor in which photosensitive drugs have accumulated (For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.; Arai Fig. 38-40; Fig. 41; [0015]; [0309]; [0400]).
Arai does not teach an illumination light irradiation section configured to emit illumination light in the first direction;
an objective optical system configured to receive observation light from an object in the first direction.
Note that Arai does teach endoscopes ([0003]; [0058]) and so illumination light source would be inherent and/or at least understood to be commonly used in the field of endoscopy. However, Mankowski teaches in the same field of endeavor (Abstract) an illumination light irradiation section configured to emit illumination light in the first direction ([0079]; Fig. 30; [0106]);
an objective optical system configured to receive observation light from an object in the first direction (Fig. 30, 12a3; [0010] “lenses”; [0076] “lenses”).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Arai to include these features as taught by Mankowski because this enables providing light for imaging ([0079]; [0106]).
The combination of Arai and Mankowski teaches a distal end part to which an irradiation direction switching section is attached, the irradiation direction switching section being disposed on a front side of the therapeutic light irradiation section, the illumination light irradiation section, and the objective optical system, the irradiation direction switching section being configured to switch an irradiation direction of both the illumination light and the therapeutic light, and a light receiving direction of the objective optical system to a second direction different from the first direction (Arai Fig. 41; [0309]; Mankowski Fig. 30; [0106]).
Regarding claim 13, the combination of Arai and Mankowski teaches wherein the first direction is along a longitudinal axis of an insertion section (Arai Fig. 41; Mankowski Fig. 30).
Regarding claim 14, the combination of Arai and Mankowski teaches the wire is longer than a lumen of an endoscope (Arai Fig. 41; [0309]; Mankowski Fig. 30; [0106]);
a distal end of the wire is connected to the rotation mechanism (Arai Fig. 41; [0309]; Mankowski Fig. 30; [0106]); and
a proximal end of the wire protrudes from a proximal end of the lumen (Arai Fig. 41; [0309] “wire operation from the outside of the body cavity”; Mankowski Fig. 30; [0106] “angulation wire is driven by a dedicated channel…to the handle”).
Regarding claim 15, in the combination of Arai and Mankowski, Arai does not teach wherein a portion of a connector disposed in the second direction comprises an optically transparent material or the connector defines a hole disposed in the second direction so that the therapeutic light can travel in the second direction between an inside and an outside of the connector. However, Mankowski teaches in the same field of endeavor (Abstract) wherein a portion of the connector disposed in the second direction comprises an optically transparent material or the connector defines a hole disposed in the second direction so that the therapeutic light can travel in the second direction between an inside and an outside of the connector ([0106] “cover”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Arai to include this feature as taught by Mankowski because this “protects patient form injury, facilitates the insertion of the endoscope and protects the mirror from damage” ([0106]).
Regarding claim 16, in the combination of Arai and Mankowski, Arai does not explicitly teach a connector configured to detachably connect a reflecting surface to an insertion section. Note that Arai does teach a connector to connect the reflecting surface to the insertion section (Fig. 41; [0309] “mirror 197 attached to the cap 196 at a variable angle may be replaced in accordance with the size of the affected area”). However, Mankowski teaches in the same field of endeavor (Abstract) a connector configured to detachably connect a reflecting surface to an insertion section (Fig. 22, 1a; Fig. 30; [0072]; [0091] “detachably mounted”; [0106]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Arai to include these features as taught by Mankowski because this enables robust connection and alignment ([0072]; [0106]); note also that making parts separate as recited in “detachably connect” is an obvious modification; MPEP 2144.04 Making Separable.
Regarding claim 17, in the combination of Arai and Mankowski, Arai does not explicitly teach a connector configured to detachably connect a reflecting surface to an insertion section. Note that Arai does teach a connector to connect the reflecting surface to the insertion section (Fig. 41; [0309] “mirror 197 attached to the cap 196 at a variable angle may be replaced in accordance with the size of the affected area”). However, Mankowski teaches in the same field of endeavor (Abstract) a connector configured to detachably connect a reflecting surface to an insertion section (Fig. 22, 1a; Fig. 30; [0072]; [0091] “detachably mounted”; [0106]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Arai to include these features as taught by Mankowski because this enables robust connection and alignment ([0072]; [0106]); note also that making parts separate as recited in “detachably connect” is an obvious modification; MPEP 2144.04 Making Separable.
Claim(s) 5, 10, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arai and Mankowski as applied to claim(s) 1, 11 above, and further in view of Watanabe (US 20100053312 A1; 3/4/2010; cited in previous office action).
Regarding claim 5, the combination of Arai and Mankowski teaches wherein a reflecting surface is configured to switch the irradiation direction of the therapeutic light having a first wavelength between the first direction and the second direction (Arai Fig. 41; [0309]; Mankowski Fig. 30; [0106]).
The combination of Arai and Mankowski does not teach the reflecting surface is configured to transmit a light having a second wavelength. However, Watanabe teaches in the same field of endeavor (Abstract) the reflecting surface is configured to transmit a light having a second wavelength (Fig. 8-9; [0091]-[0092] “dichroic mirror”; claim 1). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Arai and Mankowski to include this feature as taught by Watanabe because this enables splitting of wavelengths in order to better image from distal end of endoscope ([0032]-[0035]).
Regarding claim 10, in the combination of Arai and Mankowski, Arai teaches light emitted in the first direction has a wavelength within a wavelength range ([0309]); and
a reflecting surface is configured to switch the irradiation direction of the light between the first direction and the second direction based on the wavelength of the light being in the wavelength range (Fig. 41; [0309]).
Arai does not teach reflecting surface is configured to transmit another light having a wavelength not within the wavelength range. However, Watanabe teaches in the same field of endeavor (Abstract) the reflecting surface is configured to transmit another light having a wavelength not within the wavelength range (Fig. 8-9; [0091]-[0092] “dichroic mirror”; claim 1). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Arai and Mankowski to include this feature as taught by Watanabe because this enables splitting of wavelengths in order to better image from distal end of endoscope ([0032]-[0035]).
Regarding claim 12, the combination of Arai and Mankowski teaches a rotation mechanism configured to rotate a reflecting surface about an axis of rotation between a first position where the reflecting surface is disposed on a path of the therapeutic light and a second position where the reflecting surface is not disposed on the path of the therapeutic light (Arai Fig. 41; [0309]; Mankowski Fig. 30; [0106]).
The combination of Arai and Mankowski does not teach the illumination light emitted in the first direction for both positions. However, Watanabe teaches in the same field of endeavor (Abstract) movable reflecting surface is configured to transmit a light having a second wavelength which results in the claimed limitation (Fig. 8-9; [0091]-[0092] “dichroic mirror”; claim 1). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Arai and Mankowski to include this feature as taught by Watanabe because this enables splitting of wavelengths in order to better image from distal end of endoscope ([0032]-[0035]).
The combination of Arai, Mankowski, and Watanabe teaches a wire configured to transmit a force along the channel to operate the rotation mechanism to rotate the reflecting surface about the axis of rotation (Arai Fig. 41; [0309]; Mankowski Fig. 30; [0106]).
Conclusion
THIS ACTION IS MADE FINAL. 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 Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792