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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed 11/05/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because cite no. 35 and 36 appear to be duplicate citations of cite no. 32 and 33, respectively. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 9-12 and 16 are objected to because of the following informalities:
Claim 9, line 4, the limitation “the ultrasonic vibrator” should be changed to “the plurality of ultrasonic vibrators”;
Claim 10, line 4, the limitation “the ultrasonic vibrator” should be changed to “the plurality of ultrasonic vibrators”;
Claim 10, line 5, the limitation “a second direction” should be changed to “the second direction”;
Claim 11, line 4, the limitation “the ultrasonic vibrator” should be changed to “the plurality of ultrasonic vibrators”;
Claim 11, line 5, the limitation “an observation window” should be changed to “the observation window”;
Claim 12, line 4, the limitation “the ultrasonic vibrator” should be changed to “the plurality of ultrasonic vibrators”;
Claim 12, line 5, the limitation “a second direction where an observation window is disposed” should be changed to “the second direction where the observation window is disposed”; and
Claim 16, lines 2-3, the limitation “wherein an upper region of the wall surface on the distal end side of the erecting base housing portion is formed inclined downward toward the proximal end side” should be changed to “wherein an upper region of the wall surface on a distal end side of the erecting base housing portion is formed inclined downward toward a proximal end side of the erecting base housing portion”.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6-10, and 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 13, and 16-18 of U.S. Patent No. 12,496,039 (hereinafter ‘039) in view of Onishi (WO 2015/107801 A1, of record, hereinafter Onishi).
Regarding claim 1 of the current application, claim 1 of ‘039 discloses an ultrasonic endoscope (see claim 1 of ‘039, line 1) comprising: an ultrasonic transducer that has a plurality of ultrasonic vibrators (see claim 1 of ‘039, lines 2-3); a distal end portion body that is disposed with a proximal end side of the ultrasonic transducer (see claim 1 of ‘039, lines 4-5); an erecting base housing portion that is disposed in the distal end portion body and that has an opening whose opening direction is one side in a first direction that is perpendicular to an axial direction of the distal end portion body or whose opening direction is a direction that has a component toward one side in the first direction and a component toward a distal end side in the axial direction of the distal end portion body (see claim 1 of ‘039, lines 6-13); a treatment tool lead-out port that communicates with an inside of the erecting base housing portion and from which a treatment tool is led out (see claim 1 of ‘039, lines 14-16); an erecting base that is disposed in the inside of the erecting base housing portion and that changes a lead out direction of the treatment tool led out from the treatment tool lead-out port (see claim 1 of ‘039, lines 17-20); an observation window which is disposed on the distal end portion body and through which a subject is observed (see claim 1 of ‘039, lines 21-23); and at least one signal cable connected to the plurality of ultrasonic vibrators (see claim 1 of ‘039, lines 24-25).
Examiner notes that claim 1 of ‘039 lacks the following limitations: a cleaning communication hole that is formed in a wall surface on a side opposite to a side where the opening of the erecting base housing portion is disposed and that communicates with an outside, wherein the distal end portion body comprises a cover that is removably attached to the cleaning communication hole.
However, in the same field of endeavor of medical endoscopes, Onishi discloses (Figs. 1-4 and 10) an ultrasonic endoscope (endoscope 1) (see, e.g., Para. [0011-0019]) comprising: a cleaning communication hole (second opening 24) that is formed in a wall surface on a side opposite to a side where the opening of the erecting base housing portion (recess 23) is disposed and that communicates with an outside (see, e.g., Figs. 3-4 and 10, and Para. [0032], lines 1-2, “As shown in FIGS. 3 and 4, the second opening 24 is a hole in the tip portion 11 that penetrates from the outer surface of the tip portion 11 to the inner wall surface of the recess 23”, and Para. [0034], lines 1-3, “the second opening 24 is a hole portion that linearly penetrates the tip portion 11, and is a surface in the recess 23 that faces in the direction opposite to the guide surface 20c of the treatment tool raising table 20. It is open at a position facing the bottom surface 20d. In other words, the second opening 24 of this embodiment is open at the bottom 23c of the recess 23”, and Abstract, “This washing tool is for introducing a fluid into an endoscope… The washing tool includes the following: an engaging part that engages with the second opening in which a fluid supply opening is formed”); and
wherein the distal end portion body (tip portion 11) comprises a cover that is removably attached to the cleaning communication hole (second opening 24) (see, e.g., Para. [0032], lines 1-2, “As shown in FIGS. 3 and 4, the second opening 24 is a hole in the tip portion 11 that penetrates from the outer surface of the tip portion 11 to the inner wall surface of the recess 23”, and Para. [0034], lines 1-3, “the second opening 24 is a hole portion that linearly penetrates the tip portion 11, and is a surface in the recess 23 that faces in the direction opposite to the guide surface 20c of the treatment tool raising table 20. It is open at a position facing the bottom surface 20d. In other words, the second opening 24 of this embodiment is open at the bottom 23c of the recess 23”, and Abstract, “This washing tool is for introducing a fluid into an endoscope… The washing tool includes the following: an engaging part that engages with the second opening in which a fluid supply opening is formed”, and Figs. 3-4, where the disclosed second opening 24 is shown to have a trapezoidal shaped cover that is inserted into the opening 24, and Fig 10, where it is shown that the opening 24 does not have a cover inserted therein in which the cleaning tool is instead inserted into the opening 24 (i.e., the cover is removable)).
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 ultrasonic endoscope of claim 1 of ‘039 by including a cleaning communication hole that is formed in a wall surface on a side opposite to a side where the opening of the erecting base housing portion is disposed and that communicates with an outside, wherein the distal end portion body comprises a cover that is removably attached to the cleaning communication hole, as disclosed by Onishi. One of ordinary skill in the art would have been motivated to make this modification in order to achieve desired cleaning within the endoscope, as recognized by Onishi (see, e.g., Abstract, Para. [0001], and Para. [0006-0007]).
Regarding claim 2 of the current application, claim 2 of ‘039 discloses wherein a position of the observation window in the axial direction of the distal end portion body is located on a proximal end side relative to the erecting base housing portion (see claim 2 of ‘039, lines 5-8).
Regarding claim 3 of the current application, claim 4 of ‘039 discloses wherein a position of the observation window in the axial direction of the distal end portion body is located on a distal end side relative to the erecting base housing portion (see claim 4 of ‘039, lines 5-8).
Regarding claim 6 of the current application, claim 3 of ‘039 discloses wherein the observation window is disposed offset from the erecting base housing portion in a second direction that is perpendicular to the first direction (see claim 3 of ‘039, lines 2-4).
Regarding claim 7 of the current application, claim 5 of ‘039 discloses wherein the observation window is disposed offset from the erecting base housing portion in a second direction that is perpendicular to the first direction (see claim 5 of ‘039, lines 2-4).
Regarding claim 8 of the current application, claim 6 of ‘039 discloses wherein, when viewed in the axial direction of the distal end portion body, the erecting base housing portion is disposed offset from a center position of the distal end portion body in a second direction that is perpendicular to the first direction (see claim 6 of ‘039, lines 2-6), and wherein the at least one signal cable is disposed in the second direction of the erecting base housing portion (see claim 6 of ‘039, lines 7-8).
Regarding claim 9 of the current application, claim 13 of ‘039 discloses wherein the at least one signal cable is provided in a plurality (see claim 13 of ‘039, lines 2-3), and wherein, when viewed in the axial direction of the distal end portion body (see claim 13 of ‘039, lines 5-6), among the plurality of the signal cables that are connected to the ultrasonic vibrator (see claim 13 of ‘039, lines 2-4), at least one of the plurality of signal cables is disposed on a first side in a second direction of the erecting base housing portion, and at least another of the plurality of signal cables is disposed on a second side in the second direction of the erecting base housing portion (see claim 13 of ‘039, lines 6-12).
Regarding claim 10 of the current application, claim 7 of ‘039 discloses wherein the at least one signal cable is provided in a plurality (see claim 7 of ‘039, lines 2-3), and wherein, when viewed in the axial direction of the distal end portion body (see claim 7 of ‘039, lines 5-6), among the plurality of the signal cables that are connected to the ultrasonic vibrator (see claim 7 of ‘039, lines 2-4), at least one of the plurality of signal cables is disposed on a first side in a second direction of the erecting base housing portion, and at least another of the plurality of signal cables is disposed on a second side in the second direction of the erecting base housing portion (see claim 7 of ‘039, lines 6-12).
Regarding claim 14 of the current application, claim 16 of ‘039 discloses wherein the ultrasonic transducer has an ultrasound transmitting/receiving surface that is formed in a curved shape in the axial direction of the distal end portion body (see claim 16 of ‘039, lines 2-5).
Regarding claim 15 of the current application, claim 17 of ‘039 discloses wherein a distal end part of the erecting base protrudes from the erecting base housing portion, in a state where the erecting base is in a prostrate position (see claim 17 of ‘039, lines 2-4).
Regarding claim 16 of the current application, claim 18 of ‘039 discloses wherein an upper region of the wall surface on the distal end side of the erecting base housing portion is formed inclined downward toward the proximal end side (see claim 18 of ‘039, lines 2-4).
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 14-20 of U.S. Patent No. 12,029,611 (hereinafter ‘611) in view of Morimoto (US 2016/0073860 A1, of record, hereinafter Morimoto).
Regarding claim 1 of the current application, claim 1 of ‘611 discloses an ultrasonic endoscope (see claim 1 of ‘611, line 1) comprising: an ultrasonic transducer that has an ultrasonic vibrator (see claim 1 of ‘611, line 2); a distal end portion body that is disposed with a proximal end side of the ultrasonic transducer (see claim 1 of ‘611, lines 3-4); an erecting base housing portion that is disposed in the distal end portion body and that has an opening whose opening direction is one side in a first direction that is perpendicular to an axial direction of the distal end portion body or whose opening direction is a direction that has a component toward one side in the first direction and a component toward a distal end side in the axial direction of the distal end portion body (see claim 1 of ‘611, lines 5-12); a treatment tool lead-out port that communicates with an inside of the erecting base housing portion and from which a treatment tool is led out (see claim 1 of ‘611, lines 13-15); an erecting base that is disposed in the inside of the erecting base housing portion and that changes a lead out direction of the treatment tool led out from the treatment tool lead-out port (see claim 1 of ‘611, lines 16-19); at least one signal cable connected to the ultrasonic vibrator (see claim 1 of ‘611, lines 24-25); and a cleaning communication hole that is formed in a wall surface on a side opposite to a side where the opening of the erecting base housing portion is disposed and that communicates with an outside (see claim 1 of ‘611, lines 20-23).
Examiner notes that claim 1 of ‘611 lacks the following limitations: [1] an ultrasonic transducer that has a plurality of ultrasonic vibrators; [2] an observation window which is disposed on the distal end portion body and through which a subject is observed; and [3] wherein the distal end portion body comprises a cover that is removably attached to the cleaning communication hole.
However, in the same field of endeavor of ultrasonic endoscopes, Morimoto discloses (Figs. 1-5) [1] an ultrasonic transducer (ultrasonic transducer 50) that has a plurality of ultrasonic vibrators (see, e.g., Para. [0063], lines 1-6, “At the extended part 42, a convex ultrasonic transducer 50 is arranged in which a large number of ultrasonic vibrators that transmit and receive ultrasonic waves are set in array along an arcuate ultrasonic transmitting and receiving plane. This enables the ultrasonic transducer 50 to obtain an ultrasonic image”); [2] an observation window (observation window 44) which is disposed on the distal end portion body (40) (see, e.g., Para. [0064], lines 1-8, “The base part 40 has an outer circumference surface 36 along a cylinder surface whose center is the axis of the insertion part 10, and on a distal end side of the outer circumference surface 36, a left oblique surface 41L and a right oblique surface 41R which face the distal end side and in an oblique upward direction are provided. On the left oblique surface 41L, an observation window 44… [is] provided”) and through which a subject is observed (see, e.g., Para. [0065], lines 1-9, “Inside the base part 40 situated on a proximal end side of the observation window 44, an imaging device made by integrally assembling an imaging optics system and a solid imaging element is arranged. This allows light from an observation region in an observation field (field range) of the imaging device to be taken in from the observation window 44, lets the imaging optics system to form a light image of the observation region, and lets the solid imaging element to convert the light image into an electric signal”); and [3] wherein the distal end portion body (40) comprises a cover (hood 100) that is removably attached (see, e.g., Para. [0074], lines 1-3, “a hood for an ultrasonic endoscope to be detachably attached to the distal end part 34 of the endoscope 1” and Figs. 3-4, where the hood 100 is shown to be removably attached to the base part 40 of the distal end part 34, and where the hood 100 is shown to cover the bottom surface of the distal end part 34 while leaving the treatment instrument lead-out port 58/opening 64 uncovered, although is it not disclosed that the hood 100 suppresses any type of contamination of the erecting base housing portion while the endoscope is in use).
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 ultrasonic endoscope of claim 1 of ‘611 by including [1] an ultrasonic transducer that has a plurality of ultrasonic vibrators; [2] an observation window which is disposed on the distal end portion body and through which a subject is observed; and [3] wherein the distal end portion body comprises a cover that is removably attached, as disclosed by Morimoto. One of ordinary skill in the art would have been motivated to make this modification in order to desirably enable the ultrasonic transducer to obtain an ultrasonic/tomographic image; and in order to allow light from an observation region in an observation field of the imaging device to be taken in from the observation window, let the imaging optics system form a light image of the observation region, and let the solid imaging element convert the light image into an electric signal, as recognized by Morimoto (see, e.g., Para. [0063-0065]).
Regarding claim 2 of the current application, claim 2 of ‘611 discloses wherein a position of the observation window in the axial direction of the distal end portion body is located on a proximal end side relative to the erecting base housing portion (see claim 2 of ‘611, lines 5-8).
Regarding claim 3 of the current application, claim 5 of ‘611 discloses wherein a position of the observation window in the axial direction of the distal end portion body is located on a distal end side relative to the erecting base housing portion (see claim 5 of ‘611, lines 5-8).
Regarding claim 4 of the current application, claim 3 of ‘611 discloses wherein a position of the observation window in the first direction is located on a side opposite to the cleaning communication hole when a position of the opening is defined as a reference position (see claim 3 of ‘611, lines 2-5).
Regarding claim 5 of the current application, claim 6 of ‘611 discloses wherein a position of the observation window in the first direction is located on a side opposite to the cleaning communication hole when a position of the opening is defined as a reference position (see claim 6 of ‘611, lines 2-5).
Regarding claim 6 of the current application, claim 4 of ‘611 discloses wherein the observation window is disposed offset from the erecting base housing portion in a second direction that is perpendicular to the first direction (see claim 4 of ‘611, lines 2-4).
Regarding claim 7 of the current application, claim 7 of ‘611 discloses wherein the observation window is disposed offset from the erecting base housing portion in a second direction that is perpendicular to the first direction (see claim 7 of ‘611, lines 2-4).
Regarding claim 8 of the current application, claim 8 of ‘611 discloses wherein, when viewed in the axial direction of the distal end portion body, the erecting base housing portion is disposed offset from a center position of the distal end portion body in a second direction that is perpendicular to the first direction, and wherein the at least one signal cable is disposed in the second direction of the erecting base housing portion (see claim 8 of ‘611, lines 2-8).
Regarding claim 9 of the current application, claim 11 of ‘611 discloses wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body, among the plurality of the signal cables that are connected to the ultrasonic vibrator, at least one of the plurality of signal cables is disposed on a first side in a second direction of the erecting base housing portion, and at least another of the plurality of signal cables is disposed on a second side in the second direction of the erecting base housing portion (see claim 11 of ‘611, lines 2-9).
Regarding claim 10 of the current application, claim 9 of ‘611 discloses wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body, among the plurality of the signal cables that are connected to the ultrasonic vibrator, at least one of the plurality of signal cables is disposed on a first side in a second direction of the erecting base housing portion, and at least another of the plurality of signal cables is disposed on a second side in the second direction of the erecting base housing portion (see claim 9 of ‘611, lines 2-9).
Regarding claim 11 of the current application, claim 12 of ‘611 discloses wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body, the plurality of signal cables that are connected to the ultrasonic vibrator are disposed on a side of the erecting base housing portion in a second direction where an observation window is disposed (see claim 12 of ‘611, lines 2-6).
Regarding claim 12 of the current application, claim 10 of ‘611 discloses wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body, the plurality of signal cables that are connected to the ultrasonic vibrator are disposed on a side of the erecting base housing portion in a second direction where an observation window is disposed (see claim 10 of ‘611, lines 2-6).
Regarding claim 13 of the current application, claim 14 of ‘611 discloses wherein an expression H1 ≤ H2 holds, where, in the first direction of the distal end portion body, H1 is a shortest distance from the cleaning communication hole to the opening, and H2 is a longest distance from the cleaning communication hole to an outer peripheral surface of the ultrasonic transducer (see claim 14 of ‘611, lines 2-7).
Regarding claim 14 of the current application, claim 15 of ‘611 discloses wherein the ultrasonic transducer has an ultrasound transmitting/receiving surface that is formed in a curved shape in the axial direction of the distal end portion body (see claim 15 of ‘611, lines 2-5).
Regarding claim 15 of the current application, claim 16 of ‘611 discloses wherein a distal end part of the erecting base protrudes from the erecting base housing portion, in a state where the erecting base is in a prostrate position (see claim 16 of ‘611, lines 2-4).
Regarding claim 16 of the current application, claim 17 of ‘611 discloses wherein an upper region of the wall surface on the distal end side of the erecting base housing portion is formed inclined downward toward the proximal end side (see claim 17 of ‘611, lines 2-4).
Regarding claim 17 of the current application, claim 18 of ‘611 discloses wherein the erecting base includes a portion through which a rotation shaft extends therethrough, the rotation shaft configured to rotate the erecting base, and wherein in a case where the cleaning communication hole is viewed from the outside to the first direction, a region of a proximal end side of the erecting base, including the portion of the erecting base having the rotation shaft extending therethrough, is disposed at a position overlapping with the cleaning communication hole (see claim 18 of ‘611, lines 2-10).
Regarding claim 18 of the current application, claim 19 of ‘611 discloses wherein the cleaning communication hole includes at least two inner standing wall surfaces of the cleaning communication hole that intersect with the axial direction, and of the at least two inner standing wall surfaces of the cleaning communication hole, the inner standing wall surface of the cleaning communication hole on a proximal end side of the cleaning communication hole and a region on an other side of a treatment instrument outlet in the first direction are on a same plane (see claim 19 of ‘611, lines 2-11).
Regarding claim 19 of the current application, claim 20 of ‘611 discloses wherein a length of one of the at least two inner standing wall surfaces of the cleaning communication hole in a second direction is shorter than a length of the erecting base housing portion in the second direction where the treatment instrument outlet is disposed (see claim 20 of ‘611, lines 2-6).
Claims 1-2, 4, and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 19-20 of U.S. Patent No. 11,553,894 (hereinafter ‘894) in view of Morimoto (US 2016/0073860 A1, of record, hereinafter Morimoto).
Regarding claim 1 of the current application, claim 1 of ‘894 discloses an ultrasonic endoscope (see claim 1 of ‘894, line 1) comprising: an ultrasonic transducer that has an ultrasonic vibrator (see claim 1 of ‘894, line 2); a distal end portion body that is disposed with a proximal end side of the ultrasonic transducer (see claim 1 of ‘894, lines 3-4); an erecting base housing portion that is disposed in the distal end portion body and that has an opening whose opening direction is one side in a first direction that is perpendicular to an axial direction of the distal end portion body or whose opening direction is a direction that has a component toward one side in the first direction and a component toward a distal end side in the axial direction of the distal end portion body (see claim 1 of ‘894, lines 5-12); a treatment tool lead-out port that communicates with an inside of the erecting base housing portion and from which a treatment tool is led out (see claim 1 of ‘894, lines 13-15); an erecting base that is disposed in the inside of the erecting base housing portion and that changes a lead out direction of the treatment tool led out from the treatment tool lead-out port (see claim 1 of ‘894, lines 16-19); and a cleaning communication hole that is formed in a wall surface on a side opposite to a side where the opening of the erecting base housing portion is disposed and that communicates with an outside (see claim 1 of ‘894, lines 20-23).
Examiner notes that claim 1 of ‘894 lacks the following limitations: [1] an ultrasonic transducer that has a plurality of ultrasonic vibrators; [2] an observation window which is disposed on the distal end portion body and through which a subject is observed; [3] at least one signal cable connected to the plurality of ultrasonic vibrators; and [4] wherein the distal end portion body comprises a cover that is removably attached to the cleaning communication hole.
However, in the same field of endeavor of ultrasonic endoscopes, Morimoto discloses (Figs. 1-5) [1] an ultrasonic transducer (ultrasonic transducer 50) that has a plurality of ultrasonic vibrators (see, e.g., Para. [0063], lines 1-6, “At the extended part 42, a convex ultrasonic transducer 50 is arranged in which a large number of ultrasonic vibrators that transmit and receive ultrasonic waves are set in array along an arcuate ultrasonic transmitting and receiving plane. This enables the ultrasonic transducer 50 to obtain an ultrasonic image”); [2] an observation window (observation window 44) which is disposed on the distal end portion body (40) (see, e.g., Para. [0064], lines 1-8, “The base part 40 has an outer circumference surface 36 along a cylinder surface whose center is the axis of the insertion part 10, and on a distal end side of the outer circumference surface 36, a left oblique surface 41L and a right oblique surface 41R which face the distal end side and in an oblique upward direction are provided. On the left oblique surface 41L, an observation window 44… [is] provided”) and through which a subject is observed (see, e.g., Para. [0065], lines 1-9, “Inside the base part 40 situated on a proximal end side of the observation window 44, an imaging device made by integrally assembling an imaging optics system and a solid imaging element is arranged. This allows light from an observation region in an observation field (field range) of the imaging device to be taken in from the observation window 44, lets the imaging optics system to form a light image of the observation region, and lets the solid imaging element to convert the light image into an electric signal”); [3] at least one signal cable connected to the plurality of ultrasonic vibrators (see, e.g., Para. [0063], lines 1-11, “At the extended part 42, a convex ultrasonic transducer 50 is arranged in which a large number of ultrasonic vibrators that transmit and receive ultrasonic waves are set in array along an arcuate ultrasonic transmitting and receiving plane. This enables the ultrasonic transducer 50 to obtain an ultrasonic image (tomographic image) on a scanning surface parallel to an axis of the insertion part 10, and data on the ultrasonic image is transmitted to the system component devices connected with the universal cord 14, via a signal cable passing through the inside of the insertion part 10, the operation part 12, and the universal cord 14”); and [4] wherein the distal end portion body (40) comprises a cover (hood 100) that is removably attached (see, e.g., Para. [0074], lines 1-3, “a hood for an ultrasonic endoscope to be detachably attached to the distal end part 34 of the endoscope 1” and Figs. 3-4, where the hood 100 is shown to be removably attached to the base part 40 of the distal end part 34, and where the hood 100 is shown to cover the bottom surface of the distal end part 34 while leaving the treatment instrument lead-out port 58/opening 64 uncovered, although is it not disclosed that the hood 100 suppresses any type of contamination of the erecting base housing portion while the endoscope is in use).
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 ultrasonic endoscope of claim 1 of ‘894 by including [1] an ultrasonic transducer that has a plurality of ultrasonic vibrators; [2] an observation window which is disposed on the distal end portion body and through which a subject is observed; [3] at least one signal cable connected to the plurality of ultrasonic vibrators; and [4] wherein the distal end portion body comprises a cover that is removably attached to the cleaning communication hole, as disclosed by Morimoto. One of ordinary skill in the art would have been motivated to make this modification in order to desirably enable the ultrasonic transducer to obtain an ultrasonic/tomographic image; and in order to allow light from an observation region in an observation field of the imaging device to be taken in from the observation window, let the imaging optics system form a light image of the observation region, and let the solid imaging element convert the light image into an electric signal, as recognized by Morimoto (see, e.g., Para. [0063-0065]).
Regarding claim 2 of the current application, claim 2 of ‘894 discloses wherein a position of the observation window in the axial direction of the distal end portion body is located on a proximal end side relative to the erecting base housing portion (see claim 2 of ‘894, lines 5-8).
Regarding claim 4 of the current application, claim 3 of ‘894 discloses wherein a position of the observation window in the first direction is located on a side opposite to the cleaning communication hole when a position of the opening is defined as a reference position (see claim 3 of ‘894, lines 1-5).
Regarding claim 13 of the current application, claim 19 of ‘894 discloses wherein an expression H1 ≤ H2 holds, where, in the first direction of the distal end portion body, H1 is a shortest distance from the cleaning communication hole to the opening, and H2 is a longest distance from the cleaning communication hole to an outer peripheral surface of the ultrasonic transducer (see claim 19 of ‘894, lines 2-7).
Regarding claim 14 of the current application, claim 20 of ‘894 discloses wherein the ultrasonic transducer has an ultrasound transmitting/receiving surface that is formed in a curved shape in the axial direction of the distal end portion body (see claim 20 of ‘894, lines 2-4).
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.
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.
Claims 1, 3, 5, 7, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Morimoto (US 2016/0073860 A1, of record, hereinafter Morimoto) in view of Onishi (WO 2015/107801 A1, of record, hereinafter Onishi).
Regarding claim 1, Morimoto discloses (Figs. 1-5) an ultrasonic endoscope (ultrasonic endoscope 1) (see, e.g., Fig. 1 and Para. [0056-0061]) comprising:
an ultrasonic transducer (ultrasonic transducer 50) that has a plurality of ultrasonic vibrators (see, e.g., Para. [0063], lines 1-6, “At the extended part 42, a convex ultrasonic transducer 50 is arranged in which a large number of ultrasonic vibrators that transmit and receive ultrasonic waves are set in array along an arcuate ultrasonic transmitting and receiving plane. This enables the ultrasonic transducer 50 to obtain an ultrasonic image”);
a distal end portion body (base part 40 within distal end part 34) that is disposed with a proximal end side of the ultrasonic transducer (50) (see, e.g., Para. [0062], lines 2-5, “The distal end part 34 as illustrated in the figure includes a base part 40 arranged on a proximal end side and an extended part 42 extending from the base part 40 to a distal end side” and Fig. 2, where the extended part 42 is shown to include the ultrasonic transducer 50, and where the base part 40 is shown to be disposed proximally to the ultrasonic transducer 50);
an erecting base housing portion (concave treatment instrument erection space 62) that is disposed in the distal end portion body (40) (see, e.g., Fig. 2, where the concave treatment instrument erection space 62 is shown to be disposed within the base part 40) and that has an opening (treatment instrument lead-out port 58, opening 64) (see, e.g., Para. [0068], lines 1-6, “The treatment instrument lead-out port 58 has a concave treatment instrument erection space 62 which is recessed than a vicinity of that space 62, and an opening 64 of the treatment instrument insertion channel is arranged on a proximal end side of the treatment instrument erection space 62”) whose opening direction is one side in a first direction that is perpendicular to an axial direction of the distal end portion body (40) or whose opening direction is a direction that has a component toward one side in the first direction and a component toward a distal end side in the axial direction of the distal end portion body (40) (see, e.g., Figs. 2-4, where the opening 64 is shown to have an opening direction with a first component toward the up-direction when viewing the figure (i.e., the up-direction is one side of the first direction, where the first direction is perpendicular to the axial direction in the up and down orientation) and with a second component toward the distal end side in the axial/longitudinal direction of the base part 40);
a treatment tool lead-out port (treatment instrument lead-out port 58, opening 64) that communicates with an inside of the erecting base housing portion (62) (see, e.g., Para. [0068], lines 1-6, “The treatment instrument lead-out port 58 has a concave treatment instrument erection space 62 which is recessed than a vicinity of that space 62, and an opening 64 of the treatment instrument insertion channel is arranged on a proximal end side of the treatment instrument erection space 62”) and from which a treatment tool is led out (see, e.g., Para. [0069], lines 1-7, “The opening 64 is linked to the treatment instrument introduction port 24 of the operation part 12 through the treatment instrument insertion channel (treatment instrument insertion path) passing through the inside of the insertion part 10, and the treatment instrument inserted from the treatment instrument introduction port 24 is led out to the treatment instrument erection space 62 from the opening 64”);
an erecting base (treatment instrument erection stand 60) that is disposed in the inside of the erecting base housing portion (62) (see, e.g., Para. [0070], lines 1-4, “a treatment instrument erection stand 60 (hereinafter simply called an erection stand 60) is arranged in a distal end side of the opening 64 in the treatment instrument erection space 62”) and that changes a lead out direction of the treatment tool led out from the treatment tool lead-out port (58, 64) (see, e.g., Para. [0072], lines 1-9, “The erection stand 60 is linked to the erection operation lever 18 of the operation part 12 via an operation wire passing through the inside of the insertion part 10, and moves to a direction where the erection stand 60 stands up or falls down by operation of the erection operation lever 18. Thereby, a standing angle of the erection stand 60 is changed. This changes a lead-out direction (lead-out angle) of the treatment instrument led out from the distal end part 34 (treatment instrument lead-out port 58)”);
an observation window (observation window 44) which is disposed on the distal end portion body (40) (see, e.g., Para. [0064], lines 1-8, “The base part 40 has an outer circumference surface 36 along a cylinder surface whose center is the axis of the insertion part 10, and on a distal end side of the outer circumference surface 36, a left oblique surface 41L and a right oblique surface 41R which face the distal end side and in an oblique upward direction are provided. On the left oblique surface 41L, an observation window 44… [is] provided”) and through which a subject is observed (see, e.g., Para. [0065], lines 1-9, “Inside the base part 40 situated on a proximal end side of the observation window 44, an imaging device made by integrally assembling an imaging optics system and a solid imaging element is arranged. This allows light from an observation region in an observation field (field range) of the imaging device to be taken in from the observation window 44, lets the imaging optics system to form a light image of the observation region, and lets the solid imaging element to convert the light image into an electric signal”); and
at least one signal cable connected to the plurality of ultrasonic vibrators (see, e.g., Para. [0063], lines 1-11, “At the extended part 42, a convex ultrasonic transducer 50 is arranged in which a large number of ultrasonic vibrators that transmit and receive ultrasonic waves are set in array along an arcuate ultrasonic transmitting and receiving plane. This enables the ultrasonic transducer 50 to obtain an ultrasonic image (tomographic image) on a scanning surface parallel to an axis of the insertion part 10, and data on the ultrasonic image is transmitted to the system component devices connected with the universal cord 14, via a signal cable passing through the inside of the insertion part 10, the operation part 12, and the universal cord 14”),
wherein the distal end portion body (40) comprises a cover (hood 100) that is removably attached (see, e.g., Para. [0074], lines 1-3, “a hood for an ultrasonic endoscope to be detachably attached to the distal end part 34 of the endoscope 1” and Figs. 3-4, where the hood 100 is shown to be removably attached to the base part 40 of the distal end part 34, and where the hood 100 is shown to cover the bottom surface of the distal end part 34 while leaving the treatment instrument lead-out port 58/opening 64 uncovered, although is it not disclosed that the hood 100 suppresses any type of contamination of the erecting base housing portion while the endoscope is in use).
Morimoto does not specifically disclose [1] a cleaning communication hole that is formed in a wall surface on a side opposite to a side where the opening of the erecting base housing portion is disposed and that communicates with an outside; and [2] wherein the cover is removably attached to the cleaning communication hole.
However, in the same field of endeavor of medical endoscopes, Onishi discloses (Figs. 1-4 and 10) an ultrasonic endoscope (endoscope 1) (see, e.g., Para. [0011-0019]) comprising: a cleaning communication hole (second opening 24) that is formed in a wall surface on a side opposite to a side where the opening of the erecting base housing portion (recess 23) is disposed and that communicates with an outside (see, e.g., Figs. 3-4 and 10, and Para. [0032], lines 1-2, “As shown in FIGS. 3 and 4, the second opening 24 is a hole in the tip portion 11 that penetrates from the outer surface of the tip portion 11 to the inner wall surface of the recess 23”, and Para. [0034], lines 1-3, “the second opening 24 is a hole portion that linearly penetrates the tip portion 11, and is a surface in the recess 23 that faces in the direction opposite to the guide surface 20c of the treatment tool raising table 20. It is open at a position facing the bottom surface 20d. In other words, the second opening 24 of this embodiment is open at the bottom 23c of the recess 23”, and Abstract, “This washing tool is for introducing a fluid into an endoscope… The washing tool includes the following: an engaging part that engages with the second opening in which a fluid supply opening is formed”); and
wherein the distal end portion body (tip portion 11) comprises a cover that is removably attached to the cleaning communication hole (second opening 24) (see, e.g., Para. [0032], lines 1-2, “As shown in FIGS. 3 and 4, the second opening 24 is a hole in the tip portion 11 that penetrates from the outer surface of the tip portion 11 to the inner wall surface of the recess 23”, and Para. [0034], lines 1-3, “the second opening 24 is a hole portion that linearly penetrates the tip portion 11, and is a surface in the recess 23 that faces in the direction opposite to the guide surface 20c of the treatment tool raising table 20. It is open at a position facing the bottom surface 20d. In other words, the second opening 24 of this embodiment is open at the bottom 23c of the recess 23”, and Abstract, “This washing tool is for introducing a fluid into an endoscope… The washing tool includes the following: an engaging part that engages with the second opening in which a fluid supply opening is formed”, and Figs. 3-4, where the disclosed second opening 24 is shown to have a trapezoidal shaped cover that is inserted into the opening 24, and Fig 10, where it is shown that the opening 24 does not have a cover inserted therein in which the cleaning tool is instead inserted into the opening 24 (i.e., the cover is removable)).
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 ultrasonic endoscope of Morimoto by including [1] a cleaning communication hole that is formed in a wall surface on a side opposite to a side where the opening of the erecting base housing portion is disposed and that communicates with an outside; and [2] wherein the cover is removably attached to the cleaning communication hole, as disclosed by Onishi. One of ordinary skill in the art would have been motivated to make this modification in order to achieve desired cleaning within the endoscope, as recognized by Onishi (see, e.g., Abstract, Para. [0001], and Para. [0006-0007]).
Regarding claim 3, Morimoto modified by Onishi discloses the ultrasonic endoscope according to claim 1, as set forth above. Morimoto further discloses (Figs. 1-5) wherein a position of the observation window (observation window 44) in the axial direction of the distal end portion body (base part 40 within distal end part 34) is located on a distal end side relative to the erecting base housing portion (concave treatment instrument erection space 62) (see, e.g., Figs. 2-4, where the observation window 44 is shown to be positioned on the distal side of the concave treatment instrument erection space 62, in which the observation window 44 is positioned closer to the ultrasonic transducer 50 compared to the position of the concave treatment instrument erection space 62).
Regarding claim 5, Morimoto modified by Onishi discloses the ultrasonic endoscope according to claim 3, as set forth above. Morimoto further discloses (Figs. 1-5) wherein a position of the observation window (observation window 44) in the first direction is located on a side opposite to the bottom surface of the distal end portion body (base part 40 within distal end part 34) when a position of the opening (treatment instrument lead-out port 58, opening 64) is defined as a reference position (see, e.g., Figs. 2-4, where the observation window 44 and the treatment instrument lead-out port 58/opening 64 are shown to be positioned on the top surface (i.e., in the first/up direction when viewing the figures), which is on the opposite side when compared to the bottom surface (i.e., in the down direction when viewing the figures) of the distal end part 34).
Morimoto does not specifically disclose the cleaning communication hole.
However, in the same field of endeavor of medical endoscopes, Onishi discloses (Figs. 1-4 and 10) the cleaning communication hole (second opening 24) on the bottom surface of the distal end portion body (tip portion 11) (see, e.g., Figs. 3-4 and 10, and Para. [0032], lines 1-2, “As shown in FIGS. 3 and 4, the second opening 24 is a hole in the tip portion 11 that penetrates from the outer surface of the tip portion 11 to the inner wall surface of the recess 23”, and Para. [0034], lines 1-3, “the second opening 24 is a hole portion that linearly penetrates the tip portion 11, and is a surface in the recess 23 that faces in the direction opposite to the guide surface 20c of the treatment tool raising table 20. It is open at a position facing the bottom surface 20d. In other words, the second opening 24 of this embodiment is open at the bottom 23c of the recess 23”, and Abstract, “This washing tool is for introducing a fluid into an endoscope… The washing tool includes the following: an engaging part that engages with the second opening in which a fluid supply opening is formed”). In the case where the cleaning communication hole on the bottom surface of the distal end portion body of Onishi (second opening 24 on tip portion 11 in Figs. 3-4 and 10 of Onishi) is provided in the ultrasonic endoscope of Morimoto on the bottom surface of the distal end portion body (bottom surface of distal end part 34 in Figs. 2-4 of Morimoto), then the position of the observation window in the first/vertical direction can be located on the side opposite to the cleaning communication hole.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasonic endoscope of Morimoto modified by Onishi by including the cleaning communication hole on the bottom surface of the distal end portion body, as disclosed by Onishi. One of ordinary skill in the art would have been motivated to make this modification in order to achieve desired cleaning within the endoscope, as recognized by Onishi (see, e.g., Abstract, Para. [0001], and Para. [0006-0007]).
Regarding claim 7, Morimoto modified by Onishi discloses the ultrasonic endoscope according to claim 3, as set forth above. Morimoto further discloses (Figs. 1-5) wherein the observation window (observation window 44) is disposed offset from the erecting base housing portion (concave treatment instrument erection space 62) in a second direction that is perpendicular to the first direction (see, e.g., Para. [0064], lines 1-8, “The base part 40 has an outer circumference surface 36 along a cylinder surface whose center is the axis of the insertion part 10, and on a distal end side of the outer circumference surface 36, a left oblique surface 41L and a right oblique surface 41R which face the distal end side and in an oblique upward direction are provided. On the left oblique surface 41L, an observation window 44… [is] provided” and Fig. 2, where the observation window 44 is shown to be positioned on the right side (i.e., offset in a second/horizontal direction that is perpendicular to the first/vertical direction and to the axial/longitudinal direction) of the concave treatment instrument erection space 62 when viewing the figure with the transducer 50 shown to be in front of the observation window 44 and the space 62).
Regarding claim 13, Morimoto modified by Onishi discloses the ultrasonic endoscope according to claim 1, as set forth above. Morimoto further discloses (Figs. 1-5) wherein an expression H1 ≤ H2 holds, where, in the first direction of the distal end portion body (base part 40 within distal end part 34) (see, e.g., Modified Fig. 4 of Morimoto provided below, where the up direction of the distal end part 34 when viewing the figure corresponds to the claimed first direction of the distal end portion body that is perpendicular to the axial/longitudinal direction), H1 is a shortest distance from the bottom surface of the distal end portion body (34, 40) to the opening (treatment instrument lead-out port 58, opening 64) (see, e.g., Modified Fig. 4 of Morimoto provided below, where H1 is shown to be the shortest distance from the bottom surface of the distal end part 34 to the treatment instrument lead-out port 58/opening 64), and H2 is a longest distance from the bottom surface of the distal end portion body (34, 40) to an outer peripheral surface of the ultrasonic transducer (ultrasonic transducer 50) (see, e.g., Modified Fig. 4 of Morimoto provided below, where H2 is shown to be the longest distance from the bottom surface of the distal end part 34 to the outer surface of the ultrasonic transducer 50, and where H1 is shown to be shorter in length than H2, therefore the expression H1 ≤ H2 holds).
Morimoto does not disclose the cleaning communication hole.
However, in the same field of endeavor of medical endoscopes, Onishi discloses (Figs. 1-4 and 10) the cleaning communication hole (second opening 24) on the bottom surface of the distal end portion body (tip portion 11) (see, e.g., Figs. 3-4 and 10, and Para. [0032], lines 1-2, “As shown in FIGS. 3 and 4, the second opening 24 is a hole in the tip portion 11 that penetrates from the outer surface of the tip portion 11 to the inner wall surface of the recess 23”, and Para. [0034], lines 1-3, “the second opening 24 is a hole portion that linearly penetrates the tip portion 11, and is a surface in the recess 23 that faces in the direction opposite to the guide surface 20c of the treatment tool raising table 20. It is open at a position facing the bottom surface 20d. In other words, the second opening 24 of this embodiment is open at the bottom 23c of the recess 23”, and Abstract, “This washing tool is for introducing a fluid into an endoscope… The washing tool includes the following: an engaging part that engages with the second opening in which a fluid supply opening is formed”). In the case where the cleaning communication hole on the bottom surface of the distal end portion body of Onishi (second opening 24 on tip portion 11 in Figs. 3-4 and 10 of Onishi) is provided in the ultrasonic endoscope of Morimoto on the bottom surface of the distal end portion body (bottom surface of distal end part 34 in Modified Fig. 4 of Morimoto provided below), then the expression H1 ≤ H2 still holds.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasonic endoscope of Morimoto modified by Onishi by including the cleaning communication hole on the bottom surface of the distal end portion body, as disclosed by Onishi. One of ordinary skill in the art would have been motivated to make this modification in order to achieve desired cleaning within the endoscope, as recognized by Onishi (see, e.g., Abstract, Para. [0001], and Para. [0006-0007]).
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Modified Fig. 4 of Morimoto
Regarding claim 14, Morimoto modified by Onishi discloses the ultrasonic endoscope according to claim 1, as set forth above. Morimoto further discloses (Figs. 1-5) wherein the ultrasonic transducer (ultrasonic transducer 50) has an ultrasound transmitting/receiving surface that is formed in a curved shape in the axial direction of the distal end portion body (base part 40 within distal end part 34) (see, e.g., Para. [0063], lines 1-5, “At the extended part 42, a convex ultrasonic transducer 50 is arranged in which a large number of ultrasonic vibrators that transmit and receive ultrasonic waves are set in array along an arcuate ultrasonic transmitting and receiving plane” and Figs. 2-4, where the transmitting and receiving surface/plane of the ultrasonic transducer 50 is shown to be formed in a curved shape in the axial/longitudinal direction of the base part 40 and the extended part 42).
Regarding claim 15, Morimoto modified by Onishi discloses the ultrasonic endoscope according to claim 1, as set forth above. Morimoto further discloses (Figs. 1-5) wherein a distal end part of the erecting base (treatment instrument erection stand 60) protrudes from the erecting base housing portion (concave treatment instrument erection space 62), in a state where the erecting base (60) is in a prostrate position (see, e.g., Fig. 3, where the distal end (i.e., top end) of the treatment instrument erection stand 60 is shown to extend past the boundaries of (i.e., is positioned higher and/or more forward than) the concave treatment instrument erection space 62 when the erecting base is in a fully lowered position (i.e., prostate position) as shown in the figure).
Regarding claim 16, Morimoto modified by Onishi discloses the ultrasonic endoscope according to claim 1, as set forth above. Morimoto further discloses (Figs. 1-5) wherein an upper region of the wall surface on the distal end side of the erecting base housing portion (concave treatment instrument erection space 62) is formed inclined downward toward the proximal end side (see, e.g., Para. [0070], “a treatment instrument erection stand 60 (hereinafter simply called an erection stand 60) is arranged in a distal end side of the opening 64 in the treatment instrument erection space 62”, and Para. [0071], “the treatment instrument led out from the treatment instrument lead-out port 58 of the distal end part 34 is arranged by the erection stand 60 such that the treatment tool protrudes along an upward oblique direction toward the distal end side from the proximal end side relative to a central axis (longitudinal axis of the insertion part 10) passing through the center of the distal end part 34”, and Figs. 3-4 and 7, where it is shown that the bottom surface of the treatment instrument erection stand 60 (which corresponds to the bottom surface of the concave treatment instrument erection space 62 that holds the treatment instrument erection stand 60) is shown to be formed having an inclined downward shape extending from the top/distal end to the lower/proximal end).
Claims 2, 4, 6, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Morimoto (US 2016/0073860 A1) in view of Onishi (WO 2015/107801 A1), as applied to claim 1 above, and further in view of Kohno (US 2007/0249940 A1, of record, hereinafter Kohno).
Regarding claim 2, Morimoto modified by Onishi discloses the ultrasonic endoscope according to claim 1, as set forth above. Morimoto modified by Onishi does not specifically disclose wherein a position of the observation window in the axial direction of the distal end portion body is located on a proximal end side relative to the erecting base housing portion.
However, in the same field of endeavor of ultrasonic endoscopes, Kohno discloses (Figs. 1-3) wherein a position of the observation window (viewing device 4) in the axial direction of the distal end portion body (insertion portion 1) is located on a proximal end side relative to the erecting base housing portion (treatment equipment guide member 20, receiving space 21, treatment equipment lead-out hole 10) (see, e.g., Para. [0022], lines 1-4, “In the slant surface 5 arranged with the illuminating device 3 and the viewing device 4, a treatment equipment lead-out hole 10 is opened, for the viewing device 4, in a position closer to the tip axially of the distal hard portion 1b”, and Para. [0025], lines 3-6, “The treatment equipment guide member 20 is arranged between the arrangement region of the viewing device 4 and the arrangement region of the ultrasonic transducer 2”, and Figs. 1-3, where the viewing device 4 is shown to be positioned proximally (i.e., positioned to the left when viewing the figures) of the treatment equipment guide member 20 and the housing/receiving space 21 comprising the member 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasonic endoscope of Morimoto modified by Onishi by including wherein a position of the observation window in the axial direction of the distal end portion body is located on a proximal end side relative to the erecting base housing portion, as disclosed by Kohno. One of ordinary skill in the art would have been motivated to make this modification in order to achieve the desired observation/endoscopic examination of the subject, as recognized by Kohno (see, e.g., Abstract, Para. [0010], Para. [0020], and Para. [0029]).
Regarding claim 4, Morimoto modified by Onishi and Kohno discloses the ultrasonic endoscope according to claim 2, as set forth above. Morimoto further discloses (Figs. 1-5) wherein a position of the observation window (observation window 44) in the first direction is located on a side opposite to the bottom surface of the distal end portion body (base part 40 within distal end part 34) when a position of the opening (treatment instrument lead-out port 58, opening 64) is defined as a reference position (see, e.g., Figs. 2-4, where the observation window 44 and the treatment instrument lead-out port 58/opening 64 are shown to be positioned on the top surface (i.e., in the first/up direction when viewing the figures), which is on the opposite side when compared to the bottom surface (i.e., in the down direction when viewing the figures) of the distal end part 34).
Morimoto does not specifically disclose the cleaning communication hole.
However, in the same field of endeavor of medical endoscopes, Onishi discloses (Figs. 1-4 and 10) the cleaning communication hole (second opening 24) on the bottom surface of the distal end portion body (tip portion 11) (see, e.g., Figs. 3-4 and 10, and Para. [0032], lines 1-2, “As shown in FIGS. 3 and 4, the second opening 24 is a hole in the tip portion 11 that penetrates from the outer surface of the tip portion 11 to the inner wall surface of the recess 23”, and Para. [0034], lines 1-3, “the second opening 24 is a hole portion that linearly penetrates the tip portion 11, and is a surface in the recess 23 that faces in the direction opposite to the guide surface 20c of the treatment tool raising table 20. It is open at a position facing the bottom surface 20d. In other words, the second opening 24 of this embodiment is open at the bottom 23c of the recess 23”, and Abstract, “This washing tool is for introducing a fluid into an endoscope… The washing tool includes the following: an engaging part that engages with the second opening in which a fluid supply opening is formed”). In the case where the cleaning communication hole on the bottom surface of the distal end portion body of Onishi (second opening 24 on tip portion 11 in Figs. 3-4 and 10 of Onishi) is provided in the ultrasonic endoscope of Morimoto on the bottom surface of the distal end portion body (bottom surface of distal end part 34 in Figs. 2-4 of Morimoto), then the position of the observation window in the first/vertical direction can be located on the side opposite to the cleaning communication hole.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasonic endoscope of Morimoto modified by Onishi and Kohno by including the cleaning communication hole on the bottom surface of the distal end portion body, as disclosed by Onishi. One of ordinary skill in the art would have been motivated to make this modification in order to achieve desired cleaning within the endoscope, as recognized by Onishi (see, e.g., Abstract, Para. [0001], and Para. [0006-0007]).
Regarding claim 6, Morimoto modified by Onishi and Kohno discloses the ultrasonic endoscope according to claim 2, as set forth above. Morimoto further discloses (Figs. 1-5) wherein the observation window (observation window 44) is disposed offset from the erecting base housing portion (concave treatment instrument erection space 62) in a second direction that is perpendicular to the first direction (see, e.g., Para. [0064], lines 1-8, “The base part 40 has an outer circumference surface 36 along a cylinder surface whose center is the axis of the insertion part 10, and on a distal end side of the outer circumference surface 36, a left oblique surface 41L and a right oblique surface 41R which face the distal end side and in an oblique upward direction are provided. On the left oblique surface 41L, an observation window 44… [is] provided” and Fig. 2, where the observation window 44 is shown to be positioned on the right side (i.e., offset in a second/horizontal direction that is perpendicular to the first/vertical direction and to the axial/longitudinal direction) of the concave treatment instrument erection space 62 when viewing the figure with the transducer 50 shown to be in front of the observation window 44 and the space 62).
Regarding claim 9, Morimoto modified by Onishi discloses the ultrasonic endoscope according to claim 1, as set forth above. Morimoto modified by Onishi does not specifically disclose wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body, among the plurality of the signal cables that are connected to the ultrasonic vibrator, at least one of the plurality of signal cables is disposed on a first side in a second direction of the erecting base housing portion, and at least another of the plurality of signal cables is disposed on a second side in the second direction of the erecting base housing portion.
However, in the same field of endeavor of ultrasonic endoscopes, Kohno discloses (Figs. 1-3) wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body (insertion portion 1), among the plurality of the signal cables that are connected to the ultrasonic vibrator, at least one of the plurality of signal cables is disposed on a first side in a second direction of the erecting base housing portion (treatment equipment guide member 20, receiving space 21), and at least another of the plurality of signal cables is disposed on a second side in the second direction of the erecting base housing portion (20, 21) (see, e.g., Modified Fig. 1 of Kohno provided below, where, when viewing the insertion portion 1 of the endoscope in the cross sectional view at the cross section line indicated in the figure, a plurality signal cables grouped into two separate groups (i.e., each of the two arrows representing the signal cables in the figure above are pointing to one group of signal cables) are shown to be positioned below and on the sides of the treatment equipment guide member 20/receiving space 21 (i.e., further down in the vertical direction when viewing the figure, and in the up/down and left/right directions in the cross sectional view), therefore the plurality of signal cables are disposed in regions that are different from the erecting base housing portion in the second direction, where one first group of signal cables is disposed on the left side of the treatment equipment guide member 20/receiving space 21, and another second group of signal cables is disposed on the right side of the treatment equipment guide member 20/receiving space 21 opposite of the first group of signal cables).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasonic endoscope of Morimoto modified by Onishi by including wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body, among the plurality of the signal cables that are connected to the ultrasonic vibrator, at least one of the plurality of signal cables is disposed on a first side in a second direction of the erecting base housing portion, and at least another of the plurality of signal cables is disposed on a second side in the second direction of the erecting base housing portion, as disclosed by Kohno. One of ordinary skill in the art would have been motivated to make this modification in order to desirably drive the ultrasonic vibrators within the ultrasonic transducer, as recognized by Kohno (see, e.g., Abstract and Para. [0019]).
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Modified Fig. 1 of Kohno
Regarding claim 11, Morimoto modified by Onishi discloses the ultrasonic endoscope according to claim 1, as set forth above. Morimoto modified by Onishi does not specifically disclose wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body, the plurality of signal cables that are connected to the ultrasonic vibrator are disposed on a side of the erecting base housing portion in a second direction where an observation window is disposed.
However, in the same field of endeavor of ultrasonic endoscopes, Kohno discloses (Figs. 1-3) wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body (insertion portion 1), the plurality of signal cables that are connected to the ultrasonic vibrator are disposed on a side of the erecting base housing portion (treatment equipment guide member 20, receiving space 21) in a second direction where an observation window (viewing device 4) is disposed (see, e.g., Modified Fig. 1 of Kohno provided above, where, when viewing the insertion portion 1 of the endoscope in the cross sectional view at the cross section line indicated in the figure, a plurality signal cables grouped into two separate groups (i.e., each of the two arrows representing the signal cables in the figure above are pointing to one group of signal cables) are shown to be positioned below and on the sides of the treatment equipment guide member 20/receiving space 21 (i.e., further down in the vertical direction when viewing the figure, and in the up/down and left/right directions in the cross sectional view), therefore one group of the plurality of signal cables would be disposed on the side of the erecting base housing portion in the second direction in which the viewing device 4 is also disposed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasonic endoscope of Morimoto modified by Onishi by including wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body, the plurality of signal cables that are connected to the ultrasonic vibrator are disposed on a side of the erecting base housing portion in a second direction where an observation window is disposed, as disclosed by Kohno. One of ordinary skill in the art would have been motivated to make this modification in order to desirably drive the ultrasonic vibrators within the ultrasonic transducer, as recognized by Kohno (see, e.g., Abstract and Para. [0019]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Morimoto (US 2016/0073860 A1) in view of Onishi (WO 2015/107801 A1), as applied to claim 1 above, and further in view of Ouchi (JP 2000-185042 A, of record, hereinafter Ouchi).
Regarding claim 8, Morimoto modified by Onishi discloses the ultrasonic endoscope according to claim 1, as set forth above. Morimoto does not specifically disclose wherein, when viewed in the axial direction of the distal end portion body, the erecting base housing portion is disposed offset from a center position of the distal end portion body in a second direction that is perpendicular to the first direction, and wherein the at least one signal cable is disposed in the second direction of the erecting base housing portion.
However, in the same field of endeavor of medical endoscopes, Onishi discloses (Figs. 1-4 and 10) wherein, when viewed in the axial direction of the distal end portion body (tip portion 11), the erecting base housing portion (recess 23) is disposed offset from a center position of the distal end portion body (11) in a second direction that is perpendicular to the first direction (see, e.g., Figs. 2 and 4, where the second direction is defined as the horizontal direction of the radial cross section that is perpendicular to the first/vertical direction and to the axial/longitudinal direction (i.e., the second direction is the horizontal direction in the perspective view of Fig. 4), and where the recess 23 which corresponds to the claimed erecting base housing portion is shown to be offset in the horizontal direction (i.e., positioned to the left of the center position when viewing the figures) from the center position of the tip portion 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 further modified the ultrasonic endoscope of Morimoto modified by Onishi by including wherein, when viewed in the axial direction of the distal end portion body, the erecting base housing portion is disposed offset from a center position of the distal end portion body in a second direction that is perpendicular to the first direction, as disclosed by Onishi. One of ordinary skill in the art would have been motivated to make this modification in order to achieve the desired imaging and observation (from the observation and illumination windows) of the treatment tool that protrudes from the erecting base housing portion to the subject, as recognized by Onishi (see, e.g., Para. [0022-0023]).
Morimoto modified by Onishi still does not specifically disclose wherein the signal cable is disposed in the second direction of the erecting base housing portion.
However, in the same field of endeavor of ultrasonic treatment endoscopes, Ouchi discloses wherein the signal cable (signal cable 9 in observation window 3) is disposed in the second direction of the erecting base housing portion (treatment tool erecting piece 11 in treatment tool protrusion port 4) (see, e.g., Para. [0012], “As shown in FIG. 3, an optical observation window 3 and a first treatment tool outlet 4 are sandwiched on the rear side surface of the ultrasonic transducer array 5 of the distal end main body 2 with the axis line interposed therebetween. […] As shown in FIG. 2, an objective optical system 7 combining a prism and a lens is provided inside the optical observation window 3. Are arranged, and the imaging surface of the solid-state imaging device 8 is arranged at a position where the object is imaged by the objective optical system 7. 9 is a signal cable. […] As shown in FIG. 1, the treatment tool erecting pieces 11, 24 for adjusting the protruding directions of the distal end portions of the treatment tools 100, 200 to be protruded are provided in the treatment tool protrusion ports 4, 24”, and Fig. 3, where the observation window 3 that includes the signal cable 9 is shown to be positioned side by side to the treatment tool protrusion port 4 that includes the treatment tool erecting piece 11, in which the positions of the observation window 3 and the treatment tool protrusion port 4 are different when projected onto a plane that is perpendicular to the first direction/horizontal direction when viewing the figure (i.e., the perpendicular direction in which the plane is projected onto is the direction into the figure when viewing Fig. 3)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasonic endoscope of Morimoto modified by Onishi by including wherein the signal cable is disposed in the second direction of the erecting base housing portion, as disclosed by Ouchi. One of ordinary skill in the art would have been motivated to make this modification in order to perform high-level endoscopic treatments without making the tip end of an insertion part relatively large, as recognized by Ouchi (see, e.g., Abstract).
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Morimoto (US 2016/0073860 A1) in view of Onishi (WO 2015/107801 A1) and Ouchi (JP 2000-185042 A), as applied to claim 8 above, and further in view of Kohno (US 2007/0249940 A1, of record, hereinafter Kohno).
Regarding claim 10, Morimoto modified by Onishi and Ouchi discloses the ultrasonic endoscope according to claim 8, as set forth above. Morimoto modified by Onishi and Ouchi does not specifically disclose wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body, among the plurality of the signal cables that are connected to the ultrasonic vibrator, at least one of the plurality of signal cables is disposed on a first side in a second direction of the erecting base housing portion, and at least another of the plurality of signal cables is disposed on a second side in the second direction of the erecting base housing portion.
However, in the same field of endeavor of ultrasonic endoscopes, Kohno discloses (Figs. 1-3) wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body (insertion portion 1), among the plurality of the signal cables that are connected to the ultrasonic vibrator, at least one of the plurality of signal cables is disposed on a first side in a second direction of the erecting base housing portion (treatment equipment guide member 20, receiving space 21), and at least another of the plurality of signal cables is disposed on a second side in the second direction of the erecting base housing portion (20, 21) (see, e.g., Modified Fig. 1 of Kohno provided above, where, when viewing the insertion portion 1 of the endoscope in the cross sectional view at the cross section line indicated in the figure, a plurality signal cables grouped into two separate groups (i.e., each of the two arrows representing the signal cables in the figure above are pointing to one group of signal cables) are shown to be positioned below and on the sides of the treatment equipment guide member 20/receiving space 21 (i.e., further down in the vertical direction when viewing the figure, and in the up/down and left/right directions in the cross sectional view), therefore the plurality of signal cables are disposed in regions that are different from the erecting base housing portion in the second direction, where one first group of signal cables is disposed on the left side of the treatment equipment guide member 20/receiving space 21, and another second group of signal cables is disposed on the right side of the treatment equipment guide member 20/receiving space 21 opposite of the first group of signal cables).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasonic endoscope of Morimoto modified by Onishi and Ouchi by including wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body, among the plurality of the signal cables that are connected to the ultrasonic vibrator, at least one of the plurality of signal cables is disposed on a first side in a second direction of the erecting base housing portion, and at least another of the plurality of signal cables is disposed on a second side in the second direction of the erecting base housing portion, as disclosed by Kohno. One of ordinary skill in the art would have been motivated to make this modification in order to desirably drive the ultrasonic vibrators within the ultrasonic transducer, as recognized by Kohno (see, e.g., Abstract and Para. [0019]).
Regarding claim 12, Morimoto modified by Onishi and Ouchi discloses the ultrasonic endoscope according to claim 8, as set forth above. Morimoto modified by Onishi and Ouchi does not specifically disclose wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body, the plurality of signal cables that are connected to the ultrasonic vibrator are disposed on a side of the erecting base housing portion in a second direction where an observation window is disposed.
However, in the same field of endeavor of ultrasonic endoscopes, Kohno discloses (Figs. 1-3) wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body (insertion portion 1), the plurality of signal cables that are connected to the ultrasonic vibrator are disposed on a side of the erecting base housing portion (treatment equipment guide member 20, receiving space 21) in a second direction where an observation window (viewing device 4) is disposed (see, e.g., Modified Fig. 1 of Kohno provided above, where, when viewing the insertion portion 1 of the endoscope in the cross sectional view at the cross section line indicated in the figure, a plurality signal cables grouped into two separate groups (i.e., each of the two arrows representing the signal cables in the figure above are pointing to one group of signal cables) are shown to be positioned below and on the sides of the treatment equipment guide member 20/receiving space 21 (i.e., further down in the vertical direction when viewing the figure, and in the up/down and left/right directions in the cross sectional view), therefore one group of the plurality of signal cables would be disposed on the side of the erecting base housing portion in the second direction in which the viewing device 4 is also disposed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the ultrasonic endoscope of Morimoto modified by Onishi and Ouchi by including wherein the at least one signal cable is provided in a plurality, and wherein, when viewed in the axial direction of the distal end portion body, the plurality of signal cables that are connected to the ultrasonic vibrator are disposed on a side of the erecting base housing portion in a second direction where an observation window is disposed, as disclosed by Kohno. One of ordinary skill in the art would have been motivated to make this modification in order to desirably drive the ultrasonic vibrators within the ultrasonic transducer, as recognized by Kohno (see, e.g., Abstract and Para. [0019]).
Allowable Subject Matter
Claims 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
As set forth above, Morimoto modified by Onishi represents the closest prior art of record to claim 1. Claim 17 depends from claim 1. However, Morimoto modified by Onishi does not disclose or render obvious the following limitations as recited in claim 17: “wherein in a case where the cleaning communication hole is viewed from the outside to the first direction, a region of a proximal end side of the erecting base, including the portion of the erecting base having the rotation shaft extending therethrough, is disposed at a position overlapping with the cleaning communication hole”, in combination with the other claimed elements. Furthermore, there is no other prior art of record outside of Morimoto and/or Onishi that discloses or renders obvious claim 17.
As set forth above, Morimoto modified by Onishi represents the closest prior art of record to claim 1. Claim 18 depends from claim 1. However, Morimoto modified by Onishi does not disclose or render obvious the following limitations as recited in claim 18: “of the at least two inner standing wall surfaces of the cleaning communication hole, the inner standing wall surface of the cleaning communication hole on a proximal end side of the cleaning communication hole and a region on an other side of a treatment instrument outlet in the first direction are on a same plane”, in combination with the other claimed elements. Furthermore, there is no other prior art of record outside of Morimoto and/or Onishi that discloses or renders obvious claim 18. Even furthermore, claim 19 depends from claim 18 and would be also allowable if claim 18 was rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/T.D./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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