DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Amendments to claims 1-5, 7, 9-11, 13, 15 of 10/2/2025 acknowledged and entered.
Response to Arguments
Applicant's arguments filed 10/2/2025 have been fully considered but they are not persuasive.
Regarding p. 10, para. 2, applicant asserts that the cited reference Sorensen does not teach a channel accommodating the steering wire. Examiner is not in accordance. Sorensen [0031] discloses steering wires passing through a number of through holes forming a steering wire passage. This would comprise a “channel” through which steering wires may pass. Further, examiner asserts that most configurations of steering wires by definition have some sort of channel, as wires, being a physical object, cannot pass through the solid frame of an endoscope.
Regarding p. 12, para. 2, applicant asserts the cited reference Sorensen does not teach the at least one steering wire running through the bending section within the channel to cause bending of the bending section. Again, referring to Sorensen [0031], the steering wires are secured in the tip part, which is distal to the bending section and would require the wire to pass through it on a path from proximal to distal. Further, the paragraph elaborates the means by which manipulation of the control wires actuates the device. See above response for details on steering wire channels.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4-8, 10-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sorensen (EP 3708061 A1).
Regarding claim 1, Sorensen teaches An endoscope extending along a proximal-distal axis, the endoscope comprising:
a handle (fig. 1a, element 2, [0088], operating handle 2) comprising a control device (fig. 1a, element 21, [0088], control lever 21);
an insertion tube (fig. 1a, element 3, [0088], insertion tube 3) extending from the handle;
a bending section (fig. 2a, element 4, [0090] bending section 4) extending from the insertion tube and including segments, the segments including a proximal end segment (fig. 2a, element 43, [0090], proximal end segment 43), a distal end segment (fig. 2a, element 4a, [0090], distal end segment 41), and intermediate segments (fig. 2a, element 42, [0090], intermediate segments 42) arranged between the proximal end segment and the distal end segment, the bending section being a prefabricated component;
a distal tip part (fig. 2a, element 3b, [0090], distal end 3b) including:
an exterior housing (fig. 2a, element 6, [0090], exterior housing part 6) including a circumferentially extending side wall (fig. 2b, element 6a, [0091], circumferentially extending side wall 6a) with a proximal opening (fig. 3b, element 6d, [0091], proximal opening 6d), the circumferentially extending side wall defining an interior cavity (fig. 3b, element 6h, [0091], interior space 6h), and
a camera assembly (fig. 2b, element 8, [0091], camera assembly 8) including an image sensor (fig. 2b, element 83, [0092], image sensor 83), the camera assembly being positioned in the interior cavity of the exterior housing ([0091], interior space 6h for accommodating the camera assembly 8),
an interior housing part (fig. 2b, element 7, [0093], interior housing part 7) being a prefabricated component formed separately from the exterior housing and the bending section, the interior housing part including:
a distal portion with a circumferentially extending closure surface (fig. 3b, element 71, [0093], closure surface 71), the distal portion being positioned in the proximal opening of the exterior housing and closing the interior cavity of the exterior housing,
a proximal portion with a circumferentially extending attachment surface (fig. 3b/c, element 72, [0094], attachment surface 72), the proximal portion being distanced in a proximal direction from the exterior housing, the distal end segment being attached to the attachment surface ([0102], attachment surface 72 mates with distal end segment 41), an
a wire portion (fig. 1a, element 9) comprising a channel ([0088], steering wire 31a runs through a flexible tube 9); and
at least one steering wire ([0088], control lever 21 maneuvers the distal tip by means of steering wire 31a) attached to the control device of the handle and running through the bending section and the insertion tube and having a distal segment,
wherein the distal segment ([0088], control lever 21 maneuvers the distal tip by means of steering wire 31a) of the at least one steering wire is accommodated in the channel so that manipulation of the control device causes bending of the bending section.
Regarding claim 2, Sorensen teaches The endoscope of claim 1,
wherein the wire portion of the interior housing part is configured to bend the distal segment of the at least one steering wire away from the proximal- distal axis by an angle ([0031], steering wires accommodated in passages articulate the bending portion by tensioning/slacking in the desired direction. A bend of less than 2 degrees would be so insignificant of bending that it would be unable to be considered desired if bending at all), the angle being at least 2 degrees.
Regarding claim 4, Sorensen teaches The endoscope of claim 1,
further comprising a separately formed planar element comprising at least one through-hole ([0031], each segment of the tip part comprises a through hole through which a steering wire passes) and being arranged between the interior housing part and the bending section, wherein the at least one steering wire extends through the at least one through-hole.
Regarding claim 5, Sorensen teaches The endoscope of claim 4,
wherein the at least one through-hole of the planar element is configured to bend the distal segment of the at least one steering wire away from the proximal- distal axis by an angle ([0031], steering wires accommodated in passages articulate the bending portion by tensioning/slacking in the desired direction. A bend of less than 2 degrees would be so insignificant of bending that it would be unable to be considered desired if bending at all) at the respective through-hole, the angle being at least 20.
Regarding claim 6, Sorensen teaches The endoscope of claim 5,
wherein a portion of the distal segment of the at least one steering wire is located in the respective through-hole, wherein an angle between the portion of the distal segment and a center line of the respective through-hole is at least 20 ([0031], steering wires accommodated in passages articulate the bending portion by tensioning/slacking in the desired direction. A bend of less than 2 degrees would be so insignificant of bending that it would be unable to be considered desired if bending at all).
Regarding claim 7, Sorensen teaches The endoscope of claim 1,
wherein the distal tip part comprises a cured first adhesive ([0100], UV curable adhesive in gap 52 between closure surface 71 and interior surface 6g) adhering the circumferentially extending closure surface to an interior surface (fig. 3b, element 6g, [0100], interior surface 6g) of the circumferentially extending side wall of the exterior housing, thereby closing the interior cavity of the exterior housing and liquid-sealing the interior cavity.
Regarding claim 8, Sorensen teaches The endoscope of claim 7,
further comprising a gap between the circumferentially extending closure surface and the interior surface of the circumferentially extending side wall of the exterior housing, the gap being narrower proximally than distally and being configured to draw the first adhesive, prior to curing, into the gap by capillary forces ([0100], a capillary force draws the adhesive into gap 52).
Regarding claim 10, Sorensen teaches The endoscope of claim 1,
wherein the distal end segment of the bending section comprises a circumferentially extending outer wall (fig. 2b, element 41, distal end segment is composed of a hollow member with an outer wall) with a proximal-distal extending cut-out (fig. 2b, element 41, distal end segment has a cutout in the outer wall portion), wherein the proximal portion of the interior housing part comprises one or more locking protrusion(s) (fig. 2b, element 72a, [0094], grooves are formed in the attachment surface 72 of the interior housing part, which forms protrusions between the grooves and are designed to aid in the mechanical connection between distal end segment 41 and attachment surface 72) radially extending into the cut-out of the outer wall of the bending section so as to lock the rotation of the interior housing part with respect to the distal end segment of the bending section about the proximal-distal axis.
Regarding claim 11, Sorensen teaches The endoscope of claim 1,
wherein the interior housing part includes:
an intermediate portion (fig. 2b, element 73/74, [0093], compensating members separate the distal seats 73/74b from the proximal connector 72) arranged between and separating the distal portion of the interior housing part and the proximal portion of the interior housing part; and
a cured adhesive surface ([0100], UV curable adhesive in gap 52 between closure surface 71 and interior surface 6g) extending circumferentially and between the proximal opening of the exterior housing and the proximal portion of the interior housing part,
wherein the endoscope further comprises a bending cover (fig. 2b, element 41, distal end segment is composed of a hollow member with an outer wall) arranged exteriorly of and covering the bending section, a distal portion of bending cover being adhered to the circumferentially extending cured adhesive surface (fig. 2b, element 72a, [0094], grooves are formed in the attachment surface 72 of the interior housing part, which forms protrusions between the grooves and are designed to aid in the mechanical connection between distal end segment 41 and attachment surface 72, [0100], adhesive injected through holes 41g to fill grooves 72a) of the interior housing part.
Regarding claim 12, Sorensen teaches The endoscope of claim 1,
further comprising an electrical cable (fig. 3b, element 87, [0092], cables 87) extending from the handle and passing through the insertion tube and the bending section,
the proximal portion of the interior housing part having a first pair of locking protrusions (fig. 2b, element 72a, [0094], grooves are formed in the attachment surface 72 of the interior housing part, which forms protrusions between the grooves and are designed to aid in the mechanical connection between distal end segment 41 and attachment surface 72),
a second pair of locking protrusions opposite the first pair (fig. 3c, element 72, multiple grooves are shown),
a longitudinal cable passage between the first pair and the second pair (fig. 3b, element 75, [0093], cable tube hole 75),
a first steering wire channel intermediate locking protrusions of the first pair ([0031], each segment of the tip part comprises a through hole through which a steering wire passes), and
a second steering wire channel intermediate locking protrusions of the second pair ([0031], each segment of the tip part comprises a through hole through which a steering wire passes),
wherein the distal portion of the interior housing part is affixed to the exterior housing ([0100], UV curable adhesive in gap 52 between closure surface 71 and interior surface 6g),
wherein the proximal portion of the interior housing part is affixed to the distal end segment of the bending section (fig. 2b, element 72a, [0094], grooves are formed in the attachment surface 72 of the interior housing part, which forms protrusions between the grooves and are designed to aid in the mechanical connection between distal end segment 41 and attachment surface 72, [0100], adhesive injected through holes 41g to fill grooves 72a), and
wherein the first pair of locking protrusions and the second pair of locking protrusions traverse the longitudinal cut-out of the distal end segment, the electrical cable extends through the longitudinal cable passage (fig. 3b, element 75, [0093], cable tube hole 75), and the distal segment of the steering wire traverses the first steering wire channel and the second steering wire channel ([0031], each segment of the tip part comprises a through hole through which a steering wire passes).
Regarding claim 13, Sorensen teaches The endoscope of claim 12,
further comprising a planar element positioned between the interior housing part and the bending section, the planar element comprising opposing surfaces, a first through-hole and a second through-hole extending between the opposing surfaces, wherein the steering wire includes a first segment extending from the distal segment to the handle and a second segment extending from the distal segment to the handle, the first segment and the segment passing, respectively, through the first through-hole and the second through-hole ([0031], each segment of the tip part comprises a through hole through which a steering wire passes).
Regarding claim 14, Sorensen teaches An endoscope comprising:
a handle (fig. 1a, element 2, [0088], operating handle 2);
an insertion tube attached to and extending distally from the handle (fig. 1a, element 3, [0088], insertion tube 3);
a bending section (fig. 2a, element 4, [0090] bending section 4) attached to and extending distally from the insertion tube, the bending section including segments including a distal end segment (fig. 2a, element 4a, [0090], distal end segment 41), the distal end segment having a circumferential wall (fig. 2b, element 41, distal end segment is composed of a hollow member with an outer wall) with a longitudinal cut-out at a distal end thereof (fig. 2b, element 41, distal end segment has a cutout in the outer wall portion);
a distal tip part including an exterior housing (fig. 2a, element 6, [0090], exterior housing part 6) and an image sensor (fig. 2b, element 83, [0092], image sensor 83), the exterior housing having a circumferentially extending side wall with a proximal opening, the circumferentially extending side wall (fig. 2b, element 6a, [0091], circumferentially extending side wall 6a) defining an interior cavity (fig. 3b, element 6h, [0091], interior space 6h), and the image sensor positioned in the interior cavity ([0091], interior space 6h for accommodating the camera assembly 8);
a steering wire ([0088], control lever 21 maneuvers the distal tip by means of steering wire 31a) extending from the handle and passing through the insertion tube and the bending section, the steering wire having a distal segment;
an electrical cable (fig. 3b, element 87, [0092], cables 87) extending from the handle and passing through the insertion tube and the bending section; and
an interior housing part including a distal portion and a proximal portion, the proximal portion having a first pair of locking protrusions (fig. 2b, element 72a, [0094], grooves are formed in the attachment surface 72 of the interior housing part, which forms protrusions between the grooves and are designed to aid in the mechanical connection between distal end segment 41 and attachment surface 72), a second pair of locking protrusions opposite the first pair (fig. 3c, element 72, multiple grooves are shown), a longitudinal cable passage between the first pair and the second pair (fig. 3b, element 75, [0093], cable tube hole 75), a first steering wire channel intermediate locking protrusions of the first pair ([0031], each segment of the tip part comprises a through hole through which a steering wire passes), and a second steering wire channel intermediate locking protrusions of the second pair ([0031], each segment of the tip part comprises a through hole through which a steering wire passes), wherein the distal portion of the interior housing part is affixed to the exterior housing ([0100], UV curable adhesive in gap 52 between closure surface 71 and interior surface 6g), wherein the proximal portion of the interior housing part is affixed to the distal end segment of the bending section (fig. 2b, element 72a, [0094], grooves are formed in the attachment surface 72 of the interior housing part, which forms protrusions between the grooves and are designed to aid in the mechanical connection between distal end segment 41 and attachment surface 72, [0100], adhesive injected through holes 41g to fill grooves 72a), and wherein the first pair of locking protrusions and the second pair of locking protrusions traverse the longitudinal cut-out of the distal end segment, the electrical cable extends through the longitudinal cable passage (fig. 3b, element 75, [0093], cable tube hole 75),, and the distal segment of the steering wire traverses the first steering wire channel and the second steering wire channel ([0031], each segment of the tip part comprises a through hole through which a steering wire passes).
Regarding claim 15, Sorensen teaches The endoscope of claim 14,
further comprising a planar element positioned between the interior housing part and the bending section, the planar element comprising opposing surfaces, a first through-hole and a second through-hole extending between the opposing surfaces, wherein the steering wire includes a first segment extending from the distal segment to the handle and a second segment extending from the distal segment to the handle, the first segment and the segment passing, respectively, through the first through-hole and the second through-hole ([0031], each segment of the tip part comprises a through hole through which a steering wire passes).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sorensen as applied to claim 1 above, and further in view of Johnson (US 20220040453 A1).
Regarding claim 3, Sorensen teaches The endoscope of claim 1,
Sorensen does not explicitly teach the device wherein the distal segment of the at least one steering wire passes one or more friction-inducing section(s) of the wire portion configured to frictionally retain the at least one steering wire in the wire portion.
However, Johnson teaches the device wherein the distal segment of the at least one steering wire passes one or more friction-inducing section(s) of the wire portion configured to frictionally retain the at least one steering wire in the wire portion ([0024], friction in selected areas between pull wires and lumen causes retention of form in the catheter).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wire channels of Sorensen to include frictional elements as taught in Johnson in order to retain curved shapes in the device (Johnson [0024]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sorensen as applied to claim 7 above, and further in view of Melsheimer (US 20190091444 A1).
Regarding claim 9, Sorensen teaches The endoscope of claim 7,
Sorensen does not explicitly teach the device wherein the distal tip part comprises a cured second adhesive adhering the at least one steering wire to the wire portion of the interior housing part.
However, Melsheimer teaches the device wherein the distal tip part comprises a cured second adhesive adhering the at least one steering wire to the wire portion of the interior housing part ([0054], distal opening of tension channel 32 is filled with adhesive bonding and fixing distal end 34b of tension member within the channel 32).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wire channels of Sorensen to include adhesive fixing elements as taught in Melsheimer in order to attach the wire within the catheter channel securely (Melsheimer [0054]).
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 TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY TUAN LUU/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795