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
Amendment to claim 1, 6 of 4/22/2026 acknowledged and entered.
New claim 20-22 of 4/22/2026 acknowledged and entered.
Response to Arguments
Applicant’s arguments, see p. 6, para. 4, filed 4/22/2026, with respect to claim 1 have been fully considered and are persuasive. The USC 112 rejection of claim 1 has been withdrawn.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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) 1-4, 6, 7, 9, 10, 20-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hill (US 20130096553 A1).
Regarding claim 1, Hill teaches An endoscope comprising:
a handle (fig. 1, element 16, [0036], control and power element 16 may be held by an operator’s hand); and
an insertion cord (fig. 1, element 12, [0036], catheter 12) extending distally from the handle, the insertion cord comprising a main tube (fig. 8, element 20, [0039], catheter shaft 20), a tip part (fig. 4a, element 22, [0046], tip of electrode 22), and a bending section (fig. 7, element A/B, [0048], deflection of catheter 12 in directions A/B) arranged between the main tube and the tip part, the bending section comprising a bending section body and a bending section sleeve (fig. 8, element 20, [0039], In at least some embodiments, catheter shaft 20 may form or define an outer surface of catheter 12) positioned over the bending section body, the bending section body comprising segments (fig. 8, element 28, 32, [0042, 47], flex tube 32 with plurality of slots 34, flex body 28 with plurality of ribs 46a/b) interconnected by hinges (fig. 8, element 44a/b, 34, [0042, 47], flex tube 32 with plurality of slots 34, flex body 28 with plurality of slots 44a/b, slots in body define hinges between joints), the segments including a proximal end segment (fig. 8, element 46a.b, one rib must be proximal by definition) connected to the main tube, a distal end segment (fig. 7 shows distal tip of bending section) connected to the tip part, and intermediate segments (fig. 7, bending segments in between) between the distal end segment and the proximal end segment; and
steering wires (fig. 8, element 30, [0041], actuation members 30a/b),
wherein the bending section body comprises an active portion (fig. 8, element 28, [0041], This allows a user to actuate (e.g., "pull") one or both of wires 30a/30b to deflect flex body 28) and a passive portion (fig. 8, element 32, [0042], a flex tube 32 may be coupled to flex body 28 (e.g., at a distal end of flex body 28)) distal of the active portion, the passive portion comprising at least one of the segments (fig. 8, element 32) and at least one of the hinges (fig. 8, element 34), and the active portion comprising at least some of the intermediate segments (fig. 8, element 46a/b) and at least some of the hinges (fig. 8, element 44a/b), and
wherein all the steering wires terminate proximally of the passive portion (fig. 8, element 30 shows termination at the distal end of the flex body 28).
Regarding claim 4, Hill teaches The endoscope of claim 1,
wherein the number of segments in said passive portion is selected from the group comprising 1, 2, 3, 4 or 5 (fig. 7, passive distal section limited to 3 sets of links separated by hinges).
Regarding claim 6, Hill teaches The endoscope of claim 1,
wherein all the steering wires are connected to a most distal segment of the active portion (fig. 8, element 30, wire connected to the distal end of the flex body).
Regarding claim 7, Hill teaches The endoscope of claim 1,
wherein the passive portion of the bending section comprises at least one stiffening feature (beams that are formed in tubular member 26, and such tube segments and beams may include portions of tubular member 26 that remain after slots 34 are formed in the body of tubular member 26. Such an interconnected structure may act to maintain a relatively high degree of torsional stiffness) configured to increase resistance to bending relative to portions of the bending section without the stiffening feature.
Regarding claim 10, Hill teaches The endoscope of claim 7,
wherein the stiffening feature comprises a stiffening layer of material in the passive portion, in the bending section body and/or the bending section sleeve (beams that are formed in tubular member 26, and such tube segments and beams may include portions of tubular member 26 that remain after slots 34 are formed in the body of tubular member 26. Such an interconnected structure may act to maintain a relatively high degree of torsional stiffness).
Regarding claim 20, Hill teaches The endoscope of claim 1,
wherein the active portion is actively and directly steerable and the passive portion is not actively nor directly steerable due to all the steering wires being terminated proximally of the passive portion (fig. 8, element 30 shows termination at the distal end of the flex body 28).
Regarding claim 21, Hill teaches The endoscope of claim 1,
wherein two of the steering wires are sections of a single wire, and the sections are connected by an interconnection portion ([0041], the actuation member takes the form of a continuous wire that is looped through or otherwise coupled to a distal end of flex body 28 so as to define a pair of wire sections).
Regarding claim 22, Hill teaches The endoscope of claim 1,
wherein two of the steering wires are sections of a single wire, the sections are connected by an interconnection portion ([0041], the actuation member takes the form of a continuous wire that is looped through or otherwise coupled to a distal end of flex body 28 so as to define a pair of wire sections), and the interconnection portion is secured to a most distal segment of the active portion (fig. 8, element 30 shows termination at the distal end of the flex body 28).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill as applied to claim 1 above, and further in view of Sato (US 20230016068 A1).
Regarding claim 5, Hill teaches The endoscope of claim 3,
Hill does not explicitly teach the device wherein the number of segments in said passive portion is one.
However, Sato teaches the device wherein the number of segments in said passive portion (fig. 33, element 110, [0363], connection tube 110 is a connecting segment to the distal end of the endoscope distal to the termination of the bending cables 30 comprised of a single segment) is one.
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 connection segment of Hill to a singular segment as taught in Sato in order to secure the distal end portion of the bending section while connecting it to the distal end (Sato [0365]).
Claim(s) 8, 11, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill as applied to claims 1, 6, 12 above, and further in view of Banik (US 200470199052 A1).
Regarding claim 8, Hill teaches The endoscope of claim 1,
Hill does not explicitly teach the device wherein the hinges are live hinges and wherein the live hinges of the passive portion are stiffer than hinges in the live hinges in the active portion.
However, Banik teaches wherein the hinges are live hinges ([0010], live hinges for endoscopic shafts) and wherein the live hinges of the passive portion are stiffer than hinges in the live hinges in the active portion ([0010], live hinge stiffness may be adjusted by the spacing of the joints).
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 hinges of Hill to be live hinges with variable stiffness as taught in Banik in order to more increase strength and torque fidelity (Banik [0010]). It would have been obvious that the method of enhancing the stiffness of live hinges in endoscopes has been made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations. One of ordinary skill in the art would have been capable of applying this known method of enhancement to a "base" device, i.e. the endoscope of Hill in the prior art and the results would have been predictable to one of ordinary skill in the art.
Regarding claim 11, Hill teaches The endoscope of claim 6,
Hill does not explicitly teach the device wherein the hinges are live hinges and the live hinges in the passive portion are more resistant to bending than the live hinges in the active portion of the bending section.
However, Banik teaches wherein the hinges are live hinges ([0010], live hinges for endoscopic shafts) and the live hinges of the passive portion are more resistant to bending than live hinges in the active portion of the bending section ([0010], live hinge stiffness may be adjusted by the spacing of the joints).
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 hinges of Hill to be live hinges with variable stiffness as taught in Banik in order to more increase strength and torque fidelity (Banik [0010]). It would have been obvious that the method of enhancing the stiffness of live hinges in endoscopes has been made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations. One of ordinary skill in the art would have been capable of applying this known method of enhancement to a "base" device, i.e. the endoscope of Hill in the prior art and the results would have been predictable to one of ordinary skill in the art.
Regarding claim 13, Hill teaches The endoscope of claim 12,
Hill does not explicitly teach the device wherein the hinges are live hinges.
However, Banik teaches the device wherein the hinges are live hinges ([0010], live hinges).
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 hinges of Hill to be live hinges as taught in Banik in order to increase strength and torque fidelity (Banik [0010]).
Claim(s) 9, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill as applied to claims 6, 7 above, and further in view of Bar-On (WO 2020144693 A1).
Regarding claim 9, Hill teaches The endoscope of claim 7,
Hill does not explicitly teach wherein the stiffening feature comprises stiffening pins positioned coextensively with hinges in the passive portion.
However, Bar-On teaches wherein the stiffening feature comprises stiffening pins (fig. 2a, element 205b, p. 13, para. 9, pin 205b is stiffer than the flexible portion) positioned coextensively with hinges in the passive portion (pin 205b passes longitudinally through the bending portion).
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 stiffening mechanism of Hill to include pins as taught in Bar-On in order to prevent deformation of the passive bending section (Bar-On p. 13, para. 9).
Regarding claim 12, Hill teaches The endoscope of claim 6,
Hill does not explicitly teach wherein the stiffening feature comprises stiffening pins positioned coextensively with hinges in the passive portion.
However, Bar-On teaches wherein the stiffening feature comprises stiffening pins (fig. 2a, element 205b, p. 13, para. 9, pin 205b is stiffer than the flexible portion) positioned coextensively with hinges in the passive portion (pin 205b passes longitudinally through the bending portion).
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 stiffening mechanism of Hill to include pins as taught in Bar-On in order to prevent deformation of the passive bending section (Bar-On p. 13, para. 9).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill as applied to claim 1 above, and further in view of Hansen and Cooper (US 7320700 B2).
Regarding claim 14, Hill teaches The endoscope of claim 1,
Hill does not explicitly teach the device wherein the hinges are live hinges, wherein live hinges between the distal end segment and a most distal intermediate segment are thicker than at least some of the live hinges between intermediate segments proximal of the most distal intermediate segment.
However, Hansen teaches the device wherein the hinges are live hinges (fig. 2, element 15, [0042], hinge members 15),
However, Cooper teaches the device wherein live hinges between the distal end segment and a most distal intermediate segment are thicker than at least some of the live hinges between intermediate segments proximal of the most distal intermediate segment (col. 6, ln. 50-60, thicker end pieces, leading to increased stiffness, are desirable at end regions for additional strength).
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 hinges of Hill to be live hinges as taught in Hansen in order to more elastically bend the bending section of the endoscope (Hansen [0007]).
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 hinges of Hill to be thicker in the distal portion as taught in Cooper in order to accommodate for increased cable forces at sharp turns (Cooper col. 6, ln. 50-60).
Claim(s) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill as applied to claim 16 above, and further in view of Waters (US 20200178788 A1).
Regarding claim 15, Hill teaches The endoscope of claim 1,
Hill does not explicitly teach wherein the tip part comprises an ultrasound transceiver.
However, Waters teaches wherein the tip part comprises an ultrasound transceiver (fig. 3, element 310, [0025], ultrasound transducer assembly 310).
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 device of Hill to have an ultrasound imager as taught in Waters in order to assist in downstream image processing of the results (Waters [0037]).
Regarding claim 16, Hill teaches A system comprising a display unit and the endoscope of claim 1,
Hill does not explicitly teach the endoscope being connectable to said display unit,
However, Waters teaches the endoscope being connectable to said display unit (fig. 1A, element 22, [0020], display 22).
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 device of Hill to have an ultrasound imager as taught in Waters in order to assist in downstream image processing of the results (Waters [0037]).
Regarding claim 17, Hill teaches The system of claim 16,
Hill does not explicitly teach the device wherein the display unit comprises an integrated display.
However, Waters teaches the device wherein the display unit (fig. 10, element 22, [0020], display 22) comprises an integrated display.
Regarding claim 18, Hill teaches The system of claim 16,
Hill does not explicitly teach wherein the tip part comprises an ultrasound transceiver,
the system further comprising an ultrasound control box for sending signals to an ultrasound transceiver and receiving signals from an ultrasound transceiver.
However, Waters teaches wherein the tip part comprises an ultrasound transceiver (fig. 3, element 310, [0025], ultrasound transducer assembly 310),
the system further comprising an ultrasound control box for sending signals to an ultrasound transceiver and receiving signals from an ultrasound transceiver (fig. 8, element 606, [0033],signal-processing electronics 606).
Regarding claim 19, Hill teaches The system of claim 16,
Hill does not explicitly teach the device wherein the ultrasound control box comprises image processing electronics.
However, Waters teaches the device wherein the ultrasound control box comprises image processing electronics (fig. 8, element 606, [0033],signal-processing electronics 606).
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 circuitry of Hill to perform image processing as taught in Waters in order to assist in downstream image processing of the results (Waters [0033]).
Conclusion
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
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