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, 4-9, 11, 12 of 10/16/2025 acknowledged and entered.
Cancellation of claims 2, 3 of 10/16/2025 acknowledged and entered.
Response to Arguments
Applicant’s arguments, see p. 5, para. 2, filed 10/16/2025, with respect to claim 9.12 have been fully considered and are persuasive. The objection of 7/16/2025 has been withdrawn.
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive.
Regarding p. 5, para. 6, applicant asserts that there is no evidence linking the disclosed embodiments of Cuscuna. Examiner is in disagreement, as to the contrary Cuscuna does not disclose separate embodiments in the disclosure. A single embodiment depicted in multiple figures would not require linking of the depictions.
Regarding p. 6, para. 5, applicant asserts that the device of Cuscuna does not disclose the device as claimed in the amendments of 10/16/2025. Examiner is in accordance that Cuscuna does not explicitly teach a non-steerable section. However, examiner finds the amendment itself to raise issues of new matter and, hence, be improper. Specifically, the amendment “the passive portion being non-steerable” is a negative limitation which must appear within the specification exactly to have adequate support. Applicant does not provide citation to any particular paragraph to support this amendment. Examiner found para. 0016 of the specification to be most relevant, reciting “The segments in the second set of segments may be referred to as "passive" segments, because they are not actively, or directly, steered.” There is a crucial difference between the amended claim, which recites a device wherein the passive section is incapable of being steered and the specification, which recites a device wherein the passive section is not actively steered. Per the specification, the device does not explicitly lack the ability to be steered at the passive bending portion. Rather, active steering mechanisms are not being actuated. Hence, a device with a section capable of being steered but is not would be considered a passive steering section as outlined in the specification.
Claim Interpretation
Claim 1, which recites new matter, cannot be examined as amended. As a result, examiner would choose to interpret the offending section to mean “The passive portion being not actively, or directly, steered.”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-19 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim is amended to recite a negative limitation “the passive portion being non-steerable”. As stated in Response to Arguments, examiner does not see adequate support for such a limitation in the standing specification. A negative limitation such as the one amended would require explicit recitation in the original specification to not be considered new matter. The submitted specification reads “The segments in the second set of segments may be referred to as "passive" segments, because they are not actively, or directly, steered,” which is critically distinct from “non-steerable” in so far as to not preclude steering mechanisms so long as they remain unactuated. Examiner would suggest claim language supported by the specification and drawings such as “The passive portion being not actively, or directly, steered,” or “all actuation wires terminating proximally to the passive segments,” which would be supported while retaining a similar intention.
Claims 4-19 rejected for dependency upon claim 1.
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, 12, 15, 16, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cuscuna.
Regarding claim 1, Cuscuna teaches An endoscope comprising:
a handle ([0002], proximal end of the probe may include a control knob which an operator uses); and
an insertion cord (fig. 1, element 10, [0016], bending neck 10) extending distally from the handle, the insertion cord comprising a main tube (fig. 101, element 60, [0024], non-articulating section 60), a tip part ([0019], a transducer may be disposed at the distal tip of the distal link), and a bending section (fig. 10a, element 70, articulating section 70) arranged between the main tube and the tip part, the bending section comprising a bending section body and a bending section sleeve (fig. 6, element 20, [0021], sheath 20 over a bending neck) positioned over the bending section body, the bending section body comprising segments (fig. 1, element 11, [0016], links 11) interconnected by hinges (fig. 1, element 14, [0016], lobes 13 movably connect adjacent links), the segments including a proximal end segment ([0002], proximal end of the probe may include a control knob which an operator uses) connected to the main tube, a distal end segment ([0019], a transducer may be disposed at the distal tip of the distal link) connected to the tip part, and intermediate segments (fig. 4, bending section is comprised of a series of links) between the distal end segment and the proximal end segment; and
a steering wire (fig. 9, element 40),
wherein the steering wire is attached to one of the intermediate segments (fig. 9, element 36, [0022], anchor points 36), and
wherein the bending section body comprises an active portion (fig. 10a, element 70, [0024], articulating section 70) and a passive portion (fig. 10a, element 62, [0024], non-articulating section 62) distal of the active portion, the active portion comprising segments proximal of the one of the intermediate segments to which the steering wire is attached (fig. 9, element 36, [0022], anchor points 36), the passive portion comprising at least one of the segments (fig. 9, element 14, segments are continuous between first and second anchor points) and at least one of the hinges, the at least one of the segments and the at least one of the hinges being distal of the one of the intermediate segments to which the steering wire is attached, the passive portion being non-steerable (fig. 10a, element 62, [0024], non-articulating section 62).
Regarding claim 4, Cuscuna 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. 9, element 36, anchor point 36 is proximal to 5 links).
Regarding claim 6, Cuscuna teaches The endoscope of claim 1,
wherein the steering wire is connected to a most distal segment of the active portion.
Regarding claim 7, Cuscuna teaches The endoscope of claim 1,
wherein the passive portion of the bending section comprises at least one stiffening feature (fig. 6, element 20, [0021], sheath 20 has a stiffening property) configured to increase resistance to bending relative to portions of the bending section without the stiffening feature.
Regarding claim 10, Cuscuna 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 ([0021], sheath 20 is thicker toward the proximal end than distal, hence extra material and stiffness).
Regarding claim 15, Cuscuna teaches The endoscope of claim 1,
wherein the tip part comprises an ultrasound transceiver ([0002], imaging transducer of the ultrasound probe is located at the tip).
Regarding claim 16, Cuscuna teaches A system comprising a display unit and the endoscope of claim 1, the endoscope being connectable to said display unit ([0002], a desired view is created by the ultrasound probe, hence an operator must be able to view the results of the ultrasound probe on a display).
Regarding claim 18, Cuscuna teaches The system of claim 16,
wherein the tip part comprises an ultrasound transceiver ([0002], imaging transducer of the ultrasound probe is located at the tip),
the system further comprising an ultrasound control box for sending signals to an ultrasound transceiver and receiving signals from an ultrasound transceiver ([0002], transducer wiring is run through the hollow portion of the bending neck, hence the ultrasound must be controlled proximally).
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 Cuscuna as applied to claim 3 above, and further in view of Sato (US 20230016068 A1).
Regarding claim 5, Cuscuna teaches The endoscope of claim 3,
Cuscuna 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 Cuscuna 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 Cuscuna as applied to claims 1, 6, 12 above, and further in view of Banik (US 200470199052 A1).
Regarding claim 8, Cuscuna teaches The endoscope of claim 1,
Cuscuna 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 Cuscuna 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 Cuscuna in the prior art and the results would have been predictable to one of ordinary skill in the art.
Regarding claim 11, Cuscuna teaches The endoscope of claim 6,
Cuscuna 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 Cuscuna 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 Cuscuna in the prior art and the results would have been predictable to one of ordinary skill in the art.
Regarding claim 13, Cuscuna teaches The endoscope of claim 12,
Cuscuna 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 Cuscuna 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 Cuscuna as applied to claims 6, 7 above, and further in view of Bar-On (WO 2020144693 A1).
Regarding claim 9, Cuscuna teaches The endoscope of claim 7,
Cuscuna 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 Cuscuna 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, Cuscuna teaches The endoscope of claim 6,
Cuscuna 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 Cuscuna 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 Cuscuna as applied to claim 1 above, and further in view of Hansen and Cooper (US 7320700 B2).
Regarding claim 14, Cuscuna teaches The endoscope of claim 1,
Cuscuna 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 Cuscuna 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 Cuscuna 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) 17, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cuscuna as applied to claim 16 above, and further in view of Waters (US 20200178788 A1).
Regarding claim 17, Cuscuna teaches The system of claim 16,
Cuscuna 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.
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 display of Cuscuna to be integrated as taught in Waters in order to assist in downstream image processing of the results (Waters [0037]).
Regarding claim 19, Cuscuna teaches The system of claim 16,
Cuscuna 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 Cuscuna to perform image processing as taught in Waters in order to assist in downstream image processing of the results (Waters [0033]).
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