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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/11/2024 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In line 7, the claim 1 recites “radially misaligned.” This is unclear because the specification does not provide a definition of radially misaligned.
For the purpose of examination, radially misaligned is considered as the slots being not aligned in the same axial line as shown in FIGS. 15A-15C of the instant application which shows that the center of the slots are not in the same axial line, i.e., they are radially misaligned.
Appropriate correction is required.
Claims 2-20 are rejected for being dependent on a rejected base claim.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5, 9, 11-12, 14-16, 19, is/are rejected under 35 U.S.C. 102 as being anticipated by Konstorum (US 6749560).
Regarding claim 1, Konstorum discloses an endoscope (FIGS. 1, 3, 5, 8, annotated below) used for insertion into a patient’s body, comprising:
a shaft assembly comprising an outer sleeve (tube 40) and an inner sleeve (tube 41 can be of polymer; Inner and outer sleeves has been considered as tubes that includes at least one opening. FIG. 8; multiple tube connected in series for forming the frame; ) surrounded by the outer sleeve, wherein the shaft assembly comprises an articulating distal portion (active deflection section 18; FIG. 1) and a straight proximal portion that extends about a longitudinal axis (FIG. 1);
an image sensor (fiber optics cab be provided with the channels 70, 72, 74, and 76 with polymer tube 41; FIG. 8) at the distal portion of the shaft assembly;
a plurality of slots (slots 46a, 46b; FIG. 5) on the outer sleeve, wherein the plurality of slots are spaced along the longitudinal axis and are radially misaligned (Slots are radially misaligned, i.e., the slots are not aligned in radial direction which means that one slot is away from the other slot as considered along the radial direction. The radial direction is the direction of radius formed during bending.);
a plurality of deflecting segments spaced apart from each other (FIG. 5 annotated) and adjacent to the plurality of slots, wherein the plurality of deflecting segments are configured to be articulated with respect to the longitudinal axis to change a viewing angle of the image sensor (FIGS. 1, 5, 8).
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Regarding claim 2, Konstorum discloses wherein the inner sleeve comprises one or more extending elements at a distal portion of the inner sleeve (illumination bundle, fiber bundle, control wires can be provided with channels 70, 72, 74, and 76 of polymer tube 41).
Regarding claim 3, Konstorum discloses further comprising a working channel (control wires can be passed through one of the channels 70, 72, 74, and 76) in the inner sleeve configured to accommodate an elongated tool extending therethrough when the shaft assembly is in a deflected profile (control wire can be inside in both articulated and straight profile; FIG. 1).
Regarding claim 4, Konstorum discloses further comprising a pull-wire (Pull wire extends along a channel inside the sheath tube for deflection of the frame. Claim 9) coupled to the inner sleeve for moving the inner sleeve between an insertion profile and a deflected profile.
Regarding claim 5, Konstorum discloses wherein a distal portion of the outer sleeve is at an angle to the longitudinal axis in the deflected profile (deflection section 18; FIG. 1).
Regarding claim 9, Konstorum discloses further comprising a flexible polymer sleeve positioned around the outer sleeve (The cover 32 is preferably comprised of a resilient plastic or polymer material.).
Regarding claim 11, Konstorum discloses wherein the one or more extending elements each comprise a distal tip towards a distal end of each of the one or more extending elements, wherein the distal tip is coupled to the outer sleeve (Control wire are couple to both inner sleeve and outer sleeve; FIG. 1).
Regarding claim 12, Konstorum discloses wherein the distal tip is coupled to the outer sleeve via welding (As seen from FIG. 3, the distal tip is welded/seamless to the outer sleeve).
Regarding claim 14, Konstorum discloses wherein the viewing angle of the image sensor is parallel with respect to the longitudinal axis in a straight profile, wherein the viewing angle of the image sensor is angled with respect to the longitudinal axis in a deflected profile (FIG. 1).
Regarding claim 15, Konstorum discloses wherein the plurality of slots comprises a proximal slot and a distal slot, wherein deflection of the proximal slot is independent of deflection of the distal slot (FIG. 5 annotated).
Regarding claim 16, Konstorum discloses further comprising a plurality of flow channels within the outer sleeve (channels 70, 72, 74, and 76 are inside the outer sleeve).
Regarding claim 19, Konstorum discloses wherein a diameter of the inner sleeve is at least 50% of a diameter of a distal portion of the outer sleeve (FIG. 8).
Claim Rejections - 35 USC § 103
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) 17-18, 20, is/are rejected under 35 U.S.C. 103 as being unpatentable over Konstorum (US 6749560) in view of Truckai (US 20180084971).
Regarding claim 17, Konstorum does not expressly disclose a fluid inflow source communicating with the plurality of flow channels.
Truckai is directed to a disposable cover for use with an endoscope (abstract) and teaches a fluid inflow source communicating with the plurality of flow channels (A fluid outflow channel 270 can be provided for coupling to a negative pressure source 275 thereby providing fluid outflows from the patient's body cavity. Para [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Konstorum to include a negative pressure source in accordance with the teaching of Truckai so that fluid could be used for cleaning the surgical area.
Regarding claim 18, Konstorum as modified, teaches a negative pressure source communicating with the plurality of flow channels (Truckai: A fluid outflow channel 270 can be provided for coupling to a negative pressure source 275 thereby providing fluid outflows from the patient's body cavity. Para [0048).
Regarding claim 20, Konstorum as modified, teaches a negative pressure source communicating with a flow channel extending through the shaft assembly (Truckai: A fluid outflow channel 270 can be provided for coupling to a negative pressure source 275 thereby providing fluid outflows from the patient's body cavity. Para [0048).
Claim(s) 13, is/are rejected under 35 U.S.C. 103 as being unpatentable over Konstorum (US 6749560) in view of Germain (US 9649116).
Regarding claim 13, Konstorum does not expressly disclose wherein the distal tip is coupled to the outer sleeve via pins.
Germain is directed to medical instruments and systems (abstract) and teaches wherein the distal tip is coupled to the outer sleeve via pins (The distal ends of the shafts can be coupled together by a press-fit pins inserted into holes 566 in the sleeves (FIG. 17) or by any other suitable fastening means such as welding).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Konstorum to include pins for connecting the distal tip with the outer tube in accordance with the teaching of Germain as an alternative of welding. Since Germain teaches that welding or pins could be used alternatively, one of ordinary skill in the art would have been motivated to use pins for connecting the distal tip as an alternative way of welding.
Allowable Subject Matter
Claims 6 and 10 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.
Reasons for Allowance
Claim 6
The following is an examiner’s statement of reasons for allowance:
The prior art of record fails to explicitly teach or fairly suggest, alone or in combination, an endoscope used for insertion into a patient’s body, wherein insertion of a tool through the inner sleeve causes movement from the first articulated profile to the second articulated profile, along with the remaining features of claims 6, 4, and 1.
The closest art Konstorum (US 6749560) could not be modified to have the movement from the first articulated profile to the second articulated profile by the insertion of a tool.
Another closest prior art Ishihara (US 20190099062) teaches insertion of a tool through the inner sleeve causes movement from the first articulated profile to the second articulated profile. However, Ishihara does not teach slots that are radially misaligned as shown in FIGS. 15A-15C of the instant application.
Accordingly, claim 6 is allowed.
Claim 10
The prior art of record fails to explicitly teach or fairly suggest, alone or in combination, an endoscope used for insertion into a patient’s body,
wherein the one or more extending elements each comprise a living hinge towards a proximal end of each of the one or more extending elements, wherein the living hinge is configured to flex the inner sleeve upon retraction of the inner sleeve, along with the remaining features of claims 2, and 1.
The closest art Konstorum (US 6749560) could not be modified to have a hinge configured to flex the inner sleeve upon retraction of the inner sleeve.
Accordingly, claim 10 is allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO – 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
05/04/2026
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