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 .
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.
Claim 14 is 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.
Claim 14 recites the limitation "the jacket". There is insufficient antecedent basis for this limitation in the claim. For the purposes of the written opinion proposed, claim 14 has been analyzed as depending from claim 13 “a jacket”.
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.
Claims 1, 3, 4, 7, 9-12, 15-17, 20 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Matsuo (US 2010/0168519 A1).
Regarding Claim 1, Matsuo discloses an articulating flexible endoscope (abstract) comprising: an elongated member (insertion portion 6, Fig. 1) extending between a distal end (distal end configuration portion 11 provided at the distal end of the insertion portion 6, Fig. 1) and a proximal end (force quantity transmission portion 14 provided at the proximal end of the insertion portion 6, Fig. 1 ), the elongated member comprising: an active bending section (bending portion 12, Fig. 1) steerable by one or more pull wires (bending operation wires 32, Fig. 3; bending operation wires 32 (angle wires) are inserted into the insertion portion 6 such that the first bending portion 12a and the second bending portion 12b of the bending portion 12 are pulled and loosened to be bent from the distal end side, Para [0090]); and a passive section (the curvature transition portion 13 inserted into the body cavity is passively bent, Fig. 1) located between the active bending section and a proximal shaft section (curvature transition portion 13 is located between bending portion 12 and force quantity transmission portion 14, Fig. 1 ), wherein the passive section comprises an anti-prolapse structure (Figs. 3, 4) that determines a minimum bend radius of the passive section thereby preventing prolapse (curvature radius R3, curvature radius R4, Paras. [0113], [0114], [0117], [0118]; the curvature of the first curvature transition portion 13a ... regulate the bending with the larger curvature radius R3, Para [0143], curvature of the second curvature transition portion 13b ... smaller than that of the first curvature transition portion 13a so as to regulate the bending with the larger curvature radius R4, Para [0144], Fig. 16).
Regarding Claim 3, Matsuo discloses the articulating flexible endoscope of claim 1, wherein the proximal end is connected to a proximal portion of the articulating flexible endoscope (operation portion 7 positioned at the proximal end side of the insertion portion 6, Fig. 1) and wherein the proximal portion comprises a driving mechanism for applying a force to the one or more pull wires (bending operation wires 32 are linked with a not shown bending operation mechanism having the proximal end portion formed in the operation portion 7 ... so as to be pulled or loosened alternately, Para [0092], Fig. 1 ).
Regarding Claim 4, Matsuo discloses the articulating flexible endoscope of claim 1, wherein the anti-prolapse structure is integrally formed within the passive section (curvature transition portion 13 is formed of a plurality of curvature regulation pieces (curvature regulation node rings) which are rotatably connected in series, Para [0063]; curvature regulation pieces 23, curvature regulation pieces 24, Fig. 4).
Regarding Claim 7, Matsuo discloses the articulating flexible endoscope of claim 1, wherein the passive section has two or more different minimum bend radii (curvature radius R3, curvature radius R4, Paras. [0113]. [0114]. [0117], [0118], Fig. 10).
Regarding Claim 9, Matsuo discloses the articulating flexible endoscope of claim 1, wherein a minimum bend radius of the active bending section is smaller than the minimum bend radius of the passive section (first bending portion 12a, the second bending portion 12b, the first curvature transition portion 13a and the second curvature transition portion 13b are set such that the respective curvature radii. .. R1<R2<R3<R4, Para (0120], Fig. 10).
Regarding Claim 10, Matsuo discloses the articulating flexible endoscope of claim 9, wherein the active bending section has two or more different minimum bend radii (curvature radius R1, curvature radius R2, Paras [0104], [0105], [0109], [011 OJ, Fig. 10).
Regarding Claim 11, Matsuo discloses the articulating flexible endoscope of claim 1, further comprising one or more coil pipes (coil sheaths 34, Fig. 3) with a distal end anchored to an interface between the passive section and the active bending section (bending operation wires 32 ... where the proximal ends are inserted into a coil sheath 34 from the boundary portion between the second bending portion 12b and the first curvature transition portion 13a, Para [0090], Fig. 3).
Regarding Claim 12, Matsuo discloses the articulating flexible endoscope of claim 11, wherein a proximal end of the one or more coil pipes is anchored to a handle of the articulating flexible endoscope (bending operation wires 32 are linked with a not shown bending operation mechanism having the proximal end portion formed in the operation portion 7, Para [0090], Fig. 1; the proximal end of coil sheath covering bending wires 32 would also be linked with the operation portion 7).
Regarding Claim 15, Matsuo discloses the articulating flexible endoscope of claim 1, wherein the proximal shaft section has a stiffness greater than a stiffness of the passive section (force quantity transmission portion 14 is structured to have ... higher flexural rigidity compared with those of ... the curvature transition portion 13, Para (0089]).
Regarding Claim 16, Matsuo discloses a method (Para [0133]) for preventing prolapse or kink for an articulating flexible endoscope (the curvature of the first curvature transition portion 13a ... regulate the bending with the larger curvature radius R3, Para [0143], curvature of the second curvature transition portion 13b ... smaller than that of the first curvature transition portion 13a so as to regulate the bending with the larger curvature radius R4, Para [0144], Figs. 12-17), the method comprises: providing an elongated member (insertion portion 6, Figs. 1, 12); navigating the articulating flexible endoscope through a passageway (when the force quantity transmission portion 14 grasped by the operator is further pushed deep into the large intestine, Para [0142], Fig. 16) by steering an active bending section of the elongated member via one or more pull wires (bending operation wires 32, Fig. 3; bending operation wires 32 (angle wires) are inserted into the insertion portion 6 such that the first bending portion 12a and the second bending portion 12b of the bending portion 12 are pulled and loosened to be bent from the distal end side, Para [0090]); and providing a passive section (the curvature transition portion 13 inserted into the body cavity is passively bent, Figs. 1, 16) located between the active bending section and a proximal shaft section (curvature transition portion 13 is located between bending portion 12 and force quantity transmission portion 14, Figs. 1, 16), wherein the passive section comprises an anti-prolapse structure (Figs. 3, 4) that determines a minimum bend radius of the passive section thereby preventing prolapse while the articulating flexible endoscope is navigating through the passageway (curvature radius R3, curvature radius R4, Paras. [0113], [0114], [0117], [0118]; the curvature of the first curvature transition portion 13a ... regulate the bending with the larger curvature radius R3, Para [0143], curvature of the second curvature transition portion 13b ... smaller than that of the first curvature transition portion 13a so as to regulate the bending with the larger curvature radius R4, Para [0144], Fig. 16).
Regarding Claim 17, Matsuo discloses the method of claim 16, wherein the anti-prolapse structure is integrally formed within the passive section (curvature transition portion 13 is formed of a plurality of curvature regulation pieces (curvature regulation node rings) which are rotatably connected in series, Para [0063]; curvature regulation pieces 23, curvature regulation pieces 24, Fig. 4).
Regarding Claim 20, Matsuo discloses the method of claim 16, wherein the passive section has two or more different minimum bend radii (curvature radius R3, curvature radius R4, Paras. [0113], [0114], [0117], [0118], Fig. 10).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Matsuo (US 2010/0168519 A1) in view of Romo (WO 2021/127449).
Regarding Claim 2, Matsuo discloses the articulating flexible endoscope of claim 1, wherein the distal end is connected to a distal tip portion of the articulating flexible endoscope (distal end configuration portion 11 provided at the distal end of the insertion portion 6 which has a distal tip portion, Fig. 2) and wherein the distal tip portion comprises a structure to receive an imaging device (observation window 11 a equipped with an observation lens, Fig. 2), and an illumination device (two illumination windows 11 b equipped with the illumination lens), but fails to explicitly disclose a position sensor.
However, Romo is in the field of flexible endoscopes (abstract) and teaches a position sensor (distal tip 105 may be a rigid component that allow for positioning sensors such as electromagnetic (EM) sensors, imaging devices (e.g., camera) and other electronic components (e.g., LED light source) being embedded at the distal tip, Para [0047), Fig.1).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify Matsuo to include the distal tip portion with a position sensor as taught by Romo. The motivation being to provide a visual guide to an operator when driving the bronchoscope towards the target site (Para [0048], Romo).
Claims 5, 6, 8, 18, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Matsuo (US 2010/0168519 A1) in view of Pipe (US 2019/0247622 A1).
Regarding Claim 5, Matsuo discloses the articulating flexible endoscope of claim 4, but fails to explicitly disclose wherein the anti-prolapse structure comprises a cut pattern and the minimum bend radius is determined based at least in part on a gap size of the cut pattern.
However, Pipe is in the field of bend-limited catheters (abstract) and teaches the anti-prolapse structure comprises a cut pattern (cut-out kerf region, Figs. 3, 4A) and the minimum bend radius is determined based at least in part on a gap size of the cut pattern (Para [0139], Fig. 4C; keystone shape, and particularly the kerf width 217, 217' , height of the tooth 220, and the tooth angle 221, may be selected to set the locking bend angle ... and/or the bend radius, Figs. 2A, 28).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the anti-prolapse structure as disclosed by Matsuo with the cut-out pattern as taught by Pipe. The motivation being to provide flexible devices while maintaining stability, preventing kickback and resisting prolapse and kinking (Para [0007], Pipe).
Regarding Claim 6, modified Matsuo discloses the articulating flexible endoscope of claim 5, but fails to explicitly disclose wherein the cut pattern comprises a gap and an interlocking feature.
However, Pipe is in the field of bend-limited catheters (abstract) and teaches the cut pattern comprises a gap (gaps between the keystone features close on the inside of the arc 455 while the gaps increase along the outside of the arc 457, Fig. 4C).and an interlocking feature (pattern of interlocking and alternating teeth 403, Fig. 48).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the anti-prolapse structure as disclosed by Matsuo with the cut-out pattern as taught by Pipe. The motivation being td provide flexible devices while maintaining stability, preventing kickback and resisting prolapse and kinking (Para [0007], Pipe).
Regarding Claim 8, Matsuo discloses the articulating flexible endoscope of claim 7, but fails to explicitly disclose wherein the anti-prolapse structure comprises a cut pattern and wherein the two or more different minimum end radii are determined by selecting different gap sizes and/or selecting different pitches of the cut pattern. •
However, Pipe is in the field of bend-limited catheters (abstract) and teaches the anti-prolapse structure comprises a cut pattern (cut-out kerf region, Figs. 3, 4A) and wherein the two or more different minimum end radii are determined by selecting different gap sizes and/or selecting different pitches of the cut pattern (Para [0025]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the anti-prolapse structure disclosed by Matsuo to with the cut-out pattern wherein the two or more different minimum end radii are determined by selecting different gap sizes and/or selecting different pitches of the cut pattern as taught by Pipe. The motivation being to provide flexible devices while maintaining stability, preventing kickback and resisting prolapse and kinking (Para [0007], Pipe).
Regarding Claim 18, Matsuo discloses the method of claim 16, but fails to explicitly disclose wherein the anti-prolapse structure comprises a cut pattern including repeated gap feature and interlocking feature.
However, Pipe is in the field of bend-limited catheters (abstract) and teaches the anti-prolapse structure comprises a cut pattern (cut-out kerf region, Figs. 3, 4A) including repeated gap feature (gaps between the keystone features close on the inside of the arc 455 while the gaps increase along the outside of the arc 457, Fig. 4C) and interlocking feature (pattern of interlocking and alternating teeth 403, Fig. 48).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the anti-prolapse structure as disclosed by Matsuo with the cut-out pattern as taught by Pipe. The motivation being to provide flexible devices while maintaining stability, preventing kickback and resisting prolapse and kinking (Para [0007], Pipe).
Regarding Claim 19, modified Matsuo discloses the method of claim 18, but fails to explicitly disclose wherein the minimum bend radius is determined based at least in part on a gap size of the gap feature. However, Pipe is in the field of bend-limited catheters (abstract) and teaches the minimum bend radius is determined based at least in part on a gap size of the gap feature (Para [0139], Fig. 4C; keystone shape, and particularly the kerf width 217, 217', height of the tooth 220, and the tooth angle 221, may be selected to set the locking bend angle ... and/or the bend radius, Figs. 2A, 28).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify Matsuo to include the minimum bend radius is determined based at least in part on a gap size of the gap feature as taught by Pipe. The motivation being to provide flexible devices while maintaining stability, preventing kickback and resisting prolapse and kinking (Para [0007], Pipe).
Claims 13, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Matsuo (US 2010/0168519 A1) in view of Poncet (US 2006/0189897 A1).
Regarding Claim 13, Matsuo discloses the articulating flexible endoscope of claim 1, but fails to explicitly disclose further comprising a jacket as an outer layer of the elongated member.
However, Poncet is in the field of guidewires (abstract) and teaches a Jacket as an outer layer of the elongated member (a core 12 upon which is disposed a jacket 14, Fig. 1).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify Matsuo to include a jacket as an outer layer of the elongated member as taught by Poncet. The motivation being to provide flexible endoscope but yet to be able to transmit a linear and/or a rotary force from the proximal end to the distal end in order to navigate to the diseased segment thru anatomic tortuosity (Para [0005], Poncet).
Regarding Claim 14, Matsuo discloses the articulating flexible endoscope of claim 13, but fails to explicitly disclose wherein the jacket comprises multiple layers and has variable stiffness along a length of the jacket.
However, Poncet is in the field of guidewires (abstract) and teaches the jacket comprises multiple layers (the jacket 14 can comprise a single layer that is segmented or can be multilayered, Para [0023]) and has variable stiffness along a length of the jacket (the first segment 16 can have a higher stiffness than the second segment 18, Fig. 1; segments 16 and 18 are formed of different polymeric compositions, Para [0014]).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify Matsuo to include the jacket comprises multiple layers and has variable stiffness along a length of the jacket as taught by Poncet. The motivation being to provide flexible endoscope but yet to be able to transmit a linear and/or a rotary force from the proximal end to the distal end in order to navigate to the diseased segment thru anatomic tortuosity (Para [0005], Poncet).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gyrus (WO 2012/073072 A1), discloses endoscope shaft;
Hoya (US 2021/0393111 A1), discloses method for manufacturing an insertion tube of an endoscope.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YULIN SUN whose telephone number is (571)270-1043. The examiner can normally be reached 10AM - 6PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jay Patel can be reached at 571-272-2988. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YULIN SUN/Primary Examiner, Art Unit 2485