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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed on August 9, 2024 is being considered by the examiner.
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.
Claims 1-6, 8-14 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Joda et al. (US2022/0193367).
Regarding claim 1, Joda discloses a tip bending section of an endoscope, comprising: at least two segments (Fig. 5A: adjacent tubular segments 502 [0062]); and a connecting member arranged between two adjacent segments and fixedly connected with the two adjacent segments (Fig. 5A: adjacent tubular segments 502 are joined by respective ones of connecting segments 504 and 506 [0062]), the connecting member being capable of being bent and deformed to allow the two adjacent segments to be deflected relative to each other (connecting segments 504 and 506 are bent to allow deflection of the deflection region 108, as seen in Fig. 2 and 3 [0075-0076]); a material of the connecting member being different from that of at least one of the two adjacent segments so that bending fatigue-resistant strength of the connecting member is higher than that of the other adjacent segment with different material (bond between the tubular segments 502 and the connecting members 504 and 506 may further be strengthened by adhesives, surface treatments, or other applications that may enhance the bond [0078]; adhesive and/or surface treatments would appear to be different material than the tubular segments 502; In addition, connecting segments 506, 504 function as living hinges [0067], material of living hinges can be relatively soft to minimize the potential for stress-induced failures [0071], compared to the material of tubular segments 502, which are made of a stiffer material [0080]); and/or, the connecting member having a reinforcing structure for improving the bending fatigue-resistant strength of the connecting member (reinforcing members 508 and 510, running through the connecting segments 504 as seen in Fig. 5D, form a reinforcing structure that allow for high-strength joints between the adjacent tubular segments 502 while still maintaining desired flexibility [0078-0079]).
Regarding claim 2, Joda discloses the tip bending section of the endoscope according to claim 1, further disclosing the endoscope comprising a structure reinforcing piece that forms the reinforcing structure and is fixedly engaged with the connecting member (reinforcing member 508 and 510 run through the connecting members 504 and 506, as seen in Fig. 5D, thus is fixedly engaged with the connecting members 504 and 506).
Regarding claim 3, Joda discloses the tip bending section of the endoscope according to claim 2, further disclosing wherein the connecting member and the segments are formed integrally; or, the connecting member and the segments are different parts and are fixedly assembled (connecting segments 504, 506 function as living hinges integrally formed with tubular segments 502 [0067]).
Regarding claim 4, Joda discloses the tip bending section of the endoscope according to claim 2, further disclosing wherein the structure reinforcing piece has a lengthwise direction consistent with an axial direction of the tip bending section (Fig. 5B and 5D: reinforcing member 508 appears to run in a lengthwise, axial direction of the tip bending section, or deflection region 108 [0053])
Regarding claim 5, Joda discloses the tip bending section of the endoscope according to claim 2, further disclosing wherein the connecting members between every two segments of at least three adjacent segments are arranged along an extension axis of the tip bending section (Fig. 5A & 5C: articulation member 404 is formed of multiple tubular segments 502, thus at least three segments 502, with connecting segments 504, 506 between each tubular segment 502, along an extension axis of the articulation member 404; extension axis is analogous to longitudinal axis of the shaft 102 and deflection region 108), the at least three adjacent segments form a codirectional bending section with a same deflection direction (Fig. 2 & 3: catheter 100 is steerable in two directions, A and B [0053], the at least three adjacent segments 502 can deflect in the same direction, direction A or direction B), and the structure reinforcing piece on the codirectional bending section is arranged in a throughout manner on each segment of the codirectional bending section (reinforcing members 508, 510 are embedded within the connecting segments 504, 506, respectively, to strengthen the connections between adjacent tubular segments 502 [0063], highly suggestive that the reinforcing members 508, 510 and the connecting segments 504, 506 are engaged the entire length of the articulation member 404).
Regarding claim 6, Joda discloses the tip bending section of the endoscope according to claim 2, further disclosing wherein the structure reinforcing piece is made of metal, fiber or resin (reinforcing members 508 and 510 may include coils, stranded wire cables, stiffer polymer materials, and other metal or polymer components [0071]).
Regarding claim 8, Joda discloses the tip bending section of the endoscope according to claim 2, further disclosing wherein the structure reinforcing piece is in a form of a single strand or more than two strands (reinforcing member 508, 510 may be a helically round flat ribbon wire, coils, or stranded wire cables [0071]).
Regarding claim 9, Joda discloses the tip bending section of the endoscope according to claim 2, further disclosing wherein the connecting member is provided with a concave portion arranged on an inner wall and/or outer wall of the tip bending section and configured to make a thickness of the connecting member thinner (connecting segments 504 and 506 function as living hinges integrally formed with the tubular segments 502 [0067], living hinges created a plurality of slits 522 and 524 may be concave, substantially V-shaped or U-shaped [0068]; Fig. 5C & 5D: slits 522 and 524 make the connecting segments 504 and 506 on the outer wall of articulation member 404 thinner).
Regarding claim 10, Joda discloses the tip bending section of the endoscope according to claim 9, further disclosing wherein the structure reinforcing piece is exposed in the concave portion and fixedly engaged with a bottom wall of the concave portion (Fig. 5C and 5D: reinforcing members 508 is exposed in the concave section that is the slit 522 and 524; reinforcing members 508, 510 are embedded within the connecting segments 504, 506 [0063], appearing to be fixed to the bottom wall of the slit 522, 524).
Regarding claim 11, Joda discloses the tip bending section of the endoscope according to claim 2, further disclosing wherein the structure reinforcing piece and the connecting member are engaged everywhere along an extension axis of the tip bending section (articulation member 404 includes a pair of reinforcing members 508, 510 extending therethrough, further shown, reinforcing members 508, 510 are embedded within the connecting segments 504, 506, respectively, to strengthen the connections between adjacent tubular segments 502 [0063], highly suggestive that the reinforcing members 508, 510 and the connecting segments 504, 506 are engaged the entire length of the articulation member 404).
Regarding claim 12, Joda discloses the tip bending section of the endoscope according to claim 11, wherein each segment is an integral injection molded part and the structure reinforcing piece is an injection molded embedded piece wrapped in the integral injection molded part (reinforcing members 508, 510 are embedded within tubular segments 502 through direct overmold to form a bond between the tubular segments 502 and the connecting member 504, 506 [0078-0081]; direct overmold is a known manufacturing process that is a multi-step injection molding process wherein a base component, such as the reinforcing member 508, 510, is placed within a mold, wherein the overmold material, in this case, the material of the tubular segments 502, is injected into the mold around the base component, reinforcing members 508, 510, so that the tubular segments 502 can be bonded with the reinforcing members 508, 510, similar to applicant’s claim 12).
Regarding claim 13, Joda discloses the tip bending section of the endoscope according to claim 11, wherein the structure reinforcing piece and the segment are bonded and fixed with the connecting member (reinforcing members 508, 510 are embedded within the tubular segments 502 through direct overmold to form a bond between the tubular segments 502 and the connecting members 504, 506 [0078]).
Regarding claim 14, Joda discloses an endoscope, comprising: a handle for grasping and operating (handle 112); a tip arranged on a terminal of a distal end of the endoscope for illumination and/or imaging (distal end 110); and an insertion tube connected to a distal end of the handle for inserting into an organism (tubular shaft 102 [0053]), the insertion tube comprising a tip bending section (deflection region 108 [0053]) and an extension section (proximal portion 104 [0053]), the tip bending section being arranged between the extension section and the tip (Fig. 1: deflection region 108 is between the proximal portion 104 and distal end 110), the tip bending section being capable of being bent under a control of the handle so as to be capable of controlling a direction of the insertion tube impelled in the organism (steering actuator 118 on the handle 112 may be manipulated by operator to deflect the steerable distal portion 106, deflection region 108 [0056-0057]); wherein the tip bending section is the tip bending section according to claim 1.
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Joda in view of Kohno et al. (US2016/0100748).
Regarding claim 7, Joda discloses the tip bending section of the endoscope according to claim 6. While Joda discloses wherein the structure reinforcing piece is made of one of metal or a polymer, Joda does not further specify any particular metals or polymers, therefore failing to disclose the structure reinforcing piece to be made of one of stainless steel, tungsten, cotton, linen, nylon and PP. In the same field of endeavor, Kohno discloses an endoscope comprising at least two segments (multiple joints 30 [0031]), a connecting member arranged between two adjacent segments and fixedly connected with the two adjacent segments (rounded corners or circular shape that connect the plurality of joint pieces together 30 [0031]), the connecting member being capable of being bent and deformed to allow the two adjacent segments to be deflected relative to each other (by connecting a plurality of joint pieces 30 together so to shift from each other every 90 degrees alternately in the circumferential direction, free end 5b can bend with respect to base 5a [0031]), wherein the connecting member is made from a metal, particularly stainless steel (joint pieces 30 are made from stainless steel [0031]). Since Joda fails to specify a particular type of metal, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any metal typically used in the vertebral endoscope art, including stainless steel as taught by Kohno as the metal material of Joda.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references cited in PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI-TING SONG whose telephone number is (571)272-5771. The examiner can normally be reached 8-5.
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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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/LI-TING SONG/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
2/10/26