CTNF 18/904,299 CTNF 88249 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 statements (IDS) submitted on 10/02/2024 and 02/26/2026 have been considered by the examiner. The Examiner notes that copies of the Foreign Patent Documents cited in the IDS of 10/02/2024 were submitted in the parent application 17/562,418. Accordingly, they have been considered the by examiner. Claim Rejections - 35 USC § 112 07-30-01 AIA 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 1-12 are 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. Independent claim 1 recites, in pertinent part, (1) a connecting rod rotatably connected to the rotatable member; and (2) wherein the connecting rod consists of a first segment, a second segment, and a third segment, wherein the second segment is disposed between the first segment and the third segment, wherein the first segment is movably coupled to the rotatable member, wherein the third segment is a distal portion of the rotatable member (emphasis added). The claim recites that the first segment of the connecting rod is movably coupled to the rotatable member, a third segment is a distal portion of the rotatable member, and the second segment is disposed between the first segment and second segment. The claim language suggests a configuration wherein both the first and third segments are coupled to the rotatable member. However, such configuration is not disclosed in the specification or drawings. The specification discloses that the first segment is movably coupled to the rotatable member and that the third segment is a distal portion of the connecting rod and is coupled to the plunger (see, for example, Figs. 4A-4B; par. [0068]-[0070] of the specification as originally filed). Additionally, dependent claim 10 recites that the plunger is coupled to the third segment of the connecting rod. Accordingly, the claims fail to comply with the written description requirement. 07-30-02 AIA 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. 07-34-01 Claims 1-12 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. Independent claim 1 recites, in pertinent part, (1) a connecting rod rotatably connected to the rotatable member; and (2) wherein the connecting rod consists of a first segment, a second segment, and a third segment, wherein the second segment is disposed between the first segment and the third segment, wherein the first segment is movably coupled to the rotatable member, wherein the third segment is a distal portion of the rotatable member (emphasis added). The claim recites that the first segment of the connecting rod is movably coupled to the rotatable member, a third segment is a distal portion of the rotatable member, and the second segment is disposed between the first segment and second segment. The claim language recites a configuration wherein both the first and third segments are coupled to the rotatable member. However, such configuration is not disclosed in the specification or drawings. Moreover, it is unclear how the connecting rod can change the position of the distal member if both of its ends are coupled to the rotatable member. Accordingly, the claims are rendered indefinite. Appropriate correction is required. For purposes of examination, the third segment is interpreted to be a distal portion of the connecting rod. Claims 10 and 11, which depend from claim 1, recite that a plunger is coupled to the third segment of the connecting rod. It is unclear how the third segment can be coupled to the second segment at one end, is a distal portion of the rotatable member, and is coupled to the plunger. Accordingly, the claims are rendered indefinite. Appropriate correction is required. For purposes of examination, the third segment is interpreted to be a distal portion of the connecting rod, such that at its distal end it can be connected to the plunger. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1-3 and 5-12 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Morimoto (US 2016/0089125 A1) . Regarding claim 1, Morimoto discloses a linkage assembly (Fig. 5) for a medical device, the linkage assembly comprising: a rotatable member (154; Fig. 5; par. [0095]) configured to rotate about a rotation axis (150; Fig. 5); a connecting rod (92; Fig. 5; par. [ 0080]) rotatably connected to the rotatable member (154) and movable along a range (Fig. 5 – defined by 166a to 166b), wherein a first end of the range (166b) corresponds to an initial position of a distal member (60), wherein the connecting rod (92) consists of a first segment (92-1; see inserted Figure 5), a second segment (92-2; see inserted Figure 5), and a third segment (92-3; see inserted Figure 5), wherein the second segment (92-2) is disposed between the first segment (92-1) and the third segment (92-3), wherein the first segment (92-1) is movably coupled to the rotatable member (154), wherein the third segment (92-3) is a distal portion of the rotatable member (interpreted as connecting rod 92), wherein, in a first configuration of the linkage assembly (Fig. 5 – dashed lines), at the first end of the range (166b), a proximal end of the connecting rod (92; Fig. 5 – dashed lines) is offset from a longitudinal axis (LA) by a first distance (X1; see inserted Figure 5 below), wherein the longitudinal axis (LA) is perpendicular to the rotation axis (150), wherein, in the first configuration, the proximal end of the connecting rod is offset from the longitudinal axis (LA; Fig. 5), and the second segment is transverse to the longitudinal axis (92-2 lies on a plane that crosses LA at an angle); wherein, in a second configuration of the linkage assembly (Fig. 5 – solid lines), at the second end of the range (166a), the proximal end of the connecting rod is offset from the longitudinal axis (LA) by a second distance (X2; see inserted Figure 5 below), wherein the second distance (X2) is less than the first distance (X1; approximately half; see inserted Figure 5 below), the proximal end of the connecting rod is offset from the longitudinal axis of the linkage assembly (LA; Fig. 5), and the second segment is transverse to the longitudinal axis (92-2 lies on a plane that crosses LA at an angle). Regarding claim 2, Morimoto discloses the linkage assembly of claim 1, wherein a mechanical advantage (inverse of less than two-thirds; see par. [0066] of Applicant’s published application) of the linkage assembly is at least 175 percent higher (Fig. 5; 175 percent is between the inverse of one-half or two-thirds) in the second configuration than in the first configuration. Regarding claim 3, Morimoto discloses the linkage assembly of claim 1, wherein the rotatable member is rotatable by a lever (74; Fig. 5) fixed to the rotatable member (154). Regarding claim 5, Morimoto discloses the linkage assembly of claim 3, wherein in the first configuration (166b; Fig. 5 – dashed lines) and the second configuration (166a; Fig. 5 – solid lines), the proximal end of the lever (74) is offset from the longitudinal axis in a first direction (outward direction). Regarding claim 6, Morimoto discloses the linkage assembly of claim 1, wherein the connecting rod (92) is configured to move a control wire (98; Fig. 5) coupled to the distal member (60). Regarding claim 7, Morimoto discloses the linkage assembly of claim 1, wherein the distal member (60) is an elevator (60; Fig. 5) of the medical device. Regarding claim 8, Morimoto discloses the linkage assembly of claim 7, wherein, in the first configuration (166b; Fig. 5 – dashed lines), the elevator (60; Fig. 6 – solid lines) is in a fully lowered configuration, and wherein, in the second configuration (166a; Fig. 5 – solid lines), the elevator (60; Fig. 6 – dashed lines) is in a fully raised configuration. Regarding claim 9, Morimoto discloses the linkage assembly of claim 1, wherein the longitudinal axis (LA) is coaxial with a diameter of the rotatable member that extends through the rotation axis (diameter of 154). Regarding claim 10, Morimoto discloses the linkage assembly of claim 1, further comprising a plunger (96; Fig. 5; par. [0099]) coupled to the third segment (92-3) of the connecting rod (92), wherein movement of the plunger (96) is configured to actuate the distal member (60). Regarding claim 11, Morimoto discloses the linkage assembly of claim 10, wherein the longitudinal axis (LA) is parallel to or coaxial with a direction of the movement of the plunger (96; Fig. 5). Regarding claim 12, Morimoto discloses the linkage assembly of claim 1, wherein a protrusion (155; Fig. 5; par. [0098]) extends radially outward from the rotatable member (154; Fig. 5), and wherein the proximal end of the connecting rod (92) is coupled to the rotatable member (92) via the protrusion (155; Fig. 5) . 07-15-aia AIA Claim(s) 13-20 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Fukushima et al. (US 2015/0148598 A1) . Regarding claim 13, Fukushima discloses a linkage assembly (Fig. 4) for a medical device, the linkage assembly comprising: a rotatable member (41; Fig. 5; par. [0050]-[0051]) configured to rotate about a rotation axis (Fig. 5); a connecting rod (43; Fig. 5; par. [0059]) rotatably connected to the rotatable member (41 via 46; Fig. 5) and movable along a range (55; Fig. 5), wherein a first end of the range (Fig. 7A) corresponds to a first configuration of a distal member (30; Fig. 7A), and a second end of the range (Fig. 7C) corresponds to a second position of a distal member (30; Fig. 7C), wherein the connecting rod (43) consists of a first segment (43-1; see inserted Figure 4), a second segment (43-2; see inserted Figure 4), and a third segment (43-3; see inserted Figure 4), wherein the second segment (43-2) is disposed between the first segment (43-1) and the third segment (43-3), wherein a first angle (Θ1; see inserted Figure 4) between the first segment (43-1) and the second segment (43-2) on a first side of the connecting rod is less than a second angle (Θ2; see inserted Figure 4) between the second segment (43-2) and the third segment (43-3) on the first side of the connecting rod, and wherein the first segment (43-1), the second segment (43-2), and the third segment (43-3) are fixed relative to one another (Figs. 4 and 7A-7C), such that the first angle (Θ1; see inserted Figure 4) is the same in the first configuration (Fig. 7A) and the second configuration (Fig. 7C) and the second angle (Θ2; see inserted Figure 4) is the same in the first configuration (Fig. 7A) and the second configuration (Fig. 7C); wherein, in a first configuration, a proximal end of the connecting rod (43;) is offset from a longitudinal axis (LA) by a first angle (Θ3; see inserted Figure 7A), and wherein the second segment (43-2) is transverse to the longitudinal axis (the angled portion of 43-2 lies on a plane that crosses the longitudinal axis); wherein, in the second configuration, the proximal end of the connecting rod is offset from the longitudinal axis (of 48) by a second angle (Θ4; see inserted Figure 7A), wherein the second angle is greater than the first angle, and wherein the second segment (43-2) is transverse to the longitudinal axis (the angled portion of 43-2 lies on a plane that crosses the longitudinal axis). Regarding claim 14, Fukushima discloses the linkage assembly of claim 13, wherein the rotatable member (41) is rotatable by a lever (20; Fig. 4) fixed to the rotatable member (41), wherein in the first configuration (Fig. 7A), the lever (20) is proximal of the proximal end of the connecting rod (43), and wherein, in the second configuration (Fig. 7C), the lever (20) is distal of the proximal end of the connecting rod (43). Regarding claim 15, Fukushima discloses the linkage assembly of claim 13, wherein the connecting rod (43) is configured to move a control wire (32) coupled to the distal member (30; Figs. 7A-7C). Regarding claim 16, Fukushima discloses the linkage assembly of claim 13, wherein the control wire (32) and the connecting rod (43) are coupled to a plunger (42; Fig. 5; par. [0059]), and wherein the longitudinal axis (LA) is parallel to or coaxial with a direction of movement of the plunger (Figs. 5 and 7A-7C). Regarding claim 17, Fukushima discloses a linkage assembly (Fig. 4) for a medical device, the linkage assembly comprising: a connecting rod (43; Fig. 5; par. [0059]) rotatably connected to the rotatable member (41 via 46; Fig. 5; par. [0050]-[0051]) and a plunger (42; Fig. 5; par. [0059]), wherein the connecting rod (43; Fig. 5) is nonlinear, wherein the rotatable member (41) is configured to rotate about an axis of rotation (Figs. 5 and 7A-7C), wherein, in a first configuration of the linkage assembly (Fig. 7A), a proximal end of the connecting rod (43) is offset from a longitudinal axis of the plunger by approximately 70 degrees (Θ5; see inserted Figure 7A), wherein, in the first configuration (Fig. 7A), the plunger (42) is in a distalmost position relative to the rotatable member (41), wherein, in a second configuration of the linkage assembly (Fig. 7C), the proximal end of the connecting rod (43) is offset from the longitudinal axis, wherein, in the second configuration (Fig. 7C), the plunger (42) is in a proximalmost position relative to the rotatable member (41). Regarding claim 18, Fukushima discloses the linkage assembly of claim 17, wherein the connecting rod (43) is configured to move a control wire (32) coupled to the plunger (42; Figs. 7A-7C). Regarding claim 19, Fukushima discloses the linkage assembly of claim 17, wherein the rotatable member (41) is rotatable by a lever (20; Figs. 7A-7C) fixed to the rotatable member (41) and wherein, in the first configuration (Fig. 7A), the lever (20) is proximal of the proximal end of the connecting rod (43), and in the second configuration (Fig. 7C), the lever (a portion of 20) is distal of the proximal end of the connecting rod (43). Regarding claim 20, Fukushima discloses the linkage assembly of claim 17, wherein the rotatable member (41) includes a protrusion (48; Figs. 7A-7C), and wherein the proximal end of the connecting rod (43) is coupled to the rotatable member (41) via the protrusion (43; Figs. 7A-7C) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morimoto, as applied to claim 3 above, in view of Fukushima et al. (US 2015/0148598 A1) . Regarding claim 4, Morimoto discloses the linkage assembly of claim 3, wherein, in the first configuration (at 166b; Fig. 5 – dashed lines), the lever (74) is proximal of the proximal end of the connecting rod (92), but does not specifically disclose in the second configuration, the lever is distal of the proximal end of the connecting rod. Fukushima teaches an analogous linkage assembly wherein, in the first configuration (Fig. 7A), the lever (20) is proximal of the proximal end of the connecting rod (43), and in the second configuration (Fig. 7C), the lever (a portion of 20) is distal of the proximal end of the connecting rod (43). It would have been obvious to one having ordinary skill in the art to modify the linkage assembly with the positioning of the lever, rotatable member, connecting rod and distal member taught by Fukushima as a simple substitution of one known linkage assembly configuration for erecting a distal member for another, having the predictable result of deflecting an instrument inserted in the endoscope with the distal member. Inserted Image: Figure 5 of Morimoto [AltContent: arrow] PNG media_image1.png 744 480 media_image1.png Greyscale Inserted Image: Figure 4 of Fukushima PNG media_image2.png 520 699 media_image2.png Greyscale Inserted Image: Figure 7A of Fukushima [AltContent: arrow] PNG media_image3.png 239 478 media_image3.png Greyscale Inserted Image: Figure 7C of Fukushima PNG media_image4.png 240 456 media_image4.png Greyscale Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYNAE E BOLER whose telephone number is (571)270-3620. The examiner can normally be reached Mon - Fri 9:00-5:00. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /RYNAE E BOLER/Examiner, Art Unit 3795 /ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795, 4/24/26 Application/Control Number: 18/904,299 Page 2 Art Unit: 3795 Application/Control Number: 18/904,299 Page 3 Art Unit: 3795 Application/Control Number: 18/904,299 Page 4 Art Unit: 3795 Application/Control Number: 18/904,299 Page 5 Art Unit: 3795 Application/Control Number: 18/904,299 Page 6 Art Unit: 3795 Application/Control Number: 18/904,299 Page 7 Art Unit: 3795 Application/Control Number: 18/904,299 Page 8 Art Unit: 3795 Application/Control Number: 18/904,299 Page 9 Art Unit: 3795 Application/Control Number: 18/904,299 Page 10 Art Unit: 3795 Application/Control Number: 18/904,299 Page 11 Art Unit: 3795 Application/Control Number: 18/904,299 Page 12 Art Unit: 3795 Application/Control Number: 18/904,299 Page 13 Art Unit: 3795 Application/Control Number: 18/904,299 Page 14 Art Unit: 3795
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