DETAILED ACTION
Response to Amendment
This Office Action is responsive to the amendment filed on 03/24/2026. As indicated by the amendment: claims 1-2, 4, 6, 12, 14, 16 and 19 have been amended, claims 3, 5, 9-11, 13, 17 and 20 have been cancelled, and new claims 21-26 have been added. In response to the amendments of claims 6 and 12, the rejections of claims 6, 7 and 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn. In response to the cancellation of claim 13, its rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is rendered moot. Claims 1-2, 4, 6-8, 12, 14-16, 18-19 and 21-26 are presently pending in the application.
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.
Claim(s) 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Masubuchi et al. (US 5,460,168 A).
Regarding claim 19, Masubuchi discloses a distal tip of a medical device comprising: an elevator (74; Figs. 24a-24d) having an axle (Fig. 21 – unlabeled axle through 74 and 77) and a body (body of 74); and only one wire (76; Figs. 23-24d) or cable coupled to the elevator (35); wherein proximal or distal movement of the only one wire (76; Figs. 23-24d) or cable causes the elevator to rotate (a) about a longitudinal axis of the axle (Figs. 24a-24d – when elevator 74 is raised) and (b) about a longitudinal axis of the body (Figs. 24a-24d – when elevator 74 is twisted toward 43a/43b; see col. 20, l. 60 – col. 21, l. 29).
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.
Claim(s) 1-2, 4, 8, 12, 14-16, 18, 21-24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tinkham et al. (US 2008/0021269 A1) in view of Geitz et al. (US 2007/0197871 A1).
Regarding claim 1, Tinkham discloses a medical device (10) comprising: a handle (28; Fig. 1; par. [0043]); and a distal tip (14; Fig. 1; par. [0041]), the distal tip (14) including: a housing (Figs. 1, 4 and 7A) defining a cavity (36; par. [0046], [0050] and [0057]), wherein the cavity (36) includes a central portion (central portion of 36) and side portions (opposing sides of 14; Figs. 1 and 7A) on opposite sides of the central portion; an elevator (35; Fig. 4; par. [0046]) including an axle (40; par. [0048] and [0057]-[0059]; Figs. 4, 5, 6A, and 8A-8C), wherein the axle (40) is received within the cavity (36; Fig. 4), wherein the elevator (35) is configured to change an orientation of an accessory device (20; par. [0047]), wherein movement of the axle (40) causes the elevator (35) to rotate about a first axis (one of: angular rotation of 35; Figs. 8A-8D; par. [0059]-[0060] or about axis of 40; Fig. 4; par. [0048]) and a second axis (the other of: about axis of 40; Fig. 4; par. [0048] or angular rotation of 35; Figs. 8A-8D; par. [0059]-[0060]), wherein the first axis differs from the second axis (Figs. 4 and 8C-8D).
Although Tinkham teaches the housing defining a cavity, it does not specifically disclose wherein the side portions have a different width than the central portion. Geitz teaches an analogous medical device (Fig. 1) comprising an analogous housing (14; Figs. 1 and 4A) defining a cavity (40; Fig. 4A) for an elevator (35; Fig. 4A), the cavity (32) comprising side portions (Fig. 7 – side portions bordering the cavity holding the elevator) have a different width than the central portion (Fig. 4a – the side portions have a greater width in the z-direction as they extend to the outer circumference of the housing. The cavity does not extend to the outer circumference of the housing thereby having a smaller width in the housing in the z-direction compared to the side portions). It would have been obvious to one having ordinary skill in the art to make the side portions of the cavity a greater width than the central portion of the cavity, as taught by Geitz, in order contain the elevator and limit its rotation.
Regarding claim 2, Tinkham in view of Geitz disclose the medical device of claim 1, wherein rotation of the elevator (35) about the first axis raises and lowers the elevator (about axis of 40; Fig. 4; par. [0048]), and wherein rotation of the elevator (35) about the second axis moves the elevator about a longitudinal axis of a body of the elevator (angular rotation of 35; Figs. 8A-8D; par. [0059]-[0060]).
Regarding claim 4, Tinkham in view of Geitz disclose the medical device of claim 1, further comprising a first wire (48a; Fig. 6A; par. [0051]) or cable coupled to a first side (46a; par. [0051]; Fig. 6A) of the elevator (35) and a second wire (48b; Fig. 6A; par. [0051]) or cable coupled to a second side (46b; par. [0051]; Fig. 6A) of the elevator (35); wherein movement of the first wire (48a) or cable relative to the second wire (48b) or cable or rotates the elevator (35) about the second axis (par. [0058]-[0060]; Figs. 8C-8D).
Regarding claim 8, Tinkham in view of Geitz disclose the medical device of claim 4. Geitz teaches an analogous device wherein first and second actuators (47/39; Fig. 4D; par. [0051]) are provided on the handle for actuation of elements that move the elevator (35). It would have been obvious to one having ordinary skill in the art to provide first and second actuators on the handle of the medical device for operation by medical personnel, as taught by Geitz, in order to actuate the first and second wires, as contemplated by Tinkham, for movement of the elevator.
Regarding claim 12, Tinkham in view of Geitz disclose the medical device of claim 1, wherein the elevator includes a cylindrical axle. However, Tinkham does not specifically disclose that the axle is biconical. Instead, Tinkham discloses that the axle is cylindrical. At the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to make the axle of Tinkham biconical because Applicant has not disclosed that the biconical axle provides an advantage, is used for a particular purpose, or solves a stated problem. Moreover, Applicant teaches that the axle can have any shape, including cylindrical (see par. [0053] and [0069] of the published specification). One of ordinary skill in the art, furthermore, would have expected Tinkham’s device, and applicant’s invention, to perform equally well with either the axle taught by Tinkham or the claimed biconical axle because both axles would perform the same function of allowing rotation of the elevator about the longitudinal axis of the axle. Therefore, it would have been prima facie obvious to modify Tinkham to obtain the invention as specified in claim 12 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Tinkham.
Regarding claim 14, Tinkham in view of Geitz disclose the medical device of claim 1, axle (42) from translating within the cavity (par. [0051]-[0052] – when 39/41 is locked the axle cannot translate). It would have been obvious to one having ordinary skill in the art to provide rotational movement of the axle without translational movement, as taught by Geitz, in order to precisely control movement of the elevator, and thus surgical instrument, during a medical procedure.
Regarding claim 15, Tinkham in view of Geitz disclose the medical device of claim 14, wherein the cavity is configured to allow ends of the axle (40) to translate within the cavity (Figs. 8A-8C).
Regarding claim 16, Tinkham discloses a medical device (10’) comprising: a distal tip (14; Fig. 1; par. [0034]), the distal tip (14) including an elevator (35; Fig. 4A par. [0043]) configured to change an orientation of an accessory device (20; par. [0043]); and a handle (28; Fig. 1), the handle (28) including actuators (30; Fig. 1; par. [0036]); a first control wire (44; Fig. 6; par. [0052]) or cable, wherein the first control wire or cable is coupled to a first lateral side of the elevator; and a second control wire or cable (36; Fig. 4D; par. [0051]), wherein the second control wire or cable is coupled to a second lateral side of the elevator, wherein a lateral direction is perpendicular to a longitudinal axis of the distal tip.
However, Tinkham does not specifically disclose the medical device comprising a first actuator coupled, directly or indirectly, to the first control wire or cable and a second actuator coupled, directly or indirectly, to the second control wire or cable, wherein each of the first actuator and the second actuator is configured to rotate the elevator about at least one axis. Geitz teaches the medical device comprising a first actuator (47; Fig. 4D; par. [0052]) coupled, directly or indirectly, to a first control wire (44; Fig. 6; par. [0052]) or cable and a second actuator (39; Fig. 4D; par. [0051]) coupled, directly or indirectly, to a second control wire or cable (36 – formed as a metal braid, see par. [0040]; Fig. 4D; par. [0040] and [0051]), wherein each of the first actuator (47) and the second actuator (39) is configured to rotate the elevator (35) about at least one axis (Fig. 6 – rotation by first actuator 47 and Figs. 5A-5B – rotation by second actuator 39). It would have been obvious to one having ordinary skill in the art to provide first and second actuators on the handle of the medical device for operation by medical personnel, as taught by Geitz, in order to actuate the first and second wires or cables, as contemplated by Tinkham, for movement of the elevator.
Regarding claim 18, Tinkham in view of Geitz disclose the medical device of claim 16, wherein each of the first actuator (Geitz: 47) and the second actuator (Geitz: 39) is separately actuatable (Geitz: Fig. 4D; par. [0051]-[0052]).
Regarding claim 21, Tinkham in view of Geitz disclose the medical device of claim 1, wherein the side portions have a greater width than the central portion (Geitz: Fig. 4a – the side portions have a greater width in the z-direction as they extend to the outer circumference of the housing. The cavity does not extend to the outer circumference of the housing thereby having a smaller width in the housing in the z-direction compared to the side portions).
Regarding claim 22, Tinkham in view of Geitz disclose the medical device of claim 21, wherein the width is measured in a direction that is perpendicular to the first axis (Geitz: z-direction), wherein rotation about the first axis raises and lowers the elevator (about axis of 40; Fig. 4; par. [0048]).
Regarding claim 23, Tinkham in view of Geitz disclose the medical device of claim 21, but does not specifically disclose wherein the cavity has an hourglass shape. At the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to make the cavity an hourglass shape because Applicant has not disclosed that the hourglass shape provides an advantage, is used for a particular purpose, or solves a stated problem. Applicant discloses that the cavity may be an hourglass-like shape, may be cylindrical in shape, or may have a shape similar to two frustums joined together at their narrower ends (see par. [0069] of the published application). One of ordinary skill in the art, furthermore, would have expected Tinkham’s device, and applicant's invention, to perform equally well with either the cavity taught by Tinkham or the claimed hourglass shaped cavity because both cavities would perform the same function of containing the elevator. Therefore, it would have been prima facie obvious to modify Tinkham to obtain the invention as specified in claim 23 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Tinkham.
Regarding claim 24, Tinkham in view of Geitz disclose the medical device of claim 21, wherein the axle is cylindrical (40; Fig. 4; par. [0048]).
Regarding claim 26, Tinkham in view of Geitz disclose the medical device of claim 16, wherein joint movement of the first actuator (Geitz: 47) and the second actuator (Geitz: 39) controls movement of the elevator about a first axis (elevator moves about axis of 40; Fig. 4; par. [0048] and about its longitudinal axis).
Allowable Subject Matter
Claims 6-7 and 25 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. Regarding claims 6 and 25, the prior art of record does not specifically disclose, or otherwise render obvious, the medical device further comprising a roll bar disposed within the handle or a shaft extending from the handle to the distal tip, a third wire coupled to the roll bar, and a fourth wire coupled to the roll bar, wherein movement of the third wire is configured to rotate the elevator about the first axis, and wherein movement of the fourth wire is configured to rotate the elevator about the second axis. Neither Tinkham nor Geitz disclose the claimed roll bar and third and fourth wires to control movement of the elevator about the first and second axes. Additionally, although previously cited Hashimoto (see page 7 of the Non-Final Rejection of 01/14/2026) discloses a roll bar (2) for controlling movement of an analogous elevator (9) about two axes, it does not specifically disclose that it is disposed within the handle or a shaft extending from the handle to the distal tip.
Response to Arguments
Applicant's arguments regarding claim 1 filed 03/24/2026 have been fully considered but they are not persuasive. Applicant contends that none of the references alone, or in combination, disclose "a housing defining a cavity, wherein the cavity includes a central portion and side portions on opposite sides of the central portion, wherein the side portions have a different width than the central portion" (see pages 8-9 of the Remarks filed 03/24/2026). The Examiner respectfully disagrees. Applicant has not particularly pointed out how any of the references do not teach the claimed cavity. Moreover, the cavity is as claimed, essentially defines an opening having side walls with a greater width than that of the opening. As discussed above, Geitz teaches the claimed cavity. The Examiner recommends amending the claim to further clarify the structure.
Applicant’s arguments, see claim amendments and Remarks, filed 03/24/2026, with respect to the rejection(s) of claim(s) 16 and 19 each under 35 USC 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tinkham in view of Geitz for claim 16, and Masubuchi for claim 19.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
5/22/26
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