DETAILED ACTION
Response to Amendment
This Office Action is responsive to the amendment filed on 07/08/2026. As indicated by the amendment: claims 1-4, 6, 8, 12-13, 16 and 18 have been amended, claims 5, 9-11, 14, 17 and 19-20 have been cancelled, and new claims 21-28 have been added. In response to the cancellation of claims 9 and 17, their rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are rendered moot. Claims 1-4, 6-8, 12-13, 15-16, 18 and 21-28 are presently pending in the application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the hinge must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-4, 6-8 and 22 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.
Amended independent claim 1 recites, in pertinent part, “actuation of the actuator causes movement of an elevator of the medical device elevator”. It is neither clear what constitutes the medical device elevator nor whether the medical device has multiple elevators. Accordingly, the claim is rendered indefinite. Appropriate correction is required. For purposes of examination, the limitation is interpreted as “an elevator of the medical device”.
Claim 1 recites the limitation "the medical device elevator" in fifth line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Dependent claim 7 recites, “wherein the engaging portion is disposed on the surface of the handle body”. However, independent claim 1, from which claim 7 depends, recites, in pertinent part, “wherein an outer surface of the handle body includes an engaging portion having teeth”. It is not clear if “the surface” recited in claim 7 that the engaging portion is disposed on is the same surface as the “outer surface” recited in claim 1 that includes the engaging portion. Accordingly, the claim is rendered indefinite. Appropriate correction is required. For purposes of examination, the engaging portion as recited in claim 7 is interpreted as being disposed on the outer surface, as recited in claim 1.
Regarding claims 18 and 22, the term “approximately perpendicular” is a relative term which renders the claim indefinite. The term “approximately perpendicular” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The degree to which the lateral direction must be perpendicular to the direction that the actuator rotates to acuate the elevator to be considered “approximately” perpendicular is not clear. Accordingly, the claims are rendered indefinite.
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) 12 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Otawara (US 2007/0232857 A1).
Regarding claim 12, Otwara discloses a medical device handle comprising: a handle body (13; Fig. 1), wherein the handle body (13) includes an engaging portion (13h; Fig. 10; par. [0102]-[0104]); and[[:]] an actuator(48; par. [0037]; Fig. 1), actuation of the actuator causes movement of [[the]] an elevator (27; par. [0037]; Fig. 3) of the medical device, of the actuator, a portion of the actuator is aligned with the engaging portion (when 48t is engaged with 13h; Fig. 10; par. [0102]-[0104]) such that movement of the elevator by the actuator is inhibited (Fig. 10 – position of 48 in solid lines; par. [0102]-[0104]), and wherein, in a second configuration of the actuator, the portion of the actuator (48t) an axis, thereby allowing movement of the elevator (Fig. 10 – dashed lines of 48; par. [0102]-[0104]).
Regarding claim 13, Otawara discloses the medical device handle of claim 12, wherein the actuator (48) includes an arm (linear portion of 48b; par. [0063]; Fig. 10), wherein the arm terminates in a contact surface (48a; Fig. 10; par. [0064]) that protrudes radially outward relative to a longitudinal axis of the arm (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.
Claim(s) 1-4, 6-8 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Otawara (US 2007/0232857 A1) in view of Otawara (US 2003/0073955 A1, hereinafter referred to as “Otwara-2”).
Regarding claim 1, Otawara discloses a medical device handle comprising: a handle body (13; Fig. 1); and, [0037]; Fig. 1), actuation of the actuator causes movement of [[the]] an elevator (27; par. [0037]; Fig. 3) of the medical device elevator, wherein the actuator (48) is selectively rotatable about an axis (130; Figs. 6 and 10; par. [0059]), wherein, in a first configuration of the actuator, the [[arm]] actuator (48) is in a fixed position with respect to a surface of the handle body (Fig. 10 – position of 48 in solid lines), wherein, in a second configuration of the actuator, the actuator is movable with respect to the surface of the handle body (Fig. 10 – dashed lines of 48)to allow movement of the elevator (par. [0103]); and wherein an outer surface of the handle body includes an engaging portion (13h; Fig. 10; par. [0102]-[0104]) having a depression, wherein the actuator includes a protrusion (48t; Fig. 10; par. [0102]-[0104]) configured to selectively engage with the depression of the engaging portion (13h; Fig. 10),[[;]] wherein, in the first configuration, engagement depression of the engaging portion (13h) and the protrusion (48t) is configured to inhibit movement of the elevator (par. [0103]).
Although Otawara discloses the engaging portion having a depression that the protrusion of the actuator selectively engages with, it does not specifically disclose the engaging portion having teeth. Otawara-2 teaches an analogous medical device wherein the engaging portion (132a; Fig. 27A; par. [0218]-[0220]) has teeth (132a; Fig. 27A), wherein the actuator (48; Fig. 27B; par. [0218]-[0220]) includes a protrusion (132b; Fig. 27B; par. [0219]) configured to selectively engage with the teeth (132a) of the engaging portion (par. [0218]-[0221]). Otawara-2 teaches that the interaction between the toothed engaging portion (132a) and the protrusion (132b) allows the operator to clearly sense the presence when the elevator enters second elevation range Y (Fig. 27A; par. [0021]) such that the operator can sense when the elevator reaches its maximum elevation position (par. [0220]-[0223]). It would have been obvious to one having ordinary skill in the art to provide an engaging portion with teeth, as taught by Otawara-2, in order to allow the operator to clearly sense when the elevator is beginning to reach its maximum elevation position, as taught by Otawara-2.
Regarding claim 2, Otawara in view of Otawara-2 disclose the medical device handle of claim 1, wherein the actuator (48) includes an arm (linear portion of 48b; par. [0063]; Fig. 10) and a rotating portion (circular portion of 48b secured to the handle by 120; par. [0063]), wherein the arm extends radially outward from the rotating portion (Fig. 10), wherein the arm terminates in a contact surface (48a; Fig. 10; par. [0064]) that protrudes outward relative to a longitudinal axis of the arm.
Regarding claim 3, Otawara in view of Otawara-2 disclose the medical device handle of claim [[2]] 1, wherein the actuator (38) includes a rotating portion (circular portion of 48b secured to the handle by 120; par. [0063]) and an arm (linear portion of 48b; par. [0063]; Fig. 10), wherein the rotating portion is disposed within the handle body (Fig. 2), and wherein the arm is narrower than the rotating portion (Fig. 10).
Regarding claim 4, Otawara in view of Otawara-2 disclose the medical device handle of claim [[1]] 3, wherein the arm terminates in a contact surface (48a; Fig. 10; par. [0064]) that protrudes radially outward relative to a longitudinal axis of the arm (Fig. 10).
Regarding claim 6, Otawara in view of Otawara-2 disclose the medical device handle of claim [[1]] 2, wherein the engaging portion (Otawara-2: 132a) is disposed to a side of the arm of the actuator (Fig. 10; Otawara-2: Fig. 27A).
Regarding claim 7, Otawara in view of Otawara-2 disclose the wherein the engaging portion (Otawara-2: 132a) is disposed on the surface of the handle body, and wherein the engaging portion (Otawara-2: 132a) protrudes radially outward from the surface of the handle body (Otawara-2: Fig. 27A)
Regarding claim 8, Otawara in view of Otawara-2 disclose the medical device handle of claim 7, wherein the actuator (48) is movable from a first end of the surface of the handle body (Fig. 10 – 48 shown in dashed lines; Otwara-2: Fig. 27A – end of X movement range) to a second end of the surface of the handle body (Fig. 10 – 48 shown in solid lines; Otwara-2: Fig. 27A – end of Y movement range), wherein the engaging portion (Otwara-2: 132a) is positioned between the first end and the second end (Otawara-2: 132a is positioned between the end of the X movement range the end of the Y movement range).
Regarding claim 21, Otawara in view of Otawara-2 disclose the medical device handle of claim 1, wherein the actuator (48) is movable in a lateral direction relative to the handle body (lateral relative to the x-axis of the handle body 13; see Fig. 8) to engage or disengage the protrusion from the engaging portion (Figs. 8 and 10).
Claim(s) 15-16 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Otawara, as applied to claim 12 above, in view of Otawara (US 2003/0073955 A1, hereinafter referred to as “Otwara-2”).
Regarding claim 15, Otawara disclose the medical device of claim 12, wherein the engaging portion (13h) is disposed on a surface of the handle body (13; Fig. 10; par. [0102]-[0104]).
Although Otawara discloses the engaging portion having a depression that the protrusion of the actuator engages with, it does not specifically disclose that the engaging portion protrudes radially outward from the surface of the handle body. Otawara-2 teaches an analogous medical device wherein the engaging portion (132a; Fig. 27A; par. [0218]-[0220]) has teeth that protrude radially outward from the surface of the handle body (132a; Fig. 27A), wherein the actuator (48; Fig. 27B; par. [0218]-[0220]) includes a protrusion (132b; Fig. 27B; par. [0219]) configured to selectively engage with the teeth (132a) that protrude radially outward from the surface of the handle body of the engaging portion (par. [0218]-[0221]). Otawara-2 teaches that the interaction between the toothed engaging portion (132a) and the protrusion (132b) allows the operator to clearly sense the presence when the elevator enters second elevation range Y (Fig. 27A; par. [0021]) such that the operator can sense when the elevator reaches its maximum elevation position (par. [0220]-[0223]). It would have been obvious to one having ordinary skill in the art to provide an engaging portion with teeth, as taught by Otawara-2, in order to allow the operator to clearly sense when the elevator is beginning to reach its maximum elevation position, as taught by Otawara-2.
Regarding claim 15, Otawara in view of Otawara-2 disclose the medical device of claim 15, wherein the actuator (48) is movable from a first end of the surface of the handle body (Fig. 10 – 48 shown in dashed lines; Otwara-2: Fig. 27A – end of X movement range) to a second end of the surface of the handle body (Fig. 10 – 48 shown in solid lines; Otwara-2: Fig. 27A – end of Y movement range), wherein the engaging portion (Otwara-2: 132a) is positioned between the first end and the second end (Otawara-2: 132a is positioned between the end of the X movement range the end of the Y movement range).
Regarding claim 27, Otawara in view of Otawara-2 disclose the medical device of claim 12, wherein the engaging portion comprises a plurality of teeth (Otawara-2: 132a; Fig. 27A; par. [0218]-[0220]).
Claim(s) 18 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Otawara (US 2007/0232857 A1) in view of Konstorum (US 2013/0144125 A1).
Regarding claim 18, Otawara discloses medical device handle comprising: a handle body (13; Fig. 1) having an engaging portion (13h; Fig. 10; par. [0102]-[0104]) with a depression (13h); and, actuation of the actuator (48) causes movement of [[the]] an elevator (27; par. [0037]; Fig. 3) of the medical device, wherein the actuator is selectively rotatable about an axis in a rotation direction (130; Figs. 6 and 10; par. [0059]), wherein, in a first configuration, of the actuator (48), a portion of the actuator is aligned with and engages with the depression (13h) of the engaging portion (when 48t is engaged with 13h; Fig. 10; par. [0102]-[0104]), such that rotation of the actuator is inhibited (Fig. 10 – position of 48 in solid lines; par. [0102]-[0104]), and wherein, in a second configuration of the actuator (48), the portion of the actuator is displaced from the engaging portion (48t), such that the actuator is rotatable to move the elevator (Fig. 10 – dashed lines of 48; par. [0102]-[0104])
However, Otawara does not specifically disclose that the engaging portion has teeth and that in the second configuration of the actuator, the portion of the actuator is displaced from the engaging portion in a direction that is approximately perpendicular to the rotation direction. Konstorum teaches an analogous locking mechanism for an medical device having handle body (114; Fig. 12; par. [0051]) having an engaging portion (54; Figs. 5-6; par. [0032]) with teeth (Figs. 5-6 – portions between 58) and that in a movable configuration of an actuator (132; par. [0053]; Fig. 12), the portion of the actuator (46; Fig. 3; par. [0046]) is displaced from the engaging portion (54) in a direction that is approximately perpendicular to the rotation direction, such that the actuator is unlocked and rotatable (par. [0056]). Konstorum teaches that its actuator and engaging portion form a locking mechanism wherein a single finger of a user can be used to unlock engagement between the actuator and engaging portion, actuating/moving the actuator, and re-locking the actuator to the engaging portion (par. [0058]). It would have been obvious to one having ordinary skill in the art to provide the engaging portion and deflecting actuator, taught by Konstorum, to the device of Otawara in order to allow a user to use a single finger to unlock engagement between the actuator and engaging portion, actuating/moving the actuator, and re-locking the actuator to the engaging portion, as taught by Konstorum.
Regarding claim 28, Otawara in view of Konstorum disclose the medical device handle of claim 18, wherein the actuator (Konstorum: 132) includes a pivotable portion (Konstorum: 136; par. [0053]) that is pivotable relative to a remainder of the actuator (Konstorum: 132), and wherein the pivotable portion includes a protrusion (Konstorum: 46; Fig. 3; par. [0046]) configured to engage with the plurality of teeth of the engaging portion.
Allowable Subject Matter
Claim 23, and claims 24-26 depending therefrom, would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Regarding claim 23, the prior art of record does not disclose, or otherwise render obvious, the medical device handle wherein the actuator includes a pivotable portion that is pivotable relative to a remainder of the actuator, and wherein the protrusion is disposed on the pivotable portion, in combination with the other elements of the claim.
Response to Arguments
Applicant’s arguments, see claim amendments and remarks, filed 07/08/2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 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 Otawara and Konstorum, as discussed above.
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
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
8/5/26
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