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 .
Response to Arguments
Applicant's arguments filed 7/21/2026 have been fully considered.
Regarding the objection to the specification, Applicant’s arguments are convincing. The amendment overcomes the objection, and the objection is therefore withdrawn.
Regarding the 103 rejections, Applicant’s arguments are convincing. The amendments to the claims overcome the rejection and the rejection is therefore withdrawn. However, upon further consideration in light of the amendments, a new rejection is made over Takahashi (US 4,203,430).
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) 1-4, 9-14, 19, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takahashi (US 4,203,430).
Regarding claim 1, Takahashi discloses a steerable medical device (fig. 1) comprising: a handle 1 having a handle body and a first control assembly 4 that is movable with respect to the handle body (fig. 1; col. 2, lines 49-50); a first cam 5 housed within the handle body and coupled to the first control assembly (fig. 2; col. 2, lines 54-55), wherein movement of the first control assembly with respect to the handle body drives rotation of the first cam with respect to the handle body (col. 2, lines 55-56); a first slider 6 housed within the handle body (fig. 2), positioned adjacent the first cam and directly engaged by the first cam (fig. 2), wherein rotation of the first cam directly drives translation of the first slider away from the first cam within the handle body (fig. 2; col. 2, lines 53-56); an elongate tool 2 extending from the handle (fig. 1); and a first control wire 12 coupled between the first slider and the tool (fig. 2; col. 2, lines 64-65), whereby translation of the first slider causes tensioning of the first control wire, and tensioning of the first control wire causes deflection of the tool (col. 3, lines 30-33).
Regarding claim 2, Takahashi discloses that the first control assembly comprises a knob 4 assembly that is rotatable with respect to the handle body (fig. 1; col. 2, lines 8-11).
Regarding claim 3, Takahashi discloses that the handle body extends along a handle axis (fig. 1: axis extending left to right of page), and the knob assembly is rotatable about an axis of rotation that is perpendicular to the handle axis (fig. 1: axis of rotation coming out of page perpendicular to handle axis).
Regarding claim 4, Takahashi discloses that the first cam 5 is fixed to the knob assembly (col. 2, lines 53-54).
Regarding claim 9, Takahashi discloses that rotation of the cam in a first rotational direction with respect to the handle body drives translation of the first slider in a first translational direction to cause deflection of the tool in a first deflectional direction (col. 2, lines 53-56; fig. 2); the steerable medical device further comprises a second slider 7 housed within the handle body and coupled to the first cam (fig. 2), and a second control wire 13 coupled between the second slider and the tool (fig. 2), whereby rotation of the first cam in a second rotational direction with respect to the handle body drives translation of the second slider in a second translational direction, and translation of the second slider causes tensioning of the second control wire, and tensioning of the second control wire causes deflection of the tool in a second deflectional direction (fig. 2; col. 2, lines 53-56).
Regarding claim 10, Takahashi discloses that the tool is a sheath (col. 2, line 56: “pipe” is interpreted to be a sheath).
Regarding claim 11, Takahashi discloses a handle 1 for a medical device (fig. 1), the handle comprising: a handle body and a first control assembly 4 that is movable with respect to the handle body (fig. 1); a first cam 5 housed within the handle body and coupled to the first control assembly (fig. 2; col. 2, lines 54-55),wherein movement of the first control assembly with respect to the handle body drives rotation of the first cam with respect to the handle body (fig. 2; col. 2, lines 55-56); a first slider 6 housed within the handle body, positioned adjacent the first cam and directly engaged by the first cam (fig. 2), wherein rotation of the first cam directly drives translation of the first slider away from the first cam within the handle body (fig. 2; col. 2, lines 53-56); and a first control wire 12 coupled to the first slider, whereby translation of the first slider causes tensioning of the first control wire (fig. 2; col. 2, lines 64-65).
Regarding claim 12, Takahashi discloses that the first control assembly comprises a knob assembly that is rotatable with respect to the handle body (col. 2, lines 8-11).
Regarding claim 13, Takahashi discloses that the handle body extends along a handle body axis (fig. 1: axis extends right to left of page), and the knob assembly is rotatable about an axis of rotation that is perpendicular to the handle body axis (fig. 1: rotatable about an axis coming out of the page perpendicular to the handle axis).
Regarding claim 14, Takahashi discloses that the first cam is fixed to the knob assembly (col. 2, lines 53-54).
Regarding claim 19, Takahashi discloses that rotation of the first cam in a first rotational direction with respect to the handle body drives translation of the first slider in a first translational direction (fig. 2; col. 2, lines 63-65); the handle further comprises a second slider 7 housed within the handle body and coupled to the first cam (fig. 2), and a second control wire 13 coupled to the second slider (fig. 2), whereby rotation of the cam in a second rotational direction with respect to the handle body drives translation of the second slider in a second translational direction, and translation of the second slider causes tensioning of the second control wire (fig. 2; col. 2, lines 53-56).
Regarding claim 20, Takahashi discloses a method for operating a medical device, comprising: a. moving a control assembly 4 of a handle 1 of the medical device to drive rotation of a first cam 5 housed within a body of the handle (figs. 1, 2); b. directly driving translation of a first slider 6 away from the first cam by rotation of the first cam (fig. 2; col. 2, lines 53-56), the first slider positioned adjacent the first cam and directly engaged by the first cam (fig. 2); c. tensioning a first control wire 12 by translation of the first slider; and d. deflecting a tool coupled to the handle by tensioning of the first control wire (col. 3, lines 32-33).
Claim(s) 1, 2, 5, 6, 11, 12, 15, 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heinzelman et al (US 5,364,351).
Regarding claim 1, Heinzelman discloses a steerable medical device (fig. 1) comprising: a handle 12 having a handle body and a first control assembly 26 that is movable with respect to the handle body (fig. 2; col. 2, lines 49-50); a first cam 30 housed within the handle body and coupled to the first control assembly (figs. 2, 4; col. 2, line 50), wherein movement of the first control assembly with respect to the handle body drives rotation of the first cam with respect to the handle body (col. 2, lines 60-68); a first slider 32 housed within the handle body (fig. 2), positioned adjacent the first cam and directly engaged by the first cam (fig. 4), wherein rotation of the first cam directly drives translation of the first slider away from the first cam within the handle body (fig. 4; col. 2, lines 65-68); an elongate tool 14 extending from the handle (fig. 1); and a first control wire 56 coupled between the first slider and the tool (figs. 2, 4; col. 3, lines 10-13), whereby translation of the first slider causes tensioning of the first control wire, and tensioning of the first control wire causes deflection of the tool (col. 3, lines 17-20).
Regarding claim 2, Heinzelman discloses that the first control assembly comprises a knob 20 assembly that is rotatable with respect to the handle body (fig. 1; col. 2, lines 50-51).
Regarding claim 5, Heinselman discloses that the first cam is coupled to the first control assembly via a gear train (figs. 2, 5).
Regarding claim 6, Heinzelman discloses that the first cam 30 comprises a first spur gear (fig. 4), and the knob assembly comprises a second spur gear 28 engaged with the first spur gear (fig. 5).
Regarding claim 11, Heinzelman discloses a handle 12 for a medical device (fig. 1), the handle comprising: a handle body and a first control assembly 26 that is movable with respect to the handle body (fig. 2; col. 2, lines 49-50); a first cam 30 housed within the handle body and coupled to the first control assembly (figs. 2, 4; col. 2, line 50),wherein movement of the first control assembly with respect to the handle body drives rotation of the first cam with respect to the handle body (col. 2, lines 60-68); a first slider 32 housed within the handle body (fig. 2), positioned adjacent the first cam and directly engaged by the first cam (fig. 2), wherein rotation of the first cam directly drives translation of the first slider away from the first cam within the handle body (fig. 4; col. 2, lines 65-68); and a first control wire 56 coupled to the first slider (fig. 4), whereby translation of the first slider causes tensioning of the first control wire (col. 3, lines 17-20).
Regarding claim 12, Heinzelman discloses that the first control assembly comprises a knob 20 assembly that is rotatable with respect to the handle body (fig. 1; col. 2, lines 50-51).
Regarding claim 15, Heinselman discloses that the first cam is coupled to the first control assembly via a gear train (figs. 2, 5).
Regarding claim 16, Heinzelman discloses that the first cam 30 comprises a first spur gear (fig. 4), and the knob assembly comprises a second spur gear 28 engaged with the first spur gear (fig. 5).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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