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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-15) in the reply filed on 02/03/26 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/03/26.
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 3 & 11 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.
Claims 3 & 11 recites the limitation "the gear train" in line 2 in claims 3 & 11. There is insufficient antecedent basis for this limitation in the claims. It should be changed to --- a gear train ---.
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.
Claims 1-2, 4-10, 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schultz (US 2010/0069834).
Regarding claims 1 & 9, Schultz discloses a steerable medical device 10 in Figs. 1-6 comprising:
an elongate tool 12;
a handle 16 mounted to the tool 12 and having a handle body 20 (Fig. 2A) and a knob 18/24 that is rotatable with respect to the handle body 16; and
a steering assembly 30 comprising at least a first spool 34 housed within the handle body 20 and coupled to the knob 24 (e.g., the first spool 24 is coupled to the knob 24 via a cam device 50), and at least first control wire 35 windable about the first spool 34 and coupled to the tool 12, wherein rotation of the knob 24 with respect to the handle body drives rotation of the first spool, rotation of the first spool causes winding of the first control wire 35 about the first spool to tension the first control wire 35, and tensioning of the first control wire causes deflection of the tool, see Fig. 3B.
Regarding claims 2 & 10, wherein the steering assembly comprises a gear train 50 (Fig. 2) or 50’ (Fig. 5A) coupled between the knob 24 and the first spool 34, to transfer rotation from the knob 24 to the first spool 34. Note: a gear is a rotating machine part typically used to transmit rotational motion. In this case, the cam 50 is a rotating machine part that being used to transmit rotational motion. Therefore, with broadest interpretation, the cam 50 is equivalent to a gear/gear train.
Regarding claims 4 & 12, wherein rotation of the knob 24 with respect to the handle body 20 in a first knob rotational direction (in clock-wise direction, see Fig. 3B) drives rotation of the first spool 34 (a top spool 34 in Fig. 3B) in a first spool rotational direction (e.g., the top spool 34 towards to a right direction, in Fig. 3B) rotation of the first spool 24 in the first spool rotational direction cause winding of the first control wire about the first spool to tension the first control wire, and tensioning of the first control wire causes deflection of the tool in a first deflectional direction (U-shaped in upward direction, in Fig. 3B).
Regarding claims 5 & 13, wherein rotation of the knob 24 with respect to the handle body 20 in a second knob rotational direction (in counter-clockwise direction, in Fig. 3C) drives rotation of the first spool 34 (the top spool 34 in Fig. 3C) in a second spool rotational direction (in Fig. 3C), rotation of the first spool in the second spool rotational direction causes unwinding of the first control wire (the top spool 34 in Fig. 3C) from the first spool to release the tension on the first control wire.
Regarding claims 6 & 14, wherein the steering assembly further comprises a second spool 34 (a bottom spool 34 in Fig. 3B) housed within the handle body 20 and coupled to the knob 24, and a second control wire (a bottom control wire 35, as shown in Fig. 3A) windable about the second spool 34 (the bottom spool 34) and coupled to the tool 12, wherein rotation of the knob 24 with respect to the handle body 20 in the second rotational direction (e.g., the knob 24 towards to a left direction, see Fig. 3C) drives rotation of the second spool (the bottom spool 34) in the second spool rotational direction, rotation of the second spool in the second spool rotational direction cause winding of the second control wire (the bottom control wire 35) about the second spool to tension the second control wire (in Fig. 3C, the bottom control wire 35 is being in tension status), and tensioning of the second control wire causes deflection of the tool in a second deflectional direction (U-shaped in downward direction, in Fig. 3C).
Regarding claims 7 & 15, wherein rotation of the knob 24 with respect to the handle body 20 in the first knob rotational direction (the know 24 in Fig. 3B) drives rotation of the second spool (the bottom spool 35) in the first spool rotational direction (e.g., the top spool 34 towards to a right direction, in Fig. 3B), and rotation of the second spool (bottom spool 35) in the first spool rotational direction cause unwinding of the second control wire from the second spool to release the tension in the second control wire (e.g., the second/bottom control wire 35 is being loosed compare with the first/top control wire 35 in Fig. 3B).
Regarding claim 8, wherein the tool 12 is a sheath, a catheter, or an introducer.
Claims 1-4, 8-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bolduc (US 2016/0193450).
Regarding claims 1 & 9, Bolduc discloses a steerable medical device 10 comprising:
an elongate tool 12;
a handle 14 mounted to the tool 12 and having a handle body 14 and a knob 26 that is rotatable with respect to the handle body, see Fig. 3; and
a steering assembly (located inside the handle 14, see Figs. 8-9) comprising at least a first spool 156 housed within the handle body 14 and coupled to the knob 26, and at least first control wire 30 windable about the first spool 156 and coupled to the tool 12, wherein rotation of the knob with respect to the handle body drives rotation of the first spool, rotation of the first spool causes winding of the first control wire 30 about the first spool to tension the first control wire, and tensioning of the first control wire causes deflection of the too, see Figs. 11 & 13.
Regarding claims 2 & 10, wherein the steering assembly comprises a gear train 146 coupled between the knob 26 and the first spool 156, to transfer rotation from the knob to the first spool.
Regarding claims 3 & 11, as best as understood, wherein the knob 26 comprises an internal gear 140, the first spool 156 comprises a bevel gear 158, and the gear train comprises a planetary gear 146 engaged with the internal gear 140, a sun gear 150 coupled to the planetary gear146, and an additional bevel gear 154 coupled between the sun gear 150 and the bevel gear 158.
Regarding claims 4 & 12, wherein rotation of the knob 26 with respect to the handle body 14 in a first knob rotational direction (counter clock wise direction, Fig. 3) drives rotation of the first spool 159 in a first spool rotational direction, rotation of the first spool in the first spool rotational direction cause winding of the first control wire about the first spool to tension the first control wire, and tensioning of the first control wire causes deflection of the tool in a first deflectional direction, see Fig. 3.
Regarding claim 8, wherein the tool 12 is a sheath, a catheter, or an introducer.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783