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 .
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.
Election/Restrictions
Applicant’s election without traverse of Species I and A, in the reply filed on 25 March 2026 (“Reply”) is acknowledged.
Claims 7, 8, 17, and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the Reply.
Specification
The disclosure is objected to because of the following informalities: at para. [0029], the last sentence is missing a word.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 9-16, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,456,664, granted to Heinzelman et al. (“Heinzelman”) in view of U.S. Patent No. 5,342,299, granted to Snoke et al. (“Snoke”).
Heinzelman discloses a device substantially as claimed by Applicant, as follows.
Claim 1: A steerable medical device (10; Figs. 1, 2) comprising:
a handle (12) having a handle body (20) and a first control assembly (26) that is movable with respect to the handle body (rotatable);
a first slider (32) housed within the handle body (Fig. 2) and coupled to the first control assembly (via gear train 22, 28, 29, 30), wherein rotation of the first control assembly drives translation of the first slider within the handle body (col. 2, line 62-col. 3, line 11);
an elongate tool (14, 16) extending from the handle (Fig. 1); and
a first control wire (56) coupled between the first slider and the tool (Figs. 2, 4), 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. 2, line 62-col. 3, line 11).
Heinzelman does not, however, describe a first cam housed within the handle body and coupled to the first control assembly, 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.
Snoke relates to pull wire steerable catheters and their handles and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Snoke teaches that the drive train from the user-manipulated control (e.g., Heinzelman’s dial 26) to the pull wires can be constructed to include a cam (413 in Figs. 19 and 20; col. 7, line 67 to col. 8, line 13), in order to create a moment arm that changes depending on the angle of rotation of the dial to which it is attached, thus enabling the practitioner to amplify the force applied to one or more of the pull wires.
It 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, to construct Heinzelman’s pull wire control assembly to include a first cam housed within the handle body and coupled to the first control assembly, 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, because Snoke teaches doing so in a closely-related pull wire steerable catheter’s control handle’s control assembly, in order to create a moment arm that changes depending on the angle of rotation of the dial to which it is attached, thus enabling the practitioner to amplify the force applied to one or more of the pull wires.
Claim 2: (The steerable medical device of claim 1,) wherein the first control assembly comprises a knob assembly (26) that is rotatable with respect to the handle body (col. 2, line 62-col. 3, line 11).
Claim 3: (The steerable medical device of claim 2,) wherein the handle body extends along a handle axis (left-right in Fig. 2), and the knob assembly is rotatable about an axis of rotation that is perpendicular to the handle axis (through 24).
Claim 4: (The steerable medical device of claim 2,) wherein the first cam is fixed to the knob assembly (as implemented into Heinzelman’s pull wire control assembly, Snoke’s cam would be fixed to the knob via the gear train).
Claim 5: (The steerable medical device of claim 2,) wherein the first cam is coupled the first control assembly via a gear train (same).
Claim 6: (The steerable medical device of claim 5,) wherein the first cam comprises a first spur gear, and the knob assembly comprises a second spur gear engaged with the first spur gear (Snoke’s cam, as implemented into Heinzelman’s pull wire control assembly, would be connected to one of the gears 22, 28, 29, and thus can comprise that first spur gear; the next gear in the gear train is the second spur gear).
Claim 9: (The steerable medical device of claim 1,) wherein:
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 (Snoke’s cam, as implemented into Heinzelman’s pull wire control assembly, would rotate with the gear train and thus function as describe in Heinzelman at col. 2, line 62-col. 3, line 11);
the steerable medical device further comprises a second slider housed (34) within the handle body (Fig. 2) and coupled to the first cam (implementing Snoke’s cam into Heinzelman’s pull wire control assembly results in the claimed coupling), and a second control wire (58) 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 (Snoke’s cam, as implemented into Heinzelman’s pull wire control assembly, would rotate with the gear train and thus function as describe in Heinzelman at col. 2, line 62-col. 3, line 11).
Claim 10: (The steerable medical device of claim 1,) wherein the tool is a sheath (guide tube 14), a catheter, or an introducer.
Claim 11: A handle for a medical device (12), the handle comprising:
a handle body (20) and a first control assembly (26) that is movable with respect to the handle body (rotates);
a first cam (Snoke, 413; see explanation above) housed within the handle body and coupled to the first control assembly (see explanation above), 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 (see explanation above);
a first slider (32) housed within the handle body (Fig. 2) and coupled to the first cam (see explanation above), wherein rotation of the first cam drives translation of the first slider within the handle body (see explanation above); and
a first control wire (56) coupled to the first slider (Fig. 5), whereby translation of the first slider causes tensioning of the first control wire (Heinzelman at col. 2, line 62-col. 3, line 11).
Claim 12: (The handle of claim 11,) wherein the first control assembly comprises a knob assembly (26) that is rotatable with respect to the handle body (through 24).
Claim 13: (The handle of claim 12,) wherein the handle body extends along a handle body axis (left-right in Fig. 2), and the knob assembly is rotatable about an axis of rotation that is perpendicular to the handle body axis (through 24).
Claim 14: (The handle of claim 12,) wherein the first cam is fixed to the knob assembly (as implemented into Heinzelman’s pull wire control assembly, Snoke’s cam would be fixed to the knob via the gear train).
Claim 15: (The handle of claim 12,) wherein the first cam is coupled the first control assembly via a gear train (same).
Claim 16: (The handle of claim 15,) wherein the first cam comprises a first spur gear, and the knob assembly comprises a second spur gear engaged with the first spur gear (Snoke’s cam, as implemented into Heinzelman’s pull wire control assembly, would be connected to one of the gears 22, 28, 29, and thus can comprise that first spur gear; the next gear in the gear train is the second spur gear).
Claim 19: (The handle of claim 11,) wherein:
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 (Snoke’s cam, as implemented into Heinzelman’s pull wire control assembly, would rotate with the gear train and thus function as describe in Heinzelman at col. 2, line 62-col. 3, line 11);
the steerable medical device further comprises a second slider housed (34) within the handle body (Fig. 2) and coupled to the first cam (implementing Snoke’s cam into Heinzelman’s pull wire control assembly results in the claimed coupling), and a second control wire (58) 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 (Snoke’s cam, as implemented into Heinzelman’s pull wire control assembly, would rotate with the gear train and thus function as describe in Heinzelman at col. 2, line 62-col. 3, line 11).
Claim 20: A method for operating a medical device, comprising:
a. moving a control assembly of a handle of the medical device to drive rotation of a cam housed within a body of the handle (Snoke’s cam, as implemented into Heinzelman’s pull wire control assembly, would rotate with the gear train and thus function as describe in Heinzelman at col. 2, line 62-col. 3, line 11; see explanations above);
b. driving translation of a first slider by rotation of the cam (same);
c. tensioning a first control wire by translation of the first slider (same); and
d. deflecting a tool coupled to the handle by tensioning of the first control wire (same).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent App. Pub. Nos. 2004/0143283, 2010/0121147, and 2015/0196736 each disclose the use of cams in the handles of pull wire steerable catheters in order to create a moment arm that changes depending on the angle of rotation of the dial to which it is attached, thus enabling the practitioner to amplify the force applied to one or more of the pull wires.
The balance of the documents cited with this Office Action relate generally to the handles of pull wire steerable catheters.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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:// patentcenter.uspto.gov.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 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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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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