DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 09/20/2023.
Election/Restrictions
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Inventions II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/15/2026.
Applicant’s election without traverse of Invention I (claims 1-15) in the reply filed on 01/15/2026 is acknowledged.
Claims 1-15 are pending and examined below.
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, 5, 7, 9, 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 6607496 B1 (hereinafter referred to as “Poor”).
Regarding claim 1, Poor, a steerable guidewire (abstract), teaches a guidewire assembly (abstract) comprising:
a handle assembly (handle 60, 110; column 9, lines 20-29; Figures 10-11) including:
a handle body (main 62, 112; column 9, lines 20-29; Figures 10-11);
a shaft extending through the handle body (66; column 9, lines 20-29; Figures 10-11; 204; column 10, lines 40-58; Figure 12); and
an actuator (64; column 9, lines 20-29; Figures 10-11; 114; column 10, lines 40-58; Figure 12);
a tube extending distally from the handle assembly and including a proximal portion and a distal portion (5; column 5, lines 16-28; as shown in Figures 1-2); and
an interior body extending from the handle assembly through the tube to the distal portion of the tube (14; column 5, lines 16-28; Figures 1-2), wherein the interior body is coupled to the shaft (column 5, lines 16-28; as shown in Figures 1-2);
wherein the shaft is configured to move longitudinally through the handle body as the actuator is rotated to move interior body longitudinally through the tube (column 5, lines 16-28; Figures 1-2; “Thus, rotation of the knob 114 relative to the handle causes longitudinal movement…”; column 10, lines 40-58; Figure 12).
Regarding claim 5, Poor teaches wherein the tube is coupled to the handle assembly at a distal end of the handle assembly (as shown in Figures 1-2).
Regarding claim 7, Poor teaches wherein the actuator is cylindrical and extends longitudinally through a central longitudinal axis of the handle body, and wherein the shaft extends longitudinally through a lumen of the actuator (64; column 9, lines 20-29; Figures 10-11; 114; column 10, lines 40-58; Figure 12).
Regarding claim 9, Poor teaches wherein a distal tip of interior body is coupled to a distal tip portion of the tube.
Regarding claim 11, Poor teaches wherein the interior body is removably coupled to a proximal end of the shaft via a proximal collet and a proximal cap (Figures 10-12).
Regarding claim 12, Poor teaches wherein the actuator includes a helical recess configured to receive a helical protrusion of the shaft (as shown in Figure 12).
Regarding claim 13, Poor teaches wherein the actuator is configured to move the shaft proximally or distally when the actuator is rotated about a central longitudinal axis of the handle assembly (64; column 9, lines 20-29; Figures 10-11; 114; column 10, lines 40-58; Figure 12).
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.
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.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poor as applied to claim 1 above, and further in view of US 20150290432 A1 (hereinafter referred to as “Matthews”).
Regarding claims 2-3, Poor does not explicitly teach wherein a distal portion of the interior body is shape-memory material and wherein the distal portion of the interior body is U-shaped, S-shaped, helical shaped, spiral shaped, and/or includes a one hundred and eighty degree curve in the interior body.
However, Matthews, a guidewire device, teaches wherein a distal portion of the interior body is shape-memory material (abstract) and wherein the distal portion of the interior body is U-shaped, S-shaped, helical shaped, spiral shaped, and/or includes a one hundred and eighty degree curve in the interior body (abstract). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Poor, to be made of shape memory material and be s shaped, as taught by Matthews, because doing so allows for interior body to return to its original configuration.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poor as applied to claim 1 above, and further in view of US 20110152880 A1 (hereinafter referred to as “Alvarez”).
Regarding claim 4, Poor does not explicitly teach wherein the proximal portion of the tube includes a laser cut pattern.
However, Alvarez teaches wherein the proximal portion of the tube includes a laser cut pattern (paragraph [0011). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Poor, to have a laser cut pattern on the tube, taught by Alvarez, because doing so forms a flexible tube.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poor as applied to claim 5 above, and further in view of US 5484419 A (hereinafter referred to as “Fleck”).
Regarding claim 6, Poor does not explicitly teach wherein the tube is removably coupled to the distal end of the handle assembly via a distal cap and a distal collet.
However, Fleck teaches wherein the tube is removably coupled to the distal end of the handle assembly via a distal cap and a distal collet (abstract). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Poor, to have a removable tube, as taught by Fleck, because doing so allows the tube to be replaceable.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poor as applied to claim 7 above, and further in view of US 20150065872 A1 (hereinafter referred to as “Drake”).
Regarding claim 8, Poor does not explicitly teach wherein the handle body includes a cylindrical proximal portion, a distal portion spaced from the proximal portion, and a pair of frame arms coupled to the distal portion and the proximal portion.
Drake, a catheter device, teaches wherein the handle body includes a cylindrical proximal portion, a distal portion spaced from the proximal portion, and a pair of frame arms coupled to the distal portion and the proximal portion (claim 4). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Poor, to have a pair of arms on the handle, as taught by Drake, because doing so allows for an effective griping mechanism.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poor as applied to claim 1 above, and further in view of US 20180326178 A1 (hereinafter referred to as “Moquin”).
Regarding claim 15, Poor does not explicitly teach wherein the tube includes a laser cut pattern with a first degree of pitch in a proximal section of the tube and a second degree of pitch in a distal section of the tube, wherein the second degree of pitch is different from the first degree of pitch, and wherein the interior body includes a slot aligned with the distal section of the tube.
However, Moquin teaches wherein the tube includes a laser cut pattern with a first degree of pitch in a proximal section of the tube and a second degree of pitch in a distal section of the tube, wherein the second degree of pitch is different from the first degree of pitch, and wherein the interior body includes a slot aligned with the distal section of the tube (paragraph [0009]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Poor, to have the laser cut pattern on the tube having different pitches, as taught by Moquin, because doing so provides variable flexibility for the device.
Allowable Subject Matter
Claims 10, and claims dependent thereof (claim 14), 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 claim 10, the prior art fails to teach or suggest “wherein the actuator includes a circular protrusion received by a recess of each of the pair of frame arms.” In combination with all of the limitations of the base claim and any intervening claims.
Conclusion
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/ABID A MUSTANSIR/ Examiner, Art Unit 3791
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