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
The rejection of claims 1-3 under 35 U.S.C. 103 as being obvious over Bardsley et al. (US 2020/0229957 A1) in view of Becker (US 10,406,028 B1) has been withdrawn in light of applicant’s amendment made 12/29/2025. Specifically, Becker does not teach wherein a spring is secured to the housing and the bottom surface of the pivotable element adjacent the rear end to normally bias the rear end out of the opening.
Applicant’s arguments with respect to claims 1-6 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference Malecki et al. (US 5,626,607) teaches said limitation.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the housing” in line 4 which should read “the handle housing” for consistency purposes. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Claim 1 recites “its enlarged end” in line 18 which should read “its second enlarged end” for consistency purposes. Appropriate correction is required.
Claims 10-11 are objected to because of the following informalities: Claims 10-11 recite “the housing” in lines 2 and 1, respectively, which should read “the handle housing” for consistency purposes. Appropriate correction is required.
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) 1-3 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bardsley et al. (US 2020/0229957 A1) in view of Malecki et al. (US 5,626,607).
Regarding claim 1, Bardsley discloses a delivery system (Figs. 26A-26B) for an embolic coil (coil implant 80; see for example, Fig. 3), comprising: a hypotube (implant pusher shaft 20) having a distal end (towards implant 80) and a proximal end (away from implant) that is connected to a handle housing (similar to implant release control mechanism 30 of Fig. 1), the hypotube having a lumen extending from the proximal end to the distal end (lumen of 20), wherein the lumen has a first diameter (narrowed diameter) and a widened section that has a second diameter (widened diameter) that is greater than the first diameter (Figs. 26A-26B); a first wire (engagement filament 90) having a proximal end and a distal end (Figs. 26A-26B), with a first enlarged end (322) provided at the proximal end of the first wire (90) and an embolic coil (80) provided at the distal end of the first wire (Fig. 26B); a second wire (engagement wire 40) having a proximal end and a distal end (Figs. 26A-26B), with a second enlarged end (grasping mechanism 320a, 320b) provided at the distal end of the second wire and with the proximal end of the second wire connected to an actuation element (as engagement wire 40 retracts via control mechanism 30, similar to Fig. 1; [0107]); wherein the first wire (90) and its first enlarged end (322) extend inside the lumen of the hypotube (Fig. 26A), and the second wire (40) and its enlarged end (320a, 320b) extend inside the lumen of the hypotube (Fig. 26A), with the first and second enlarged ends engaging each other (Fig. 26A); and wherein the actuation element (control 30) is manipulated to pull the second wire (40) in a proximal direction to cause the first and second enlarged ends to disengage when the first and second enlarged ends are both in the widened section (when the engagement wire 40 retracts proximally, the collapsible grasping mechanism 320a, 320b travels to a portion of the implant pusher shaft lumen where internal space allows the collapsible grasping mechanism to open, thereby releasing 322 and the coil implant; [0107]; Figs. 26A-26B).
Bardsley fails to disclose the handle housing having a pivotable element that has a front end, a rear end, and a bottom surface, wherein the pivotable element extends through an opening in the handle housing, and wherein a spring is secured to the housing and the bottom surface of the pivotable element adjacent the rear end to normally bias the rear end out of the opening, the proximal end of the second wire connected to the front end of the pivotable element, wherein the pivotable element is pivoted against the bias of the spring to pull the second wire in a proximal direction.
However, Malecki teaches a handle housing having (base 462; Fig. 31A) having a pivotable element (handle 460) that has a front end (towards ball opening 458), a rear end (towards free end of handle 460), and a bottom surface (surface facing 462), wherein the pivotable element extends through an opening in the handle housing (as the portion of 460 that includes 458 is within 462; Fig. 31A), and wherein a spring (spring 466) is secured to the housing (462) and the bottom surface of the pivotable element adjacent the rear end (Fig. 31A) to normally bias the rear end out of the opening (i.e. away from 462; column 19, lines 7-10), the proximal end of a wire (cable 442) connected to the front end of the pivotable element (as a second ball end 456 of cable 442 fits within a ball opening 458 on the handle 460; column 19, lines 7-9; Fig. 31A), wherein the pivotable element (460) is pivoted against the bias of the spring to pull the wire in a proximal direction (column 19, lines 14-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle housing of Bardsley to have a pivotable element that has a front end, a rear end, and a bottom surface, wherein the pivotable element extends through an opening in the handle housing, and wherein a spring is secured to the housing and the bottom surface of the pivotable element adjacent the rear end to normally bias the rear end out of the opening, the proximal end of the second wire connected to the front end of the pivotable element, wherein the pivotable element is pivoted against the bias of the spring to pull the second wire in a proximal direction as taught by Malecki. All of the elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of proximally pulling the second wire to cause the first and second enlarged ends to disengage when the first and second enlarged ends are both in the widened section.
Regarding claim 2, Bardsley modified discloses the invention as claimed, and Bardsley further discloses wherein the lumen (lumen of 20) further includes a distal narrowed section (portion with 322, 320a, 320b in Fig. 26A) and a proximal narrowed section (portion proximal widened section; Fig. 26A), with the widened section positioned between the distal narrowed section and the proximal narrowed section (Fig. 26A), and wherein the first (322) and second enlarged ends (320a, 320b) engage each other at the distal narrowed section during delivery of the embolic coil (Fig. 26A).
Regarding claim 3, Bardsley modified discloses the invention as claimed, and Bardsley further discloses wherein the diameter of the lumen at the distal narrowed section gradually decreases from the second diameter adjacent the widened section to the first diameter at the distal end of the hypotube (via distal sloped edges; Fig. 26A), and the diameter of the lumen at the proximal narrowed section gradually decreases from the second diameter adjacent the widened section to the first diameter adjacent the proximal end of the hypotube (via proximal sloped edges; Fig. 26B).
Regarding claim 10, Bardsley modified discloses wherein the pivoting element (460 of Malecki) is pivotably secured inside the housing (at the portion of 460 comprising the ball opening 458; column 19, lines 7-9; Fig. 31A of Malecki) via a connecting pin (pivot 464 of Malecki) that acts as a fulcrum (Fig. 31A of Malecki).
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bardsley et al. (US 2020/0229957 A1) in view of Malecki et al. (US 5,626,607), as applied to claim 1, and further in view of Aboytes et al. (US 10,939,916 B2) in view of Shrivastava et al. (US 2012/0041470 A1).
Regarding claims 4-6, Bardsley modified discloses the invention as claimed, and Bardsley further discloses wherein each of the first and second enlarged ends has a width W (width of 322 and 320a, 320b within narrowed section; Fig. 26A), and wherein the diameter of the lumen at the widened section is greater than 2W (so as to allow 322 to move distally; Figs. 26A-26B).
Bardsley modified fails to disclose the diameter of the lumen at locations other than the widened section is less than 2W, wherein each of the first and second enlarged ends is an olive-shaped end that has a longitudinal dimension and a width, and the longitudinal dimension is greater than the width, and wherein each olive-shaped end has a completely smooth surface.
However, Aboytes teaches a delivery system (insertion device 2854; Fig. 40) comprising hypotube (first elongate member 2856) having a lumen (lumen 2857), a first wire (wire 2868) with a first enlarged ball end (implant ball member 2870) at the proximal end of the first wire and an implant (implant 2810) provided at the distal end of the first wire (Fig. 4), a second wire (second elongate member 2858) with a second enlarged ball end (insertion ball member 2860) provided at the distal end of the second wire and the proximal end of the second wire connected to an actuation element (as the second elongate member 2858 is unlocked and moved distally outside of the first elongate member 2856, un-trapping the implant ball member 2870; column 34, lines 17-23), wherein the first wire (2868) and its first enlarged end (2870) having a width W extend inside the lumen of the hypotube (2856), and the second wire (2858) and its enlarged end (2860) having a width W extend inside the lumen of the hypotube (Fig. 40), with the first and second enlarged ball ends engaging each other (Fig. 40) such that the diameter of the lumen (2857) is less than 2W (Fig. 40); wherein the second wire (2858) is manipulated outside of the hypotube to cause the first and second enlarged ball ends to disengage (as the second elongate member 2858 is unlocked and moved distally outside of the first elongate member 2856, un-trapping the implant ball member 2870; column 34, lines 17-23).
Shrivastava teaches a delivery system (Figs. 29-33) having a least one enlarged ball end with a completely smooth surface (ball 232; Fig. 33) that may be other shapes such as egg-shaped i.e. olive shaped ([0309]). An egg-shaped ball would have a longitudinal dimension and a width, and the longitudinal dimension would be greater than the width.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second enlarged ends of modified Bardsley to be olive-shaped, with a greater longitudinal dimension than a width, and each having a completely smooth surface such that the diameter of the lumen at locations other than the widened section is less than 2W in light of the teachings of Aboytes and Shrivastava. Aboytes teaches it was known in the art to use ball-like enlarged ends as locking means within a lumen that has a diameter less than 2W. Thus, the claim would have been obvious because the substitution of one known element (enlarged ends 322 and 320a, 320b of Bardsley) for another (ball ends of Aboytes) would have yielded the predictable result of locking the enlarged ends together in the narrowed lumen. This modification would result in the diameter of the lumen of Bardsley at locations other than the widened section to be less than 2W. It would have been obvious to one of ordinary skill in the art to change the shape of the enlarged ball ends of modified Bardsley to be olive-shaped ends with completely smooth surfaces in light of the teachings of Shrivastava as a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed enlarged end was significant. In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bardsley et al. (US 2020/0229957 A1) in view of Malecki et al. (US 5,626,607), as applied to claim 1, and further in view of Lee et al. (US 2007/0276430 A1).
Regarding claim 11, Bardsley modified fails to explicitly disclose wherein a roller is provided inside the housing adjacent the front end of the pivoting element to smoothen the movement of the second wire as it is pulled or released.
However, Lee teaches a handle housing having a pivotable element (locking lever 140; Figs. 5-6) that has a front end, a rear end, and a bottom surface (Figs. 5-6), wherein the pivotable element (140) extends through an opening in the handle housing (Figs. 5-6), and wherein a spring (spring 146) is secured to the pivotable element to normally bias the rear end out of the opening ([0070]), the proximal end of a wire (cable 150) connected to the front end of the pivotable element (Figs. 5-6), wherein the pivotable element (140) is pivoted against the bias of the spring to pull the wire in a proximal direction ([0071]), wherein a roller (pulley 152; Fig. 6) is provided inside the housing adjacent the front end of the pivoting element (140) to smoothen the movement of the second wire as it is pulled or released ([0070]; Fig. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle housing of modified Bardsley to include a roller adjacent the front end of the pivoting element as taught by Lee in order to ease the pulling force necessary to retract the second wire.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Newman et al. (US 2019/0369381 A1) is noted for teaching a pivotable element with a spring secured to the bottom surface of the pivotable element (Figs. 9A-9B).
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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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