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 .
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.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Que et al. (US 2008/0306503).
Regarding claim 1, an invention relating to occlusive device delivery, Que discloses (Fig. 1A) an embolic device deployment system to place an embolic device at a predetermined site within a vessel (Abstract) comprising: an elongated flexible deployment catheter (30) having a first lumen (36) extending therethrough and having proximal and distal ends (Par. 0030); a notch section (50) disposed in the first lumen of the catheter and forming a second lumen (52); an embolic device (12) having a retaining ring (20) at a proximal end thereof (Par. 0028); an engagement member (60 & 64) partially disposed in the second lumen, comprising: a distal loop (70) extending through the retaining ring; a proximal loop (60) extending into the first lumen; an elongated detachment member (40) being slidably disposed within the first lumen of the deployment catheter and disposed through the proximal and distal loops (Par. 0039), and a clamp (90) removably attached to the proximal end of the deployment catheter (Par.0033); wherein when the elongated detachment member is disposed within the distal loop and the distal loop is disposed within the retaining ring, the embolic device is in an engaged position (Par. 0039), wherein when the elongated detachment member is pulled proximally, the elongated detachment member is withdrawn from the distal loop (Par. 0040), and wherein the clamp prevents movement of the elongated detachment member and the engagement member until the embolic device is to be deployed (Par. 0033). However, Que fails to disclose the elongated detachment member comprising a detachment member bump disposed on the elongated detachment member between the proximal and distal loops; and wherein the detachment member bump contacts the proximal loop and proximally displaces the engagement member to assist in the disengagement of the distal loop from the retaining ring to thereby release the embolic device.
In an alternative embodiment, Que teaches (Fig. 4A) an elongated detachment member (40) comprising a detachment member bump (40a) disposed on the elongated detachment member between proximal and distal loops (60, 70, 76); and wherein the detachment member bump contacts the proximal loop [i.e. contacts element 76 (Fig. 4A)] and proximally displaces the engagement member to assist in the disengagement of the distal loop from the retaining ring to thereby release the embolic device [Note, after the elongated detachment member has been moved proximally to deploy the embolic device, the element 90 can be screwed back on to fixedly secure the elongate releasing member relative to the catheter and pulled proximally to disengage the distal loop from the retaining ring] (Par. 0033 & 0046).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Que to have the elongated detachment member comprising a detachment member bump disposed on the elongated detachment member between the proximal and distal loops; and wherein the detachment member bump contacts the proximal loop and proximally displaces the engagement member to assist in the disengagement of the distal loop from the retaining ring to thereby release the embolic device. Doing so would allow compressive stress to build within the elongate releasing member [i.e. elongated detachment member] without buckling or failing (Par. 0046), as taught by an alternate embodiment of Que.
Regarding claim 2, Que, as modified by the alternate embodiment of Que, discloses the embolic device deployment system as defined in claim 1. Que further discloses wherein the clamp is a Tuohy- Borst clamp (Par. 0033).
Regarding claim 3, Que, as modified by the alternate embodiment of Que, discloses the embolic device deployment system as defined in claim 1. Que further discloses (Fig. 1A) further comprising: a retainer bump (72) disposed on a proximal end of the engagement member outside the second lumen, wherein the retainer bump prevents movement of the engagement member in the distal direction (Par. 0036).
Regarding claim 4, Que, as modified by the alternate embodiment of Que, discloses the embolic device deployment system as defined in claim 3. Que further discloses (Fig. 1A) wherein the retainer bump comprises at least one dimension (see annotated figure below) larger than the second lumen (52).
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Regarding claim 5, Que, as modified by the alternate embodiment of Que, discloses the embolic device deployment system as defined in claim 3. Que further discloses wherein the retainer bump and the detachment member bump are sized to prevent interference with each other [i.e. do not contact each other] (Fig. 4A).
Regarding claim 6, Que, as modified by the alternate embodiment of Que, discloses the embolic device deployment system as defined in claim 1. Que further discloses (Fig. 1A) wherein the embolic device is an embolic coil (14; Par. 0025).
Regarding claim 7, an invention relating to occlusive device delivery, Que discloses (Fig. 1A) an embolic device deployment system to place an embolic device at a predetermined site within a vessel (Abstract) comprising: an elongated flexible deployment catheter (30) having a first lumen (36) extending therethrough and having proximal and distal ends (Par. 0030); a notch section (50) disposed in the first lumen of the catheter and forming a second lumen (52); an embolic device (12) having a retaining ring (20) at a proximal end thereof (Par. 0028); an engagement member (60 & 64) partially disposed in the second lumen, comprising: a distal loop (70) extending through the retaining ring; a proximal loop (60) extending into the first lumen; and an elongated detachment member (40) being slidably disposed within the first lumen of the deployment catheter and disposed through the proximal and distal loops (Par. 0039); wherein when the elongated detachment member is disposed within the distal loop and the distal loop is disposed within the retaining ring, the embolic device is in an engaged position (Par. 0039), wherein when the elongated detachment member is pulled proximally, the elongated detachment member is withdrawn from the distal loop (Par. 0040), and wherein when the elongated detachment member is pulled proximally and completely withdrawn from the deployment system, the engagement member is also completely withdrawn from the deployment system (Par. 0029, 0040, 0053). Que fails disclose the elongated detachment member comprising a detachment member bump disposed on the elongated detachment member between the proximal and distal loops; and wherein the detachment member bump contacts the proximal loop and proximally displaces the engagement member to assist in the disengagement of the distal loop from the retaining ring to thereby release the embolic device.
In an alternative embodiment, Que teaches (Fig. 4A) an elongated detachment member (40) comprising a detachment member bump (40a) disposed on the elongated detachment member between proximal and distal loops (60, 70, 76); and wherein the detachment member bump contacts the proximal loop [i.e. contacts element 76 (Fig. 4A)] and proximally displaces the engagement member to assist in the disengagement of the distal loop from the retaining ring to thereby release the embolic device [Note, after the elongated detachment member has been moved proximally to deploy the embolic device, the element 90 can be screwed back on to fixedly secure the elongate releasing member relative to the catheter and pulled proximally to disengage the distal loop from the retaining ring] (Par. 0033 & 0046).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Que to have the elongated detachment member comprising a detachment member bump disposed on the elongated detachment member between the proximal and distal loops; and wherein the detachment member bump contacts the proximal loop and proximally displaces the engagement member to assist in the disengagement of the distal loop from the retaining ring to thereby release the embolic device. Doing so would allow compressive stress to build within the elongate releasing member [i.e. elongated detachment member] without buckling or failing (Par. 0046), as taught by an alternate embodiment of Que.
Regarding claim 8, Que, as modified by the alternate embodiment of Que, discloses the embolic device deployment system as defined in claim 7. Que discloses (Fig. 1A) further comprising: a retainer bump (72) disposed on a proximal end of the engagement member outside the second lumen, wherein the retainer bump prevents movement of the engagement member in the distal direction (Par. 0036).
Regarding claim 9, Que, as modified by the alternate embodiment of Que, discloses the embolic device deployment system as defined in claim 8. Que further discloses (Fig. 1A) wherein the retainer bump comprises at least one dimension (see annotate figure below) larger than the second lumen (52).
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Regarding claim 10, Que, as modified by the alternate embodiment of Que, discloses the embolic device deployment system as defined in claim 8. Que further discloses wherein the retainer bump and the detachment member bump are sized to prevent interference with each other [i.e. do not contact each other] (Fig. 4A).
Regarding claim 11, Que, as modified by the alternate embodiment of Que, discloses the embolic device deployment system as defined in claim 7. Que further discloses (Fig. 1A) wherein the embolic device is an embolic coil (14; Par. 0025).
Regarding claim 12, Que, as modified by the alternate embodiment of Que, discloses the embolic device deployment system as defined in claim 7. Que further discloses wherein other surgical tools are deployed from the elongated flexible deployment catheter (Par. 0025 & 0027).
Regarding claim 13, an invention relating to occlusive device delivery, Que discloses (Fig. 1A) an embolic device deployment system to place an embolic device at a predetermined site within a vessel (Abstract) comprising: an elongated flexible deployment catheter (30) having a first lumen (36) extending therethrough and having proximal and distal ends (Par. 0030); a notch section (50) disposed in the first lumen of the catheter and forming a second lumen (52); an embolic device (12) having a retaining ring (20) at a proximal end thereof (Par. 0028); an engagement member (60 & 64) partially disposed in the second lumen, comprising: a distal loop (70) extending through the retaining ring; a proximal loop (60) extending into the first lumen; and an elongated detachment member (40) being slidably disposed within the first lumen of the deployment catheter and disposed through the proximal and distal loops (Par. 0039); wherein when the detachment member is disposed within the distal loop and the distal loop is disposed within the retaining ring, the embolic device is in an engaged position (Par. 0039), wherein when the elongated detachment member is pulled proximally, the elongated detachment member is withdrawn from the distal loop (Par. 0040), and wherein the elongated flexible deployment catheter is used to guide a second catheter over an outer surface of the elongated flexible deployment catheter after the embolic device is deployed [Note, the claim is an apparatus claim, and is to be limited by structural limitations. Since the “second catheter” is not positively recited a part of the claimed invention, the limitation constitutes functional claim language, indicating that the claimed device only need claimed structure to be used in such a manner. The Office submits that the device of “Que” meets the structural limitations of the claim, and the “elongated flexible deployment catheter” is structured to “guide a second catheter over an outer surface of the elongated flexible deployment catheter after the embolic device is deployed”]. However, Que fails to disclose the elongated detachment member comprising a detachment member bump disposed on the elongated detachment member between the proximal and distal loops; and wherein the detachment member bump contacts the proximal loop and proximally displaces the engagement member to assist in the disengagement of the distal loop from the retaining ring to thereby release the embolic device.
In the alternative embodiment, Que teaches (Fig. 4A) an elongated detachment member (40) comprising a detachment member bump (40a) disposed on the elongated detachment member between the proximal and distal loops (60, 70, 76); and wherein the detachment member bump contacts the proximal loop [i.e. contacts element 76 (Fig. 4A)] and proximally displaces the engagement member to assist in the disengagement of the distal loop from the retaining ring to thereby release the embolic device [Note, after the elongated detachment member has been moved proximally to deploy the embolic device, the element 90 can be screwed back on to fixedly secure the elongate releasing member relative to the catheter and pulled proximally to disengage the distal loop from the retaining ring] (Par. 0033 & 0046).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Que to have the elongated detachment member comprising a detachment member bump disposed on the elongated detachment member between the proximal and distal loops; and wherein the detachment member bump contacts the proximal loop and proximally displaces the engagement member to assist in the disengagement of the distal loop from the retaining ring to thereby release the embolic device. Doing so would allow compressive stress to build within the elongate releasing member [i.e. elongated detachment member] without buckling or failing (Par. 0046), as taught by an alternate embodiment of Que.
Regarding claim 14, Que, as modified by the alternate embodiment of Que, discloses the embolic device deployment system as defined in claim 13. Que discloses (Fig. 1A) further comprising: a retainer bump (72) disposed on a proximal end of the engagement member outside the second lumen, wherein the retainer bump prevents movement of the engagement member in the distal direction (Par. 0036).
Regarding claim 15, Que, as modified by the alternate embodiment of Que, discloses the embolic device deployment system as defined in claim 14. Que further discloses (Fig. 1A) wherein the retainer bump comprises at least one dimension (see annotated figure below) larger than the second lumen (52).
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Regarding claim 16, Que, as modified by the alternate embodiment of Que, discloses the embolic device deployment system as defined in claim 14. Que further discloses wherein the retainer bump and the detachment member bump are sized to prevent interference with each other [i.e. do not contact each other] (Fig. 4A).
Regarding claim 17, Que, as modified by the alternate embodiment of Que, discloses (Fig. 1A) the embolic device deployment system as defined in claim 13. Que further discloses wherein the embolic device is an embolic coil (14; Par. 0025).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771 /ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 December 24, 2025