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
Applicant's arguments filed July 8, 2026 have been fully considered but they are not persuasive in view of the rejection set forth below addressing the amendments to the claims.
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.
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Trommeter et al (US 20140039542).
Regarding claim 1, Trommeter et al (hereafter Trommeter) discloses a system for delivering an implant with an apparatus controlling movement of a wire configured to deploy an implant (108), the apparatus comprising: a delivery tube (102) comprising: a distal spring portion, an intermediate flexible portion, and a proximal portion comprising a majority of a length of the delivery tube, a wire (106 or 158) comprising a bump (118 or 154), wherein the wire is configured to deploy the implant upon a proximal retraction of the wire; and a valve (112 or 110) comprising a friction element (116, 150 or 110, 152) configured to apply a friction force to the wire, wherein the friction force varies based on one or more of: a speed at which the wire is pulled through the friction element, a direction in which the wire is pulled through the friction element, and a contact between the bump and the friction element (paragraph 0061-0062), wherein the friction element comprises a block (116, figure 10, when 186a forms a square) configured to move radially with respect to a longitudinal axis of the valve from a first position to a second position (move apart, paragraph 0083), wherein the block when in the first position hinders the wire from moving longitudinally in the valve, and wherein the block when in the second position allows the wire to move longitudinally in the valve (figure 10, paragraph 0083). It further would’ve been obvious to one with ordinary skill in the art at the time of the invention to locate the bump just proximal of a distal end of the wire, since it has been held that rearrangement of the essential ports to modify location (changing the bump to be proximal of the distal end of the wire) involves only routine skill in the art, absent any showing of unexpected results and it appears that the device would perform equally well with either designs. In re Kuhle (1975)
Regarding claim 6, Trommeter discloses all of the limitations set forth in claim 1, wherein the implant (108) is deployed upon the proximal retraction of the wire through a detachment feature (104), the detachment feature being disposed on a proximal end of the implant and configured to receive the wire (figure 6).
Claims 8-10, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Trommeter et al (US 20140039542) in view of LV et al (US 20160302837).
Regarding claim 8, Trommeter et al (hereafter Trommeter) discloses a system for delivering an implant with an apparatus controlling movement of a wire configured to deploy an implant (108), the apparatus comprising: a delivery tube (102) comprising: a distal portion (distal end, paragraph 0063), an intermediate portion, and a proximal portion comprising a majority of a length of the delivery tube (delivery tube inherently has a distal, intermediate and proximal portion since it is an elongated tube), a wire (106 or 158) comprising a bump (118 or 154), wherein the wire is configured to deploy the implant upon a proximal retraction of the wire; and a valve (112 or 110) comprising a friction element (116, 150 or 152) configured to apply a friction force to the wire, wherein the friction force varies based on one or more of: a speed at which the wire is pulled through the friction element, a direction in which the wire is pulled through the friction element, and a contact between the bump and the friction element (paragraph 0061-0062). Trommeter fails to specifically disclose the distal portion is a spring portion and that the intermediate portion is flexible. However, LV et al (hereafter LV) teaches it was well known in the art at the time of the invention for medical delivery tubes to comprise a spring from the intermediate portion to the distal portion (paragraph 0015) with a flexible intermediate portion (221, paragraph 0052) to reach a target site (paragraph 0023). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to also make the delivery tube of Trommeter comprise a flexible spring extending from the intermediate portion to the distal portion, such that the distal portion comprises a spring and the intermediate portion is flexible as taught as known in the art by LV for implant delivery catheters at the time of the invention, in order to allow the delivery tube to more easily reach a target site, since it has been held that since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. In re Leshin, 125 USPQ 416. 10. It furthermore would’ve been obvious to one with ordinary skill in the art at the time of the invention to locate the bump just proximal of a distal end of the wire, since it has been held that rearrangement of the essential ports to modify location (changing the bump to be proximal of the distal end of the wire) involves only routine skill in the art, absent any showing of unexpected results and it appears that the device would perform equally well with either designs. In re Kuhle (1975)
Regarding claim 9, Trommeter in view of LV teaches all of the limitations set forth in claim 8, wherein Trommeter teaches the valve (110) is disposed in the delivery tube (102) proximate a proximal end of the distal portion (figure 2A-2B), and thus the distal spring portion of the device of Trommeter in view of LV.
Regarding claim 10, Trommeter in view of LV teaches all of the limitations set forth in claim 9, wherein the friction element comprises a block (116, figure 10, when 186a forms a square) configured to move radially with respect to a longitudinal axis of the valve from a first position to a second position (move apart, paragraph 0083), wherein the block when in the first position hinders the wire from moving longitudinally in the valve, and wherein the block when in the second position allows the wire to move longitudinally in the valve (figure 10, paragraph 0083).
Regarding claim 15, Trommeter in view of LV teaches all of the limitations set forth in claim 8, wherein Trommeter further teaches the system comprising an implantable coil (126, figures 3A-3B) disposed proximate a distal end of the distal portion, and thus the distal spring portion in the device of Trommeter in view of LV would be configured to deploy the implantable coil distally upon the proximal retraction of the wire (Trommeter, figures 3A-3B).
Regarding claim 16, Trommeter in view of LV teaches all of the limitations set forth in claim 15, wherein Trommeter further teaches a detachment feature (110) disposed on a proximal end of the implantable coil and configured to receive the wire (158), wherein the implantable coil is deployed upon the proximal retraction of the wire through the detachment feature (figure 6).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Trommeter et al (US 20140039542), as applied to claim 2 above, and further in view of Bardsley et al (US 20200229957).
Regarding claims 3 and 4, Trommeter discloses all of the limitations set forth in claim 2, wherein the friction element is configured to resist a sudden movement of the block from the first position to the second position and to allow a gradual movement of the block from the first position to the second position (paragraph 0083, tensile and shear strength of block material properties would allow for this), but does not specifically disclose that a piezoelectric element is configured to resist the sudden movement of the block from the first position to the second position. Bardsley teaches an implant delivery system having an implant release control mechanism utilizing a engagement wire to release an implant (paragraph 0220) comprising a member (1295) configured to move radially with respect to a longitudinal axis of a valve (1291) from a first position to a second position, wherein the member in the first position hinders the wire from moving longitudinally in the valve (figure 120A) and the member in the second position allows the wire to move longitudinally in the valve (figure 120B), wherein it was known in the art at the time of the invention to additionally or alternatively utilize an electrical induced force comprising a piezo electric component (paragraph 0221) to facilitate the implant release. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the friction element further comprise a piezoelectric element to control the release of the implant at the valve, as taught as a known art-recognized equivalent mechanism for implant release valves at the time of the invention by Bardsley, such that the friction element modified by the piezoelectric element resists sudden movement of the block from the first position to the second position and allow controlled gradual movement of the block from the first to the second position, since it has been held that substituting art-recognized equivalents at the time of the invention involves routine skill in the art.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Trommeter et al (US 20140039542) in view of LV et al (US 20160302837), as applied to claim 10 above, and further in view of Bardsley et al (US 20200229957).
Regarding claims 11 and 12, Trommeter in view of LV teaches all of the limitations set forth in claim 10, wherein Trommeter teaches the friction element is configured to resist a sudden movement of the block from the first position to the second position and to allow a gradual movement of the block from the first position to the second position (paragraph 0083, tensile and shear strength of block material properties would allow for this), but does not specifically disclose that a piezoelectric element is configured to resist the sudden movement of the block from the first position to the second position. Bardsley teaches an implant delivery system having an implant release control mechanism utilizing a engagement wire to release an implant (paragraph 0220) comprising a member (1295) configured to move radially with respect to a longitudinal axis of a valve (1291) from a first position to a second position, wherein the member in the first position hinders the wire from moving longitudinally in the valve (figure 120A) and the member in the second position allows the wire to move longitudinally in the valve (figure 120B), wherein it was known in the art at the time of the invention to additionally or alternatively utilize an electrical induced force comprising a piezo electric component (paragraph 0221) to facilitate the implant release. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the friction element of Trommeter in view of LV further comprise a piezoelectric element to control the release of the implant at the valve, as taught as a known art-recognized equivalent mechanism for implant release valves at the time of the invention by Bardsley, such that the friction element modified by the piezoelectric element resists sudden movement of the block from the first position to the second position and allow controlled gradual movement of the block from the first to the second position, since it has been held that substituting art-recognized equivalents at the time of the invention involves routine skill in the art.
Conclusion
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 ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/ Primary Examiner, Art Unit 3771
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