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 .
DETAILED ACTION
Status of Claims
This office action is responsive to the amendment filed on 08/26/2026. As directed by the amendment: Thus, claims 1-5, 7, 10-16 and 20 are presently pending in this application.
Response to Arguments
Applicant's arguments with respect to claims 1-5, 7, 10-16 and 20 rejected under 35 U.S.C. 103 as being unpatentable over Dwyer et al. (6395017) “Dwyer” in view of Chao et al. (2015/0257908) “Chao” have been fully considered but they are not persuasive.
Applicants argue on page 8 of the response that Dwyer in view of Chao fails to disclose the newly amended limitations “the ejection element comprises a head that is configured to grip a proximal end portion of the wire of the implantable expander and to push and pull the implantable expander along the catheter to effect movement of the implantable expander distally and proximally with respect to the outer sheath; wherein the implantable expander is configured for deployment in the urethra without blocking a verumontanum”. This is not found to be persuasive since Dwyer discloses an ejection element 36 having a head 40 which grips the end portion of the wire 42 of the implantable expander 12 using projections or jigs 38 (Fig. 7-8). The structure of Dwyer is similar to the ejection element of the instant application where the ejection element 205 comprises a head 210 with projection 211 forming jigs that engage the curved wire prongs of the expander.
Furthermore, the structure of Dwyer comprises the implantable expander having a wire configured for adjustment between a delivery orientation and a radially expanded orientation configured for dilating an anatomy (Figs. 7-8 and col. 1, lin. 23-26) and Chao is relied on for the teaching of deploying an implantable expander in a urethra between a bladder neck and an external sphincter (Fig. 1B). The combination of the catheter and outer sheath structure of Dwyer when combined with the implantation location in the urethra between a bladder neck and an external sphincter is fully capable of performing the intended use of not blocking the verumontanum. Therefore, Dwyer in view of Chao discloses the claimed invention of claims 1 and 10 including the newly amended limitations.
Rejection under 112 (a) of claims 1 and 10 has been withdrawn.
The objections to the drawings have been withdrawn
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 1-5, 7, 10-16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dwyer et al. (6395017) “Dwyer” in view of Chao et al. (2015/0257908) “Chao”.
Regarding claims 1, 2, 10, 14-15 and 20, Dwyer discloses a catheter (abstract and delivery device shown in Fig. 3) configured for deploying an implantable expander 4 (Figs. 1, 8 and 10A-C disclose implant assembly 4 having a graft 8 and anchors 10/12), the catheter comprising: an outer sheath 22 (Figs. 10A-10C), a distal end configured to receive an implantable expander (distal end of pod 23 which engages expander 26; Figs. 3-5); wherein the implantable expander comprises a wire configured for adjustment between a delivery orientation and a radially expanded orientation configured for dilating a urethra (the implantable expander is not positively recited and is only configured to be deployed by the catheter; furthermore, Dwyer discloses an implantable expander 12 comprising a wire; Fig. 8) and an ejection element 36 configured to engage the implantable expander 4 during placement of the implantable expander (Fig. 7-9 disclose the ejection element 36 includes spokes 38 that engage the expander anchor 12 at bends 42); wherein the ejection element 36 comprises a head 40 that is configured to grip a proximal end portion of the wire of the implantable expander (Fig. 8 discloses the head 40 grips the curved wire end portion 42 of the expander 12 via spokes 38) and to push and pull the implantable expander with respect to the outer sheath along the catheter to effect movement of the implantable expander distally and proximally with respect to the outer sheath (Fig. 7-9 disclose the ejection element 36 includes spokes 38 that engage the expander anchor 12 at bends 42 and col. 6, lin. 64-67 disclose the implant can be repositioned by repeating the deployment process and col. 7, lin. 9-20 disclose the implant can be moved back and forth within the sheath to reposition if needed); wherein the implantable expander is configured for deployment in the anatomy (the implantable expander 12 is fully capable of performing this intended use; furthermore the implantable expander is not positively recited);
wherein the outer sheath is configured to be advanced along the anatomy until the distal end is located within the anatomy when the implantable expander is engaged by the ejection element within the outer sheath (Figs. 5 and 10A-10C and col. 7, lin. 21-33 disclose the outer sheath is advanced along an artery and deploys the implant engaged by ejection element 36), wherein the outer sheath is configured to be withdrawn and to facilitate withdrawal thereby allowing the implantable expander to expand in the anatomy (Figs 10B-10C).
Dwyer is silent regarding a catheter configured for deploying an implantable expander in a prostatic urethra thereby allowing the implantable expander to expand in the prostatic urethra between a bladder neck and an external sphincter without blocking the verumontanum; a cystoscope configured to illuminate and image a part of the urethra at the distal end of the catheter and further comprising a balloon configured to facilitate expansion of the implantable expander in the prostatic urethra; wherein the balloon is configured to deploy at, or proximal to, a bladder neck. However, Chao teaches a similar catheter 210 (Fig. 16 and par. 0083) configured for deploying an implantable expander 150A/B (par. 0083) in a prostatic urethra thereby allowing the implantable expander to expand in the prostatic urethra (abstract and par. 0009) between a bladder neck and an external sphincter without blocking the verumontanum (Fig 1B and Fig. 6 disclose the structure of the expander is fully capable of being implanted in a way that is configured to perform the intended use of being configured to effect in-situ dilation of the prostatic urethra without blocking a verumontanum); a cystoscope configured to illuminate and image a part of the urethra at the distal end of the catheter (pars. 0030 and 0083 discloses a cystoscope visualization system) and further comprising a balloon configured to facilitate expansion of the implantable expander in the prostatic urethra wherein the balloon is configured to deploy at, or proximal to, a bladder neck (pars. 0029 and 0030; 1B).
Therefore, 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 catheter in Dwyer to include a catheter configured for deploying an implantable expander in a prostatic urethra thereby allowing the implantable expander to expand in the prostatic urethra between a bladder neck and an external sphincter without blocking the verumontanum; a cystoscope configured to illuminate and image a part of the urethra at the distal end of the catheter and further comprising a balloon configured to facilitate expansion of the implantable expander in the prostatic urethra; wherein the balloon is configured to deploy at, or proximal to, a bladder neck, as taught and suggested by Chao, for providing relief from urinary retention (par. 0002); facilitating the expansion of the expander and providing visualization while implanting the expander to ensure proper anatomic positioning of the expander (par. 0030).
Regarding claim 3, Dwyer further comprising a handle 20 (Fig. 11) that is operably coupled to the ejection element 36 and is configured for placement of the implantable expander within the urethra (the handle 20 is coupled to positioning tube 24 which is coupled to ejection element 36; Figs. 8 and 15).
Regarding claim 4, Dwyer in view of Chao discloses the claimed invention of claim 1; Chao further discloses wherein the implantable expander is configured to fit within the urethra between a bladder neck and an external sphincter (Fig. 1B). Furthermore, the structure of the expanders in Dwyer and Chao are fully capable of performing this intended use.
Regarding claims 5, 7, 13 and 16, Dwyer in view of Chao discloses the claimed invention of claim 1; wherein Dwyer discloses the implantable expander 4 is configured to exert an outward radial force; further comprising a radially expansible member configured to facilitate expansion of the implantable expander and wherein the implantable expander is configured to be resiliently deformable from a relaxed radially expanded configuration to a radially contracted configuration (col. 2, lin. 13-17) and Chao discloses an expander placed against the urethra for delivery through the prostatic urethra (abstract of Chao).
Regarding claims 11-12, Dwyer in view of Chao discloses the claimed invention of claim 10; except for wherein the implantable expander is configured to effect in-situ dilation of the prostatic urethra without impinging the verumontanum to thereby avoid blocking an ejaculatory duct or a prostatic duct and wherein the implantable expander is configured for treatment of benign prostatic hyperplasia (BPH). However, Chao teaches a similar expander configured to effect in-situ dilation of the prostatic urethra without impinging the verumontanum to thereby avoid blocking an ejaculatory duct or a prostatic duct (Fig 1B and Fig. 6 disclose the structure of the expander is fully capable of being implanted in a way that is configured to perform the intended use of being configured to effect in-situ dilation of the prostatic urethra without impinging the verumontanum) and wherein the implantable expander is configured for treatment of benign prostatic hyperplasia (BPH) (par. 0002). Therefore, 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 expander in Dwyer to include wherein the implantable expander is configured to effect in-situ dilation of the prostatic urethra without impinging the verumontanum to thereby avoid blocking an ejaculatory duct or a prostatic duct and wherein the implantable expander is configured for treatment of benign prostatic hyperplasia (BPH), as taught and suggested by Chao, for providing relief from urinary retention while facilitating the invagination of the tissue wall (pars. 0002 and 0014).
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri. If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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