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
Election/Restrictions
Applicant’s election without traverse of claims 1-20 and Figs. 33A-33D and 37 in the reply filed on 06/17/2026 is acknowledged. Claims 6, 8, 9 and 17-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Thus, claims 1-5, 7, 10-16 and 20 are presently pending in this application.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show cut-out 316 as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1 and 10 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 10 require the ejection element 205 is configured to grip the implantable expander and to push and pull the implantable expander along the catheter. This is best shown in Fig. 32 where the expander is gripped by the projection 211 forming a jig and gripping the prongs of the expander (par. 0171 of the PGPub). Elected Fig. 37 is directed to a different embodiment of expander 300 which does not include prongs as shown in Fig. 32. It is unclear from the disclosure how the ejection element 205 grips the expander 300 in Fig. 37.
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); 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 is configured to grip the implantable expander and to push and pull the implantable expander with respect to the outer sheath along the catheter (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 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; 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); 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; 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 blocking a verumontanum 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 blocking a 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) 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 blocking a verumontanum 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
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 (MT).
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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