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 Status
Applicant’s Remarks and Amendments filed 30 April 2026 have been entered. Claim 6 is cancelled. Claims 1-5, and 7-20 are pending. Claims 2, 5, 7, 10, 14-15, and 18-20 remain withdrawn.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 11 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1, 8-9, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (US 2021/0052403 A1), “Chu” in view of Ponsky et al. (US 2017/0319324 A1), “Ponsky”.
Regarding claim 1, Chu teaches a stent (Fig. 2A, stent 200), comprising: a midportion (Fig. 2A, body 205) extending along a longitudinal axis (Fig. 2A, longitudinal axis l) between a proximal end (Fig. 2A, proximal end 205p) and a distal end (Fig. 2A, distal end 205d); a distal retention member (Fig. 2A, distal retention member 201) extending distally from the distal end of the midportion (Fig. 2A, distal retention member 201 extends distally from distal end 205d of body 205) and from a proximal end of the distal retention member to a distal end of the distal retention member (Fig. 2A, distal retention member 201 extends from distal end 200d (i.e., distal end of distal retention member) to distal tube 203 (i.e., proximal end of the distal retention member)); a proximal retention member (Fig. 2A, proximal retention member 202) extending proximally from the proximal end of the midportion (Fig. 2A, proximal retention member 202 extends proximally from proximal end 205p of body 205) and from a distal end of the proximal retention member to a proximal end of the proximal retention member (Fig. 2A, proximal retention member 202 extends from proximal tube 204 (i.e., distal end of proximal retention member) to suture 221 (i.e., proximal end of proximal retention member)), but fails to teach wherein the proximal retention member comprises at least one closed loop; an elastic band extending from the proximal end of the proximal retention member and through the at least one closed loop, the elastic band comprising a first portion and a second portion; and a suture looped through the elastic band, wherein the elastic band extends between the at least one closed loop and the suture.
Ponsky teaches a ureteral stent wherein the proximal retention member comprises at least one closed loop (Fig. 19, tether 1056 forms loop between kidney portion 1054 and bladder portion 1052); an elastic band (Fig. 19, bladder portion 1052 comprises elastomer [0051]) extending from the proximal end of the proximal retention member and through the at least one closed loop (Fig. 19, bladder portion 1052 is attached to tether 1056 at second end 1068 and further, both ends of bladder portion 1052 may be eyelets (i.e., comprise a loop) [0079-0080]), the elastic band comprising a first portion and a second portion (Fig. 19, bladder portion 1052 comprises first and second ends 1066, 1068, respectively [0079] (which may both be eyelets [0080])); and a suture looped through the elastic band (Fig. 19, tether 1112 may be a pullout suture and is looped through eyelet 1110 end of bladder portion 1052 [0079]), wherein the elastic band extends between the at least one closed loop and the suture (Fig. 19, bladder portion 1052 is between tether 1056 and tether 1112). Ponsky discloses that the bladder portion comprises a smaller diameter than traditional stents while maintaining the same uncoil force of traditional bladder portions [0076]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Chu with the proximal retention member, elastic band, and suture taught by Polsky in order to increase patient comfort during delivery by providing a smaller, less irritating, stent.
Regarding claim 8, Chu teaches a system comprising: a stent (Fig. 2A, stent 200) having a midportion (Fig. 2A, body 205) extending along a longitudinal axis (Fig. 2A, longitudinal axis l) between a proximal end (Fig. 2A, proximal end 205p) and a distal end (Fig. 2A, distal end 205d), and a proximal retention member (Fig. 2A, proximal retention member 202) extending proximally from the proximal end (Fig. 2A, proximal retention member 202 extends proximally from proximal end 205p of body 205) of the midportion from a distal end of the proximal retention member to a proximal end of the proximal retention member (Fig. 2A, proximal retention member 202 extends from proximal tube 204 (i.e., distal end of proximal retention member) to suture 221 (i.e., proximal end of proximal retention member)); and a tubular member (Fig. 2A, pusher (not shown)) comprising a lumen along a length (Fig. 2A, lumen 206 extends along longitudinal axis l) and a notch (FIG. 2C, first and second apertures 211, 212 form gap) at a distal end of the tubular member (Fig. first and second apertures 211, 212 are at distal tube 203 (pusher (not shown) is layered within)), but fails to teach an elastic band extending about the proximal end of the proximal retention member, the elastic band comprising a first portion and a second portion; a suture looped through the second portion of the elastic band; wherein the proximal retention member comprises at least one closed loop and the elastic band extends between the at least one closed loop and the suture.
Ponksy teaches a ureteral stent comprising an elastic band (Fig. 19, bladder portion 1052 comprises elastomer [0051]) extending about the proximal end of the proximal retention member (Fig. 19, bladder portion 1052 is attached to tether 1056 at second end 1068 and further, both ends of bladder portion 1052 may be eyelets (i.e., comprise a loop) [0079-0080]), the elastic band comprising a first portion and a second portion (Fig. 19, bladder portion 1052 comprises first and second ends 1066, 1068, respectively [0079] (which may both be eyelets [0080])); a suture looped through the second portion of the elastic band (Fig. 19, tether 1112 may be a pullout suture and is looped through eyelet 1110 end of bladder portion 1052 [0079]); wherein the proximal retention member comprises at least one closed loop (Fig. 19, tether 1056 forms loop between kidney portion 1054 and bladder portion 1052) and the elastic band extends between the at least one closed loop and the suture (Fig. 19, bladder portion 1052 is between tether 1056 and tether 1112). Ponsky discloses that the bladder portion comprises a smaller diameter than traditional stents while maintaining the same uncoil force of traditional bladder portions [0076]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Chu with the proximal retention member, elastic band, and suture taught by Polsky in order to increase patient comfort during delivery by providing a smaller, less irritating, stent.
Regarding claim 9, Chu fails to teach the limitations of claim 9. Ponksy teaches a ureteral stent wherein the elastic band extends through the at least one closed loop and the suture (Fig. 19, bladder portion 1052 is attached to tether 1056 at second end 1068 and further, both ends of bladder portion 1052 may be eyelets (i.e., comprise a loop) [0079-0080]). Ponsky discloses that the bladder portion comprises a smaller diameter than traditional stents while maintaining the same uncoil force of traditional bladder portions [0076]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Chu with the proximal retention member, elastic band, and suture taught by Polsky in order to increase patient comfort during delivery by providing a smaller, less irritating, stent.
Regarding claim 11, Chu teaches a notch in the tubular member (Fig. 2C, first and second apertures 211, 212).
Regarding claim 12, Chu teaches a system comprising a guidewire (Fig. 2A, guidewire 220) extending through the lumen of the tubular member (Fig. 2A, guidewire 220 extends through lumen 206 and pusher (not shown)), wherein the tubular member is configured to advance the stent along at least a portion of the guidewire (Fig. 2A, pusher (not shown) distally translates stent within the patient [0009]).
Claims 3-4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (US 2021/0052403 A1), “Chu” in view of Ponsky et al. (US 2017/0319324 A1), “Ponsky”, and further in view of Clayman et al. (US Pat. No. 6849069 B1), “Clayman”.
Regarding claim 3, Chu fails to teach the limitations of claim 3. Ponsky teaches a ureteral stent comprising the second portion of the elastic band and the first portion of the elastic band (Fig. 19, bladder portion 1052 comprises first and second ends 1066, 1068, respectively [0079] (which may both be eyelets [0080])). Ponsky discloses that the bladder portion comprises a smaller diameter than traditional stents while maintaining the same uncoil force of traditional bladder portions [0076]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Chu with the proximal retention member, elastic band, and suture taught by Polsky in order to increase patient comfort during delivery by providing a smaller, less irritating, stent. However, Chu in view of Ponsky fails to teach a shape memory material and a filament.
Clayman teaches a first embodiment of a ureteral stent having a second portion (Fig. 7, portion of thread at point E) of the band (Fig. 7, thread from point C to point E) and the first portion (Fig. 7, portion of thread at point C) of the elastic band (Fig. 7, thread from point C to point E) comprises a filament (Fig. 7, thread from point C to E use a supple monofilament (col. 8, lines 28-30)), but Chu in view of Clayman fails to explicitly teach wherein the second portion of the band comprises a shape-memory material, and that the band is elastic. Clayman discloses that this lower segment of the stent is important to both comfort and function, and allows for considerable tolerance in sizing and length of the stent (col. 8, par. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent system taught by Chu with the elastic band taught by Clayman in order to provide more adjustable sizing of the system from patient to patient.
Clayman further teaches a second embodiment of a tail of a stent that comprises a shape-memory material (Fig. 1, tail 110 has memory such that when a force is removed it is generally straight (col. 6, lines 17-19)). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the material of the second portion of the elastic band to comprise a shape-memory material in order to allow for easy advancement and removal into and out of the body.
Regarding claim 4, Chu fails to teach the limitations of claim 4. Ponsky teaches a ureteral stent comprising the first and second portions of the elastic band (Fig. 19, bladder portion 1052 comprises first and second ends 1066, 1068, respectively [0079] (which may both be eyelets [0080])). Ponsky discloses that the bladder portion comprises a smaller diameter than traditional stents while maintaining the same uncoil force of traditional bladder portions [0076]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Chu with the proximal retention member, elastic band, and suture taught by Polsky in order to increase patient comfort during delivery by providing a smaller, less irritating, stent. However, Chu in view of Ponsky fails to teach a first half of the closed loop and a second half of the closed loop.
Clayman teaches a ureteral stent wherein the first portion of the band (Fig. 7, portion of thread at point C) comprises a first half of a closed loop (Fig. 7A, portion of thread at point C is part of closed loop of thread that extends from point C to point E) and the second portion of the band (Fig. 7, portion of thread at point E) comprises a second half of the closed loop (Fig. 8A, portion of thread at point E is part of closed loop of thread that extends from point C to point E). Clayman discloses that this lower segment of the stent is important to both comfort and function and allows for considerable tolerance in sizing and length of the stent (col. 8, par. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the elastic band taught by Ponsky to reflect the loop of elastic band taught by Clayman in order to provide more adjustable sizing of the system from patient to patient. However, Chu in view of Clayman fails to teach the band is elastic.
Regarding claim 13, Chu teaches a proximal retention member (Fig. 2A, proximal retention member 202), but fails to teach wherein the first portion of the elastic band is slidable with respect to the proximal retention member.
Ponksy teaches a ureteral stent comprising an elastic band (Fig. 19, bladder portion 1052 comprises elastomer [0051]). Ponsky discloses that the bladder portion comprises a smaller diameter than traditional stents while maintaining the same uncoil force of traditional bladder portions [0076]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Chu with the proximal retention member, elastic band, and suture taught by Polsky in order to increase patient comfort during delivery by providing a smaller, less irritating, stent. However, Chu in view of Ponksy fails to teach the elastic band is slidable.
Clayman teaches a ureteral stent wherein the first portion of the band (Fig. 7, portion of thread at point C) is slidable (Fig. 7A, portion of thread at point C can pass smoothly in both directions throughout the instruments used for insertion of the stent (col. 8, par. 2). Clayman discloses that this lower segment of the stent is important to both comfort and function and allows for considerable tolerance in sizing and length of the stent (col. 8, par. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the elastic band taught by Ponksy with the band taught by Clayman in order to provide more adjustable sizing of the system from patient to patient.
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 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.
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/G.G.R./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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