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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2 December 2025 has been entered.
Claim Status
Applicant’s Remarks and Amendments filed 10 November 2025 have been entered. Claims 1-20 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 Claims 2, 5, 7, 10, 14-15, and 18-20 remain withdrawn.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 interpretation 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, 3-4, 6, 8-9 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (US 2021/0052403 A1), “Chu” in view of Clayman et al. (US Pat. No. 6849069 B1), “Clayman” and further in view of Pendleton et al. (US 20150223953 A1), “Pendleton”.
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 and, an elastic band extending from the proximal end of the proximal retention member, the elastic band comprising a first portion and a second portion; and a suture looped through the elastic band.
Clayman teaches a ureteral stent wherein the proximal retention member comprises at least one closed loop (Fig. 7, thread from point C to point E forms a closed loop), and a band (Fig. 7, thread from point C to point E on left and right side of the loop form bands that are loops) extending from the proximal end of the proximal retention member (Fig. 7, 7A, threads forming left and right side loops/bands are attached at point C), the band comprising a first portion (Fig. 7, left side loop/band of thread from point C to point E) and a second portion (Fig. 7, right side loop/band of thread from point C to point E); and a suture looped through the band (Figs. 7 and 8A, thread 830 is looped through thread at 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 combine the stent system taught by Chu with the 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 that the band is elastic.
Pendleton teaches a telescoping ureteral stent having an elastic band (Fig. 1, flexible member 120 may be a monofilament [0071] (i.e., nylon band which is elastic)). Pendleton discloses that the flexible member may be made from another material that is strong in tension when at a very-small cross-section [0071]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the material of the band taught by Clayman to be an elastic band as taught by Pendleton in order to provide a more stable delivery of the stent.
Regarding claim 3, Chu fails to teach the limitations of claim 3. However, 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.
Pendleton teaches a telescoping ureteral stent having an elastic band (Fig. 1, flexible member 120 may be a monofilament [0071] (i.e., nylon band which is elastic)). Pendleton discloses that the flexible member may be made from another material that is strong in tension when at a very-small cross-section [0071]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the material of the band taught by Clayman to be an elastic band as taught by Pendleton in order to provide a more stable delivery of the stent.
Regarding claim 4, Chu fails to teach the limitations of claim 4. 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 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. However, Chu in view of Clayman fails to teach the band is elastic.
Pendleton teaches a telescoping ureteral stent having an elastic band (Fig. 1, flexible member 120 may be a monofilament [0071] (i.e., nylon band which is elastic)). Pendleton discloses that the flexible member may be made from another material that is strong in tension when at a very-small cross-section [0071]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the material of the band taught by Clayman to be an elastic band as taught by Pendleton in order to provide a more stable delivery of the stent.
Regarding claim 6, Chu fails to teach the limitations of claim 6. Clayman teaches wherein the band extends through the at least one closed loop (Fig. 7, thread from point C to point E on left and right side of the loop form bands that are loops which extend through the overall loop of thread from point C to the point). 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. However, Chu in view of Clayman fails to teach the band is elastic.
Pendleton teaches a telescoping ureteral stent having an elastic band (Fig. 1, flexible member 120 may be a monofilament [0071] (i.e., nylon band which is elastic)). Pendleton discloses that the flexible member may be made from another material that is strong in tension when at a very-small cross-section [0071]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the material of the band taught by Clayman to be an elastic band as taught by Pendleton in order to provide a more stable delivery of the 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.
Clayman teaches a ureteral stent having an band (Fig. 7, thread from point C to point E on left and right side of the loop form bands that are loops) extending about the proximal end of the proximal retention member (Fig. 7, 7A, threads forming left and right side loops/bands are attached at point C) comprising a first portion (Fig. 7, left side loop/band of thread from point C to point E) and a second portion (Fig. 7, right side loop/band of thread from point C to point E); a suture looped through the second portion of the band (Fig. 8A, thread 830 is looped through thread at point E) and wherein the proximal retention member comprises at least one closed loop (Fig. 7, thread from point C to point E forms a closed loop). 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 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.
Pendleton teaches a telescoping ureteral stent having an elastic band (Fig. 1, flexible member 120 may be a monofilament [0071] (i.e., nylon band which is elastic)). Pendleton discloses that the flexible member may be made from another material that is strong in tension when at a very-small cross-section [0071]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the material of the band taught by Clayman to be an elastic band as taught by Pendleton in order to provide a more stable delivery of the stent.
Regarding claim 9, Chu fails to teach the limitations of claim 9. Clayman teaches a ureteral stent wherein the band extends through the at least one closed loop (Fig. 7, thread from point C to point E on left and right side of the loop form bands that are loops which extend through the overall loop of thread from point C to the point). 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. However, Chu in view of Clayman fails to teach the band is elastic.
Pendleton teaches a telescoping ureteral stent having an elastic band (Fig. 1, flexible member 120 may be a monofilament [0071] (i.e., nylon band which is elastic)). Pendleton discloses that the flexible member may be made from another material that is strong in tension when at a very-small cross-section [0071]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the material of the band taught by Clayman to be an elastic band as taught by Pendleton in order to provide a more stable delivery of the stent.
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]).
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.
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 stent system taught by Chu with the band taught by Clayman in order to provide more adjustable sizing of the system from patient to patient. Chu in view of Clayman fails to teach wherein the first portion of the elastic band is slidable. However, Chu in view of Clayman fails to teach the band is elastic.
Pendleton teaches a telescoping ureteral stent having an elastic band (Fig. 1, flexible member 120 may be a monofilament [0071] (i.e., nylon band which is elastic)). Pendleton discloses that the flexible member may be made from another material that is strong in tension when at a very-small cross-section [0071]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the material of the band taught by Clayman to be an elastic band as taught by Pendleton in order to provide a more stable delivery of the stent.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (US 2021/0052403 A1), “Chu” in view of Clayman et al. (US Pat. No. 6849069 B1), “Clayman”, and further in view of Opolski et al. (US Pat. No. 7419498 B2), “Opolski”.
Regarding claim 11, Chu teaches a notch (Fig. 2C, first and second apertures 211, 212 form gap) and the proximal end (Fig. 2A, proximal end 205p) of the stent (Fig. 2A, stent 200) in a notch in the tubular member, but fails to teach further comprising a notch in the releasably holding a portion of the band and the proximal end of the stent in a notch in the tubular member, and that the band is elastic.
Clayman teaches a ureteral stent first portion of the band (Fig. 7, portion of thread at point C). 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 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 wherein the notch is configured to reversibly mate with the first portion of the band, and that the band is elastic.
Opolski teaches a medical delivery system comprising a band (Fig. 4, suture 50) which reversibly mates (Fig. 4, suture 50 forms quick release knot 60 (col. 5, lines 46-47)). Opolski discloses that the sutures may be used as an attachment system for the implant and to collapse or expand the implant during delivery (col. 3, par. 14). 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 notch and stent taught by Chu with the band taught by Clayman and the mating mechanism taught by Opolski in order to best control the placement of the stent during delivery. However, Chu in view of Clayman and Opolski fails to teach the band is elastic.
Pendleton teaches a telescoping ureteral stent having an elastic band (Fig. 1, flexible member 120 may be a monofilament [0071] (i.e., nylon band which is elastic)). Pendleton discloses that the flexible member may be made from another material that is strong in tension when at a very-small cross-section [0071]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to change the material of the band taught by Clayman to be an elastic band as taught by Pendleton in order to provide a more stable delivery of the stent.
Conclusion
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799