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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election with traverse of Species A, Figures 1A-1E, in the reply filed on 04/06/2026 is acknowledged. The traversal is on the ground(s) that the restriction requirement filed on 04/04/2026 failed to apply the unity of invention standard. This is found persuasive because the application is a national stage application. The restriction requirement is deemed improper and is thereby fully withdrawn.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.
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 1-7, 10-15, 18-20, and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et al. (Gerber, Glenn Scott et al. “Removal of Obstructed or Kinked Ureteral Stents Using Coaxial Dilation Stylet and Safety Wire Introducer Sheath.” Journal of Endourology 5 (1991): 297 - 299.), in view of Oswal et al. (Oswal, A. T., Maheshwari, P. N., & Amlani, D. (2017). Cystoscopic stent removal using a guidewire loop. Indian journal of urology : IJU : journal of the Urological Society of India, 33(3), 253–254. https://doi.org/10.4103/iju.IJU_88_17), and in further view of Nguyen et al. (US 20200390456 A1).
Regarding claim 1, Gerber discloses a retained ureteral stent removal technique (pg. 297 col. 2) comprising: attaching a proximal end of the stent to a pulling member (pg. 298 col. 1 discloses the stents drainage hole/proximal end to a stylet/pulling member using a suture); placing the proximal end of the stent through a lumen of an elongate device (fig. 3c) and advancing so that a distal end of the elongate device advances along the stent up a ureter towards a blockage retaining the stent (fig. 3c-d), wherein: pressure applied by the distal end of the elongate device in opposition to the stent pulled in respective tension removes the blockage (pg. 298 col.2 discloses withdrawing/pulling the stent from the elongated device with traction/force and pg. 299 col. 1 discloses results of e.g. a straightened stent from a previously knotted/kinked/double-backed stent i.e. pressure removes the blockage due to the sheaths compression/contact),
Gerber fails to disclose pulling the proximal end of the stent using a pulling member. Oswal also discloses a ureteral stent removal technique (introduction). Oswal teaches pulling the proximal end of the stent using a pulling member (pg. 253 col. 1-2 discloses a pulling the proximal end of the stent using a pulling member/cystoscope; see fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the technique of Gerber to include pulling the proximal end of the stent using a pulling member as the modification merely involves a combination of known methods of pulling a stent that achieves predictable results removing a ureteral stent.
Gerber in view of Oswal fails to disclose that the elongate device comprises an outer sheath coaxially and slidably retaining an inner sheath therein and wherein the inner sheath is pulled from the outer sheath to allow the blockage to enter a distal end of the outer sheath.
Nguyen also discloses a removal technique (¶ 0010) and an elongated device (200). Nguyen teaches an elongated device (200) comprises an outer sheath coaxially (210) and slidably retaining an inner sheath (220) therein and wherein the inner sheath is pulled from the outer sheath to allow the blockage to enter a distal end of the outer sheath (¶ 0612 and ¶ 0615; see figs. 10c-10e).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the technique of Gerber in view of Oswal to include that the elongate device comprises an outer sheath coaxially and slidably retaining an inner sheath therein and wherein the inner sheath is pulled from the outer sheath to allow the blockage to enter a distal end of the outer sheath as the modification merely involves a combination of known methods of securing/ensnaring/trapping an obstruction that achieves predictable results removing an obstruction from bodily lumen (Nguyen ¶ 0002).
Regarding claim 2, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 1. Gerber further discloses that the proximal end of the stent is pulled via an opening of the urethra (fig. 3d illustrates the ureteral stent removed/pulled from the urethral meatus).
Regarding claim 3, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 2. Gerber further discloses that the proximal end of the stent is exposed from the opening of the urethra prior the proximal end of the stent being attached to the pulling member (pg. 298 col. 1 discloses that the initial step is to grasp the distal stent tip/end and bring it as far as the urethral meatus and subsequently attaching a pulling member e.g. suture with stylet/pulling member).
Regarding claim 4, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 2. Gerber further discloses that the proximal end of the stent is exposed from the opening of the urethra (see fig. 3a) prior the distal end of the elongate device engaging the proximal end of the stent (see fig. 3c-d).
Regarding claim 5, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 1. Gerber further discloses that the distal end of the elongate device is advanced to the blockage (pg. 299 discloses that the distal end of the elongate device/sheath is advanced to the blockage e.g. to straighten a knotted/kinked/double-backed stent i.e. blockage).
Regarding claim 6, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 1. Gerber further discloses that the distal end of the stent is pulled through the distal end of the elongate device whilst the elongate device remains substantially in position (fig. 3d discloses that the distal end of the stent is pulled through the distal end of the elongate device/sheath whilst the elongate device/sheath remains substantially in position e.g. remains within the urethral meatus).
Regarding claim 7, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 1. Gerber further discloses that the distal end of the stent is pulled through the proximal end of the elongate device whilst the elongate device remains substantially in position (fig. 3d discloses that the distal end of the stent is pulled through the distal end of the elongate device/sheath whilst the elongate device/sheath remains substantially in position e.g. remains within the urethral meatus and pg. 298 col. 2 discloses that the stent is withdrawn completely from the elongate member/sheath i.e. from its proximal end).
Regarding claim 10, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 1. Gerber discloses that the blockage is caused by encrustation of an exterior surface of the distal end of the stent (pg. 297, col. 1) and wherein pressure is applied by the distal end of the elongate device in opposition to the stent under relative tension (pg. 298 col. 2 discloses that the stent is pulled relative to the elongated device/sheath), and Nguyen discloses that pressure applied by the distal end of an elongate device (figs. 10c-e; 210) in opposition to a blockage under relative tension causes at least some of the encrustation/blockage/obstruction to enter the distal end of the elongate device (¶ 0615).
Regarding claim 11, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 10. Nguyen further discloses that the elongate device is removed from the bodily lumen, e.g. ureter as disclosed in Gerber, with at least some of the encrustation/blockage/obstruction therein (¶ 0615; fig. 10e).
Regarding claim 12, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 10. Nguyen further discloses that the inner sheath (220) is pulled from the outer sheath (210) to allow at least some of the encrustation to enter a distal end of the outer sheath (¶ 0613; see figs. 10c-e).
Regarding claim 13, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 12. Nguyen further discloses that the inner sheath is removed from the outer sheath with the outer sheath remaining substantially in position (¶ 0613; see figs. 10c-e).
Regarding claim 14, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 1. Gerber further discloses that the blockage is caused by knotting of the stent (pg. 297 discloses that in a usual circumstance when there is no knuckle formation, e.g. knotted/kinked/double-backed stent, a guidewire passes through the stents lumen to straighten it, i.e. when a knuckle formation is present it creates an obstruction/blockage to e.g. a guidewire) and wherein the pressure applied by the distal end of the elongate device in opposition to the stent under relative tension unknots the knotting (pg. 298 col.2 discloses withdrawing/pulling the stent from the elongated device with traction/force and pg. 299 col. 1 discloses results are a straightened stent from a previously knotted/kinked/double-backed stent i.e. pressure removes the blockage due to the sheaths compression/contact onto the stent).
Regarding claim 15, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 14. Gerber further discloses that the distal end of the stent is pulled free of knotting through the distal end of the elongate device (pg. 299 col. 1 discloses results of e.g. a straightened stent from a previously knotted/kinked/double-backed stent when pulled through an elongated device/sheath, i.e. pulled free from knotting).
Regarding claim 18, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 1. Gerber discloses that the blockage is caused by knotting of a distal end of the stent (pg. 297 discloses that in a usual circumstance when there is no knuckle formation, e.g. knotted/kinked/double-backed stent, a guidewire passes through the stents lumen to straighten it, i.e. when a knuckle formation is present it creates an obstruction/blockage to e.g. a guidewire) and wherein the pressure applied by the distal end of the elongate device in opposition to the stent under relative tension causes at least some of the knotting enter the distal end of the elongate device (pg. 298 col.2 discloses withdrawing/pulling the stent from the elongated device with traction/force and pg. 299 col. 1 discloses that upon the sheath advancing over the stent the results are a straightened stent from a previously knotted/kinked/double-backed stent i.e. pressure removes the blockage due to the sheaths compression/contact onto the stent).
Regarding claim 19, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 18. Gerber discloses a knotted stent (pg. 297 discloses that in a usual circumstance when there is no knuckle formation, e.g. knotted/kinked/double-backed stent, a guidewire passes through the stents lumen to straighten it, i.e. when a knuckle formation is present it creates an obstruction/blockage to e.g. a guidewire) and Nguyen further discloses that an inner sheath is pulled from the outer sheath to allow a stent-like structure/mesh 140 to enter a distal end of the outer sheath (¶ 0612 and ¶ 0615; see figs. 10c-10e).
Regarding claim 20, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 19. Gerber discloses the removal of a knotted/kinked/double-backed stent from the ureter (pg. 299 col. 1) and Nguyen discloses that an outer sheath (210) containing an obstruction is removed from a bodily lumen (¶ 0615; see fig. 10e).
Regarding claim 22, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 19. Nguyen discloses that the inner sheath is removed from the outer sheath with the outer sheath remaining substantially in position (¶ 0613; see figs. 10c-e).
Regarding claim 23, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 1. Gerber discloses a stylet/pulling member comprises a rod slidably passing through the elongate device (se fig. 3). Gerber fails to disclose that the pulling member is specifically a flexible rod. Oswal further teaches that the pulling member/cystoscope may be flexible (introduction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the technique of Gerber to include pulling the proximal end of the stent using a pulling member as the modification merely involves a combination of known methods of pulling a stent that achieves predictable results removing a ureteral stent.
Regarding claim 24, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 23. Oswal further discloses that the distal end of the flexible rod comprises an attachment hole (see fig. 1 for a rod with an attachment hole/opening/end of cytoscope).
Regarding claim 25, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 23. Gerber discloses that a suture attaches to the proximal end of the stent (see fig. 3). Gerber fails to discloses that the suture specifically attaches an attachment hole to the proximal end of the stent. Oswal further teaches that a thread/wire attaches the attachment hole to a proximal end of the stent (see figs. 1 and 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the technique of Gerber to include that the suture specifically attaches an attachment hole to the proximal end of the stent as the modification merely involves a combination of known methods of securing/ensnaring/trapping a stent that achieves predictable results removing a ureteral stent.
Regarding claim 26, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 23. Gerber discloses that the suture goes through a proximal side drainage hole of the stent (pg. 298 col. 1 discloses and fig. 3 illustrates a suture going through a proximal side drainage hole of the stent).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et al. (Gerber, Glenn Scott et al. “Removal of Obstructed or Kinked Ureteral Stents Using Coaxial Dilation Stylet and Safety Wire Introducer Sheath.” Journal of Endourology 5 (1991): 297 - 299.), in view of Oswal et al. (Oswal, A. T., Maheshwari, P. N., & Amlani, D. (2017). Cystoscopic stent removal using a guidewire loop. Indian journal of urology : IJU : journal of the Urological Society of India, 33(3), 253–254. https://doi.org/10.4103/iju.IJU_88_17), and in further view of Nguyen et al. (US 20200390456 A1), as applied to claim 1 above, in further view of Casey et al. (EP 3420978 A1).
Regarding claim 8, Gerber in view of Oswal in further view of Nguyen discloses the invention as claimed as discussed with respect to claim 1. Gerber in view of Oswal in further view of Nguyen discloses that a blockage is caused by encrustation of a surface of the stent (pg. 297, col. 1). Gerber in view of Oswal in further view of Nguyen fails to disclose that the blockage is specifically on the exterior surface of the stent and that the pressure applied by the distal end of the elongate device in opposition to the stent under relative tension dislodges the encrustation from the exterior surface of the stent.
Casey also discloses an analogous removal technique (pg. 2 col. 1 ¶ 0002 discloses a technique for removing an obstruction/blockage from bodily lumen e.g. removal of a clot from a blood vessel) and an elongated device (140). Casey teaches a blockage/encrustation on the exterior surface of a stent-like structure (130; see figs. 2a-2c) and that the pressure applied by the distal end of the elongate device in opposition to the stent under relative tension dislodges the encrustation from the exterior surface of the stent (pg. 8 col. 14 ¶ 0062 discloses that the tension between an elongate device 140 and the stent-like structure 130 must be maintained/constant so that the pinch/pressure between the stent-like structure 130 and the blockage/encrustation doesn’t deteriorate, i.e. because the elongated member and the stent-like structure pinches the obstruction/blockage, an increase in tension/pulling force/pressure increases the force, e.g. shear forces, exerted on the obstruction/blockage at the pinch-point, dislodging the obstruction/blockage from the exterior surface of the stent-like structure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the technique of Gerber to include that that the blockage is specifically on the exterior surface of the stent and that the pressure applied by the distal end of the elongate device in opposition to the stent under relative tension dislodges the encrustation from the exterior surface of the stent as taught by Casey as the modification merely involves a combination of known methods of dislodging a stent-like structure that achieves predictable results removing a ureteral stent.
Regarding claim 9, The technique as claimed in claim 8, wherein the stent is pulled substantially free of encrustation through the distal end of the elongate device (pg. 8 col. 14 ¶ 0062 discloses that the tension between an elongate device 140 and the stent-like structure 130 must be maintained/constant so that the pinch/pressure between the stent-like structure 130 and the blockage/encrustation doesn’t deteriorate i.e. because the elongated member and the stent-like structure pinches the obstruction/blockage, an increase in tension/pulling force/pressure increases the force, e.g. shear forces, exerted on the obstruction/blockage at the pinch-point, displacing/freeing the stent-like structure from the blockage/encrustation).
Claims 16-17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et al. (Gerber, Glenn Scott et al. “Removal of Obstructed or Kinked Ureteral Stents Using Coaxial Dilation Stylet and Safety Wire Introducer Sheath.” Journal of Endourology 5 (1991): 297 - 299.), in view of Oswal et al. (Oswal, A. T., Maheshwari, P. N., & Amlani, D. (2017). Cystoscopic stent removal using a guidewire loop. Indian journal of urology : IJU : journal of the Urological Society of India, 33(3), 253–254. https://doi.org/10.4103/iju.IJU_88_17), and in further view of Nguyen et al. (US 20200390456 A1), as applied to claim 1 above, in further view of Martin et al. (US 20170325830 A1).
Regarding claim 16, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 1. Gerber discloses wherein the blockage is caused by knotting of a distal end of the stent (pg. 297 discloses that in a usual circumstance when there is no knuckle formation, e.g. knotted/kinked/double-backed stent, a guidewire passes through the stents lumen to straighten it, i.e. when a knuckle formation is present it creates an obstruction/blockage to e.g. a guidewire). Gerber fails to disclose that a pressure applied by the distal end of the elongate device in opposition to the stent under tension tightens the knotting to decrease size of the knotting.
Martin also discloses a removal technique (¶ 0002) and an elongated device (102). Martin teaches that pressure/pull applied by the distal end of the elongate device in opposition to the stent under tension tightens the knotting to decrease the size of the knotting (see figs. 5a-f illustrating that pulling/applying pressure to a knotted/braided/tangled stent-like structure 226 decreases the size of the knotting/braid/tangled stent see figs. 5c and 5f).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the technique of Gerber in view of Oswal in further view of Nguyen to include a pressure applied by the distal end of the elongate device in opposition to the stent under tension tightens the knotting to decrease size of the knotting as taught by Martin as the modification merely involves a combination of known methods of securing/ensnaring/trapping an obstruction that achieves predictable results removing/retrieving obstructions from the bodily lumen (Martin ¶ 0002).
Regarding claim 17, Gerber in view of Oswal in further view of Nguyen and in further view of Martin discloses the invention as claimed as discussed above with respect to claim 16.
Martin discloses that the knotting of decreased size is removed from the ureter with the elongate device (¶ 0002 discloses a device that is used to retrieve obstructions from the body with applicability throughout the body, including clearing of blockages within body lumens e.g. a ureter as disclosed in Gerber and fig. 5f illustrates removal of a knotting of decreased size).
Regarding claim 21, Gerber in view of Oswal and in further view of Nguyen discloses the invention as claimed as discussed above with respect to claim 19. Gerber in view of Oswal and in further view of Nguyen fails to disclose that the pressure applied by the distal end of the elongate device in opposition to the stent under tension tightens the knotting to decrease size of the knotting for entry into the outer sheath.
Martin also discloses a removal technique (¶ 0002) and an elongated device (102). Martin teaches that the pressure applied by the distal end of the elongate device in opposition to the stent under tension tightens the knotting to decrease size of the knotting for entry into the outer sheath (see figs. 5a-f illustrating that pulling/applying pressure to a knotted/braided/tangled stent-like structure 226 tightens the knotting and decreases the size of the knotting/braid/tangled stent for entry into the outer sheath 102 see figs. 5c and 5f).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the technique of Gerber in view of Oswal in further view of Nguyen to include that a pressure applied by the distal end of the elongate device in opposition to the stent under tension tightens the knotting to decrease size of the knotting for entry into the outer sheath as taught by Martin as the modification merely involves a combination of known methods of securing/ensnaring/trapping an obstruction that achieves predictable results removing/retrieving obstructions from the bodily lumen (Martin ¶ 0002).
Conclusion
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/A.G.B./Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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