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 .
Information Disclosure Statement
The IDS form(s) submitted on 1/29/2026 is/are in compliance with the requirements of the provisions of 37 CFR 1.97. Accordingly, the information disclosure(s) are being considered by the examiner.
Response to Amendment
This office action is responsive to the claim amendments filed on 1/29/2026. As directed by the amendment: claims 1, and 5 have been amended; claims 8-14 have been cancelled; and claims 21-24 have been added. Thus, claims 1-7 and 15-24 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 1/29/2026 regarding “Independent claim 15 states “after confirming the sheath is in the body space, advancing the sheath over the probe to the first material.” Ference fails to teach advancing the sheath over the probe to the first material after confirming the sheath is in the body space” is not found persuasive. Examiner notes Applicant merely states WO 2024/091496 A1 to Ference et al. does not teach the limitation without providing evidence or arguments to rebut the rejection under 35 USC 102(a)(2) made in the Non-Final OA dated 10/29/2025 of claim 15. See page 8 claim 15 rejection in Non-Final OA.
Applicant arguments filed 1/29/2026 regarding “Ference Fails to teach advancing the sheath over the probe to the first material after confirming the sheath is in the body space” on page 5 beginning line 12. This argument is not found persuasive as noted above Applicant merely states WO 2024/091496 A1 to Ference et al. does not teach the limitation without providing evidence or arguments to rebut the rejection under 35 USC 102(a)(2) made in the Non-Final OA dated 10/29/2025 of claim 15. See page 8 claim 15 rejection in Non-Final OA. Ference’s cannula element element 2520 is considered the sheath and Fig. 15 element 12 is demonstrated the entry of a probe “delivery member”. Therefore, Applicant’s argument is not found persuasive.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 22 and 24 are 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. Applicants’ specification does not provide support for “preventing the agitating of the first material and the irrigating of the second material if the placement of the sheath in the body lumen is not confirmed” and the limitation “preventing delivery of the second material into the body space if the sheath cannot be confirmed to be positioned in the body space”. See paras. 344-346 of specification.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 and 15-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2024/091496 A1 to Ference et al.
In regard to claim 1:
A method of removing a first material (Fig. 2 element 1110 first material. Abstract “Methods for removing a biomaterial implant and reversing occlusive effects of the biomaterial implant are described”), a second material (Para. 1011 “In some embodiments, following the exertion of the force on the upstream portion of the implant, a flush solution is conveyed into the body lumen. The flush solution conveys a remnant of the implant downstream towards the second body lumen”. Flush solution considered second material it is inserted then removed from the first body lumen due to “conveys a remnant of the implant downstream towards the second body lumen” and para. 1102 “the second removal fluid RF2 can be a contrast flush. The contrast flush can be employed to verify patency. For example, a portion of the second removal fluid RF2 introduced upstream of the implant location within the vas deferens will be detectable within the bladder when the occlusion resulting from the implant 1110 has been removed”. Examiner notes limitation not required due to use of “and/or”), and/or a third material (non-required limitation due to use of “and/or”) from a body lumen (Fig. 2 element 1120) comprising: inserting a sheath into the body lumen (Fig. 1 element 1510 “catheter”); inserting a probe into the body lumen (Fig. 2 elements 1600, 1550, and 1700, para. 1082 “The tool member can include a guidewire 1600 (FIG. 2), a microcatheter 1550 (FIG. 3), a retrieval tool 1700 (FIGS. 4-5), an expandable member 1800 (FIGS. 6-7), an ablation device (not shown), and/or other tool member having a rigidity that is greater than the cohesion of the implant 1110”); confirming a placement of the sheath in the body lumen (Fig. 15 element 12 “Inserting a delivery member into a first body lumen”, considered to be confirmation the sheath is in the body space as the delivery member element 2500 is inserted through the sheath); advancing the sheath after the confirming (Para. 1109 “the distal end portion 2512 of the delivery member 2500 is positioned, at step 28. at an initial position IP in contact with the implant 1110.”), agitating the first material in the body lumen with the probe (Para. 1082 “In some embodiments, the structural integrity of the implant 1110 can be mechanically disrupted by advancing a tool member at least partially through the implant 1110”); irrigating the second material into the body lumen (Fig. 9 element 86); and removing the first material (Fig. 9 element 90 “Moving the implant downstream to a second body lumen via the force” considered to be removing the first material from the body lumen as the second body lumen is a different body lumen then the first. See Fig. 8 elements 1120 and 1130), the second material (Limitation not required due to use of “and/or”), and/or the third material from the body lumen (Limitation not required due to use of “and/or”).
In regard to claim 2:
The method of claim 1, wherein inserting the probe into the body lumen comprises advancing the probe into the body lumen an advanced distance greater than or equal to a threshold distance (Para. 1084 “Said another way, the guidewire 1600 can be inserted through the over-the-needle catheter into the vas deferens and advanced to place a distal end portion 1602 of the guidewire 1600 at a location that is downstream of the implant 1110.” Threshold distance considered to be distance from catheter element 1510 to the distal end side of implant 1100).
In regard to claim 3:
The method of claim 2, wherein inserting the probe into the body lumen comprises advancing the probe into the body lumen from an irrigation lumen or an aspiration lumen of the sheath (Fig. 2 element 1510, considered to be an irrigation lumen due to para. 1092 “the flush solution 1900 is supplied to the first body lumen 1120 directly via the delivery member 1500”, element 1510 is the “catheter” and therefore lumen of element 1500).
In regard to claim 4:
The method of claim 1, wherein inserting the probe into the body lumen comprises advancing the probe into the body lumen from an irrigation lumen or an aspiration lumen of the sheath (Fig. 2 element 1510, considered to be an irrigation lumen due to para. 1092 “the flush solution 1900 is supplied to the first body lumen 1120 directly via the delivery member 1500”, element 1510 is the “catheter” and therefore lumen of element 1500).
In regard to claim 5:
The method of claim 1, wherein confirming the placement of the sheath in the body lumen further comprises confirming the sheath has access to the body lumen by inserting the probe into the body lumen (Para. 1035 “The load sensor is configured to detect a condition in which the distal end portion is in contact with the implant based at least in part on a stiffness of the implant. The control device produces an indication of contact between the distal end portion and the implant based on the detection by the load sensor.”).
In regard to claim 6:
The method of claim 5, wherein confirming the sheath has access to the body lumen by inserting the probe into the body lumen comprises advancing the probe into the body lumen an advanced distance greater than or equal to a threshold distance (Para. 1084 “Said another way, the guidewire 1600 can be inserted through the over-the-needle catheter into the vas deferens and advanced to place a distal end portion 1602 of the guidewire 1600 at a location that is downstream of the implant 1110.” Threshold distance considered to be distance from catheter element 1510 to the distal end side of implant 1100).
In regard to claim 7:
The method of claim 1, further comprising agitating the second material in the body lumen with the probe ((Para. 1082 “In some embodiments, the structural integrity of the implant 1110 can be mechanically disrupted by advancing a tool member at least partially through the implant 1110” and Fig. 9 element 88, sub-elements 80-86 and “Exerting a force on the upstream portion of the implant”. Considered to agitate the second material as the second material is shown to be present in the body lumen during the advancement of the probe and agitation of the first material (implant) and therefore would also be agitated by the applied force to the first material. Further, para. 1104 “In some embodiments, the delivery pressure of the first removal fluid RFi and/or the second removal fluid RF2 upon exit from the delivery member 2500 is within a specified pressure range. For example, the delivery' pressure can be within a range of 2 psi to 400 psi. In some embodiments, the delivery pressure is less than a burst pressure of the first body lumen 1120.” As the flush solution is delivered under pressure it would experience turbulent flow around the probe and thus be agitated by the probe due to the no-slip condition at the interface surface between the second material and the probe.).
In regard to claim 15:
A method of removing a first material (Fig. 11 element 1110 first material. Abstract “Methods for removing a biomaterial implant and reversing occlusive effects of the biomaterial implant are described”) and/or a second material (Para. 1109 “first removal fluid RFi.”. Examiner notes limitation not required due to use of “and/or”) from a body space (Fig. 1 element 1120) comprising: advancing a sheath into the body space (cannula element 2520, para. 1095 “The delivery member can, in some embodiments, be inserted through a cannula 2520”); confirming the sheath is in the body space by advancing a probe into the body space (Fig. 15 element 12 “Inserting a delivery member into a first body lumen”, considered to be confirmation the sheath is in the body space as the delivery member element 2500 is inserted through the sheath); after confirming the sheath is in the body space, advancing the sheath over the probe to the first material (Para. 1109 “the distal end portion 2512 of the delivery member 2500 is positioned, at step 28. at an initial position IP in contact with the implant 1110.”); delivering the second material into the body space through the sheath (Para. 1109 “At step 31, the distal end portion 2512 is oscillated between the initial position IP and the delivery position DP to mechanically disrupt the structural integrity of the implant 1110 during delivery of the first removal fluid RFi.” as the delivery member 2500 is inserted through the sheath the first removal material (second material) delivered through it is also delivered through the sheath); and/or removing the first material and/or the second material from the body space through the sheath (Para. 1098 “In some embodiments, flow of the eroded portion 1117 can be additionally facilitated by aspirating the first body lumen 1120 via a vacuum source (not shown) applied at the cannula 2520”. Examiner notes limitation not required due to the use of “and/or”).
In regard to claim 16:
The method of claim 15, wherein advancing the sheath into the body space comprises advancing the sheath into the body space while the probe is in the sheath (Para. 1111 “In some embodiments, inserting the delivery member 2500 into the first body lumen 1120 includes inserting the delivery member through the cannula 2520 (FIG. 10) positioned at least partially in the first body lumen 1120.”.
In regard to claim 17:
The method of claim 15, wherein confirming the sheath is in the body space by advancing the probe into the body space comprises advancing the probe an advanced distance into the body space, and wherein the advanced distance is greater than or equal to a threshold distance (Para. 1109 “the distal end portion 2512 of the delivery member 2500 is positioned, at step 28. at an initial position IP in contact with the implant 1110.” Threshold distance considered to be the distance between “entry orifice” and initial position (IP)).
In regard to claim 18:
The method of claim 15, wherein the sheath comprises an irrigation lumen (Fig. 13 element 2152), an irrigation hole (Fig. 13 element 2516), an aspiration lumen (Para. 1111 “The cannula 2520 has an inner diameter that is sized to receive an outer diameter of the delivery member 2500 while still permitting passage of the eroded portion 1117. Said another way, the cannula 2520 is oversized such that there is sufficient space between an inner wall of the cannula and the delivery member 2500 to permit passage (e.g., exit from the first body lumen 1120) of the eroded portion 1117 while the delivery' member 2500 is in situ.”), and an aspiration hole (Fig. 10 element 2520 distal opening. Considered aspiration opening due to Para. 1098 “In some embodiments, flow of the eroded portion 1117 can be additionally facilitated by aspirating the first body lumen 1120 via a vacuum source (not shown) applied at the cannula 2520”), wherein delivering the second material into the body space through the sheath comprises delivering the second material to the body space through the irrigation lumen and the irrigation hole (Fig. 13 elements 2152, 2516, Para. 1113 “. The distal orifice 2516 is axially aligned with the longitudinal axis ALO. AS such, a portion of the first removal fluid RFi and/or the second removal fluid RF2 exiting the distal orifice 2516 at the delivery pressure is directed into the implant 1110”), and wherein removing the first material and/or the second material from the body space through the sheath comprises aspirating the first material and/or the second material from the body space through the aspiration hole and the aspiration lumen (Para. 1098 “In some embodiments, flow of the eroded portion 1117 can be additionally facilitated by aspirating the first body lumen 1120 via a vacuum source (not shown) applied at the cannula 2520”. Para. 1111 “The cannula 2520 has an inner diameter that is sized to receive an outer diameter of the delivery member 2500 while still permitting passage of the eroded portion 1117. Said another way, the cannula 2520 is oversized such that there is sufficient space between an inner wall of the cannula and the delivery member 2500 to permit passage (e.g., exit from the first body lumen 1120) of the eroded portion 1117 while the delivery' member 2500 is in situ.”)
In regard to claim 19:
The method of claim 15, further comprising simultaneously delivering the second material into the body space through the sheath and removing the first material and/or the second material from the body space (Fig. 15. Para. 1098 “In some embodiments, flow of the eroded portion 1117 can be additionally facilitated by aspirating the first body lumen 1120 via a vacuum source (not shown) applied at the cannula 2520”. Para. 1111 “The cannula 2520 has an inner diameter that is sized to receive an outer diameter of the delivery member 2500 while still permitting passage of the eroded portion 1117. Said another way, the cannula 2520 is oversized such that there is sufficient space between an inner wall of the cannula and the delivery member 2500 to permit passage (e.g., exit from the first body lumen 1120) of the eroded portion 1117 while the delivery' member 2500 is in situ.”).
In regard to claim 20:
The method of claim 15, wherein the first material comprises hydrogel (para. 1074 “implant 1110 (e.g., a hydrogel implant)”), and/or wherein the second material comprises sodium bicarbonate (Para. 1021 “the first removal fluid includes at least one of sodium bicarbonate”).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2024/091496 A1 to Ference et al. in view of US 5,741,288 to Rife.
In regard to claim 21:
The method of claim 1, taught by Ference as described in parent claim rejection above.
Ference does not appear to teach the spring-loaded retractable lancet as claimed. Rife teaches, wherein the probe (Fig. 1 element 23) comprises a spring-loaded retractable lancet configured to traverse into the body lumen (Fig. 1 elements 29, 28, and 30).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the probe taught by Ference to include a spring-loaded retractable lancet as taught by Rife. This would have been motivated by aiding in penetration of the removal tool through the implant by penetrating said implant to leave a channel.
In regard to claim 23:
The method of claim 15, taught by Ference as described in parent claim rejection above.
Ference does not appear to teach the spring-loaded retractable lancet as claimed. Rife teaches, wherein the probe (Fig. 1 element 23) comprises a spring-loaded retractable lancet configured to traverse into the body space (Fig. 1 elements 29, 28, and 30).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the probe taught by Ference to include a spring-loaded retractable lancet as taught by Rife. This would have been motivated by aiding in penetration of the removal tool through the implant by penetrating said implant to leave a channel.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark A Igel whose telephone number is (571)272-7015. The examiner can normally be reached Monday through Thursday 11 am to 5 pm EST.
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/M.A.I./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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