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 .
Response to Amendment
As of the reply filed 8/25/2025, claims 1, 3-7, 9-13, 15-21, and 23 are currently pending. Claims 3-6, 10-11, and 18-20 remain withdrawn from consideration. Claims 2, 8, 14, and 22 are canceled. Claims 1, 21, and 23 have been amended.
Response to Arguments
Applicant’s amendment to claim 23 has overcome the previously filed claim objection, therefore this objection is withdrawn.
Applicant’s amendments to claims 21 and 22 have overcome the previously filed 112(a) and 112(b) rejections, therefore these rejections are withdrawn.
With respect to the Applicant’s argument that “Jenson’s jet tube is not extendable parallel to the cutting length” because “Jenson’s jet tube moves in a direction perpendicular to Jenson’s cutting length” (see pages 8-9 of Remarks), the Examiner respectfully disagrees. The cutting length of Jensen et al. can be considered to be the space between orifice 58 (as seen in Fig. 6) and the distal end of the catheter 20, as highlighted by the arrows in Fig. 6 of the disclosure. The claim language does not require that the jet tube only extend in a direction that is parallel to a cutting length direction, and the use of the transitional phrase “comprising” renders the claim open-ended, since the MPEP states that this term “is inclusive or open-ended and does not exclude additional, unrecited elements or method steps” (see MPEP 2111.03). The extendable tube (22 and 38) of Jenson et al. has elements which extend in a plurality of directions, including perpendicularly as argued, however this extension does not render it untrue that parts of this structure are extendable parallel to the cutting length. Furthermore, the capture basket 32 is axially extendable relative to the distal end of the catheter 20, since Jenson et al. recites that the capture basket 32 is a separate structure (PP [0047]: “an expandable capture basket 32 that may, if desired, be used in conjunction with or even incorporated into the thrombectomy catheter 10 discussed with respect to FIG. 1”, PP [0056]: “tube forming the first loop 38 is hollow and is in fluid communication with a high pressure fluid source such as the high pressure lumen 22. In some instances, it is contemplated that the high pressure jet 58 may be an orifice provided in a separate fluid line (not illustrated)”). Although not explicitly recited by Jenson et al., this would yield a capture basket configured to extend relative to the catheter, which would read on the present functional limitation.
Applicant further argues that “Jenson does not disclose first and second cutting lengths that differ with jet tube position” (see page 9 of Remarks), and the Examiner respectfully disagrees. As stated above, the capture basket 32 is axially extendable relative to the distal end of the catheter 20, since Jenson et al. recites that the capture basket 32 is a separate structure (PP [0047]: “an expandable capture basket 32 that may, if desired, be used in conjunction with or even incorporated into the thrombectomy catheter 10 discussed with respect to FIG. 1”, PP [0056]: “tube forming the first loop 38 is hollow and is in fluid communication with a high pressure fluid source such as the high pressure lumen 22. In some instances, it is contemplated that the high pressure jet 58 may be an orifice provided in a separate fluid line (not illustrated)”). This would yield a capture basket configured to axially move relative to the catheter, which would therefore be configured to maintain multiple longitudinal positions relative to the catheter such that the device is configured to have differing first and second cutting lengths. Since these limitations are functional language, and since the MPEP states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established” (see MPEP 2112.01), Jenson et al. reads on these limitations.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 7-9, 12-13, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jenson et al. (PGPub US 2008/0255596 A1).
With respect to claim 1, Jenson et al. discloses a surgical instrument (10 in Fig. 6) comprising:
a catheter (12) comprising:
a distal end configured and adapted to perform a thrombus removal (see Fig. 6 showing distal end);
a proximal end (PP [0042]: “Thrombi 26 may be drawn towards and into the evacuation lumen 18 by applying a low pressure source to a proximal end (not illustrated) of the evacuation lumen 18”);
an evacuation lumen (18) disposed within the catheter (12) between the distal end and the proximal end, the evacuation lumen (18) in communication with a console and configured to channel a waste from the distal end to the proximal end (PP [0042]: “Thrombi 26 may be drawn towards and into the evacuation lumen 18 by applying a low pressure source to a proximal end (not illustrated) of the evacuation lumen 18”); and
a jet lumen (22) defined by an extendable jet tube (PP [0056]: “a high pressure jet 58 located near the distal end 44 of the first loop 38. In some cases, the high pressure jet 58 may simply be a small aperture formed within a tube forming the first loop 38, particularly if the tube forming the first loop 38 is hollow and is in fluid communication with a high pressure fluid source such as the high pressure lumen 22”) and disposed within the catheter (12) between the distal end and the proximal end, the jet lumen (22 including hollow portion of 38, see PP [0056]) configured to channel a liquid from the proximal end to the distal end (see PP [0056]),
wherein the extendable jet tube (22 including extendable portion of 38) is extendable relative to the distal end of the catheter and configured to occupy at least one of an extended position and a non-extended position relative to the distal end of the catheter (32 is extendable relative to the distal end of 12 therefore 38 is extendable at these positions);
a jet nozzle (58 in Fig. 6) disposed on the distal end of the jet tube (22 including hollow portion of 38, see PP [0056]), the jet nozzle (58) in liquid communication with the console (see PP [0056]),
wherein the jet nozzle (58) is configured to spray a cutting jet stream towards the evacuation lumen (PP [0057]: “the high pressure jet 58 may be considered as being pointed at least partially towards the distal opening 20 of the evacuation lumen 18”); and
a cutting length (space between 58 and 20) disposed distal to the distal end of the catheter (12) between the jet nozzle (58) and a rim of the evacuation lumen (rim 20 of 18),
wherein the extendable jet lumen (22 including extendable portion of 38) extends in a direction parallel to the cutting length (22 and the extendable portion of 38 each extend along a longitudinal axis parallel to the arrows in Fig. 6, the claim language does not require that the entirety of the extendable jet lumen be parallel to the cutting length, since the fluid travels through 22 and parts of the frame of basket 32 in a direction parallel to the arrows exiting 58 Jenson reads on this limitation, PP [0057]: “As illustrated, the high pressure jet 58 may be considered as being pointed at least partially towards the distal opening 20 of the evacuation lumen 18. In some cases, the high pressure jet 58 may be pointed in a more downward direction”),
wherein, when in use, the jet stream traverses the cutting length (see arrows in Fig. 6 exiting out of 58),
wherein, while the extendable jet tube (22 including hollow portion of 38, see PP [0056]) is in the extended position, the cutting length extends beyond the distal end of the catheter (12) by a first length (32 is configured to be translated relative to 20, therefore the extendable jet tube including 38 is configured for this),
wherein, while the extendable jet tube (22 including hollow portion of 38, see PP [0056]) is in the non-extended position, the cutting length extends beyond the distal end of the catheter (12) by a second length, the first length being greater than the second length (32 is configured to be translated relative to 20, therefore the extendable jet tube including 38 is configured for this),
wherein an aim of the cutting jet stream toward the evacuation lumen is maintained during transition between the non-extended position and the extended position (see MPEP 2112.01, PP [0057]: “the high pressure jet 58 may be considered as being pointed at least partially towards the distal opening 20 of the evacuation lumen 18”).
Regarding claim 7, Jenson et al. further discloses a cage (40 and 36 of 32 in Fig. 6) disposed on the distal end such that the cage (40 and 36) partially covers the jet nozzle (40 and 36 extend distally beyond 58 and cover it), wherein the cage (40 and 36) comprises at least one strip (40 comprises several strips/filaments) attached to one of the following: the catheter, the evacuation lumen, or the jet lumen (40 is attached to catheter 12, evacuation lumen 18, and the jet lumen 22 including 38).
Regarding claim 9, Jenson et al. further discloses wherein the jet nozzle (58 in Fig. 6) is adjustable (32 can be translated relative to 12 therefore jet nozzle 58 is adjustable).
Regarding claim 12, Jenson et al. further discloses wherein the Venturi Effect is employed to channel waste from the distal end to the proximal end via the evacuation lumen (the fluid jet exiting 58 in Fig. 6 goes from a large area, the open cutting length space, to a more narrow area, the mouth of evacuation lumen 18, therefore the Venturi Effect is employed).
Regarding claim 13, Jenson et al. further discloses wherein an external source of suction is employed to channel the waste from the distal end to the proximal end via the evacuation lumen (PP [0042]: “Thrombi 26 may be drawn towards and into the evacuation lumen 18 by applying a low pressure source to a proximal end (not illustrated) of the evacuation lumen 18”).
Regarding claim 16, Jenson et al. further discloses wherein the jet nozzle (58 in Fig. 6) is disposed distal to the evacuation lumen (58 is distal relative to 18).
Regarding claim 17, Jenson et al. further discloses wherein the extendable jet tube (22 including hollow portion of 38 in Fig. 6, see PP [0056]) comprises a jet tube distal end (38) and a jet tube proximal end (22), the jet tube distal end (38) being bent at or near a 90-degree angle (see Fig. 6, “near” is a broad term, 38 is bent near 90 degrees relative to the straight portion 22), the jet nozzle (58) disposed on the underside of the jet tube distal end (58 is on an underside of 38 directed into 18).
With respect to claim 21, Jenson et al. discloses a surgical instrument (10 in Fig. 6) comprising:
a catheter (12) comprising:
a distal end configured and adapted to perform a thrombus removal (see Fig. 6);
a proximal end (PP [0042]: “Thrombi 26 may be drawn towards and into the evacuation lumen 18 by applying a low pressure source to a proximal end (not illustrated) of the evacuation lumen 18”);
an evacuation lumen (18) disposed within the catheter (12) between the distal end and the proximal end, the evacuation lumen (18) in communication with a console and configured to channel a waste from the distal end to the proximal end (PP [0042]: “Thrombi 26 may be drawn towards and into the evacuation lumen 18 by applying a low pressure source to a proximal end (not illustrated) of the evacuation lumen 18”); and
a jet lumen defined by a jet tube (22 and 38, PP [0056]: “a high pressure jet 58 located near the distal end 44 of the first loop 38. In some cases, the high pressure jet 58 may simply be a small aperture formed within a tube forming the first loop 38, particularly if the tube forming the first loop 38 is hollow and is in fluid communication with a high pressure fluid source such as the high pressure lumen 22”) and disposed within the catheter (12) between the distal end and the proximal end (22 is disposed within the catheter 12), the jet lumen (lumen through 22 and 38, see PP [0056]) configured to channel a liquid from the proximal end to the distal end (see PP [0056]), wherein the jet tube (22 and 38) is extendable relative to the distal end of the catheter and configured to occupy at least one of an extended position and a non-extended position relative to the distal end of the catheter (see Figs. 1-2 and 6, the basket is a separate attachment that is able to extend relative to the distal end of the catheter), and wherein the jet lumen (22 and 38) and the evacuation lumen (18) run along a length of the catheter (12, see 22 and 18 run the length of 12); and
a jet nozzle (58) disposed on the distal end of the jet tube (22 and 38), the jet nozzle (58) in liquid communication with the console (PP [0056]: “a high pressure jet 58 located near the distal end 44 of the first loop 38. In some cases, the high pressure jet 58 may simply be a small aperture formed within a tube forming the first loop 38, particularly if the tube forming the first loop 38 is hollow and is in fluid communication with a high pressure fluid source such as the high pressure lumen 22”),
wherein the jet nozzle (58) is configured to spray a cutting jet stream through a cutting length (space between 58 and 20) towards the evacuation lumen (18), the cutting length (space between 58 and 20) extending from the jet nozzle (58) to the rim of the evacuation lumen (18), wherein the extendable jet lumen (22 including extendable portion of 38) extends in a direction parallel to the cutting length (22 and the extendable portion of 38 each extend along a longitudinal axis parallel to the arrows in Fig. 6, the claim language does not require that the entirety of the extendable jet lumen be parallel to the cutting length, since the fluid travels through 22 and parts of the frame of basket 32 in a direction parallel to the arrows exiting 58 Jenson reads on this limitation, PP [0057]: “As illustrated, the high pressure jet 58 may be considered as being pointed at least partially towards the distal opening 20 of the evacuation lumen 18. In some cases, the high pressure jet 58 may be pointed in a more downward direction”), and wherein the cutting jet stream is at least partially exposed at the distal end of the catheter body such that, when in use, the cutting jet stream propelling from the jet nozzle (58) intersects and cuts the thrombus as the thrombus enters the cutting length (see arrows in Fig. 6, the jet stream exiting 58 is configured to cut thrombi).
Regarding claim 23, Jenson et al. further discloses wherein, while the jet tube (22 and 38 in Fig. 6, see PP [0056]) is in the extended position, the cutting length (space between 58 and 20) extends beyond the distal end of the catheter by a second length, the first length being greater than the second length (32 is configured to be translated relative to 20, therefore the extendable jet tube including 38 is configured for this), and
wherein, while the jet tube is in the non-extended position, the cutting length extends (space between 58 and 20) beyond the distal end of the catheter by a second length, the first length being greater than the second length (32 is configured to be translated relative to 20, therefore the extendable jet tube including 38 is configured for this), and
wherein an aim of the cutting jet stream toward the evacuation lumen (18) is maintained during transition between the non-extended position and the extended position (see MPEP 2112.01, PP [0057]: “the high pressure jet 58 may be considered as being pointed at least partially towards the distal opening 20 of the evacuation lumen 18”).
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 15 is rejected under 35 U.S.C. 103 as being further unpatentable over Jenson et al. (PGPub US 2008/0255596 A1).
Regarding claim 15, Jenson et al. fails to disclose wherein the jet nozzle is extendable to 5 mm distal to the evacuation lumen.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Jenson et al. disclosure such that the jet nozzle is extendable to 5 mm distal to the evacuation lumen because this limitation appears to be an arbitrary design choice which fails to patentably distinguish over the prior art of record and since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” (Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)). The present specification does not provide any statements of criticality regarding the amount the jet nozzle may be extended, stating only that “The jet tube 213 may be extendable. Thus, it may be flush with the distal end of the tip, and extend outward, up to, for example 2.5 mm beyond the tube opening” and “The jet tube 213 may incorporate a forward cutting design, with a straight tip, and may extend flush from the distal end of the evacuation lumen and outward, up until a suitable amount, such as 5 mm” (PP [0067]). Additionally, the device of Jenson et al. would operate the same with these dimensions as it currently does, since the device of Jenson et al. is also a thrombectomy catheter configured to remove a variety of differently sized thrombus with an extendable jet tube confirmed to translate relative to the evacuation catheter.
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 Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached on (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771