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 Arguments
Applicant’s arguments filed on 06/12/2026 have been fully considered and are moot in view of a new grounds of rejection.
Claim Objections
Claim 1 is objected to because of the following informalities. Appropriate correction is required.
In re claim 1, the limitation “said capture device configured to capture move proximally material of a clot in a blood vessel of a patient;” should read “said capture device configured to capture and move proximally material of a clot in a blood vessel of a patient;”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention
In re claim 1,
The second instance of the limitation “a blood vessel” raises a clarity concern. Specifically, it is unclear whether the second instance of “a blood vessel” is meant to refer to the same blood vessel recited previously or a second different blood vessel. For examination purposes the second instance of the limitation “a blood vessel” will be interpreted as “the blood vessel”.
The second instance of the limitation “a patient” raises a clarity concern. Specifically, it is unclear whether the second instance of “a patient” is meant to refer to the same patient recited previously or a second different patient. For examination purposes the second instance of the limitation “a patient” will be interpreted as “the patient”.
Examiner notes that dependent claims 2-12 inherit the same deficiencies.
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.
Claims 1, 3, 4 and 10-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tu (US 6,068,645).
In re claim 1, Tu discloses thrombectomy or atherectomy device (abstract: “medical system for…removing blood clots”; FIG. 2) comprising:
a catheter (2);
a capture device (12; shown in greater detail in FIG. 5) disposed at a distal end (3) of the catheter, said capture device comprising
a distal end (right most end of 12) having a first width and
a proximal end (left most end of 12) having a second width
wherein said first width is different from said second width (FIG. 5);
said capture device configured to *capture move proximally material of a clot (FIG. 6: 45; col. 2, lines 19-21; col. 6, lines 64-67: “debris 45 tends to be entrapped at a proximal end”) in a blood vessel (46) of a patient; and
a laser aperture (21/26; col. 6, lines 21-23; col. 5, lines 37-38; col. 6, lines 56-60: “plurality of laser fiber optics”) disposed proximate to the capture device (FIG. 5) and configured to ablate the material of a clot in a blood vessel of a patient that is *captured and moved proximally by the capture device (col. 6, lines 60-67; FIG. 6).
*Examiner notes that under the broadest reasonable interpretation the capture device is configured to “capture and move proximally material of a clot” as it is retracted back into a lumen of the catheter (2; see FIG. 3 which shows “capture device” in a retracted state and FIGS. 4-6 which shows “capture device” in a deployed state).
In re claim 3, Tu discloses, wherein the capture device comprises an expandable structure configured to capture the material of the clot (col. 5, lines 57-65; col. 6, lines 6-10).
In re claim 4, Tu discloses, wherein the expandable structure comprises a cage or a basket (FIG. 2, FIG. 5).
In re claim 10, Tu discloses, wherein the laser aperture comprises an end or ends of one or more optical fibers (col. 6, lines 56-60: “plurality of laser fiber optics”) integrated into a portion of the capture device (FIG. 5).
In re claim 11, Tu discloses, wherein the capture device comprises a funnel (FIG. 2, FIG. 5; Examiner notes that under the broadest reasonable interpretation “a funnel” is being interpreted as a cone shaped tool designed to direct flow).
In re claim 12, Tu discloses, wherein the laser aperture comprises one or more laser fibers mounted adjacent to the funnel (col. 5, lines 59-63; col. 6, lines 17-22; col. 6, lines 56-60: “a plurality of laser fiber optics”; Examiner notes that under the broadest reasonable interpretation “a funnel” is being interpreted as a cone shaped tool designed to direct flow).
In re claim 13, Tu discloses a thrombectomy or atherectomy method (abstract: “methods for removing blood clots) comprising:
inserting a catheter (FIG. 5, FIG. 6: 2) carrying an expandible capture device (12) into a blood vessel (46) to deliver the capture device to a clot (45; col. 2, lines 19-21) disposed on an inner wall of the blood vessel (col. 3, lines 64- col. 4 line 5);
deploying the expandible capture device from a lumen (inside of 2) of the catheter (col. 4, lines 1-5) to a position (location where 12 touches 46) that is distal to a region of interest of the clot (location of clot accumulation; Examiner asserts that the “position” is distal to location of clot accumulation as shown in FIG. 6 and described in col. 6, lines 64-67);
retrieving the deployed expandible capture device back into the lumen of the catheter (col. 5, lines 32-35: “retractable”); and
during the deploying and/or during the retrieving, ablating material of the clot that is captured by the capture device with laser light (col. 6, lines 56-60: “debris treatment means may be…a plurality of laser fiber optics”) emitted by a laser aperture (26/27) disposed at a distal end of the catheter (3) or on the capture device.
In re claim 14, Tu discloses, wherein
the laser aperture is disposed at the distal end of the catheter (FIG. 5), and
the retrieving moves the material of the clot that is captured by the capture device toward the laser aperture to effectuate the ablation of the captured material with the laser light (FIG. 6; col. 6, lines 62-67).
In re claim 15, Tu discloses, wherein the ablation of the captured material occurs within a working distance of 200 microns or less from the laser aperture (FIG. 6; apparent as the captured material (46) is touching the laser aperture; col. 6, lines 64-67).
In re claim 16, Tu discloses, wherein the laser aperture is disposed adjacent to the capture device (FIG. 5, FIG. 6).
In re claim 17, Tu discloses, a thrombectomy or atherectomy device (abstract: “system for…removing blood clots”; FIGS. 2, 5 and 6: combination of 2, 12 and 21/26 ), comprising:
an intravascular clot retrieval device (combination of 2 and 12) configured to mechanically transport clot material (45) in a proximal direction (col. 6, lines 64-67: “debris 45 tends to be entrapped at a proximal end”) to a lumen (inside of 2) of the intravascular clot retrieval device (col. 5, lines 31-35; col. 5 lines 41-46) ; and
a laser aperture (21/26; col. 6, lines 21-23; col. 5, lines 37-38; col. 6, lines 56-60: “plurality of laser fiber optics”) arranged to ablate the clot material as it is mechanically transported to the lumen of the intravascular clot retrieval device by the intravascular clot retrieval device (col. 5, lines 31-46; col. 6, lines 64-67).
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.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 6,068,645), in view of Schmaltz (US 2006/0224155).
In re claim 2, Tu discloses wherein the capture device comprises a self-expanding device .
Tu does not disclose:
wherein the capture device comprises a self-expanding Nitinol device.
Schmaltz discloses an analogous thrombectomy device (FIG. 3) that uses a capturing element (124) made out of Nitinol [0038] to trap emboli (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the capturing device of Tu to be made out of Nitinol, as taught by Schmaltz. One would have been motivated to use Nitinol because of its unique properties, like shape memory (Schmaltz, [0038]).
Examiner notes however that even in the absence of Schmaltz, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the capture device out of Nitinol, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use or purpose.
Claims 5, 8, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 6,068,645), in view of Bruzzi et al. (US 10,743,907).
In re claim 5, Tu does not disclose,
wherein the catheter comprises a deployment sheath configured to deploy the capture device from a lumen of the deployment sheath.
Bruzzi, like Tu, discloses a thrombectomy device (abstract; Fig. 1) that includes a catheter (2) and a capturing device (3) disposed on a distal end of the catheter (Fig. 1). As discussed in Bruzzi, the thrombectomy device also includes a sheath (FIG. 8: 50) to help keep the capturing device in an unexpanded configuration (col. 11, lines 31-42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Tu to include a deployment sheath configured to deploy the capture device from a lumen of the deployment sheath, as taught by Bruzzi. One would have been motivated to make this modification to have more control over the expansion of the capturing device (Bruzzi, col. 11, lines 31-42).
In re claim 8, the proposed combination yields (all mapping directed to Tu) wherein the catheter further comprises
a tether (9) passing through the lumen of the deployment sheath (see above In re claim 5) and secured to the capture device (FIG. 5) to draw the capture device back into the lumen of the deployment sheath after deployment of the capture device (col. 5, lines 32-33: “retractable elongated element 9”) ;
an optical fiber or bundle of optical fibers (col. 6, lines 56-60: “plurality of laser fiber optics”) disposed in the lumen of the deployment sheath (FIG. 5)
wherein an end of the optical fiber or bundle of optical fibers defines the laser aperture (see above In re claim 1).
In re claim 18, Tu discloses, wherein the intravascular clot retrieval device comprises:
an expandable capture device (FIG. 2: 12, shown in greater detail in FIG. 5); and
a catheter (2) including a retrieval tether (9) secured to the expandable capture device (FIG. 5; col. 5, lines 32-41),
the catheter being configured to deploy the expandable capture device out of the lumen and to subsequently retrieve the deployed expandable capture device back into the lumen (see FIG. 3 which shows the expandable capture device in a non-deployable state and FIG. 4 which shows the expandable capture device in a deployable state);
wherein the laser aperture is arranged at a distal end (3) of the catheter to apply ablating laser light (col. 6, lines 56-59: “a plurality of laser fiber optics”) to the expandable capture device (FIG. 6; col. 6, lines 56-67) as the expandable capture device is retrieved back into the lumen (col. 5, lines 31-34).
Tu does not disclose the catheter including
a deployment sheath having a lumen receiving the expandable capture device and
a retrieval tether passing through the lumen and secured to the expandable structure
For substantially the same reasons as described above In re claim 5, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Tu to include a deployment sheath having a lumen receiving the expandable capture device, as taught by Bruzzi. Accordingly, such a modification would yield a retrieval tether “passing through the lumen”.
In re claim 20, the proposed combination yields (all mapping directed to Tu), wherein the laser aperture comprises an end of an optical fiber (col. 6, lines 56-59: “a plurality of laser fiber optics” )or optical fiber bundle disposed in the lumen .
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 6,068,645), in view of Bruzzi et al. (US 10,743,907), in view of Schmaltz (US 2006/0224155).
In re claim 6, the proposed combination does not yield,
wherein the catheter further comprises an outer sheath configured to enclose the deployment sheath.
Schmaltz discloses an analogous thrombectomy device (FIG. 3) that also uses a capturing element (124) to trap emboli (abstract). Schmaltz further discloses the thrombectomy device having a sleeve (102) that provides the thrombectomy device with characteristics that promote precise intravascular navigation and advancement [0035].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Tu to include an outer sheath, as taught by Schmaltz. One would have been motivated to make this modification because doing so would promote more precise intravascular navigation (Schmaltz, [0035]). Accordingly, such a modification would yield an outer sheath “configured to enclose the deployment sheath”.
Claim 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 6,068,645), in view of Bruzzi et al. (US 10,743,907), in view of Schmaltz (US 2006/0224155), in view of Yao et al. (CN 113693720).
In re claim 7, the proposed combination does not yield, wherein the laser aperture comprises a ring of optical fiber ends disposed at a circumference of the distal end of the outer sheath.
Yao discloses an analogous device that like the proposed combination delivers laser energy to treat a thrombotic material in a blood vessel (abstract). As disclosed by Yao, the laser energy is delivered by a ring of optical fibers (FIG. 2) located in a wall of a sleeve (3).
It would have been obvious to one of ordinary skill in the art to modify the laser aperture of the proposed combination to comprise a ring of optical fiber ends disposed at a circumference of the distal end of the outer sheath, as taught by Yao. One would have been motivated to make this modification because doing so would lead to a more even distribution of the laser energy.
In re claim 19, the proposed combination does not yield wherein
the catheter further includes an outer sheath surrounding the deployment sheath and
the laser aperture comprises a laser aperture ring disposed on the outer sheath.
Regarding the limitation “the catheter further includes an outer sheath surrounding the deployment sheath” for substantially the same reasons as described above In re claim 6, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of the proposed combination to further include an outer sheath, as taught by Schmaltz. Accordingly, such a modification would yield an outer sheath “surrounding the deployment sheath”.
Regarding the limitation “the laser aperture comprises a laser aperture ring disposed on the outer sheath” for substantially the same reasons as described above In re claim 7, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the laser aperture of the proposed combination to comprise a laser aperture ring disposed on the outer sheath, as taught by Yao.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 6,068,645), in view of Bruzzi et al. (US 10,743,907), in view of Ziebol et al. (US 2003/0711741).
In re claim 9, the proposed combination does not yield wherein the capture device is configured to expand eccentrically respective to a center of the deployment sheath (regarding the limitation “expand eccentrically” see above section Claim Interpretation).
Ziebol discloses an analogous thrombectomy device (FIG. 2R) that uses light from one or more optical fibers (16; [0026]) to ablate or irradiate a clot (abstract). The thrombectomy device also includes a basket (58R) attached to an end of the one or more optical fibers (FIG. 2R). As shown in FIG. 2R the basket has a unique shape with a center of expansion that is offset from a center of the thrombectomy device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the capture device of the proposed combination to be configured to expand eccentrically respective to a center, as taught by Ziebol. One would have been motivated to make this modification both because eccentrically expanded capture devices are known in the art and because one of ordinary skill in the art would have the ability to choose a capture device that would best meet their needs (Ziebol, FIG. 2R). Accordingly, such a modification would yield wherein the capture device is configured to expand eccentrically respective to a center “of the deployment sheath”.
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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
Prosecution Insights