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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature canceled from the claims. No new matter should be entered.
In re claim 12, “one or more laser fibers mounted in an interior of the funnel”.
In re claim 16, “wherein the laser aperture is disposed on the capture device”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
While not necessarily unclear, it is conceivable that the following terms could be interpreted in ways other than the manner in which they are interpreted herein. Accordingly, Examiner seeks correction or confirmation of the following claim interpretations.
For examination purposes the limitation “wherein the capture device is configured to expand eccentrically respective to a center of the deployment sheath” is being interpreted as requiring the center of expansion of the capture device to be different than the center of expansion of the deployment sheath.
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 7, 16, and 17 are being 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 7,
There is insufficient antecedent basis for the limitation “the outer sheath”. For examination purposes, the limitation “the outer sheath” will be interpreted as “an outer sheath”.
There is insufficient antecedent basis for the limitation “the distal end”. For examination purposes, the limitation “the distal end” will be interpreted as “a distal end”.
In re claim 16, the limitation “wherein the laser aperture is disposed on the capture device”, raises a clarity concern. Specifically, it is unclear what Applicant means by the phrase “disposed on”. For example, does “dispose on” imply that the laser fiber is located on top of the capture device? or does the phrase imply that the laser aperture is simply in contact with the capture device? For examination purposes, the limitation “wherein the laser aperture is disposed on the capture device” is being interpreted as requiring the laser aperture to be in contact with the capture device.
In re claim 17, the limitation “A thrombectomy or atherectomy device, comprising: an intravascular clot retrieval device configured to mechanically transport clot material to a lumen of the intravascular clot retrieval device; and a laser aperture arranged to ablate the clot material as it is mechanically transported to the lumen of the intravascular clot retrieval device.”, promotes a clarity concern. Specifically, it is unclear how a “thrombectomy device” would further comprise “an intravascular clot retrieval device”, given that a thrombectomy device is an intravascular retrieval device. A thrombectomy device is an intravascular clot retrieval device as it is designed to be inserted into a patient’s vasculature (blood vessels, arteries, viens) to mechanically remove blood clots. For examination purposes the limitation “A thrombectomy or atherectomy device, comprising: an intravascular clot retrieval device configured to mechanically transport clot material to a lumen of the intravascular clot retrieval device; and a laser aperture arranged to ablate the clot material as it is mechanically transported to the lumen of the intravascular clot retrieval device.” will be interpreted as requiring “A thrombectomy or atherectomy device” that is configured to both mechanically transport clot material into its lumen, and includes a laser aperture arranged to ablate the clot material as it is mechanically transported into the lumen.
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, 10-15 and 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); 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 material of a clot (FIG. 6: 45; col. 2, lines 19-21) in a blood vessel (46) of a patient that is captured by the capture device (col. 6, lines 60-67).
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 in an interior of the funnel (col. 5, lines 59-63; col. 6, lines 17-22; col. 6, lines 56-60: “a plurality of laser fiber optics”).
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);
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 17, Tu discloses a thrombectomy or atherectomy device (abstract: “system for…removing blood clots”), comprising:
an intravascular clot retrieval device (FIG. 2, FIG. 5, FIG. 6) configured to mechanically transport clot material (45) 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 (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, 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 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 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.
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”.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Tu (US 6,068,645).
In re claim 16, Tu does not disclose wherein the laser aperture is disposed on the capture device (regarding the limitation “disposed on” see above section Claim Rejection 112 (In re claim 16)).
Tu further discloses an additional configuration of the thrombectomy device (FIG. 7, FIG. 8) where the laser aperture is disposed on the capture device (see element 26 in FIG. 8).
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 taught by Tu to be disposed on the capture device, as taught by another configuration of Tu. One would have been motivated to make this modification to ensure that the laser aperture is in close contact with clots captured by the capture device.
Claim 19 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 view of Yao et al. (CN 113693720).
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.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Hu et al. (CN 214342507) discloses a thrombectomy device with a self-expanding capture device (abstract).
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