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 .
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 3-6 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.
Claims 3-6 recite “the one or more tethers.” There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-4, 7-8, 10-12, 16-18, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by de Palma et al. [US 2012/0059309 A1, hereinafter “di Palma”].
Re. claim 1, di Palma discloses: A thrombus removal device [Pars. 0008; 7C-7D], comprising
an elongate shaft [110];
at least one aspiration lumen in the elongate shaft [the space between 10 and 110, as an spiration lumen as described in Par. 0055];
a funnel [“expandable cone member” 120] disposed at or near a distal end of the elongate shaft [Fig. 7C]; and
an expandable scaffold assembly [“expandable infusion segment” 20] deployable distally from the funnel [Figs. 7C-D], the scaffold assembly being configured to capture clots [Fig. 7D; “any thrombus debris…may be dragged…by retracting… expandable infusion segment 20. Alternatively, the expandable infusion segment 20 can be used to hold the thrombus 134 stationary while distally advancing the expandable cone member 120,” Par. 0055];
wherein an axial position of the scaffold assembly relative to the funnel is adjustable to bring the scaffold assembly near or into contact with the funnel to aspirate clots in the scaffold assembly through the funnel [Figs. 7C-D; Par. 0055].
Re. claim 2, di Palma discloses: The system of claim 1, further comprising one or more tethers [10] coupled to the scaffold assembly.
Re. claim 3, di Palma discloses: The system of claim 1, wherein the one or more tethers [10] are routed internally to the elongate shaft [10 is internal to 110, Fig. 7C-D].
Re. claim 4, di Palma discloses the one or more tethers [10] are routed internally to the funnel [Fig. 7C-D].
Re. claim 7, di Palma discloses The system of claim 2, wherein the one or more tethers are configured to adjust the axial position of the scaffold assembly relative to the funnel [Par. 0055].
Re. claim 8, di Palma discloses The system of claim 1, wherein the funnel is configured to engage with the scaffold assembly [Par. 0055].
Re. claim 10, di Palma discloses The system of claim 8, wherein the scaffold assembly is configured to be inserted into the funnel [see Fig. 7D and Par. 0051 and 0054].
Re. claim 11, di Palma discloses The system of claim 8, wherein a proximal opening of the scaffold assembly is configured to mate with the funnel [see Fig. 7D and Par. 0051 and 0054].
Re. claim 12, di Palma discloses The system of claim 1, wherein the thrombus removal device is configured to produce one or more fluid streams within the funnel to interact with clots in the funnel or scaffold assembly [Par. 0055].
Re. claim 16, di Palma discloses The The system of claim 1, wherein the scaffold assembly is configured to self- expand from a delivery configuration to a deployed configuration [Par. 0039].
Re. claim 17, di Palma discloses: A thrombectomy method [Par. 0008, Figs. 7C-7D], comprising:
positioning a thrombectomy device [comprising 5, 10, 110, 120, together] near a target thrombus in a patient [Fig. 7C-D, Par. 0054];
deploying a scaffold assembly [20] from the thrombectomy device [Par. 0054];
capturing the target thrombus in the scaffold assembly [“the expandable infusion segment 20 can be used to hold the thrombus 134 stationary while distally advancing the expandable cone member 120,” Par. 0055];
positioning a funnel of the thrombectomy device near or in contact with the scaffold assembly [Figs. 7C-D]; and
aspirating the target thrombus from the scaffold assembly through the funnel with the thrombectomy device [“Clot fragments can be aspirated into an annular space between the outer wall or shaft 10 and the inner wall or shaft 110 and out of the hub,” Par. 0055, Fig. 7D].
Re. claim 18, di Palma discloses: The method of claim 17, wherein the thrombectomy device is positioned proximal to the target thrombus [Figs. 7C-D].
Re. claim 20, di Palma discloses: the scaffold assembly is deployed distal to the target thrombus [Fig. 7C].
Claim(s) 1-9, 11, 13, 17-18, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen et al. [US 20170035445 A1, hereinafter “Nguyen”].
Re. claim 1, Nguyen discloses: A thrombus removal device [Pars. 0003, Figs. 5-9], comprising
an elongate shaft [2];
at least one aspiration lumen in the elongate shaft [“suction catheter 2 can function to aspirate thrombus,” Par. 0106];
a funnel [“distal funnel tip” 9] disposed at or near a distal end of the elongate shaft [Fig. 9]; and
an expandable scaffold assembly [“ALTC device” 8] deployable distally from the funnel [Fig. 9], the scaffold assembly being configured to capture clots [Par. 0071];
wherein an axial position of the scaffold assembly relative to the funnel is adjustable to bring the scaffold assembly near or into contact with the funnel to aspirate clots in the scaffold assembly through the funnel [Figs. 5-7, Par. 0106].
Re. claim 2, Nguyen discloses: The system of claim 1, further comprising one or more tethers [10] coupled to the scaffold assembly.
Re. claim 5, Nguyen discloses: The system of claim 1, wherein the one or more tethers [10] are routed externally to the elongate shaft [Fig. 9].
Re. claim 6, Nguyen discloses: the one or more tethers [10] are routed externally to the funnel [Fig. 9].
Re. claim 7, Nguyen discloses The system of claim 2, wherein the one or more tethers are configured to adjust the axial position of the scaffold assembly relative to the funnel [Par. 0095].
Re. claim 8, Nguyen discloses The system of claim 1, wherein the funnel is configured to engage with the scaffold assembly [Fig. 7].
Re. claim 9, Nguyen discloses The system of claim 8, wherein the funnel is configured to be inserted into the scaffold assembly [Fig. 7].
Re. claim 11, Nguyen discloses The system of claim 8, wherein a proximal opening of the scaffold assembly is configured to mate with the funnel [Fig. 7].
Re. claim 13, Nguyen discloses the scaffold assembly is configured to evert [Par. 0085] into the funnel [Par. 0071 discloses that the scaffold assembly may be positioned inside the housing of 2. Thus, it may be positioned inside the funnel 9. Because it may evert upon expansion, reversing this process results in the scaffold assembly “everting” inside funnel 9].
Re. claim 17, Nguyen discloses: A thrombectomy method [Par. 0021], comprising:
positioning a thrombectomy device [Fig. 5, excluding element 8] near a target thrombus in a patient [“positioning the expanding guiding catheter such that a distal end of the device is proximal to a thrombus; retracting the expanding guide catheter outer member to expand a funnel tip and exposing an expandable inner member; advancing a thrombus capture device comprising a capture assembly through the expanding guide catheter; positioning the thrombus capture device such that a distal end of the device is distal to or within the thrombus,” Par. 0021];
deploying a scaffold assembly [“capture device”] from the thrombectomy device [“actuating the capture assembly to isolate the thrombus within the capture device, wherein the capture assembly is movable from a first configuration having a first axial length and a second configuration having a second axial length,” Par. 0021];
capturing the target thrombus in the scaffold assembly [“isolate the thrombus within the capture device,” Par. 0021];
positioning a funnel [9] of the thrombectomy device near or in contact with the scaffold assembly [Figs. 5-7]; and
aspirating the target thrombus from the scaffold assembly through the funnel with the thrombectomy device [“retracting the thrombus into an expanding guide catheter funnel tip and expandable inner body,” Par. 0021, and “suction catheter 2 can function to aspirate thrombus within the ALTC Device 8,” Par. 0106].
Re. claim 18, Nguyen discloses: The method of claim 17, wherein the thrombectomy device is positioned proximal to the target thrombus [“positioning the expanding guiding catheter such that a distal end of the device is proximal to a thrombus,” Par. 0021].
Re. claim 20, Nguyen discloses: the scaffold assembly is deployed distal to the target thrombus [“positioning the thrombus capture device such that a distal end of the device is distal to or within the thrombus,” Par. 0021].
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.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Wallace et al. [US 20210068854 A1, hereinafter “Wallace”]
Re. claim 14, Nguyen discloses the scaffold assembly is configured to evert [Par. 0085] into the funnel [Par. 0071 discloses that the scaffold assembly may be positioned inside the housing of 2. Thus, it may be positioned inside the funnel 9. Because it may evert upon expansion, reversing this process results in the scaffold assembly “everting” inside funnel 9]. Nguyen fails to disclose manipulation of one or more tethers causing this eversion. However, Wallace teaches manipulation of one or more tethers [“puller,” Par. 0008] coupled to a scaffold is configured to evert the scaffold assembly [Par. 0008]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Nguyen by adding a tether to ever the scaffold, as taught by Wallace, in order to allow a user to control the eversion process.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over di Palma or Nguyen in view of Macoviak et al. [US 6361545 B1, hereinafter “Macoviak”]
Re. claim 15, di Palma or Nguyen fails to teach the scaffold assembly comprising a superelastic material. However, Macoviak teaches a scaffold assembly [394, Fig. 32] comprises a superelastic material [Col. 17 lines 40-45]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of di Palma or Nguyen by forming the scaffold assembly of superelastic material because this amounts to a simple substitution of one material known in the art as suitable for another with predictable results.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over di Palma or Nguyen in view of Tran et al. [US 20190365395 A1, hereinafter “Tran”]
Re. claim 19, di Palma or Nguyen fails to teach wherein the thrombectomy device is positioned distal to the target thrombus. However, Tran teaches a thrombectomy method wherein the thrombectomy device is positioned distal to the target thrombus [Figs. 2A-C]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of di Palma or Nguyen by placing the thrombectomy device distal to the target thrombus as taught by Tran, in order to prevent the clot from migrating distally during the procedure [Par. 0017].
Conclusion
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
