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 .
Claim Objections
Claim 3 is objected to because of the following informalities: claim 3 should be amended to read: “wherein the apparatus further comprises a guidewire” since the guidewire is not positively recited in claim 1. Claim 7 is objected to and should be amended to recite: “…comprising one or more openings….” Claim 9 is objected to and should be amended to recite: “…free to move within the suction lumen….” Appropriate correction is required.
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 10 and 18 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 10 and 18 set forth that the guide channel is fluidly connected to the suction lumen. There is no disclosure of such a connection within the specification. All of the depicted embodiments show the guide channel as a separate and distinct lumen from the suction lumen, and the guide channel is only used for the passage of guiding elements or the diagnostic catheter. The limitation is not sufficiently disclosed so as to provide proper antecedent basis for the limitation in the disclosure. For this reason, the claim will be examined in the manner disclosed and depicted in the embodiments, whereby the guide channel is fluidly separate from the suction lumen.
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) 1-7, 9-15, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smalling (US 2007/0161963) in view of Shockey et al. (US 4,932,413).
Regarding claim 1, Smalling discloses an apparatus comprising: an elongate body (shaft 104; Figure 1) comprising a suction lumen (112, 114; ¶ [0033]) and an aspiration orifice (108a, 108b, 108c; ¶ [0033]) on a tapered side (the distal end as seen in Figure 1 is tapered as claimed; ¶ [0035]) of the flexible elongate body and in communication with the suction lumen (¶ [0033]), wherein the elongate body comprises a guide channel extending distally of the aspiration orifice (¶ [0031] discloses that the catheter can comprise a wire lumen, which is not shown, for passing the guidewire 122 through the catheter; the guide wire lumen extends to the terminal distal tip of the catheter which is distal to the openings as claimed). Smalling fails to explicitly disclose a diagnostic catheter movably positioned within the elongate body and extending distally out of the guide channel; and a guidewire channel extending through the diagnostic catheter wherein the guidewire channel is configured so that a guidewire is movably positioned within the diagnostic catheter and extendable distally out of the diagnostic catheter.
Shockey et al. (henceforth Shockey) teaches a guidewire exchange catheter (10; this catheter may be considered diagnostic as claimed) which is movable positioned within another catheter (34) body and which is capable of extending distally out of the guide channel of the catheter (Figures 2a-2c); and a guidewire channel (lumen for receiving either guidewires 36 or 38) extending through the diagnostic catheter (10; Figures 2a-2c) and wherein the guidewire is movably positionable within the diagnostic catheter and extendable distally out of the diagnostic catheter (Figures 2a-2c; Col. 4, lines 32-68).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the catheter system of Smalling to include the rapid exchange catheter device of Shockey so as to allow a user to swap different guidewires during insertion of a device, without requiring the removal of the fist guidewire, depending on the configuration of the vasculature, as taught by Shockey (e.g., Col. 4, lines 15-31).
Regarding claim 2, Smalling further discloses wherein the aspiration orifice (108a-108c) is eccentrically located on the tapered side of the flexible elongate body (Figure 1; the openings are offset from the centerline of the catheter lumen around the tip).
Regarding claim 3, Smalling further discloses wherein the apparatus comprises a guidewire (122, Figure 1).
Regarding claim 4, Smalling/Shockey further teach wherein the guidewire comprises a pre-bent steering region (see distal tip of guidewire 36 in Figure 2a).
Regarding claim 5, Smalling/Shockey further teach wherein the diagnostic catheter comprises a pre-bent steering region (absent some bend angle or reference, a straight end or steering section can meet the limitation; there’s no indication that the shaft was not straightened via bending during formation of the device).
Regarding claim 6, Smalling further discloses wherein the guide channel extends distally along the length of the elongate body (Figure 1, the guide channel, which is not depicted, extends along the length of the catheter to the distal tip; see ¶ [0031] for disclosure of the wire lumen).
Regarding claim 7, Smalling further discloses one or more openings through the elongate body opposite from the aspiration opening (Smalling can be interpreted whereby openings 108A are the aspiration openings, and openings 108C can be considered “opposite” from them as they extend across some arbitrary plane between the openings; the claim does not require the openings to be on the opposite side of the body wherein the opposite side is across the longitudinal axis of the elongate body).
Regarding claim 9, Smalling/Shockey further teach wherein the diagnostic catheter is radially and longitudinally free to move within the suction lumen proximal to the guide channel (the limitation is broad enough to be interpreted wherein the exchange catheter of Shockey can be placed into one of the aspiration lumens prior to being inserted into the guide channel and it would be free to move as claimed within the lumen before being removed and inserted into the actual intended guide channel during a procedure).
Regarding claim 10, Smalling further discloses wherein the guide channel is fluidly separate from the suction lumen (the guide channel of smalling, which is not depicted, is a separate lumen extending through the elongate body and which is fluidly separate from the aspiration lumens).
Regarding claim 11, Smalling discloses an apparatus comprising: an elongate body (shaft 104, Figure 1) comprising a suction lumen (112, 114; ¶ [0033]) and an aspiration orifice (108a, 108b, 108c; ¶ [0033]) that is eccentrically located on a tapered lateral portion of the flexible elongate body (the distal end as seen in Figure 1 is tapered as claimed; ¶ [0035]; the openings are offset from the centerline of the catheter lumen around the tip and are therefore considered eccentric as claimed) and in communication with the suction lumen, wherein the elongate body further comprises a guide channel extending distally of the aspiration orifice (¶ [0031] discloses that the catheter can comprise a wire lumen, which is not shown, for passing the guidewire 122 through the catheter; the guide wire lumen extends to the terminal distal tip of the catheter which is distal to the openings as claimed); and a guidewire (122) movably held within and extending distally out of the elongate body (Figure 1, the guidewire extends through a guidewire lumen and out the distal end of the catheter as claimed). Smalling fails to explicitly disclose the use of a diagnostic catheter within the guide channel or the pre-bent steering region of the guidewire or diagnostic catheter.
Shockey et al. (henceforth Shockey) teaches a guidewire exchange catheter (10; this catheter may be considered diagnostic as claimed) which is movable positioned within another catheter (34) body and which is capable of extending distally out of the guide channel of the catheter (Figures 2a-2c); and a guidewire channel (lumen for receiving either guidewires 36 or 38) extending through the diagnostic catheter (10; Figures 2a-2c) and wherein the guidewire is movably positionable within the diagnostic catheter and extendable distally out of the diagnostic catheter (Figures 2a-2c; Col. 4, lines 32-68); and wherein the guidewire comprises a pre-bent steering region (see distal tip of guidewire 36 in Figure 2a).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the catheter system of Smalling to include the rapid exchange catheter device of Shockey so as to allow a user to swap different guidewires during insertion of a device, without requiring the removal of the fist guidewire, depending on the configuration of the vasculature, as taught by Shockey (e.g., Col. 4, lines 15-31).
Regarding claim 12, Smalling/Shockey further teach wherein the guidewire comprises a pre-bent steering region (see distal tip of guidewire 36 in Figure 2a).
Regarding claim 13, Smalling/Shockey further teach wherein the diagnostic catheter comprises a pre-bent steering region (absent some bend angle or reference, a straight end or steering section can meet the limitation; there’s no indication that the shaft was not straightened via bending during formation of the device).
Regarding claim 14, Smalling further discloses wherein the guide channel extends distally along the length of the elongate body (Figure 1, the guide channel, which is not depicted, extends along the length of the catheter to the distal tip; see ¶ [0031] for disclosure of the wire lumen).
Regarding claim 15, Smalling further discloses one or more openings through the elongate body opposite from the aspiration opening (Smalling can be interpreted whereby openings 108A are the aspiration openings, and openings 108C can be considered “opposite” from them as they extend across some arbitrary plane between the openings; the claim does not require the openings to be on the opposite side of the body wherein the opposite side is across the longitudinal axis of the elongate body).
Regarding claim 17, Smalling/Shockey further teach wherein the diagnostic catheter is radially and longitudinally free to move within the suction lumen proximal to the guide channel (the limitation is broad enough to be interpreted wherein the exchange catheter of Shockey can be placed into one of the aspiration lumens prior to being inserted into the guide channel and it would be free to move as claimed within the lumen before being removed and inserted into the actual intended guide channel during a procedure).
Regarding claim 18, Smalling further discloses wherein the guide channel is fluidly separate from the suction lumen (the guide channel of smalling, which is not depicted, is a separate lumen extending through the elongate body and which is fluidly separate from the aspiration lumens).
Claim(s) 8 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smalling in view of Shockey, and further in view of Osypka (US 2015/0250982).
Regarding claims 8 and 16, Smalling/Shockey teach the claimed invention substantially as set forth above for claims 1 and 11 but fail to teach one or more sensors in communication with the aspiration opening.
Osypka teaches (Figure 2) a catheter (10) comprising an opening (6) and one or more sensors (7a, 7b) in communication with the opening (¶ [0023], the sensors are used to surround the opening so as to allow exact positioning of the opening at the desired site; this is considered to be in communication with the opening as the two sensors span the opening to provide such a location).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the catheter system of Smalling/Shockey to comprise the positioning electrodes of Osypka so as to provide a means of locating the openings precisely at the desired treatment site as taught by Osypka.
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smalling in view of Shockey, and further in view of Millar (US 4,771,782).
Regarding claim 19, Smalling/Shockey teach the structure of the thrombectomy device substantially as set forth above for claims 1 and 11, however, they fail to explicily teach the positioning and advancing steps as claimed.
Millar teaches a known catheter insertion method which comprises the steps of positioning a guidewire within a vessel lumen, advancing a first device over the guidewire within the vessel lumen, and advancing a second device over the first device and the guidewire to the target treatment location within the vessel lumen (Col. 3, lines 30-58).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of use of the catheter device of Smalling/Shockey so that the guidewire is introduced, then the diagnostic catheter, and finally the elongate body, since Millar teaches that such an insertion method is known in the art for the placement of vascular interventional devices and provides a means for accurately locating the catheter at the treatment site.
Regarding claim 20, Smalling/Shockey further teach eccentrically rotating the thrombectomy apparatus within the vessel lumen over the diagnostic catheter (see ¶¶ [0029] and [0048] of Smalling which disclose the catheter is rotated during use).
Regarding claim 21, Regarding claim 13, Smalling/Shockey further teach wherein the diagnostic catheter comprises a pre-bent steering region (absent some bend angle or reference, a straight end or steering section can meet the limitation; there’s no indication that the shaft was not straightened via bending during formation of the device) and the guidewire comprises a pre-bent guidewire (see distal tip of guidewire 36 in Figure 2a of Shockey) .
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
