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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/7/26 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/311,797 in view of Wilson et al. (US 2018/0193042 A1) (“Wilson”).
Regarding claims 1 and 20, copending Application No. 18/311,797 discloses a method of treating a vasculature (claim 1), the method comprising: advancing a catheter system through a base sheath towards a vessel having a blood vessel narrowing, wherein the vessel is at least at a level of a carotid artery or a cerebral artery (claim 1), the catheter system comprising: an inner catheter comprising no more than one lumen and having a non-expandable, flexible, distal end region with a taper (claim 1); and an outer catheter having a catheter lumen and a distal end (claim 1); positioning the taper of the distal end region of the inner catheter distal to the distal end of the outer catheter (claim 1); and crossing the blood vessel narrowing with the taper to dilate the blood vessel narrowing (claim 1). Copending application 18/311,797 fails to disclose at least one radiopaque marker to identify a proximal end of the taper, a second radiopaque marker identifying a distal end of the inn catheter, and crossing the blood vessel narrowing based on a position of the at least one radiopaque marker relative to the blood vessel narrowing.
Wilson teaches (Figures 2A and 2B) an inner catheter (300) comprising no more than one lumen (368; paragraph 0150) and having a non-expandable, flexible, distal end region (346) with a taper and at least one radiopaque marker (344a/344b) to identify the taper (paragraphs 0145, 0158). Wilson further teaches (Figure 7C) a distal end region can have a first radiopaque marker (344a) and a second radiopaque marker (344b) can be located to indicate the border between the tapering of the distal tip (346) and the more proximal region of the inner catheter. This provides a user with information regarding an optimal extension of the distal tip (346) relative to the outer catheter (paragraph 0158).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the copending Application to comprises at least one radiopaque marker to identify a proximal end of the taper and the inner catheter to further comprise a second radiopaque marker identifying a distal end of the inner catheter, as taught by Wilson. This modification would provide a user with information regarding an optimal extension of the distal tip of the inner catheter relative to the outer catheter during a procedure (Wilson, paragraph 0158) and would provide a user with a visual indication that an entirety of the tapered tip crossed the blood vessel narrowing during the procedure.
This is a provisional nonstatutory double patenting rejection.
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.
Claim 28 is 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.
Claim 28 recites that the method further requires a second radiopaque marker identifying a distal end of the inner catheter. Claim 28 is dependent on claim 23. There is not a first radiopaque marker recited in claim 23. Claim 28 is indefinite because it is unclear how many radiopaque markers the invention has. Appropriate correction is required.
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.
Claims 1, 3-5, 7, 16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 2019/0255299 A1) (“Fischell”) in view of Jago (US 2020/0253579 A1) and Stenzel (US 2007/0010863 A1).
Regarding claims 1, 5, and 7, Fischell discloses (Figures 23A-23F) a method of treating a vasculature (45), the method comprising: advancing a catheter system through a base sheath (44) towards a vessel having a blood vessel narrowing (52), the catheter system comprising: an inner catheter (54) having a non-expandable, flexible, distal end region (118) with a taper (paragraphs 0037, 0125) and at least one radiopaque marker (310) to identify the taper (Figure 8A; paragraph 0195); and an outer catheter (142) having a catheter lumen and a distal end; positioning the taper of the distal end region (118) of the inner catheter distal to the distal end of the outer catheter (Figure 23A); and crossing the blood vessel narrowing with the taper based on a position of the at least one radiopaque marker relative to the blood vessel narrowing to dilate the blood vessel narrowing (Figures 23B, 23C; paragraphs 0205-0207). Fischell fails to disclose that the vessel is at least at a level of a carotid artery or a cerebral artery, wherein the blood vessel narrowing is a proximal atherosclerotic lesion in a proximal vessel that is a common carotid artery, an external carotid artery, or an internal carotid artery, and wherein crossing the blood vessel narrowing comprises advancing the catheter system through the proximal atherosclerotic lesion and advancing towards a distal blood vessel occlusion in a distal vessel. Fischell also fails to disclose that the inner catheter comprises no more than one lumen and that the distal end region is substantially unreinforced and fully polymeric. Fischell discloses that the inner catheter serves to pre-dilate a lesion with a pre-dilatation balloon (96; paragraph 0125).
Jago teaches (Figure 2) that it is known in the art for a proximal atherosclerotic lesion (72) to be formed in a proximal vessel and a distal occlusion to form in a distal vessel (74). Jago teaches that the proximal vessel is a common carotid artery (10a) and the distal vessel is a distal carotid artery (10b).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Fischell treat a blood vessel narrowing at the level of a carotid artery, wherein the blood vessel narrowing is a proximal atherosclerotic lesion in a proximal vessel that is a common carotid artery, and wherein crossing the blood vessel narrowing comprises advancing the catheter system through the proximal atherosclerotic lesion and advancing towards a distal blood vessel occlusion in a distal vessel, as Jago teaches it is known in the art for obstructions to form in the common carotid artery and the distal carotid artery. This modification would treat an occlusion that restricts flow of blood to the brain (Jago, paragraph 0013).
In the same field of endeavor, Stenzel teaches (Figures 11-13) advancing a catheter (30) with a single (NOTE: Figure 11 depicts a balloon. However, Stenzel teaches the device may include an inflation balloon) lumen (38) and a flexible (paragraphs 0033 and 0035), distal tapered end region (20) over a guidewire (12) to a lesion (16). Stenzel teaches the guidewire (12) is positioned within the single lumen (38) of the inner catheter (Figure 11). Stenzel teaches the size and shape of the lesion (16) may block the vessel (14) to the extent that the guidewire is unable to cross the lesion (16). Stenzel teaches using the tapered end region (20) of inner catheter (30) to cross an occlusion (16) in the artery (Figures 12 and 13). Stenzel teaches (Figures 12 and 13) that the tapered end region (20) of the inner catheter (30) pre-dilates the occlusion (16) in the artery (14) as the catheter system is advanced (Stenzel, paragraph 0061). Stenzel teaches that the distal tapered end region is substantially unreinforced and fully polymeric (paragraphs 0033 and 0035).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the inner catheter having a single lumen configuration and a substantially unreinforced and fully polymeric distal end region, taught by Stenzel, for the inflatable inner catheter configuration taught by Fischell in view of Jago. Substitution of one known element (the pre-dilating catheter configuration taught by Stenzel) for another element (the expandable pre-dilating inner catheter configuration disclosed by Fischell) providing the same function to yield predictable results (pre-dilating occlusions to allow the catheter system to pass through occlusions where the size and shape of the occlusion may block the vessel) would have been obvious to one of ordinary skill in the art at the time of the invention.
Regarding claim 3, Fischell as modified by Jago and Stenzel teaches that the blood vessel narrowing (52) is due to an atherosclerotic lesion (Fischell, paragraph 0145).
Regarding claim 4, Fischell as modified by Jago and Stenzel teaches withdrawing the inner catheter from the catheter lumen (Fischell, Figure 23E); advancing a stent delivery system comprising a stent (200) through the catheter lumen; and deploying the stent of the stent delivery system against the atherosclerotic lesion (Fischell, Figure 23F; paragraph 0211).
Regarding claim 16, Fischell as modified by Jago and Stenzel teaches (Stenzel Figure 11) inner catheter comprises a maximum outer diameter and the taper of the distal end region tapers from the maximum outer diameter to a second outer diameter at a distal-most end.
Regarding claim 21, Fischell as modified by Jago and Stenzel teaches (Fischell, Figures 23A-23F) advancing the catheter system through the base sheath comprises advancing the catheter system over a guidewire (42).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 2019/0255299 A1) (“Fischell”) in view of Jago (US 2020/0253579 A1) and Stenzel (US 2007/0010863 A1) as applied to claim 5 above, and further in view of Chermoni (US 2002/0156496 A1).
Regarding claim 6, Fischell as modified by Jago and Chermoni teaches the invention substantially as claimed. However, the combined teaching fails to teach treating the distal blood vessel occlusion.
In the same field of endeavor, Chermoni teaches that it is often necessary to treat multiple occlusions in a single procedure. For example, it may be necessary to insert a large diameter stent at one location, a small diameter stent at a second location and to perform a balloon angioplasty without a stent at a third location (paragraph 0003). Chermoni teaches (Figures 1-13) that a catheter system is inserted towards a distal occlusion, but first treats a first desired location, a first occlusion. After the first occlusion is treated, the catheter is navigated to the distal occlusion, and the distal occlusion is treated (paragraph 0044).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to first treat a proximal occlusion in a proximal vessel and then navigate the catheter system towards a distal occlusion in a distal vessel, and then treat the distal occlusion, as taught by Chermoni. This modification would allow multiple occlusions to be treated in the same procedure, without removing the catheter system from the body, which would cause much discomfort to the patient, prolong the duration of the procedure, and increase the chances of damaging a blood vessel (Chermoni, paragraph 0003).
Claims 8, 9, 14, 15, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 2019/0255299 A1) (“Fischell”) in view of Jago (US 2020/0253579 A1) and Stenzel (US 2007/0010863 A1) as applied to claim 1 above, and further in view of Wilson et al. (US 2018/0193042 A1) (“Wilson”).
Regarding claims 8 and 9, Fischell as modified by Jago and Stenzel teaches the invention substantially as claimed. However, the combined teaching fails to teach the taper of the distal end region is 0.5 cm - 4.0 cm and the taper has a taper angle relative to a center line of the distal end region that is 0.9 - 1.6 degrees.
Wilson teaches (Figures 2A and 2B) an inner catheter (300) comprising no more than one lumen (368; paragraph 0150) and having a non-expandable, flexible, distal end region (346) with a taper and at least one radiopaque marker (344a/344b) to identify the taper (paragraphs 0145, 0158), wherein the taper of the distal end region is 0.5 cm - 4.0 cm (paragraph 0166), and wherein the taper has a taper angle relative to a center line of the distal end region that is 0.9 - 1.6 degrees (paragraph 0145).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the taper of the distal end region to be 0.5 cm - 4.0 cm and the taper to have a taper angle relative to a center line of the distal end region that is 0.9 - 1.6 degrees, as taught by Wilson. This modification provides a tapered tip with dimensions that facilitate improved tracking through a tortuous and often diseased vasculature (Wilson, paragraph 0161).
Regarding claims 14 and 15, Fischell as modified by Jago and Stenzel teaches the invention substantially as claimed. However, the combined teaching fails to teach an outer diameter of the outer catheter approaches a size of an intracranial vessel, wherein the intracranial vessel is located between a cervical carotid to an M2 segment of a cerebral vessel.
Wilson further teaches an outer diameter of an outer catheter (200) approaches a size of an intracranial vessel, wherein the intracranial vessel is located between a cervical carotid to an M2 segment of a cerebral vessel (paragraphs 0097, 0105, 0107, 0144).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify an outer diameter of the outer catheter to approach a size of an intracranial vessel, wherein the intracranial vessel is located between a cervical carotid to an M2 segment of a cerebral vessel, as taught by Wilson. This modification would provide a catheter system sized to navigate the carotid anatomy in order to treat various neurovascular pathologies at the level of the cerebral arteries, such as acute ischemic stroke (Wilson, paragraph 0065).
Regarding claim 20, Fischell as modified by Jago and Stenzel teaches the invention substantially as claimed. However, the combined teaching fails to explicitly teach the at least one radiopaque marker identifies a proximal end of the taper and the inner catheter further comprises a second radiopaque marker identifying a distal end of the inner catheter.
Wilson further teaches (Figure 7C) a distal end region can have a first radiopaque marker (344a) and a second radiopaque marker (344b) can be located to indicate the border between the tapering of the distal tip (346) and the more proximal region of the inner catheter. This provides a user with information regarding an optimal extension of the distal tip (346) relative to the outer catheter (paragraph 0158).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one radiopaque marker to identify a proximal end of the taper and the inner catheter to further comprise a second radiopaque marker identifying a distal end of the inner catheter, as taught by Wilson. This modification would provide a user with information regarding an optimal extension of the distal tip of the inner catheter relative to the outer catheter during a procedure (Wilson, paragraph 0158) and would provide a user with a visual indication that an entirety of the tapered tip crossed the blood vessel narrowing during the procedure.
Regarding claim 22, Fischell as modified by Jago and Stenzel teaches the invention substantially as claimed. However, the combined teaching fails to teach advancing the catheter system through the base sheath comprises advancing the catheter system without a guidewire.
Wilson further teaches that the catheter system can be advanced together with a guidewire, over a guidewire pre-positioned, or without any guidewire at all (paragraphs 0150, 0167).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter system such that advancing the catheter system through the base sheath comprises advancing the catheter system without a guidewire, as taught by Wilson. Wilson teaches that it was well known in the art before the effective filing date of the claimed invention to advance a catheter system without a guidewire to effectively reach a treatment location (Wilson, paragraphs 0150, 0167). This modification would reduce the number of steps in the procedure.
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 2019/0255299 A1) (“Fischell”) in view of Jago (US 2020/0253579 A1) and Stenzel (US 2007/0010863 A1) as applied to claim 1 above, and further in view of Mas et al. (US 2009/0270808 A1) (“Mas”).
Regarding claims 10 and 11, Fischell as modified by Jago and Stenzel teaches the invention substantially as claimed. The combined teaching teaches that that blood vessel narrowing (52) is an atherosclerotic lesion. However, the combined teaching fails to explicitly teach prior to crossing the atherosclerotic lesion, positioning the distal end of the outer catheter proximal to the atherosclerotic lesion; withdrawing the inner catheter from the catheter lumen; and aspirating the atherosclerotic lesion through the catheter lumen, wherein withdrawing the inner catheter creates an internal vacuum within the distal end of the outer catheter and draws embolic material towards and/or through the distal end of the outer catheter.
Mas teaches (Figures 10 and 11) aspiration catheters are used commonly in connection with interventional vascular procedures such as angioplasty, atherectomy, stent placement, and the like to aspirate debris that may result from an interventional procedure (paragraph 0002). Mas teaches positioning a distal end of an outer catheter (28) proximal to a clot/lesion/debris (48); withdrawing an inner catheter (74) from the catheter lumen; and aspirating the clot/lesion/debris through the catheter lumen, wherein withdrawing the inner catheter creates an internal vacuum within the distal end of the outer catheter and draws embolic material towards and/or through the distal end of the outer catheter (paragraph 0035).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Fischell in view of Jago and Stenzel such that prior to crossing the atherosclerotic lesion, positioning the distal end of the outer catheter proximal to the atherosclerotic lesion; withdrawing the inner catheter from the catheter lumen; and aspirating the atherosclerotic lesion through the catheter lumen, wherein withdrawing the inner catheter creates an internal vacuum within the distal end of the outer catheter and draws embolic material towards and/or through the distal end of the outer catheter, as taught by Mas. This modification would aspirate debris and reduce the significant medical risk of migration downstream with blood flow. This modification would also remove thrombus that form on the luminal wall of the vessel that causes a clinically significant, even a total occlusion (Mas, paragraph 0002).
Regarding claim 12, Fischell as modified by Jago, Stenzel, and Mas teaches (Fischell, Figures 23A-23F) the atherosclerotic lesion (52) is a partial occlusion or a complete occlusion.
Regarding claim 13, Fischell as modified by Jago, Stenzel, and Mas teaches (Stenzel, Figures 11-13) probing the atherosclerotic lesion with the distal end region (20) of the inner catheter and finding a passage through the atherosclerotic lesion prior to crossing the atherosclerotic lesion and dilating the atherosclerotic lesion as the distal end region advances through the passage (Stenzel, paragraph 0063).
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 2019/0255299 A1) (“Fischell”) in view of Jago (US 2020/0253579 A1) and Stenzel (US 2007/0010863 A1) as applied to claim 16 above, and further in view of Wilson et al. (US 2018/0193042 A1) (“Wilson”).
Regarding claims 17-19, Fischell as modified by Jago and Stenzel teaches the invention substantially as claimed. However, the combined teaching fails to explicitly teach the maximum outer diameter approaches an inner diameter of the catheter lumen, wherein the maximum outer diameter is about 0.048" to about 0.080", and wherein the inner diameter of the catheter lumen is about 0.054" to about 0.088".
Wilson teaches (Figures 2A and 2B) an inner catheter (300) that comprises a maximum outer diameter that is between about 0.048” to about 0.080” and a taper (346) of the distal end region tapers from the maximum outer diameter to a second outer diameter at a distal-most end. Wilson teaches that the maximum outer diameter approaches an inner diameter of the catheter lumen, wherein the inner diameter of the catheter lumen is about 0.054" to about 0.088" (paragraph 0148). This produces an appropriately sized gap between the inner catheter and the outer catheter while still maintaining a high degree of flexibility for navigating tortuous anatomy (paragraph 0147).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the maximum outer diameter to approach an inner diameter of the catheter lumen, wherein the maximum outer diameter is about 0.048" to about 0.080", and wherein the inner diameter of the catheter lumen is about 0.054" to about 0.088", as taught by Wilson. This modification would result in an appropriately sized gap between the inner catheter and the outer catheter while still maintaining a high degree of flexibility for navigating tortuous anatomy (Wilson, paragraph 0147). When the gap between the two components is too tight (e.g. less than about 0.003″), the force needed to slide the inner catheter relative to the outer catheter can result in damage to one or both of the components and increases risk to the patient during the procedure. The gap results in too tight of a fit to provide optimum relative sliding. When the gap between the two components is too loose (e.g. greater than about 0.010″), the distal end of the outer catheter forms a lip that is prone to catch on branching vessels during advancement through tortuous vasculature (Wilson, paragraph 0147).
Claims 23, 24, 28, and 30 rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 2019/0255299 A1) (“Fischell”) in view of Chermoni (US 2002/0156496 A1) and Jago (US 2020/0253579 A1).
Regarding claim 23, Fischell discloses (Figures 23A-23F) a method of treating a vasculature (45), the method comprising: inserting a catheter system through a base sheath (44) and towards an occlusion (52) in a vessel, the catheter system comprising: an outer catheter (142) having a catheter lumen; and an inner catheter (54) sized to insert through the catheter lumen, the inner catheter comprising a flexible, distal end region (118) with a taper (paragraphs 0037, 0125); advancing the taper of the inner catheter through the occlusion (52) in the vessel to dilate the proximal occlusion (Figures 23B and 23C; paragraphs 0205-0207); advancing the outer catheter (142) through the occlusion (52) that is dilated (Figure 23D; paragraph 0208); and withdrawing the inner catheter from the outer catheter (Figure 23E).
Fischell fails to disclose that the occlusion is a proximal occlusion in a proximal vessel and the catheter system is inserted towards a distal occlusion in a distal vessel. Fischell fails to disclose treating the distal occlusion in the distal vessel. Fischell also fails to disclose that the proximal vessel is a common carotid artery, an external carotid artery, or an internal carotid artery.
In the same field of endeavor, Chermoni teaches that it is often necessary to treat multiple occlusions in a single procedure. For example, it may be necessary to insert a large diameter stent at one location, a small diameter stent at a second location and to perform a balloon angioplasty without a stent at a third location (paragraph 0003). Chermoni teaches (Figures 1-13) that a catheter system is inserted towards a distal occlusion, but first treats a first desired location, a first occlusion. After the first occlusion is treated, the catheter is navigated to the distal occlusion, and the distal occlusion is treated (paragraph 0044).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to first treat a proximal occlusion in a proximal vessel and then navigate the catheter system towards a distal occlusion in a distal vessel, and then treat the distal occlusion, as taught by Chermoni. This modification would allow multiple occlusions to be treated in the same procedure, without removing the catheter system from the body, which would cause much discomfort to the patient, prolong the duration of the procedure, and increase the chances of damaging a blood vessel (Chermoni, paragraph 0003).
Jago teaches (Figure 2) that it is known in the art for a proximal occlusion (72) to be formed in a proximal vessel and a distal occlusion to form in a distal vessel (74). Jago teaches that the proximal vessel is a common carotid artery (10a) and the distal vessel is a distal carotid artery (10b).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Fischell in view of Chermoni to first treat a proximal occlusion in a common carotid artery, as taught by Jago. This modification would treat a proximal occlusion that restricts flow of blood to the brain (Jago, paragraph 0013).
Regarding claim 24, Fischell as modified by Chermoni and Jago teaches (Fischell, Figure 23F) deploying a stent (200) against the proximal occlusion (Fischell, paragraph 0211).
Regarding claim 28, Fischell as modified by Chermoni and Jago teaches (Fischell, Figure 8A) a second radiopaque marker (310) identifying a distal end of the inner catheter (Fischell, paragraph 0195).
Regarding claim 30, Fischell as modified by Chermoni and Jago teaches the taper of the distal end region is 0.5 cm - 4.0 cm (Fischell, paragraph 0064).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 2019/0255299 A1) (“Fischell”) in view of Chermoni (US 2002/0156496 A1) and Jago (US 2020/0253579 A1) as applied to claim 23 above, and further in view of Zadno-Azizi et al. (US 2001/0049517 A1) (“Zadno-Azizi”).
Regarding claim 25, Fischell as modified by Chermoni and Jago teaches the invention substantially as claimed. However, the combined teaching fails to teach that treating the distal occlusion comprises drawing aspiration through the outer catheter.
In the same field of endeavor, Zadno-Azizi teaches (Figures 25 and 26) utilizing an outer catheter (406) for aspiration and irrigation of an occlusion (410’).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Fischell in view of Chermoni and Jago such that treating the distal occlusion comprises drawing aspiration through the outer catheter, as taught by Zadno-Azizi. This modification would allow blood containing emboli or other particles to be aspirated away and removed from the patient to reduce the risk of embolization and stroke caused by particles and other debris moving downstream to the brain (Zadno-Azizi, paragraphs 0010 and 0135).
Claims 26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 2019/0255299 A1) (“Fischell”) in view of Chermoni (US 2002/0156496 A1) and Jago (US 2020/0253579 A1) as applied to claim 23 above, and further in view of Stenzel (US 2007/0010863 A1).
Regarding claims 26 and 29, Fischell as modified by Chermoni and Jago teaches the invention substantially as claimed. However, the combined teaching fails to teach that treating the inner catheter comprises no more than one lumen. The combined teaching further fails to teach that the distal end region is substantially unreinforced and fully polymeric. The combined teaching teaches that the inner catheter serves to pre-dilate a lesion with a pre-dilatation balloon (96; paragraph 0125).
In the same field of endeavor, Stenzel teaches (Figures 11-13) advancing a catheter (30) with a single (NOTE: Figure 11 depicts a balloon. However, Stenzel teaches the device may include an inflation balloon) lumen (38) and a flexible (paragraphs 0033 and 0035), distal tapered end region (20) over a guidewire (12) to a lesion (16). Stenzel teaches the guidewire (12) is positioned within the single lumen (38) of the inner catheter (Figure 11). Stenzel teaches the size and shape of the lesion (16) may block the vessel (14) to the extent that the guidewire is unable to cross the lesion (16). Stenzel teaches using the tapered end region (20) of inner catheter (30) to cross an occlusion (16) in the artery (Figures 12 and 13). Stenzel teaches (Figures 12 and 13) that the tapered end region (20) of the inner catheter (30) pre-dilates the occlusion (16) in the artery (14) as the catheter system is advanced (Stenzel, paragraph 0061). Stenzel teaches that the distal tapered end region is substantially unreinforced and fully polymeric (paragraphs 0033 and 0035).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the inner catheter having a single lumen and a substantially unreinforced and fully polymeric distal end region, taught by Stenzel, for the inner catheter taught by Fischell in view of Chermoni and Jago. Substitution of one known element (the pre-dilating catheter taught by Stenzel) for another element (the expandable pre-dilating inner catheter disclosed by Fischell) providing the same function to yield predictable results (pre-dilating occlusions to allow the catheter system to pass through occlusions where the size and shape of the occlusion may block the vessel) would have been obvious to one of ordinary skill in the art at the time of the invention.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (US 2019/0255299 A1) (“Fischell”) in view of Chermoni (US 2002/0156496 A1) and Jago (US 2020/0253579 A1) as applied to claim 23 above, and further in view of Wilson et al. (US 2018/0193042 A1) (“Wilson”).
Regarding claim 27, Fischell as modified by Chermoni and Jago teaches (Fischell, Figure 8A) a radiopaque marker (310) that identifies a distal end of the taper (Fischell, paragraph 0195). However, the combined teaching fails to teach a radiopaque marker that identifies a proximal end of the taper.
Wilson teaches (Figure 1) an inner catheter (300) comprising a tapered distal tip (346). Wilson further teaches (Figure 7C) a distal end region can have a first radiopaque marker (344a) and a second radiopaque marker (344b) can be located to indicate the border between the tapering of the distal tip (346) and the more proximal region of the inner catheter. This provides a user with information regarding an optimal extension of the distal tip (346) relative to the outer catheter (paragraph 0158).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the inner catheter taught by Fischell in view of Chermoni and Jago to comprise a radiopaque marker that identifies a proximal end of the taper, as taught by Wilson. This modification would provide a user with information regarding an optimal extension of the distal tip of the inner catheter relative to the outer catheter during a procedure (Wilson, paragraph 0158) and would provide a user with a visual indication of when the entirety of the tapered tip is advanced through the occlusion during the procedure.
Conclusion
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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