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 12/4/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Italy on 3/8/22. It is noted, however, that applicant has not filed a certified copy of the IT102022000004412 application as required by 37 CFR 1.55.
Drawings
The drawings are objected to because: Figures 1A-5 are not of sufficient quality such at all details in the drawings are reproducible in black and white in the printed patent. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning.
Numbers, lines, and reference characters. (1) Reference characters (numerals are preferred), sheet numbers, and view numbers must be plain and legible, and must not be used in association with brackets or inverted commas, or enclosed within outlines, e.g., encircled. They must be oriented in the same direction as the view so as to avoid having to rotate the sheet. Reference characters should be arranged to follow the profile of the object depicted.
(2) The English alphabet must be used for letters, except where another alphabet is customarily used, such as the Greek alphabet to indicate angles, wavelengths, and mathematical formulas.
(3) Numbers, letters, and reference characters must measure at least .32 cm. (1/8 inch) in height. They should not be placed in the drawing so as to interfere with its comprehension. Therefore, they should not cross or mingle with the lines. They should not be placed upon hatched or shaded surfaces. When necessary, such as indicating a surface or cross section, a reference character may be underlined and a blank space may be left in the hatching or shading where the character occurs so that it appears distinct.
(4) The same part of an invention appearing in more than one view of the drawing must always be designated by the same reference character, and the same reference character must never be used to designate different parts.
(5) Reference characters not mentioned in the description shall not appear in the drawings. Reference characters mentioned in the description must appear in the drawings.
Lead lines are those lines between the reference characters and the details referred to. Such lines may be straight or curved and should be as short as possible. They must originate in the immediate proximity of the reference character and extend to the feature indicated. Lead lines must not cross each other. Lead lines are required for each reference character except for those which indicate the surface or cross section on which they are placed. Such a reference character must be underlined to make it clear that a lead line has not been left out by mistake. Lead lines must be executed in the same way as lines in the drawing.
Arrows may be used at the ends of the lines, provided that their meaning is clear, as follows:
(1) On a lead line, a freestanding arrow to indicate the entire section towards which it points;
(2) On a lead line, an arrow touching a line to indicate the surface shown by the line looking along the direction of the arrow; or
(3) To show the direction of movement.
The use of shading in views is encouraged if it aids in understanding the invention and if it does not reduce legibility. Shading is used to indicate the surface or shape of spherical, cylindrical, and conical elements of an object. Flat parts may also be lightly shaded. Such shading is preferred in the case of parts shown in perspective, but not for cross sections. Spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings. As a substitute for shading, heavy lines on the shade side of objects can be used except where they superimpose on each other or obscure reference characters. Light should come from the upper left corner at an angle of 45°. Surface delineations should preferably be shown by proper shading. Solid black shading areas are not permitted, except when used to represent bar graphs or color.
See 37 CFR 1.84. Appropriate correction is required.
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.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-20 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of copending Application No. 18/226,194 (US 2024/0299047 A1). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 1-20 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of copending Application No. 18/750,536 (US 2024/0341796 A1). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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 6, 12, 13, 19, and 20 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 6 recites the step of: between steps c) and d), confirming the accurate placement of the guidewire for targeted reentry by injecting a contrast media into the subintimal space (through a microcatheter) (near simultaneously) or after having performed a contralateral coronary injection to opacify distal lumen. This claim is indefinite for a number of reasons. First, because of the use of parentheses, it is unclear if “(through a microcatheter)” and “(near simultaneously)” are part of the invention. If “a microcatheter” is part of the invention, it is unclear if “a microcatheter” is the same microcatheter recited in claim 1, or a different microcatheter. It is unclear what “near simultaneously or after” entails. The term “near simultaneously” is a relative term which renders the claim indefinite. The term “near simultaneously” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate correction is required. Further, claim 6 references “after having performed a contralateral coronary injection to opacify distal lumen.” This is unclear because there is no reference to a “distal lumen” in claim 6 or claim 1. Appropriate correction is required.
Claim 12 recites the step of: after step f), performing one or more inflations of the balloon catheter in a position distal to proximal of the occlusion. It is unclear what “distal to proximal the occlusion” entails. For examination purposes, the Examiner is interpreting this to mean performing one or more inflations of the balloon catheter in a position distal to a proximal end of the occlusion. Appropriate correction is required.
Claim 13 recites the step of: after step f), exchanging, through the microcatheter, the guidewire with a workhorse guidewire. In claim 1, step g) requires traversing the at least one opening with the guidewire. If a workhorse guidewire is exchanged with the guidewire after step f), it is unclear how the guidewire would perform step g) if it is exchanged with the workhorse guidewire. Appropriate correction is required.
Claim 19 recites the limitation "the length" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 20 is dependent on rejected claim 19, thus is also rendered indefinite. 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, 4, 5, 8, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Elsesser et al. (US 2016/0135827 A1) (“Elsesser”) in view of Brilakis (“Antegrade dissection and re-entry: step-by-step”, IDS submitted 12/4/24).
Regarding claim 1, Elsesser discloses (Figures 1-3D) an endovascular method for bypassing an occlusion (501), comprising the steps of: a) advancing a distal end (507) of a guidewire into a subintimal space (502) of an artery of a patient; b) forming a knuckle at the distal end (507) of the guidewire (Figure 3A); c) advancing the guidewire with the knuckle at the distal end to the occlusion (Figure 3B); d) placing an inflatable balloon catheter (509) over the advanced guidewire distal to the occlusion (Figure 3C; paragraph 0034); e) maintaining the distal end of the guidewire distal to a distal end of the balloon catheter (Figures 3C and 3D); f) forming at least one opening in a layer separating the subintimal space from a true lumen by inflating the inflatable balloon catheter (paragraph 0034); and g) traversing the at least one opening with the guidewire (Figures 3C and 3D). However, Elsesser fails to explicitly disclose that the guidewire is advanced through a microcatheter.
Brilakis teaches that it is known in the art to advance a guidewire through a microcatheter because a microcatheter provides support for forming a knuckle in a guidewire and advancing the knuckle (7:25/20:42).
Therefore, 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 Elsesser to include advancing the guidewire through a microcatheter, as taught by Brilakis. This modification would provide a structure to support forming the knuckle in the guidewire and advancing the knuckle (Brilakis, 7:25/20:42).
Regarding claim 4, Elsesser as modified by Brilakis teaches (Elsesser, Figures 3A and 3B) forming the knuckle of step b) further comprises the distal end (507) of the guidewire (506) not forming a closed loop.
Regarding claim 5, Elsesser as modified by Brilakis teaches that step c) further comprises advancing the knuckle no further distal to the occlusion than is required to place a distal portion of the balloon catheter across a distal end of the occlusion. Figure 3B of Elsesser shows that the knuckle is advanced distal to the occlusion to a position where a distal portion of the balloon catheter is placed across a distal end of the occlusion. Brilakis also teaches that the knuckle is advanced just distally of the distal cap of the occlusion to minimize the size of the dissection (10:10/20:42).
Regarding claim 8, Elsesser as modified by Brilakis teaches (Elsesser, Figure 3C) that step d) further comprises placing the inflatable balloon catheter (509) over the advanced guidewire along an entire length of the occlusion (paragraph 0034); and forming at least one opening of step e) further comprises inflating the balloon catheter along the entire length of the occlusion (Figure 3D). Brilakis also teaches placing an inflatable balloon catheter over the advanced guidewire along an entire length of the occlusion; and forming at least one opening of step e) further comprises inflating the balloon catheter along the entire length of the occlusion (11:25/20:42).
Regarding claim 16, Elsesser discloses (Figures 1-3D) an endovascular method for bypassing an occlusion (501), comprising the steps of: a) advancing a distal end (507) of a guidewire (506) into a subintimal space (502) of an artery of a patient; b) forming an open-loop knuckle at the distal end (507) of the guidewire (Figure 3A); c) advancing the knuckle of the guidewire in the subintimal space to a location adjacent and distal to a distal end of the occlusion (Figure 3B); d) placing an inflatable balloon catheter (509) over the advanced guidewire distal to the occlusion (501) and along an entire length of the occlusion (Figure 3C; paragraph 0034); e) forming at least one opening in a layer separating the subintimal space from a true lumen by inflating the inflatable balloon catheter along the entire length of the occlusion (paragraph 0034); and f) traversing the at least one opening into the true lumen with the guidewire (Figures 3C and 3D); and wherein throughout steps c) through f), the knuckle is maintained in a position distal to a distal end of the inflatable balloon catheter (Figures 3B-3D).
However, Elsesser fails to disclose that the guidewire is advanced through a microcatheter.
Brilakis teaches that it is known in the art to advance a guidewire through a microcatheter because a microcatheter provides support for forming a knuckle in a guidewire and advancing the knuckle (7:25/20:42). Brilakis teaches a) advancing a distal end of a guidewire into a subintimal space of an artery of a patient (10:10/20:42); b) forming an open-loop knuckle at the distal end of the guidewire (7:25/20:42); c) advancing the knuckle of the guidewire in the subintimal space to a location adjacent and distal to a distal end of the occlusion (10:10/20:42); d) placing an inflatable balloon catheter over the advanced guidewire distal to the occlusion and along an entire length of the occlusion (11:25/20:42); e) forming at least one opening in a layer separating the subintimal space from a true lumen by inflating the inflatable balloon catheter along the entire length of the occlusion (11:25/20:42); and f) traversing the at least one opening into the true lumen with the guidewire (11:25/20:42); and wherein throughout steps c) through f), the knuckle is maintained in a position distal to a distal end of the inflatable balloon catheter (11:25/20:42).
Brilakis teaches that it is known in the art to advance a guidewire through a microcatheter because a microcatheter provides support for forming a knuckle in a guidewire and advancing the knuckle (7:25/20:42).
Therefore, 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 Elsesser to include advancing the guidewire through a microcatheter, as taught by Brilakis. This modification would provide a structure to support forming the knuckle in the guidewire and advancing the knuckle (Brilakis, 7:25/20:42).
Regarding claim 18, Elsesser as modified by Brilakis teaches (Elsesser, Figures 3B-3D) that after step c) and before step f), avoiding advancing the guidewire (506) past the location of the knuckle.
Claims 1, 3, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kugler et al (US 2019/0269434 A1) in view of Elsesser et al. (US 2016/0135827 A1) (“Elsesser”).
Regarding claim 1, Kugler discloses (Figures 1-3 and 12A-12D) an endovascular method for bypassing an occlusion (1200), comprising the steps of: a) advancing a distal end of a guidewire (1210) through a microcatheter (303; Figure 1) into a subintimal space (1202) of an artery of a patient; c) advancing the guidewire (1210) to the occlusion (Figure 12B); d) placing an inflatable balloon catheter (1220) over the advanced guidewire distal to the occlusion (paragraph 0033); f) forming at least one opening in a layer (1204) separating the subintimal space (1202) from a true lumen (1208) by inflating the inflatable balloon catheter (paragraph 0034).
However, Kugler fails to disclose:
b) forming a knuckle at the distal end of the guidewire;
e) maintaining the distal end of the guidewire distal to a distal end of the balloon catheter; and
g) traversing the at least one opening with the guidewire.
Kugler discloses (Figures 12C and 12D) that the guidewire is replaced and a sharpened stylet is used to penetrate the intimal/medial layers to establish re-entry from the subintimal space to the true lumen (paragraph 0033).
Elsesser teaches a guidewire that does not need to be replaced by a sharpened stylet to establish re-entry from the subintimal space to the true lumen. Elsesser teaches a) advancing a distal end (507) of a guidewire into a subintimal space (502) of an artery of a patient; b) forming a knuckle at the distal end (507) of the guidewire (Figure 3A); c) advancing the guidewire with the knuckle at the distal end to the occlusion (Figure 3B); d) placing an inflatable balloon catheter (509) over the advanced guidewire distal to the occlusion (Figure 3C; paragraph 0034); e) maintaining the distal end of the guidewire distal to a distal end of the balloon catheter (Figures 3C and 3D); f) forming at least one opening in a layer separating the subintimal space from a true lumen by inflating the inflatable balloon catheter (paragraph 0034); and g) traversing the at least one opening with the guidewire (Figures 3C and 3D).
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 Kugler to utilize a guidewire with a knuckle at the distal end of the guidewire, maintain the distal end of the guidewire distal to a distal end of the balloon catheter, and traversing the at least one opening with the guidewire, as taught by Elsesser, instead of replacing the guidewire with a sharpened stylet. Forming a knuckle allows the guidewire to traverse and advance through hardened lesions and will provide little to no resistance when crossing the lesion through the subintimal layer (Elsesser, paragraph 0023). Using a guidewire with a knuckle to establish re-entry into the from the subintimal space to the true lumen in the method disclosed by Kugler would save time during the procedure, because the steps of removing the guidewire and replacing it with a sharpened stylet would no longer be necessary.
Regarding claim 3, Kugler as modified by Elsesser teaches that step g) occurs simultaneously with step f). Kugler teaches that inflating the balloon causes radial displacement of the distal end of the balloon catheter (1220). As modified by Elsesser, the guidewire is maintained distally of the balloon catheter, and inflation of the balloon would direct the knuckle of the guidewire to form an opening in a layer separating the subintimal space from a true lumen and position the knuckle through the opening into the true lumen to establish re-entry.
Regarding claim 10, Kugler as modified by Elsesser teaches before step f), maintaining the distal end of the guidewire distal to the distal end of the balloon catheter; and step f) further comprises forcing the distal end of the guidewire against the layer separating the subintimal space from the true lumen (Kugler, paragraph 0033).
Claims 2, 7, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Elsesser et al. (US 2016/0135827 A1) (“Elsesser”) in view of Brilakis (“Antegrade dissection and re-entry: step-by-step”) as applied to claim 1 above, and further in view of Panian (US 10,226,603 B1).
Regarding claim 2, Elsesser as modified by Brilakis teaches the invention substantially as claimed. However, the combined teaching fails to teach the step of: between steps e) and f), deflating the balloon catheter before traversing the at least one opening with the guidewire.
Panian teaches (Figures 1-7D): e) maintaining a distal end (307) of a guidewire (306) distal to a distal end of the balloon catheter (100; Figures 4-6); f) forming at least one opening (600) in a layer separating the subintimal space (305) from a true lumen (301) by inflating the inflatable balloon catheter (Column 7, lines 53-58). Panian teaches between steps e) and f), deflating the balloon catheter before traversing the at least one opening with a guidewire (Figure 6; Column 7, line 60 – Column 8, line 2). Panian teaches inflating and deflating the balloon to create a transient fenestration between the subintimal space and the true lumen. Panian further teaches that dilatation of the balloon within the subintimal space will squeeze and dilate the area of the distal cap (Column 7, lines 53-56).
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 Elsesser in view of Brilakis to include deflating the balloon catheter before traversing the at least one opening with the guidewire between steps e) and f), as taught by Panian. This modification would allow the guide wire to smoothly pass through the fenestration from the subintimal space and into the true lumen (Panian, Column 8, lines 35-38).
Regarding claim 7, Elsesser as modified by Brilakis teaches the invention substantially as claimed. However, the combined teaching fails to teach forming the at least one opening of step e) further comprises inflating the balloon catheter at least two times.
Panian teaches forming the at least one opening of step e) further comprises inflating the balloon catheter at least two times. Panian teaches that if the clinician has trouble to re-enter the guidewire into the true lumen, the process of dilating the balloon to create another fenestration may be repeated again at a more distal location (Column 8, lines 35-43).
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 Elsesser in view of Brilakis to include inflating the balloon catheter at least two times to form the at least one opening of step e), as taught by Panian. This modification would allow the clinician to form the fenestration if the clinician has difficulty re-entering the guidewire into the true lumen (Column 8, lines 35-43).
Regarding claim 12, Elsesser as modified by Brilakis teaches the invention substantially as claimed. However, the combined teaching fails to teach after step f), performing one or more inflations of the balloon catheter in a position distal to proximal of the occlusion.
Panian teaches after step f), performing one or more inflations of the balloon catheter in a position distal to proximal of the occlusion. Panian teaches that if the clinician has trouble to re-enter the guidewire into the true lumen, the process of dilating the balloon to create another fenestration may be repeated again at a more distal location (Column 8, lines 35-43).
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 Elsesser in view of Brilakis to include performing one or more inflations of the balloon catheter in a position distal to proximal of the occlusion after step f), as taught by Panian. This modification would allow the clinician to form the fenestration if the clinician has difficulty re-entering the guidewire into the true lumen (Column 8, lines 35-43).
Claims 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Elsesser et al. (US 2016/0135827 A1) (“Elsesser”) in view of Brilakis (“Antegrade dissection and re-entry: step-by-step”) as applied to claim 1 above, and further in view of Kugler et al. (US 2007/0093781 A1) (“Kugler”).
Regarding claim 6, Elsesser as modified by Brilakis teaches the invention substantially as claimed. However, the combined teaching fails to teach between steps c) and d), confirming the accurate placement of the guidewire for targeted reentry by injecting a contrast media into the subintimal space (through a microcatheter) (near simultaneously) or after having performed a contralateral coronary injection to opacify distal lumen.
Kugler teaches (Figures 1A, 1B, 12A-12C) confirming the accurate placement of a guidewire (paragraph 0081) for targeted reentry by injecting a contrast media into the subintimal space (through a microcatheter 1210) (near simultaneously) or after having performed a contralateral coronary injection to opacify distal lumen (paragraph 0058, 0060, 0082).
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 Elsesser in view of Brilakis to include confirming the accurate placement of the guidewire for targeted reentry by injecting a contrast media into the subintimal space (through a microcatheter) (near simultaneously) or after having performed a contralateral coronary injection to opacify distal lumen between steps c) and d), as taught by Kugler. This modification would allow fluoroscopic visualization of the subintimal space, and/or may be used to delaminate the intimal layer and medial layer defining the subintimal space (Kugler, paragraph 0082) and would eventually be used to achieve visualization of the distal segment of the artery (Kugler, paragraph 0060)
Regarding claim 11, Elsesser as modified by Brilakis teaches the invention substantially as claimed. However, the combined teaching fails to teach after step f), injecting a contrast media into the subintimal space through the microcatheter.
Kugler teaches (Figures 1A, 1B, 12A-12C) injecting a contrast media into the subintimal space through the microcatheter (paragraphs 0058, 0060, 0082) to allow a physician to visualize the occluded segment. Visualization of the artery in the area of occlusion may allow subsequent interventional devices (i.e., balloons, stents, etc.) to be successfully deployed (paragraph 0121).
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 Elsesser in view of Brilakis to include injecting a contrast media into the subintimal space through the microcatheter after step f), as taught by Elsesser. This modification would achieve visualization of the distal segment of the artery (Kugler, paragraph 0060) and would allow a physician to visualize the occluded segment. Visualization of the artery in the area of occlusion may allow subsequent interventional devices (i.e., balloons, stents, etc.) to be successfully deployed (paragraph 0121).
Claims 9 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Elsesser et al. (US 2016/0135827 A1) (“Elsesser”) in view of Brilakis (“Antegrade dissection and re-entry: step-by-step”) as applied to claim 1 above, and further in view of Alaswad et al. (US 11,779,362 B1) (“Alaswad”).
Regarding claim 9, Elsesser as modified by Brilakis teaches the invention substantially as claimed. The combined teaching fails to explicitly teach between steps e) and f), retracting the balloon catheter. However, Brilakis teaches that the knuckle is advanced just distally of the distal cap of the occlusion to minimize the size of the dissection (10:10/20:42).
Alaswad further teaches (Figures 11S-11V) utilizing a balloon catheter with an ultrasound transducer to confirm that the balloon catheter has been advanced into a desired position where it is sufficiently distal of the obstructive plaque P to clear the obstruction and a desirable re-entry location has been identified. Alaswad teaches that if the balloon catheter is not in the correct orientation, it can be moved axially, or may be rotated to the desired position (Column 14, lines 40-57).
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 Elsesser in view of Brilakis to include retracting the balloon catheter between steps e) and f), as taught by Alaswad. This modification would ensure that the balloon catheter is in a desired position where it is sufficiently distal of the obstructive plaque P to clear the obstruction and a desirable re-entry location has been identified (Alaswad, Column 14, lines 40-57).
Regarding claim 13, Elsesser as modified by Brilakis teaches the invention substantially as claimed. However, the combined teaching fails to teach after step f), exchanging, through the microcatheter, the guidewire with a workhorse guidewire.
Alaswad teaches (Figures 11A-11AR) that it is known in the art to exchange, through the microcatheter, the guidewire with a workhorse guidewire after forming at least one opening in a layer separating the subintimal space from a true lumen. Alaswad teaches that a workhorse guidewire has more desirable mechanical properties for the remainder of the procedure. The workhorse guidewire may be less stiff than the and therefore be less traumatic and therefore safer to use (Column 17, lines 32-48).
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 Elsesser in view of Brilakis to include exchanging, through the microcatheter, the guidewire with a workhorse guidewire after step f) as taught by Alaswad. This modification would provide a guidewire with more desirable mechanical properties (less stiff and therefore less traumatic and safer to use) for the remainder of the procedure (Alaswad, Column 17, lines 32-48).
Regarding claims 14 and 15, Elsesser as modified by Brilakis teaches the invention substantially as claimed. Elsesser as modified by Brilakis teaches placing a stent (510) in at least a portion of the true lumen and the subintimal space (Figure 3D; paragraph 0034). However, the combined teaching fails to teach after step f), removing the balloon catheter; and placing a stent in at least a portion of the true lumen and the subintimal space and imaging a location for placement of the stent by intravascular ultrasound (IVUS).
Alaswad teaches (Figures 11A-11AR) forming at least one opening in a layer separating the subintimal space from a true lumen by inflating an inflatable balloon catheter (Figures 11S-11V). Alaswad teaches removing the balloon catheter (Figure 11AC) and thereafter placing a stent (Figures 11AO-11AR). Alaswad teaches (Figures 11S-11V utilizing intravascular ultrasound (IVUS) to image a location for placement of the stent. Specifically, the ultrasound beam (1116) is emitted from the ultrasound transducer (1114) at an angle to form an image that guides the operator during the procedure (Column 14, lines 58-60).
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 Elsesser in view of Brilakis to include removing the balloon catheter after step f), placing a stent in at least a portion of the true lumen and the subintimal space, and imaging a location for placement of the stent by intravascular ultrasound (IVUS), as taught by Alaswad. These modifications would provide scaffolding that supports the vessel wall and the angioplastied plaque region after the balloon catheter is removed (Alaswad, Column 18, lines 23-25). Imaging a location for placement of the stent by intravascular ultrasound (IVUS) would form an image that guides the operator during the procedure (Column 14, lines 58-60).
20. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Elsesser et al. (US 2016/0135827 A1) (“Elsesser”) in view of Brilakis (“Antegrade dissection and re-entry: step-by-step”) as applied to claim 16 above, and further in view of Kugler et al. (US 2007/0093781 A1) (“Kugler”).
Regarding claim 6, Elsesser as modified by Brilakis teaches the invention substantially as claimed. However, the combined teaching fails to teach between steps c) and d), confirming the accurate placement of the guidewire for targeted reentry by injecting a contrast media into the subintimal space.
Kugler teaches (Figures 1A, 1B, 12A-12C) confirming the accurate placement of a guidewire (paragraph 0081) for targeted reentry by injecting a contrast media into the subintimal space (paragraph 0058, 0060, 0082).
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 Elsesser in view of Brilakis to include confirming the accurate placement of the guidewire for targeted reentry by injecting a contrast media into the subintimal space between steps c) and d), as taught by Kugler. This modification would allow fluoroscopic visualization of the subintimal space, and/or may be used to delaminate the intimal layer and medial layer defining the subintimal space (Kugler, paragraph 0082) and would eventually be used to achieve visualization of the distal segment of the artery (Kugler, paragraph 0060).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Elsesser et al. (US 2016/0135827 A1) (“Elsesser”) in view of Brilakis (“Antegrade dissection and re-entry: step-by-step”) as applied to claim 1 above, and further in view of Panian (US 10,226,603 B1).
Regarding claim 19, Elsesser as modified by Brilakis teaches the invention substantially as claimed. However, the combined teaching fails to teach after step f), inflating the inflatable balloon catheter along the length of the occlusion.
Panian teaches inflating and deflating a balloon catheter multiple times between the subintimal space and a true lumen. Panian teaches that multiple dilatations of the balloon within the subintimal space will squeeze and dilate the area of the distal cap (Column 7, lines 53-56).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to inflate the inflatable balloon catheter along the length of the occlusion, as taught by Panian, after step f). This modification would provide multiple dilatations of the balloon within the subintimal space to squeeze and dilate the area of the occlusion (Panian, Column 7, lines 53-56).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Elsesser et al. (US 2016/0135827 A1) (“Elsesser”) in view of Brilakis (“Antegrade dissection and re-entry: step-by-step”) and Panian (US 10,226,603 B1) as applied to claim 19 above, and further in view of Kugler et al. (US 2007/0093781 A1) (“Kugler”).
Regarding claim 20, Elsesser in view of Brilakis and Panian teaches the invention substantially as claimed. However, the combined teaching fails to teach the step of: injecting a contrast media into the true lumen antegrade the occlusion; and injecting the contrast media into the subintimal space through the microcatheter.
Kugler teaches (Figures 1A, 1B, 12A-12C) injecting a contrast media into the true lumen antegrade the occlusion (Figure 1B; paragraph 0058, 0060); and injecting the contrast media into the subintimal space through the microcatheter (paragraph 0082) to allow a physician to visualize the occluded segment. Visualization of the artery in the area of occlusion may allow subsequent interventional devices (i.e., balloons, stents, etc.) to be successfully deployed (paragraph 0121).
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 Elsesser in view of Brilakis and Panian to include injecting a contrast media into the true lumen antegrade the occlusion and into the subintimal space through the microcatheter after, as taught by Elsesser. This modification would achieve visualization of the distal segment of the artery (Kugler, paragraph 0060) and would allow a physician to visualize the occluded segment. Visualization of the artery in the area of occlusion may allow subsequent interventional devices (i.e., balloons, stents, etc.) to be successfully deployed (paragraph 0121).
Conclusion
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771