DETAILED ACTION
The following Office Action is in response to the Non-Provisional Patent Application filed on June 21, 2024. Claims 1-20 are currently pending.
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 (reference application). 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 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.
Concerning claim 6, lines 4-5 of the claim recites the phrase “(through a microcatheter) (near simultaneously) or after having performed a contralateral coronary injection”. However, due to the use of parentheses, it is indefinite as to whether the “(through a microcatheter)” and “(near simultaneously)” are optional or if they are intended to be within the scope of the claims, therein making the scope of the claims indefinite. Furthermore, claim 1 already recites a microcatheter, therein making it indefinite as to whether this recitation of “a microcatheter” refers to the same microcatheter of claim 1 or if it is a different microcatheter altogether.
The term “near simultaneously” is also a relative term, the scope of which is indefinite, given the claim and the Specification do not provide a definition or a standard for ascertaining the requisite degree, and one having ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Line 5 also recites the phrase “after having performed a contralateral coronary injection to opacify distal lumen”. However, the limitation of “distal lumen” is indefinite because it can not be determined what structure this distal lumen is intended to refer to.
Concerning claim 12, line 3 of the claim recites the limitation of “distal to proximal of the occlusion”. This phrase is indefinite because it cannot be interpreted as to what the position “distal to proximal” refers. For the purposes of compact prosecution, the limitation will be interpreted as being “distal to a proximal end of the occlusion”.
Concerning claim 13, the claim recites “after step (f), exchanging, through the microcatheter, the guidewire with a workhorse guidewire”. However, claim one recites step (g) including “traversing the at least one opening with the guidewire”, therein making it indefinite as to how step (g) may be performed if the guidewire has been replaced with a workhorse guidewire.
Concerning claim 19, lines 2-3 of the claim recite the limitation of “the length of the occlusion”. There is a lack of antecedent basis for this limitation in the claim.
Claim 20 is rejected for being dependent on an indefinite claim.
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, 4, 5, 8, 16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elsesser et al. (US 2016/0135827, hereinafter Elsesser) in view of Brilakis (Antegrade dissection and re-entry: step-by-step; IDS submitted 12/4/24).
Concerning claim 1, the Elsesser et al. prior art reference teaches 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 | [¶ 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 ([¶ 0034]); and g) traversing the at least one opening with the guidewire (Figures 3C and 3D), but it does not specifically teach the guidewire being advanced through a microcatheter.
However, the Brilakis reference teaches a method for bypassing an occlusion similar to that of the Elesser reference, wherein the Brilakis reference 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 (Brilakis; [7:20/20:42]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method of the Elsesser reference include advancing the guidewire through a microcatheter as in the Brilakis reference to provide a structure to support forming the knuckle in the guidewire and advancing the knuckle (Brilakis; [7:20, 20:42]).
Concerning claim 4, the combination of the Elsesser and Brilakis references as discussed above teaches the method of claim 1, wherein the Elsesser reference further teaches forming the knuckle of step b) further comprising the distal end (Figure 3A; 507) of the guidewire (Figure 3A; 506) not forming a closed loop.
Concerning claim 5, the combination of the Elsesser and Brilakis references as discussed above teaches the method of claim 1, wherein the combination further 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, given the Elsesser reference 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 (Elsesser; Figure 3B), while the Brilakis reference also teaches that the knuckle is advanced just distally of the distal cap of the occlusion to minimize the size of the dissection (Brilakis; [10:10/20:42).
Concerning claim 8, the combination of the Elsesser and Brilakis references as discussed above teaches the method of claim 1, wherein the Elsesser reference further teaches that step d) further comprises placing the inflatable balloon catheter (Elsesser; Figure 3C; 509) over the advanced guidewire along an entire length of the occlusion (Elsesser; [¶ 0034]); and forming at least one opening of step e) further comprising inflating the balloon catheter along the entire length of the occlusion (Elsesser; Figure 3D), while the Brilakis reference 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 comprising inflating the balloon catheter along the entire length of the occlusion (Brilakis; [11:25/20:42]).
Concerning claim 16, the Elsesser et al. prior art reference teaches 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; [¶ 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 ([¶ 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), but it does not specifically teach the guidewire being advanced through a microcatheter.
However, the Brilakis reference teaches a method for bypassing an occlusion similar to that of the Elesser reference, wherein the Brilakis reference 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 (Brilakis; [7:20/20:42]), and also teaches a) advancing a distal end of a guidewire into a subintimal space of an artery of a patient (Brilakis; [10:10/20:42]); b) forming an open-loop knuckle at the distal end of the guidewire (Brilakis; [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 (Brilakis; [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 (Brilakis; [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 (Brilakis; [11:25/20:42]); and f) traversing the at least one opening into the true lumen with the guidewire (Brilakis; [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]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method of the Elesser reference include advancing the guidewire through a microcatheter as in the Brilakis reference to provide a structure to support forming the knuckle in the guidewire and advancing the knuckle (Brilakis; [7:20, 20:42]).
Concerning claim 18, the combination of the Elsesser and Brilakis references as discussed above teaches the method of claim 1, wherein the Elsesser reference further teaches after step c) and before step f), avoiding advancing the guidewire past the location of the knuckle (Figures 3B-D; 506).
Claim(s) 1, 3, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kugler et al. (US 2019/0269434, hereinafter Kugler) in view of Elsesser et al. (US 2016/0135827, hereinafter Elsesser).
Concerning claim 1, the Kugler et al. prior art reference teaches an endovascular method for bypassing an occlusion (Figures 1-3 and 12A-D; 1200), comprising the steps of: a) advancing a distal end of a guidewire (1210) through a microcatheter (Figure 1; 303) 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 ([¶ 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 ([¶ 0034]), but does not specifically teach 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.
However, the Kugler reference teaches 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 (Kugler; Figures 12CD | [¶ 0033]), while the Elsesser reference a method for bypassing an occlusion similar to that of the Kugler reference comprising a) advancing a distal end (Elsesser; Figure 3A; 507) of a guidewire into a subintimal space (Elsesser; Figure 3A; 502) of an artery of a patient; b) forming a knuckle at the distal end (Elsesser; Figure 3A; 507) of the guidewire (Elsesser; Figure 3A); c) advancing the guidewire with the knuckle at the distal end to the occlusion (Elsesser; Figure 3B); d) placing an inflatable balloon catheter (Elsesser; Figure 3C; 509) over the advanced guidewire distal to the occlusion (Elsesser; Figure 3C; [¶ 0034]); e) maintaining the distal end of the guidewire distal to a distal end of the balloon catheter (Elsesser; 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 (Elsesser; [¶ 0034]); and g) traversing the at least one opening with the guidewire (Elsesser; Figures 3C and 3D), wherein the guidewire of the Elsesser reference does not need to be replaced by a sharpened stylet to establish re-entry from the subintimal space to the true lumen.
Therefore, it would have been obvious to a person 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 traverse the at least one opening with the guidewire, as taught by Elsesser, instead of replacing the guidewire with a sharpened stylet, given 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, [¶ 0023]), and given 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.
Concerning claim 3, the combination of the Kugler and Elsesser references as discussed above teaches the method of claim 1, wherein step g) occurs simultaneously with step f) given the Kugler reference teaches that inflating the balloon causes radial displacement of the distal end of the balloon catheter (Kugler; 1220), and the Elsesser reference teaches the guidewire being 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.
Concerning claim 10, the combination of the Kugler and Elsesser references as discussed above teaches the method of claim 1, wherein the Kugler reference further 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, [¶ 0033]).
Claim(s) 2, 7, 12, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elsesser et al. (US 2016/0135827, hereinafter Elsesser) in view of Brilakis (Antegrade dissection and re-entry: step-by-step; IDS submitted 12/4/24) as applied to claims 1, 4, 5, 8, 16, and 18 above, and further in view of Panian (US 10,226,603).
Concerning claim 2, the combination of the Elsesser and Brilakis references as discussed above teaches the method of claim 1, but does not specifically teach between steps e) and f), deflating the balloon catheter before traversing the at least one opening with the guidewire.
However, the Panian reference teaches a method of bypassing an occlusion similar to that of the Elsesser and Brilakis references, wherein the Panian reference further teaches maintaining a distal end (Figure 3; 307) of a guidewire (Figure 3; 306) distal to a distal end of the balloon catheter (Figures 4-6); 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), and between steps maintain the distal end of the guidewire and forming the at least one opening, deflating the balloon catheter before traversing the at least one opening with a guidewire (Figure 6; Column 7, line 60 – Column 8, line 2), inflating and deflating the balloon to create a transient fenestration between the subintimal space and the true lumen, and that dilatation of the balloon within the subintimal space will squeeze and dilate the area of the distal cap (Column 7, lines 53-56).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the Elsesser and Brilakis combination to include deflating the balloon catheter before traversing the at least one opening with the guidewire between steps e) and f) as in the Panian reference to 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).
Concerning claim 7, the combination of the Elsesser and Brilakis references as discussed above teaches the method of claim 1, but does not specifically teach forming the at least one opening of step e) further comprises inflating the balloon catheter at least two times.
However, the Panian reference further teaches a method of bypassing an occlusion similar to that of the Elsesser and Brilakis references, wherein the Panian reference teaches maintaining a distal end (Figure 3; 307) of a guidewire (Figure 3; 306) distal to a distal end of the balloon catheter (Figures 4-6); 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), wherein forming the at least one opening of further comprises inflating the balloon catheter at least two times (Panian; Column 8, lines 35-43, if clinican has trouble with re-entering guidewire, the dilation process may be repeated).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention modify the method of the Elsesser and Brilakis combination to include inflating the balloon catheter at least two times as in the Panian reference to allow the clinician to form the fenestration if the clinician has difficulty re-entering the guidewire into the true lumen (Panian; Column 8, lines 35-43).
Concerning claim 12, the combination of the Elsesser and Brilakis references as discussed above teaches the method of claim 1, but does not specifically teach after step f), performing one or more inflations of the balloon catheter in a position distal to proximal of the occlusion.
However, the Panian reference further teaches a method of bypassing an occlusion similar to that of the Elsesser and Brilakis references, wherein the Panian reference teaches maintaining a distal end (Figure 3; 307) of a guidewire (Figure 3; 306) distal to a distal end of the balloon catheter (Figures 4-6); 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), wherein after forming the at least one opening, performing one or more inflations of the balloon catheter in a position distal to proximal of the occlusion (Panian; Column 8, lines 35-43, if clinician has trouble with re-entering guidewire, the dilation process may be repeated).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention modify the method of the Elsesser and Brilakis combination performing one or more inflations of the balloon catheter in a position distal to proximal of the occlusion after step f) as in the Panian reference to allow the clinician to form the fenestration if the clinician has difficulty re-entering the guidewire into the true lumen (Panian; Column 8, lines 35-43).
Concerning claim 19, the combination of the Elsesser and Brilakis references as discussed above teaches the method of claim 16, but does not specifically teach after step f), inflating the inflatable balloon catheter along the length of the occlusion.
However, the Panian reference further teaches a method of bypassing an occlusion similar to that of the Elsesser and Brilakis references, wherein the Panian reference teaches inflating and deflating a balloon catheter multiple times between the subintimal space and a true lumen to squeeze and dilate the area of the distal cap (Panian; Column 7, Lines 53-56).
Therefore, it would have been obvious to a person 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 in the Panian, reference after step f), to 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(s) 6, 11, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elsesser et al. (US 2016/0135827, hereinafter Elsesser) in view of Brilakis (Antegrade dissection and re-entry: step-by-step; IDS submitted 12/4/24) as applied to claims 1, 4, 5, 8, 16, and 18 above, and further in view of Kugler et al. (US 2019/0269434, hereinafter Kugler).
Concerning claims 6 and 17, the combination of the Elsesser and Brilakis references as discussed above teaches the methods of claims 1 and 16, but does not specifically 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.
However, the Kugler reference teaches a method of bypassing an occlusion similar to that of the Elsesser and Brilakis combination, wherein the Kugler reference teaches the step of confirming the accurate placement of a guidewire (Kugler; [¶ 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 (Kugler; [¶ 0058, 0060, 0082]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method of the Elsesser and Brilakis combination include the step of 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 in the Kugler reference to allow fluoroscopic visualization of the subintimal space, and/or delaminate the intimal layer and medial layer defining the subintimal space (Kugler; [¶ 0082]) and would further eventually be used to achieve visualization of the distal segment of the artery (Kugler; [¶ 0060]).
Concerning claim 11, the combination of the Elsesser and Brilakis references as discussed above teaches the method of claim 1, but does not specifically teach after step f), injecting a contrast media into the subintimal space through the microcatheter.
However, the Kugler reference teaches a method of bypassing an occlusion similar to that of the Elsesser and Brilakis combination, wherein the Kugler reference teaches the step of injecting a contrast media into the subintimal space through a microcatheter (1210) to allow a physician to visualize the occluded segment (Kugler; [¶ 0058, 0060, 0082]) and allow visualization of the artery area of occlusion, therein allowing subsequent interventional devices to be successfully deployed (Kugler; [¶ 0121]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the Elsesser and Brilakis combination to include injecting a contrast media into the subintimal space through the microcatheter after step f) as in the Kulger reference to achieve visualization of the distal segment of the artery (Kugler; [¶ 0060]) and to further allow a physician to visualize the occluded segment to allow subsequent interventional to be successfully deployed (Kugler; [¶ 0121]).
Claim(s) 9 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elsesser et al. (US 2016/0135827, hereinafter Elsesser) in view of Brilakis (Antegrade dissection and re-entry: step-by-step; IDS submitted 12/4/24) as applied to claims 1, 4, 5, 8, 16, and 18 above, and further in view of Alaswad et al. (US 11,779,362, hereinafter Alaswad).
Concerning claim 9, the combination of the Elsesser and Brilakis references as discussed above teaches the method of claim 1, but does not specifically teach between steps e) and f), retracting the balloon catheter.
However, the Brilakis reference teaches that the knuckle is advanced just distally of the distal cap of the occlusion to minimize the size of the dissection (Brilakis; [10:10/20:42]), while the Alaswad reference teaches a balloon catheter for use in bypassing an occlusion, therein being in the same field of endeavor as the Elsesser and Brilakis references, wherein the Alaswad reference teaches the balloon catheter including 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; Column 14, lines 40-57, if balloon catheter is not in correct orientation, it can be axially moved or rotated to desired position).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the Elsesser and Brilakis combination to include the step of retracting the balloon catheter between steps e) and f) as in the Alaswad reference to 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).
Concerning claim 13, the combination of the Elsesser and Brilakis references as discussed above teaches the method of claim 1, but does not specifically teach after step f), exchanging, through the microcatheter, the guidewire with a workhorse guidewire.
However, the Alaswad reference teaches a balloon catheter for use in bypassing an occlusion, therein being in the same field of endeavor as the Elsesser and Brilakis references, wherein the Alaswad reference teaches 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; Column 17, lines 32-48, workhouse guidewire has more desirable mechanical properties).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the Elsesser and Brilakis combination to include the step of exchanging, through the microcatheter, the guidewire with a workhorse guidewire after step f) as in the Alaswad reference to provide a guidewire that is less stiff and therefore less atraumatic and safer to use for the remainder of the procedure (Alaswad; Column 17, Lines 32-48).
Concerning claims 14 and 15, the combination of the Elsesser and Brilakis references as discussed above teaches the method of claim 1, wherein the Elsesser reference teaches placing a stent (Figure 3D; 510) in at least a portion of the true lumen and the subintimal space (Figure 3D | [¶ 0034]), but does not specifically 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).
However, the Alaswad reference teaches a balloon catheter for use in bypassing an occlusion, therein being in the same field of endeavor as the Elsesser and Brilakis references, wherein the Alaswad reference teaches forming at least one opening in a layer separating the subintimal space from a true lumen by inflating an inflatable balloon catheter (Alaswad; Figures 11S-11V), removing the balloon catheter (Alaswad; Figure 11AC), and thereafter placing a stent (Alaswad; Figures 11AO-11AR), and utilizing intravascular ultrasound (IVUS) to image a location for placement of the stent (Alaswad; Figures 11S-11V), specifically, via an ultrasound beam (1116) that is emitted from an ultrasound transducer (1114) at an angle to form an image that guides the operator during the procedure (Alaswad; Column 14, lines 58-60).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the Elsesser and Brilakis combination 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 in the Alaswad reference to provide scaffolding that supports the vessel wall and the angioplastied plaque region after the balloon catheter is removed (Alaswad; Column 18, lines 23-25), and to form an image that guides the operator during the procedure (Alaswad; Column 14, lines 58-60).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elsesser et al. (US 2016/0135827, hereinafter Elsesser) in view of Brilakis (Antegrade dissection and re-entry: step-by-step; IDS submitted 12/4/24) and Panian (US 10,226,603) and as applied to claims 19 above, and further in view of Kugler et al. (US 2007/0093781, hereinafter Kugler ‘781).
Concerning claim 20, the combination of the Elsesser, Brilakis, and Panian references as discussed above teaches the method of claim 19, but does not specifically teach injecting a contrast media into the true lumen antegrade the occlusion; and injecting the contrast media into the subintimal space through the microcatheter.
However, the Kugler ‘781 reference teaches a method of bypassing an occlusion similar to that of the Elsesser, Brilakis, and Panian combination, wherein the Kugler reference teaches injecting a contrast media into the true lumen antegrade the occlusion (Kugler ‘781; Figure 1B | [¶ 0058, 0060]); and injecting a contrast media into the subintimal space through a microcatheter (1210) to allow a physician to visualize the occluded segment (Kugler ‘781; [¶ 0058, 0060, 0082]) and allow visualization of the artery area of occlusion, therein allowing subsequent interventional devices to be successfully deployed (Kugler ‘781; [¶ 0121]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the Elsesser, Brilakis, and Panian combination to include injecting a contrast media into the true lumen antegrade the occlusion and into the subintimal space through the microcatheter as in the Kugler ‘781 reference to achieve visualization of the distal segment of the artery (Kugler ‘781; [¶ 0060]) and to further allow a physician to visualize the occluded segment to allow subsequent interventional to be successfully deployed (Kugler ‘781; [¶ 0121]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Kugler et al. reference (US 2021/0307752), the Rizk et al. reference (US 2016/0206334), the Root et al. reference (US 2016/0008584), the Silvestro reference (US 2015/0112304), and the Cullet et al reference (US 2012/0095485) all teach methods for bypassing an occlusion via the subintimal space.
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/MARTIN T TON/Examiner, Art Unit 3771 9/30/2025