Suspension
The period set forth in the letter of suspension mailed 06/05/2025 has expired. Considering the dismissal of the concurrent litigation Vascular Solutions LLC v. Medtronic, Inc. 0:19cv1790 (D. Minn.) on 04/28/2026 and Qxmedical LLC v. Vascular Solutions LLC, 0:17cv1969 (D. Minn.) on 10/01/2025, action will now be taken in this reissue application.
Notice of Pre-AIA Status
The present reissue application is being examined under the pre-AIA first to invent provisions. It is noted that while the examination of the current reissue application falls under the pre-AIA first to invent provisions due to the priority date of US Patent No. 8,292,850 (the ‘850 patent); the application for reissue filing date is after September 16, 2012 and therefore is subject to the reissue rule changes enacted under the Leahy-Smith American Invents Act (AIA ), see Federal Register, Vol. 77, No. 157, pg. 48820, August 16, 2012. For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Reissue Applications
Applicant is reminded of the continuing obligation under 37 CFR § 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which the ‘850 patent is or was involved. These proceedings would include interferences, reissues, reexaminations and litigations.
Applicant is further reminded of the continuing obligation under 37 CFR § 1.56 to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 08/14/2024 has been entered.
Allowable Subject Matter
The indicated allowability of claims 25-46 is withdrawn in view of the newly discovered reference(s) to at least USPN 6,626,889. Rejections based on the newly cited reference(s) follow.
Application Data Sheet (ADS)
A corrected ADS was filed 03/26/2024 with a request under 37 CFR 1.46(c) to correct inventorship, an updated 37 CFR 3.73 and a new power of attorney. This should have been accompanied by a request for corrected filing receipt. A request for corrected filing receipt will need to be submitted with a marked up copy of the most recent filing receipt including corrections with appropriate markings. The most recent filing receipt is dated 03/29/2024 and does not include the new attorney customer number and domestic priority data that this application is a REI of 13/359,059 (USPN 8,292,850).1 Therefore, the marked-up copy of the filing receipt that must be submitted with the request for corrected filing receipt should include markings as shown below.
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Claim Construction
The ‘850 patent specification minimally recites the claim term “rail.” The Summary of the Invention describes the rail structure disclosing “a coaxial guide catheter that is deliverable through standard guide catheters by utilizing a guidewire rail segment to permit delivery without blocking use of the guide catheter.” Claims 25 and 41 set forth that the substantially rigid portion defines the rail structure. The ‘850 patent discloses that rigid portion 20 “may be formed from a hypotube or a section of stainless steel or Nitinol tubing. Other substantially rigid materials may be used as well. Rigid portion 20 includes first full circumference portion 34, hemicylindrical portion 36, arcuate portion 38, and second full circumference portion 40.” See col. 6, ll. 47-52. Figs 1, 4, 10, 12 and 13 show rigid portion 20. None of this disclosure describes or shows specifically “a rail structure without a lumen;” conversely, the disclosure sets forth the rail structure being a hypotube or tubing which inherently includes a lumen.
This was first addressed in reissue application 16/184,706 (“the ‘706 application”) in the non-final office action mailed 03/19/2020 which rejected claim 35 under 35 USC 112 second paragraph since claim 35 recited a hypotube while independent claim 25 recited a rigid portion without a lumen. In response, applicant amended claim 25 to recite “a rail structure without a lumen through which an interventional cardiology device is insertable.” See the ‘706 application, amendment filed 09/18/2020. The next non-final office action mailed 11/17/2020 withdrew the 35 USC 112 second paragraph rejection. The next set of claim amendments filed 04/16/2021 maintained this claim limitation. After a period of suspension, a non-final office action was mailed 01/16/2024 rejecting claims 25 and 41 and thereby dependent claims 26-40 under 35 USC 251 for not claiming subject matter directed to the invention disclosed in the original patent specifically pertaining to the “through which an interventional cardiology device is insertable” limitation. See the ‘706 application, non-final office action mailed 01/16/2024 pages 7-8. Claims 25 and 41 were then amended in the amendment filed 04/16/2024 to remove “through which an interventional cardiology device is insertable” returning the limitation to the original form of “a rail structure without a lumen.”
Therefore, it is understood that the claim term “rail structure without a lumen” refers to the rail structure not having a lumen that is dimensioned and structured to allow an interventional cardiology device to be inserted. The rail structure being a hypotube or small diameter tubing supports this construction since a hypotube or small diameter metal tubing is typically too small to allow passage of an interventional cardiology device therethrough. This is the claim interpretation that has been used in the evaluation of the prior art. See also the ‘706 application, remarks filed 09/18/2020, pp. 19-20.
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 44-46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 44-46 recite numerical dimensions but fail to recite what those dimensions refer. For examination purposes below, it is assumed that the dimensions refer to the diameter of the lumen.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 44-46 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Each of claims 44-46 recite “The guide extension catheter of claim 43,” however, claim 43 recites “A method.” Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 43 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US Pub. No. 2003/0050600 to Ressemann et al. (“Ressemann”).
Regarding claim 43, Ressemann discloses a method (see para. [0002] stating, “The present invention relates to apparatus and methods …;” see para. [0207] stating the method of use is the same as that for the embodiment of Figs. 6A-6I and para. [0117] with Fig. 6C) comprising: advancing a distal end of a predefined length guide catheter (2160) having a continuous lumen through a blood vessel to an ostium of a coronary artery (see para. [0115] stating, “the guide catheter 160 may be positioned within the ostium of the target vessel, and the evacuation sheath assembly 100 may be advanced through the catheter and beyond a major side branch of the target vessel.”); advancing a distal end of a guide extension catheter (see Fig. 16A, 2100) through, and beyond the distal end of, the guide catheter (see Fig. 6B and para. [0115] stating, “the evacuation sheath assembly 100 then is advanced over the guide wire 170 and positioned within the vessel 150 with the distal radiopaque marker 146b distal of the distal tip of the guiding catheter 160 (i.e., within the vessel 150)”), wherein a flexible tip portion (see para. [0181] stating, “a soft, beveled tip 2144 … reducing the tendency for embolic material to hang-up or get caught on the distal ends of the lumens.”) of the guide extension catheter defines a tubular structure having a single lumen (as shown in Fig. 16F, there is a single lumen at the distal tip) coaxial with the continuous lumen (this lumen will be coaxial with the lumen of the guide catheter since the proximal balloon 2134 will center the lumen within the guide catheter), a circular cross section and a length that is shorter than a length of the guide catheter (see Fig. 6B), wherein advancing the distal end comprises advancing a push member (2110 and 2120) of the guide extension catheter that is proximal of (see Fig. 16A), operably connected to (see Fig. 16A), and more rigid along a longitudinal axis (see Figs. 16A and 16B and para. [0175] stating, “The evacuation head 2132 includes a multi-lumen tube 2138. Multi-lumen tube 2138 is preferably made of a relatively flexible polymer, for example, a polyester blend such as Hytrel 6356. Hytrel 6356…;” stainless steel hypotubing and corewire will be more rigid than the flexible polymer of the tubular structure) than the tubular structure (2132) of the guide extension catheter (embodiment of Figs. 16A-16J), into the continuous lumen of the guide catheter (see para. [0174] stating, “evacuation sheath assembly is sized to fit within and to be used with a guide catheter during the treatment of a vascular stenosis, e.g. within a coronary artery, such as a native coronary artery or an SVG.” and para [0186] stating, “[a] first proximal sealing balloon 2134 is configured to form a seal within the guide catheter which delivers the evacuation sheath assembly 2100 to the surgical site…”), the push member defining a rail structure without a lumen (hypotube and core wire do not have a lumen that can accept an interventional device, see claim construction above) and having a maximal cross-sectional dimension at a proximal portion that is smaller than a cross-sectional outer diameter of the tubular structure (see Figs. 16A and 16B) and having a length (see para. [0174] stating, “The total length of the evacuation sheath assembly 2100 for coronary applications, not including any luer fittings, is preferably between about 110 cm and about 200 cm, and most preferably about 135 cm in length.”) such that, when combined with the length of the tubular structure, a distal end portion of the tubular structure is extendable through the continuous lumen of the guide catheter and beyond the distal end of the guide catheter (see para. [0207] stating the method of use is the same as that for the embodiment of Figs. 6A-6I and para. [0117] with Fig. 6C) while a proximal end of the push member is extendable through a hemostatic valve (2185) positioned at a proximal end of the guide catheter, the advancing of the push member causing advancement of the distal end portion of the tubular structure beyond the distal end of the guide catheter while a side opening (2141) of the guide extension catheter remains within the continuous lumen of the guide catheter, the side opening extending for a distance along a longitudinal axis of the guide extension catheter and accessible from a longitudinal side transverse to the longitudinal axis (see para. [0183] stating, “the evacuation head 2132 may include a structure to reinforce the proximal opening of the multi-lumen tube 2138. A support collar 2141 is positioned about the proximal end of the multi lumen tube 2138 and serves to reinforce the proximal opening of the evacuation lumen 2140 in the presence of deforming forces, particularly torsional stresses that may be created unintentionally by rotation of the catheter shaft near its proximal end. As shown in FIG. 16J, the support collar 2141 includes a cylindrical portion 2141a that fits into the proximal opening of the evacuation lumen 2140 and provides hoop support to the opening of the multi-lumen tube 2138.” and see Fig. 16J); maintaining the distal end portion of the tubular structure in position beyond the distal end of the guide catheter; and while maintaining the distal end portion of the tubular structure positioned beyond the distal end of the guide catheter (see Figs. 6B-6H, advancing a balloon catheter or a stent catheter (see para. [0122]) at least partially through the continuous lumen of the guide catheter, into the side opening and through the single lumen of the tubular structure, and into the coronary artery (see Fig. 6E).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim(s) 25-46 is/are rejected under pre-AIA 35 U.S.C. 103(a) as obvious over US Pub. No. 2003/0050600 to Ressemann et al. (“Ressemann”).
Regarding claim 25, Ressemann discloses advancing a distal end of guide catheter (2160) having a continuous lumen extending for a predefined length to or adjacent to an ostium of an artery (see para. [0207] stating the method of use is the same as that for the embodiment of Figs. 6A-6I and para. [0115] stating, “the guide catheter 160 may be positioned within the ostium of the target vessel, and the evacuation sheath assembly 100 may be advanced through the catheter and beyond a major side branch of the target vessel.”), the continuous lumen of the guide catheter having a circular cross-sectional inner diameter sized such that stent catheters are insertable into and through the continuous lumen to the artery (see para. [0122]).
Ressemann also discloses advancing a guide extension catheter (embodiment of Figs. 16A-16J), comprising: a tubular structure (2132) having a circular cross-section (see Fig. 16E) and defining a lumen (2140) coaxial with the lumen of the guide catheter (see para. [0174] stating, “evacuation sheath assembly is sized to fit within and to be used with a guide catheter during the treatment of a vascular stenosis, e.g. within a coronary artery, such as a native coronary artery or an SVG.” and para [0186] stating, “[a] first proximal sealing balloon 2134 is configured to form a seal within the guide catheter which delivers the evacuation sheath assembly 2100 to the surgical site…” it is noted that sealing balloon 2134 once sealing with the lumen of the guide catheter will position the lumen 2140 to be coaxial with the lumen of the guide catheter, see also Fig. 16E showing how the lumen 2140 is concentric to at least ballon 2136) and having a cross-sectional inner diameter greater than or equal to 0.056 inches (see para. [0175] stating, “an inner diameter ID1 of between 0.060 and 0.075 inches, and most preferably 0.067 inches (see FIG. 16E)”, through which an interventional cardiology device is insertable (see para. [0176 stating, “The first and preferably larger of the lumens, an evacuation lumen 2140, is designed to allow for the passage of interventional devices such as, but not limited to, stent delivery systems and angioplasty catheters.”), the tubular structure (2132) having a length that is shorter than a length of the guide catheter (see para. [0174] stating, “For coronary-type applications, the evacuation head may be between about 3 and 40 cm in length, and is preferably between about 10 and 20 cm in length. In a most preferred embodiment, the evacuation head is about 15 cm in length.”); and a substantially rigid portion (2110 and 2120) that is rigid enough to push the tubular structure through the guide catheter and into a coronary artery (portions 2110 and 2120 are rigid enough to push the tubular structure 2132 through a guide catheter since portion 2110 is made from a metallic tube such as a stainless steel hypotube and portion 2120 is made from a stainless steel core wire 2135, see paras. [0197-0199]), the substantially rigid portion being proximal of, operably connected to, and more rigid along a longitudinal axis than the tubular structure (see Figs. 16A and 16B and para. [0175] stating, “The evacuation head 2132 includes a multi-lumen tube 2138. Multi-lumen tube 2138 is preferably made of a relatively flexible polymer, for example, a polyester blend such as Hytrel 6356. Hytrel 6356…;” stainless steel hypotubing and corewire will be more rigid than the flexible polymer of the tubular structure) and defining a rail structure without a lumen (hypotube and core wire do not have a lumen that can accept an interventional device, see claim construction above), the substantially rigid portion having a maximal cross- sectional dimension at a proximal portion that is smaller than the cross-sectional outer diameter of the tubular structure (see Figs. 16A and 16B) and having a length that, when combined with the length of the tubular structure, defines a length of the guide extension catheter along the longitudinal axis that is longer than the length of the guide catheter (see para. [0174] stating, “The total length of the evacuation sheath assembly 2100 for coronary applications, not including any luer fittings, is preferably between about 110 cm and about 200 cm, and most preferably about 135 cm in length.”), such that when at least part of the tubular structure is extended distally of the distal end of the guide catheter (see para. [0207] stating the method of use is the same as that for the embodiment of Figs. 6A-6I and para. [0117] with Fig. 6C) when the tubular structure extends past the guide catheter the tubular structure assists in resisting axial and shear forces exerted by the stent catheter passed through and beyond the coaxial lumen that would otherwise tend to dislodge the guide catheter from the artery (see Fig. 6E-6I), at least part of the substantially rigid portion extends proximally through a hemostatic valve (2185) in common with the interventional cardiology device (2170) that is insertable into the lumen of the guide catheter and the lumen of the tubular structure (see para. [0202] and Fig. 16I); wherein the tubular structure includes a flexible cylindrical distal tip portion (see para. [0181] stating, “a soft, beveled tip 2144 to the distal end of the multi-lumen tube 2138. The tip 2144 creates a tapered transition to the distal ends of the core wire lumen 2142 and the inflation lumen 2143, reducing the tendency for embolic material to hang-up or get caught on the distal ends of the lumens.”) and a flexible cylindrical portion (2138) with a braid or coil (2139) that is proximal (see Fig. 16F) to the flexible cylindrical distal tip portion (2144), and wherein a distal portion of the tubular structure (the distal tip region without the coil) is more flexible than a proximal portion of the tubular structure (see para. 0180 and Fig. 16F showing the kink resisting coil 2139 on the tube 2138 proximal to the distal end).
Ressemann also discloses a proximal side opening (2141) extending for a distance along a side of the extension catheter (see para. [0183] stating, “the evacuation head 2132 may include a structure to reinforce the proximal opening of the multi-lumen tube 2138. A support collar 2141 is positioned about the proximal end of the multi lumen tube 2138 and serves to reinforce the proximal opening of the evacuation lumen 2140 in the presence of deforming forces, particularly torsional stresses that may be created unintentionally by rotation of the catheter shaft near its proximal end. As shown in FIG. 16J, the support collar 2141 includes a cylindrical portion 2141a that fits into the proximal opening of the evacuation lumen 2140 and provides hoop support to the opening of the multi-lumen tube 2138.” and see Fig. 16J). The side opening includes a first inclined region that tapers into a uniform non-inclined region (see annotated Fig. 16J below).
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Ressemann further discloses maintaining the distal end portion of the tubular structure in position beyond the distal end of the guide catheter; and while maintaining the distal end portion of the tubular structure positioned beyond the distal end of the guide catheter (see Figs. 6B-6H, advancing a balloon catheter or a stent catheter (see para. [0122]) at least partially through the continuous lumen of the guide catheter, into the side opening and through the single lumen of the tubular structure, and into the coronary artery (see Fig. 6E).
Regarding the claim limitation of “advancing a distal end of a standard 6 French guide catheter;” one skilled in the art would have found it obvious to modify the sheath assembly as shown in Figs. 16A to 16J to be used with a standard 6 French guide catheter.
Ressemann discloses a range of outer and inner diameters envisioned for the tubular structure (see para. [0175]). The outer diameters provided range from 0.065 to 0.080 in. and the inner diameters provided range from 0.060 to 0.075 in with a wall thickness of 0.0025 in. Therefore, using the measurements provided by Ressemann one skilled in the art could easily construct a tubular structure with an inner diameter of 0.060 in. with a total wall thickness of 0.0050 in. resulting in an outer diameter of 0.065 in. A tubular structure having an outer diameter of 0.065 in. can be used with a standard 6 French guide catheter such as the 6 French guide catheter as disclosed by Takahashi (see Materials and Methods disclosing a 6 Fr guide catheter having an inner diameter of 0.071 in.).
Additionally, both 6 and 8 French guide catheters are used in percutaneous coronary interventions such as coronary balloon angioplasty and stent placement. Ressemann discloses such a procedure as shown in at least Fig. 6F. The selection of a 6 or 8 French guide catheter can be decided based on factors such as vessel size and complexity of the procedure. A 6 French guide catheter would be specifically selected for delivery to smaller coronary arteries and the need for a smaller puncture site for less trauma. The prior art discloses the use of both 6 and 8 French guide catheters for percutaneous coronary interventions. See USPNs 4,898,575 (see col. 6, ll. 48-50, describing selecting the size of the guide catheter depending on the artery); 5,120,323 (see col. 3, ll. 17-18, describing selecting the size of the catheter from the range of 5-9 French for guide catheter placement in the coronary ostium); and 5,701,905 to Esch (“Esch”) (see col. 1, ll. 36-41, stating “It is often desirable to use as small a guide catheter as possible, to minimize clinical complications associated with the arterial puncture in the groin. Eight French (2.66 mm) guides are standard, but seven French or six French guides are also commonly used, particularly for diagnostic procedures.”).
Therefore, at the time of the invention, it would have been obvious to one skilled in the art to modify the dimensions of the tubular structure of Ressemann with at least the lower ranges of the inner diameter of the tubular structure as provided by Ressemann in order to provide a tubular structure that could be utilized with a standard 6 French guide catheter. The motivation to make the modification is provided in the art itself and would have been readily known to one skilled in the art. The motivation is exemplified by Esch which teaches that “It is often desirable to use as small a guide catheter as possible, to minimize clinical complications associated with the arterial puncture in the groin” and additionally, motivation to use a 6 French guide catheter would have been for procedures involving smaller vessels.
Regarding claim 26, Ressemann discloses the method of claim 25 and further teaches wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes establishing fluid communication between the single lumen of the tubular structure and the continuous lumen of the guide catheter. See Fig. 6D.
Regarding claim 27, Ressemann discloses the method of claim 26 and further teaches comprising injecting one or more fluids into the coronary artery via the hemostatic valve positioned at the proximal end of the guide catheter. See para. [0118]; Fig. 16I and para. [0202].
Regarding claim 28, Ressemann discloses the method of claim 25 and further teaches wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes opening the hemostatic valve and advancing the distal end portion of the tubular structure through the hemostatic valve and into the guide catheter. See para. [0118]; Fig. 16I and para. [0202].
Regarding claim 29, Ressemann discloses the method of claim 25 and further teaches wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes advancing the distal end portion of the tubular structure proximal to a location of a lesion to be treated in the coronary artery. See Figs. 6C-6H.
Regarding claim 30, Ressemann discloses the method of claim 25 and further teaches wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes resisting dislodgement of the distal end of the guide catheter from a position adjacent the ostium of the coronary artery when the balloon catheter or stent is advanced into the coronary artery. See balloon 136 and Figs. 6C-6H.
Regarding claim 31, Ressemann discloses the method of claim 25 and further teaches wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes sealing around the push member with the hemostatic valve positioned at the proximal end of the guide catheter. See para. [0202].
Regarding claim 32, Ressemann discloses the method of claim 25 and further teaches wherein advancing the distal end of the guide extension catheter through, and beyond the distal end of, the guide catheter includes aligning the single lumen of the tubular structure with the continuous lumen of the guide catheter. See para. [0174] stating, “evacuation sheath assembly is sized to fit within and to be used with a guide catheter during the treatment of a vascular stenosis, e.g. within a coronary artery, such as a native coronary artery or an SVG.” and para [0186] stating, “[a] first proximal sealing balloon 2134 is configured to form a seal within the guide catheter which delivers the evacuation sheath assembly 2100 to the surgical site…” it is noted that sealing balloon 2134 once sealing with the lumen of the guide catheter will position the lumen 2140 to be coaxial with the lumen of the guide catheter, see also Fig. 16E showing how the lumen 2140 is concentric to at least ballon 2136.
Regarding claim 33, Ressemann discloses the method of claim 25 and further teaches wherein advancing the push member into the continuous lumen of the guide catheter includes advancing the side opening to a position within the continuous lumen of the guide catheter. See Figs. 6B-6H.
Regarding claim 34, Ressemann discloses the method of claim 25 and further teaches wherein advancing the balloon catheter or the stent catheter at least partially through the continuous lumen of the guide catheter includes advancing the balloon catheter or the stent catheter through a single hemostatic valve, which is the hemostatic valve positioned at the proximal end of the guide catheter. See para. [0202].
Regarding claim 35, Ressemann discloses the method of claim 34 and further teaches wherein, subsequent to advancing the balloon catheter or the stent catheter through the single hemostatic valve, the method further comprises sealing around a proximal end portion of the balloon catheter or the stent catheter with the hemostatic valve positioned at the proximal end of the guide catheter. See para. [0202].
Regarding claim 36, Ressemann discloses the method of claim 25 and further teaches wherein advancing the balloon catheter or the stent catheter into the side opening includes accessing the side opening of the guide extension catheter within the continuous lumen of the guide catheter. See para. [0202].
Regarding claim 37, Ressemann discloses the method of claim 36 and further teaches wherein accessing the side opening includes advancing the balloon catheter or the stent catheter along a concave track of the side opening.
Regarding claim 38, Ressemann discloses the method of claim 37 and further teaches wherein the concave track includes at least one inclined slope. The side opening includes a first inclined region that tapers into a uniform non-inclined region (see annotated Fig. 16J below).
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Regarding claim 39, Ressemann discloses the method of claim 37 and further teaches wherein the concave track includes at least two inclined slopes. See annotated Fig. 16J above.
Regarding claim 40, Ressemann discloses the method of claim 37 and further teaches wherein the concave track includes at least one inclined region that tapers into a non-inclined region. See annotated Fig. 16J above.
Regarding claims 41-42, Ressemann discloses the method of claim 25 and further teaches wherein advancing the balloon catheter or the stent catheter into the side opening includes advancing the balloon catheter or the stent catheter through a portion of the guide extension catheter that is more rigid along the longitudinal axis than the distal portion of the tubular structure. Portions 2110 and 2120 are rigid enough to push the tubular structure 2132 through a guide catheter since portion 2110 is made from a metallic tube such as a stainless steel hypotube and portion 2120 is made from a stainless steel core wire 2135, see paras. [0197-0199]), the substantially rigid portion being proximal of, operably connected to, and more rigid along a longitudinal axis than the tubular structure (see Figs. 16A and 16B and para. [0175] stating, “The evacuation head 2132 includes a multi-lumen tube 2138. Multi-lumen tube 2138 is preferably made of a relatively flexible polymer, for example, a polyester blend such as Hytrel 6356. Hytrel 6356…;” stainless steel hypotubing and corewire will be more rigid than the flexible polymer of the tubular structure. See also para. [0183] stating, “the evacuation head 2132 may include a structure to reinforce the proximal opening of the multi-lumen tube 2138. A support collar 2141 is positioned about the proximal end of the multi lumen tube 2138 and serves to reinforce the proximal opening of the evacuation lumen 2140 in the presence of deforming forces, particularly torsional stresses that may be created unintentionally by rotation of the catheter shaft near its proximal end. As shown in FIG. 16J, the support collar 2141 includes a cylindrical portion 2141a that fits into the proximal opening of the evacuation lumen 2140 and provides hoop support to the opening of the multi-lumen tube 2138.” and see Fig. 16J.
Regarding claims 44-46, Ressemann discloses the guide extension catheter of claim 43 as described above and further teaches wherein the guide catheter comprises an 8 French guide catheter (see paras. [0102] and [0175]), and wherein the tubular structure defines a single lumen that is greater than or equal to both 0.056 in. and 0.070 in. (see paras. [0102] and [0175]). Ressemann fails to specifically disclose using a 6 or 7 French guide catheter.
Ressemann discloses a range of outer and inner diameters envisioned for the tubular structure (see para. [0175]). The outer diameters provided range from 0.065 to 0.080 in. and the inner diameters provided range from 0.060 to 0.075 in with a wall thickness of 0.0025 in. Therefore, using the measurements provided by Ressemann one skilled in the art could easily construct a tubular structure with an inner diameter of 0.060 in. with a total wall thickness of 0.0050 in. resulting in an outer diameter of 0.065 in. A tubular structure having an outer diameter of 0.065 in. can be used with either a standard 6 or 7 French guide catheter such as the 6 French guide catheter as disclosed by Takahashi (see Materials and Methods disclosing a 6 Fr guide catheter having an inner diameter of 0.071 in.).
Additionally, 6-8 French guide catheters are used in percutaneous coronary interventions such as coronary balloon angioplasty and stent placement. Ressemann discloses such a procedure as shown in at least Fig. 6F. The selection of a 6, 7 or 8 French guide catheter can be decided based on factors such as vessel size and complexity of the procedure. A 6 French guide catheter would be specifically selected for delivery to smaller coronary arteries and the need for a smaller puncture site for less trauma. The prior art discloses the use of 6, 7 and 8 French guide catheters for percutaneous coronary interventions. See USPNs 4,898,575 (see col. 6, ll. 48-50, describing selecting the size of the guide catheter depending on the artery); 5,120,323 (see col. 3, ll. 17-18, describing selecting the size of the catheter from the range of 5-9 French for guide catheter placement in the coronary ostium); and 5,701,905 to Esch (“Esch”) (see col. 1, ll. 36-41, stating “It is often desirable to use as small a guide catheter as possible, to minimize clinical complications associated with the arterial puncture in the groin. Eight French (2.66 mm) guides are standard, but seven French or six French guides are also commonly used, particularly for diagnostic procedures.”).
Therefore, at the time of the invention, it would have been obvious to one skilled in the art to modify the dimensions of the tubular structure of Ressemann with at least the lower ranges of the inner diameter of the tubular structure as provided by Ressemann in order to provide a tubular structure that could be utilized with a standard 6 or 7 French guide catheter. The motivation to make the modification is provided in the art itself and would have been readily known to one skilled in the art. The motivation is exemplified by Esch which teaches that “It is often desirable to use as small a guide catheter as possible, to minimize clinical complications associated with the arterial puncture in the groin” and additionally, motivation to use a 6 or 7 French guide catheter would have been for procedures involving smaller vessels.
Ressemann fails to specifically disclose the tubular structure defining a lumen greater than 0.078 in. At the time of the invention, it would have been obvious to increase the disclosed inner diameter of the tubular structure of Ressemann by 0.002 since 8 French guide catheters are classified by their outer diameter but are not standard with respect to their inner diameter. Ressemann itself discloses that the inner diameter of an 8 French catheter can range from 0.088-0.096 in (see para. [0102]). Ressemann also discloses that the preferred embodiment is for use with an SVG and specifies an inner diameter of the 8 French guide catheter of 0.090 in. (see para. [0104]). Further, the largest outer and inner diameters of the tubular structure is disclosed as 0.080 in. and 0.075 in. (see para. [0175]). Using these dimensions, the clearance between the outer diameter of the tubular structure and the inner diameter of the guide catheter is 0.010 in. and the total wall thickness of the tubular structure is 0.005 in. Therefore, at the disclosed upper range of the inner diameter of an 8 Frech guide catheter, i.e., 0.096 in. as set forth in para. [0102] of Ressemann, the outer diameter of the tubular structure would be 0.086 in. and the corresponding inner diameter of the tubular structure would be 0.081 in. which is greater than the claimed 0.078 in. lumen.
Conclusion
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/CATHERINE S WILLIAMS/ Reexamination Specialist, Art Unit 3993
Conferees:
/Laura Davison/ Reexamination Specialist, Art Unit 3993
/Patricia L Engle/ SPRS, Art Unit 3991
1 The ADS filed 10/08/2020 correctly lists the current application as both a continuation of 14/984273 (USPN RE47,379) and a reissue of 13/359,059 (USPN 8,292,850)
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