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 .
Election/Restrictions
Applicant’s election without traverse of Species 1c, species 2b, species 3a, species 4b2 and species 5b (claims 1-5 and 10-18) in the reply filed on 09/29/2025 is acknowledged.
Claims 6-9 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/29/2025.
Claims 1-5 and 10-18 are examined on the merits.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “the delivery catheter including a dual-lobed balloon, wherein a first lobe of the dual lobed balloon and a second lobe of the dual-lobbed balloon are configured to be inflated individually from one another” of claim 18 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show “dual-lobbed ballon can be formed from separate inflatable balloon” as described in the specification [0037]. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
Claim Objections
Claims 1, 2, 5 and 16 are objected to because of the following informalities:
Claim 1 line 3 recites “a prosthesis” which should read “the tubular prosthesis”
Claim 1 line 9 recites “the ostium” which should read “the first ostium
Claim 1 line 16 recites “the prosthesis” which should read “the tubular prosthesis”
Claim 1 line 17 recites “delivery catheter” which should read “percutaneous delivery catheter”
Claim 1 line 22 recites “first of the proximal sealing flange” which should read “one of the proximal sealing flange”
Claim 2 line2 recites “the prosthesis” which should read “the tubular prosthesis”
Claim 5 line 3 recites “the prosthesis” which should read “the tubular prosthesis”
Claim 16 line 2 recites “at least one radiopaque marker” which should read “the at least one radiopaque marker”
Appropriate correction is required.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “wherein the first lobe of the dual lobed balloon and the second lobe of the dual-lobbed balloon are configured to be inflated individually from one another and further wherein deploying each of the proximal sealing flange and distal flange is accomplished by individually inflating each of the first lobe and the second lobe of the dual-lobed balloon”
Claim Rejections - 35 USC § 112
Claims 3 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites “about” which renders the claim indefinite. The use of word “about” when indicating a value, duration, numerical range, location, shape, or comparative sizing or proximity is considered indefinite as the specification or arguments previously presented fails to provide some standard for measuring that degree; and there is no standard that is recognized in the art for measuring the meaning of the term of said degree. Terms of Degree: When a term of degree is used in the claim, the examiner should determine whether the specification provides some standard for measuring that degree. If the specification does not provide some standard for measuring that degree, a determination must be made as to whether one of ordinary skill in the art could nevertheless ascertain the scope of the claim (e.g., a standard that is recognized in the art for measuring the meaning of the term of degree). The claim is not indefinite if the specification provides examples or teachings that can be used to measure a degree even without a precise numerical measurement (e.g., a figure that provides a standard for measuring the meaning of the term of degree). During prosecution, an applicant may also overcome an indefiniteness rejection by submitting a declaration under 37 CFR 1.132 showing examples that meet the claim limitation and examples that do not. <Federal Register / Vol. 76, No. 27 / February 9, 2011 / Notices, (Page 7165: Col 3, Par. 0003)>.
Claim 18 recites “wherein the first lobe of the dual lobed balloon and the second lobe of the dual-lobbed balloon are configured to be inflated individually from one another” which renders claim indefinite when read in light of the specification. For instance, specification [0047] illustrate the dual-lobed balloon as “The dual-lobed balloon can be formed from separate inflatable balloons” and “Such a balloon with multiple lobes, or proximal and distal neck regions and a larger central lobe can be used to selectively flare ends of prostheses as described below.” In the examiner’s view, without feature that provide individual fluid communication to each individual lobes, it is not clear how the dual-lobed balloon accomplish the claimed feature, i.e., individually inflating from one to another”, and therefore it is not clear if the claim refers the dual-lobbed ballon comprising separate inflatable balloons or the dual-lobbed ballon comprising separate inflatable balloons can be inflated individually from one another as claimed. In an effort to compact prosecution, the limitation is being interpreted in light of specification above, i.e., dual-lobed balloon formed of separate inflatable balloons that are configured to be selectively flare ends of the prostheses.
Examiner’s note: Applicant is suggested to amend the claim to avoid potential 112(a) issue.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 10-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 14 of U.S. Patent No. 12376956 (hereinafter '956) in view of Evard et al (US 6616675 B1) and Anand (US 20170367820 A1).
Examiner’s note, Although, patented claim and the instant claims are not identical, i.e., ‘956 claims an apparatus claim, whereas the instant claims directed to method claims, they are not patentably distinct from each other because the instant application claims a method of using substantially same apparatus of the patented claim.
Regarding claim 1, Claims 1 and 14 of ‘956 substantially claims applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
A method of delivering a tubular prosthesis in a Potts procedure, comprising:
providing a prosthesis on a percutaneous delivery catheter including:
an elongate compliant tubular body having a proximal end and a distal end (claim 1, A tubular prosthesis, comprising: an elongate compliant tubular body having a proximal end and a distal end);
a distal sealing flange (claim 1, distal sealing flange) coupled to the distal end of the elongate compliant tubular body, the distal sealing flange being configured and arranged to facilitate seating the tubular prosthesis against a first concave vessel wall of a first vessel, wherein the tubular prosthesis is configured to extend outwardly through a first ostium formed in the first concave vessel wall when deployed, wherein the distal sealing flange remains inside the ostium after deployment (claim 1 “wherein the tubular prosthesis is configured to extend outwardly through an ostium formed in the first concave vessel wall when deployed” and “wherein the distal sealing flange remains inside the ostium after deployment”);
a proximal sealing flange (claim 14, “a proximal sealing flange”) coupled to the proximal end of the elongate compliant tubular body, the proximal sealing flange being configured and arranged to facilitate seating the tubular prosthesis against a second concave vessel wall of a second vessel, wherein the tubular prosthesis is configured to extend outwardly through a second ostium formed in the second concave vessel wall when deployed, wherein the distal sealing flange remains inside the second ostium after deployment (claim 14, “wherein the tubular prosthesis is configured to extend outwardly through a second ostium formed in the second concave vessel wall when deployed, wherein the proximal sealing flange remains inside the second ostium after deployment”);
introducing the prosthesis on the percutaneous delivery catheter into a patient's vasculature, the delivery catheter including a dual-lobed balloon, a first lobe of the dual-lobed balloon being disposed underneath the distal sealing flange, and a second lobe of the dual-lobed balloon being disposed underneath the proximal sealing flange;
forming an ostium into a wall of the patient's left pulmonary artery and an ostium into a wall of the patient's descending aorta;
deploying a first of the proximal sealing flange and distal sealing flange into the ostium formed into the wall of the left pulmonary artery by inflating at least one of the lobes of the dual- lobed balloon, respectively; and
deploying the other of the proximal sealing flange and distal sealing flange into the ostium formed into the wall of the patient's descending aorta by inflating at least one of the lobes of the dual-lobed balloon.
‘956 does not claim the method comprising introducing the prosthesis on the percutaneous delivery catheter into a patient's vasculature, the delivery catheter including a dual-lobed balloon, a first lobe of the dual-lobed balloon being disposed underneath the distal sealing flange, and a second lobe of the dual-lobed balloon being disposed underneath the proximal sealing flange;
forming an ostium into a wall of the patient's left pulmonary artery and an ostium into a wall of the patient's descending aorta;
deploying a first of the proximal sealing flange and distal sealing flange into the ostium formed into the wall of the left pulmonary artery by inflating at least one of the lobes of the dual- lobed balloon, respectively; and
deploying the other of the proximal sealing flange and distal sealing flange into the ostium formed into the wall of the patient's descending aorta by inflating at least one of the lobes of the dual-lobed balloon.
In the same field of endeavor, namely a method and apparatus for connecting openings formed in adjacent blood vessels, Evard teaches introducing the prosthesis on the percutaneous delivery catheter into a patient's vasculature, the delivery catheter including a dual-lobed balloon (figure 3 and col 10 line 10 – col 11 line 45inserting mesh connector on the delivery catheter in a compressed configuration into blood vessel), a first lobe of the dual-lobed balloon being disposed underneath the distal sealing flange, and a second lobe of the dual-lobed balloon being disposed underneath the proximal sealing flange (figure 3, first and second balloons 28 and 30 disposed underneath the flanges );
forming an ostium into a wall (figure 1 and col 10 line 10 – col 11 line 45 forming openings on blood vessels BV1 and BV2) of the patient's left pulmonary artery and an ostium into a wall of the patient's descending aorta;
deploying one of the proximal sealing flange and distal sealing flange into the ostium formed into the wall of the left pulmonary artery by inflating at least one of the lobes of the dual- lobed balloon, respectively (figure 1 and col 10 line 65-col 11 line 45, inflating the first and second balloons 28 and 30 causing the compressed apparatus 10b to splay or deform outwardly forming sealing flanges ); and
deploying the other of the proximal sealing flange and distal sealing flange into the ostium formed into the wall of the patient's descending aorta by inflating at least one of the lobes of the dual-lobed balloon (figure 1 and col 10 line 65-col 11 line 45, inflating the first and second balloons 28 and 30 causing the compressed apparatus 10b to splay or deform outwardly forming sealing flanges).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘956 to incorporate the teachings of Evard and provide the claimed percutaneous delivery catheter for the purpose of safely deploy the apparatus to desired implantation site as taught by Evard (col 2 lines 40-50)
The combination is still silent as to the method of delivering the tubular prosthesis including forming an ostium into a wall of the patient’s left pulmonary artery and descending aorta, and deploying the tubular prosthesis into the patient’s left pulmonary artery and descending aorta.
In the same field of endeavor, namely a pulmonary-systemic shunt devices and related methods, Anand teaches a method of delivering the tubular prosthesis including forming an ostium into a wall of the patient’s left pulmonary artery and descending aorta, and deploying the tubular prosthesis into the patient’s left pulmonary artery and descending aorta (figure 4 and [0028] implanting tubular member int a patent ducts arteriosis or connecting the two vessels in a region of the ductus arteriosis including aorta 20 and pulmonary artery 18).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘956, as modified by Evard, to incorporate the teachings of Anand and provide the method comprising forming ostium into a wall of the patient’s left pulmonary artery and descending aorta and providing tubular body therebetween for the purpose of treating pulmonary hypertension as taught by Anand ([0021]).
Regarding claim 2, ‘956, as modified by Evard and Anand, claims the method of claim 1.
‘956 further claims wherein at least one of the proximal and distal ends of the prosthesis further includes at least one laterally extending projection structurally distinct from the distal and proximal sealing flanges, the at least one laterally extending projection being located proximate the distal or proximal sealing flange and extending laterally beyond the distal or proximal sealing flange, respectively, the at least one laterally extending projection being configured and arranged to resist being pulled through said wall of said aorta or left pulmonary artery (claim 1, two opposing laterally extending projections).
Regarding claim 3, ‘956, as modified by Evard and Anand, claims the method of claim 1.
The combination further teaches wherein the at least one laterally extending projection includes at least two laterally extending projections oriented about 180 degrees with respect to each other about a longitudinal axis of the tubular prosthesis, and further wherein the at least two laterally extending projections are configured and arranged to rest near a bottom of a concavity of the left pulmonary artery or right descending aorta (‘956; claim1 and 14, two opposing laterally extending projections).
The combination does not expressly teach the at least two laterally extending projections oriented about 180 degrees with respect to each other.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘956, as modified by Evard and Anand, such that the at least two laterally extending projections oriented about 180 degrees with respect to each other as such a modification would have been an obvious matter of design choice involving a rearrangement of parts. A rearrangement of parts is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.0 VI.C). One of skill in the art motivated to do so for the purpose of uniformly distributing pressure exerted on the projections.
Regarding claim 10, ‘956, as modified by Evard and Anand, claims the method of claim 1.
‘956 further claims wherein a membrane covers the elongate compliant tubular body and the distal flange (claim 2).
‘956 does not teach the membrane covers the proximal flange.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified’ 956, as modified by Evard and Anand, such that the membrane further covers the proximal flange as such a modification would have been an obvious matter of design choice involving a duplication of parts. A duplication of parts is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04.V.D). One of skill in the art motivated to do so for the purpose of providing enhanced sealing at proximal flange
Regarding claim 11, ‘956, as modified by Evard and Anand, claims the method of claim 10.
‘956 claims wherein the membrane includes a woven or non-woven fabric (claim 3)
Regarding claim 12, ‘956, as modified by Evard and Anand, claims the method of claim 10.
‘956 claims wherein the membrane includes an expanded polytetrafluoroethylene ("ePTFE") material (claim 4)
Regarding claim 13, ‘956, as modified by Evard and Anand, claims the method of claim 10.
‘956 claims wherein the membrane includes a biological tissue material (claim 5)
Regarding claim 14, ‘956, as modified by Evard and Anand, claims the method of claim 10.
‘956 claims wherein the at least two laterally extending projections are not covered by the membrane (claim 6)
Regarding claim 15, ‘956, as modified by Evard and Anand, claims the method of claim 10.
‘956 claims wherein each of the at least two laterally extending projections includes at least one radiopaque marker formed thereon (claim 7)
Regarding claim 16, ‘956, as modified by Evard and Anand, claims the method of claim 15.
‘956 claims wherein each of the at least two laterally extending projections includes at least one radiopaque marker formed thereon at a location that resides at a respective ostium after implantation. (claim 8)
Regarding claim 17, ‘956, as modified by Evard and Anand, claims the method of claim 15.
‘956 claims wherein each of the at least two laterally extending projections further includes at least one radiopaque marker formed near an outward lateral tip of each of the two laterally extending projections, respectively (claim 9)
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14 of U.S. Patent No. 12376956 (hereinafter '956) in view of Evard et al (US 6616675 B1) and Anand (US 20170367820 A1) and in further view of Barthold (US 20180133042 A1).
Regarding claim 18, ‘956, as modified by Evard and Anand, claims the method of claim 15.
The combination further teaches wherein the first lobe of the dual lobed balloon and the second lobe of the dual-lobed balloon are configured to be inflated individually from one another and further wherein deploying each of the proximal sealing flange and distal flange (Evard; figure 3 and col 15 line 45- col 16 line 33, the mesh connector apparatus 10b is delivered in compressible configuration and inflating first and second balloon 28 and 30 expand the mesh connector in an hourglass shape forming the proximal and distal flanges) is accomplished by individually inflating each of the first lobe and the second lobe of the dual- lobed balloon.
The combination does not expressly teach the dual-lobbed balloon are configured to be inflated individually from one another and deploying of the distal and proximal sealing flanges are accomplished by individually inflating each of the first lobe and the second lobe of the dual-lobbed ballon.
In the same field of endeavor, namely an balloon catheter, Barthold teaches teach the dual-lobbed balloon are configured to be inflated individually from one another and deploying of the distal and proximal sealing flanges are accomplished by individually inflating each of the first lobe and the second lobe of the dual-lobbed ballon (figure 1, [0079] catheter 10 comprising balloon segments 21, 22 and 23 which can be inflated one after another to expand prosthesis for example stent/stent graft).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘956, as modified by Evard and Anand, to incorporate the teachings of Barthold and provide the dual lobed ballon as claimed for the purpose of shaping the stent into the desired shape as taught by Barthold ([0079]). For example, this independent expansion facilitates the shaping of the stent to accommodate varying apertures sizes in the aorta and pulmonary artery, thereby allowing the device to adapt to diverse anatomical structure without requiring a custom-modified balloon catheter for each procedure.
Claim Rejections - 35 USC § 103
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 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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Evard et al (US 6616675 B1) in view of Anand et al (US 20170367820 A1).
Regarding claim 1, Evard substantially teaches applicant’s claimed invention, and specifically discloses a method of using device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
a method of delivering a tubular prosthesis in a Potts procedure, comprising:
providing the tubular prosthesis (figures 3-3” and col 10 line 10 – col 11 line 45, providing mesh connector 10b on a delivery catheter 26) on a percutaneous delivery catheter including:
an elongate compliant tubular body (figure 3 and col 10 line 10 – col 11 line 45, body of the mesh connector 10b formed of resilient wire segments) having a proximal end and a distal end (figure 3, proximal and distal end of the body having diameter D1);
a distal sealing flange (flange at distal end of mesh body, figure 3 and col 10 line 10 – col 11 line 45, the mesh connector is shaped in an hourglass configuration, where the proximal and distal ends having have a first diameter D1 that forms sealing flanges) coupled to the distal end of the elongate compliant tubular body, the distal sealing flange being configured and arranged to facilitate seating the tubular prosthesis against a first concave vessel wall of a first vessel (figures 1, 3 and col 10 line 10 – col 11 line 45, the distal and proximal sealing flanges engage wall of the adjacent blood vessels BV1 and BV2 facilitate the device anchoring within the blood vessels), wherein the tubular prosthesis is configured to extend outwardly through a first ostium formed in the first concave vessel wall when deployed, wherein the distal sealing flange remains inside the ostium after deployment (figures 1, 3 and col 10 line 10 – col 11 line 45, flanges positioned within blood vessels while mid portion having diameter D2 extend through the opening of the blood vessel);
a proximal sealing flange (flange at proximal end of the mesh body, figure 3 col 10 line 10 – col 11 line 45, the mesh connector is shaped in an hourglass configuration, where the proximal and distal ends having have a first diameter D1 that forms sealing flanges) coupled to the proximal end of the elongate compliant tubular body, the proximal sealing flange being configured and arranged to facilitate seating the tubular prosthesis against a second concave vessel wall of a second vessel (figures 1, 3 and col 10 line 10 – col 11 line 45, the distal and proximal sealing flanges engage wall of the adjacent blood vessels BV1 and BV2 facilitate the device anchoring within the blood vessels), wherein the tubular prosthesis is configured to extend outwardly through a second ostium formed in the second concave vessel wall when deployed, wherein the distal sealing flange remains inside the second ostium after deployment (figures 1, 3 and col 10 line 10 – col 11 line 45, flanges positioned within blood vessels while mid portion having diameter D2 extend through the opening of the blood vessel);
introducing the prosthesis on the percutaneous delivery catheter into a patient's vasculature, the delivery catheter including a dual-lobed balloon (figure 3 and col 10 line 10 – col 11 line 45, inserting mesh connector 10b on the delivery catheter 26 in a compressed configuration into blood vessel, the delivery catheter comprising first and second balloons 28 and 30), a first lobe of the dual-lobed balloon being disposed underneath the distal sealing flange, and a second lobe of the dual-lobed balloon being disposed underneath the proximal sealing flange (figure 3, first and second balloons 28 and 30 disposed underneath the flanges);
forming an ostium into a wall (figure 1 and col 10 line 10 – col 11 line 45 forming openings on wall of the blood vessels BV1 and BV2) of the patient's left pulmonary artery and an ostium into a wall of the patient's descending aorta;
deploying one of the proximal sealing flange and distal sealing flange into the ostium formed into the wall of the left pulmonary artery by inflating at least one of the lobes of the dual- lobed balloon, respectively (figures 1, 14a-e and col 10 line 65-col 11 line 45, inflating the first and second balloons 28 and 30 causing the compressed apparatus 10b to splay or deform outwardly forming sealing flanges); and
deploying the other of the proximal sealing flange and distal sealing flange into the ostium formed into the wall of the patient's descending aorta by inflating at least one of the lobes of the dual-lobed balloon (figure 1, 14a-e and col 10 line 65-col 11 line 45, inflating the first and second balloons 28 and 30 causing the compressed apparatus 10b to splay or deform outwardly forming sealing flanges).
Evard does not explicitly teach the method of delivering the tubular prosthesis including forming an ostium into a wall of the patient’s left pulmonary artery and descending aorta, and deploying the tubular prosthesis into the patient’s left pulmonary artery and descending aorta.
In the same field of endeavor, namely a pulmonary-systemic shunt devices and related methods, Anand teaches a method of delivering the tubular prosthesis including forming an ostium into a wall of the patient’s left pulmonary artery and descending aorta, and deploying the tubular prosthesis into the patient’s left pulmonary artery and descending aorta (figure 4 and [0028] implanting tubular member int a patent ducts arteriosis or connecting the two vessels in a region of the ductus arteriosis including aorta 20 and pulmonary artery 18).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Evard to incorporate the teachings of Anand and provide the method comprising forming ostium into a wall of the patient’s left pulmonary artery and descending aorta and providing tubular body therebetween for the purpose of treating pulmonary hypertension as taught by Anand ([0021]).
Regarding claim 2, Evard, as modified by Anand, teaches the method of claim 1.
The combination further teaches wherein at least one of the proximal and distal ends of the prosthesis further includes at least one laterally extending projection structurally distinct from the distal and proximal sealing flanges (Evard; figure 3, engagement members 20 located proximate the distal and proximal sealing flanges as set forth in claim 1), the at least one laterally extending projection being located proximate the distal or proximal sealing flange and extending laterally beyond the distal or proximal sealing flange, respectively, the at least one laterally extending projection being configured and arranged to resist being pulled through said wall of said aorta or left pulmonary artery (Evard; figure 1 and col 10 line 65-col 11 line 45, the engagement member 20 configured to be engage the wall of blood vessels prevent the mesh connector pulled through the opening of the blood vessels).
Regarding claim 3, Evard, as modified by Anand, teaches the method of claim 2.
The combination further teaches wherein the at least one laterally extending projection includes at least two laterally extending projections oriented about 180 degrees with respect to each other about a longitudinal axis of the tubular prosthesis, and further wherein the at least two laterally extending projections are configured and arranged to rest near a bottom of a concavity of the left pulmonary artery or right descending aorta (Evard; figure 1 col 10 line 65 – col 11 line 45, the engagement member 20 including at least two laterally extending projections and are configured to be arranged near a bottom of a concavity of the left pulmonary artery or right descending aorta as taught by Anand).
The combination does not expressly teach the at least two laterally extending projections oriented about 180 degrees with respect to each other.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Evard, as modified by Anand, such that the at least two laterally extending projections oriented about 180 degrees with respect to each other as such a modification would have been an obvious matter of design choice involving a rearrangement of parts. A rearrangement of parts is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.0 VI.C). One of skill in the art motivated to do so for the purpose of uniformly distributing pressure exerted on the projections.
Regarding claim 4, Evard, as modified by Anand, teaches the method of claim 3.
The combination further teaches wherein the at least two laterally extending projections are connected to a framework of the tubular prosthesis (Evard; figure 3 and col 10 line 65- col 11 line 45, the engagement members 20 are connected to the mesh frame of the connector apparatus 10b and extends radially outward from the sealing flanges. The engagement members further extends laterally beyond the flanges into a respective blood vessel lumen upon expansion), and extend radially outwardly with respect to the proximal sealing flange or the distal sealing flange and extend further into a respective blood vessel than the proximal sealing flange or distal sealing flange.
Regarding claim 5, Evard, as modified by Anand, teaches the method of claim 4.
The combination further teaches the at least two laterally extending projections are integrated into a circumferential ring structure that forms a proximal or distal end portion of the prosthesis (Evard; figure 3, the mesh connector apparatus defines a circumferential ring structure at its proximal and distal ends and the engagement members 20 are integrated therewith).
Claims 10, 11, 13 and 14 rejected under 35 U.S.C. 103 as being unpatentable over Evard et al (US 6616675 B1) in view of Anand et al (US 20170367820 A1), and in further view of an alternate embodiment of Evard (US 6616675 B1; figures 7c-7d’ and col 15 line 45- col 16 line 33)
Regarding claim 10, Evard, as modified by Anand, teaches the method of claim 1.
The combination does not teach wherein a membrane covers the elongate compliant tubular body and the distal flange and proximal flange.
However, in an alternate embodiment of Evard teaches wherein a membrane covers the elongate compliant tubular body and the distal flange and proximal flange (col 15 line 45- col 16 line 33, wire connector member with optional coverings may cover all or any portion of the apparatus).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Evard, as modified by Anand, to incorporate the teachings of Evard and provide the membrane as claimed, and one of skill in the art motivated to do so for the purpose of reducing leaking of blood through mesh structure.
Regarding claim 11, Evard as modified by Anand, teaches the method of claim 10.
The combination further teaches wherein the membrane includes a woven or non-woven fabric (Evard’ col 15 line 45 – col 16 line 35 “Such coverings may be formed of any suitable material including, but not limited to, elastomeric material, fabrics (e.g., woven polyester)”).
Regarding claim 13, Evard as modified by Anand, teaches the method of claim 10.
The combination further teaches wherein the membrane includes a biological tissue material (Evard; col 15 line 45 – col 16 line 35, covering may be formed of any suitable material including natural materials such as autologous or xenograft material).
Regarding claim 14, Evard as modified by Anand, teaches the method of claim 10.
The combination further teaches wherein the at least two laterally extending projections are not covered by the membrane (Evard; col 15 line 45 – col 16 line 35 and figure 7c “such covering may be formed on the connecting portion or mid-portion of the apparatus so as to form a sleeve”)
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Evard et al (US 6616675 B1) in view of Anand et al (US 20170367820 A1), an alternate embodiment of Evard (US 6616675 B1; figures 7c-7d’ and col 15 line 45- col 16 line 33), and in further view of Verkaik et al (US 20120143141 A1).
Regarding claim 12, Evard as modified by Anand, teaches the method of claim 10.
The combination does not teach wherein the membrane includes an expanded polytetrafluoroethylene ("ePTFE") material.
In the same field of endeavor, namely conformal cannula device and related methods, Verkaik teaches wherein the membrane includes an expanded polytetrafluoroethylene ("ePTFE") material ([0057] ePTFE sleeve affixed to frame assembly 60).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Evard, as modified by Anand, to incorporate the teachings of Verkaik and provide the membrane as claimed for the purpose of facilitating the formation of a controlled biological layer on the surface as taught by Verkaik ([0057]) which effectively reduces tissue overgrowth preventing restenosis.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Evard et al (US 6616675 B1) in view of Anand et al (US 20170367820 A1), an alternate embodiment of Evard (US 6616675 B1; figures 7c-7d’ and col 15 line 45- col 16 line 33), and in further view of Kassab et al (US 20150142094 A1).
Regarding claim 15, Evard as modified by Anand, teaches the method of claim 10.
The combination does not teach wherein each of the at least two laterally extending projections includes at least one radiopaque marker formed thereon;
In the same field of endeavor, namely systems and methods for the prevention of stroke, Kassab teaches wherein each of the at least two laterally extending projections includes at least one radiopaque marker formed thereon (figure 3b-c and [0053], radiopaque markers 214 located on the flanges portion 204).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Evard, as modified by Anand, to incorporate the teachings of Kassab and provides the radiopaque marker as claimed for the purpose of assisting proper positioning of the device as taught by Kassab ([0080]).
Regarding claim 16, Evard as modified by Anand, teaches the method of claim 15.
The combination further teaches wherein each of the at least two laterally extending projections includes the at least one radiopaque marker formed thereon at a location that resides at a respective ostium after implantation (Kassab; [0059] and figure 5a, flange portion 204 including radiopaque marker 214 resides at respective ostium after implantation).
Regarding claim 17, Evard as modified by Anand, teaches the method of claim 10.
The combination further teaches wherein each of the at least two laterally extending projections further includes at least one radiopaque marker formed near an outward lateral tip of each of the two laterally extending projections, respectively (Kassab; figure 3b, the radiopaque marker 214 formed near an outward lateral tip of each of the laterally extending projections 304).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Evard et al (US 6616675 B1) in view of Anand et al (US 20170367820 A1), and in further view of Barthold (US 20180133042 A1).
Regarding claim 18, Evard as modified by Anand, teaches the method of claim 1.
The combination further teaches wherein the first lobe of the dual lobed balloon and the second lobe of the dual-lobed balloon are configured to be inflated individually from one another and further wherein deploying each of the proximal sealing flange and distal flange (Evard; figures 3, 14a-e, abstract and col 10 line 65-col 11 line 45, the mesh connector apparatus 10b is delivered in compressible configuration and inflating first and second balloon 28 and 30 expand the mesh connector in an hourglass shape defining the proximal and distal flanges) is accomplished by individually inflating each of the first lobe and the second lobe of the dual- lobed balloon.
The combination does not expressly teach the dual-lobbed balloon are configured to be inflated individually from one another and deploying of the distal and proximal sealing flanges are accomplished by individually inflating each of the first lobe and the second lobe of the dual-lobbed ballon.
In the same field of endeavor, namely an balloon catheter, Barthold teaches teach the dual-lobbed balloon are configured to be inflated individually from one another and deploying of the distal and proximal sealing flanges are accomplished by individually inflating each of the first lobe and the second lobe of the dual-lobbed ballon (figure 1, [0079] catheter 10 comprising balloon segments 21, 22 and 23 which can be inflated one after another to expand prosthesis for example stent/stent graft).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Evard, as modified by Anand, to incorporate the teachings of Barthold and provide the dual lobed ballon as claimed for the purpose of shaping the stent into the desired shape as taught by Barthold ([0079]). For example, this independent expansion facilitates the shaping of the stent to accommodate varying apertures sizes in the aorta and pulmonary artery, thereby allowing the device to adapt to diverse anatomical structure without requiring a custom-modified balloon catheter for each procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Drasler (US 20150306359 A1) is cited as disclosing dual balloon catheter which relatively pertinent to the claimed invention.
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/SETH HAN/Examiner, Art Unit 3781