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 .
Response to Amendment
This office action is responsive to the amendment filed on 07/23/2026. As directed by the amendment: claims 1 and 12-14 have been amended and claims 11, 17-20, 22-25, and 28-44 have been cancelled. Thus, claims 1-10, 12-16, 21, and 26-27 are presently pending in this application.
Response to Arguments
Applicant's arguments, see pages 6-7, filed 07/23/2026, with respect to the rejections of claim 11 now incorporated into claim 1 under 35 U.S.C. 103 as being unpatentable over Roche et al (US 20220313233 A1), herein referenced to as “Roche” in view of Delaloye et al (US 20120083832 A1), herein referenced to as “Delaloye” have been fully considered but they are not persuasive.
The applicant has amended claim 1 to incorporate the limitations of claim 11, adding “a flap that is hingedly attached to the first surface or the second surface, the flap configured to allow passage of a 0.035-inch guidewire, but close upon removal of the 0.035- inch guidewire” and adding the limitation “a flap covering the opening”.
The applicant argues that Delaloye does not teach a flap covering an opening that is hingedly attached to the substrate. They argue that Delaloye teaches a valve that can include flaps or leaflets where the slits would define the openings and that there is no flap hingedly that covers the opening. They assert that there is no separate opening for Delaloye’s flaps to cover.
As such they argue that the combination of Roche and Delaloye does not teach the limitations of claim 1. The examiner respectfully disagrees.
The flaps, when lifted or moved, widen the opening created by the slits, hence when they fold back over, the opening is covered. The opening thus is defined by the slit and the area which is covered by the flaps. Additionally, one of ordinary skill in the art would recognize that a leaflet or a flap is an element that hingedly connects to the surface of the valve the leaflet is connected with, as in the art the terms are related the to function of a heart valve, the leaflets of which are hingedly connected and operate. Delaloye further illustrates this as it notes that its cover component includes fascia (tissue) in [0091], stating “The fascia portion 330 may additionally extend over the central lumen of the support structure to occlude the lumen. The fascia portion 330 may optionally comprise or carry a self-closing valve or aperture 332 through which a guidewire may pass. The valve 332 may comprise one or more flaps or leaflets. The valve 332 may be integrated as part of the cover component 300. The valve 332 may be made of the same material as the cover component”.
The online Merriam-Webster dictionary definition of leaflet as an example is “a leaflike organ or part (such as one of the flaps of a heart valve). See also the image provided below that shows the hingedly flapping of an exemplary leaflet as known in the field of art. This clearly shows that leaflets cover an opening through the valve, hence allowing functioning as a valve. Otherwise, if the leaflets did not cover an opening of a valve, it would not operate as a valve.
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As such the rejection of the claims will be maintained.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-10, and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roche et al (US 20220313233 A1), herein referenced to as “Roche” in view of Delaloye et al (US 20120083832 A1), herein referenced to as “Delaloye”.
Claim 1
Roche discloses: A bioresorbable device 1 (see Figs. 1A-3, [0202]), comprising: a disk-shaped substrate layer 5 (see Figs. 1A-3, [0202], fabric patch) comprising fibers (see [0202], fabric patch, which is made of biocompatible fibers), the disk-shaped substrate layer 5 having a first surface (see annotated Fig. 3 below) and a second surface (see annotated Fig. 3 below) opposing the first surface, and the disk-shaped substrate layer 5 having an opening 4 (see Figs. 1A-3, [0204]) extending from the first surface (see [0204], 4 can extend through 5) to the second surface configured to allow a guidewire (see [0204], a delivery device can pass through 4) to pass through the opening; and a coating 6 (see Figs. 1A-3, [0205], the patch (5) is coated with 6) on the first surface (see annotated Fig. 3 below) configured to encourage adhesion (see [0205], effective attachment of the patch 5 to the atrial wall W) to an interior vessel wall (see [0205], atrial wall).
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Roche does not explicitly disclose: a flap covering the opening, the flap being hingedly attached to the first surface or the second surface, the flap configured to allow passage of a 0.035-inch guidewire, but close upon removal of the 0.035- inch guidewire.
However, Delaloye in a similar field of invention teaches a bioresorbable device 300 (see Figs. 6A-6B) with a disk-shaped substrate layer 300 (see Figs. 6A-6B) with a first surface 310 (see Figs. 6A-6B), a second surface 330 (see Figs. 6A-6B) and an opening 332 and the space covered by the flaps to operate as a valve (see Figs. 6A-6B, [0091]). Delaloye further teaches: further comprising a flap one or more flaps or leaflets of 332 (see Fig. 6B, [0091]) covering the opening the space covered by the flaps to operate as a valve (see Figs. 6A-6B, [0091]) that is hingedly attached (see Fig. 6B, [0091], leaflets are known hingedly attached in the field of art, like heart valve leaflets) to the first surface (will not be examined due to being an optional claim limitation) or the second surface 330, the flap configured to allow passage of a 0.035-inch guidewire, but close upon removal of the 0.035- inch guidewire.
The language, " the flap configured to allow passage of a 0.035-inch guidewire, but close upon removal of the 0.035- inch guidewire," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Delaloye meets the structural limitations of the claim, and is capable of having a guidewire pass and then to self-close after it is removed (see [0091]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Roche to incorporate the teachings of Delaloye and teach a bioresorbable device with a flap that is hingedly attached to the first surface or the second surface, the flap configured to allow passage of a 0.035-inch guidewire, but close upon removal of the 0.035- inch guidewire. Motivation for such can be found in Delaloye as this self-closing valve can allow a guidewire to pass and then close after it is removed (see [0091]).
Claim 2
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above. Roche further discloses: wherein the disk-shaped substrate layer 5 is a woven substrate (see [0105], woven bioabsorbable material).
Claim 3
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above. Roche further discloses: wherein the disk-shaped substrate layer 5 is a nonwoven substrate (see [0105], nonwoven bioabsorbable material).
Claim 4
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above.
The language, "wherein the opening is configured to allow a 0.035-inch guidewire to pass through the opening," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Roche meets the structural limitations of the claim, and is capable of the opening allowing a thin, 0.035-inch guidewire to pass through the opening, as it is capable of allowing delivery devices through it (see [0204], a delivery device can pass through 4).
Claim 5
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above. Roche does not explicitly disclose: wherein the disk-shaped substrate layer has a thickness of 0.1 mm - 0.2 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Roche to have the disk-shaped substrate layer has a thickness of 0.1 mm - 0.2 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Roche would not operate differently with the disk-shaped substrate layer has a thickness of 0.1 mm - 0.2 mm. Further, applicant places no criticality on the range claimed, see [0028] of applicant’s patent application publication notes that the thickness may be less than 0.5 mm, which is greater than 0.2 mm, hence thickness of 0.3-0.5 mm are acceptable alternatives and hence the thickness of 0.1 mm – 0.2 mm is not critical.
Claim 6
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above. Roche does not explicitly disclose: wherein the disk-shaped substrate layer has a diameter of 15 mm - 25 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Roche to have the disk-shaped substrate layer has a diameter of 15 mm - 25 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Roche would not operate differently with the disk-shaped substrate layer has a diameter of 15 mm - 25 mm. Further, applicant places no criticality on the range claimed, see [0029] of applicant’s patent application publication notes that the diameter may be 10 mm, which is less than 15 mm, hence diameter of 10 mm is an acceptable alternative and hence the thickness of 15 mm – 25 mm is not critical.
Claim 7
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above. Roche further discloses: wherein the opening 4 is a slit (see Fig. 1b, 4 is a slit with a length parallel to the first surface of 5) having a length in a direction parallel to the first surface (see annotated Fig. 3 below claim 1).
Roche does not explicitly disclose: the length of the slit is 0.5 mm – 1 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Roche to have the length of the slit is 0.5 mm – 1 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Roche would not operate differently with the length of the slit is 0.5 mm – 1 mm. Further, applicant places no criticality on the range claimed, see [0033] of applicant’s patent application publication notes that the length may be 0.1 mm, which is less than 0.5 mm, hence a length of 0.1 mm is an acceptable alternative and hence the length of 0.5 mm – 1 mm is not critical.
Claim 8
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above. Roche further discloses: wherein the disk-shaped substrate layer comprises polydioxanone (will not be examined due to being an optional claim limitation), polycaprolactone (see [0129], poly(caprolactone)), polyglycolide (see [0202], polyglycolic acid or PGA, which in the field of art is known also as polyglycolide), poly L-lactide (see [0129], poly(L-lactic acid), or a combination thereof (see [0129]).
Claim 9
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above. Roche further discloses: wherein the second surface (see annotated Fig. 3 below claim 1, this surface only has 5, see [0038], velour-like surface, which is a soft smooth surface, velvet) is smoother than the first surface (see annotated Fig. 3 below claim 1, this surface has 6 over it, [0041], (6) does not have a velour surface, hence is rougher than the first surface/5, see also Fig. 18b, 6 has a rough uneven surface) .
Claim 10
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above. Roche further discloses: wherein the coating 6 comprises collagen (see [0064], collagen), chitin (will not be examined due to being an optional claim limitation), chitosan (will not be examined due to being an optional claim limitation), a oligo(ethylene glycol) methylacrylate (OEGMA) (will not be examined due to being an optional claim limitation), methacrylic acid (MAA) (will not be examined due to being an optional claim limitation) or a combination thereof.
Claim 12
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above. Delaloye further discloses: wherein the flap 332 is adhered onto the disk-shaped substrate layer 300 (see Fig. 6B, [0091], 332 is integrated as part of 300).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Roche to incorporate the teachings of Delaloye and teach a bioresorbable device with flap adhered onto the disk-shaped substrate layer by being integrated with the disk-shaped layer. Motivation for such can be found in Delaloye as this self-closing valve can allow a guidewire to pass and then close after it is removed (see [0091]).
Claim 13
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above.
The combination of Roche and Delaloye teaches the flap (which as modified from Delaloye into Roche is to be made of the same material as the disk-shaped substrate layer, which in Roche a polycaprolactone or polyglycolide material) comprises a polycaprolactone material, but is silent to the method of attachment of the flap to the disk-shaped substrate layer. The claimed phrase “wherein the flap is thermally bound to the disk-shaped substrate layer” is being treated as a product by process limitation; that is, that the flap is made by thermal bonding. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though the combination of Roche and Delaloye is silent as to the process used to attach the flap to the disk-shaped substrate layer, it appears that the product in Roche and Delaloye would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of a polycaprolactone material (see applicant’s patent application publication [0007]).
Claim 14
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above. The combination of Roche and Delaloye further teaches: wherein the flap (which as modified from Delaloye into Roche is to be made of the same material as the disk-shaped substrate layer, which in Roche a polycaprolactone or polyglycolide material) comprises polydioxanone (will not be examined due to being an optional claim limitation), polycaprolactone (see [0129]), polyglycolide (see [0202], polyglycolic acid or PGA, which in the field of art is known also as polyglycolide), poly L-lactide (see [0129], poly(L-lactic acid), or a combination thereof (see [0129]).
Claim 15
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above. Roche (Figs. 1A-3) does not explicitly disclose: wherein the disk-shaped substrate layer comprises a radiopaque material.
However, a variant embodiment (Fig. 21A) of Roche in the same field of invention teaches a bio bioresorbable device (see Fig. 21a) with a disk-shaped substrate layer 1 (see Fig. 21a). Roche (Fig. 21A) further teaches: wherein the disk-shaped substrate layer 1 comprises a radiopaque material 106 (see Fig. 21a, [0244]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Roche to incorporate the teachings of a variant embodiment (Fig. 21A) of Roche and teach a bioabsorbable device with the disk-shaped substrate layer comprises a radiopaque material. Motivation for such can be found in Roche as this radio-opaque material provides contrast in radio-imaging (see [0026]) and furthermore can provide information on proper adhesion and positioning of the implant (see [0028]).
Claim(s) 16, 21, 26, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roche in view of Delaloye as applied to claim 1 above, and further in view of Walsh et al (US 20170079717 A1), herein referenced to as “Walsh”.
Claim 16
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above.
The combination of Roche and Delaloye does not explicitly teach: A kit comprising: a first tubular member having a proximal end and a distal end, and a first lumen extending therethrough; a second tubular member having a proximal end and a distal end, and a second lumen extending therethrough, the second tubular member configured to be slidably positioned within the first lumen; a guidewire comprising an expandable portion, the guidewire configured to be slidably positioned within the second lumen; and an inflation device configured to be removably couplable to the guidewire.
However, Walsh in a similar field of invention teaches a bioresorbable device 22 (see Figs. 1-30) that is a disk-shaped substrate layer 22 (see Figs. 1-30) with an opening 22 has an opening that allows 23 + 21 to pass through it (see Figs. 1-30 and [0061]). Walsh further teaches: A kit (see Figs. 1-30, [0054], kit with instructions) comprising: a first tubular member 25 (see Figs. 1-30, [0055]) having a proximal end proximal end of 25 (see Figs. 1-30) and a distal end distal end of 25 (see Figs. 1-30), and a first lumen the lumen of 25 which 24 and 23 extend through (see Fig. 24) extending therethrough; a second tubular member 24 (see Figs. 1-30, [0055]) having a proximal end proximal end of 24 (see Figs. 1-30) and a distal end distal end of 24 (see Figs. 1-30), and a second lumen the lumen of 24 which 23 extends through (see Fig. 24) extending therethrough, the second tubular member 24 configured to be slidably positioned within the first lumen the lumen of 24 (see [0061], relative movements of 23, 24, and 25); a guidewire 23 (see Figs. 1-30, [0055]) comprising an expandable portion 21 (see Figs. 1-30, [0055]), the guidewire 23 configured to be slidably positioned (see [0061], relative movements of 23, 24, and 25) within the second lumen the lumen of 24; and an inflation device 32 (see Fig. 3, [0086]) configured to be removably couplable to the guidewire 21 (see Fig. 3, [0086], the syringe is connected to a luer stopcock and can be removed as known in the art).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Roche to incorporate the teachings of Walsh and teach having the bioresorbable device within a kit comprising a first tubular member having a proximal end and a distal end, and a first lumen extending therethrough; a second tubular member having a proximal end and a distal end, and a second lumen extending therethrough, the second tubular member configured to be slidably positioned within the first lumen; a guidewire comprising an expandable portion, the guidewire configured to be slidably positioned within the second lumen; and an inflation device configured to be removably couplable to the guidewire. Motivation for such can be found in Walsh as the components necessary for implantation of the device can be packaged together and marketed as a kit with instructions for a customer to use (see [0054]).
Claim 21
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above.
The combination of Roche and Delaloye does not explicitly teach: A system, comprising: a first tubular member having a proximal end and a distal end, and a first lumen extending therethrough; a second tubular member having a proximal end and a distal end, and a second lumen extending therethrough, the second tubular member slidably positioned within the first lumen such that the distal end is within the first lumen; and the bioresorbable device positioned within the first lumen distally from the distal end of the second tubular member, the bioresorbable device being in a compressed configuration and arranged to allow a guidewire to pass through the opening in the bioresorbable device.
However, Walsh in a similar field of invention teaches a bioresorbable device 22 (see Figs. 1-30) that is a disk-shaped substrate layer 22 (see Figs. 1-30) with an opening 22 has an opening that allows 23 + 21 to pass through it (see Figs. 1-30 and [0061]). Walsh further teaches: A system (see Figs. 1-30), comprising: a first tubular member 25 (see Figs. 1-30, [0055]) having a proximal end proximal end of 25 (see Figs. 1-30) and a distal end distal end of 25 (see Figs. 1-30), and a first lumen the lumen of 25 which 24 and 23 extend through (see Fig. 24) extending therethrough; a second tubular member 24 (see Figs. 1-30, [0055]) having a proximal end proximal end of 24 (see Figs. 1-30) and a distal end distal end of 24 (see Figs. 1-30), and a second lumen the lumen of 24 which 23 extends through (see Fig. 24) extending therethrough, the second tubular member 24 slidably positioned within the first lumen the lumen of 24 (see [0061], relative movements of 23, 24, and 25, the distal end of 24 can move through the lumen of 23, see also Figs. 16-19) such that the distal end distal end of 24 is within the first lumen the lumen of 25; and the bioresorbable device 22 positioned within the first lumen the lumen of 25 distally from the distal end distal end of 24 of the second tubular member 24 (see Figs. 16-17 and 24, the bioresorbable device is distal of 24, and can be released with retraction of 24, [0061]), the bioresorbable device 22 being in a compressed configuration (see Figs. 16-17 and [0061], compressed in 24 until released by 24) and arranged to allow a guidewire 23 (see Figs. 1-30, [0055]) to pass through the opening 22 has an opening that allows 23 + 21 to pass through it (see Figs. 1-30 and [0061]) in the bioresorbable device 22.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Roche to incorporate the teachings of Walsh and teach having the bioresorbable device within a system, comprising: a first tubular member having a proximal end and a distal end, and a first lumen extending therethrough; a second tubular member having a proximal end and a distal end, and a second lumen extending therethrough, the second tubular member slidably positioned within the first lumen such that the distal end is within the first lumen; and the bioresorbable device positioned within the first lumen distally from the distal end of the second tubular member, the bioresorbable device being in a compressed configuration and arranged to allow a guidewire to pass through the opening in the bioresorbable device. Motivation can be found in Walsh as there is a system for stabilizing the patch via the balloons to assist in proper positioning and sealing (see [0064] and [0068]) with applying pressure to the patch against the tissue defect site.
Claim 26
The combination of Roche, Delaloye, and Walsh teaches: The system of claim 21. Walsh further teaches: further comprising a guidewire 23 (see Figs. 1-30, [0055]) comprising an expandable portion 21 (see Figs. 1-30, [0055]), the guidewire 23 configured to be slidably positioned (see [0061], relative movements of 23, 24, and 25) within the second lumen the lumen of 24 and extending through the opening in the bioresorbable device 22 (see Fig. 24, 23 with its expandable portion 21 extends through 22).
Claim 27
The combination of Roche and Delaloye teaches: The bioresorbable device of claim 1, see 103 rejection above.
The combination of Roche and Delaloye does not explicitly teach: a method, comprising: inserting a guidewire comprising an expandable portion into a subject, through an entry point in a blood vessel; inserting a delivery system over the guidewire, through the entry point, and to a desired location in the blood vessel, the delivery system comprising: a first tubular member having a proximal end and a distal end, and a first lumen extending therethrough; a second tubular member having a proximal end and a distal end, and a second lumen extending therethrough, the second tubular member slidably positioned within the first lumen such that the distal end is within the first lumen; and the bioresorbable device positioned within the first lumen distally from the distal end of the second tubular member, the bioresorbable device being in a compressed configuration, where the guidewire extends through the opening in the bioresorbable device and through the second lumen; inserting a delivery system over the guidewire, through the entry point, and to a desired location in the blood vessel, the delivery system comprising: expanding the expandable portion of the guidewire to a diameter less than a diameter of the blood vessel; repositioning the second tubular member to cause the distal end of the second tubular member to move distally towards the distal end of the first tubular member, causing the bioresorbable device to exit the first lumen and exhibit a partially expanded configuration; retracting the guidewire with the expandable portion in a partially expanded position to move the expandable portion into contact with the bioresorbable device, and the bioresorbable device in contact with the first tubular member and/or second tubular member; retracting the first tubular member, second tubular member, bioresorbable device, and guidewire together until the bioresorbable device is positioned over the entry point; expanding the expandable portion of the guidewire to fully oppose the bioresorbable device to a wall of the blood vessel; and deflating the expandable portion.
However, Walsh in a similar field of invention teaches a bioresorbable device 22 (see Figs. 1-30) that is a disk-shaped substrate layer 22 (see Figs. 1-30) with an opening 22 has an opening that allows 23 + 21 to pass through it (see Figs. 1-30 and [0061]). Walsh further teaches: a method (see Figs. 1-30), comprising: inserting a guidewire the guidewire + 23 (see Figs. 1-30, [0055] and [0070]) comprising an expandable portion 21 (see Figs. 1-30, [0055]) into a subject (see Figs. 1-30, heart of a patient), through an entry point in a blood vessel (see [0115], cranial or aortic aneurysms which are parts of blood vessels); inserting a delivery system 23 + 24 + 25 (see Figs. 16-17 and 24-30, [0070]) over the guidewire the guidewire + 23, through the entry point, and to a desired location in the blood vessel (see [0115], cranial or aortic aneurysms which are parts of blood vessels), the delivery system 23 + 24 + 25 comprising: a first tubular member 25 (see Figs. 1-30, [0055]) having a proximal end proximal end of 25 (see Figs. 1-30) and a distal end distal end of 25 (see Figs. 1-30), and a first lumen the lumen of 25 which 24 and 23 extend through (see Fig. 24) extending therethrough; a second tubular member 24 (see Figs. 1-30, [0055]) having a proximal end proximal end of 24 (see Figs. 1-30) and a distal end distal end of 24 (see Figs. 1-30), and a second lumen the lumen of 24 which 23 extends through (see Fig. 24) extending therethrough, the second tubular member 24 slidably positioned within the first lumen the lumen of 24 (see [0061], relative movements of 23, 24, and 25, the distal end of 24 can move through the lumen of 23, see also Figs. 16-19) such that the distal end distal end of 24 is within the first lumen the lumen of 25; and the bioresorbable device 22 positioned within the first lumen the lumen of 25 distally from the distal end distal end of 24 of the second tubular member 24 (see Figs. 16-17 and 24, the bioresorbable device is distal of 24, and can be released with retraction of 24, [0061]), the bioresorbable device 22 being in a compressed configuration (see Figs. 16-17 and [0061], compressed in 24 until released by 24), where the guidewire 23 extends through the opening 22 has an opening that allows 23 + 21 to pass through it (see Figs. 1-30 and [0061]) in the bioresorbable device 22 and through the second lumen the lumen of 24; inserting a delivery system over the guidewire (see Figs. 16-17, [0070]), through the entry point (see [0115], cranial or aortic aneurysms which are parts of blood vessels), and to a desired location in the blood vessel (see [0115], cranial or aortic aneurysms which are parts of blood vessels), the delivery system comprising: expanding the expandable portion 21 (see Fig. 27, [0075]) of the guidewire 21 to a diameter less than a diameter of the blood vessel (see Fig. 27, the diameter of 21 is less than the lumen which it is in, hence it would be less than the diameter of the blood vessel it is in an aneurysm, see also [0056], is designed to prevent damage to internal tissue); repositioning the second tubular member 24 (see Fig. 16 and Fig. 25, [0061], 24 is moved past the distal end of 25 and then retract to cause 22 to leave the lumen of 25) to cause the distal end distal end of 24 of the second tubular member 24 to move distally towards the distal end distal end of 25 of the first tubular member 25, causing the bioresorbable device 22 to exit the first lumen the lumen of 22 and exhibit a partially expanded configuration (see [0061]); retracting the guidewire 23 with the expandable portion 21 (see [0056] and [0068], applying pressure on 22 by expanding it retracts to push 21 into contact with 40 of 24, [0068]) in a partially expanded position to move the expandable portion 21 into contact with the bioresorbable device 22, and the bioresorbable device 22 in contact with the first tubular member (will not be examined here due to being an optional claim limitation) and/or second tubular member 24 via 40 (see Fig. 24 and [0068]); retracting the first tubular member 25 (see [0086], 22 is released by retracting a portion of 25, the open suture loop see [0059]), second tubular member 24 (see [0061], retract for deployment), bioresorbable device 22, and guidewire 23 together until the bioresorbable device 22 is positioned over the entry point (see [0115], aneurysm neck, similar to defect shown in Figs. 24-30); expanding the expandable portion 21 of the guidewire 23 to fully oppose the bioresorbable device 22 to a wall of the blood vessel (see [0051], apply compressive force onto 22 to the tissue wall, see [0072]); and deflating the expandable portion 21 (see [0075], deflated and removed through a valve/opening in the center of the patch 22).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Roche to incorporate the teachings of Walsh and teach having the bioresorbable device used with a method comprising: inserting a guidewire comprising an expandable portion into a subject, through an entry point in a blood vessel; inserting a delivery system over the guidewire, through the entry point, and to a desired location in the blood vessel, the delivery system comprising: a first tubular member having a proximal end and a distal end, and a first lumen extending therethrough; a second tubular member having a proximal end and a distal end, and a second lumen extending therethrough, the second tubular member slidably positioned within the first lumen such that the distal end is within the first lumen; and the bioresorbable device positioned within the first lumen distally from the distal end of the second tubular member, the bioresorbable device being in a compressed configuration, where the guidewire extends through the opening in the bioresorbable device and through the second lumen; inserting a delivery system over the guidewire, through the entry point, and to a desired location in the blood vessel, the delivery system comprising: expanding the expandable portion of the guidewire to a diameter less than a diameter of the blood vessel; repositioning the second tubular member to cause the distal end of the second tubular member to move distally towards the distal end of the first tubular member, causing the bioresorbable device to exit the first lumen and exhibit a partially expanded configuration; retracting the guidewire with the expandable portion in a partially expanded position to move the expandable portion into contact with the bioresorbable device, and the bioresorbable device in contact with the first tubular member and/or second tubular member; retracting the first tubular member, second tubular member, bioresorbable device, and guidewire together until the bioresorbable device is positioned over the entry point; expanding the expandable portion of the guidewire to fully oppose the bioresorbable device to a wall of the blood vessel; and deflating the expandable portion. Motivation for such can be found in Walsh as there is a system for stabilizing the patch via the balloons to assist in proper positioning and sealing (see [0064] and [0068]) with applying pressure to the patch against the tissue defect site.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Spencer et al (US 20240156447 A1) teaches a disk-shape device deployed using a distal balloon pressing proximally on a disk
Miller et al (US 20130245534 A1) teaches a disk-shape device with a flap hingedly covering an opening of the disk
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Art Unit 3771
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