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 Arguments
Applicant’s arguments, see Page 7, filed 1 June 2026, with respect to the 35 U.S.C. § 112(b) rejection of c have been fully considered and are persuasive. The 35 U.S.C. § 112(b) rejection of claim 19 has been withdrawn.
Applicant’s arguments, see Page 7-8, filed 1 June 2026, with respect to the 35 U.S.C. § 101 rejection of claims 1-9 have been fully considered and are persuasive. The 35 U.S.C. § 101 rejection of claims 1-9 has been withdrawn.
Applicant’s arguments with respect to claim(s) 16 & 25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see Pages 9 & 10, filed 1 June 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Azakie in further view of Gering in furthest view of Schmid. Schmid teaches that the sheath can include cutouts to alter the characteristics of the sheath. Examiner interprets these cutouts to allow for the material to include cutouts that when connected create a three-dimensional structure needed to reconstruct parts of the cardiovascular system.
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.
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.
Claim(s) 1-4, 9-11, & 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0078356 hereinafter Pekkan in view of US 2008/0049991 hereinafter Gering in view of WO 2018/148714 hereinafter Azakie.
In regards to Claim 1: Pekkan teaches A method of manufacturing a patch for reconstructing a cardiovascular structure (Pekkan, Paragraph 29; Figure 1), the method comprising: obtaining a three-dimensional model of the cardiovascular structure based on information regarding the cardiovascular structure (Pekkan, Paragraph 33; Figure 1 Item 2); creating a three-dimensional model of a patch corresponding to the three- dimensional model of the cardiovascular structure, wherein the patch is configured to reconstruct the cardiovascular structure to a normal geometry (Pekkan, Paragraphs 34 & 37; Figure 1 Item 4). However, Pekkan does not teach wherein the three-dimensional model includes an outermost perimeter, and flattening the three-dimensional model of the patch to a two-dimensional plan; identifying one or more cutouts in the patch, wherein the one or more cutouts are configured to be closed to apply a curvature to the patch when the patch is assembled into a three-dimensional structure; and cutting along a border formed by the outermost perimeter and the one or more cutouts.
Gering teaches wherein the three-dimensional model includes an outermost perimeter (Gering, Paragraph 63 & 69; Figure 12), and flattening the three-dimensional model of the patch to a two-dimensional plan (Gering, Paragraphs 59, 60, & 68); identifying one or more cutouts in the patch, wherein the one or more cutouts are configured to be closed to apply a curvature to the patch when the patch is assembled into a three-dimensional structure (Gering, Paragraphs 63 & 64).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the flattening the three-dimensional model and identifying cutouts taught in Gering to the system of cardiovascular patch construction taught in Pekkan, the motivation being to provide a model that can be easily wrapped around a three-dimensional structure.
Azakie teaches cutting along a border formed by the outermost perimeter and the one or more cutouts (Azakie, Figure 6 Item 620; Page 11 Lines 26-28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add cutting around the border taught in Azakie to the system of cardiovascular patch construction taught in a modified Pekkan, the motivation being to provide a method of turning a three-dimensional object into a two-dimensional template.
In regards to Claim 2: A modified Pekkan teaches all of claim 1, and characterizing the cardiovascular structure (Pekkan, Paragraph 33; MRI and CT scans described are used to characterize the cardiovascular structure).
In regards to Claim 3: A modified Pekkan teaches all of claims 1 & 2, and the characterizing cardiovascular structure includes producing one or more images of the cardiovascular structure (Pekkan, Paragraph 33; MRI and CTs are imaging system).
In regards to Claim 4: A modified Pekkan teaches all of claim 1, and wherein obtaining a three-dimensional model of the cardiovascular structure includes producing the three-dimensional model based on the information regarding the cardiovascular structure (Pekkan, Paragraph 29; Figure 1 Item 5).
In regards to Claim 9: A modified Pekkan teaches all of claim 1, and wherein the one or more cutouts are interior cutouts (Gering, Paragraph 64).
In regards to Claim 10: A modified Pekkan teaches all of claim 1, and projecting the two-dimensional plan onto at least one layer of anisotropic material (Gering, Paragraph 61; Figure 10 Item 1000).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the projection of a plan taught in Gering to the system of a modified Pekkan, the motivation being to provide an easily handled projection of the biological structure that physicians can use in a presentation to the patient.
In regards to Claim 11: A modified Pekkan teaches all of claim 1 & 10, and cutting the at least one layer of the anisotropic material along the border formed by the outermost perimeter and the one or more cutouts (Azakie, Figure 6 Item 620; Page 11 Lines 2-28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the cutouts of anisotropic material taught in Azakie to the system of a modified Pekkan, the motivation being to allow for the user to cut the material down to a desired size.
In regards to Claim 13: A modified Pekkan teaches all of claim 1, and selecting a patch template corresponding to the two-dimensional plan from a plurality of templates (Pekkan, Paragraph 60; Multiple different prototypes are fabricated to be selected from); and cutting at least one layer of an anisotropic material along a border formed by the patch template (Azakie, Page 11 Lines 26-28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add cutting of the anisotropic material taught in Azakie to the system of a modified Pekkan, the motivation being to allow for the material to be cut and shaped to fit into any cardiovascular space needed.
In regards to Claim 14: A modified Pekkan teaches all of claim 1, and printing the three-dimensional model of the patch (Pekkan, Paragraph 63) using an anisotropic material (Azakie, Figure 1; Abstract, Page 4 Lines 25- Page 6 Line 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the use of an anisotropic material when printing the patch as taught by Azakie to the system taught by a modified Pekkan, the motivation being to allow for stretching of the materials to accommodate the different movements of the heart.
In regards to Claim 15: A modified Pekkan teaches all of claim 1, and a non-transitory computer readable memory including processor executable instructions that when executed perform the method of claim 1 (Pekkan, Paragraphs 95 & 96; Figure 1 Item 7).
Claim(s) 7 & 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0078356 hereinafter Pekkan in view of US 2008/0049991 hereinafter Gering in view of WO 2018/148714 hereinafter Azakie in further view of US 2008/0183275 hereinafter Schmid.
In regards to Claim 7: A modified Pekkan teaches all of claims 6, 5 & 1, but does not teach wherein the one or more cutouts include one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter.
Schmid teaches wherein the one or more cutouts include one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter (Schmid, Paragraph 253 & 254).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the cutouts in the material taught in Schmid to the system described in a modified Pekkan, the motivation being to provide more flexibility and allow access to veins and arteries.
In regards to Claim 8: A modified Pekkan teaches all of claims 7, 6, 5, 1, and wherein each of the one or more notches is triangular (Schmid, Paragraph 253 & 254).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0078356 hereinafter Pekkan in view of US 2008/0049991 hereinafter Gering in further view of WO2018/148714 hereinafter Azakie in furthest view of US 2017/0027683 hereinafter Douthitt.
In regards to Claim 12: A modified Pekkan teaches claims 10, 6, 5, & 1, but does not teach projecting the two-dimensional plan includes projecting the two-dimensional plan onto a horizontal surface with a laser projector.
Douthitt teaches projecting the two-dimensional plan includes projecting the two-dimensional plan onto a horizontal surface with a laser projector (Douthitt, Paragraphs 51 & 52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the laser projection of the two-dimensional plan taught in Douthitt to the system of a modified Pekkan, the motivation being to provide a template that can be followed for cutting the material to size.
Claim(s) 16-21, 23, 25, 26, & 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/148714 hereinafter Azakie in view of 2008/0049991 hereinafter Gering in view of US 2008/0183275 hereinafter Schmid.
In regards to Claim 16: Azakie teaches a patch for a cardiovascular structure (Azakie, Page 4 Lines 17-24), comprising: at least one layer of anisotropic material including an outermost perimeter (Azakie, Page 4 Line 25 – Page 6 Line 22) and wherein the one or more cutouts are configured to be closed to apply a curvature to the at least one layer of anisotropic material when the at least one layer of anisotropic material is assembled into a three-dimensional structure (Azakie, Page 4 Line 25 – Page 6 Line 22). However, Azakie does not teach one or more cutouts formed in the at least one layer of anisotropic material, and wherein the patch is configured to reconstruct the cardiovascular structure to a normal geometry.
Gering teaches one or more cutouts formed in the at least one layer of material (Gering, Paragraph 64).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the cutouts into the layer of material taught in Gering to the conduit taught in Azakie, the motivation being to preserve the contours of the cardiovascular structure.
Schmid teaches wherein the patch is configured to reconstruct the cardiovascular structure to a normal geometry (Schmid, Paragraph 253 & 254).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the patch configured to reconstruct cardiovascular structures taught in Schmid to the conduit taught by a modified Azakie, the motivation being to provide a structure to a patient’s damaged cardiovascular system.
In regards to Claim 17: A modified Azakie teaches all of claim 16, but does not teach wherein the one or more cutouts are interior cutouts.
Schmid teaches wherein the one or more cutouts are interior cutouts (Schmid, Paragraphs 253 &254).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the cutouts taught in Schmid to the conduit taught in a modified Azakie, the motivation being to provide more flexibility to the patch and allow access for branching arteries and veins.
In regards to Claim 18: A modified Azakie teaches all of claim 16, but does not teach wherein the one or more cutouts are one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter.
Schmid teaches wherein the one or more cutouts are one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter (Schmid, Paragraphs 253 & 254).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the cutouts taught in Schmid to the conduit taught in a modified Azakie, the motivation being to provide greater flexibility to the patch to better match the contours of the cardiovascular structure that is being repairs.
In regards to Claim 19: A modified Azakie teaches all of claim 18 but does not teach, wherein each of the one or more cutouts includes a first edge and a second opposing edge, wherein the first edge and the second edge of each notch are joined together.
Schmid teaches wherein each of the one or more cutouts includes a first edge and a second opposing edge, wherein the first edge and the second edge of each notch are joined together (Schmid, Paragraphs 253 & 254; Triangular cutouts).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the triangular cutouts taught in Schmid to the conduits taught by a modified Azakie, the motivation being to provide greater flexibility to the patch to better match the contours of the cardiovascular structure that is being repairs.
In regards to Claim 20: A modified Azakie teaches all of claims 19 & 16, and wherein the joined first edge and second edge of each of the one or more cutouts are configured to apply tension to the least one layer of anisotropic material (Azakie, Page 4 Line 25 – Page 6 Line 22) to curve the at least one layer of anisotropic material (Schmid Paragraphs 253 & 254) (The edges being described in the prior art that make up the cutouts come into contact with the anisotropic material and are therefore configured to apply tension).
In regards to Claim 21: A modified Azakie teaches wherein the one or more cutouts are sized and shaped such that the at least one layer has a curvature corresponding to the cardiovascular structure (Schmid, Paragraph 253 & 254) (Cutouts increase flexibility to follow the contours of the cardiovascular structure and allow access to branches off of the artery or vein).
In regards to Claim 23: A modified Azakie teaches wherein the one or more cutouts are one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter, and wherein the joined first edge and second edge of each of the one or more notches are configured to remove the discontinuities in the outermost perimeter (Gering, Paragraph 64; when edges are brought together, the material takes a form including the angular relationships of the cardiovascular structure involved).
In regards to Claim 27: A modified Azakie teaches all of claim 15 but does not teach wherein the one or more cutouts are one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter.
Schmid teaches wherein the one or more cutouts are one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter (Schmid, Paragraphs 253 & 254).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the cutouts in the material taught in Schmid to the conduit taught in a modified Azakie, the motivation being to increase the flexibility of the material and allow access to arteries that branch off.
In regards to Claim 25: Azakie teaches A method of forming a patch for a cardiovascular structure (Azakie, Page 4 Lines 17-24), and projecting a two-dimensional plan of the patch onto at least one layer of anisotropic material (Azakie, Page 4 Line 25 – Page 6 Line 22), and wherein the one or more cutouts are configured to be closed to apply a curvature to the at least one layer of anisotropic material when the at least one layer of anisotropic material is assembled into a three-dimensional structure (Azakie, Page 4 Line 25 – Page 6 Line 22). Azakie does not teach the method comprising: wherein the two-dimensional plan is a flattened three-dimensional model of the patch, wherein the two-dimensional plan of the patch includes an outermost perimeter and one or more cutouts in the patch, and wherein the patch is configured to reconstruct the cardiovascular structure to a normal geometry.
Gering Teaches the method comprising: wherein the two-dimensional plan is a flattened three-dimensional model of the patch (Gering, Paragraphs 59, 60, & 68), wherein the two-dimensional plan of the patch includes an outermost perimeter and one or more cutouts in the patch (Gering, Paragraph 63 & 64).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the two-dimensional plan including cutouts taught in Gering to the conduit taught in Azakie, the motivation being to provide an easily handled template of the biological structure that physicians can maneuver into place during a procedure.
Schmid teaches wherein the patch is configured to reconstruct the cardiovascular structure to a normal geometry (Schmid, Paragraph 253 & 254).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the patch configured to reconstruct cardiovascular structures taught in Schmid to the conduit taught by a modified Azakie, the motivation being to provide a structure to a patient’s damaged cardiovascular system.
In regards to Claim 26: A modified Azakie teaches wherein the one or more cutouts are interior cutouts (Gering, Paragraph 64).
In regards to Claim 28: A modified Azakie teaches further comprising cutting the at least one layer of the anisotropic material along a border formed by the outermost perimeter and one or more cutouts (Azakie, Page 11 Lines 26-28).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/148714 hereinafter Azakie in view of 2008/0049991 hereinafter Gering in further view of US 2008/0183275 hereinafter Schmid in furthest view of US 2005/0049667 hereinafter Ardefeuille.
In regards to Claim 22: A modified Azakie teaches all of claims 22, 21, 20, 19, & 16; but does not teach wherein the cardiovascular structure is an aortic transverse arch.
Ardefeuille teaches wherein the cardiovascular structure is an aortic transverse arch (Ardefeuille, Paragraph 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the area of interest in the cardiovascular system as taught in Ardefeuille with the conduit system taught in a modified Azakie, the motivation being to further specialize the device allowing it to focus on solving specific problems associated with the region in question.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/148714 hereinafter Azakie in view of 2008/0049991 hereinafter Gering in view of US 2008/0183275 hereinafter Schmid in view of US 5,480,424 hereinafter Cox.
In regards to Claim 24: A modified Azakie teaches all of claim 16, but does not teach wherein the anisotropic material is one selected from the group of human cardiovascular homograft and autologous pericardium.
Cox teaches wherein the anisotropic material is one selected from the group of human cardiovascular homograft and autologous pericardium (Cox, Column 3 Lines 54-56).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the homograft taught in Cox to the conduit taught in a modified Azakie, the motivation being to use a material that is proven to work under the same stress as what is needed for repairing the cardiovascular system.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/148714 hereinafter Azakie in view of 2008/0049991 hereinafter Gering in view of US 2008/0183275 hereinafter Schmid in view of US 2017/0027683 hereinafter Douthitt.
In regards to Claim 29: A modified Azakie teaches all of claim 25, but does not teach wherein projecting the two-dimensional plan includes projecting the two-dimensional plan onto a horizontal surface with a laser projector.
Douthitt teaches wherein projecting the two-dimensional plan includes projecting the two-dimensional plan onto a horizontal surface with a laser projector (Douthitt, Paragraphs 51 & 52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the projection by a laser projector taught in Douthitt to the conduit taught in a modified Azakie, the motivation being to provide a template that can be followed when cutting the material to the desired size.
Claim(s) 30, 31, & 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/148714 hereinafter Azakie in view of 2008/0049991 hereinafter Gering in view of US 2008/0183275 hereinafter Schmid in view of US 2005/0070994 hereinafter Sievers.
In regards to Claim 30: A modified Azakie teaches Claim 25, but does not teach wherein each of the one or more cutouts includes a first edge and a second opposing edge, wherein the method further comprising sewing the first edge to the second opposing edge of each of the one or more cutouts.
Sievers teaches wherein each of the one or more cutouts includes a first edge and a second opposing edge, the method further comprising sewing the first edge to the second opposing edge of each of the one or more cutouts (Sievers, Paragraph 53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add sewing the edges of the cutouts together as taught in Sievers to the conduit taught in a modified Azakie, the motivation being to form the material into a three-dimensional shape that follows the contours of the area that is being repaired.
In regards to Claim 31: A modified Azakie teaches wherein sewing the first edge to the second opposing edge of each of the one or more cutouts includes applying tension to the least one layer of anisotropic material to curve the at least one layer of anisotropic material (Sievers, Paragraph 53; the sewing fixes the material into a shape, therefore must be applying tension to the edges).
In regards to Claim 32: A modified Azakie teaches wherein the one or more cutouts are one or more notches extending inward from the outermost perimeter, wherein each of the one or more notches creates a discontinuity in the outermost perimeter, and wherein sewing the first edge to the second opposing edge of each of the one or more notches includes removing the discontinuities in the outermost perimeter (Sievers, Paragraph 53; By sewing the edges of the cutout together, there perimeter of the material would become continuous).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOE R DIETZ whose telephone number is (571)272-1135. The examiner can normally be reached Mon-Fri 8am - 5pm.
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/N.R.D./Patent Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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