DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is responsive to the arguments presented on 09/10/2025. As directed by the response: claim 1 has been amended and claims 5, 7, 10 are canceled. Thus, claims 1-4, 6, 8-9, 11-18 are presently pending in the application.
Response to Arguments
In light of the amendment to cancel claims 5 and 7, the examiner has withdrawn the previous objections to the drawings.
Applicant's arguments filed 09/10/2025 have been fully considered but they are not persuasive. Applicant argues on pages 2-3, the prior art Soletti fails to teach or suggest a conduit comprising one or more conduit breaches, wherein each conduit breach comprises at least one conduit breach edge, wherein a biodegradable structure is affixed to the at least one conduit breach edge. The examiner respectfully disagrees. Soletti et al. discloses in Figure 3B, a device 300 having a single layer having at least two longitudinal segments, the first longitudinal segment and a second longitudinal segment 362 each surrounds a partial circumferential portion of conduit 340 and extend along the length of the device to form a tubular graft (see Figure 3A and paragraph [0059]). Soletti further discloses the first segment 361 includes an adhesive and the second segment includes a fiber matrix (see paragraph [0059]), since Soletti discloses each segment forms a partial circumferential portion and the first longitudinal segment 361 comprises an adhesive, the figure shows the segments are attached together to form a complete tubular graft, therefore disclosing the first longitudinal segment has a seam area for attaching said second longitudinal segment to the first longitudinal segment to create a complete tubular graft extending along the entire axial length.
The examiner apologizes for the typographical error on page 9 of the office action, wherein the rejection of Claim 11 had a heading as unpatentable over Soletti et al. in view of Jaffe. However, the rejection clearly shows Soletti in view of Lewis and further in view of Jaffee. Furthermore, claim 18 was also included in this header, which depends from claim 12, where claim 12 was rejected under Soletti et al. in view of Lewis. Therefore, further confirming the examiner’s standpoint that claims 11 and 18 was intended to have a header with Soletti et al. in view of Lewis and further in view of Jaffe. Applicant argues on page 3, with respect to claim 18, Jaffee fails to teach or suggest a conduit having one or more breaches each having at least one breach edge wherein a biodegradable structure is affixed to the at least one conduit breach edge. The examiner respectfully disagrees. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the argued limitation “a conduit having one or more breaches each having at least one breach edge wherein a biodegradable structure is affixed to the at least one conduit breach edge” appears in claim 12 (although not verbatim). Claim 12 includes the limitation “a conduit comprising a conduit breach along a longitudinal axis of the conduit, the conduit breach having a first conduit breach edge and a second conduit breach edge; and a biodegradable structure having a first side affixed to the first conduit breach edge and a second side affixed to the second conduit breach edge.” Jaffe was not used to reject this limitation. This limitation was rejected under 103 over Soletti et al. in view of Lewis (see page 7, Regarding claim 12). Soletti a discloses device 300 having a single layer having at least two longitudinal segments, the first longitudinal segment and a second longitudinal segment 362 each surrounds a partial circumferential portion of conduit 340, wherein each segment forms a partial circumferential portion and the first longitudinal segment 361 comprises an adhesive, the figure shows the segments are attached together to form a complete tubular graft, therefore disclosing the first longitudinal segment has a seam area for attaching said second longitudinal segment to the first longitudinal segment to create a complete tubular graft extending along the entire axial length. Lewis teaches a conduit 50 having one or more conduit breaches 51 having a seam or breach edge extending longitudinally and forming adhesion with the edges to create a seamline to form a tubular construct. Furthermore, Jaffee was used to reject claim 18, which depends from claim 12, to teach a conduit having a conduit breach/seam 210 used in conjunction with a heart valve multi-leaflet structure 202, 204, 206 for the purpose of forming a conduit that can be used as a bioprosthetic valve for a heart replacement or heart repair device.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-3, 6, 8-9 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Soletti et al. U.S. Publication 2014/0288632 A1 (provisional application filed on Oct. 25, 2011).
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Regarding Claim 1, Soletti et al. discloses a conduit 361 comprising: one or more conduit breaches, wherein each conduit breach comprises at least one conduit breach edge (the edge that forms the second material 361); and a conduit wall 361; wherein the at least one conduit breach edge is affixed to the conduit wall (as seen in the annotated Figure 3A above, the edges of the conduit 361 forms a continuous structure, therefore, the edges were formed on the mandrel as a unitary/affixed structure). Soletti further discloses the first segment 361 includes an adhesive and the second segment includes a fiber matrix (see paragraph [0059]), since Soletti discloses each segment forms a partial circumferential portion and the first longitudinal segment 361 comprises an adhesive, the figure shows the segments are attached together to form a complete tubular graft, therefore disclosing the first longitudinal segment has a seam area for attaching said second longitudinal segment to the first longitudinal segment to create a complete tubular graft extending along the entire axial length.
Regarding Claim 2, Soletti et al. discloses wherein the one or more conduit breaches comprise one or more of a biocompatible polymer and a hemocompatible polymer (wherein Soletti discloses the segment 361 includes a fiber matrix, similar to fiber matrix 320, wherein the fiber matrix comprises thermoplastics such as polydimethylsiloxane, polyurethane, see paragraphs [0010], [0015], [0019] and [0051-0052]).
Regarding Claim 3, Soletti et al. discloses wherein the one or more conduit breaches are disposed along a longitudinal axis with respect to the longitudinal axis of the conduit (as seen in the annotated Figure 3A above).
Regarding Claim 6, Soletti et al. discloses wherein the one or more conduit breaches do not overlap along one or more circumferential portions of the conduit wall (as seen in the annotated Figure 3A above).
Regarding Claim 8, Soletti et al. discloses wherein the one or more conduit breaches extend along at least a portion of a longitudinal length of the conduit (as seen in the annotated Figure 3A).
Regarding Claim 9, Soletti et al. discloses wherein the one or more conduit breaches are arranged in one or more straight line segments (as seen in the annotated Figure 3A, second portion 361 extends longitudinally and so does the breaches of the conduit).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 4, 12-14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Soletti et al. U.S. Publication in view of Lewis et al. WO 95/05131.
Regarding Claim 4, Soletti et al. does not expressly disclose wherein the one or more conduit breaches are disposed along a circumferential axis of the conduit. Lewis teaches a conduit 50 in the same field of endeavor comprising one or more conduit breaches 63 disposed on a circumferential axis of the conduit 50 and forms a helical curve along a longitudinal axis of the conduit (the breaches 63 extends around the circumference of the conduit and extends in a helical pattern, as seen in Figure 6) for the purpose of forming the graft into a tubular intraluminal conduit (page 6, lines 28-35). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Soletti’s one or more conduit breaches overlap one or more circumferential portions of the conduit wall and form overlapped seams as taught by Lewis for the purpose of forming a tubular intraluminal graft.
Regarding Claim 12, Soletti et al. discloses a conduit 361 comprising: a conduit breach along a longitudinal axis of the conduit 361, the conduit breach having a first conduit breach edge and a second conduit breach edge (the edge that form the C-shaped conduit, would have seams that form said “breach edge”); and a biodegradable structure 362 (Soletti et al. discloses the segments 361 and 362 each can include a fiber matrix, similar to fiber matrix 320, wherein the fiber matrix comprises thermoplastics such as polydimethylsiloxane, polyurethane, see paragraphs [0010], [0015], [0019] and [0051-0052]). However, Soletti does not expressly disclose the biodegradable structure having a first side affixed to the first conduit breach edge and a second side affixed to the second conduit breach edge. Lewis teaches a conduit 50 in the same field of endeavor comprising one or more conduit breaches 51 having a seam or conduit breach edge extending longitudinally and forming adhesion with the edges to create a seamline (as seen in Figures 5 and 7 and page 6, lines 28-35 and page 8, lines 10-18) for the purpose of forming a tubular intraluminal graft (page 6, lines 28-35). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Soletti’s one or more breaches to have conduit breach edge as taught by Lewis for the purpose of having a surface that would form a seam that could be adhered together to create a tubular intraluminal graft. Soletti discloses the conduit 361 is a different material than biodegradable structure 362, therefore, the conduit would comprise a seam/edge located at the ends of the C-shaped conduit and complementary seams would be located on the biodegradable structure 362 formed of a second material to form a tubular structure. The teachings of Lewis of affixing the edges to form a seam would be applied to Soletti to form a tubular structure.
Regarding Claim 13, Soletti et al. discloses wherein the conduit comprise one or more of a biocompatible polymer and a hemocompatible polymer (wherein Soletti discloses the segment 361 includes a fiber matrix, similar to fiber matrix 320, wherein the fiber matrix comprises thermoplastics such as polydimethylsiloxane, polyurethane, see paragraphs [0010], [0015], [0019] and [0051-0052]).
Regarding Claim 14, Soletti et al. discloses wherein the biodegradable structure is a composite material (paragraphs [0019], [0051-0052], wherein Soletti discloses the fiber matrix comprises polymers or a combination of polymers thereby forming a composite material).
Claims 11 and 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Soletti et al. U.S. Publication in view of Lewis et al. WO 95/05131 and further in view Jaffe U.S. Publication 2009/0105810 A1.
Regarding Claim 11, Soletti et al. discloses a conduit 361 comprising an inner conduit surface; an outer conduit surface; a diameter (as seen in the annotated Figure 3A above); at least one conduit breach having a first conduit breach edge and a second conduit breach edge (these edges would be present as Soletti discloses the conduit 361 is a first segment that forms a C-shaped structure, therefore, the ends of the C-shape would form breach edges and the second segment formed of a second material is situated to complete the C shape of the conduit, see paragraph [0059]) and at least one biodegradable structure 362. However, Soletti et al. does not expressly disclose wherein a biodegradable structure having a first side affixed to the first conduit breach edge and a second side affixed to the second conduit breach edge. Lewis teaches a conduit 50 in the same field of endeavor comprising one or more conduit breaches 51 having a seam or conduit breach edge extending longitudinally and forming adhesion with the edges to create a seamline (as seen in Figures 5 and 7 and page 6, lines 28-35 and page 8, lines 10-18) for the purpose of forming a tubular intraluminal graft (page 6, lines 28-35). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Soletti’s one or more breaches to have conduit breach edge as taught by Lewis for the purpose of having a surface that would form a seam that could be adhered together to create a tubular intraluminal graft. However, Soletti et al. does not expressly disclose a heart valve multi-leaflet structure. Jaffe teaches a conduit 200 in the same field of endeavor comprising a conduit breach having seam 210 and a heart valve multi-leaflet structure 202, 204, 206 disposed on an inner surface of the conduit and forming a trileaflet from a heart valve (paragraph [0010], [0034]) for the purpose of having a bioprosthetic valve for replacement or repairing of a venous valve (abstract). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Soletti’s conduit to further include a heart valve multi-leaflet structure as taught by Jaffe for the purpose of having a bioprosthetic valve for replacement or repairing of a venous valve.
Regarding Claim 18, Soletti et al. does not expressly disclose further comprising a valve disposed on an inner surface of the conduit. Jaffe teaches a conduit 200 in the same field of endeavor comprising a conduit breach having seam 210 and a heart valve multi-leaflet structure 202, 204, 206 disposed on an inner surface of the conduit and forming a trileaflet from a heart valve (paragraph [0010], [0034]) for the purpose of having a bioprosthetic valve for replacement or repairing of a venous valve (abstract). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Soletti’s conduit to further include a heart valve multi-leaflet structure as taught by Jaffe for the purpose of having a bioprosthetic valve for replacement or repairing of a venous valve.
Claims 15-17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Soletti et al. in view Lewis as applied in the claim rejections above and further in view of Flugelman CA2637662 A1.
Regarding Claim 15, 16, 17, Soletti et al. discloses a conduit having multiple segmented portions including a first portion that is formed of one material and a second portion formed of a second material (paragraph [0059]), wherein the first portion comprises a material that is not bioerodible and a second portion that is bioerodible (paragraph [0053]). Soletti et al. does not expressly disclose wherein the biodegradable structure comprises collagen fibers and further comprising one or more cells seeded onto the biodegradable structure., wherein the cells comprise CD34 cells, mesenchymal cells, myocytes, smooth muscle cells, endothelial cells, or cardiac stem cells. Ludlow et al. teaches a conduit 12 in the same field of endeavor comprising a biocompatible structure formed of collagen fibers (page 20, lines 18-27) for the purpose of having a structure that can facilitate cell seeding and allow cellular proliferation, the collagen fiber is seeded with endothelial cells, growth factors (page 10, lines 12-25 and page 20, lines 28-33 and page 21, lines 1-33) for the purpose of enhancing the performance of the graft and prevent thrombosis (page 20, lines 1-5 and page 21, lines 19-32). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Soletti’s biodegradable portion to further include collagen fibers that is seeded with endothelial cells for the purpose of having a structure that can facilitate cell seeding and allow cellular proliferation and enhance the performance of the graft by preventing thrombosis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Xu et al. U.S. Publication 2011/0054588.
THIS ACTION IS MADE FINAL. 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 SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774