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 Group I and Species A in the reply filed on 11/19/2025 is acknowledged. Claims 2 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II and the unelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/19/2025. The requirement is deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-7, and 13-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arbefeuille et al. (Pub. No. US 2018/0206972 A1; hereinafter “Arbefeuille”).
Arbefeuille discloses the following regarding claim 1: an endovascular stent graft comprising: a body (e.g., 230, 250) (e.g., Figs. 5-8C) including a gate (e.g., upper openings at elements 182 and/or 184) having an internal surface (Figs. 6, 8B); a joining liner (e.g., 174, 176) joined to the internal surface of the gate with a joint (e.g., 204) (Figs. 5-6) and having a bunched state and a crumpled state (due to the flexible and conformable properties of the joining liner) (Figs. 7C; 8B-8C; paras. 0006-0007, 0046); and an implant (e.g., 206, 208, 266, 268) at least partially disposed within the joining liner (Figs. 7C, 8C) and having a radially compressed state and a radially expanded state (paras. 0012-0014), the implant in the radially expanded state (paras. 0012-0014) exerting a radial force on the joining liner to maintain the joining liner in the crumpled state (paras. 0006-0007, 0012-0014).
Arbefeuille discloses the following regarding claim 3: the endovascular stent graft of claim 1, wherein the joining liner has a joining liner axial length (Figs. 5-6, 8A), the gate has a gate axial length (Figs. 5-6, 8A), and the bunched state includes an axially bunched state (paras. 0006-0007, 0046) where the joining liner axial length is greater than the gate axial length (Figs. 5-6 8A).
Arbefeuille discloses the following regarding claim 4: the endovascular stent graft of claim 1, wherein the joining liner has a joining liner radial circumference (Figs. 6, 7C, 8B-8C), the gate has a gate radial circumference (Fig. 6), and the bunched state includes a radially bunched state where the joining liner radial circumference is greater than the gate radial circumference at one or more locations along a longitudinal axis of the joining liner and gate (Figs. 6, 7C, 8B).
Arbefeuille discloses the following regarding claim 5: the endovascular stent graft of claim 1, wherein the joining liner is formed of a semi-permeable material or a non-permeable material (para. 0046).
Arbefeuille discloses the following regarding claim 6: the endovascular stent graft of claim 1, wherein the body includes first (256) and second (258) branches, and the gate is located at a distal end of the first or second branch of the body (Figs. 8A-8C).
Arbefeuille discloses the following regarding claim 7: the endovascular stent graft of claim 1, wherein the gate is formed of a first material and the joining liner is formed of a second material (Fig. 6; paras. 0044-0046, 0052-0054).
Arbefeuille discloses the following regarding claim 13: an endovascular stent graft comprising: a body (e.g., 230, 250) (e.g., Figs. 5-8C) including a gate (e.g., openings at elements 182 and/or 184) having an internal surface (Figs. 6, 8); a joining liner (e.g., 174, 176) joined to the internal surface of the gate with a distal joint (e.g., 200) and a proximal joint (e.g., 204), at least one of the distal and proximal joints extending around at least one of distal and proximal circumferences, respectively, of the gate (Figs. 6, 8B); and an implant (e.g., 206, 208, 266, 268) at least partially disposed within the joining liner (Figs. 7C, 8C) and having a radially compressed state and a radially expanded state, the implant in the radially expanded state contacting the joining liner (paras. 0006-0007, 0012-0014).
Arbefeuille discloses the following regarding claim 14: the endovascular stent graft of claim 13, wherein the at least one of the distal and proximal joints extend continuously around the at least one of the distal and proximal circumferences, respectively, of the gate (Figs. 6, 8B).
Arbefeuille discloses the following regarding claim 15: the endovascular stent graft of claim 13, wherein the distal and proximal joints extend continuously around the distal and proximal circumferences, respectively, of the gate to form a seal between the joining liner and the gate (Figs. 6, 8B; paras. 0053-0054).
Arbefeuille discloses the following regarding claim 16: the endovascular stent graft of claim 13, wherein the body includes a graft material (e.g., 238, 254) and a stent (e.g., 240, 255) joined to the graft material with a body joint (Figs. 6, 8A), and the at least one of the distal and proximal joints includes a portion of the body joint (Figs. 7C, 8C).
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.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arbefeuille in view of Quigley (Pub. No.: US 2007/0208421 A1).
Arbefeuille discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite that the first and the second material have different flexibility properties. Quigley teaches that it is well known in the art that stent grafts are provided with a less flexible first material and a more flexible second material (paras. 0016-0020, 0026, 0051-0053), for the purpose of providing the stent graft with the proper flexibilities needed for a particular implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the first and the second materials of Arbefeuille to comprise different flexibilities, as taught by Quigley, in order to provide the stent graft with the proper flexibilities needed for a particular implantation site. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case, replacing one type of graft material for another, is generally considered to be within the level of ordinary skill in the art.
Claim(s) 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arbefeuille in view of Gries (EP 2699719 B1).
Arbefeuille discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite that the first and the second material have different strength properties. Gries teaches that it is well known in the art that stent grafts are provided with a stronger first material than a second material (paras. 0028-0032), for the purpose of providing the stent graft with the proper radial strengths needed for a particular implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the first and the second materials of Arbefeuille to comprise different strengths, as taught by Gries, in order to provide the stent graft with the proper radial strengths needed for a particular implantation site. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case, replacing one type of graft material for another, is generally considered to be within the level of ordinary skill in the art.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arbefeuille in view of Karavany et al. (Pub. No.: US 2019/0183629; hereinafter “Karavany”).
Arbefeuille discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite that the gate and the joining liner are formed of a continuous graft material; and the joining liner is formed from a first piece of the continuous graft folded inwardly into the gate, which is formed of a second piece of the continuous graft material. Karavany teaches that it is well known in the art that stent grafts are provided with a joining liner (e.g., 120, 122, 124) formed from a first piece of the continuous graft folded inwardly into a gate (lumen openings), which is formed of a second piece of the continuous graft material (Figs. 3A-6B, 8A-8B; paras. 0128-0130, 0136-0142). This configuration providing the implant with desired dimensions and a better seal. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the device of Arbefeuille to comprise a continuous graft, as taught by Karavany, in order to provide the implant with desired dimensions and a better seal. Such a modification would be made with a reasonable expectation of success.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arbefeuille in view of White et al. (US Pat. No. 6,652,571; hereinafter “White”).
Arbefeuille discloses the limitations of the claimed invention, as described above. Arbefeuille further recites a graft (e.g., 238, 254) and a stent (e.g., 240, 255). However, it does not recite at least one of the distal and proximal joints including a melted and solidified portion of the graft material and the joining liner. White teaches that it is well known in the art that graft materials and their associated components are joined through a melting process (col. 18, lines 26-65), for the purpose of securely attaching the components together and avoiding potential fraying. It would have been obvious to one having ordinary skill in the art to modify the device of Arbefeuille to comprise a melted and solidified portion of the graft material and the joining liner, as taught by White, in order to securely attach the components together and avoid potential fraying. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
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/ANN HU/Primary Examiner, Art Unit 3774