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 with respect to claim(s) 1, 3-17, and 21-24 have been considered, but are moot in view of the new grounds of rejection. Regarding claims 13-17 and 21-22, the Arbefeuille reference has been re-interpreted, as described below, to address the claim amendments of 4/27/2026.
Election/Restrictions
Newly submitted claim 23 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the elected species embodiment does not comprise the distal joint of the joining liner being longitudinally offset the distal end of the gate.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 23 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 and its dependent claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Amended claim 1 recites “the medial portion extending inwardly from the proximal and distal end portions to a central portion in the bunched state of the joining liner.” The disclosure does not appear to have adequate support for this limitation. Appropriate correction is required.
Claim 1 and its dependent claims rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Amended claim 1 describes the joining liner having a medial portion located between the proximal and the distal liner ends. It further recites the medial portion extending inwardly to a central portion. It is unclear which parts of the joining liner constitute the medial versus the central portions. Appropriate correction and/or clarification is required.
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, 3-4, 13-16, 22, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thistle et al. (US Pat. No.: 8,048,144 B2; hereinafter “Thistle”).
As best interpreted, Thistle discloses the following regarding claim 1: an endovascular stent graft comprising: a body (105) (Figs. 1-1B) including a gate (openings on element 105) having an internal surface (interior surfaces of element 105) (Figs. 1-1B) and extending along a longitudinal axis (central axis of element 105) (Figs. 1-1B); a joining liner (103, 104) joined to the internal surface of the gate with a joint (e.g., 108, 109) (Figs. 1-2) and having a bunched state and a crumpled state (due to the flexible and expandable properties of the joining liner) (col. 2, lines 36-41; col. 3, lines 18-26), the joining liner includes proximal (upper end portion) and distal (lower end portion) end portions and a medial portion (central, side portion) extending therebetween (Figs. 1-1B), the medial portion extending inwardly from the proximal and distal end portions (at the side, inwardly recessed area) (Figs. 1-1B) to a central portion (middle portions) in the bunched state of the joining liner (Figs. 1-1B; col. 2, lines 36-41; col. 3, lines 18-26), the central portion having a central portion diameter (diameter at the inwardly recessed area), the proximal and distal end portions having proximal and distal end portion diameters greater than the central portion diameter (Figs. 1-1B); and an implant (106) at least partially disposed within the joining liner (Figs. 1-1B; col. 2, lines 18-35) and having a radially compressed state and a radially expanded state (col. 2, lines 18-41; col. 3, lines 18-26), the implant in the radially expanded state exerting a radial force on the joining liner to maintain the joining liner in the crumpled state (col. 2, lines 18-41; col. 3, lines 18-26).
Thistle discloses the following regarding claim 3: the endovascular stent graft of claim 1, wherein the joining liner has a joining liner axial length (Figs. 1-1B), the gate has a gate axial length (Figs. 1-1B), and the bunched state includes an axially bunched state (col. 2, lines 36-41; col. 3, lines 18-26) where the joining liner axial length is greater than the gate axial length (Figs. 1-1B).
Thistle discloses the following regarding claim 4: the endovascular stent graft of claim 1, wherein the joining liner has a joining liner radial circumference (Figs. 1-1B), the gate has a gate radial circumference (Figs. 1-1B), 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 (at the central portion of element 103 vs. the indented portion of the gate opening) (Figs. 1-1B).
Thistle discloses the following regarding claim 13: an endovascular stent graft comprising: a tubular body (105) (e.g., Figs. 1-2) including a tubular gate (openings on element 105) (Figs. 1-1B) having a tubular internal surface (interior surfaces of element 105) (Figs. 1-1B); a joining liner (103, 104) joined directly to the tubular internal surface of the tubular gate (Figs. 1-1B) with a distal joint (lower end contact between the tubular body and the joining liner) and a proximal joint (upper end contact between the tubular body and the joining liner), at least one of the distal and proximal joints extending around at least one of distal and proximal circumferences, respectively, of the tubular gate (Figs. 1-2); and an implant (106) at least partially disposed within the joining liner and having a radially compressed state and a radially expanded state (col. 2, lines 18-41; col. 3, lines 18-26), the implant in the radially expanded state contacting the joining liner (col. 2, lines 18-41; col. 3, lines 18-26).
Thistle 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. 1-1B).
Thistle 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. 1-1B; col. 2, lines 18-67).
Thistle discloses the following regarding claim 16: the endovascular stent graft of claim 13, wherein the body includes a graft material and a stent joined to the graft material with a body joint (contact portions between stent and graft) (Fig. 1; col. 2, lines 18-41), and the at least one of the distal and proximal joints includes a portion of the body joint (Figs. 1-1B).
Thistle discloses the following regarding claim 22: the endovascular stent graft of claim 13, wherein the tubular body includes one or more stents aligned with the proximal and/or distal joints (Figs. 1-1B; col. 2, lines 18-41).
Thistle discloses the following regarding claim 24: the endovascular stent graft of claim 1, wherein the medial portion of the joining liner is inwardly curving toward the central portion in the bunched state of the joining liner (Figs. 1-1B).
Claim(s) 13-16 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arbefeuille et al. (Pub. No.: US 2018/0206972; hereinafter “Arbefeuille”).
Arbefeuille discloses the following regarding claim 13: an endovascular stent graft comprising: a tubular body (e.g., 232, 252) (e.g., Figs. 5-8C) including a tubular gate (e.g., openings of elements 232, 252) having a tubular internal surface (interior surfaces of element 232, 252) (Figs. 6, 8); a joining liner (e.g., 172, 260) joined directly to the tubular internal surface of the tubular gate (Figs. 7B-7C, 8B-8C) with a distal joint (lower end contact between the tubular body and the joining liner) and a proximal joint (upper end contact between the tubular body and the joining liner), at least one of the distal and proximal joints extending around at least one of distal and proximal circumferences, respectively, of the tubular gate (Figs. 6, 7B-7C, 8B-8C); 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).
Arbefeuille discloses the following regarding claim 22: the endovascular stent graft of claim 13, wherein the tubular body includes one or more stents aligned with the proximal and/or distal joints (Figs. 6-8C).
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) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thistle in view of Arbefeuille.
Regarding claims 5 and 7, Thistle discloses the limitations of the claimed invention, as described above. However, it does not specify the materials used for the joining liner and the gate. Arbefeuille teaches that it is well known in the art that stent grafts are provided with a joining liner (e.g., 174, 176) formed of a semi-permeable material or a non-permeable material (para. 0046); and that a gate (e.g., upper openings at elements 182 and/or 184) is formed of a first material and the joining liner is formed of a second material (Fig. 6; paras. 0044-0046, 0052-0054), for the purpose of providing the stent graft with the proper physical characteristics needed for its implantation site. It would have been obvious to one having ordinary skill in the art to modify the materials of Thistle according to the teachings of Arbefeuille, in order to provide the stent graft with the proper physical characteristics needed for its 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 implant material for another, is generally considered to be within the level of ordinary skill in the art.
Regarding claim 6, Thistle discloses the limitations of the claimed invention, as described above. However, it does not recite the body including first and second branches, where the gate is located at a distal end of the first or second branch of the body. Arbefeuille teaches that it is well known in the art that stent grafts are designed with a body having first (256) and second (258) branches, and a gate is located at a distal end of the first or second branch of the body (Figs. 8A-8C), for the purpose of designing the stent to accommodate branching diseased vasculature. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the body of Thistle to comprise first and second branches, as taught by Arbefeuille, as would be needed to ensure that the stent design accommodates branching diseased vasculature. Such a modification would be made with a reasonable expectation of success.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thistle in view of Quigley (Pub. No.: US 2007/0208421 A1).
Thistle 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 Thistle 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 Thistle in view of Gries (EP 2699719 B1).
Thistle 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 Thistle 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 Thistle in view of Karavany et al. (Pub. No.: US 2019/0183629; hereinafter “Karavany”).
Thistle 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 Thistle 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.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thistle in view of White.
Thistle discloses the limitations of the claimed invention, as described above. 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 Thistle 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.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arbefeuille.
Arbefeuille discloses the limitations of the claimed invention, as described above. It further shows that the axial length of the joining liner is greater than the axial length of the tubular gate (Figs. 6-8C). However, it does not specify that the axial length of the joining liner is greater than an axial length of the tubular gate by 5%. The optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal sizes and dimensions of the parts of the prosthesis needed to properly fit the implantation site and achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the lengths of the joining liner and the tubular gate, would have been obvious at the time of applicant's invention in view of the teachings of Arbefeuille. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thistle.
Thistle discloses the limitations of the claimed invention, as described above. It further shows that the axial length of the joining liner is greater than the axial length of the tubular gate (Figs. 1-1B). However, it does not specify that the axial length of the joining liner is greater than an axial length of the tubular gate by 5%. The optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal sizes and dimensions of the parts of the prosthesis needed to properly fit the implantation site and achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the lengths of the joining liner and the tubular gate, would have been obvious at the time of applicant's invention in view of the teachings of Thistle. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
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 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).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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