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 .
DETAILED ACTION
Election/Restrictions
Applicants timely traversed the restriction requirement in the reply filed on 12/05/2023 with the election of claims 1-2, 4-10, 12-19 and 21-23. Therefore, claims 3, 4, 11 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species (claim 4 is directed to the non-elected species of Fig. 2), there being no allowable generic or linking claim. Thus, claims 1-2, 4-10, 12-19 and 21-23 are presently pending in this application.
Applicant's election with traverse is acknowledged. The traversal is on the grounds that the species are sufficiently related to permit examination of all and that a manageable number of classes and subclasses would be required if all were considered. This is not found to be persuasive, if the applicant believes that the species are similar and should not be considered mutually exclusive species, the applicant is required to state that these embodiments do not have mutually exclusive characteristics and a single prior art disclosing one would disclose the other since they are obvious variants of each other.
Applicants’ arguments regarding Figs. 6 and 7 are persuasive, subspecies A and B are rejoined. Applicants’ arguments regarding Figs. 16-17 are not persuasive as they are showing two different patterns of extension of a distal portion of a wire (pars 0030 and 0031). Applicants arguments regarding Figs. 18 and 20 are persuasive, however, the restriction inadvertently labeled Fig. 20 as subspecies F. Subspecies F should be Fig. 19 which discloses a alternate counterclockwise orientation of the wire.
The requirement is still deemed proper and is therefore made FINAL.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: specification should be amended to include the “a second wire extending longitudinally along the first side of the graft material tube in an undulating pattern of successive curves in alternate directions, which undulating pattern of successive curves of the second wire is opposite the undulating pattern of successive curves of the first wire and repeatedly overlaps the first wire, the second wire repeatedly extending through the graft material sidewall from inside the graft material tube to outside the graft material tube such that a portion of the second wire extends over the guidewire catheter over and along a longitudinal length of the guidewire catheter to secure the guidewire catheter at least partially to an internal wall of the stent graft, wherein the second wire has a plurality of successive curves in the proximal portion and a plurality of successive curves in the distal portion, each of the plurality of successive curves in the proximal portion and the distal portion have an X-displacement and a Y-displacement, wherein the X-displacement of the plurality of successive curves in the distal portion is greater than the X-displacement of the plurality of successive curves in the proximal portion, and wherein the Y-displacement of the plurality of successive curves in the distal portion is greater than the Y-displacement of the plurality of successive curves in the proximal portion” limitations in claims 8, 16 and 23.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a second wire extending longitudinally along the first side of the graft material tube in an undulating pattern of successive curves in alternate directions, which undulating pattern of successive curves of the second wire is opposite the undulating pattern of successive curves of the first wire and repeatedly overlaps the first wire, the second wire repeatedly extending through the graft material sidewall from inside the graft material tube to outside the graft material tube such that a portion of the second wire extends over the guidewire catheter over and along a longitudinal length of the guidewire catheter to secure the guidewire catheter at least partially to an internal wall of the stent graft, wherein the second wire has a plurality of successive curves in the proximal portion and a plurality of successive curves in the distal portion, each of the plurality of successive curves in the proximal portion and the distal portion have an X-displacement and a Y-displacement, wherein the X-displacement of the plurality of successive curves in the distal portion is greater than the X-displacement of the plurality of successive curves in the proximal portion, and wherein the Y-displacement of the plurality of successive curves in the distal portion is greater than the Y-displacement of the plurality of successive curves in the proximal portion” in claims 8, 16 and 23 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1, 2, 7, 9, 10, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg et al. (2007/0088424) “Greenberg” in view of Roeder et al. (2013/0116773) “Roeder” further in view of Strecker (2001/0003801).
Regarding claims 1, 2 and 9, 10, Greenberg discloses a delivery system 2 for a stent graft 6 (Fig. 2; par. 0044), the delivery system 2 comprising: a stent graft 6 having a proximal end, a distal end, a proximal portion, a distal portion (two opposing ends of stent graft 6; Fig. 5), an internal lumen between the proximal end and the distal end (as shown in Fig. 3A), a graft material tube 22 (Figs. 3A-3B disclose the graft tube of stent graft 6), a graft material sidewall (dotted line in Fig. 5 of stent graft 6) and a guidewire catheter 3 (Fig. 5) extending longitudinally through the lumen of the stent graft (as shown in Figs. 3A and 5); and a first wire 20 (Fig. 5) extending longitudinally along only a first side of the graft material tube 22 in an undulating pattern of successive curves in alternate directions (par. 0047 discloses the wire 20 is wound around the catheter in a spiral manner and holds the catheter against a selected longitudinal portion of the stent graft; Fig. 7), the first wire repeatedly extending through the graft material sidewall from inside the graft material tube to outside the graft material tube such that a portion of the first wire extends over the guidewire catheter over and along a longitudinal length of the guidewire catheter to secure the guidewire catheter at least partially to an internal wall of the stent graft (par. 0047 discloses the wire 20 is wound around the catheter 3 through the material of the stent graft 22 so there are lengths 24 of the release wire outside the stent graft body; Fig. 3B), wherein the first wire has a plurality of successive curves in the proximal portion and a plurality of successive curves in the distal portion, each of the plurality of successive curves in the proximal portion and the distal portion have an X-displacement and a Y-displacement (as shown in Figs. 5 and 7, the wire 20 has successive spiral curves along the stent graft length including distal and proximal portions where the spiral curves have a certain X and Y displacement);
Greenberg is silent regarding a plurality of longitudinally spaced apart self-expanding stents attached to the graft material sidewall and including at least an end stent and a plurality of intermediate stents; wherein the X-displacement of the plurality of successive curves in the distal portion is greater than the X-displacement of the plurality of successive curves in the proximal portion, and wherein the Y-displacement of the plurality of successive curves in the distal portion is greater than the Y-displacement of the plurality of successive curves in the proximal portion; and at least two fenestrations (claim 9); and wherein each of the plurality of successive curves in the proximal portion and the distal portion has a take off angle, wherein the take off angle of at least one of the plurality of successive curves in the distal portion is greater than the take off angle of at least one of the plurality of successive curves in the proximal portion (claim 2).
However, Roeder teaches a similar delivery system (par. 0048) comprising a stent graft 10 (Fig. 1) having a plurality of longitudinally spaced apart self-expanding stents (16a-e; Fig. 1 and par. 0044 disclose self-expandable stents 16) attached to a graft material sidewall (as shown in Fig. 1) and including at least an end stent 16e and a plurality of intermediate stents (16b-d); and at least two fenestrations 12/12b (Fig. 1 and par. 0037). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent graft in Greenberg to include a plurality of longitudinally spaced apart self-expanding stents attached to the graft material sidewall and including at least an end stent and a plurality of intermediate stents; and at least two fenestrations, as taught and suggested by Roeder, for providing a system of interconnected stent grafts to provide sufficient intraluminal support and for allowing bifurcated components to treat branched vessels (par. 0002).
Furthermore, Greenberg in view of Roeder is silent regarding the X-displacement of the plurality of successive curves in the distal portion is greater than the X-displacement of the plurality of successive curves in the proximal portion, and wherein the Y-displacement of the plurality of successive curves in the distal portion is greater than the Y-displacement of the plurality of successive curves in the proximal portion and wherein each of the plurality of successive curves in the proximal portion and the distal portion has a take off angle, wherein the take off angle of at least one of the plurality of successive curves in the distal portion is greater than the take off angle of at least one of the plurality of successive curves in the proximal portion.
However, Strecker teaches a similar stent graft 1 (Fig. 25; par. 0114-0115) comprising a first wire 2 having a plurality of successive curves 46/47 extending along a side of the graft comprising the X-displacement of the plurality of successive curves in the distal portion is greater than the X-displacement of the plurality of successive curves in the proximal portion, and wherein the Y-displacement of the plurality of successive curves in the distal portion is greater than the Y-displacement of the plurality of successive curves in the proximal portion and wherein each of the plurality of successive curves in the proximal portion and the distal portion has a take off angle, wherein the take off angle of at least one of the plurality of successive curves in the distal portion is greater than the take off angle of at least one of the plurality of successive curves in the proximal portion (par. 0115 discloses the spiral loops 46/47 have different pitches which by definition have an X and Y displacement and a take off angle; par. 0014 discloses the pitch of the spiral loops can be modified over the length of the stent where the smaller pitch can be placed at one end of the stent).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent graft in Greenberg in view of Roeder to include a the X-displacement of the plurality of successive curves in the distal portion is greater than the X-displacement of the plurality of successive curves in the proximal portion, and wherein the Y-displacement of the plurality of successive curves in the distal portion is greater than the Y-displacement of the plurality of successive curves in the proximal portion and wherein each of the plurality of successive curves in the proximal portion and the distal portion has a take off angle, wherein the take off angle of at least one of the plurality of successive curves in the distal portion is greater than the take off angle of at least one of the plurality of successive curves in the proximal portion, as taught and suggested by Strecker, for providing an improved anchoring of stent within the blood vessel by providing varying load or support capacity (par. 0014).
Regarding claims 7, 14 and 15, Greenberg discloses wherein the first wire 20 is disposed substantially externally along the stent graft (external portions 24; Fig. 3B; par. 0047); wherein the first wire repeatedly crosses over the guidewire catheter along a length of the guidewire catheter to secure the guidewire catheter at least partially to the internal wall of the stent graft (par. 0047 and Fig. 3B) and to keep the guidewire catheter away from fenestrations of the stent graft (the combination of the catheter 3 and the fenestrations of Roeder would arrive at the catheter being kept away from the fenestrations of the stent graft).
Allowable Subject Matter
Claims 17-19 and 21-23 are allowed.
Claims 5-6, 8, 12-13 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter is allowable due to the limitations of “wherein the plurality of stents each comprise a series of struts and the first wire crosses over two adjacent struts of each of the plurality of stents at an angle to a longitudinal axis of the stent graft” as set forth in claims 5 and 12; “wherein the first wire crosses over the two adjacent struts within the lumen of the stent graft” as set forth in claims 6 and 13; “a second wire extending longitudinally along the first side of the graft material tube in an undulating pattern of successive curves in alternate directions, which undulating pattern of successive curves of the second wire is opposite the undulating pattern of successive curves of the first wire and repeatedly overlaps the first wire, the second wire repeatedly extending through the graft material sidewall from inside the graft material tube to outside the graft material tube such that a portion of the second wire extends over the guidewire catheter over and along a longitudinal length of the guidewire catheter to secure the guidewire catheter at least partially to an internal wall of the stent graft, wherein the second wire has a plurality of successive curves in the proximal portion and a plurality of successive curves in the distal portion, each of the plurality of successive curves in the proximal portion and the distal portion have an X-displacement and a Y-displacement, wherein the X-displacement of the plurality of successive curves in the distal portion is greater than the X-displacement of the plurality of successive curves in the proximal portion, and wherein the Y-displacement of the plurality of successive curves in the distal portion is greater than the Y-displacement of the plurality of successive curves in the proximal portion” as set forth in claims 8 and 16 and “the plurality of stents each comprise a series of struts and the first wire crosses over two adjacent struts of each of the plurality of stents at an angle to a longitudinal axis of the stent graft” as set forth in claim 17, which has not been found anticipated by or obvious over prior art.
The closest prior art of record of Greenberg et al. (2007/0088424) “Greenberg” in view of Roeder et al. (2013/0116773) “Roeder” further in view of Strecker (2001/0003801) fail to disclose the first wire crosses over two adjacent struts of each of the plurality of stents at an angle to a longitudinal axis of the stent graft and the second wire repeatedly extending through the graft material sidewall from inside the graft material tube to outside the graft material tube such that a portion of the second wire extends over the guidewire catheter over and along a longitudinal length of the guidewire catheter to secure the guidewire catheter at least partially to an internal wall of the stent graft.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached 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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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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