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 .
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 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) 21 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Escamilla et al. (20040059407).
Escamilla discloses the following claimed limitations:
Claim 21: A middle member (see figure below) of an endovascular delivery system, the middle member comprising: a proximal member ( see figure below) having a proximal member diameter (diameter of part 32, [0041]) (Fig. 2), the proximal member has a first surface portion (32, see figure below) formed of a first material (polymeric material as stated in [0041]) and a second surface portion (part of 26, see figure below) formed of a second material (Nitinol as stated in [0040]) different than the first material ([0040-41]); a distal member (34, see figure below) having a proximal and distal ends (see figure below) and a distal member diameter (diameter of part 34 as stated in [0041]) (Fig. 2) extending between the proximal and distal ends (see figure below), and a medial member (30, see figure below) having a medial member diameter (diameter of 30 as stated in [0040]) (Fig. 2) extending between the proximal member and the distal member (see figure below), the medial member diameter is less than the proximal member diameter and the distal member diameter to form a notch (see figure below) configured to retain a proximal most end of a stent graft (Fig. 1), the distal member diameter less than the proximal member diameter ([0041]), the proximal member and the medial member form a shoulder therebetween (see figure below), the shoulder having a radially extending face (see figure below) configured to contact the proximal most end of the stent graft (Fig. 5 where it abuts as the cover is being retracted), and the radially extending face of the shoulder has an outer radially extending shoulder face diameter (diameter of 32) (Fig. 2) greater than the distal member diameter ([0041]).
Claim 22: wherein the radially extending face of the shoulder extends perpendicular to a surface of the medial member (see figure below where the surface is the edge as seen in the figure below which is perpendicular to the surface of the medial member where the stent seats on as seen in Fig. 1).
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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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Escamilla et al. (20040059407) in view of Gunderson (2004/0204749).
Claim 1:
Escamilla discloses an endovascular delivery system comprising: a stent (10) (Fig. 1 and [0039]) including a first end (48) and a second end (50) (Fig. 1 and [0043]), the first end including an engagement member (52) (Fig. 1 and [0043]), the stent configured to change between a radially compressed configuration and a radially deployed configuration (Fig. 4-6); a guide member (26) (Fig. 1) carrying the stent and including a proximal end portion (28) (Fig. 1 and [0040]) and a distal end portion (30) (Fig. 1 and [0040]); and a graft cover (14) (Fig. 1 and [0039]) radially covering at least a portion of the stent (Fig. 1) and configured to retract to uncover the stent graft so that the stent graft changes from the radially compressed configuration to the radially deployed configuration (Fig. 4-6), the first end of the stent is arranged closer to the proximal end portion of the guide member than the second end of the stent (Fig. 1), the guide member securing the first end of the stent in a first position (Fig. 1 and 4) where the engagement member is held between the graft cover and the guide member to hold the first end of the stent in the first position as the graft cover is retracted to deploy the stent (Fig. 4-6), the engagement member is axially spaced apart from a proximal most stent (see figure below) of the stent (Fig. 1 and [0043]), the distal end portion of the guide member includes a proximal member (see figure below), a distal member (see figure below), and a medial member (see figure below) extending between the proximal member and the distal member (see figure below), the proximal member and the medial member form a shoulder (see figure below) therebetween (see figure below), the first end of the stent abuts a radially extending face of the shoulder (see figure below and Fig. 1) and the radially extending face of the shoulder terminates at the graft cover (see figure below) and wherein the proximal most end of the stent is in contact with the graft cover (Fig. 1), the guide member terminates at a distalmost end (see figure below) of the distal member of the guide member (see figure below).
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Escamilla teaches all the limitations discussed above, however Escamilla is silent with regards to the stent being a stent graft.
Gunderson discloses another well-known stent delivery device where it states that the delivery device can be used to deliver a stent or a stent graft ([0003 and [0032]). Therefore, it would have been obvious to one of ordinary skill in the art to modify the stent of Parker to be a stent graft, as taught by Gunderson, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the stent in Escamilla for a stent graft in view of Gunderson since these mechanisms perform the same function of supporting an endovascular lumen. Simply substituting one stent for another would yield the predicable result of supporting a larger lumen. See MPEP 2143.
Claim 2: Escamilla discloses that the radially extending face of the shoulder extends perpendicular to a surface of the medial member (see figure above where the surface is the edge as seen in the figure below which is perpendicular to the surface of the medial member where the stent seats on as seen in Fig. 1).
Claim 3: Escamilla discloses that the proximal end portion, the medial member, and the distal member define a notch (see figure above) (note that the notch is the same as the notch defined by applicant in the original disclosure as 124) extending in a circumferential direction and receiving the engagement member (see figure above and Fig. 1).
Claim 4: Escamilla discloses that a length of the notch is less than a length of the proximal most stent (see figure above where the notch is the size of the engagement member which is smaller than the length of the proximal most stent as defined by the examiner).
Claim 5: Escamilla discloses that the proximal member is connected to a flared member (see figure above) tapered in a proximal direction (see figure above).
Claim 6: Escamilla discloses that the medial member terminates at the proximal member and the distal member (see figure above).
Claim 7: Escamilla discloses that the medial member and the proximal member form a radiused portion therebetween (see figure above).
Claim 8: Escamilla discloses that the engagement member is a radiopaque marker ([0044]).
Claim 9: Escamilla discloses wherein the engagement member has a first thickness (Fig. 6) and the proximal most stent has a second thickness less than the first thickness (see figure above and Fig. 6 where the coil of the engagement member is thicker than the stent wall)
Allowable Subject Matter
Claims 10-17 and 19 are allowed.
The following is an examiner’s statement of reasons for allowance: the art of record when considered alone or in combination neither renders obvious nor anticipates an endovascular delivery system comprising: a stent graft including stent rings and a graft wall; a graft cover, and a guide member includes a distal end portion which has a proximal member, a distal member, and a medial member extending between the proximal member and the distal member, and the engagement member contacts the medial member and is spaced apart from the graft cover by the stent graft including the stent rings and the graft wall, the stent graft which is radially situated between the graft cover and the engagement member; in conjunction with the rest of the claimed limitations.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments filed 12/11/25 have been considered but are moot in view of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited prior art appears to teach some of the claimed limitations.
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 DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771