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 of Group I, Species A and F in the reply filed on 10/22/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 9 and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Groups and Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/22/2025. The requirement is still 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) 1-8, 10, 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hachtman et al. (Pat. No.: US 5,645,559; hereinafter “Hachtman”).
Hachtman discloses the following regarding claim 1: a system of stents, comprising: an outer stent (66b) (Figs. 19-21, 28; col. 6, lines 37-48) comprising: an elongate body (Figs. 19, 28) configured to be expandable between a constrained configuration and an unconstrained configuration (col. 3, lines 45-49), the elongate body in the unconstrained configuration including a retention member (72, 74) (please see annotated Figure A, below; col 7, lines 31-41) and a cylindrical saddle region (central region of element 66b) (Figure A) adjacent the retention member (Figure A; Fig. 19), the cylindrical saddle region defining a lumen (central opening of element 66b) extending along a longitudinal axis of the outer stent (Figs. 19-20); wherein the retention member of the outer stent comprises a double-walled flange (Figure A) having an axially inward wall (Figure A), an axially outward wall (Figure A), and a radial wall (Figure A) extending therebetween; and an inner stent (66a) (Figs. 19-21, 28; col. 6, lines 37-48) comprising: an elongate body (Figs. 19, 28) configured to be expandable between a constrained configuration and an unconstrained configuration (col. 3, lines 45-49), the elongate body in the unconstrained configuration including a retention member (flared members of element 66a) (Figs. 19-21 and col. 6, lines 37-58 disclose that the inner and the outer stents have substantially the same dimensions and aligned filaments, where the inner stent has the shape of the outer stent. Therefore, the labels of the outer stent elements shown in Figure A apply to the corresponding inner stent features.) and a cylindrical saddle region (central region of element 66a) adjacent the retention member (Fig. 19; Figure A), the cylindrical saddle region defining a lumen (central opening of element 66a); wherein the retention member of the inner stent comprises a double-walled flange (Figure A) having an axially inward wall (Figure A), an axially outward wall (Figure A), and a radial wall (Figure A) extending therebetween; wherein the axially inward wall of the retention member of the inner stent is configured to removably engage the axially outward wall of the retention member of the outer stent (col. 6, lines 49-58, as the inner and the outer stent are constructed as separate elements, the axially inward wall of the retention member of the inner stent would be fully capable of being removably engaged with the axially outward wall of the retention member of the outer stent prior to the full assembly and insertion of the device). Please note that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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Figure A.
Hachtman discloses the following regarding claim 2: the system of claim 1, wherein the axially inward wall of the retention member of the inner stent and the axially outward wall of the retention member of the outer stent each comprise a concave surface (dipped section between filaments at the inward wall of the inner stent and the outward wall of the outer stent) (Figs. 19-21).
Hachtman discloses the following regarding claim 3: the system of claim 1, wherein the axially outward wall of the retention member of the inner stent member and the axially inward wall of the retention member of the outer stent each comprise a convex surface (arched protruding section formed by the filaments at the axially outward wall of the inner stent and the axially inward wall of the outer stent) (Figs. 19-21).
Hachtman discloses the following regarding claim 4: the system of claim 1, wherein the retention member of the outer stent is located at a distal portion of the elongate body (Figs. 19, 28) and wherein the retention member of the inner stent is located at a proximal portion of the elongate body (Figs. 19, 28).
Hachtman discloses the following regarding claim 5: the system of claim 1, wherein a longitudinal cross-sectional profile of the retention member of the inner stent substantially matches a longitudinal cross-sectional profile of the retention member of the outer stent (Figs. 19, 28; col. 6, lines 37-48).
Hachtman discloses the following regarding claim 6: the system of claim 1, wherein the axially outward wall of the retention member of the inner stent extends to a flexible sleeve (silicone sleeve) contiguous with the lumen of the outer stent (col. 6, lines 49-67).
Hachtman discloses the following regarding claim 7: the system of claim 1, wherein a diameter of the cylindrical saddle region of the inner stent is different than a diameter of the cylindrical saddle region of the outer stent (Figs. 19-20; col. 6, lines 36-58).
Hachtman discloses the following regarding claim 8: the system of claim 1, wherein the radial wall of the outer stent comprises a diameter greater than a diameter of the cylindrical saddle region of the outer stent (Figure A; Figs. 19, 28).
Hachtman discloses the following regarding claim 10: the system of claim 1, wherein the radial wall of the outer stent comprises a diameter greater than a diameter of the radial wall of the inner stent (Figs. 19-20; col. 6, lines 36-58).
Hachtman discloses the following regarding claim 11: the system of claim 1 further comprising a covering (silicone covering) extending at least partially along a length of the elongate body of the outer stent (col. 6, lines 49-67).
Hachtman discloses the following regarding claim 14: the system of claim 1, further comprising a flexible sleeve (silicone film along element 66a) coupled to the inner stent and extending axially away from the retention member of the outer stent (col. 6, lines 49-65).
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) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hachtman in view of Rucker et al. (Pub. No.: US 2011/0093002 A1; hereinafter “Rucker”).
Regarding claim 12, Hachtman discloses the limitations of the claimed invention, as described above. However, it does not recite a radiopaque marker at each of the retention member of the inner stent and the retention member of the outer stent. Rucker teaches that it is well known in the art that the distal ends of inner and outer stents are provided with radiopaque markers (paras. 0066-0068), for the purpose of enabling visualization of the inner and outer stents during deployment. It would have been obvious to one having ordinary skill in the art to modify the inner and the outer stents of Hachtman to comprise radiopaque markers at their distal end retention members, as taught by Rucker, in order to enable visualization of the inner and the outer stents during deployment.
Regarding claim 13, Hachtman discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the inner stent further comprising an element configured for reducing a profile of the inner stent and removing the inner stent from the outer stent. Rucker teaches that it is well known in the art that an inner stent comprises an element (120) configured for reducing a profile of the inner stent and allowing for its removal from the outer stent prior to the device’s full assembly (paras. 0034-0036, 0042), for the purpose of ensuring the proper positioning and easier insertion of the inner stent into the outer stent. It would have been obvious to one having ordinary skill in the art to modify the inner stent of Hachtman to comprise an element, as taught by Rucker, in order to ensure the proper positioning and insertion of the inner stent into the outer stent.
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).
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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