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) 1-8 and 10-14 have been considered, but are moot in view of the new grounds of rejection.
Claim Rejections - 35 USC § 112
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.
Claims 2, 3, and their dependent claims are 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. Claims 2 and 3 recite the limitation "the longitudinal axis of the associated stent." There is insufficient antecedent basis for this limitation in the claim, as the claims have not established a longitudinal axis for the inner stent. Appropriate correction 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8, 10-11, and 14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Folan et al. (Pub. No.: US 2023/0149195 A1; hereinafter “Folan”).
Folan discloses the following regarding claim 1: a system of stents, comprising: an outer stent (e.g., 210) comprising: an elongate body (e.g., Fig. 2) configured to be expandable between a constrained configuration and an unconstrained configuration (para. 0052), the elongate body in the unconstrained configuration including a retention member (216a and/or 216b) and a cylindrical saddle region (214) adjacent the retention member (Fig. 2), the cylindrical saddle region defining a lumen (212) extending along a longitudinal axis (LA) of the outer stent (Fig. 2); wherein the retention member of the outer stent comprises a double-walled flange (Fig. 2) having an axially inward wall (216ai and/or 216bi) extending radially outwardly from the longitudinal axis of the outer stent (Fig. 2), an axially outward wall (216ao and/or 216bo) extending radially outwardly from the longitudinal axis of the outer stent (Fig. 2), and a radial wall (please see Figure A, below) extending circumferentially around the longitudinal axis of the outer stent and between the axially inward wall and the axially outward wall (Figure A; Fig. 2); and an inner stent (e.g., 220) comprising: an elongate body (e.g., Fig. 2) configured to be expandable between a constrained configuration and an unconstrained configuration (para. 0052), the elongate body in the unconstrained configuration including a retention member (240) and a cylindrical saddle region (224) adjacent the retention member (Fig. 2), the cylindrical saddle region defining a lumen (222); wherein the retention member of the inner stent comprises a double-walled flange (Fig. 2) 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 (para. 0048, 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 via intermediate elements). 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.
Folan 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 (Figure B) curving about an axis oblique to the longitudinal axis (LA for inner and outer stents) of the associated stent (Figure B).
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Figure B.
Folan 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 (Figure B) curving about an axis oblique to the longitudinal axis (LA for inner and outer stents) of the associated stent (Figure B).
Folan 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 (e.g., Fig. 2) and wherein the retention member of the inner stent is located at a proximal portion of the elongate body (e.g., Fig. 2).
Folan discloses the following regarding claim 5: the system of claim 1, wherein a longitudinal cross-sectional profile of the axially inward wall of the retention member of the inner stent substantially matches a longitudinal cross-sectional profile of the axially outward wall of the retention member of the outer stent (e.g., Fig. 2).
Folan 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 contiguous with the lumen of the outer stent (para. 0044).
Folan 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 (e.g., Fig. 2).
Folan 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 (e.g., Fig. 2).
Folan 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 (e.g., Fig. 2).
Folan discloses the following regarding claim 11: the system of claim 1 further comprising a covering (230) extending at least partially along a length of the elongate body of the outer stent (paras. 0043-0044, 0054).
Folan discloses the following regarding claim 14: the system of claim 1, further comprising a flexible sleeve (240) coupled to the inner stent and extending axially away from the retention member of the outer stent (Fig. 2; para. 0056).
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 Folan in view of Rucker et al. (Pub. No.: US 2011/0093002 A1; hereinafter “Rucker”).
Regarding claim 12, Folan 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 Folan 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. Such a modification would be made with a reasonable expectation of success.
Regarding claim 13, Folan 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 Folan 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. Such a modification would be made with a reasonable expectation of success.
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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