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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/08/2026 has been entered.
Priority
This application claims priority from provisional application 61/457,604, filed 04/29/2011.
Status of Claims
Claims 1-22 are pending.
Election/Restrictions
Applicant elected Species 3 (Figures 13-15d) without traverse on 07/16/2024.
Claim Objections
The previous claim objections have been withdrawn in view of the applicant’s amendments.
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) 1-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz USPN 5,954,765 in view of Schnepp-Pesch et al (Schnepp) 5,354,309 and Freidberg et al (Freidberg) USPN 6,699,277 B1
Claim 1 Ruiz discloses a self-expanding endovascular prosthesis (Figure 5A) comprising:
a first expandable portion (far right side of Figure 5A) expandable from a first, unexpanded state to a second, expanded state to urge the first expandable portion against a vascular lumen (abstract); and
a retractable leaf portion (middle and left side of Figure 5A) attached to the first expandable portion (Figure 5A), the retractable leaf portion comprising a single spine portion 42 connected to the first expandable portion and a plurality of rib portions 41 attached to the single spine portion (Figure 5A), the plurality of rib portions comprising a pair of rows of rib portions (upper and lower rows Figure 5A), each row of rib portions connected to one side of the single spine portion (Figure 5A), longitudinally adjacent pairs of rib portions being free of interconnecting struts (Figure 5A);
wherein, in an expanded configuration of the self-expanding endovascular prosthesis, the single spine portion comprises a first radius of curvature over the length of the single spine portion about an axis transverse to a longitudinal axis of the endovascular prosthesis (It is noted that the curvature of the prosthesis wholly depends upon the delivery device and method used to deliver the prosthesis. If the delivery device is flexed or curved, if the path to the implant site is curved, and if the implant site itself is curved, then the spine of the prosthesis of Ruiz will inherently have a radius of curvature. Additionally, it is almost impossible for the path to and implant site of a natural blood vessel to be perfectly straight. In order for the stent of Ruiz to be implanted within a blood vessel it is rolled up to a compressed configuration and inserted within a delivery device such as a catheter, whether compressed within the delivery device, partially expanded, or fully expanded outside of the delivery device the spine and ribs are fully capable of having a variety of radius of curvatures. Ruiz disclosed the prosthesis as being flexible and formed from flexible material nitinol (abstract) which will inherently result in the stent being capable of obtaining the arcuate shape along its longitudinal axis having a first radius of curvature shown in Figures 3B)
wherein the first expandable portion comprises an anchor spine (portion of 42 connecting on the far right) one end of which is connected to an end of the single spine portion (just like the applicant’s invention the prosthesis comprises a single spine connecting the entire implant) and a plurality of anchor ribs (four ribs 41 on far-right side of Figure 5A) ends of which are attached to the anchor spine (Figure 5A),
However, Ruiz does not disclose the different longitudinal spacing of the anchor and leaf portions or loops .
Schnepp teaches the use of a similar self-expanding endovascular prosthesis (Figure 8) comprising spines and ribs wherein a first expandable portion (lower half of Figure 8) comprises greater longitudinal spacing between the ribs compared to the ribs of a retractable leaf portion (upper half of Figure 8) in the same field of endeavor for the purpose of providing varied anchoring forces and distribution along varied surface areas.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the spacing of the ribs of the first expandable portion of the prosthesis of Ruiz so that it is greater than the spacing of the ribs of the leaf portion as taught by Schnepp in order to distribute the anchoring forces of the implant along a greater surface area of the implant site adjacent the leaflet portion.
Freidberg teaches the use of a similar self-expanding endovascular prosthesis (Figure 14) comprising a plurality of loops at each end of the prosthesis in the same field of endeavor for the purpose of providing varied anchoring loops for securement to the implant site or delivery instruments.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the prosthesis of Ruiz to include a loop at the end of the anchor spine as taught by Freidberg in order to provide a point for suturing to the implant site or being engaged by insertion/removal devices.
Claim 2 Ruiz discloses the rib portions comprises a rib proximal portion (near spine), a rib distal portion (tip of each rib) and a rib intermediate portion disposed therebetween (Figure 5A).
Claim 3 Ruiz discloses the rib distal portion of each rib portion configured to be directed toward the first expandable portion (the tips of each rib are shown directed at the far right where the first expandable portion is in Figure 5A).
Claim 4 Ruiz discloses, in two dimensions, each row of rib portions is a substantial mirror image of an adjacent row of rib portions along the single spine portion (the ribs are offset but still considered to be a substantial mirror of each other Figure 5A).
Claim 5 Ruiz discloses, in two dimensions, each rib portion has a variable width along a length of the rib portion (Ruiz’s ribs are tapered, therefore the width along their length is considered to be variable).
Claim 6 Ruiz discloses the plurality of first connection points and the plurality of second connection points being longitudinally staggered with respect to one another (Figure 5A).
Claim 7 Ruiz discloses, in two dimensions, each rib portion is configured to form an acute angle with respect to a spine longitudinal axis (Ruiz further discloses another embodiment with the ribs forming acute angles Figure 5A).
Claim 8 Ruiz discloses, in two dimensions, each rib portion is curved (tips of each rib are rounded which reads upon the curved requirement).
Claim 9 Ruiz discloses,, in two dimensions, each rib portion comprises at least two sub-portions each sub-portion form a different angle with respect to a longitudinal axis of the endovascular prosthesis (in view of the broad use of portions, the claims can be interpreted to utilize any area in any configuration of each rib, for example the rounded tip of each rib has an edge that forms a different angle than the edge of the intermediate portion of each rib).
Claim 10 Ruiz discloses the first radius of curvature is variable from a proximal portion of the single spine portion to a distal portion of the single spine portion (the ribs and spine are flexible which makes their radius of curvature variable along the length of the spine).
Claim 11 Ruiz discloses the first radius of curvature decreases from a proximal portion of the single spine portion to a distal portion of the single spine portion (as explained above the ribs and spine are flexible which means they can be adjusted to larger or smaller radius of curvature; therefore, the first radius of curvature is fully capable of decreasing in the proximal to distal direction).
Claims 12. and 13. Ruiz discloses, in an expanded configuration, the retractable leaf portion comprises an arc of curvature about a longitudinal axis of the endovascular prosthesis of about 200 degrees (Ruiz discloses the ribs arc of curvature can be varied depending on the size and shape of the vessel and growth over time, Ruiz further discloses the ribs are functional without overlap. Therefore, if placed within the correct sized implant site the prosthesis will inherently form an arc of curvature of 200 degrees).
Claim 14. Ruiz discloses, the ratio of the perpendicular distance from the longitudinal axis to the distal tip portion of the rib portion in two dimensions to 50% of the circumference of the first expandable portion in the second, expanded state in three dimensions is in the range of from about 1:4 to about 1:1 (in view of the flexible and adjustable nature of the ribs including those defining the first expandable portion, it is inherent that the claimed ratio can be achieved by placing the prosthesis of Ruiz in the correct diameter vessel).
Claims 15. and 16. Ruiz discloses the retractable leaf portion comprises a second substantially constant radius of curvature over the entire length of the retractable leaf portion spine (Figure 5A it is noted that the claims do not require it to be different from the first radius).
Regarding claims 17 and 19, Ruiz does not disclose the specific spacing between the ribs. The applicant has not disclosed that having the rib spacing in this range solves any stated problem or is for any particular purpose. The identified range appears to be an obvious routine optimization. Furthermore, the applicant has failed to provide evidence that this range provides for an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to space the ribs of Ruiz adjacent the spine about 0.14 mm to about 0.254 mm in order to achieve the optimal ratio of rib surface area to open area in order to support the implant site and restore its original functionability.
Claim 18 Ruiz discloses an aneurysm treatment system comprising the endovascular prosthesis defined in Claim 1 (described above) detachably coupled to an endovascular prosthesis delivery device (2:21-23).
Claim 19 Ruiz discloses endovascular prosthesis (Figure 5A) comprising:
a first expandable portion (far right side near reference number 32 of Figure 5A) expandable from a first, unexpanded state to a second, expanded state to urge the first expandable portion against a vascular lumen (abstract); and
a retractable leaf portion (middle and left side of Figure 5A) attached to the first expandable portion (Figure 5A), the retractable leaf portion comprising a single spine portion 32 connected to the first expandable portion and a plurality of rib portions 31 attached to the spine portion (Figure 5A), the single spine portion comprising a pair of rows of rib portions (upper and lower rows Figure 5A), each row of rib portions connected to one side of the single spine portion (Figure 5A), longitudinally adjacent pairs of rib portions being free of interconnecting struts (Figure 5A);
wherein, in an expanded configuration of the endovascular prosthesis, the single spine portion comprises a first radius of curvature over a length of the single spine portion about an axis transverse to a longitudinal axis of the endovascular prosthesis (Figure 4D see explanation with respect to claim 1 above);
wherein a pair of longitudinally adjacent rib portions coupled to the spine portion at respective connection points that are spaced at a distance ranging from about 0.14 mm to about 0.254 mm (see explanation above with respect to claim 17).
wherein the first expandable portion comprises an anchor spine (portion of 42 connecting on the far right), one end of which is connected to an end of the single spine portion (just like the applicant’s invention the prosthesis comprises a single spine connecting the entire implant), and a plurality of anchor ribs (four ribs 41 on far right side of Figure 5A), one ends of which are attached to the anchor spine (Figure 5A), longitudinally adjacent anchor ribs of the plurality of anchor ribs being more distantly longitudinally spaced from one another arranged than the longitudinally adjacent rib portions of the retractable leaf portion (see modification in view of Schnepp), wherein the first expandable portion further comprises a loop connected to another end of the anchor spine and configured to be connected to a delivery device (see modification in view of Freidberg).
Claim 20 Ruiz discloses an endovascular prosthesis (Figure 5A) comprising:
a first expandable portion (far right side of Figure 5A) expandable from a first, unexpanded state to a second, expanded state to urge the first expandable portion against a vascular lumen (abstract); and
a retractable leaf portion (middle and left side of Figure 5A) attached to the first expandable portion, the retractable leaf portion comprising a single spine portion 32 connected to the first expandable portion and a plurality of rib portions 31 attached to the single spine portion, the plurality of rib portions comprising a pair of rows of rib portions (top and bottom rows Figure 5A), each row of rib portions connected to one side of the single spine portion (Figure 5A), longitudinally adjacent pairs of rib portions being free of interconnecting struts (Figure 5A);
wherein, in an expanded configuration of the endovascular prosthesis, the retractable leaf portion comprises an arc of curvature about a longitudinal axis of the endovascular prosthesis of from about 200 to about 360 degrees (see explanation with respect to claim 1 above, additionally Figure 3B shows an arc of curvature slightly less than 360 degrees, which is within the range)
wherein the first expandable portion comprises an anchor spine (portion of 42 connecting on the far right), one end of which is connected to an end of the single spine portion (just like the applicant’s invention the prosthesis comprises a single spine connecting the entire implant), and a plurality of anchor ribs (four ribs 41 on far right side of Figure 5A), one ends of which are attached to the anchor spine (Figure 5A), longitudinally adjacent anchor ribs of the plurality of anchor ribs being more distantly longitudinally spaced from one another arranged than the longitudinally adjacent rib portions of the retractable leaf portion (see modification in view of Schnepp), wherein the first expandable portion further comprises a loop connected to another end of the anchor spine and configured to be connected to a delivery device (see modification in view of Freidberg).
Claim 21 Ruiz discloses the first radius of the curvature is over the length of the single spine from a proximal portion of the single spine portion to a distal portion of the single spine portion (Ruiz discloses a flexible prosthesis capable of bending to a plurality of radius of curvatures, as explained above the first radius of curvature depends upon the delivery device and use of the prosthesis. Additionally this claim is considered very broad because the length and actual radius values are not specifically defined (the length could be a full length or any identifiable shorter length of the spine from a portion within the proximal end to a portion within the distal end) Ruiz anticipates this claim because his prosthesis is fully capable of being provided with a curvature along a length of the spine because his prosthesis is formed from a flexible material and has a readily bendable shape, elongated rod-line spine).
Claim 22 Ruiz discloses the single spine portion comprises the first radius of the curvature in a fully expanded configuration of the self- expanding prosthesis (As explained above Ruiz discloses a flexible prosthesis capable of bending to a plurality of radius of curvatures in all expanded and unexpanded configurations. The first radius of curvature depends upon the delivery device and use of the prosthesis. Ruiz anticipates this claim because his prosthesis is fully capable of being provided with a curvature along a length of the spine because his prosthesis is formed from a flexible material and has a readily bendable shape, elongated rod-line spine). .
Response to Arguments
Applicant's arguments filed 06/08/2026 have been fully considered but they are not persuasive. The applicant’s arguments are focused on the newly claimed spacing and loop requirements. However, these arguments are moot because the prior art rejection has been amended to include the teachings of Schnepp and Friedberg, who teach that these concepts are known in the art of stent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
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