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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/16/2026 has been entered.
Priority
This application claims priority from provisional application 62768803, filed on 11/16/2018.
Status of Claims
Claims 1, 2, 4, 5, 7, 8, 32-36, 38-42, and 45-46 are pending.
Claims 3, 6, 9-31, 37, and 43-44 have been cancelled.
Election/Restrictions
Applicant elect Invention I (System) and Species 4 (Figure 9) on 04/15/2022 without traverse (MPEP § 818.03(a)).
Information Disclosure Statement
The Information Disclosure Statement filed on 07/07/2026 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The previous 112 rejection have been withdrawn in view of the applicant’s amendments.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.
Claims 1-2, 4-5, 7-8, 32-33, and 45-46, are rejected under 35 U.S.C. 103 as being unpatentable over Tieu et al (Tieu) USPN 9,867,725 B2 in view of Stinson US 2004/0143317 A1 and Pung et al (Pung) USPN 10,039,655 B2.
Tieu discloses a stent system comprising: a stent (Figure 1) formed from and consisting of a single wire (4:4-7) wound into a generally tubular shaped main body 4 and having proximal and distal extensions (flared ends 104/107 Figure 1) extending from the generally tubular shaped main body;
a pusher 130 to deploy the stent from a catheter 135 (Figures 7-8).
However, Tieu does not disclose the stent is formed from the DFT wire or the use of reinforcing elements within the main body.
Stinson teaches the use of DFT wires (22 Figures 2AB [0057]) comprising nitinol jackets [0058] wrapped around a platinum core [0065] is known in the art of vascular stents for the purpose of maintaining mechanical characteristics while improving imaging/visibility along the entire stent.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the single continuous nitinol wire of Tieu with just the DFT wire of Stinson in order to improve visibility along and throughout the entire stent.
The applicant’s prior patent, Pung (published well more than a year before the earliest priority of this application), teaches the use of stents comprising reinforcing coil elements (31 in Figures 6B and D) tightly wound around the stent wire such that they follow a length of a single wire segment (Figures 6D and B show 31 wound around only a single section or segment of the wire) throughout the main body of the stent (30 Figure 8) in the same field of endeavor for the purpose of reinforcing the main stent body adjacent cross-over points and improving visibility.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to add additional tightly wound coil reinforcing elements of Pung spaced throughout the main stent body adjacent to crossover points of Tieu as taught by Pung in order to reinforce the main body at staggered cross-over points and improve visibility throughout the stent.
In regards to the requirement for the reinforcing element to augment the opening force along the single wire segment in the deployed configuration, the current application specifies that this is achieved merely by stiffening the segments [0081]-[0089]. Any wire that has additional structure wrapped around it will inherently be stiffer than without it. Therefore addition of the coils of Pung to the wire segments of Tieu will inherently augment the opening force along the single wire segment in the deployed configuration because they increase the stiffness of those segments.
In regards to claim 2, the applicant’s stent in the current application has the same Figure 1 depicting the flared angles. Additionally, the loop’s angles depend upon the implant site and are fully capable of expanding to a 60 degree angle when implanted into an appropriate implant site using the appropriate expansion tools.
In regards to claims 4, 5, 7, and 8, the ratios and values are not disclosed by the applicant as having any criticality.
In regards to claim 4, the applicant has not disclosed that the platinum core having about 10% of a total area of the wire solves any stated problem or is for any particular purpose. Specifically [0039] discloses this as just one example and goes on to say that further production steps will vary this percentage by reducing the area of the jacket. However, Stinson discloses the platinum core having about 10% of a total area of the single DFT [0058].
In regards to claim 5, Tieu discloses the wire is 0.001 inches in diameter (6:30-33.) Routine experimentation would provide a person of ordinary skill in the art with an optimal diameter of the central core would be obtained. The applicant’s previous arguments identify the ratios requiring routine optimization to provide the best structural and visual effects. Therefore, it would have been obvious to one of ordinary skill in the art to provide the core with a diameter in the range of 0.0005-0.001 inches.
In regards to claim 7, Tieu discloses the pusher includes a pair of enlarged bands 136/140 disposed on a distal region of the pusher; and terminal ends of the proximal extensions at a proximal end of the DFT stent each being located between the enlarged bands when the DFT stent is in an undeployed state (Figures 7-8).
In regards to claim 8, Tieu discloses the proximal and distal extensions (Figure 1) each including at least 3 large extensions 104 and at least 3 smaller extensions (107) (Figures 1 and 6).
In regards to claims 32-33, Tieu discloses the reinforcing element is comprised of a coil wound around the wire (See Figures 6A-F Pung).
In regards to claims 45 and 46, Pung later discloses that his coiled members may all take the shape of a sleeve (10:24-27), which would anticipate the claimed tube and linear wire elements. It would have been obvious at the time of filing to provide the reinforcing elements as explained above but in the form of a tube/linear wire element (sleeve).
Claims 34-36 and 38-42, are rejected under 35 U.S.C. 103 as being unpatentable over Tieu et al (Tieu) USPN 9,867,725 B2 in view of Pung et al (Pung) USPN 10,039,655 B2.
Tieu discloses a stent system comprising:
a pusher 130 (Figures 7-8)
a stent (Figure 1) body portion 4 and a plurality of proximal and distal extensions (flared ends 104/107 Figure 1) wherein the stent is adjustable between collapsed and expanded configurations (4:12-17);
However, Tieu does not disclose the use of reinforcing elements within the body portion.
Pung teaches the use of stents comprising first and second reinforcing coil elements (31 in Figures 6B and 6D) tightly wound around the stent wire such that they follow first and second lengths of the wire segments (Figures 6B and 6D) throughout the main body of the stent (30 Figure 8) in the same field of endeavor for the purpose of reinforcing the main stent body adjacent cross-over points and improving visibility.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to add additional tightly wound coil reinforcing elements of Pung spaced throughout the main stent body adjacent to crossover points of Tieu as taught by Pung in order to reinforce the main body at staggered cross-over points and improve visibility throughout the stent. As explained above, the addition of the coils of Pung to the wire segments of Tieu will inherently augment the opening force along the two wire segments in the deployed configuration because they increase the stiffness of those segments.
In regards to claim 35, Tieu discloses the first reinforcing element is comprised of a coil wound around the wire (Pung 31 in Figures 6A-F).
In regards to claim 36, Tieu discloses the first reinforcing element is transverse to a longitudinal axis extending through a center of the body portion of the stent (Pung 31 follows the path of wires diagonal to the central axis which would be up and down in Figures 6A-F).
In regards to claim 38, Tieu discloses the first reinforcing element is substantially parallel to the second reinforcing element (Pung discloses multiple elements 31 arranged along the same wire making them parallel in Figures 6B and D).
In regards to claim 39, Tieu discloses the first reinforcing element and the second reinforcing element are both transverse to a longitudinal axis extending through a center of the body portion of the stent (Pung both elements 31 follow the path of wires diagonal to the central axis which would be up and down in Figures 6B and D).
In regards to claim 40, Tieu discloses the first reinforcing element is positioned along a proximal region of the body portion of the stent (Top of Figure 14 of Pung shows multiple reinforcing elements at the proximal end, Figure 8 of Pung shows the reinforcing elements can be offset to both distal and proximal ends).
In regards to claim 41. Tieu as modified above in view of Pung discloses a stent delivery system, comprising:
a pusher 130 (Figures 7-8) including a pair of bands 136/140; and
a stent (Figure 1) body portion 4 and a plurality of end loops (flared ends 104/107 Figure 1) wherein the stent is adjustable between collapsed and expanded configurations (4:12-17);
a reinforcing element (See 31 Pung Figures 6B and 6D) secured along a portion of a length of a wire of the body portion of the stent (See 31 Pung Figures 6B and 6D), wherein the reinforcing element is wound around the wire of the body portion of the stent (30 Figure 8) and,
wherein, in the collapsed configuration, the plurality of end loops of the stent are positioned between the pair of bands of the pusher.
In regards to claim 42, Tieu discloses the pair of bands are composed of a radiopaque material (5:34-52).
Response to Arguments
Applicant's arguments filed 04/16/2026 have been fully considered but they are not persuasive.
The applicant argues that the prior art rejection fails to address the newly claimed reinforcing elements that secure along a portion of a length of a single wire segment of the stent body that when in deployment configuration augments opening forces along the wire segment. This is not persuasive because the limitations are newly added and there was no opportunity for the examiner to previously address them. Additionally the applicant failed to provide and evidence or factual support as to why the previously cited reinforcing elements do not perform this new function. As explained above, the application discloses that the reinforcing elements augment the opening forces merely by making those segments stiffer. Any coil or support wrapped around or attached to a wire segment of a stent would likewise augment the opening forces because that segment would inherently be stiffer based on the additional thickness alone. Accordingly the coils of Pung added to Tieu will inherently augment the opening forces of the wire segments because they add additional stiffening through their additional bulking of the thickness.
Therefore all claims remain anticipated by prior art and the rejections have been made final.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 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 at (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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