DETAILED ACTION
Status of Application
The present application, has a pre-appeal brief conference request filed by the applicant on 04/14/2025. A notice of defective appeal pre-brief appeal went out on 04/25/2025. The issue was described as the applicant’s filing of a proposed amendment after filing the request but before the decision. During the preparation for the pre-appeal brief conference the examiner found the following reference with a clearer teaching of the DFT material. In response the applicant broadened the claims by deleting most of the DFT material limitations and is now focused on the reinforcing element and pusher.
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 .
Priority
This application claims priority from provisional application 62768803, filed on 11/16/2018.
Status of Claims
Claims 1, 2, 4, 5, 7, 8, and 31-44 are pending.
Claims 3, 6, and 9-30 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)).
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the stent comprising a body and extensions/loops with the proximal extensions positioned between the enlarged bands of the pusher as described in the specification and claims 31 and 41. The original figures only support for the pusher with respect to the extensions is Figure 11. However, Figure 11 only shows the extensions without the body, the extensions are not consistent with the shapes and position of the other figures, the longer extensions extend outside of the enlarged band, and the smaller extensions are positioned radially inward of the enlarged bands. Noting these differences and the lack of the rest of the stent, it is unclear how the stent is actually positioned and how it is moved by the pusher.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Information Disclosure Statement
The Information Disclosure Statements filed on 11/24/25 and 06/23/25 have been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 38 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 38 defines the two reinforcing elements as being parallel, but there is no specific support within the original disclosure of them being parallel. Figure 12 shows two reinforcing elements that extend in similar directions, but without a specific disclosure within the original filing a person of ordinary skill in the art would have no way to know if they are actually parallel or not. The applicant is advised to amend the claim to say they are substantially parallel.
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) 41-42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tieu et al (Tieu) USPN 9,867,725 B2.
The assignee’s previous patent Tieu, published 6 years prior to this application’s priority date, discloses the invention substantially as claimed.
In regards to claim 41. Tieu 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); 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).
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, and 31-33, 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 6A-F) tightly wound around the stent wire such that they follow a length of the wire (Figures 6A-F) 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 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 claims 7 and 31, 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).
Claims 34-40 and 43-44, 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 reinforcing coil elements (31 in Figures 6A-F) tightly wound around the stent wire such that they follow a length of the wire (Figures 6A-F) 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 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 37, Tieu discloses a second reinforcing element secured to the body portion of the stent (Pung discloses multiple elements 31 in Figures 6A-F).
In regards to claim 38, Tieu discloses the first reinforcing element is 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 claims 43-44. Tieu discloses a reinforcing element comprising a coil secured/wound along a portion of a length of a wire of the body portion of the stent (See Figures 6A-F Pung).
Response to Arguments
Applicant's arguments filed 10/03/2025 have been fully considered but they are not persuasive.
The applicant argues that the coils of Pung are not reinforcing elements. It is noted that any separate wire or strut could be interpreted as a reinforcing element, because the claims fail to identify any functionality of the reinforcing elements. The broadest reasonable interpretation of a reinforcing element in this situation would include any additional strut or wire will act to support, redistribute force, or fortify the body wire so they would be considered a reinforcing element. The coils of Tieu are clearly disclosed as coils wrapped around the wires throughout the body because they are never depicted along the extensions. They are specifically designed and placed to reinforce the wires around crossings. Since the applicant has failed to show any factual evidence as to why these coils cannot be considered reinforcing elements, they continue to anticipate the claimed reinforcing element.
With respect to the newly claimed pusher and bands, Tieu clearly discloses the pusher and placement of the stent extensions, which was also stated by the Japanese Patent Office.
Therefore all claims remain anticipated by prior art and the rejections have been made final.
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.
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/Christopher D. Prone/ Primary Examiner, Art Unit 3774