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 without traverse of Group I, claims 1-12, in the reply filed on 01/14/2026 is acknowledged.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the spring recited in claim 9 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(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, 3-7, and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weldon et. al. (U.S. Pub. No. 2003/0191516), hereinafter, “Weldon.”
Regarding claim 1, Weldon teaches a delivery device (30; Fig. 2A) for an auxetic device (10; Fig. 2A), comprising:
a hollow tubular constraining device with a longitudinal axis (28; Fig. 2A);
a longitudinal controlling device (27; Fig. 2A), sized to fit concentrically within the constraining device (28) along its longitudinal axis; and
a mechanism (50; Fig. 4) coupled to the constraining device (28) and the controlling device (27), wherein:
an end of the controlling device (27) is offset along the longitudinal axis of the constraining device (28) from an end of the constraining device so as to form a chamber ("LC"; Fig. 2A) between the end of the constraining device (28) and the end of the controlling device (27), the chamber (LC) configured to accept the auxetic device (10), and
the mechanism (50) is configured to cause a size of the chamber (LC) to be adjusted
along the longitudinal axis of the constraining device (28; see Fig. 2B showing the chamber
reduced in size as the "linkage" 32 moves "pusher" 27 distally relative to "sheath" 28.).
Regarding claim 3, Weldon teaches the mechanism (50) is a user-actuated mechanism (pp. [0041]) comprised of a plurality of gears (54 and 58; Fig. 4, it is noted, “threaded flight” 54 and 58 are considered gears as they have similar structure to elements 116 and 118 in Fig. 4 of Applicant’s Specification which are considered gears by Applicant (pp. [0043] of Applicant’s Specification)) coupled to the constraining device (28) and the controlling device (27, pp. [0014]), and the chamber size is adjusted in response to a user actuating the mechanism (see pp. [0041]).
Regarding claim 4, Weldon teaches each of the plurality of gears (54 and 58) comprise a jack screw (“threaded flight” pp. [0041]), and the constraining device (28) and controlling device (27) are each coupled to a respective one of the jack screws (54/58) by a runner (56 and 60; Fig. 4, pp. [0014]).
Regarding claim 5, Weldon teaches the jack screw (54) coupled to the constraining device (28) has a different thread pitch than the jack screw (58) coupled to the controlling device (27, pp. [0041]).
Regarding claim 6, Weldon teaches wherein the jack screw (54) coupled to the constraining device (28) has a coarser thread pitch than the jack screw (58) coupled to the controlling device (27, pp. [0041]).
Regarding claim 7, Weldon teaches each of the jack screws (54/58) is coupled to a thumb wheel (62; Fig. 4) such that rotation of the thumb wheel (62) imparts a corresponding rotation to each of the jack screws (pp. [0041]).
Regarding claim 11, Weldon teaches an end of the controlling device (27) abuts an end of the auxetic device (10) when the auxetic device (10) is inserted into the chamber (LC, pp. [0034]).
Regarding claim 12, Weldon teaches the auxetic device (10) is a stent (pp. [0034]).
For the purposes of claim 9, the following embodiment of Weldon applies.
Regarding claim 1, Weldon teaches a delivery device (30; Fig. 2A) for an auxetic device (10; Fig. 2A), comprising:
a hollow tubular constraining device with a longitudinal axis (28; Fig. 2A);
a longitudinal controlling device (27; Fig. 2A), sized to fit concentrically within the constraining device (28) along its longitudinal axis; and
a mechanism (500; Fig. 5) coupled to the constraining device (28) and the controlling device (27), wherein:
an end of the controlling device (27) is offset along the longitudinal axis of the constraining device (28) from an end of the constraining device so as to form a chamber ("LC"; Fig. 2A) between the end of the constraining device (28) and the end of the controlling device (27), the chamber (LC) configured to accept the auxetic device (10), and
the mechanism (500) is configured to cause a size of the chamber (LC) to be adjusted
along the longitudinal axis of the constraining device (28; pp. [0053], see Fig. 2B showing the chamber
reduced in size as "pusher" 27 moves distally relative to "sheath" 28.)
Regarding claim 9, Weldon teaches the mechanism (500) is a spring (506; Fig. 5) coupled to the constraining device (28) and the controlling device (27, pp. [0053], it is noted, spring 506 is coupled to the constraining device and controlling device through biasing racks 34 and 36 to move them).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weldon in view of Sullivan et. al. (U.S. Pub. No. 2004/0106977), hereinafter, “Sullivan.”
Regarding claim 2, Weldon teaches a central core (26; Fig. 2B), but does not exility disclose radiopaque markers as claimed.
Weldon further teaches protrusions (25; Fig. 2C) on the central core (26) for engaging with the auxetic device (10).
Sullivan teaches a similar configured stent deliver device with a hollow tubular constraining device (40; Fig. 2B), a longitudinal controlling device (30; Fig. 2B), and a central core (32; Fig. 2B) with protrusions (38; Fig. 2B) for engaging with the auxetic device (34; Fig. 2B, pp. [0032]). Sullivan further teaches radiopaque markers can be placed where the protrusions (38) are located (see pp. [0047]).
Sullivan is considered to be analogous to the claimed invention because it is in the same field of stent delivery devices. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the central core of Weldon to incorporate the teachings of Sullivan by providing radiopaque markers at the stent engaging protrusions. Doing so would allow a practitioner to better position the auxetic device by being able to see when the auxetic device begins exiting the constraining device and when it has been fully deployed.
Claim(s) 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weldon in view of Ringwala et. al. (U.S. Pub. No. 2021/0137715)(priority to 11/12/2019), hereinafter, “Ringwala.”
Regarding claim 8, Weldon does not explicitly teach a motor as claimed.
Ringwala teaches a stent delivery device with a hollow tubular constraining device (150; Fig. 7), a longitudinal controlling device (152; Fig. 7), and a mechanism (162; Fig. 13) for moving the controlling device (152) relative to the constraining device (150) to push a stent (120; Fig. 7) wherein the mechanism can be manually driven via a thumbwheel of alternatively driven by an electric motor (pp. [0086]).
Ringwala is considered to be analogous to the claimed invention because it is in the same field of stent delivery devices. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mechanism control means of Weldon to incorporate the teachings of Ringwala by providing a motor coupled to the jack screws. Doing so would be a simple substitution of one known actuation mechanism for another to obtain predictable results of providing a stent delivery device with a reasonable expectation of success.
Regarding claim 10, Weldon does not explicitly disclose the controlling device inserts at least partially into the auxetic device.
Ringwala teaches a stent delivery device with hollow tubular constraining device (150; Fig. 7) and a longitudinal controlling device (152; Fig. 7), that inserts at least partially into the auxetic device (120; Fig. 7) when the auxetic device (120) is inserted into the chamber (see Figs. 6 and 7, pp. [0070]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controlling device of Weldon to incorporate the teachings of Ringwala by inserting it at least partially into the auxetic device. Doing so would provide a more secure connection between the controlling device and stent which would allow the stent to be pushed and retracted in needed as taught by Ringwala (pp. [0070]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL A. ICET whose telephone number is (571)272-0488. The examiner can normally be reached M-F: 8:00-5:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL ICET/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771