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 .
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 “at least two second sub-rings” recited in claims 7 and 17, and “a first embedded support…wherein the first embedded support is arranged at the first interface, is located in the inner cavity of the main stent” recited in claims 10 and 20, 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 § 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 7, 9, 10, 17, 19, and 20 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.
Regarding claims 7 and 17, it is unclear how “a first ring” (singular) can comprise at least one first sub-ring and at least two second sub-rings (this is at least three rings)? The specification calls the first ring 120, first sub-ring 121 and second sub-ring 122. It appears the “first ring” should actually be called a plurality of rings. Please clarify what the first ring is.
Claims 7 and 17 are further unclear because the claims require the first sub-ring and the at least two second sub-rings form the collapsed area but the figures only show two rings within the collapsed area (see figs.2, 3, and 12b). The figures only point to one first sub-ring 121 and one second sub-ring 122. What is the difference between a first sub-ring and a second sub-ring? What are all the other rings (that aren’t labeled 121 or 122) of the stent graft considered? For example, see the annotated fig.11b below. It is possible that first sub-rings are located in the collapsed area while second sub-rings are located outside of the collapsed area (this possibility is based on the fact that reference number 121 is only ever used to point to a ring within the collapsed area while reference number 122 is only ever used to point to rings outside of the collapsed area), but if this is the case how do the second sub-rings, assumed to be located outside of the collapsed area “form the collapsed area” as claimed in claims 7 and 17?
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Regarding claims 10 and 20, the claims require a first embedded support, wherein the first embedded support is arranged at the first interface and is located in the inner cavity of the main stent. This is unclear because claims 1 and 11 require that the first interface is configured to receive the first branch stent and the figures and specification only show embedded supports associated with the second and third interfaces (see first embedded support 610 and second embedded support 620 in fig.3 wherein there is no embedded support associated with the first interface 101). It is possible the claim was intended to recite that the first embedded support is arranged at the second interface. Please clarify.
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 1-3, 5, 6, 8, 11-13, 15, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. US 2013/0218257 (hereafter referred to as Sun) in view of Ducke US 2022/0280280 (hereafter referred to as Ducke).
Regarding claims 1 and 11, Sun discloses medical device comprising a delivery mechanism configured to deliver and release a covered stent (par.84) and the covered stent, the covered stent comprising a main stent 100 and a first branch stent (par.88 discloses secondary stent-grafts are advanced into the branch vessels of which there are three in fig.15), wherein a first interface 140, a second interface 140, and a third interface 140 are provided on a side surface of the main stent and spaced along an axial direction of the main stent (figs. 7a and 15), the first interface is configured to receive the first branch stent, the second interface is configured to receive a second branch stent, and/or the third interface is configured to receive a third branch stent (see par.88 for the secondary stents advanced into the branch vessels of which there are three). Sun discloses the medical device of claims 1 and 11 substantially as claimed, but Sun does not disclose that the covered stent further comprises a restraining assembly arranged on the main stent, and wherein the restraining assembly is configured to apply to the main stent a tensile force toward an inner cavity of the main stent, so that at least a portion of the main stent that is provided with the second interface and the third interface is recessed toward the inner cavity of the main stent.
Ducke teaches a covered stent 10, in the same field of endeavor, wherein a restraining assembly 80, 90, 100 is arranged on a main stent, wherein the restraining assembly is configured to apply to the main stent a tensile force toward an inner cavity of the main stent, so that at least a portion of the main stent that is provided with a fenestration 70 for access to a branch lumen is recessed toward the inner cavity of the main stent (figs. 1A, 6A, and 7) for the purpose of releasably constraining a fenestration for more accurate positioning and alignment (pars. 36-37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the restraining assembly of Ducke to the main stent of Sun such that the interfaces/fenestrations of Sun are recessed toward the inner cavity of the stent in order to allow the surgeon to control the delivery of the covered stent to achieve more accurate positioning and alignment of the interfaces with the branch vessels.
Regarding claims 2 and 12, Sun discloses recessed area 120 and the restraining assembly of Ducke is capable of adjusting the recessed area further, if necessary, to provide an inner diameter for a recessed state that is 20% to 80% of an inner diameter for a natural state.
Regarding claims 3 and 13, see Sun fig.15 for the interfaces 140 being located in collapsed area 120.
Regarding claims 5 and 15, see Sun fig.15 for collapsed area 120 and an inner diameter for a natural state that is 50% to 90% of maximum inner diameter for main stent.
Regarding claims 6 and 16, the restraining assembly of Ducke is capable of adjusting the collapsed area 120 of Sun further toward the inner cavity of the main stent.
Regarding claims 8 and 18, see Sun par.88 for secondary stents advanced into the branch vessels, of which there are three.
Claims 7, 9, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sun in view of Ducke as applied to claims 6 and 16 above, and further in view of Lauterjung et al. US 6,635,080 (hereafter referred to as Lauterjung).
Regarding claims 7 and 17, Sun in view of Ducke discloses the medical device of claims 1 and 11 as discussed above. Sun further discloses a plurality of rings 150, 160 and a membrane (considered the graft material; see at least par.52) at least partially covering the rings (figs. 7a and 15), wherein the plurality of rings comprises at least one first sub-ring 160 (considered the rings in the intermediate portion 120) and at least two second sub-rings 150 (considered the rings in portions 110 and 130). While the limitation, “the at least one first sub-ring and the at least two second sub-rings form the collapsed area” is unclear as discussed above, the examiner notes that collapsed area 120 of Sun comprises sub-stents 160 and the proximal and distal ends comprise sub-stents 150 which is the same layout as the instant application which shows two stents in the collapsed area and stents on either side of the collapsed area. While Sun in view of Ducke discloses the invention substantially as claimed, Sun in view of Ducke does not disclose wherein the restraining assembly comprises a plurality of coils and a restraining wire, and wherein at least some of the coils are disposed in the collapsed area and connected to at least one of the at least one first sub-ring, and at least two of the coils are arranged circumferentially on one of the at least one first sub-ring along a circumferential direction of the main stent; the restraining wire passes through all the coils; when the restraining wire is tense, the tensile force is applied from the restraining wire to the collapsed area through the coils.
Lauterjung teaches a stent graft (fig.11), in the same field of endeavor, wherein a restraining assembly comprises a plurality of coils 82 and a restraining wire 74, wherein the coils 82 are connected to a stent ring 30, and at least two of the coils are arranged circumferentially on the stent ring along a circumferential direction, wherein the restraining wire 74 passes through all the coils (fig.11), and wherein when the restraining wire is tense, a tensile force is applied from the restraining wire through the coils for the purpose of controlling expansion of the stent graft to facilitate accurate and controllable placement of the prosthesis in a particular location (col.7, lines 6-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the restraining assembly including coils circumferentially disposed on a stent and a restraining wire passing through all coils as taught by Lauterjung with a ring within the collapsed area of the stent graft of Sun in view of Ducke in order to facilitate accurate and controllable placement of the stent graft in a desired location.
Regarding claims 9 and 19, see fig.15 of Sun. The claims do not define any particular “predetermined distance” and the second and third interfaces and rings 150, 160 inherently have a distance between them.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sun in view of Ducke as applied to claims 1 and 11 above, and further in view of Greenberg US 2009/0048663 (hereafter referred to as Greenberg). Sun in view of Ducke discloses the medical device of claims 1 and 11 as discussed above. Sun further discloses supports 140, 141 at the first, second, and third interfaces 140, wherein the supports are in communication with the inner cavity of the main stent (fig.15), but Sun in view of Ducke does not disclose that the supports are embedded supports located in the inner cavity of the main stent.
Greenberg teaches a stent graft, in the same field of endeavor, wherein embedded supports 40, 18, and 20 are provided in an inner cavity of a main body 10 (fig.2A) for the purpose of receiving the flow of blood and directing it into branch arteries (par.61).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the supports of Sun in view of Ducke to be embedded supports located in the inner cavity of the main body as taught by Greenberg in order to direct blood flow from the inner cavity into the branch vessels.
Allowable Subject Matter
Claims 4 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claims 4 and 14 require that the first interface is located in a portion of the main stent other than the collapsed area while the second and third interfaces are both arranged in the collapsed area. Sun is considered the closest prior art and as discussed above discloses first, second, and third interfaces, but in Sun all three interfaces are located in the collapsed area and there is no reason to move one of the interfaces to a portion of the main stent other than the collapsed area since the collapsed area is where the branch vessels are located.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lostetter US 2019/0231571 discloses selectively constricting the radial dimension of a stent graft at a fenestration to enable more accurate and safe rotation to align with a branch. Zhang US 2023/0248506 discloses a covered stent with three interfaces located in a collapsed area.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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