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 .
Response to Arguments
Applicant’s arguments filed 5/28/2026 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made as discussed below.
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 5 and 12 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.
Claim 5, line 2 recites “wherein the respective membrane ends overlap between the first stent and the second stent, respectively”. It is unclear what the respective membrane ends include. Does the claim require opposite ends of one membrane overlap with each other, or an end of one membrane overlaps an end of another membrane, or all ends overlap? Please clarify. Note that claim 5 depends from claim 4 which is interpreted to include both the first and second membranes since line 3 of claim 4 recites “and….the second membrane” (as opposed to and/or as in claim 1). This means that claim 5 also includes first and second membranes which means there are four ends total.
Claim 12, line 2 recites “at least one stent of the.” which is unclear. For examination this is interpreted to mean --at least one stent of the multiple stent device--.
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.
Claims 1, 3-9, 11-14, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neuss DE 102016120445 A1 (hereafter referred to as Neuss; refer to the English language US version US 2019/0262150 for passages referenced herein).
Regarding claim 1, Neuss discloses a multiple stent device comprising: at least two coaxially arranged stents 2,3 including a first stent 2 and a second stent 3 arranged on an outside of the first stent (par.36; fig.1), and at least one membrane including a first membrane 4 arranged on an inside of the first stent with first membrane ends (considered the portions of the membrane at the opposite ends of the stent and including the inner and outer portions) folded around first stent ends and guided between the first stent and the second stent (the ends are located between the first and second stents in their final configuration; the method by which they are positioned is not germane to the issue of patentability of the device itself; see MPEP 2113 for product by process limitations), and/or (while Neuss discloses first and second membranes, the claim only requires one of the first or second membrane) a second membrane 5 arranged on an outside of the second stent with second membrane ends folded around second stent ends and guided between the first stent and the second stent (the final product has second membrane ends located between the first and second stent; the method of making the device, i.e. folded and guided, is not germane to the issue of patentability of the device itself; see the annotated fig.1 below which illustrates the locations of the membranes and their ends). As shown in the annotated fig.1 below and fig.2 of Neuss, tongues 6 are part of the first/inner stent 2. Therefore, portions of all ends of the membranes are located between the first/inner and second/outer stents.
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Regarding claims 3 and 6, see par.39 for the membranes being tubular films.
Regarding claim 4, Neuss discloses the membranes are folded over the ends of the stent therefore they must each have an unfolded length that is longer than each of the first and second stents.
Regarding claim 5, see fig.1 for the ends of the membranes 4 and 5 overlapping each other between the first and second stents in the region of tongues 6.
Regarding claims 7-9, see annotated fig.1 above which shows both the first and second membranes arranged as claimed.
Regarding claims 11-13, see retaining elements 6 positioned on and extending from an end portion of the first stent 2, wherein the retaining elements have a hook-shape and are directed radially outward (figs. 1 and 2).
Regarding claim 14, see fig.3 for the second stent 3 comprising a plurality of individual stent bodies.
Regarding claim 17, Neuss discloses a multiple stent device comprising at least two coaxially arranged stents, including a first stent 2 disposed radially inward and a second stent 3 disposed radially outward (par.36; fig.1), and at least one membrane including a first membrane 4 arranged on an inner lumen-facing side of the first stent with first membrane ends folded around first stent ends and clamped between the first stent and the second stent, and/or a second membrane 5 arranged on an outer vessel wall-facing side of the second stent with second membrane ends folded around second stent ends and clamped between the first stent and the second stent (see annotated fig.1 above).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Neuss as applied to claim 1 above, and further in view of Rucker et al. US 2011/0093002 (hereafter referred to as Rucker). Neuss discloses the multiple stent device according to claim 1 as discussed above, but Neuss does not disclose that the first stent has a diameter of at least the same size as the second stent.
Rucker teaches a multiple stent device, in the same field of endeavor, wherein a first/inner stent 110 has a larger diameter than a second/outer stent 100 for the purpose of ensuring the inner stent expands tightly against the interior surface of the outer stent to ensure an adequate fit between the stents (par.36).
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 diameters of the first and second stents of Neuss such that the first stent has a diameter of at least the same size as the second stent as taught by Rucker in order to ensure an adequate fit between the stents.
Allowable Subject Matter
Claim 10 is 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: Neuss is considered the closest prior art. Neuss discloses a plurality of outer stents 3 in fig.3 such that a third coaxially arranged stent is disclosed by Neuss, but Neuss does not disclose a third stent positioned between the first and second stents, wherein the first membrane ends are folded over to the outside of the first stent and are clamped in place between the first stent and the third stent, and the second membrane ends are folded over to an inside of the second stent and are clamped in place between the second stent and the third stent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
