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 .
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.
Election/Restrictions
Applicant’s election without traverse of species 3, Fig. 3, in the reply filed on 9/25/2025 is acknowledged. Claims 9, 12, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. It is noted that claim 9 was not indicated as withdrawn in the election. However, the first and second preformed flaps being longitudinally offset from each other along the outer layer of the stent is encompassed by, for example, non-elected species 4, Fig. 7.
Claim Objections
Claims 18 and 20 are objected to because of the following informalities: typographical error.
Claim 18 should be amended as follows: “the plurality of preformed flaps”.
Claim 20 should be amended as follows: “wherein a first preformed flap of the plurality of preformed flaps is positioned along the first end region, and wherein a second preformed flap of the plurality of preformed flaps is positioned…”
Appropriate corrections are required.
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 10-11 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 10 recites the limitation "the second preformed flap" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 11 is also rendered indefinite due to its dependency from claim 10.
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 1-4, 7, 8, 10, 11, 13, 14, 17, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kelly (US 2017/0035587).
Regarding claim 1, Kelly discloses an expandable stent (100) comprising a tubular scaffold (the stent portion described in [0031]) including an inner surface, an outer surface and a lumen extending therein (Fig. 4), an outer layer (the graft portion described in [0031]) disposed along the outer surface of the tubular scaffold (see [0031] describing the graft may be disposed on the stent’s interior, exterior, or both), and a first preformed flap (114) attached to the outer layer (Fig. 4, [0046]), wherein the preformed flap is configured to releasably engage a vessel wall when the stent is implanted therein (via free end 126).
Regarding claim 2, Kelly discloses the first preformed flap (114) is configured to pivot between a radially extended position and a collapsed position (can be in the radially extended position as illustrated in Fig. 4 and in the collapsed position as illustrated in Fig. 1, thereby is configured to pivot as claimed).
Regarding claim 3, Kelly discloses the first preformed flap (114) is configured to deflect radially inward from a radially extended position (can be in the radially extended position as illustrated in Fig. 4 and in the radially inward position as illustrated in Fig. 1, thereby is configured to deflect as claimed).
Regarding claim 4, Kelly discloses the first preformed flap (114) includes a first attachment region (124) positioned along a first edge of the flap (Fig. 4), and wherein the first preformed flap is attached to the outer layer along the first attachment region (Fig. 4).
Regarding claim 7, Kelly discloses a second preformed flap (116), and wherein the first preformed flap (114) and the second preformed flap (116) are uniformly spaced around the tubular scaffold (Fig. 4).
Regarding claim 8, Kelly discloses the first preformed flap (114) and the second preformed flap (116) are longitudinally aligned with each other along the outer layer of the stent (Fig. 4).
Regarding claim 10, Kelly discloses the first preformed flap (114) is positioned along a proximal end region (104) of the tubular scaffold, and wherein a second preformed flap (116) is positioned along a distal end region (106) of the tubular scaffold.
Regarding claim 11, Kelly discloses the first preformed flap (114) extends in a distal direction toward a distal end of the tubular scaffold (towards 106), and wherein the second preformed flap (116) extends in a proximal direction toward a proximal end of the tubular scaffold (towards 104).
Regarding claim 13, Kelly discloses a stent (100) comprising a tubular scaffold (the stent portion described in [0031]), the scaffold including an inner surface, an outer surface and a lumen extending therein (Fig. 4), an outer layer (the graft portion described in [0031]) disposed along the outer surface of the tubular scaffold (see [0031] describing the graft may be disposed on the stent’s interior, exterior, or both), and a plurality of preformed flaps (114, 116) formed separated from and attached to the outer layer (Fig. 4, [0046]), wherein each of the preformed flaps (114, 116) is configured to pivot between a radially extended position and a collapsed position (can be in the radially extended position as illustrated in Fig. 4 and in the collapsed position as illustrated in Fig. 1, thereby is configured to pivot as claimed), wherein each of the plurality of preformed flaps (114, 116) is configured to releasably engage a vessel wall when the stent is implanted therein (via free end 126, 132).
Regarding claim 14, Kelly discloses each of the plurality of preformed flaps (114, 116) is configured to deflect radially inward from a radially extended position (can be in the radially extended position as illustrated in Fig. 4 and in the radially inward position as illustrated in Fig. 1, thereby is configured to deflect as claimed).
Regarding claim 17, Kelly discloses the plurality of preformed flaps (114, 116) are uniformly spaced around a circumference of the tubular scaffold (Fig. 4).
Regarding claim 18, Kelly the plurality of preformed flaps are longitudinally aligned along the tubular scaffold (114s are longitudinally aligned with 116s).
Regarding claim 20, Kelly discloses a stent (100) comprising an expandable tubular scaffold (the stent portion described in [0031]) having an outer surface and an opposite inner surface (Fig. 4), the tubular scaffold including a first end region (104), a second end region (106) and a medial region positioned between the first and second end regions (Fig. 4), an outer layer (the graft portion described in [0031]) disposed along the outer surface of the tubular scaffold (see [0031] describing the graft may be disposed on the stent’s interior, exterior, or both), and a plurality of preformed flaps (114, 116) attached to the outer layer and extending outward therefrom (Fig. 4), wherein each of the preformed flaps (114, 116) is configured to pivot between a radially extended position and a collapsed position (can be in the radially extended position as illustrated in Fig. 4 and in the collapsed position as illustrated in Fig. 1, thereby is configured to pivot as claimed), wherein a first preformed flap (114) of the plurality of preformed flaps is positioned along the first end region (104), and wherein a second preformed flap (116) of the plurality of preformed flaps is positioned along the second end region (106), and wherein each of the plurality of preformed flaps (114, 116) is configured to releasably engage a vessel wall when the stent is implanted therein (via free end 126, 132).
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.
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.
Claims 5, 6, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly as applied to claim 1 above, and further in view of Folan et al. (US 2018/0125682).
Kelly fails to disclose how the preformed flaps are coupled to the outer layer, thereby fails to disclose the preformed flaps being bonded to the outer layer using a bonding material. Folan also discloses preformed flaps (34) coupled to an outer surface of a stent (10; Fig. 1). Folan teaches the preformed flaps (34) being bonded to the stent using a bonding material (glue; see [0058]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the clamed invention to have coupled the preformed flaps to the outer layer in Kelly using a bonding material as taught by Folan as doing so provides a suitable means for attachment ([0058]).
With further respect to claims 6 and 16, Applicant discloses the outer layer, preformed flaps, and bonding material may be formed from the same materials or from different materials (page 11, line 20 – page 12, line 2) and there is no evidence that establishes that using the same materials to form the outer layer, preformed flaps, and bonding material over using different materials would result in a difference in function of the device. It would have been an obvious matter of design choice to a person of ordinary skill in the art to provide the outer layer, preformed flaps, and bonding material of Kelly in view of Folan of the same materials, because Applicant has not disclosed that an outer layer, preformed flaps, and bonding material of the same materials provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the device of Kelly in view of Folan, and Applicant’s invention, to perform equally well with either the outer layer, preformed flaps, and bonding material being formed from same materials or different materials because Applicant indicates both configurations are equally suitable (page 11, line 20 – page 12, line 2) and both configurations would yield radially extendable flaps configured to releasably engage a vessel wall when the stent is implanted therein.
Therefore, it would have been prima facie obvious to modify Kelly in view of Folan to obtain the invention as specified in claims 6 and 16 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Kelly in view of Folan.
Conclusion
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/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774