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.
Response to Amendment
This action is in response to the applicant’s amendment received 8/11/2026. The amendments made to the claims do not place the application in condition for allowance for the reasons set forth below. Claims 1-20 are pending. Claims 6-8, 12-14, and 18-20 remain withdrawn from consideration.
Response to Arguments
Applicant's arguments filed 8/11/2026 with respect to amended claim 1 have been fully considered but they are not persuasive. Applicant argues that Krause fails to disclose the radially expandable tubular framework is configured to expand from a radially collapsed position to a first radially expanded configuration and then to a second radially expanded configuration. However, Krause explicitly discloses that the radially expandable tubular framework is configured to expand from a radially collapsed position to an expanded configuration (see [0017]), wherein an initial radially expanded configuration that is less than an expansion amount that eliminates the overlap of the plurality of covering strips is considered the first radially expanded configuration as claimed. Applicant further argues that nothing in Krause teaches or suggests that full coverage necessarily persists after radial expansion has started. However, Fig. 13 illustrates the extent of overlap of the plurality of cover strips, thereby initial expansion that separates the plurality of cover strips less than the extent of overlap shown in Fig. 13 meets the limitation as claimed.
Applicant’s arguments with respect to amended claim 15 have been considered and are persuasive. Examiner agrees Krause and Thompson fail to disclose or suggest the plurality of covering strips each formed from a polymer, positioned along the medial region, and coupled to the first and second polymeric coverings as now required by amended claim 15. Therefore, the 35 U.S.C. 103 rejection of claims 15-17 by Krause in view of Thompson has been withdrawn.
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 2 and 9 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.
Claims 2 and 9 recite the limitation "the radially expanded configuration". There is insufficient antecedent basis for this limitation in the claims because claim 1 has been amended to require first and second radially expanded configurations.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krause et al. (US 2008/0140176).
Regarding claim 1, Krause discloses a stent comprising a radially expandable tubular framework (12) having a radially outward surface, a radially inward surface, a first end region, a second end region, a medial region positioned between the first end region and the second end region, and a lumen extending therethrough (see Figures 1-12), wherein the radially expandable tubular framework (12) is configured to expand from a radially collapsed configuration to a first radially expanded configuration (see abstract and [0017]; an initial radially expanded configuration that is less than an expansion amount that eliminates the overlap of the plurality of covering strips shown in Fig. 13) and then to a second radially expanded configuration (a radially expanded configuration in which the plurality of covering strips no longer overlap), and a plurality of covering strips (27, 28, 29) positioned along at least one of the first end region, the medial region, and the second end region (the medial region; see Fig. 12), the plurality of covering strips (27, 28, 29) fully covering the radially expandable tubular framework in the radially collapsed configuration (see Figs. 12-13) and in the first radially expanded configuration (the initial radially expanded configuration that is less than an expansion amount that eliminates the overlap of the plurality of covering strips), and the plurality of covering strips (27, 28, 29) configured to separate from one another in the radially expanded configuration to expose portions of the radially expandable tubular framework therebetween (Fig. 14 illustrates spaces formed between 27, 28, and 29 in an expanded configuration, thereby the covering strips are configured to separate as claimed; see also paragraph [0078]).
Regarding claim 2, Krause discloses each of the plurality of covering strips (27, 28, 29) extends longitudinally along the medial region of the stent (see Fig. 12), the plurality of covering strips fully covering the medial region in the radially collapsed configuration (see Figs. 12-13), and the plurality of covering strips (27, 28, 29) configured to separate from one another in the radially expanded configuration to expose portions of the medial region of the radially expandable tubular framework therebetween (Fig. 14 illustrates spaces formed between 27, 28, and 29 in the expanded configuration; see also paragraph [0078]).
Regarding claim 3, Krause discloses a first longitudinal edge of each of the plurality of covering strips (27, 28, 29) is secured to the expandable tubular framework and a second longitudinal edge of each of the plurality of covering strips is unsecured to the expandable tubular framework (see paragraph [0078] describing 27, 28, and 29 being fixed to 12 at an upstream end, which includes a portion of a longitudinal edge, and left unattached over the rest of their length, which includes a portion of a longitudinal edge).
Regarding claim 4, Krause discloses the second longitudinal edge of each of the plurality of covering strips is overlapped with the first longitudinal edge of an adjacent one of the plurality of covering strips in the radially collapsed configuration (see Figs. 12-13).
Regarding claim 5, Krause discloses the second longitudinal edges are located radially outward of the first longitudinal edges in the radially collapsed configuration (see Fig. 13).
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Krause as applied to claim 1 above, and further in view of Jordan et al. (US 2016/0175124).
Regarding claim 9, Krause fails to disclose whether the radially expandable tubular framework is formed of one or more interwoven filaments defining interstices therebetween. Jordan also discloses a stent comprising a radially expandable tubular framework (see Fig. 2). Jordan teaches the radially expandable tubular framework is formed of one or more interwoven filaments (18; see claims 9 and 12) defining interstices therebetween (see Fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have formed the radially expandable tubular framework of Krause of one or more interwoven filaments defining interstices therebetween as taught by Jordan since doing so would have yielded predictable results, namely, yielded a radially expandable tubular framework suitable for treating a diseased area in a lumen (see paragraphs [0003] and [0037]). Krause as modified by Jordan discloses that tissue is permitted to grow into the interstices in the medial region in the radially expanded configuration due to the spacing between 27, 28, and 29 in the radially expanded configuration (see Fig. 14) and that tissue is precluded from growing into the interstices in the medial region in the radially collapsed configuration due to the overlap of 27, 28, and 29 in the radially collapsed configuration (see Figs. 12-13).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Krause and Jordan et al. as applied to claim 9 above, and further in view of Thompson et al. (Patent No. 5,957,974).
Regarding claim 10, Krause as modified by Jordan fails to disclose the first end region includes a polymeric cover fully covering the interstices in the first end region, and the second end region includes a polymeric cover fully covering the interstices in the second end region. Thompson also discloses a stent (128) comprising a radially expandable tubular framework (130) having first and second end regions (see Fig. 17). Thompson teaches the first end region includes a polymeric cover (132) fully covering the interstices in the first end region (see Fig. 17), and the second end region includes a polymeric cover (134) fully covering the interstices in the second end region. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Krause’s tubular framework having a first end region with a polymeric cover fully covering the interstices in the first end region and a second end region with a polymeric cover fully covering the interstices in the second end region as taught by Thomson in order to provide regions where shunting blood flow is desired (see column 14, lines 47-49).
Regarding claim 11, Krause as modified by Jordan and Thompson discloses the plurality of covering strips (27, 28, 29) are separate from the polymeric cover of the first end region (132) and the polymeric cover of the second end region (134).
Allowable Subject Matter
Claims 15-17 are allowed. The following is an examiner’s statement of reasons for allowance: the prior art fails to disclose or suggest, in combination with other limitations recited in the claims, a first polymeric covering fully covering the first end region, a second polymeric covering fully covering the second end region, and a plurality of covering strips each formed from a polymer and positioned along the medial region and coupled to the first and second polymeric coverings, the plurality of covering strips fully covering the medial region of the radially expandable tubular framework between the first polymeric covering and the second polymeric covering in the radially collapsed configuration, and the plurality of covering strips configured to separate from one another in the radially expanded configuration to expose portions of the medial region of the radially expandable tubular framework therebetween. Applicant discloses this combination of features advantageously covers the framework as needed until exposure of portions of the medial region is desired to permit tissue ingrowth, thereby reducing migration of the stent.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Folan et al. (US 2022/0062016) discloses a radially expandable tubular framework (206, Fig. 10) having a plurality of covering strips (204) each formed from a polymer ([0077]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELANIE TYSON whose telephone number is (571)272-9062. The examiner can normally be reached M-F 8:00 AM - 4:00 PM (ET).
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/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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