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
In view of the amendments filed on 12/18/2025, the claim objections, cited in the office action of 9/29/2025, are moot.
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive. The Applicant contends that the Kaplan reference does not recite the stent being made of only a single filament. However, as presently worded, the claim language does not mandate that only a single filament is used to construct the tubular scaffolding. The claims use the open ended transitional phrase “comprising.” The transitional term "comprising,” which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). Since the claim language allows for additional, unrecited single filament elements, it is maintained that Kaplan reads on the claims as described below.
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.
Claim(s) 1, 2, 4-6, 9-13, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaplan (WO 94/13268 A1).
Kaplan discloses the following regarding claim 1: a stent, comprising: a tubular scaffolding (2) (Fig. 3A) having a first end (upper end), a second end (lower end), and a length extending longitudinally therebetween (Fig. 3A), the tubular scaffolding having an outer surface (exterior surfaces of elements 6, 8) and an inner surface (interior surfaces) defining a lumen (central opening) extending from the first end to the second end (Figs. 3A-3B), wherein the tubular scaffolding is configured to radially expand from a delivery configuration to a deployed configuration (pg. 4); and at least first and second protruding elements (protruding portions of elements 14, 16, 18, 20) extending radially outward from the outer surface in the deployed configuration (Fig. 3A), wherein the at least first and second protruding elements are longitudinally aligned and have different circumferential positions (Fig. 3A); wherein the tubular scaffolding is formed from a single filament (6, 8, 14, 16, 18, 20) interwoven about a central longitudinal axis of the stent (Fig. 3A), the single filament extending along an entirety of the length of the tubular scaffolding (Fig. 3A); wherein the at least first and second protruding elements are formed from a portion of the single filament (14, 16, 18, 20) (Figs. 3A-3B).
Kaplan discloses the following regarding claim 2: the stent of claim 1, further comprising a cover (coating) secured to the tubular scaffolding (pg. 8, lines 32-pg. 9, lines 4).
Kaplan discloses the following regarding claim 4: the stent of claim 2, wherein the cover is configured to prevent tissue ingrowth into the lumen (pg. 8, lines 32-pg. 9, lines 4; where the physical barrier formed by the cover is fully capable of preventing tissue ingrowth).
Kaplan discloses the following regarding claim 5: the stent of claim 1, wherein each protruding element is configured to engage a wall of a body lumen when the tubular scaffolding is in the deployed configuration within the body lumen (Fig. 3A; where the radially extended position of the protruding elements would be fully capable of engaging a wall of the surrounding body lumen).
Kaplan discloses the following regarding claim 6: the stent of claim 1, wherein each protruding element defines a gap (open space below the protruding element) between the protruding element and the outer surface (Fig. 3A).
Kaplan discloses the following regarding claim 9: the stent of claim 1, wherein each protruding element is oriented non-parallel to the central longitudinal axis of the stent (at the sides of the protruding elements).
Kaplan discloses the following regarding claim 10: a stent, comprising: a tubular scaffolding (2) (Fig. 3A) having a first end (upper end), a second end (lower end), and a length extending longitudinally therebetween (Fig. 3A), the tubular scaffolding having an outer surface (exterior surfaces of elements 6, 8) and an inner surface (interior surfaces) defining a lumen (central opening) extending from the first end to the second end (Figs. 3A-3B), wherein the tubular scaffolding is configured to radially expand from a delivery configuration to a deployed configuration (pg. 4); and a plurality of protruding elements (protruding portions of elements 14, 16, 18, 20) extending radially outward from the outer surface in the deployed configuration (Fig. 3A), wherein at least first and second of the plurality of protruding elements are longitudinally aligned and have different circumferential positions (Fig. 3A); wherein the tubular scaffolding is formed from a single filament (6, 8, 14, 16, 18, 20) interwoven about a central longitudinal axis of the stent (Figs. 3A-3C), the single filament extending along an entirety of the length of the tubular scaffolding (Fig. 3A); wherein each of the plurality of protruding elements is formed from the single filament (Figs. 3A-3B).
Kaplan discloses the following regarding claim 11: the stent of claim 10, wherein the plurality of protruding elements is disposed between the first end of the tubular scaffolding and the second end of the tubular scaffolding opposite the first end (Figs. 3A).
Kaplan discloses the following regarding claim 12: the stent of claim 10, wherein the plurality of protruding elements is configured to engage a wall of a body lumen when the tubular scaffolding is in the deployed configuration within the body lumen (Fig. 3A; where the radially extended position of the protruding elements would be fully capable of engaging a wall of the surrounding body lumen).
Kaplan discloses the following regarding claim 13: the stent of claim 12, wherein the plurality of protruding elements permits tissue ingrowth between the plurality of protruding elements and the outer surface when engaged with the wall of the body lumen (Fig. 3A; where the open spaces formed by the gaps under the protruding elements are fully capable of allowing tissue ingrowth).
Kaplan discloses the following regarding claim 15: the stent of claim 10, further comprising a cover (coating) extending along at least a portion of the tubular scaffolding to prevent tissue ingrowth into the lumen (pg. 8, lines 32-pg. 9, lines 4; where the physical barrier formed by the coating is fully capable of preventing tissue ingrowth).
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 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan in view of Stinson et al. (US Pat. No. 6,340,367; hereinafter Stinson).
Kaplan discloses the limitations of the claimed invention, as described above. Kaplan further discloses the tubular scaffolding including a plurality of scaffold openings (open cell spaces between the filaments) extending through the tubular scaffolding from the outer surface to the inner surface (Figs. 3A-3C). However, it does not explicitly recite that the cover spans at least some of the plurality of openings. Stinson teaches that it is well known in the art that stent grafts comprise covers that span at least some of the plurality of openings (col. 9, lines 33-55; col. 10, lines 22-50), for the purpose of providing the stent with the desired structural integrity and controlling the fluid flow around the stent. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the cover of Kaplan, to cover at least some of the stent openings, as taught by Stinson, in order to provide the stent with the desired structural integrity and to control the fluid flow around the stent. Such a modification would be made with a reasonable expectation of success.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan.
Kaplan discloses the limitations of the claimed invention, as described above. However, it is silent as to the value of the maximum radial extent of the protruding elements. The optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal maximum radial extent of the protruding elements needed to achieve the desired results and suit the implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of maximum radial extent of the protruding elements, would have been obvious at the time of applicant's invention in view of the teachings of Kaplan. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Claim 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaplan in view of Sirhan et al. (US Pat. No. 7,018,405; hereinafter Sirhan).
Kaplan discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite that the plurality of protruding elements is configured to prevent axial migration of the stent within the body lumen in the deployed configuration. Sirhan teaches that it is well known in the art that stent grafts are held within a vessel lumen by expanding the components of the stent (col. 8, lines 3-28), for the purpose of securely anchoring the device at its desired location. It would have been obvious to one having ordinary skill in the art to modify the device of Kaplan, such that its expansion of the protruding elements and the stent are configured to prevent axial migration, as taught by Sirhan, in order to securely anchor the device at its desired location. Such a modification would be made with a reasonable expectation of success.
Conclusion
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 Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
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/ANN HU/Primary Examiner, Art Unit 3774