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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/27/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15 have been considered, but are moot in view of the new grounds of rejection.
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) 1-6, 9-10, and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wood et al. (AU 2010295834 B2; hereinafter “Wood”).
Wood discloses the following regarding claim 1: a stent, comprising: a tubular scaffolding (e.g., 30) (e.g., Figs. 3-7) having a first end (upper end), a second end (lower end), and a length extending longitudinally therebetween (Figs. 3, 7), the tubular scaffolding having an outer surface (exterior surfaces) and an inner surface (interior surfaces) defining a lumen (central opening) extending from the first end to the second end (Figs. 3, 7), wherein the tubular scaffolding is configured to radially expand from a delivery configuration to a deployed configuration (pg. 26); and at least first and second protruding elements (e.g., 42) extending radially outward from the outer surface in the deployed configuration (Fig. 7), wherein the at least first and second protruding elements are longitudinally aligned and have different circumferential positions (Fig. 7); wherein the tubular scaffolding is formed from only one single filament interwoven about a central longitudinal axis of the stent (Fig. 7; pg. 13), the one single filament extending along an entirety of the length of the tubular scaffolding (Fig. 7; pg. 13); wherein the at least first and second protruding elements are formed from a portion of the one single filament (Fig. 7; pgs. 2-3, 13).
Wood discloses the following regarding claim 2: the stent of claim 1, further comprising a cover secured to the tubular scaffolding (pg. 14).
Wood discloses the following regarding claim 3: the stent of claim 2, wherein the tubular scaffolding includes a plurality of scaffold openings (Fig. 7) extending through the tubular scaffolding from the outer surface to the inner surface and the cover spans at least some of the plurality of openings (Fig. 7; pgs. 14-15).
Wood discloses the following regarding claim 4: the stent of claim 2, wherein the cover is configured to prevent tissue ingrowth into the lumen (pg. 1 4; where the physical barrier formed by the cover is fully capable of preventing tissue ingrowth).
Wood 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. 7; where the radially extended position of the protruding elements would be fully capable of engaging a wall of the surrounding body lumen).
Wood 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. 7).
Wood discloses the following regarding claim 9: the stent of claim 1, wherein each protruding element is oriented non-parallel (at the downwardly angled portion of the protrusion) to the central longitudinal axis of the stent (Fig. 7).
Wood discloses the following regarding claim 10: a stent, comprising: a tubular scaffolding (e.g., 30) (Fig. 7) having a first end (upper end), a second end (lower end), and a length extending longitudinally therebetween (Figs. 3, 7), the tubular scaffolding having an outer surface (exterior surfaces) and an inner surface (interior surfaces) defining a lumen (central opening) extending from the first end to the second end (Figs. 3, 7), wherein the tubular scaffolding is configured to radially expand from a delivery configuration to a deployed configuration (pg. 26); and a plurality of protruding elements (e.g., 42) extending radially outward from the outer surface in the deployed configuration (Fig. 7), wherein at least first and second of the plurality of protruding elements are longitudinally aligned and have different circumferential positions (Fig. 7); wherein the tubular scaffolding is formed from only one single filament interwoven about a central longitudinal axis of the stent (Figs. 3, 7; pg. 13), the one single filament extending along an entirety of the length of the tubular scaffolding (Fig. 7; pg. 13); wherein each of the plurality of protruding elements is formed from the single filament (Fig. 7; pgs. 2-3, 13).
Wood 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. 7; where the radially extended position of the protruding elements would be fully capable of engaging a wall of the surrounding body lumen).
Wood 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. 7; pgs. 15-18; where the open spaces formed by the gaps under the protruding elements are fully capable of allowing tissue ingrowth).
Wood discloses the following regarding claim 14: the stent of claim 12, wherein the plurality of protruding elements is configured to prevent axial migration of the stent within the body lumen in the deployed configuration (pgs. 13-14, when unengaged and in the expanded state, the device is frictionally held against the vessel wall to help prevent unintended axial migration).
Wood discloses the following regarding claim 15: the stent of claim 10, further comprising a cover extending along at least a portion of the tubular scaffolding to prevent tissue ingrowth into the lumen (pg. 14; 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(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood.
Wood 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 Wood. 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 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wood in view of Brady et al. (WO 2006/124541 A2; hereinafter “Brady”).
Wood discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the plurality of protruding elements being disposed between the first end of the tubular scaffolding and the second end of the tubular scaffolding opposite the first end. Brady teaches that it is well known in the art that the protruding elements for stent grafts are positioned between the first end of the tubular scaffolding and the second end of the tubular scaffolding opposite the first end (Figs. 3, 6, 8-9, 11A, 18, 20; pgs. 13-14), for the purpose of positioning the protruding members at their desired location and allowing easier access to the stent for a practitioner. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the position of the protruding elements of Wood to be placed between the terminal first and second ends of the scaffolding, as taught by Brady, in order to position the protruding members at their desired locations and allow easier access to the stent for a practitioner. Such a modification would be made with a reasonable expectation of success.
Conclusion
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).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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