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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/21/2026 has been entered.
Response to Arguments
The amendments have overcome the previously presented claim objections. Applicant's arguments filed 4/21/2026 with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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) 1, 3-8, 10-16, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera et al. (US 2011/0160763) in view of Jang et al. (US 2002/0049493). Ferrera discloses a self-expandable medical device (e.g., fig. 38) for advancement through vasculature to an expansion site in a blood vessel, comprising: a working portion (see annotated figure below) having a compressed configuration and an expanded configuration ([0302] – self-expanding), a diameter of the expanded configuration being greater than a diameter of the compressed configuration ([0302]), the working portion being configured to provide an outward radial force at every diameter between and including the diameter of the compressed configuration and the diameter of the expanded configuration (due to self-expandable material), the working portion comprising a plurality of crowns of cells, each cell comprising an open area bordered by two proximal cell struts, two distal cell struts, and two middle cell struts (see examiner-annotated reproduction of a portion of fig. 8, on which two proximal cell struts, two distal cell struts, and two middle cell struts are labelled), the proximal cell struts each extending distally from a common proximal end to a proximal end of a respective one of the two middle cell struts, the distal cell struts each extending proximally from a common distal end to a distal end of a respective one of the two middle cell struts, each middle cell strut in each crown bordering two adjacent cells in that crown, each of the middle cell struts being adapted and configured to be more flexible than the distal cell strut and proximal cell strut to which it extends (note: the S-shape results in a middle strut having a hinge or articulation point that reduces bending stiffness as compared to the substantially linear proximal or distal cell struts as understood by one of ordinary skill in the art); a connection portion having a cylindrical shape (note: expandable tips may have a cylindrical collar formed at their proximal ends that connect the expandable tip to the pusher, such that the collar, similar to 809 in figs. 8A-C or 909 in figs. 9A-B, is considered part of the claimed connection portion; see at least [0176] and [0406]), the connection portion being adapted to be connected to a pusher (3805) for advancing the device through the vasculature to the expansion site, and a tapered portion extending between the proximal end of the working portion and a distal end of the connection portion. The tapered portion comprises a plurality of tapered portion struts and includes one or more crowns of cells of the plurality of crowns of cells, noting that this limitation necessitates that the working portion and the tapered portion overlap, since the working portion comprises the plurality of crowns of cells as currently claimed. See the examiner-annotated figures below.
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Ferrera fails to disclose wherein the common proximal ends of a distal cell strut ring are circumferentially offset from the common distal ends of a proximal cell strut ring.
Jang discloses another expandable frame (figs. 2a, 2b) meant to be advanced through vasculature and expanded therein once at a treatment site. Jang discloses distal cell struts disposed in a distal cell strut ring at equal distal cell strut positions along the longitudinal ais of the clot mobilizer device and the proximal cell struts are disposed in a proximal cell strut ring at equal proximal cell strut positions along the longitudinal axis of the clot mobilizer device. Jang discloses that the common proximal ends of the distal cell strut ring are circumferentially offset from the common distal ends of the proximal cell strut ring (note dotted arrows in examiner-annotated figure below).
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According to Jang, this arrangement prevents axial warping of the expandable frame during delivery and expansion ([0082]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Ferrera to position the crowns of cells such that the common proximal ends of a distal cell strut ring are circumferentially offset from the common distal ends of a proximal cell strut ring in view of the teachings of Jang in order to prevent axial warping of the clot mobilizer device during delivery and expansion.
Regarding claim 3, the tapered portion has an expanded configuration defining a frustoconical shape with a closed structure (consider portion of tapered portion that is frustoconical, thus defining a frustoconical shape).
Regarding claims 4 and 16, the tapered portion further comprises a crown of cells with each cell comprising an open area bordered by two proximal cell struts and two distal cells struts, in each cell the proximal cell struts each extending distally from a common proximal end to proximal ends of the distal cell struts, the distal cell struts each extending distally from their proximal ends to a common distal end. Consider the proximal-most crown of cells of the tapered portion labelled in the above drawing noting that the connection portion may be considered only the cylindrical collar while the entirety of the proximal most cells in fig. 38 are considered within the tapered portion.
Regarding claims 6 and 19, the plurality of crowns of cells of the working portion defines a tubular-shaped section forming a cylindrically closed structure (e.g., consider constant diameter section of working portion).
Regarding claim 20, the connection portion comprises a tubular-shaped section forming a cylindrically closed structure (connection portion comprises the tubular-shaped collar formed at the proximal end of the tapered portion, which is not illustrated in fig. 38, but described in [0176], similar to collar 809 or 909, noting also [0406]).
Regarding claims 5 and 18, the tapered portion converges (i.e., extends radially inward toward central axis) at a distal end of the connection portion. Note that the connection portion can be considered the tubular-shaped collar formed at the proximal end of the tapered portion (not illustrated in fig. 38, but described in [0176], similar to collar 809 or 909).
Regarding claim 10, each of the middle cell struts comprises one or two hinge portions (forming S-shape of middle cell struts in Ferrera), each hinge portion comprising one or two bends.
Regarding claim 11, each hinge portion of each middle cell strut is disposed between the proximal and distal ends of the middle cell strut (note first annotated figure above).
Regarding claim 12, the device further comprising a pusher (3805) extending proximally from the connection portion, the connection portion having a first attachment surface, and the pusher comprising a pusher connection portion extending distally, the pusher connection portion having a pusher attachment surface (consider respective surfaces of connection portion and pusher connection portion that contact each other).
Regarding claim 13, the pusher comprises a tube ([0029]- hypotube), the pusher attachment surface comprising a distal portion of the tube attached to the first attachment surface.
Regarding claim 14, wherein the tube is a catheter or a hypotube ([0029]).
Regarding claim 15, the device comprises a clot mobilizer or a funnel (see fig. 38 – funnel shaped and able to trap clot, similar to fig. 3).
Regarding claim 7, the connection portion and working portion are now being interpreted consistent with the annotated figure shown below. The connection portion comprises at least one crown of cells (consider distal-most crown of closed cells in connection portion below, noting connection portion includes a cylindrical collar at its proximal-most end as discussed above), each cell comprising an open area bordered by two proximal cell struts, two distal cell struts, and two middle cell struts, the proximal cell struts each extending distally from a common proximal end to a proximal end of a respective one of the two middle cell struts, the distal cell struts each extending proximally from a common distal end to a distal end of a respective one of the two middle cell struts, each middle cell strut bordering two radially adjacent cells, each of the middle cell struts being adapted and configured to be more flexible than the distal cell strut and proximal cell strut to which it extends (due to their s-shaped bends as discussed above). The tapered portion (see below) extends between a proximal end of the working portion and a distal end of the connection portion, noting that the term “portion” merely requires a section or part of a larger element and the connection and tapered portions may overlap as currently claimed. Because part of the tapered portion extends between the proximal end of the working portion and a distal end of the connection portion as shown in the below annotated figure, it meets this limitation.
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Regarding claim 8, the connection portion comprises a tubular-shaped section forming a cylindrically closed structure noting that the connection portion comprises a cylindrical collar as discussed above (see [0176] and [0406]; similar to collar 809 or 909).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera in view of Jang as applied to claim 1 above and further in view of Wainwright et al. (US 2012/0245671). Ferrera in view of Jang discloses the invention substantially as stated above except for wherein the middle cell struts bordering each cell have a width less than a width of the distal cell struts bordering that cell and less than a width of the proximal cell struts bordering that cell.
Wainwright discloses another expandable frame (100; fig. 1a) meant to be advanced through vasculature and expanded therein once at a treatment site, the frame comprising a plurality of crowns of cells (110), each cell having an open area bordered by two proximal cell struts (struts 103 in row 106), two distal cell struts (struts 103 in another row 106), and two middle cell struts (104). Wainwright discloses that a width of the middle cell struts is less than a width of the proximal and distal cell struts in order to enhance longitudinal flexibility and provide better arching capability ([0020],[0166]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Ferrera to size the middle struts to have a width less than that of the proximal and distal cell struts in view of the teachings of Wainwright in order to further enhance longitudinal flexibility and provide better arching capability, thus facilitating advancement through, and expansion within, tortuous vasculature.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera in view of Jang as applied to claim 1 above and further in view of Pinchasik et al. (US 5,449,373). Ferrera in view of Jang discloses the invention substantially as stated above including a first hinge formed in each of the middle cell struts of a crown on a distal segment of the working portion, a second hinge formed in each of the middle cell struts of a crown on a proximal segment of the working portion. However, Ferrera fails to disclose at least one crown positioned between the distal segment and the proximal segment without a hinge.
Pinchasik discloses another expandable frame meant to be advanced through vasculature and expanded therein once at a treatment site. The expandable frame comprises a crown of cells on a proximal segment and a crown of cells on a distal segment of the working portion, each cell comprising an open area bordered by two proximal cell struts (v-shaped proximal struts of cell), two distal cell struts (v-shaped distal struts of cell), and two middle cell struts (124), each of the two middle cells struts including a hinge (128; fig. 3a-3c) Pinchasik further discloses at least one crown of intermediate cells (see cell shaded lighter gray in annotated figure below), each intermediate cell comprising an open area bordered by proximal cell struts intersecting with two distal cell struts (noting absence of middle cell struts 124 in the intermediate cells). The crown of intermediate cells does not include any middle struts or any hinges (kinks 128).
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According to Pinchasik, the frame having these two different cell structures provides continuous and uniform support for both straight and curved portions of a bodily conduit (col. 2, ll. 6-27). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Ferrera to include at least one crown of intermediate cells without middle cell struts or hinges as taught by Pinchasik in order to ensure that the expandable frame provides a sufficient outward radial force in both straight and curved portions of a body conduit.
Claim(s) 1, 3-8, 10-16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera et al. (US 2011/0160763) in view of Niermann (US 2006/0106452 now issued as US 7,867,272; citations taken from ‘452). Ferrera discloses a self-expandable medical device (e.g., fig. 38) for advancement through vasculature to an expansion site in a blood vessel, comprising: a working portion (see annotated figure below) having a compressed configuration and an expanded configuration ([0302] – self-expanding), a diameter of the expanded configuration being greater than a diameter of the compressed configuration ([0302]), the working portion being configured to provide an outward radial force at every diameter between and including the diameter of the compressed configuration and the diameter of the expanded configuration (due to self-expandable material), the working portion comprising a plurality of crowns of cells, each cell comprising an open area bordered by two proximal cell struts, two distal cell struts, and two middle cell struts (see examiner-annotated reproduction of a portion of fig. 8, on which two proximal cell struts, two distal cell struts, and two middle cell struts are labelled), the proximal cell struts each extending distally from a common proximal end to a proximal end of a respective one of the two middle cell struts, the distal cell struts each extending proximally from a common distal end to a distal end of a respective one of the two middle cell struts, each middle cell strut in each crown bordering two adjacent cells in that crown, each of the middle cell struts being adapted and configured to be more flexible than the distal cell strut and proximal cell strut to which it extends (note: the S-shape results in a middle strut having a hinge or articulation point that reduces bending stiffness as compared to the substantially linear proximal or distal cell struts as understood by one of ordinary skill in the art); a connection portion having a cylindrical shape (note: expandable tips may have a cylindrical collar formed at their proximal ends that connect the expandable tip to the pusher, such that the collar, similar to 809 in figs. 8A-C or 909 in figs. 9A-B, is considered part of the claimed connection portion; see at least [0176] and [0406]), the connection portion being adapted to be connected to a pusher (3805) for advancing the device through the vasculature to the expansion site, and a tapered portion extending between the proximal end of the working portion and a distal end of the connection portion. The tapered portion comprises a plurality of tapered portion struts and includes one or more crowns of cells of the plurality of crowns of cells, noting that this limitation necessitates that the working portion and the tapered portion overlap, since the working portion comprises the plurality of crowns of cells as currently claimed. See the examiner-annotated figures below.
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Ferrera fails to disclose wherein the common proximal ends of a distal cell strut ring are circumferentially offset from the common distal ends of a proximal cell strut ring.
Niermann discloses another expandable frame (figs. 6a,b) meant to be advanced through vasculature and expanded therein once at a treatment site. Niermann discloses distal cell struts disposed in a distal cell strut ring (e.g., 606c) at equal distal cell strut positions along the longitudinal axis of the clot mobilizer device and the proximal cell struts are disposed in a proximal cell strut ring (e.g., 606d) at equal proximal cell strut positions along the longitudinal axis of the clot mobilizer device. Niermann discloses that the common proximal ends of the distal cell strut ring are circumferentially offset (see “630” in fig. 6b) in one circumferential direction from the common distal ends of the proximal cell strut ring. According to Niermann, longer middle struts are necessary to accommodate this circumferential offset, which results in a greater tendency to bend in a direction perpendicular to the stent longitudinal axis, which improves the middle strut flexibility (called “flex connector 614” in Niermann), which is particularly useful when the frame is being navigated through tortuous vasculature ([0062]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Ferrera such that the common proximal ends of a distal cell strut ring are circumferentially offset from the common distal ends of a proximal cell strut ring, in view of the teachings of Niermann in order to further facilitate navigation of the device through tortuous vasculature.
Regarding claim 3, the tapered portion has an expanded configuration defining a frustoconical shape with a closed structure (consider portion of tapered portion that is frustoconical, thus defining a frustoconical shape).
Regarding claims 4 and 16, the tapered portion further comprises a crown of cells with each cell comprising an open area bordered by two proximal cell struts and two distal cells struts, in each cell the proximal cell struts each extending distally from a common proximal end to proximal ends of the distal cell struts, the distal cell struts each extending distally from their proximal ends to a common distal end. Consider the proximal-most crown of cells of the tapered portion labelled in the above drawing noting that the connection portion may be considered only the cylindrical collar while the entirety of the proximal most cells in fig. 38 are considered within the tapered portion.
Regarding claims 6 and 19, the plurality of crowns of cells of the working portion defines a tubular-shaped section forming a cylindrically closed structure (e.g., consider constant diameter section of working portion).
Regarding claim 20, the connection portion comprises a tubular-shaped section forming a cylindrically closed structure (connection portion comprises the tubular-shaped collar formed at the proximal end of the tapered portion, which is not illustrated in fig. 38, but described in [0176], similar to collar 809 or 909, noting also [0406]).
Regarding claims 5, 17 and 18, the tapered portion converges (i.e., extends radially inward toward central axis) at a distal end of the connection portion. Note that the connection portion can be considered the tubular-shaped collar formed at the proximal end of the tapered portion (not illustrated in fig. 38, but described in [0176], similar to collar 809 or 909).
Regarding claim 10, each of the middle cell struts comprises one or two hinge portions (forming S-shape of middle cell struts in Ferrera), each hinge portion comprising one or two bends.
Regarding claim 11, each hinge portion of each middle cell strut is disposed between the proximal and distal ends of the middle cell strut (note first annotated figure above).
Regarding claim 12, the device further comprising a pusher (3805) extending proximally from the connection portion, the connection portion having a first attachment surface, and the pusher comprising a pusher connection portion extending distally, the pusher connection portion having a pusher attachment surface (consider respective surfaces of connection portion and pusher connection portion that contact each other).
Regarding claim 13, the pusher comprises a tube ([0029]- hypotube), the pusher attachment surface comprising a distal portion of the tube attached to the first attachment surface.
Regarding claim 14, wherein the tube is a catheter or a hypotube ([0029]).
Regarding claim 15, the device comprises a clot mobilizer or a funnel (see fig. 38 – funnel shaped and able to trap clot, similar to fig. 3).
Regarding claim 7, the connection portion and working portion are now being interpreted consistent with the annotated figure shown below. The connection portion comprises at least one crown of cells (consider distal-most crown of closed cells in connection portion below, noting connection portion includes a cylindrical collar at its proximal-most end as discussed above), each cell comprising an open area bordered by two proximal cell struts, two distal cell struts, and two middle cell struts, the proximal cell struts each extending distally from a common proximal end to a proximal end of a respective one of the two middle cell struts, the distal cell struts each extending proximally from a common distal end to a distal end of a respective one of the two middle cell struts, each middle cell strut bordering two radially adjacent cells, each of the middle cell struts being adapted and configured to be more flexible than the distal cell strut and proximal cell strut to which it extends (due to their s-shaped bends as discussed above). The tapered portion (see below) extends between a proximal end of the working portion and a distal end of the connection portion, noting that the term “portion” merely requires a section or part of a larger element and the connection and tapered portions may overlap as currently claimed. Because part of the tapered portion extends between the proximal end of the working portion and a distal end of the connection portion as shown in the below annotated figure, it meets this limitation.
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Regarding claim 8, the connection portion comprises a tubular-shaped section forming a cylindrically closed structure noting that the connection portion comprises a cylindrical collar as discussed above (see [0176] and [0406]; similar to collar 809 or 909).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera in view of Niermann as applied to claim 1 above and further in view of Wainwright et al. (US 2012/0245671). Ferrera discloses the invention substantially as stated above except for wherein the middle cell struts bordering each cell have a width less than a width of the distal cell struts bordering that cell and less than a width of the proximal cell struts bordering that cell.
Wainwright discloses another expandable frame (100; fig. 1a) meant to be advanced through vasculature and expanded therein once at a treatment site, the frame comprising a plurality of crowns of cells (110), each cell having an open area bordered by two proximal cell struts (struts 103 in row 106), two distal cell struts (struts 103 in another row 106), and two middle cell struts (104). Wainwright discloses that a width of the middle cell struts is less than a width of the proximal and distal cell struts in order to enhance longitudinal flexibility and provide better arching capability ([0020],[0166]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Ferrera to size the middle struts to have a width less than that of the proximal and distal cell struts in view of the teachings of Wainwright in order to further enhance longitudinal flexibility and provide better arching capability, thus facilitating advancement through, and expansion within, tortuous vasculature.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera in view of Niermann as applied to claim 1 above and further in view of Pinchasik et al. (US 5,449,373). Ferrera in view of Niermann discloses the invention substantially as stated above including a first hinge formed in each of the middle cell struts of a crown on a distal segment of the working portion, a second hinge formed in each of the middle cell struts of a crown on a proximal segment of the working portion. However, Ferrera fails to disclose at least one crown positioned between the distal segment and the proximal segment without a hinge.
Pinchasik discloses another expandable frame meant to be advanced through vasculature and expanded therein once at a treatment site. The expandable frame comprises a crown of cells on a proximal segment and a crown of cells on a distal segment of the working portion, each cell comprising an open area bordered by two proximal cell struts (v-shaped proximal struts of cell), two distal cell struts (v-shaped distal struts of cell), and two middle cell struts (124), each of the two middle cells struts including a hinge (128; fig. 3a-3c) Pinchasik further discloses at least one crown of intermediate cells (see cell shaded lighter gray in annotated figure below), each intermediate cell comprising an open area bordered by proximal cell struts intersecting with two distal cell struts (noting absence of middle cell struts 124 in the intermediate cells). The crown of intermediate cells does not include any middle struts or any hinges (kinks 128).
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According to Pinchasik, the frame having these two different cell structures provides continuous and uniform support for both straight and curved portions of a bodily conduit (col. 2, ll. 6-27). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Ferrera to include at least one crown of intermediate cells without middle cell struts or hinges as taught by Pinchasik in order to ensure that the expandable frame provides a sufficient outward radial force in both straight and curved portions of a body conduit.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KSH 5/28/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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