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
The amendments have overcome the previously presented non-statutory double patenting rejections. Applicant's arguments filed 12/3/2025 with respect to the amendments overcoming the previously presented 35 USC 102a1 rejections over Ferrera and the previously presented non-statutory double patenting rejections have been fully considered and are persuasive. However, independent claim 1 is now rejected under 35 USC 103 over Ferrera in view of Jang and Ferrera in view of Niermann as presented below. Although the prior art of Jang and the prior art of Niermann were each used in the previous office action to teach the limitation added to independent claim 1 (noting this limitation originally appeared in claim 7), applicant did not provide any specific arguments with respect to how the prior art of Jang or Niermann fail to make obvious the limitation added to claim 1. The rejections have been updated to reflect the amendments to the claims.
Claim Objections
Claim 13 is objected to because of the following informalities: the end of the claim should read “..the first diameter and the second diameter.” for consistency. Appropriate correction is 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 1-5, 7-16 and 20-22 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.
In the last two lines of claim 1, “the distal cell strut ring” and “the proximal cell strut ring” each lacks antecedent basis. Claims 2-5, 7-16 and 20-22 depend from claim 1 and are thus also indefinite. It is further noted that claim 7 introduces a distal cell strut ring and a proximal cell strut ring, which appear to be one and the same as the distal cell strut ring and the proximal cell strut ring recited in claim 1, but are not claimed as such. Similarly, claim 20 introduces “a distal cell strut ring” (line 2) and “a proximal cell strut ring” (line 4) which appear to be one and the same as the distal cell strut ring and the proximal cell strut ring recited in claim 1, but are not claimed as such. Additionally, claims 8 and 9 each recites “the distal cell strut ring” and “the proximal cell strut ring”, which lacks clear antecedent basis as it is unclear if the recitations in claims 8 and 9 are meant to refer back to the distal cell strut ring and proximal cell strut ring recited in claim 1 or the distal cell strut ring and proximal cell strut ring recited in claim 7. For purposes of claim interpretation, claim 1 is being treated as though it reads “..and wherein, in each crown of cells, the common proximal ends of [[the]] a distal cell strut ring are circumferentially offset from the common distal ends of [[the]] a proximal cell strut ring.” Claims 7 and claim 20 are each being treated as though line 2 reads “…[[a]] the distal cell strut ring” and line 4, “…[[a]] the proximal cell strut ring”.
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, 5, 7, 9, 10, 14, 16 and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera (US 2011/0160763) in view of Jang et al. (US 2002/0049493).
Ferrera discloses an expandable clot mobilizer device for extraction of an occlusion from a blood vessel, comprising: a 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. 38 below, on which proximal, distal, and middle cell struts of one cell 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 the proximal cell strut to which it extends (note: the S-shape results in a middle strut having 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); and a tapered portion extending proximally from a proximal end of the working portion, the tapered portion comprising a plurality of tapered portion struts, the tapered portion having a smaller diameter at a proximal end than a diameter of the working portion in an expanded configuration.
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Regarding claims 1, 7, and 20, Ferrera discloses the invention substantially as stated above including wherein in each crown of cells, the distal cell struts are disposed in a distal cell strut ring 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 at equal proximal cell strut positions along the longitudinal axis of the clot mobilizer device (see fig. 38), but fails to disclose wherein, in each crown of cells, 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). Regarding claim 9, Jang discloses the common proximal ends of the distal cell strut ring of a first crown of cells are offset from the common distal ends of the proximal cell strut ring of the first crown of cells in a first circumferential direction and the common proximal ends of the distal cell strut ring of a second crown of cells are offset from the common distal ends of the proximal cell strut ring of the second crown of cells in a second circumferential direction opposite to the first circumferential direction. See the annotated figure below, wherein the first and second circumferential directions are indicated by the dotted arrows.
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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 in the manner claimed in claims 1, 7 and 9 in view of the teachings of Jang in order to prevent axial warping of the clot mobilizer device during delivery and expansion.
Regarding claims 3 and 16, Ferrera discloses the invention substantially as stated above including middle struts which are more flexible than proximal and distal struts due to the presence of hinge portions (s-shaped curve). Ferrera does not expressly disclose that the middle struts bordering each cell have a width less than the distal cell struts and proximal cell struts bordering that cell.
Jang discloses another expandable frame (figs. 2a, 2b) meant to be advanced through vasculature and expanded therein once at a treatment site. The frame includes a plurality of cells having proximal cell struts, distal cell struts, and middle cells struts (connecting struts 38 of Jang). Jang teaches that longitudinal flexibility can be further increased by using a narrow width connecting strut, providing additional flexibility and suppleness to the expandable frame ([0071]), the connecting strut having a width less than that of the proximal and distal cell struts ([0088]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Ferrera to construct the middle cell struts to have a width less than that of the proximal and distal cell struts as taught by Jang in order to provide additional flexibility and suppleness to the frame.
Regarding claim 2, the working portion defines a tubular-shaped section forming a cylindrically closed structure (fig. 38 of Ferrera).
Regarding claim 5, the working portion comprises at least four crowns of cells and each crown of cells comprises at least four cells (as shown in fig. 38 of Ferrera).
Regarding claim 10, the middle cell struts of a second crown of cells extend distally from common distal ends of distal cell struts of a first crown of cells to common proximal ends of proximal cell struts of a third crown of cells, and the middle cell struts of the third crown of cells extend distally from common distal ends of distal cell struts of the second crown of cells to common proximal ends of proximal cell struts of a fourth crown of cells. See the 1st, 2nd, 3rd, and 4th crown of cells labelled below.
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Regarding claim 14, at least some of the plurality of tapered portion struts border a plurality of tapered portion cells, wherein at least some of the plurality of tapered portion struts converge from a proximal end of the working portion to a distal end of a proximal connection portion, the clot mobilizer device further comprising a pusher extending proximally from the proximal connection portion. In particular, Ferrera discloses, as an alternative to the tapered portion struts connecting directly with the pusher (3805 in fig. 38), a proximal connection portion in the form of a collar (similar to 809 in figs. 8a-c or 909 in figs. 9a-9b) formed at the proximal end of the tapered portion that connects to a distal end of the pusher ([0176], [0406]).
Regarding claim 21, the device of Ferrera further comprises a first hinge formed in each of the middle cells struts of a crown on a distal segment of the working portion and a second hinge formed in each of the middle struts of a crown on a proximal segment of the working portion, noting that Ferrea discloses all cells of the working portion have a hinge (s-shaped bend) in their respective middle cell struts.
Regarding claim 22, the working portion is configured to expand in apposition to the interior wall of a blood vessel along the entire length of the working portion. It is noted that this is a recitation of intended use and the prior art must only be capable of performing the function in order to meet the limitation. Since the working portion of Ferrera may be expanded within a blood vessel having the same diameter as the working portion of the device of Ferrera, it is capable of being expanded to be in apposition to the interior wall of the blood vessel along the entire length of the working portion.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera in view of Jang as applied above and further in view of Wainwright et al. (US 2012/0245671). Ferrera in view of Jang discloses the invention substantially as stated above including the middle cell struts having a width less than that of the distal and proximal cell struts, but does not expressly disclose the claimed widths.
Wainwright discloses another expandable frame (100; fig. 1) meant to be advanced through vasculature and expanded therein once at a treatment site, the frame comprising a plurality of crowns of cells, each cell having an open area bordered by two proximal cell struts (103), two distal cell struts (103), 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]). Wainwright discloses that the distal and proximal cell struts can have a width between 0.03 and 0.10 mm and the middle cell struts have a width between 0.025 and 0.095mm, which overlaps the respective claimed ranges.
It would have been obvious to one of ordinary skill in the art to have further 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, the widths of the proximal, distal, and middle struts falling with the claimed values, in view of the teachings of Wainwright in order to further enhance longitudinal flexibility and provide better arching capability, and it has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facia case of obviousness exists (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Claim(s) 11 and 12 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 except for at least one crown of intermediate cells as claimed.
Pinchasik discloses another expandable frame meant to be advanced through vasculature and expanded therein once at a treatment site. The expandable frame comprises a plurality of crowns of cells, 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 (112). Pinchasik further discloses at least one crown of intermediate cells (see cell shaded lighter gray in annotated figure bleow), each intermediate cell comprising an open area bordered by proximal cell struts intersecting with two distal cell struts (noting absence of middle cell struts 112 in the intermediate cells).
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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 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.
Regarding claim 12, as taught by Pinchasik, the distal cell struts of each intermediate cell in the at least one crown of intermediate cells comprise the proximal cell struts of cells in an adjacent crown of cells, and the proximal cell struts of each intermediate cell in the at least one crown of intermediate cells comprise the distal cell struts of cells in an adjacent crown of cells (as understood in view of the annotated figure above).
Claim(s) 13 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 Leon-Yip (US 2017/0079767). Ferrera discloses the invention substantially as stated above except for the working portion being configured to expand from a compressed configuration with a first diameter of less than 1.5 mm to an expanded configuration with a second diameter of at least 3.0 mm and to exert an outward radial force between 0.5 N and 3 N at every diameter between and including the first diameter and the second diameter.
Leon-Yip discloses another expandable clot mobilizer (112; fig. 5) having a working portion comprising a plurality of crowns of cells (126). Leon-yup discloses that the working portion is configured to expand from a compressed configuration with a first diameter of less than 1.5 mm to an expanded configuration with a second diameter of at least 3.0 mm and to exert an outward radial force of 0.040N/mm to 0.050 N/mm when the diameter is reduced to between 1.0 and 1.5mm, and 0.010N/mm to 0.020 N/mm when the diameter is 3.0mm ([0007], [0090]). According to Leon-Yip, these values allow the cell structures to engage with an embolic obstruction in a manner that permits partial or full removal of the obstruction from the patient ([0007]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Ferrara to use dimensional and material characteristics for the cells that result in an outward radial force of 0.040N/mm to 0.050 N/mm when the diameter of the device is reduced to between 1.0 and 1.5mm, and 0.010N/mm to 0.020 N/mm when the diameter is 3.0mm in order to permit partial or full removal of the obstruction from the patient as taught by Leon-Yip. When such a teaching is applied to the device of Ferrera, which can have a frame length of 50mm ([0031]), the outward radial force at every diameter between and including the first and second diameters will be between 0.5 N and 3N (0.050N/mm * 50mm = 2.5N at diameter of 1.0mm; 0.020N/mm*50mm = 1.0N at diameter of 3 mm; it is understood that the force is between 1.0 and 2.5N at every diameter between the first diameter and second diameter).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera in view of Jang as applied to claim 14 above and further in view of Palmer et al. (US 6,402,771) and Banas et al. (US 4,794,231). Ferrera in view of Jang discloses the invention substantially as stated above except for the following which is taught by Palmer and Banas.
Palmer discloses an expandable clot mobilizer device comprising a working portion (20) comprising a plurality of crowns of cells (fig. 13), and a tapered portion extending proximally from the working portion. Palmer further discloses a proximal connection portion (174) extending proximally from the tapered portion and including a first attachment surface that attaches to a second attachment surface of a second connection portion (164) of a pusher (162), the second attachment surface (fig. 14) facing and extending longitudinally aligned to the first attachment surface to define an overlapping portion (see figs. 13, 14) and to define first and second seams extending longitudinally along first and second lateral extents of the overlapping portion.
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Palmer discloses a first joint (see solder 176 on left in fig. 14) attaching portions of the first and second connection portions along the first seam and a second joint (see solder 176 on right in fig. 14) attaching portions of the first and second portions along the second seam. Palmer discloses using a first solder and a second solder along the first and second seams (see solder 176 along both seams; fig. 14). However, Palmer discloses joining other elements of the device using soldering, laser welding, adhesive, or shrink wrap (col. 10, ll. 20-28) and therefore discloses laser welding as a known alternative to soldering. Banas discloses attaching first and second connection portions (28,29) along first and second seams (along left and right side of interface 30; fig. 1) via a first weld extending from the first seam toward the second seam and a second weld attaching the first and second connection portions extending from the second seam toward the first seam (fig. 1, 3a; claim 1 of Banas). Banas discloses that the such laterally formed first and second welds that extend towards each other reduce energy consumption and improve the quality of the welded joint as compared to a single weld from a single laser beam having sufficient intensity for the laser beam to penetrate through the entire interface between the two elements being joined (col. 5, ll. 3-67).
It would have been obvious to one of ordinary skill in the art to have modified the prior art of Ferrara to construct the connection between the proximal connection portion and the pusher as claimed (i.e., overlapping attachment surfaces between the proximal connection portion and the pusher joined by first and second welds formed along first and second seams) in view of Palmer’s disclosure that an overlapping attachment between a proximal connection portion of an expandable frame and pusher is known in the art, and Bana’s disclosure that laterally formed first and second welds reduce energy consumption and improve the quality of the welded joint.
Claim(s) 1-2, 5, 7, 8, 10, 14, and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera (US 2011/0160763) in view of Niermann (US 2006/0106452 now issued as US 7,867,272; citations taken from ‘452).
Ferrera discloses an expandable clot mobilizer device for extraction of an occlusion from a blood vessel, comprising: a 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. 38 below, on which proximal, distal, and middle cell struts of one cell 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 the proximal cell strut to which it extends (note: the S-shape results in a middle strut having 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); and a tapered portion extending proximally from a proximal end of the working portion, the tapered portion comprising a plurality of tapered portion struts, the tapered portion having a smaller diameter at a proximal end than a diameter of the working portion in an expanded configuration.
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Regarding claims 1, 7, 8, and 20, Ferrera discloses the invention substantially as stated above including wherein in each crown of cells, the distal cell struts are disposed in a distal cell strut ring 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 at equal proximal cell strut positions along the longitudinal axis of the clot mobilizer device (see fig. 38), but fails to disclose wherein, for each crown of cells, 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 to position the crowns of cells in the manner claimed in claims 1, 7, 8, and 20, in view of the teachings of Niermann in order to further facilitate navigation of the device through tortuous vasculature.
Regarding claim 2, the working portion defines a tubular-shaped section forming a cylindrically closed structure (fig. 38 of Ferrera).
Regarding claim 5, the working portion comprises at least four crowns of cells and each crown of cells comprises at least four cells (as shown in fig. 38 of Ferrera).
Regarding claim 10, the middle cell struts of a second crown of cells extend distally from common distal ends of distal cell struts of a first crown of cells to common proximal ends of proximal cell struts of a third crown of cells, and the middle cell struts of the third crown of cells extend distally from common distal ends of distal cell struts of the second crown of cells to common proximal ends of proximal cell struts of a fourth crown of cells. See the 1st, 2nd, 3rd, and 4th crown of cells labelled below.
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Regarding claim 14, at least some of the plurality of tapered portion struts border a plurality of tapered portion cells, wherein at least some of the plurality of tapered portion struts converge from a proximal end of the working portion to a distal end of a proximal connection portion, the clot mobilizer device further comprising a pusher extending proximally from the proximal connection portion. In particular, Ferrera discloses, as an alternative to the tapered portion struts connecting directly with the pusher (3805 in fig. 38), a proximal connection portion in the form of a radiopaque marker (618; fig. 6c) that is provided between the proximal end of the tapered portion and a distal end of the pusher, or a collar (809,909) formed at the proximal end of the tapered portion that connects to a distal end of the pusher ([0176]).
Regarding claim 21, the device of Ferrera further comprises a first hinge formed in each of the middle cells struts of a crown on a distal segment of the working portion and a second hinge formed in each of the middle struts of a crown on a proximal segment of the working portion, noting that Ferrea discloses all cells of the working portion have a hinge (s-shaped bend) in their respective middle cell struts.
Regarding claim 22, the working portion is configured to expand in apposition to the interior wall of a blood vessel along the entire length of the working portion. It is noted that this is a recitation of intended use and the prior art must only be capable of performing the function in order to meet the limitation. Since the working portion of Ferrera may be expanded within a blood vessel having a lumen with the same diameter as the working portion of the device of Ferrera, it is capable of being expanded to be in apposition to the interior wall of the blood vessel along the entire length of the working portion.
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 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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KSH 1/15/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771