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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/8/2026 has been entered.
Response to Arguments
Applicant's arguments filed 1/8/2026 have been fully considered but they are not persuasive. Regarding the prior art of Hopkins, applicant argues that the addition of the limitation “the guidewire extending to the porous filter” to claim 1 distinguishes the claimed invention from the prior art of Hopkins because guidewire 61 is discontinuous and does not extend to the porous filter. The examiner respectfully disagrees. The claim does not require that the guidewire is continuous. Hopkins designates element 61 as “guidewire 61”. In fig. 7a, the distal region of the guidewire 61 attaches to turns 65 at point 68, and extends along the entire length of the filter (64). Therefore, the guidewire can be considered to extend to the porous filter (e.g., from its distal-most end) since the distal region (labelled 61 in fig. 7A) extends along the length of the porous filter (see figs. 7A, 7B).
Regarding claim 1 and 22, applicant argues that the prior art of Daniel in view of Brady fails to make obvious the invention of claims 1 and 22. It is noted that the examiner has relied on the embodiment shown in fig. 21B of Daniel (not fig. 21A). The rejection does not suggest removing the self-expanding nature of the frame of Daniel. Rather, the legs (358 and 360) of Daniel are being modified to include a crossover point as taught by Brady in view of Brady’s disclosure that such a crossover point facilitates adjustment of an expandable frame to different vessel diameters ([0056] of Brady). Brady expressly discloses that “frame struts 33 and 34 at crossover point 32 can move relative to each other to facilitate adjustment of the frame to different vessel diameters” ([0056]). Applicant argues that this movement refers to the proximal and distal loops of fig. 6 changing angles with respect to the axis of a vessel, with no change in the cross-sectional area of either aperture formed by the loops. Applicant also asserts that there is no disclosure of the crossover point moving. The examiner respectfully disagrees as the struts (33, 34) labelled in fig. 6 of Brady form opposing sides of a loop and thus movement of 33 and 34 relative to each other at the crossover would result in the crossover point moving along the length of the struts in the same manner as the instant invention. There is no indication in the disclosure of Brady that the frame struts 33 and 34 are fixed to each other at the crossover point. Since Brady expressly discloses that the struts 33 and 34 move relative to each other at the crossover point, it is understood that the frame struts 33 and 34 are not fixed to each other at the crossover point and the crossover point can move along the length of the support member in the same manner as the instant invention (i.e. by adjustment of the size of the loops by pinching one of the loops to a smaller diameter in order to enlarge the other loop). Applicant also asserts that the rejection does not allege any benefit or improvement resulting from the modification. The examiner respectfully disagrees, noting that Brady teaches that the crossover point facilitates adjustment of an expandable frame to different vessel diameters, and thus one skilled in the art would have been motivated to modify Daniel in view of Brady to include the crossover point in order to improve the frame’s ability to adjust to different vessel diameters.
The amendments to claim 17 have overcome the previously presented 35 USC 103 rejections of claims 17 and 19-21 over Daniel in view of Brady (and further in view of Hopkins in the case of claim 20). However, these claims have been rejected under 35 USC 112a in view of the amendments as discussed below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17, 19-21 and 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 17 and claim 28 each include the limitation “wherein the first leg is oriented at a first angle to the central axis and the aperture is oriented at a second angle to the central axis, the second angle greater than the first angle” (wherein “the central axis” refers to the central axis of a lumen in which the apparatus is arranged for use according to the claims). This limitation is not supported in the application as originally filed, as the specification is completely silent on the angle between the first leg and the central axis of a lumen in which the device is arranged in use, disclosing only the angle of the first leg relative to wire 102 (see [0043]). Although applicant points to figures 6A and 6B as support, there is no indication that the drawings are drawn to scale, and the 2-D perspective drawings do not clearly show at least the angle of the first leg (or second leg) relative to the central axis of the (vessel) lumen since the dimension into/out of the page when viewing figs. 6A and 6B has been flattened. In other words, it is unclear from this 2-dimensional drawing whether the legs are oriented “at a first angle to the central axis” because the legs may be offset radially from the central axis, and thus don’t form an angle with the central axis. It is also unclear if the expansion shown from figs. 6a-6b occurs in the plane of the paper when viewing fig. 6b, or if this expansion actually occurs in the third dimension (i.e., into/out of the plane of the paper when viewing fig. 6b) as this is a perspective drawing.
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, 9, and 12 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Hopkins et al. (US 6,589,263).
Hopkins discloses an embolic protection apparatus comprising a guide wire (61; figs. 7a, 7b) with a collapsible basket positioned near a distal end of the guidewire, and the collapsible basket comprising a support member (63) comprising an expandable loop (see examiner-annotated reproduction of fig. 7b below), a first leg and a second leg (see below), the first leg attached to the guidewire (61), the second leg attached to the guidewire, and a porous filter (64) attached at one end to the expandable loop, the guidewire extending to the porous filter (noting distal region of 61 in fig. 7A extends to the porous filter; see figs. 7A,7B). The support member crosses itself in a radial direction at a crossover point (see below), the first leg and the second leg oriented proximal to the crossover point, the loop oriented distal to the crossover point, the crossover point moving along a length of the support member as the expandable loop changes size.
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Regarding claim 2, the expandable loop comprises a material which enables the expandable loop to expand to an open configuration from a delivery configuration (self-expanding, as per col. 5, ll. 6-12).
Regarding claim 4, the first leg is positioned on a first side of the guide wire and the second leg is positioned on a second side of the guide wire and wherein the first leg is directly connected to a section of the expandable loop that is positioned on the second side of the guide wire and the second leg is directly connected to a section of the expandable loop that is positioned on the first side of the guide wire (see examiner-annotated figure above, noting that each leg can be considered to extend just distal of the crossover point, and the loop can be considered to start just distal of crossover point, such that a leg directly connects to a section of the loop positioned on an opposite side from which the respective leg attaches to the guidewire).
Regarding claim 9, the expandable loop, when expanded in an unconstrained fashion, has a non-circular shape (fig. 7a,7b).
Regarding claim 12, the porous filter comprises holes (30; fig. 2a) and the holes are arranged in a staggered pattern, i.e., the holes are offset from each other and form part of an alternating pattern of filter material, hole, filter material, hole, etc.
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) 1-2, 4, 12, 22 and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel et al. (US 2006/0100662) in view of Brady et al. (US 2013/0197567).
Regarding claim 1, Daniel discloses an embolic protection apparatus comprising a guidewire (346; fig. 21B) having a collapsible basket positioned near a distal end of the guidewire, the collapsible basket comprising a support member comprising an expandable loop (356)), a first leg (358), and a second leg (360) the first and second legs attached to the guidewire, and a porous filter (344) attached at one end to the loop, the guidewire (346) extending to the porous filter (fig. 21B). Daniel fails to disclose that the support member crosses itself in a radial direction at a crossover point as claimed.
Regarding claim 22, Daniel disclose an embolic protection apparatus (fig. 21b) comprising a guide wire (346), a support member comprising a continuous wire forming a first leg (358), a loop (356), and a second leg (360), the first leg attached to the guide wire at a junction (362) and extending distally along a length of the guide wire, the first leg oriented to a first side of a bisecting longitudinal plane, the second leg oriented to a second side of the bisecting longitudinal plane and attached to the guidewire at the junction (fig. 21b). The loop defines an aperture (central opening of loop), and a porous filter (344) is attached to the loop. Daniel fails to disclose the support member crossing the bisecting longitudinal plane at a crossover point and transitioning from the first leg into a first portion of the loop, the loop comprising the first portion oriented to a second side of the bisecting longitudinal plane and a second portion oriented to the first side of the bisecting longitudinal plane, the support member again crossing the bisecting longitudinal plane and crossing itself in a radial direction at the crossover point and transitioning from the second portion of the loop into the second leg, the second leg oriented to the second side of the bisecting longitudinal plane and extending proximally along the length of the guide wire, wherein the crossover point moves along a length of the support member as a cross-sectional area of the aperture changes.
Brady discloses another embolic protection system comprising a support member having a first leg (34), a loop (e.g., distal loop of figure eight pattern in figs. 5, 6), and a second leg (33). The loop defines an aperture and has a porous filter (8) attached to the loop. Brady teaches that the legs (33,34) may cross over each other (at 32) such that, when the aperture defined by the loop is in a smaller “second” orientation, a distance between the first leg and the second leg is greater than when the aperture is in a larger “first” orientation due to the figure eight pattern of frame 31. Regarding claims 1 and 22, the crossover point (32) moves along a length of the support member as the expandable loop changes size (in order to allow loop to expand or contract). Brady discloses that such a crossover point between the two legs allows the loop and legs to move relative to each other to facilitate the adjustment of the loop to different vessel diameters ([0056]).
It would have been obvious to one of ordinary skill in the art to have modified the prior art of Daniel to provide a cross over point between the first and second legs, the crossover point moving along a length of the support member as the loop changes in size such that when the aperture defined by the loop is smaller, the distance between the first and second legs is greater, in view of Brady in order to facilitate the adjustment of the loop size to different vessel diameters. Regarding claim 22, as noted above Daniel has been modified in view of Brady to include a crossover point at which the support member crosses over itself at a bisecting longitudinal plane. The support member of Daniel in view of Brady crosses the bisecting longitudinal plane at a crossover point and transitions from the first leg into a first portion of the loop, the loop comprising the first portion oriented to a second side of the bisecting longitudinal plane and a second portion oriented to the first side of the bisecting longitudinal plane, and the support member again crosses the bisecting longitudinal plane and crossing itself in a radial direction at the cross over point and transitions from the second portion of the loop into the second leg, the second leg oriented to the second side of the bisecting longitudinal plane and extending proximally along the length of the guide wire.
Regarding claim 2, the expandable loop comprises a material which enables the loop to expand to an open configuration from a delivery configuration ([0099]), [0102]).
Regarding claim 4, the first leg (358) is positioned on a first side of the guide wire and the second leg (360) is positioned on a second side of the wire (see fig. 21b). As modified in view of Brady to include a crossover point as discussed above, the first leg is directly connected to a section of the expandable loop that is positioned on the second side of the wire and the second leg is connected to a section of the expandable loop that is positioned on the first side of the wire.
Regarding claim 12, the porous filter comprises holes ([0034]) and the holes are arranged in a staggered pattern, i.e., the holes are offset from each other and form part of an alternating pattern of filter material, hole, filter material, hole, etc.
Regarding claim 24, a length of the first leg changes as a cross-sectional area of the aperture changes, noting that the first leg is considered to extend from its attachment with the guidewire to the crossover point in the case of independent claim 22. The crossover point moves along a length of the support member as the cross-sectional area of the aperture changes (due to figure-8 like configuration). Thus, the length of the first leg changes.
Regarding claim 25, the first leg spans a first length portion of the guidewire and the loop spans a second length portion of the guidewire. Daniel in view of Brady does not expressly disclose that the first length portion is longer than the second length portion. However, it would have been obvious to one of ordinary skill in the art to have sized the device of Daniel in view of Brady to have the claimed relative dimensions since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984, cert. denied, 468 U.S. 830, 225,SPQ 232 (1984). In the instant case, the prior art device of Daniel in view of Brady would not operate differently with the claimed dimensions since the embolic protection apparatus of Daniel in view of Brady is meant to provide a filtering device having a loop with an adjustable size that conforms to the diameter of a blood vessel, and such dimensions would not interfere with this function. Further, it appears that applicant places no criticality on this feature.
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel in view of Brady as applied to claim 1 above, and further in view of Hopkins et al. (US 6,589,263). Daniel in view of Brady discloses the invention substantially as stated above except for a preferential bend region.
Hopkins discloses another embolic protection apparatus comprising an expandable loop (24 or 66/67; figs. 2a,b or 7a,b) to which a porous filter (28 or 64) is attached. The expandable loop has a preferential bend region (26 or 67) positioned approximately on an opposite side of the expandable loop from two legs of the expandable loop. The preferential region comprises what can be considered a u-shape (see esp. fig. 2b, 7; col 6, ll. 4-17). Hopkins teaches that such a preferential bend region enables the loop to be contracted to very small radii of curvature without the problems of increased stiffness and kinking (col. 2, ll. 62-col. 3, ll. 8). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Daniel to include a preferential bend region as claimed in view of Hopkins in order to enable to the loop to be contracted to very small radii of curvature without the problems of increased stiffness and kinking. With the positioning taught by Hopkins (i.e., side of loop farthest from legs), the preferential bend region will be positioned approximately on an opposite side of the loop from the crossover point.
Regarding claim 9, when a preferential bend region having a u-shape as taught by Hopkins is added to the device of Daniel, the expandable loop has a non-circular shape when expanded in an unconstrained fashion.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel in view of Brady as applied to claim 1 above, and further in view of Don Michael (US 2016/0338821). Daniel in view of Brady discloses the invention substantially as stated above except for the expandable loop having a non-circular shape in the unconstrained fashion.
Don Michael discloses another embolic protection apparatus comprising a collapsible basket comprising an expandable loop (4) at the open end of the collapsible basket. Don Michael discloses that the loop, when expanded in an unconstrained fashion, has an oval shape (considered a non-circular shape) with a larger major axis than minor axis ([0007]). According to Don Michael, such a shape allows the loop to better conform to the somewhat oval shape of some vessels such as a normal aorta ([0007]). It would have been obvious to one of ordinary skill in the art to have further modified the prior art of Daniel to construct the loop to have an oval shape (considered a non-circular) in view of Don Micheal in order to better conform to the somewhat oval shape of some vessels such as a normal aorta.
Regarding claims 10 and 11, the loop has a major diameter that is at least 5 percent longer than the minor diameter as taught by Don Micheal (40 mm versus 30 mm; [0007]). Daniel in view of Don Michael does not expressly disclose whether the vertical or horizontal diameter is larger when the loop is positioned with the guide wire at a bottom of the loop (i.e., which one of the vertical and horizontal diameters forms the major diameter and which forms the minor diameter). However, applicant has not disclosed any advantage gained, purpose served, or particular problem solved by the vertical diameter being the smaller diameter, as opposed to the horizontal diameter being the smaller diameter. The instant application discloses both configurations (see [0038] and [0039] of US 2023/0414337), with no advantage associated to either. Therefore, it would have been considered an obvious design choice to have the long dimension of the oval loop, when positioned with the wire at the bottom of the loop, form the horizontal diameter of the loop since either configuration (oval that is wider than it is tall versus oval that is taller than it is wide) would appear to perform equally well, noting that the user is free to rotate the device of Daniel as modified by Don Michael within a blood vessel to better position the shape of the loop to match that of the blood vessel.
Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel in view of Brady as applied to claims 1 and 22 above, and further in view of Ruiz (US 5,928,261). Daneil in view of Brady discloses the invention substantially as stated above but does not expressly disclose that the porous filter comprises a material arranged to fold and overlap as the expandable loop is reduced in size.
Ruiz discloses another embolic protection apparatus (fig. 1a, 1b) comprising an expandable loop (14) with a porous filter (12) attached at one end to the expandable loop. Ruiz discloses that the porous filter comprises a material arranged to fold and overlap as the expandable loop is reduced in size. In particular, Ruiz teaches including a fold (16) that enhances the ability of the filter to fold over itself when the loop is reduced in size (col. 3, ll. 33-38). It would have been obvious to one of ordinary skill in the art to have constructed the porous filter of Daniel out of a material arranged to fold and overlap as the expandable loop is reduced in size in view of the teachings of Ruiz in order to facilitate conversion of the porous filter from an expanded configuration to a lower profile retrieval/delivery configuration.
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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KSH 3/13/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771