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 .
Election/Restrictions
Applicant’s election without traverse of Species E, shown in figs. 27-28, in the reply filed on 9/24/2025 is acknowledged. Applicant lists claims 3-5,8, 11, 13-14, 16, 22, 25-26 and 32 as reading on the elected species. However, claim 13 has been withdrawn as it does not read on elected species E, noting that the expandable shield (650) of species E does not have a trailing end that expands outwardly in response to the second direction of fluid flow (that causes movable panel to close; see claim 3) as required by claim 13. Rather, the movable panel (680) expands outwardly (movement from fig. 26 to fig. 27) in response to fluid flow in the second direction to close off fluid flow (“F2” in fig. 28).
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.
Claim 22 is 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.
Claim 22 claims a movable panel (680 in figs. 27,28) located at the leading end and coupled to the internal side of the expandable shield (650) such that fluid flow causes a leading end of the expandable shield to contract along the central axis, thereby permitting fluid flow. Although this language matches that of paragraphs [00105] and [00107] of the instant application as originally filed, figures 27 and 28 of the elected embodiment as well as the remainder of the description of this particular embodiment appear to show that fluid flow causes a leading end of the movable panel 680 (not the expandable shield 650) to contract along the central axis. See figs. 27 and 28, noting expandable shield position has not changed, but the movable panel 680 contracts along the central axis when fluid direction changes from F2 (fig. 28) to F1(fig. 27). This is in contrast to the embodiment shown in figs. 29-30, which does have a shield with a leading end that contracts along the central axis caused by fluid flow, but the movable panel is coupled to an exterior side of the shield in the embodiment of figs. 29-30. As best understood in view of the remaining description of figs. 27-28, and what is illustrated in figs. 27-28, it appears claim 22 should read “…such that fluid flow that impinges the movable panel causes a leading edge of the movable panel to contract toward the center axis, thereby permitting fluid flow.” and has been thus treated for purposes of claim interpretation in the interest of compact prosecution.
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) 3-5, 8, 11, 14, 16, 25-26 and 32 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Cohn et al. (US 2005/0015112). Cohn discloses a surgical system, comprising: a shaft (2; figs. 9a,9b) that is elongated along a central axis; an expandable shield (3) carried by the shaft, the expandable shield having an insertion configuration (fig. 3a), where the expandable shield is collapsed toward the central axis, and an expanded configuration (fig. 3b), where the expandable shield is expanded outwardly away from the central axis ([0119]); and a movable panel (26; figs. 9a, 9b) coupled to the expandable shield, wherein the movable panel is configured to open (fig. 9b) in response to a fluid flow in a first direction that impinges the expandable shield, and close (fig. 9a) in response to fluid flow in a second direction that is opposite the first direction that impinges the expandable shield ({0119]).
Regarding claim 4, the expandable shield has a non-porous section (when considering a section that consists only of a length of a strand of the mesh forming the expandable shield 3; this interpretation is consistent with how the elected species would read on this claim), a porous section (conical section over which 26 lies that includes openings within mesh), wherein the movable panel overlies the porous section (fig. 9a).
Regarding claim 5, the movable panel is configured, such that, 1) fluid flow in the first direction opens the movable panel to permit fluid to flow through the porous section (fig. 9b), and 2) fluid flow in the second direction that is opposite the first direction causes the movable panel to close to inhibit fluid flow through the porous section (fig. 9a).
Regarding claim 8, the movable panel is one of: a tapered panel that overlies a porous section of the expandable shield (considered tapered since it tapers inward as shown in fig. 9a); and a curved panel that overlies the porous section of the expandable shield (considered curved as it overlies conical shield and thus is understood to be conical).
Regarding claim 11, the movable panel is a) configured to rotate into an open configuration or b) configured to slide into the open configuration. In particular, the movement shown from figs. 9a to 9b can be considered pivotal rotation about the distal, attached end of the movable panel.
Regarding claim 14, the movable panel is a plurality of movable panels (see fig. 4b, wherein valve mechanism 26 comprises two panels) that overlie a plurality of porous sections, respectively, wherein the plurality of movable panels are independently responsive to fluid flow to open or close, noting that movement of one panel does not affect the other and therefore are considered independently responsive to fluid flow.
Regarding claim 16, the surgical system further comprises: an elongated shaft (constant diameter portion of guiding catheter 700; fig. 3a) that extends through a central portion of the expandable shield (as understood in view of figs. 3a,3b); and a nose cone (tapered end of 700 in fig. 3a) carried by the elongated shaft, wherein the nose cone is movable relative to the expandable shield in at least a distal direction (as understood in view of figs. 3a, 3b, nose cone is movable relative to shield and could be moved distally from a position retracted within shaft 2 to the position shown in fig. 3a).
Regarding claim 25, the system further comprising at least one deployment actuator (sheath 1) coupled the expandable shield, the at least one deployment actuator configured to cause the expandable shield to transition between the insertion configuration and the expanded configuration (e.g., retracting sheath to expose shield causes shield to expand).
Regarding claim 26, the expandable shield has a frame (mesh structure 3) that is configured to expand outwardly away from the central axis.
Regarding claim 32, the system further comprising a sheath (1) configured for placement in an aorta of a cardiovascular system, the sheath having a distal end, a proximal end, and a sheath channel that extends from the distal end to the proximal end.
Claim(s) 3-5, 8, 11, 14, 16, 22, 25-26 and 32 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Snyders (6,821,297). Snyders discloses a surgical system, comprising: a shaft (e.g., 94/90) that is elongated along a central axis; an expandable shield (20) carried by the shaft, the expandable shield having an insertion configuration (fig. 5), where the expandable shield is collapsed toward the central axis, and an expanded configuration (fig. 6; 10A), where the expandable shield is expanded outwardly away from the central axis; and a movable panel (22) coupled to the expandable shield, wherein the movable panel is configured to open (shown in phantom lines in fig. 3) in response to a fluid flow in a first direction that impinges the expandable shield, and close (solid lines in fig. 3) in response to fluid flow in a second direction that is opposite the first direction that impinges the expandable shield (col. 7, ll. 7-35).
Regarding claim 4, the expandable shield (20) has a non-porous section (when considering a section that consists only of a length of one of the struts 30 forming the expandable shield; this interpretation is consistent with how the elected species would read on this claim), a porous section (when considering a section that includes adjacent struts and the space between the adjacent wire), wherein the movable panel overlies the porous section (see fig. 2).
Regarding claim 5, the movable panel is configured, such that, 1) fluid flow in the first direction opens the movable panel to permit fluid to flow through the porous section (see configuration of movable panel that forms openings 60 in fig. 3, phantom lines), and 2) fluid flow in the second direction that is opposite the first direction causes the movable panel to close (openings 60 are closed; shown in solid lines in fig. 3) to inhibit fluid flow through the porous section.
Regarding claim 8, the movable panel is one of: a tapered panel that overlies a porous section of the expandable shield (note tapered shape in fig. 2); and a curved panel that overlies the porous section of the expandable shield (see figs. 2,3; panel is also curved).
Regarding claim 11, the movable panel (22) is a) configured to rotate into an open configuration or b) configured to slide into the open configuration. Since panel (22) rotates inwardly relative to its fixed apex 54, which is attached to the shield 20 at junction 32 and material of the panel functions as a living hinge, it is considered to rotate into an open configuration.
Regarding claim 14, the movable panel is a plurality of movable panels (valve element 22 forms “flaps 58”, which are each considered a movable panel) that overlie a plurality of porous sections (corresponding to each movable panel), respectively, wherein the plurality of movable panels are independently responsive to fluid flow to open or close (note: since movement of one panel does not affect movement of the others, they are considered independently response to fluid flow).
Regarding claim 22, as best understood in view of the 35 USC 112b rejection above, the expandable shield has a leading end (closed end near 32; see fig. 2 and fig. 5), a trailing end (larger diameter end) spaced rearward of the leading end, an internal side, an external side that opposes the internal side, and an expandable wire frame (formed by struts 30) that defines the trailing end, such that, the trailing end is expandable outwardly away from the central axis to open the expandable shield into the expanded configuration (from fig. 5 to fig. 1), wherein the movable panel is located at the leading end and coupled to the internal side of the expandable shield (see fig. 2,3), such that fluid flow that impinges the movable panel causes a leading portion of the movable panel to contract toward the central axis (to form openings 60 as understood in view of figs. 2, 3), thereby permitting fluid flow. See the 35 USC 112b rejection above, noting that it appears that “a leading portion of the expandable shield” should read “a leading portion of the movable panel” as discussed above.
Regarding claim 25, the system further comprising at least one deployment actuator (96/102) coupled the expandable shield, the at least one deployment actuator configured to cause the expandable shield to transition between the insertion configuration and the expanded configuration (i.e., by pushing the shield out of holder 90).
Regarding claim 26, the expandable shield has a frame (formed by struts 30) that is configured to expand outwardly away from the central axis.
Regarding claim 32, the system further comprising a sheath (90) configured for placement in an aorta of a cardiovascular system, the sheath having a distal end, a proximal end, and a sheath channel that extends from the distal end to the proximal end (fig. 5), noting that the shaft (claim 2, from which claim 32 ultimately depends) may be considered either manipulator 94 or push rod 102.
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 10/23/2025
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771