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 to the claims have overcome the previously presented 35 USC 112b rejection and 35 USC 102a1 rejections over Cohn et al. (US 2005/0015112).
Applicant's arguments filed 4/28/2026 with respect to the amendments overcoming the prior art of Snyders (6,821,297) have been fully considered but they are not persuasive. Applicant asserts that Snyders fails to disclose that the rearward end of the movable panel collapses toward the central axis to permit fluid flow as now required by the amended claims since a part of the rearward end remains attached to the frame at three attachment points 56 as illustrated in fig. 3. The examiner respectfully disagrees. The attachment points occur at three points equally spaced about the circumference of the rearward end. At all points between these three attachment points, the rearward end of the movable panel collapses toward the central axis to permit fluid flow as best illustrated by the phantom lines shown in fig. 3 of Snyders. Thus, the prior art of Snyders meets this limitation, and the remaining limitations of claim 3 as discussed in the below rejections in more detail. Applicant notes that, in the case of the instant invention, the entire rearward end of the movable panel moves towards the central axis. However, the claim as currently worded does not require that the entire rearward end of the movable panel moves toward the central axis.
Claims 6-7, 10, 13, 23, and 27-31 were indicated as withdrawn in the previous office action and remain withdraw. Claims 6-7, 10, 13, 23, and 27-31 should have the status identifier “withdrawn”.
Claim Objections
Claim 22 is objected to because of the following informalities: “a rearward end” should read “the rearward end” as it has been previously recited in amended claim 3, from which claim 22 depends. 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.
Claim 16 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. The amendment to claim 16 has rendered the claim indefinite, as the claim now reads “wherein the nose cone is movable relative to in at least a distal direction”, and does not include what the nose cone is movable relative to. For purposes of claim interpretation, claim 16 is being treated as though it reads “wherein the nose cone is movable
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, 22, 25-26 and 32 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Snyders (US 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 a leading end, a trailing end spaced rearward of the leading end, an internal side and an external side opposite the internal side, 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) having a forward end coupled to the leading end of the expandable shield, and a rearward end, wherein while the expandable shield is in the expanded configuration, the movable panel is configured to, in a first state (shown phantom lines in fig. 3), in response to fluid flow in a first direction that impinges the movable panel, cause the rearward end of the movable panel to collapse toward the central axis to permit fluid flow, and in a second state (solid lines in fig. 3), in response to fluid flow in a second direction that is opposite the first direction that impinges the movable panel, cause the rearward end of the movable panel to expand away from the central axis to inhibit fluid flow. open (shown in phantom lines in fig. 3) in response to a fluid flow in a first direction that impinges the expandable shield (col. 7, ll. 7-35).
Regarding claim 4, the expandable shield is a membrane (noting shield is considered struts 30 and strips 42,40 of Dacron or porous ePTFE) having a non-porous section (e.g., section that consists only of a strut 30), a porous section including pores (section that includes two adjacent struts, the space between these adjacent struts, and the porous ePTFE strip 42 on the two struts; col. 6, ll. 56-col. 7, ll. 6; wherein the movable panel overlies the porous section (noting panel 22 overlies the inner surface of band 40 as well as the struts and spaces therebetween; figs. 2, 3).
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 16, Snyder discloses an elongated shaft (guidewire 214) that extends through a central portion of the expandable shield (fig. 16) and a nosecone (see conical portion near end of 352, which includes a conical portion connecting smaller and larger diameter portions) carried by the elongated shaft (328 is mounted on 214), wherein the nosecone is movable in at least a distal direction.
Regarding claim 22, the expandable shield is an expandable wire frame (noting wire struts 30) that defines the trailing end, and 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 in the first direction that impinges the movable panel causes the rearward end 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.
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.
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) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snyders in view of Gailloud et al. (US 2009/0018636). Snyders discloses the invention substantially as stated above including that the leading end of the expandable shield includes a tip (36/300) which may include an opening therethrough to accommodate a surgical device such as a guidewire (214; best shown in fig. 16), but fails to disclose that the tip is expandable to allow one or more surgical devices to pass through.
Gailloud discloses another intravascular device used to control blood flow, the intravascular device comprising an expandable shield (110) that includes a tip (150/160; fig. 3a), the tip expandable to allow one or more surgical devices (guidewire) to pass through. In particular, the tip includes elastic leaflets (162; fig. 4) that deform outwardly such that the passage through the tip expands to accommodate a guidewire, and thereafter snap back on each other to close the hole after the guidewire is removed to prevent material from passing through the tip ([0059]-[0060]). It would have been obvious to one of ordinary skill in the art to have modified the tip of the prior art of Snyders include elastic flaps that deform outwardly to expand the opening through the tip in order to form a seal around the guidewire when the guidewire is passed through the tip, and to block fluid flow through the tip when the guidewire is removed. Because the tip of Snyders as modified by Gailloud has an expandable opening formed by the elastic flaps of the tip, it is considered “expandable to allow one or more surgical devices to pass through”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 5,413,599 to Imachi et al. discloses a medical valve comprising a funnel shaped shield (8; figs. 3A-C) and a movable panel (7) having a rearward end (free end) that collapses towards the central axis of the device to permit fluid flow (movement from fig. 3C to fig. 3A).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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 6/11/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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