DETAILED ACTION
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
This application contains claims directed to the following patentably distinct species:
Species A, encompassing FIGs 27-41, drawn to claims 1-14.
Species B, encompassing FIGs 63-67, drawn to claims 15-20.
The species are independent or distinct because they recite mutually exclusive characteristics of a prosthetic valve. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, no claims appear to be generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
The species or groupings of patentably indistinct species have acquired a separate status in the art in view of their different classification
The species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter
The species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Thomas Richardson on 08/04/2026 a provisional election was made without traverse to prosecute the invention of Species A, claims 1-14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 15-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ratz et al. (US 2017/0340440).
Regarding claim 1, Ratz discloses a prosthetic valve (FIG 3-6) for deployment to a native valve (Mitral valve 90, FIGS 5-6), the prosthetic valve comprising: a valve frame (Cylindrical inner portions of 20 including 12/14, FIG 1, 3, 6) surrounding a flow channel (Lumen formed by the frame); one or more prosthetic valve leaflets coupled to the valve frame and extending radially inward from the valve frame and positioned within the flow channel (60, [0017, 0038], FIG 6); a proximal tensioning body (24) positioned at a proximal portion of the prosthetic valve (FIG 3-4 and 6, [0017]); a distal tensioning body (22) positioned at a distal portion of the prosthetic valve (FIG 3-4 and 6, [0017]); and a sealing skirt (30’ or 30’’) including a proximal end portion and a distal end portion and positioned radially outward from the valve frame (FIGs 3-4 and 6 show 30 is located radially outward form the frame) with a space between the sealing skirt and the valve frame (The cross section of FIG 6 shows multiple points there 30 is separated from 20 by a space), the proximal end portion of the sealing skirt coupled to the proximal tensioning body (At 68’/68’’, FIG 3-4 and 6, [0047, 0050-0052]) and the distal end portion of the sealing skirt coupled to the distal tensioning body (See covering in FIGs 3-4 and 6), the sealing skirt being tensioned by the proximal tensioning body and the distal tensioning body ([0049-0052]; the skirt being attached to the proximal and distal tensioning body means that the skirt is tensioned by relative movement between the two elements. See FIG 6 where 30 is pulled taut) and being deflectable to conform to a shape of the native valve ([0054-0056], the skirt is made of an elastic material such that it can flex to conform to a shape of the native valve), and wherein at least one of the proximal tensioning body or the distal tensioning body comprises a ring extending circumferentially about the prosthetic valve ([0026] discloses regarding at least one or each of anchors 22 and 24 “all or part of the structure connected to the anchor tip and extending radially from the frame, including one or more rings and/or struts, can be considered part of the anchor”. Therefore, at least one of the proximal or distal tensioning bodies is understood to comprise a ring. Further, the consecutively attached tips 26 or 28 form respective rings as they extend circumferentially completely around the valve, FIG 1).
Regarding claim 2, Ratz discloses the sealing skirt surrounds the valve frame (FIG 3, 4, and 6), and a central portion of the sealing skirt is uncoupled from the valve frame and is free from the valve frame (See annotated FIG 6 below).
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Regarding claim 3, Ratz discloses the sealing skirt is elastic ([0054] “The outer skirt 30 can be made of a layer of resilient material, such as knit polyester or another stretchable or flexible fabric”) and configured to deflect radially inward to conform to the shape of the native valve (the skirt is made of an elastic material such that it can flex to conform to a shape of the native valve and deflect radially inward at the uncoupled portions).
Regarding claim 4, Ratz discloses the proximal tensioning body and the distal tensioning body each comprise a ring extending circumferentially about the prosthetic valve ([0026] discloses regarding each of anchors 22 and 24 “all or part of the structure connected to the anchor tip and extending radially from the frame, including one or more rings and/or struts, can be considered part of the anchor”. Therefore, both of the proximal and distal tensioning bodies is understood to comprise a ring).
Regarding claim 5, Ratz discloses the ring is compressible and biased to expand radially outward (The ring is formed of the same strut members and material as the frame 20. [0019] discloses the properties of the frame as being able to compress and biased to expand radially outward).
Regarding claim 6, Ratz discloses the ring includes overlapping end portions (The atraumatic tips of 28 or 26 form ends which overlap at least the more radially inward portion of the device. Examiner notes the claim as written does not specify what the end portions are overlapping relative to).
Regarding claim 7-8, Ratz discloses the distal tensioning body comprises a hook shaped distal anchor for the prosthetic valve (At least one of the tips 26, FIG 1, 3-4, and 6 is interpreted as a hook shaped anchor, [0029 and 0037]).
Regarding claim 9, Ratz discloses a slidable coupler (68, FIG 4 and 6) coupled to the distal end portion of the sealing skirt and coupled to the distal anchor (FIG 4 and 6, [0047]), the slidable coupler adapted to slide relative to the distal anchor (68 is a tab of looped material which surrounds the strut of the distal anchor at 26. This loop of material is slidable because it can rotate around the anchor since the fabric is wrapped around the strut as described in [0047]).
Regarding claim 10, Ratz discloses the sealing skirt includes a pocket (Open space formed by the loop of tab material 68, FIG 6, [0047]), and the ring is positioned within the pocket of the sealing skirt (See tip 26 received within the loop. This tip 26 is interpreted as a portion of the ring. FIG 1 shows that consecutively attached tips 26 form a ring that extends circumferentially about the valve).
Regarding claim 11, Ratz discloses the prosthetic valve is a mitral prosthetic valve or a tricuspid prosthetic valve (FIG 5, [0056-0059], the prosthetic valve is a mitral prosthetic valve).
Regarding claim 12, Ratz discloses a system for treatment of a native heart valve ([0016]), the system comprising: a prosthetic valve (FIG 3-6) for deployment to a native valve (Mitral valve 90, FIGS 5-6), the prosthetic valve comprising: a valve frame (Cylindrical inner portions of 20 including 12/14, FIG 1, 3, 6) surrounding a flow channel (Lumen formed by the frame); one or more prosthetic valve leaflets coupled to the valve frame and extending radially inward from the valve frame and positioned within the flow channel (60, [0017, 0038], FIG 6); a proximal tensioning body (24) positioned at a proximal portion of the prosthetic valve (FIG 3-4 and 6, [0017]); a distal tensioning body (22) positioned at a distal portion of the prosthetic valve (FIG 3-4 and 6, [0017]); and a sealing skirt (30’ or 30’’) including a proximal end portion and a distal end portion and positioned radially outward from the valve frame (FIGs 3-4 and 6 show 30 is located radially outward form the frame) with a space between the sealing skirt and the valve frame (The cross section of FIG 6 shows multiple points there 30 is separated from 20 by a space), the proximal end portion of the sealing skirt coupled to the proximal tensioning body (At 68’/68’’, FIG 3-4 and 6, [0047, 0050-0052]) and the distal end portion of the sealing skirt coupled to the distal tensioning body (See covering in FIGs 3-4 and 6), the sealing skirt being tensioned by the proximal tensioning body and the distal tensioning body ([0049-0052]; the skirt being attached to the proximal and distal tensioning body means that the skirt is tensioned by relative movement between the two elements. See FIG 6 where 30 is pulled taut) and being deflectable to conform to a shape of the native valve ([0054-0056], the skirt is made of an elastic material such that it can flex to conform to a shape of the native valve), and wherein at least one of the proximal tensioning body or the distal tensioning body comprises a ring extending circumferentially about the prosthetic valve ([0026] discloses regarding at least one or each of anchors 22 and 24 “all or part of the structure connected to the anchor tip and extending radially from the frame, including one or more rings and/or struts, can be considered part of the anchor”. Therefore, at least one of the proximal or distal tensioning bodies is understood to comprise a ring. Further, the consecutively attached tips 26 or 28 form respective rings as they extend circumferentially completely around the valve); and a delivery apparatus ([0059] discloses the valve to be mounted on a delivery device) including an elongate shaft for being advanced through vasculature of a patient to the native heart valve, the delivery apparatus including an implant retention area for retaining the prosthetic valve ([0059] discloses “The replacement valve can be mounted on a delivery device and delivered to the native mitral valve annulus while the replacement valve is in a radially compacted state” and “ At least a portion of the replacement valve can be released from the delivery device to thereby expand the distal anchors radially outwardly”. [0030] discloses “struts 80 may terminate at their proximal ends in an enlarged portion such as a tab 8 that may facilitate holding or retaining the proximal end of the frame, such as in a delivery system as described below”. Therefore, it is understood that the valve is loaded on to the delivery apparatus at an implantation retention area, and delivered to the native mitral valve annulus via at least some elongate shaft).
Regarding claim 13, Ratz discloses the sealing skirt surrounds the valve frame (FIG 3, 4, and 6), and a central portion of the sealing skirt is uncoupled from the valve frame and is free from the valve frame (See annotated FIG 6 above).
Regarding claim 14, Ratz discloses the proximal tensioning body and the distal tensioning body each comprise a ring extending circumferentially about the prosthetic valve ([0026] discloses regarding each of anchors 22 and 24 “all or part of the structure connected to the anchor tip and extending radially from the frame, including one or more rings and/or struts, can be considered part of the anchor”. Therefore, both of the proximal and distal tensioning bodies is understood to comprise a ring).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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