DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
This application contains claims directed to the following patentably distinct species: Species I: claims 1-9 and Species II: claims 10-20. The species are independent or distinct because the claims to different species recite the mutually exclusive characteristics of such species, particularly the features of the sealing feature wherein Species I comprises a partial sealing feature and Species II comprises a full sealing feature. 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, claims 1, 10, and 16 are 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; and
--the species or groupings of patentably indistinct species require a different field of search.
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 Mark Stevenosky on 11 March 2026 a provisional election was made without traverse to prosecute the invention of Species II, claims 10-20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-9 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 § 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 10-20 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.
The term “substantially” in claims 10 and 16 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what qualifies as “substantially” blocking blood flow and what qualifies as “substantially” orthogonal regarding the claims. Applicant’s definition of “substantially” in [0040] of the specification does not provide any clarification. Claims 11-14 and 17-20 are rejected by dependency.
The term “partially” in claims 11, 16, and 20 are a relative term which renders the claim indefinite. The term “partially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what qualifies as “partially bounded” with respect to the pockets mentioned in the claims, such as whether it means the pocket is partially covered by a layer/flap, etc. or whether there is a limitation to the permeability of the pocket. Further clarification is required. Claims 15 and 17-20 are rejected by dependency.
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.
Claims 10-12 and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkart et al. (US 2022/0183831 A1), “Burkhart”.
Regarding claim 10, Burkart teaches
A prosthetic heart valve (Fig. 2A, prosthetic valve 1000), comprising: an inner frame (Fig. 2A, leaflet frame subcomponent 1200) having a longitudinal axis (Fig. 2A, longitudinal axis X);
a plurality of prosthetic leaflets coupled to the inner frame (Fig. 2A, leaflet frame subcomponent 1200 comprising leaflets 1230),
the plurality of prosthetic leaflets configured to allow blood to flow through the inner frame in an antegrade direction along the longitudinal axis (flexible leaflets coupled to the leaflet frame are operable to open to allow flow in antegrade direction [0036]) and
to substantially block blood from flowing through the inner frame in a retrograde direction along the longitudinal axis (flexible leaflets coupled to leaflet frame are operable to close to restrict flow in a retrograde direction [0036]);
an outer frame connected to the inner frame (Fig. 2A, anchor frame subcomponent 1100);
a sealing feature (Fig. 11A, connecting sheath 1300) including a first portion coupled to the inner frame at a first coupling point (Fig. 11A, portion of connecting sheath 1300 connected to leaflet frame subcomponent 1200 at inflow end 1202),
a second portion coupled to the outer frame at a second coupling point (Fig. 11A, portion of connecting sheath 1300 connected to anchor frame subcomponent 1100 at outflow end 1104); and
an embolic retention feature coupled to the outer frame at a third coupling point (Fig. 11A, inflow annular groove cover 1400 connected to anchor frame subcomponent 1100 nearest inflow end 1102),
wherein the embolic retention feature has a permeability that is greater than at least one of the first portion or the second portion (Fig. 11A, inflow annular groove cover is blood-permeable in extended configuration [0122] whereas connecting sheath 1300 is less permeable to blood [0181, 0184-0185]).
Regarding claim 11, Burkart teaches
wherein the first portion (Fig. 11A, portion of connecting sheath 1300 connected to leaflet frame subcomponent 1200 at inflow end 1202),
the second portion (Fig. 11A, portion of connecting sheath 1300 connected to anchor frame subcomponent 1100 at outflow end 1104),
the inner frame (Fig. 2A, leaflet frame subcomponent 1200), and
the outer frame (Fig. 2A, anchor frame subcomponent 1100) define a partially bounded first pocket that is open and faces a ventricular side of the prosthetic valve (Fig. 11A, connecting sheath lumen 1340), and
the second portion (Fig. 11A, portion of connecting sheath 1300 connected to anchor frame subcomponent 1100 at outflow end 1104),
embolic retention feature (Fig. 11A, inflow annular groove cover 1400 connected to anchor frame subcomponent 1100 nearest inflow end 1102), and
outer frame (Fig. 2A, anchor frame subcomponent 1100) define a bounded pocket configured to retain a blood clot therein (Fig. 11A, embolus may form in inflow annular groove 1704 [0210]).
Regarding claim 12, Burkart teaches
wherein the embolic retention feature has a permeability that is greater than both of the first portion and the second portion (Fig. 11A, inflow annular groove cover is blood-permeable in extended configuration [0122] whereas connecting sheath 1300 is less permeable to blood [0181, 0184-0185]).
Regarding claim 15, Burkart teaches
wherein the third coupling point is positioned radially outward relative to the second coupling point (Figs. 11A, inflow end 1102 is further radially distanced from axis X than outflow end 1104).
Regarding claim 16, Burkart teaches
A prosthetic heart valve (Fig. 2A, prosthetic valve 1000), comprising:
an inner frame (Fig. 2A, leaflet frame subcomponent 1200) having a longitudinal axis (Fig. 2A, longitudinal axis X);
a plurality of prosthetic leaflets coupled to the inner frame (Fig. 2A, leaflet frame subcomponent 1200 comprising leaflets 1230),
the plurality of prosthetic leaflets configured to allow blood to flow through the inner frame in an antegrade direction along the longitudinal axis (flexible leaflets coupled to the leaflet frame are operable to open to allow flow in antegrade direction [0036]) and
to substantially block blood from flowing through the inner frame in a retrograde direction along the longitudinal axis (flexible leaflets coupled to leaflet frame are operable to close to restrict flow in a retrograde direction [0036]);
an outer frame (Fig. 2A, anchor frame subcomponent 1100);
a sealing feature (Fig. 11A, connecting sheath 1300) coupled to the inner frame at a first coupling point (Fig. 11A, portion of connecting sheath 1300 connected to leaflet frame subcomponent 1200 at inflow end 1202) and
extending radially outward and coupling to the outer frame at a second coupling point (Fig. 11A, portion of connecting sheath 1300 extends diagonally to connect to anchor frame subcomponent 1100 at outflow end 1104); and
an embolic retention feature coupled to the outer frame at a third coupling point (Fig. 11A, inflow annular groove cover 1400 connected to anchor frame subcomponent 1100 nearest inflow end 1102) that is distinct from the second coupling point such that a partially bounded pocket is defined (Fig. 11A, connecting sheath lumen 1340) and
a bounded pocket is defined (Fig. 11A, inflow annular groove 1704), wherein the bounded pocket is configured to retain a blood clot therein (Fig. 11A, embolus may form in inflow annular groove 1704 [0210]).
Regarding claim 17, Burkart teaches
wherein the sealing feature (Fig. 11A, connecting sheath 1300) comprises a first portion (Fig. 11A, portion of connecting sheath 1300 connected to leaflet frame subcomponent 1200 at inflow end 1202) and a second portion (Fig. 11A, portion of connecting sheath 1300 connected to anchor frame subcomponent 1100 at outflow end 1104).
Regarding claim 18, Burkart teaches
wherein a combination of the first portion (Fig. 11A, portion of connecting sheath 1300 connected to leaflet frame subcomponent 1200 at inflow end 1202) and
the embolic retention feature (Fig. 11A, inflow annular groove cover 1400 connected to anchor frame subcomponent 1100 nearest inflow end 1102) spans an entire annular span (Fig. 11A, inflow annular groove cover 1400 extends from inflow end 1202 to inflow end 1102) between the first coupling point (Fig. 11A, inflow end 1202) and the third coupling point (Fig. 11A, inflow end 1102).
Regarding claim 19, Burkart teaches:
wherein the embolic retention feature has a greater permeability than both of the first portion and the second portion (Fig. 11A, inflow annular groove cover is blood-permeable in extended configuration [0122] whereas connecting sheath 1300 is less permeable to blood [0181, 0184-0185]).
Regarding claim 20, Burkart teaches
wherein the partially bounded pocket (Fig. 11A, connecting sheath lumen 1340) is defined in part by the first portion (Fig. 11A, portion of connecting sheath 1300 connected to leaflet frame subcomponent 1200 at inflow end 1202 forms upper region of connecting sheath lumen 1340) and the second portion (Fig. 11A, portion of connecting sheath 1300 connected to anchor frame subcomponent 1100 at outflow end 1104 forms lower region of connecting sheath lumen 1340)
such that the partially bounded pocket is radially inward relative to the bounded pocket (Fig. 11A, connecting sheath lumen 1340 is nearer axis X than inflow annular groove 1704).
Claim Rejections - 35 USC § 103
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 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.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Burkart et al. (US 2022/0183831 A1), “Burkhart” in view of Hariton et al. (US 2022/0249230 A1), “Hariton”.
Regarding claim 13, Burkart teaches the inner frame (Fig. 2A, leaflet frame subcomponent 1200) and outer frame (Fig. 2A, anchor frame subcomponent 1100), but fails to teach wherein the inner frame comprises a first coupling arm extending radially outward of the longitudinal axis and the outer frame comprises a second coupling arm extending radially inward toward the longitudinal axis such that the first coupling arm and the second coupling arm meet and are coupled together at an anchoring point.
Hariton teaches an expandable prosthetic valve wherein the inner frame comprises a first coupling arm extending radially outward of the longitudinal axis (Fig. 2A, inner frame 2400 comprises struts that lead to strut junctions 3204) and the outer frame comprises a second coupling arm extending radially inward toward the longitudinal axis (Fig. 2A, outer frame 2200 comprises struts that lead to leg attachment junctions 3802) such that the first coupling arm and the second coupling arm meet and are coupled together at an anchoring point (Fig. 2A, outer frame 2200 and inner frame 2400 are connected by a plurality of connector pins 2040 [0066]). Hariton discloses that the connector pins may be positioned away from the atrial ends of the inner and outer frames to secure the two frames together [0157-0158]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the inner and outer frames taught by Burkart with the coupling arms and anchoring point taught by Hariton in order to secure the frames together without obstructing the valve.
Regarding claim 14, Burkart teaches wherein the second coupling point (Fig. 11A, outflow end 1104) is on a ventricular side [0098] and the third coupling point (Fig. 11A, inflow end 1102) is on an atrial side [0098], but fails to teach an anchoring point.
Hariton teaches an expandable prosthetic valve comprising an anchoring point (Fig. 2A, outer frame 2200 and inner frame 2400 are connected by a plurality of connector pins 2040 [0066]). Hariton discloses that the connector pins may be positioned away from the atrial ends of the inner and outer frames to secure the two frames together [0157-0158]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the coupling points taught by Burkart with the anchoring point taught by Hariton in order to secure the frames together without obstructing the valve.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.G.R./Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774