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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/05/26 has been entered.
Response to Arguments
Applicant's arguments filed 02/05/26 have been fully considered but they are not persuasive.
On page 9 regarding specification objections it appears Applicant is requesting an amendment be made to the specification.
The Examiner respectfully note amendments to the specification should be submitted in accordance with MPEP 714, and CFR 1.121.
On pages 12-14 regarding prior art rejections Applicant argues amendments overcome the rejections of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Specification
The disclosure is objected to because of the following informalities: The specification [0132] references “dashed lines at T” showing a taper, but there are no dashed lines or taper in the figures.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the shoulder must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 is objected to for missing a word between “and” and “resiliently”.
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.
Claims 1-2, 5-7, 9-17, 22-25, 32-35 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 pre-AIA the applicant regards as the invention.
Claims 1-2 is indefinite for claiming the stent device includes a plurality of closed loops that extend from the proximal end of the body and extend radially outwards from the body in the deployed state, but also claiming that the support arms bias against the native heart valve annulus, to decouple the body from cardiac-motion induced deformation. Claim 2 further clarifies that the closed loops from the proximal end of the body are for conforming to an atrial portion of the annulus. However, since claim 1 has established that the body is decoupled from cardiac-induced deformation of the annulus, and the support arms are already exerting an outward pressure against the native annulus, it is unclear how there are closed loops present, particularly when they are meant to also be conforming to the atrial portion of the annulus. Notably, as the Examiner best understands, either the body (which is defined as attaching to the closed loops) is decoupled from native annulus movement, OR the closed loops/body are connected to the native annulus. The Examiner is unclear how both can be happening at the same time. The figures do not show how this can happen, and the specification does not elaborate in any way on how both can happen at one time.
Remaining claims are rejected for depending on an indefinite claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 5-7, 9-17, 22-25, 32-33, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLean et al. (US 20130304200 A1) hereinafter known as McLean in view of Geist et al. (US 20140222136 A1) hereinafter known as Geist.
Regarding claim 1 McLean discloses a stent device for a prosthetic heart valve (Abstract) comprising:
a body (120) extending in an axial direction (101), the body comprising a tube (Figure 11a), and being configured to fit within a native heart valve annulus (Figure 10b) and defining an inner channel for providing a passageway from a proximal end to a distal end of the body (Figures 11a-c), and
a plurality of support arms (110 (e.g. 114)) extending from the distal end of the body (Figure 10a) and resilient biased radially away from the body ([0221]), each support arm, viewed in an axial profile when the stent is in a deployed state, extending radially outwards from the distal end of the body towards the proximal end (Figure 10a) such that each support arm is configured to contact and conform to the native annulus (Figure 10b, [0143]), and
wherein in the deployed state, the arms exert an outwardly-directed spring force biasing the arms against the native annulus, and decouple the body from cardiac-induced deformation, (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Geist discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed language. Notably, the isolation of the body from cardiac-induced motion deformation would appear to depend entirely on the size of the annulus into which the stent device is implanted, as well as the method and position in which it is implanted. See also [0143].),
and a plurality of closed loops extending from the proximal end of the body (Figure 26a-d, item 410 atrial retainer; [0254]-[0255] loops 416), each closed loop extending radially outward from the body in the deployed state (Figures 26a-d).
but is silent with regards to the shape of each support arm.
However, regarding claim 1 Geist teaches a stent device for a prosthetic valve which includes an axially extending body with an inner channel (Figures 35-36 item 622), and a plurality of support arms extending from the distal end of the body (626) such that each support arm comprises a convex portion (between point B to midway between points C-D) joined to a concave portion (midway between points C-D to a point between point D-E) by a transition region (the region between points C-D), and wherein each arm is formed as a loop (Figure 36) spaced apart from other arms (Figures 35-36).
McLean and Geist are involved in the same field of endeavor, namely prosthetic valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the shape of the support arms of Mclean so they are shaped as is taught by Geist since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by McLean.
Regarding claim 2 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein McLean further discloses the body is configured to fit within the native annulus (Figure 10b) and the closed loops are adapted to conform to an atrial portion of the annulus (Figure 26a-d, and [0254]-[0255]).
Regarding claim 5 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein McLean further discloses each of the closed loops comprises a rounded end (Figure 26c item 416).
Regarding claim 6 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein McLean further discloses each support arm is coupled to the distal end of the body by a shoulder (Figure 24a shows a shoulder 356).
Regarding claim 7 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein McLean further discloses each of the closed loops is spaced apart from one another (Figure 26a-d).
Regarding claim 9 the McLean Geist Combination teaches the stent device of claim 6 substantially as is claimed,
wherein Geist further teaches the axial profile is formed as an inverted S-shape or sine wave shape (Figure 35).
Regarding claim 10 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein Geist further teaches the convex portion of each arm includes a curvature forming at least one linking arm that couples the support arm to the body (Figure 36 shows two linking arms that couple the support arm to the body: left and right).
Regarding claim 11 the McLean Geist Combination teaches the stent device of claim 10 substantially as is claimed,
wherein Geist further teaches the curvature comprises two linking arms (Figure 36 shows two linking arms, a left and right linking arm for one support arm).
Regarding claim 12 the McLean Geist Combination teaches the stent device of claim 10 substantially as is claimed,
wherein Geist further teaches the curvature comprises an angle of more than 90 degrees (Figure 35).
Regarding claim 13 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein McLean further discloses there are an even number of support arms (Figure 10e shows 12 arms 114) adapted to engage a tricuspid valve (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Geist was considered capable of performing the cited intended use of implantation within a tricuspid valve if desired. Notably, it appears to be sized appropriately to fit within a tricuspid valve (see [0165].).
Regarding claim 14 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein McLean further discloses there are six support arms (Figure 10e shows at least 6 arms 114), and the device is configured for implantation in a tricuspid valve (this is stated as an intended use (see the explanation in the rejection to claim 13 above). See also [0165].).
Regarding claim 15 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein McLean further discloses a spacing between each of the support arms is symmetric (Figure 10e).
Regarding claim 16 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein McLean further discloses the body is formed by a lattice of a plurality of cells with a diamond shape (Figure 11a shows diamond-shaped cells within the lattice. See also [0199].).
Regarding claim 17 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein McLean further discloses the body is formed by a lattice of a plurality of diamond-shaped cells which are directly connected to each other, and the cells are equal in size and/or shape (Figure 11a; [0199]).
Regarding claim 22 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein McLean further discloses the body and arms are formed as a wire frame ([0150] the anchoring member can be made of wires, Figure 10a the anchoring member and body are formed of the same construction),
alternatively, Geist further teaches the body and arms are formed as a wire frame (Figure 35; [0126], [140]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the McLean Geist Combination so the body and arms are formed as a wire frame as is taught by Geist it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. In this case, the use of a wire is obvious since it is a known type of stent frame material.
Regarding claim 23 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein McLean further discloses the body or passageway defined thereby comprises an inner diameter between 29-36 mm ([0204]).
Regarding claim 24 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein McLean further discloses a portion of the arms or an outer surface of the proximal end is covered with a liquid impermeable of semi-impermeable material so as to form a cuff (Figure 11c-d item 140, [0240] blood flow inhibiting), configured to reduce peri-prosthetic leaks (this is stated as a functional limitation, which the structure of the impermeable material is understood capable of performing. See [0191]).
Regarding claim 25 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein McLean further discloses the body comprises at least two windows (Figure 11b item 129) configured for fixation of the prosthetic valve (this is stated as an intended use of the windows (see the explanation in the rejection to claim 14 above). The windows are considered capable of being “for fixation” of the valve if desired).
Regarding claim 32 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein Geist further teaches each of the arms in a deployed state tapers in a circumferential direction between a proximal end and its respective concave portion (Figure 36 shows the arms tapering to point E).
Regarding claim 33 the McLean Geist Combination teaches the stent device of claim 11 substantially as is claimed,
wherein Geist further teaches the linking arms are connected to the distal end of the body (Figure 35).
Regarding claim 35 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
wherein McLean further discloses the rounded end of the support arms is closed to the proximal end of the body than to the distal end (Figure 10a).
Claim 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mclean and Geist as is applied above, further in view of Ratz et al (US 20140277427 A1) hereinafter known as Ratz.
Regarding claim 34 the McLean Geist Combination teaches the stent device of claim 1 substantially as is claimed,
but is silent with regards to whether the loops and arms are circumferentially staggered relative to one another.
However, regarding claim 34 Ratz teaches a stent device in which proximal and distal anchors (Figures 9a items 22, 24) are circumferentially staggered relative to one another (Figures 9a-b). McLean and Ratz are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the McLean Geist Combination so that the arms and loops are staggered circumferentially with respect to one another as is taught by Ratz in order to adjust the location at which stress concentrates on the native valve annulus therebetween, in order to distribute the stress in more areas of the native tissue and potentially preserving its health and reducing injury.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/10/26
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