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 .
Response to Arguments
Applicant's arguments filed 05/20/26 have been fully considered but they are not persuasive.
On page 10 regarding drawing objections Applicant argues amendments overcome most of the drawing objections, but Figures 17e-g show the subject matter the Examiner believes is missing from the drawings
The Examiner respectfully disagrees, noting it doesn’t appear all the elements are shown in the drawings. Please see the drawing objection below regarding the amended scope of the claims.
On pages 10-11 Applicant argues amendments to the claims overcome the specification objections.
The Examiner respectfully refers to the specification objections below, which are updated in light of amendments to the claim.
On page 11 Applicant argues amendments to the claims overcome the 112 rejections.
The Examiner respectfully refers to the rejections below, which are updated in light of amendments to the claim.
On pages 11-12 regarding prior art rejections Applicant argues amendments overcome the rejection of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
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 distalmost free end of the engaging arms, the retraction direction of the tubular delivery sheath 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: distalmost free end of the engaging arms, the retraction direction of the tubular delivery sheath.
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 20, 23-25, 27-31 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 20 is indefinite for claiming the engaging arms are “generally” parallel with the tubular delivery sheath, but it is unclear what it means to be “generally” parallel (for example, as is compared to being parallel with the sheath or not parallel with the sheath). The specification does not elaborate on what might be considered “generally parallel” and what would not be, meaning the Examiner has no guidance as regards what might fit within the scope of the claim and what might not. Without understanding the boundaries of the claim, it is considered to be indefinite.
Further, the claim is unclear for claiming “the plurality of engaging arms being pivotally moveable between a loaded condition in which the plurality of engaging arms is generally parallel with the tubular delivery sheath, and the distalmost free end of each of the plurality of engaging arms points in a first direction that is opposite a retraction direction of the tubular sheath,
a partially released condition, and a fully-released condition in response to axial movement of the tubular delivery sheath”.
The phrasing and wording of this makes it unclear whether the arms’ distalmost free end needs to point in the first direction opposite the retraction direction of the sheath in the loaded condition, or whether this is the alternative condition the arms are pivotally moveable between. It appears from the specification that either situation could be the possible interpretation, but the grammar and separation in lines relating to the “partially released” and “fully-released” conditions make this confusing.
Remaining claims are rejected for depending on an indefinite claim.
Claim Rejections - 35 USC § 102
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) 20, 23-25, 27-30, is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Moriss et al. (US 20150327994 A1) hereinafter known as Moriss (as is evidenced by Gabbay (US 20080114452 A1)).
Regarding claim 20 Moriss discloses a method of treating a native tricuspid valve ([0091] an aortic valve is a native tricuspid valve; alternatively, the Examiner notes that since Moriss describes their leaflets being useful for replacing either bi-leaflet or tri-leaflet valves in the heart, and there are only four valves in the healthy human heart, the person of ordinary skill in the art at the time the invention was filed would have found it obvious for treating the native tricuspid valve in the manner consistent with tri-leaflet repair) comprising:
providing a tubular delivery sheath (Figures 2b1-2, 8-12 all show delivery sheaths (e.g. item 20, 226, 200, 238, etc.));
loading a prosthetic tricuspid valve within the sheath (Figures 2b1-2, 8-12),
wherein the valve includes: a collapsible and self-expandable stent ([0203]) extending along a longitudinal axis (110a) and having an inflow and outflow end ([0098]), the stent including a plurality of struts forming a plurality of cells ([0150]) annularly arranged around the stent in at least two rows (for example, Figure 2a1), wherein a first row is positioned adjacent the outflow end of the stent (for example, Figure 2a1 near the bottom of the figure); and a collapsible and expandable valve assembly within the stent ([0166], [0103]) which includes a cuff ([0148]) and a plurality of leaflets ([0155]), the cuff covering at least some of the cells ([0148]); and a plurality of engaging arms (120) disposed adjacent the first row of cells (for example, Figure 2a1; see also [0098]) and being disposed radially outward of the cuff (for example, see Figure 2a1), each of the arms being connected to the stent ([0098], see also, for example Figure 2a1) and having a free end (for example, see Figure 2a1; see also [0098] atraumatic tips), the arms being pivotally moveable between a loaded condition in which each of the arms is generally parallel with the sheath (Figure 2b2 shows the arms generally parallel with the sheath in this loaded condition), and the distalmost free end of each arm points in a first direction that is opposite a retraction direction of the sheath (Figures 12e-g show the ends of the arms being bent outward, Figure 6a2 shows how the arms can also take a shape so that the distalmost free end of the arm points in a first direction (Figure 6a2 shows the arm’s distalmost free end pointing downward) which is opposite from the retraction direction of the tubular sheath (Figure 12g)), a partially-released condition, and a fully-released condition ([0110]), in response to axial movement of the sheath ([0110] the arms automatically expand in response to the support’s expansion, [0166] the support self-expands when the sheath is withdrawn (axially)), and
withdrawing the sheath toward an operator by a first distance (Figure 12f) to transition the arms from the loaded condition where the arms are oriented substantially parallel with the longitudinal axis of the stent to the partially-released condition in which each of the arms extends radially outward from the stent to form a first angle with the longitudinal axis (Figure 12f), and
withdrawing the sheath toward the operator by an additional second distance after the first distance (Figure 12g) to transition the arms from the partially-released condition to the fully-released condition in which each of the arms extends radially outward from the a second angle with the longitudinal axis of the stent, wherein the first angle is larger than the second angle ([0102], [0203], [0110]; the sheath covering the arms and self-expandable support is withdrawn to allow arms to be extended; the support is moved upward towards the valve so the native leaflets are located between the support and arms; the arms automatically move to close the distance to grasp the leaflets more tightly),
wherein a combination of the axial movement of the sheath and biasing of the engaging arms is solely responsible for transitioning the arms from the partially-released to the fully-released condition ([0110] the arms automatically expand in response to the support’s expansion, [0166] the support self-expands when the sheath is withdrawn (axially). See also evidence from Gabbay [0020] who indicates that “automatic” movement is known to be attributable to self-expansion).
Regarding claim 23 Moriss discloses the method of claim 21 substantially as is claimed,
wherein Moriss further discloses transitioning the arms includes moving the arms back closer to the longitudinal axis to capture one or more native leaflets between the arms and the stent ([0102], [0203], [0110]; the sheath covering the arms and self-expandable support is withdrawn to allow arms to be extended; the support is moved upward towards the valve so the native leaflets are located between the support and arms; the arms automatically move to close the distance to grasp the leaflets more tightly).
Regarding claim 27 Moriss discloses the method of claim 21 substantially as is claimed,
wherein Moriss further discloses withdrawing the sheath comprises sequentially transitioning each of the arms from the loaded to the partially-released condition, and from the partially-released condition to the fully-released condition ([0102], [0203], [0110]; the sheath covering the arms and self-expandable support is withdrawn to allow arms to be extended from the loaded condition to the partially-released condition; the support is moved upward towards the valve so the native leaflets are located between the support and arms; the arms automatically move to the fully-released condition to close the distance to grasp the leaflets more tightly).
Regarding claim 30 Moriss discloses the method of claim 21 substantially as is claimed,
wherein Moriss further discloses the sheath withdrawing the second distance transitions each of the arms from an intermediate configuration in the partially-released condition to a relaxed configuration in the fully-released condition ([0102], [0203], [0110]).
Regarding claim 24 Moriss discloses the method of claim 20 substantially as is claimed,
wherein Moriss further discloses a sequential release from the sheath causes each of the arms to extend further away from the longitudinal axis and then back closer to the axis ([0102], [0203], [0110]; the sheath covering the arms and self-expandable support is withdrawn to allow arms to be extended; the support is moved upward towards the valve so the native leaflets are located between the support and arms; the arms automatically move to close the distance to grasp the leaflets more tightly).
Regarding claim 25 Moriss discloses the method of claim 20 substantially as is claimed,
wherein Moriss further discloses the arms are spaced circumferentially from one another ([0164]).
Regarding claim 26 Moriss discloses the method of claim 20 substantially as is claimed,
wherein Moriss further discloses the arms include a curved, smooth atraumatic feature adjacent a terminal end ([0120]; see also, for example, Figure 2a5 item 122).
Regarding claim 28 Moriss discloses the method of claim 20 substantially as is claimed,
wherein Moriss further discloses the sheath is withdrawn to release the arms simultaneously (see Figure 12f; the arms are the same length indicating their release is simultaneous).
Regarding claim 29 Moriss discloses the method of claim 20 substantially as is claimed,
wherein Moriss further discloses loading the valve includes radially compressing the arms in the loaded condition within the sheath (see Figure 12e).
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) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss (evidenced by Gabbay) as is applied above, further in view of Quill et al. (US 20140194975 A1) hereinafter known as Quill.
Regarding claim 31 the Moriss Combination teaches the method of claim 20 substantially as is claimed. Moriss further teaches the arms move from the partially-released to the fully-released configuration automatically when the stent is self-expanded ([0110], and Gabbay indicates that automatic movement indicates self-expansion ([0020]), which indicates to the person of ordinary skill that the arms are expanded to the various partially-released and fully-released configurations once they are free from the sheath. Moriss is not explicit within their disclosure regarding the position of the stent when the arms transition from the partially-released to fully-released configurations. However, various embodiments (see at least Figures 9, 11), show the stent being partially located within the sheath even though arms are released, although other embodiments show the stent fully out of the sheath when the arms are expanding.
Further, regarding claim 31 Quill teaches that stents with arms can be deployed with the stent remaining in the sheath until the arms are fully deployed ([0008]. Moriss and Quill are involved in the same field of endeavor, namely valves. The person of ordinary skill in the art, at the time the invention was filed, would have accordingly found it obvious to have at least a portion of the stent maintained within the sheath when the sheath withdraws the second distance and the arms transition from the partially-released to the fully-released condition since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the person of ordinary skill would have found it obvious to try either method (having the arms deployed with the stent either partially retained in the sheath, or fully released).
Claim 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss as is applied above in view of Essinger et al. (US 20140200649 A1) hereinafter known as Essinger.
Regarding claim 32 Moriss discloses the method of claim 20 substantially as is claimed,
but is silent with regards to the distalmost free end being the first portion of the arms to be released from the sheath.
However, regarding claim 32 Essinger teaches that delivery sheaths can be split, so that the distalmost part of the implant located therein is released before any other portion of the implant (Figures 2a-c). Moriss and Essinger are involved in the same field of endeavor, namely delivery methods of implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the delivery method of Moriss so that any part of the arm or valve therein is released first, including so the distalmost free ends of the arm is a first portion to be released from the sheath, such as is supported by Essinger since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). The use of any known release mechanism, order of delivery, or type of sheath would have been obvious to one of ordinary skill in the art to try.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 06/02/26
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