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 07/17/26 have been fully considered but they are not persuasive.
On pages 8-9 regarding claim objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws outstanding objections.
On pages 9-11 regarding drawing objections Applicant argues amendments overcome the objections of record. Applicant argues the elements from the claim need not be referred to by name in the specification, and states the elements are shown, listing where they are seen.
The Examiner respectfully disagrees, noting for example, that while Applicant states that the “tubular wall” is seen in at least 12 figures, there are many elements that might be representing this “tubular wall”, but since it is not discussed, pointed out, or labeled in any way, the Examiner is unclear on what exactly the tubular wall is and where in any of those figures the element might be. Similarly, Applicant states generally that the plurality of closed wire shapes, inner perimeter, through opening, closed wire shapes, wire segments, the weld, wire diameter, etc. are all seen in figures 9a-c and 10, none of these elements have been pointed out by the figures or specification, and the Examiner is unable to understand what exactly Applicant thinks any of these structures are. The Examiner suggests amending the claims to correspond to the specification/drawings, or amending the specification and drawings to include reference to the claimed elements. The objections are maintained.
On pages 11-13 regarding 112 rejections Applicant argues amendments overcome the rejections of record.
The Examiner respectfully agrees and withdraws 112 rejections.
On pages 13-16 regarding prior art rejections, Applicant argues that Dibie’s eyelets 44 are “clearly not attached to the frame, but are instead formed in situ as part of its laser cutting process”.
The Examiner respectfully disagrees. With regards to suggestions that eyelets are not attached to the frame since they have an integral formation with the frame, this is not persuasive. Merriam-Webster defines “attached” as “connected or joined to something”. There is no part of this definition that indicates something needs to be separately formed in order to be considered attached to something else. An integral attachment is understood to meet the broadest reasonable limitation of this claim.
On pages 14-16 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 tubular wall, closed delivery loop, the central lumen, the plurality of closed shapes, the inner perimeter, the through opening, the closed delivery loop attached to the closed stent shapes, the closed stent shapes (claim 1), the plurality of closed wire shapes, wire segment, the wire segments being welded end-to-end (claim 5), the wire diameter, and maximum wire transverse cross-sectional dimension (claim 6), the plurality of closed shape opening diameter, the maximum opening transverse cross-sectional dimension (claim 7), the end region of the plurality of longitudinal struts (claim 10), the end of the longitudinal struts (claim 11), the folded double wall (claim 13), the first plurality of closed shapes (claim 14), the junction comprising two circumferential struts (claim 19), the junctions comprising four struts from the circumferential struts (claim 22), the longitudinal slots and barb projecting from each slot (claim 23) 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
Claims 1, 12-13 are objected to because of the following informalities:
Claim 1 is objected to for referring to “closed stent shapes” when it is unclear how, if at all, this relates back to the previously claimed “closed shapes”.
Claim 12 is objected to for referring to “a longitudinal strut” when it is unclear how, if at all, this relates back to the previously claimed “plurality of longitudinal struts”.
Claim 13 is objected to for referring to a “folded double wall configuration” when it is believed this requires a hyphen for proper grammar.
Appropriate correction is required.
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.
Claims 1, 3-7, 9-14, 19, 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dibie et al. (US 20220175523 A1) hereinafter known as Dibie in view of Dahl et al. (US 20090012541 A1) hereinafter known as Dahl.
Regarding claim 1 Dibie discloses a replacement heart valve comprising:
a unibody stent frame ([0038], Figure 4a item 10) comprising a collapsed and expanded configuration ([0014]), and a plurality of longitudinal struts and a plurality of circumferential struts (Figure 4a shows a plurality of struts 13, any of which can be considered to be longitudinal and any of which can be considered to be circumferential, since they all extend both longitudinally and circumferentially), configured to form a tubular inner wall (Figure 4a item 12) with a central lumen (Figure 4b item 15),
a plurality of closed shapes attached to the frame (Figure 10 item 44), each of the shapes comprising an inner perimeter surrounding a through opening (Figure 10 item 44),
a replacement leaflet valve located in the central lumen of the wall ([0070]),
but is silent with regards to there being a closed delivery loop slidably attached to the plurality of closed shapes.
However, regarding claim 1 Dahl teaches an endovascular prosthesis that includes a closed delivery loop (Figure 3a-b shows a closed loop formed with elements 1102 and 1106 together) slidably attached to the plurality of closed shapes (Figure 3b item 1106; see Figures 3a-d to see the loop slide to a smaller size). Dibie and Dahl 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 valve of Dibie so that there is a delivery loop slidably attached to the closed shape as is taught by Dahl 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, since Dibie has disclosed these eyelets 44 are for delivery attachment of a delivery device, the use of any delivery mechanism would have been obvious to try, including one with a closed delivery loop.
Regarding claim 3 the Dibie Dahl Combination teaches the valve of claim 1 substantially as is claimed,
wherein Dibie further discloses the closed shapes comprise a plurality of rings (Figure 10 item 44).
Regarding claim 4 the Dibie Dahl Combination teaches the valve of claim 3 substantially as is claimed,
wherein Dibie further discloses the rings are circular or oval (Figure 10 item 44 shows circular rings).
Regarding claim 5 the Dibie Dahl Combination teaches the valve of claim 1 substantially as is claimed,
wherein Dibie further discloses the closed shapes comprise a plurality of closed wire shapes (Figure 10 item 44), wherein each shape comprises a wire segment ([0058] the body can be a wire frame), and
wherein Dahl further teaches that closed wire shapes can be manufactured via welding a wire segment ([0047]). Dibie and Dahl are involved in the same field of endeavor, namely endovascular implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the Dibie Dahl Combination by manufacturing the shapes via end-to-end wire welding as is taught by Dahl in order to ensure the shapes are less traumatic to luminal tissue than as compared to a laser-cut shape ([0047]). The person of ordinary skill understands there may be benefits or drawbacks to manufacture via either method.
Further, regarding claim 5 as regards the wire being welded “end-to-end”, this is considered to be obvious to the person of ordinary skill who is making the circular shape of Dibie’s Figure 10 item 44, since the desired final shape is thin and annular.
Regarding claim 6 the Dibie Dahl Combination teaches the valve of claim 5 substantially as is claimed,
wherein the Combination further teaches the wire segment comprises a wire diameter or a maximum wire transverse cross-sectional dimension (this is considered to be inherent).
Regarding claim 7 the Dibie Dahl Combination teaches the valve of claim 6 substantially as is claimed,
wherein Dibie further teaches the closed shapes (Figure 10 item 44) each has an opening diameter no greater than 300% of the wire diameter (While the figures are not understood to be drawn to scale, they are not considered to be completely misleading either. The person of ordinary skill in the art at the time the invention was filed would have viewed DiBie Figure 10 and understand that it would be obvious to have the opening diameter no greater than 300% of the wire diameter. See annotated figure 10 below which shows how only two complete wire diameters can fit within the opening diameter.)
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Regarding claim 9 the Dibie Dahl Wallace Combination teaches the valve of claim 7 substantially as is claimed,
wherein Dibie further discloses the stent frame further comprises a plurality of stent frame openings that are located within the plurality of longitudinal struts (Figure 3a-b item 40: for the purposes of this claim, the “longitudinal struts” are understood to be these with the openings 40).
Regarding claim 10 the Dibie Dahl Wallace Combination teaches the valve of claim 9 substantially as is claimed,
wherein Dibie further discloses the stent frame openings are located at an end region of the plurality of longitudinal struts (see the annotated Figure 3b.1, below).
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Regarding claim 11 the Dibie Dahl Wallace Combination teaches the valve of claim 9 substantially as is claimed,
wherein Dibie further discloses the openings are spaced apart from an end of the plurality of longitudinal struts (see annotated Figure 3b.2, below).
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Regarding claim 12 the Dibie Dahl Wallace Combination teaches the valve of claim 11 substantially as is claimed,
wherein Dibie further teaches the openings are spaced from the end of a longitudinal strut by a distance greater than 300% of the opening diameter (see the annotated Figure 3b.2 above, which shows the distance the openings are spaced from the end far exceeding 3x the dimensions of the openings (Fig 10 item 44, for reference).).
Regarding claim 13 the Dibie Dahl Combination teaches the valve of claim 1 substantially as is claimed,
wherein Dibie further discloses the frame further comprises a folded double wall (Figure 4a), which includes an outer wall (Figure 4a item 18) comprising an open enlarged diameter region (Figure 4a item 22), a middle reduced diameter region (Figure 4a item 24), and a closed enlarged diameter region (Figure 4a item 20), and the frame also includes a transition wall between the outer wall and the tubular wall (Figure 4a item 32).
Regarding claim 14 the Dibie Dahl Combination teaches the valve of claim 13 substantially as is claimed,
wherein Dibie further discloses the closed shapes comprise a first plurality of closed shapes attached to the outer wall (Figure 10 item 44 the closed shapes are attached to the outer wall indirectly, through the inner wall 12).
Regarding claim 19 the Dibie c Combination teaches the valve of claim 1 substantially as is claimed,
wherein Dibie further discloses each of the closed shapes are coupled to one of a plurality of junctions, with the one junction comprising at least two of the circumferential struts (Figure 10; since all the struts extend both circumferentially and longitudinally the junction between two of the struts are considered to be between circumferential struts).
Regarding claim 21 the Dibie Dahl Combination teaches the valve of claim 19 substantially as is claimed,
wherein Dibie further discloses some junctions of the plurality of junctions further comprise one of the longitudinal struts from the plurality of longitudinal struts (Figure 10; since all the struts extend both circumferentially and longitudinally the junction between two of the struts are considered to be between longitudinal struts).
Regarding claim 22 the Dibie Dahl Combination teaches the valve of claim 21 substantially as is claimed,
wherein Dibie further discloses some junctions of the plurality comprise four stuts from the plurality of circumferential struts (see annotated Figure 4a below).
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Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dibie, and Dahl as is applied above, further in view of Moriss et al. (US 20150142100 A1) hereinafter known as Moriss.
Regarding claim 8 the Dibie Dahl Combination teaches the valve of claim 7 substantially as is claimed,
but is silent with regards each closed shape has an opening diameter no greater than 150% of the wire diameter.
However, regarding claim 8 Moriss teaches a valve which includes a plurality of closed shapes (Figure 11b item 129 ([0172])), wherein the opening diameter of those closed shapes is no greater than 150% the diameter of the wire forming the remainder of the valve (While the figures are not understood as being drawn to scale, they are also not understood to be completely misleading. Accordingly, the person of ordinary skill, in viewing Figure 11b of Moriss, would find it obvious to ensure the openings of 129 are not more than 150% the diameter forming the remainder of the frame.). Dibie and Moriss are involved in the same field of endeavor, namely valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the Dibie Dahl Combination so that there are openings within the struts that are sized similarly thereto as is taught by Moriss since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04 (IV)(A). Further, this difference in relative dimension is not critical in nature, and does not affect the function of the prior art.
Claim 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dibie and Dahl as is applied above, further in view of Tafti (US 20190321173 A1).
Regarding claim 23 the Dibie Dahl Combination teaches the valve of claim 1 substantially as is claimed,
wherein Dibie further discloses the plurality of longitudinal struts each comprises a longitudinal slot (Figure 3a item 40; for the purposes of this claim, only those struts with the slot are considered to be the “longitudinal struts”),
but is silent with regards to each of the longitudinal slots comprise an elongate barb projecting into each of the slots.
However, regarding claim 23 Tafti teaches that a valve can include longitudinal slots which comprise an elongate barb projecting from each of the slots (Figure 1c item 416). Dibie and Tafti are involved in the same field of endeavor, namely valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the Dibie Dahl Combination so that there are longitudinal slots which comprise an elongate barb projecting into each one as is taught by Tafti in order to provide the stent extra mechanisms for anchoring into neighboring vasculature upon deployment, thereby increasing the security of the deployed valve and preventing movement thereof.
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
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