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
Applicant’s election without traverse of species 1f, 2a, 3a, 4b, 5c, 6e, 7b, and 8d in the reply filed on 12/02/25 is acknowledged.
Claims 15, 16, 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/02/25.
Claim Objections
Claims 1, 9-12, 17, 21-22 are objected to because of the following informalities:
Claim 1 is objected to for referring to “the first wall” with improper antecedent basis. It is unclear how this relates (if at all) to the previously claimed “inner wall”.
Further, the claim is unclear for claiming the stent frame comprises longitudinal and circumferential struts, as well as a tubular inner wall. It appears from the disclosure/specification that the longitudinal and circumferential struts might actually be a part of the inner wall, although the claim lists them as separate elements of the stent body.
The claim is further unclear for claiming “the plurality of longitudinal struts comprise a plurality of longitudinal slots”, because it appears to claim that each of the plurality of struts comprise a plurality of longitudinal slots, when the originally filed disclosure appears to only have a maximum of one longitudinal slot in each longitudinal strut (although this is unclear, since the Examiner isn’t entirely sure what the “longitudinal slots” are since they are not labeled in the figures).
Claim 9 is objected to for referring to “a plurality of longitudinal struts” and “a plurality of circumferential struts” when claim 1, from which this claim depends, has already established that there are longitudinal and circumferential struts. The Examiner is unclear how, if at all, these newly recited struts relate to the previously claimed ones.
Claim 10-12 are further objected to for also referring to “a longitudinal strut” with improper antecedent basis.
Claims 11-12 are further objected to for referring to “the end” with improper antecedent basis.
Claim 17 is objected to for referring to “closed stent shapes” with improper antecedent basis.
Claim 21 is objected to for referring to “some junctions” when claim 19, from which this claim depends, has only identified one junction. It is unclear how, if at all, these plurality of junctions relate back to the previously claimed “junction”, if at all.
The claim is further objected to for having improper antecedent basis for “a longitudinal strut”.
Claim 22 is unclear for the same reasons as claim 21 regarding “some junctions”.
The claim is further unclear, for claiming that the junctions comprise four struts “from the plurality of longitudinal struts and/or the plurality of circumferential struts” when the scope of this claim covers the junctions being formed from 4 longitudinal struts alone, 4 circumferential struts alone, 3 longitudinal and 1 circumferential struts alone, and 3 circumferential and 1 longitudinal struts alone, when the disclosure fails to support this. It appears that the only combination that appears to be known is there being 2 circumferential and 2 longitudinal struts. Clarification is required.
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 first wall, the longitudinal slots, plurality of closed shapes, inner perimeter, through opening, (claim 1) closed wire shapes, wire segment, being welded end-to-end (claim 5), the wire diameter, and maximum wire transverse cross-sectional dimension (claim 6), the plurality of stent frame openings, opening diameter, maximum opening transverse cross-sectional dimension (claim 7), the end of the longitudinal strut (claims 10-11), the folded double wall (claim 13), the first plurality of closed shapes (claim 14), the junction comprising two circumferential struts (claim 19), the end (claim 20), must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Further, item 13010 is in the specification, but not the figures.
Further, throughout the figures, item 116 at least (possibly item 118 as well), appears to be pointing to different structures, and does not seem to always be pointing at the “first opening”.
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 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, 3-14, 17, 20, 19-23 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.
Claim 1 is indefinite for claiming that the stent frame is unibody, but that the unibody stent frame includes the closed shapes attached to the stent frame. The claim appears to be requiring two distinct things: the shapes to be a part of the stent frame in a unibody way, but also to be attached thereto (i.e. not unibody with the frame). The figures do not actually show the “shapes”, so the Examiner cannot be certain what they are, but it is believed they may actually be the disclosed rings seen, for example, in Figure 12a as item 1212. This shape appears to be distinct from the remainder of the frame and does not appear to be unibody therewith. Accordingly, the Examiner is unclear on what the meaning of the claim actually is – whether the frame should be unibody including its shapes, or whether the frame is not unibody, and the shapes are distinct thereto.
Claim 5 is indefinite for depending on a cancelled claim. For the purposes of examination, claim 5 will be understood to depend from claim 1.
The claim is further indefinite for claiming the closed shapes comprise a plurality of “closed wire shapes” since it is unclear what a “closed wire shape” is. Notably, the shapes can be made from wire, but it is unclear what “shape” a closed wire is supposed to take.
Additionally, the claim is unclear since claim 1, from which this claim is assumed to depend from, has already required the stent frame (and its shapes) to be unibody, which makes it unclear how the shapes can be a wire segment welded end-to-end, as this would apparently result in a shape that is not unibody with the remainder of the frame.
Claim 7 is indefinite for claiming the closed wire shapes are attached to a plurality of stent frame “openings” since it is unclear how something (e.g. a shape) can be attached to nothing (e.g. an opening). An “opening” is considered to be open space, and so attaching something physical to something which is the absence of something physical does not make sense to the Examiner.
Claim 10 is indefinite for claiming the stent frame openings are “located at an end of a longitudinal strut”, when the disclosure appears to show the openings located spaced from an end, at least by part of the longitudinal strut itself. If the openings were located at an end of the strut, it would simply be a slit made into the end, to separate the strut in two halves, whereas the figures appear to all show the openings being formed within the strut, meaning there is inherently some part of the strut present to separate the opening from the end. The Examiner is accordingly unclear on how to interpret this claim.
Claim 13 is indefinite for claiming the unibody stent frame comprises a folded double wall when claim 1, from which this depends, has already identified the frame comprising a “tubular inner wall”. As the Examiner best understands from the figures and disclosure, the inner wall and outer wall would necessarily have to be a part of the folded double wall (e.g. not be separate elements therefrom, as they are currently claimed).
Claim 14 is indefinite for claiming the “plurality of closed shapes attached to the stent frame comprise a first plurality of closed shapes attached to the outer wall”, when claims 1 and 13, from which this depends, has already established that the stent frame comprises the plurality of closed shapes (meaning the shapes are a part of the stent frame, just like the inner wall and double wall (which includes the outer wall) are). It is accordingly unclear how the shapes are both separate from the double wall (and outer wall), but also attached to the outer wall (e.g. are now a part of the outer wall as opposed to being a part of the frame) as the claim requires.
Claim 20 is indefinite for claiming some of the closed shapes are coupled to “an end” but it is unclear what this “end” is a part of (or what has the end).
Claim 23 is indefinite for claiming the longitudinal slots comprise an elongate barb “projecting into” each of the slots. While this is somewhat unclear since the Examiner is unclear what the longitudinal slots refer to since they are not depicted by the drawings, none of the barbs that are shown appear to be “projecting into” any slot. In one configuration they appear to be flush with an outer member, and in another configuration they appear to project away from outer members, but nothing describes or shows barbs projecting into a slot.
Remaining claims are rejected for depending on a rejected claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-4, 13-14, 19-21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dibie et al. (US 20220175523 A1) hereinafter known as Dibie.
Regarding claim 1 Dibie discloses a replacement heart valve comprising:
a unibody stent frame ([0038], Figure 4a item 10) comprising a tubular inner wall (Figure 4a item 12) with a central lumen (Figure 4b item 15), a collapsed and expanded configuration ([0014]), 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), wherein the longitudinal struts comprise a plurality of longitudinal slots (Figure 3a item 40), and
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), and
a replacement leaflet valve located in the central lumen of the wall ([0070]),
Regarding claim 3 Dibie discloses 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 Dibie discloses 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 13 Dibie discloses the valve of claim 1 substantially as is claimed,
wherein Dibie further discloses the frame 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 inner wall (Figure 4a item 32).
Regarding claim 14 Dibie discloses 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 Dibie discloses the valve of claim 1 substantially as is claimed,
wherein Dibie further discloses each of the closed shapes are coupled to a junction of 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 20 Dibie discloses the valve of claim 19 substantially as is claimed,
wherein Dibie further discloses some of the closed shapes are coupled to an end (Figure 10 item 44).
Regarding claim 21 Dibie discloses the valve of claim 19 substantially as is claimed,
wherein Dibie further discloses some junctions comprise one of the 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).
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dibie as is applied above in view of Dahl et al. (US 20090012541 A1) hereinafter known as Dahl.
Regarding claim 5 Dibie discloses 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),
but is silent with regards to the wire segment being welded end to end.
However, regarding claim 5 Dahl teaches that circular 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 Dibie 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).
Claim 7-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dibie and Dahl as is applied above, further in view of Wallace (US 20210267755 A1).
Regarding claims 7-8 the Dibie Dahl Combination teaches the valve of claim 6 substantially as is claimed,
but is silent with regards the closed wire shapes being attached to a plurality of stent frame openings, wherein each of the openings has an opening diameter no greater than 300% (or 150% - claim 8) of the wire diameter.
However, regarding claims 7-8 Wallace teaches a valve which includes a plurality of stent frame openings (Figure 1c shows a rectangular slit opening within the strut 151 near the ventricular end), wherein the opening diameter is no greater than 300% (or 150% - claim 8) the diameter of the wire forming the remainder of the valve (Figure 1c shows the opening being sized similarly to the size of the wire forming the remainder of the valve). Dibie and Wallace 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 Dibie so that there are openings within the struts that are sized similarly thereto as is taught by Wallace in order to provide a location to attach the leaflets of the device thereto. The Examiner notes that when applied to the Combination, the person of ordinary skill would understand that the diameter of the wire forming the remainder of the valve is the same diameter as the wire forming the wire shapes (see Dibie Figure 10), meaning the diameter of the opening would obviously be no greater than 300% (or 150%) the diameter of the wire forming the shape.
Regarding claim 9 the Dibie Dahl Wallace Combination teaches the valve of claim 7 substantially as is claimed,
wherein Wallace further discloses the frame openings are located within the longitudinal struts (Figure 1c).
Regarding claim 10 the Dibie Dahl Wallace Combination teaches the valve of claim 8 substantially as is claimed,
wherein Wallace further teaches the openings are located at an end of one of the longitudinal struts (Figure 1c shows the openings located at a ventricular end of the longitudinal strut 151).
Regarding claim 11 the Dibie Dahl Wallace Combination teaches the valve of claim 8 substantially as is claimed,
wherein Wallace further teaches the openings are spaced apart from an end of the longitudinal strut (Figure 1c shows the openings are located spaced slightly from the end of the longitudinal strut).
Regarding claim 12 the Dibie Dahl Wallace Combination teaches the valve of claim 11 substantially as is claimed,
wherein Wallace further teaches the openings are spaced from the end of the longitudinal strut by a distance greater than 300% of the opening diameter (Figure 1c).
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dibie as is applied above in view of Von Oepen as is applied above.
Regarding claim 17 Dibie discloses the valve of claim 14 substantially as is claimed,
wherein Dibie further discloses the closed shapes are used for delivery ([0130]),
but is silent with regards to whether delivery includes a delivery line/loop slidably attached to the shape.
However, regarding claim 17 Von Oepen teaches a valve which includes closed shapes (Figure 1b item 120) that receive a delivery line or loop slidably attached to the first closed shapes ([0021], [0006]-[0008]). Dibie and Von Oepen 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 Dibie by including a delivery line or loop as is taught by Von Oepen 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). In this case, it would have been obvious to utilize any known delivery technique.
Claim 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dibie as is applied above in view of Moriss et al. (US 20150142100 A1) hereinafter known as Moriss.
Regarding claim 22 Dibie discloses the valve of claim 21 substantially as is claimed,
but is silent with regards to some junctions comprising at least four struts.
However, regarding claim 22 Moriss teaches that four-way strut junctions can include a closed shape (Figure 11d shows the lowest opening of item 128 located at the junction of four stuts). 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 Dibie by including shapes at the junction of four struts as is taught by Moriss in order to provide the valve with a commissure attachment feature to secure a valve in place.
Claim 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dibie as is applied above in view of Tafti (US 20190321173 A1).
Regarding claim 23 Dibie discloses the valve of claim 1 substantially as is claimed,
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 [out of?] 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 Dibie 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
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 01/06/26