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 1e (Figures 8a-c), species 2a (valve supports are continuous with the frame (fusion, welding, continuous piece of material), subspecies 3a3 (anchor can be physically uncoupled from the frame while still providing an anchor for the frame as it expands), species 4a (prosthesis can have the proximal end oriented toward the atrium and distal end oriented towards the ventricle when deployed), species 4a (the frame has a flared inflow portion and outflow portion), species 2b (the inflow edge of the leaflet extends only partially proximally beyond the proximal arches as is seen in figure 9a), species 7a (there is no minimal valve support), species 8b (the seal support has an undulating or sinusoidal element or wireform (e.g. seen in figures 15a-b)), subspecies 8b3 ( the seal support has axially-extending elements positioned within the seal), species 9d (there is both a seal support and nadir support skirt (seen in fig 18a-c)), species 10d (the valve is sutured to the central annular portion of the frame and to the outflow end of the frame but is unattached to proximal arches (seen in fig 8a and 11)), species 11c (the seal support is laminated into the seal in place of the minimal valve supports), and species 12a (the inflow edge of the leaflets is entirely unsupported), in the reply filed on 01/26/26 is acknowledged.
Applicant's election with traverse of species 3a (prosthesis is intended to be coupled with a spiral anchor), subspecies 3a4 (expanded diameter of the frame is greater than the inner diameter of the frame), in the reply filed on 01/26/26 is acknowledged. The traversal is on the ground(s) that none of the prostheses are intended to be self-anchoring, meaning all prostheses are required to have an external anchor. Figure 2 only shows the prosthesis by itself, before coupling to the anchor. This is not found persuasive since there is no support from the specification supporting this statement. Further traversal is due to a typographical error, indicating the expanded diameter of the frame should be greater than the inner diameter of the anchor. The Examiner respectfully acknowledges the typographical error.
Claim 13 is withdrawn for being drawn towards non-elected species 3c.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 9, 17, and 19 are objected to because of the following informalities:
Claim 9 is objected to for referring to “the inflow edge” with improper antecedent basis.
Claim 16 is objected to for referring to the “central annular portion” when it is unclear if this is referring back to the “central annular section” or whether this is a new element.
Claim 17 is objected to for referring to “flared outflow section” when it is unclear whether or not this is intending to refer back to the flared outflow portion or whether this is a new element.
Claim 19 is objected to for referring to “at least portion” when it is understood there might be a word missing between “least” and “portion”.
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 leaflets being unsupported by the frame must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because:
-item 159 is present in the specification but not figures
-item 15 is used to represent “anchor”, “valve segment”, and “arches”
-item numbers 14 and 15 are both use to represent “valve segment”
-item 15 and item 115 are both used to represent “proximal arches”
-item 124 is used to represent both “valve supports” and “frame”
-items 12 and 124 are both used to represent “frame”
-item 157 is used to represent both “atrial flared portion” and “inflow portion”
-item 133, 141, and 238 are in figures but not the specification
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 disclosure is objected to because of the following informalities:
the specification [0073] states that the valve segment is attached at the proximal end of the frame, and unattached at the proximal end of the frame. Since both cannot be true at the same time, the Examiner believes this might be an error.
the specification [0074] states figure 5 shows an “aperture 97} but this is not in the figures of in figure 5.
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 1-12, 14-19 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 the leaflets have an inflow edge which is “unsupported by the frame structure”. This is indefinite since it isn’t known how the valve segment (which contains the leaflets) is coupled to the frame structure. If the leaflets are coupled to the frame structure, they and all parts thereof would be considered to be “supported” by its connection to the frame. The figures also all show the leaflets being supported by the frame structure which it is attached to, making it unclear how the inflow edge is considered “unsupported”. The specification states that the valve segment is ”completely unsupported” meaning it does not include any valve supports ([0075]-[0076]), and that the valve segment can be “unsupported by and/or unconnected from the frame structure”, again indicating that the lack of connection/support to the frame indicates that it is unsupported. The Examiner is unclear on how the valve segment and leaflets can accordingly be claiming two opposite things at the same time. Either the leaflets are connected to (and so supported by) the frame, or they leaflets are floating free without connection to anything (and so unsupported). This does not appear to be explained anywhere by the figures or in the specification, and the Examiner is unclear on how to interpret this for the purposes of claim examination.
Claim 12 is indefinite for claiming the seal support is “disconnected” from the frame structure, when all the figures show them connected to one another through at least the seal or other indirect means. It is clear that the two elements are connected to one another in order to form the disclosed device, making it unclear how the two are described by the claims as being “disconnected” while they are shown/described as being connected throughout the specification and figures.
Claim 18 is further indefinite for apparently also requiring a further connection between the frame and valve leaflets at “commissures”, again reinforcing the fact that connection is required, in addition to the leaflets being “unsupported”.
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 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.
Claim(s) 1-4, 6, 8-11, 14-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Drasler et al. (US 20190209320 A1) hereinafter known as Drasler.
Regarding claim 1 Drasler discloses a device for treating a diseased native valve in a patient comprising:
a frame structure (Figure 34C, 34G item 865) having an unexpanded configuration and an expanded configuration ([0309] the securement band 865 can be expanded), and
a valve segment (190) coupled to the frame and comprising:
a plurality a leaflets (270), wherein an inflow edge of the leaflets (at 730) is unsupported by the frame (Figure 34C, 34G shows the inflow edge 730 not supported by frame 865),
a seal attached to the inflow edge of the leaflets (285) and positioned radially between the frame and the leaflets (Figure 34G, 34C; [0319] the covering can be attached adjacent and radially outwards of the leaflet and attached to the stent-valve frame), and
a seal support (920) attached to or within the seal which provides axial rigidity to the seal (Figure 34C, 34G; [0319]).
Regarding claim 2 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the inflow edge of the leaflets (730) is spaced radially inward from an inflow edge of the frame when the frame is expanded (Figure 34c shows band 865 extending radially outward further than the inflow edge 730 of leaflets 270).
Regarding claim 3 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses a nadir support skirt extending between the seal (Figure 34c item 285) and an inflow edge of the frame (730) ([0297] the covering 285 can include a skirt-shaped portion as is seen in Figure 34G).
Regarding claim 4 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses a portion of the inflow edge of the leaflets (730) extends axially beyond an inflow edge of the frame (Figure 34c item 865) such that the portion of the inflow edge of the leaflets extends further in an inflow direction than the inflow edge of the frame (Figure 34c).
Regarding claim 6 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the seal (285) comprises polyurethane ([0016]).
Regarding claim 8 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the seal support (920) comprises an undulating wireform (Figure 34c shows the support 920 undulating; [0380] the frames can comprise Nitinol wire in a zig-zag shape ([0315] the seal support 920 is described as a “frame surface”)).
Regarding claim 9 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the seal support (920) extends proximate to the inflow edge (730) of the valve segment (Figure 34c).
Regarding claim 10 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the seal support (920) extends closer to an inflow edge (730) of the seal than an outflow edge (740) of the seal (285) (Figure 34G shows how the outflow edge 740 is occupied by a nadir support skirt 285 instead of the seal 285 seen in figure 34c.).
Regarding claim 11 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the seal support (920) is configured to pretension the seal (285) ([0037] self-expansion pre-tensions the seal to an expanded configuration).
Regarding claim 14 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the frame (865) has a longitudinal length (Figure 34d item 941) of less than 35 mm in its expanded configuration ([0331] 1-10 mm).
Regarding claim 15 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the frame (865) comprises a flared inflow section, a central annular section, and a flared outflow portion (Figure 34G shows frame 865 with an hourglass shape).
Regarding claim 16 Drasler discloses the device of claim 15 substantially as is claimed,
wherein Drasler further discloses the seal (285) is attached to the central annular portion (Figure 34G).
Regarding claim 17 Drasler discloses the device of claim 15 substantially self- as is claimed,
wherein Drasler further discloses the flared inflow and outflow sections are configured to engage an exterior anchor therebetween when the frame is expanded (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 Drasler was considered capable of performing the cited intended use.).
Regarding claim 18 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the leaflets are attached to the frame only at commissures of the leaflets (see Figures 34f, 34g item 312).
Regarding claim 19 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses at least a portion of the inflow edge of the leaflets (730) extends axially beyond the frame structure (865) while an entire outflow edge of the leaflets (740) is positioned within the frame (Figure 34G).
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 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drasler as is applied above in view of Bonyuet et al. (US 10045846 B2) hereinafter known as Bonyuet.
Regarding claim 5 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the seal support (920) is bonded to the seal ([0312]),
but is silent with regards to the seal support being laminated within the seal.
However, regarding claim 5 Bonyuet teaches that support (frames) can be laminated within coverings (Column 2 lines 10-15). Drasler and Bonyuet 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 Drasler by having the seal support laminated within the seal as is taught by Bonyuet 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 use of any known attachment method of the support to the seal would have been obvious to try.
Regarding claim 7 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the seal support (920) extends annularly with the seal (285) (Figure 34c),
but is silent with regards to the seal support extending within the seal.
However, regarding claim 7 Bonyuet teaches that support (frames) can be laminated within coverings (Column 2 lines 10-15). Drasler and Bonyuet 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 Drasler by having the seal support extend within the seal as is taught by Bonyuet 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 use of any known attachment method of the support to the seal would have been obvious to try.
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drasler as is applied above in view of Oba et al. (US 20160310268 A1) hereinafter known as Oba.
Regarding claim 12 Drasler discloses the device of claim 1 substantially as is claimed,
but is silent with whether or not the seal support (920) is disconnected from the frame (865).
However, regarding claim 12 Oba teaches that heart valve frames can have frame portions that are disconnected (or not directly connected) from one another (Figure 1 item 11 show connections between frame portions 302, 304 only thorugh a sleeve 306). Drasler and Oba 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 Drasler so that the support 920 and frame 865 are disconnected from one another as is taught by Oba in order to allow adjusting the flexibility of the frame as a whole, which might be desirable based on the geometry and ailments of a particular patient.
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 02/27/26