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 02/19/26 have been fully considered but they are not persuasive.
On page 8 regarding drawing objections Applicant argues amendments overcome the objection of record with respect to figure 25e, and argues paragraphs [21] and [231]-[234] discuss “tooling to construct the flange” which “can include top plates and nested contoured rings”.
The Examiner respectfully points out this does not appear to address the drawing objection, which states that the figures are not showing what the specification is referring to.
On page 8 regarding 112 rejections Applicant argues amendments overcome the rejections of record with the exception of claim 21. Applicant argues paragraph [238]-[251] discuss “embodiments of a replacement valve that is separate and removeable after deployment”.
The Examiner respectfully notes this does not appear to be a response to the rejections of record. These are accordingly maintained.
On page 9 regarding prior art rejections Applicant argues amendments overcome the rejection of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
On pages 9-10 regarding priority dates, Applicant argues support for “the subject matter” is found in [208]-[226].
The Examiner respectfully notes Applicant’s argument appears to state there is support in the priority applications, but then states support is found in the instant application in specific paragraphs. The Examiner points out there is no 112a rejection stating the elements are new matter. Rather, the claims have a priority date to those dates indicated in the rejection of record, since there is no support in the priority applications. To address this, the Applicant should point to the locations in all priority documents that provide support for these claims.
Drawings
The drawings are objected to for the following informalities:
The specification refers to the figures (Fig 25e) showing the flange comprising a first underside surface, a first contoured ring interior to and topographically below the top plate comprising a second underside surface, and a second contoured ring interior to and topographically below the first contoured ring comprising a third underside surface, and while the figures point to structures which supposedly indicate the top plate and first/second rings, the figures don’t appear to be pointing towards a “plate” at all, or towards two “rings. The figures appear to just be pointing towards areas of a spiral stent, which don’t have rings or plates, and none of which has an underside surface.
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.
Priority
Claims 10-19 have a priority date of 09/05/2024, since the following subject matter was first presented in the claims filed on this date:
“lowering the medial and lateral strut anchors into the native sub-annular space prior to securing the medial and lateral strut anchors into the native sub-annular space”.
Claims 11-19 have a priority date of 09/05/2024, since the following subject matter was first presented in the claims filed on this date:
“placing the medial and lateral strut anchors in between the chordae permits movement of the native mitral annulus”.
Claims 13-19 have a priority date of 09/05/2024, since the following subject matter was first presented in the claims filed on this date:
“the medial and lateral strut anchors are spaced from each other by no more than 150 degrees.”
Claims 17-19 have a priority date of 09/05/2024, since the following subject matter was first presented in the claims filed on this date:
“the helically braided nitinol wire frame…is deformable and preserves natural basal left ventricular function…”.
Claim 19 has a priority date of 09/05/2024, since the following subject matter was first presented in the claims filed on this date:
“a native left ventricle outflow tract is preserved by the valve frame when deployed in the native mitral valve in part by the valve frame being shape set to no more than 10% larger than the native annulus of the native mitral valve.”
Claim 27 has a priority date of 09/05/2024, since the following subject matter was first presented in the claims filed on this date:
“the…valve frame…[is] self-expanding”.
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 18-19, 21-24, 27-29 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 18-19 are indefinite for claiming the nitinol wire frame is “shape-set to no more than 10% larger than the native annulus” but it is unclear what this means. The specification appears to reference a method of manufacture in [0208] which notes a valve frame can be shape-set to a size about 10% oversize in relation to the annulus hole, but it is unclear whether Applicant’s “helically braided nitinol wire frame” is the same from the “valve frame” of the specification.
Claim 21 is indefinite for claiming the leaflet structure is “separate and removeable from the self-expandable valve frame when deployed”. It is unclear how the leaflet structure is removeable from the tubular body when deployed, since the specification indicates they are interconnected when deployed. The specification indicates that the two can be separate from one another during delivery ([0006], [0012], [0095]), but it does not address the separability or removability they have from one another when deployed.
Remaining claims are indefinite 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) 1-3, 5-12, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss et al. (US 20150327994 A1) hereinafter known as Moriss in view of Moriss et al. (US 20150351903 A1) hereinafter known as Moriss ‘903, and further in view of Lane et al. (US 20190060071 A1) hereinafter known as Lane.
Regarding claim 1 Moriss discloses a method of replacing a native mitral valve ([0086]) comprising:
advancing a deployment catheter (Figure 1f item 10) to a native mitral valve comprising a native mitral annulus (Figures 1f-1g), the catheter carrying an expandable valve frame having a replacement valve (Figures 2B-1 and 2B-2; Figures 2A1 shows the frame 100 with valve 150), posterior and anterior clips (Figure 2A1 shows at least two clips 120 that can be considered anterior and posterior clips), medial and lateral strut anchors (Figure 2A1 shows at least two struts 120 that can be considered medial and lateral strut anchors), and an atrial flange (Figure 2h-1 item 165) comprising, as fabricated, a perimeter configured to be positioned on tissue above the native mitral annulus for supra-annular securement ([0217]) and
releasing the anterior clip and securing a native anterior leaflet with the anterior clip ([0212]; Abstract); and releasing the posterior clip and securing a native posterior leaflet with the posterior clip ([0212]; Abstract);
releasing the medial and lateral strut anchors and securing the medial and lateral strut anchors into a native sub-annular space ([0212]; Abstract);
expanding the valve frame across the native mitral valve (Abstract; Figure 2G, 2H-1); and
deploying the flange against native tissue of the native mitral valve (Figure 2H-1, and [0217]),
but is silent with regards to the atrial flange’s perimeter being D-shaped, as fabricated,
and the release of the anterior clip and securing to the anterior leaflet occurs before the release of the posterior clip and securing to the posterior leaflet.
However, regarding claim 1, Moriss ‘903 teaches that a mitral valve implant frame flange can have, as fabricated, a D-shaped perimeter ([0123], [0084], [0147]). Moriss and Moriss ‘903 are involved in the same field of endeavor, namely mitral valve implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of Moriss by having the perimeter of the flange of the valve frame be D-shaped, as is taught by Moriss ‘903, since this shape mimics the natural shape of a native mitral valve, and the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results.
Further, regarding claim 1 Lane teaches that the deployment of an anterior clip for securing to a native anterior leaflet can occur before deployment of a posterior clip for securing to a native posterior leaflet ([0017]). Moriss and Lane are involved in the same field of endeavor, namely mitral valve implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Moriss Moriss ‘903 Combination to secure to an anterior leaflet before a posterior leaflet as is taught by Lane 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, deployment of the clips in any known order would have been obvious to the person of ordinary skill to try.
Regarding claim 2 the Moriss Moriss ‘903 Lane Combination teaches the method of claim 1 substantially as is claimed,
wherein Moriss further discloses the flange resists migration of the tubular body ([0217] and Figure 2H-1 the skirt located on flange 165 prevents migration towards the ventricle inherently by its enlarged flange shape) and minimizes perivalvular leaks ([0217] the flange 165 with skirt includes a polyester cover; [0206] polyester materials prevent leakage; also see [0217] where the cover material encourages ingrowth which will inherently prevent leakage where the tissue grows).
Regarding claim 3 the Moriss Moriss ‘903 Lane Combination teaches the method of claim 2 substantially as is claimed,
wherein Moriss further discloses the deployment of the flange comprises placing a portion of the flange against a native mitral annulus and a floor of a left atrium ([0217]).
Regarding claim 5 the Moriss Moriss ‘903 Lane Combination teaches the method of claim 1 substantially as is claimed,
wherein Moriss further discloses the atrial flange further comprises a contoured funnel shape (Figure 2h-1).
Regarding claim 6 the Moriss Moriss ‘903 Lane Combination teaches the method of claim 3 substantially as is claimed,
wherein Moriss further discloses securing the anterior leaflet with the anterior clip comprises securing an A2 region of the native mitral leaflets ([0212] the tips of clips 120 are passed easily behind the anterior and posterior leaflets near a middle portion of the native leaflet (A2 and P2 regions are in the middle of the leaflet)).
Regarding claim 7 the Moriss Moriss ‘903 Lane Combination teaches the method of claim 6 substantially as is claimed,
wherein Moriss further discloses securing the posterior leaflet with the posterior clip comprises securing a P2 region of the native mitral leaflets ([0212] the tips of clips 120 are passed easily behind the anterior and posterior leaflets near a middle portion of the native leaflet (A2 and P2 regions are in the middle of the leaflet).
Regarding claim 8 the Moriss Moriss ‘903 Lane Combination teaches the method of claim 7 substantially as is claimed,
wherein Moriss further discloses securing the regions controls movement of the native leaflets ([0212] engaging the central portions of the leaflets together and against the outer surface of the support with gentle constraint).
Regarding claim 9 the Moriss Moriss ‘903 Lane Combination teaches the method of claim 8 substantially as is claimed,
wherein Moriss further discloses securing the medial and lateral strut anchors comprising deploying the anchors and placing them between chordae ([0096]).
Regarding claim 10 the Moriss Moriss ‘903 Lane Combination teaches the method of claim 9 substantially as is claimed,
wherein Moriss further discloses lowering the medial and lateral anchors into the sub-annular space before securing them therein (Figure 1g shows the delivery which requires lowering the device in place; Figures 1B-1 to Figure 2c shows how the device is implanted before securing).
Regarding claim 11 the Moriss Moriss ‘903 Lane Combination teaches the method of claim 9 substantially as is claimed,
wherein Moriss further discloses placing the medial and lateral strut anchors between the chordae permits movement of the native mitral annulus ([0007] indicates that the annulus changes shape based on heart movement; [0180] indicates how the arms are purposely designed flexibly so they move when they experience force from the cyclic bearing of the heart (e.g. the native annulus continues to move)).
Regarding claim 12 the Moriss Moriss ‘903 Lane Combination teaches the method of claim 11 substantially as is claimed,
wherein Moriss further discloses the securing of the native leaflets with the clips and securing the anchors in the sub-annular space resists migration of the valve frame toward the left atrium (see Figure 2H-1, and Figure 2G along with the Abstract; the arms 120 which attach under the leaflets inherently help to resist migration north of the annulus).
Regarding claim 20 the Moriss Moriss ‘903 Lane Combination teaches the method of claim 1 substantially as is claimed,
wherein Moriss further discloses the replacement valve of the valve frame comprises an atrial end and a ventricular end (this is considered inherent: the atrial end is considered to be the end of the valve which is closest to the atrium when implanted, and the ventricular end is considered to be the end of the valve which is closest to the ventricle when implanted), and a central lumen ([0205] the valve allows flow, indicating the presence of the lumen) with leaflets (Figure 2f item 152),
wherein the replacement valve is cooperatively sized with and configured to seat within the valve frame when deployed in the native valve ([0155]; Figure 2f or 2a1).
Claims 13-15, 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss, Moriss ‘903, and Lane as is applied above, further in view of Oba et al. (US 20180055629 A1) hereinafter known as Oba.
Regarding claim 13 the Moriss Moriss ‘903 Lane Combination teaches the method of claim 9 substantially as is claimed,
but is silent with regards to the medial and lateral anchor strut placement.
However, regarding claim 13 Oba teaches a valve with medial and lateral anchor struts (Figures 5-6 show medial/lateral struts and anterior/posterior leaflet clips extending around the circumference of the frame. The annotated figure below shows how at least one medial and one lateral anchor strut are spaced from one another by no more than 150 degrees (see at least one medial and one lateral strut positioned 90 degrees apart)). Moriss 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 positioning of the arms of Moriss so that the medial and lateral struts are placed within 150 degrees of one another 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 arms positioned any known distance from one another would have been obvious to try.
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Regarding claim 14 the Moriss Moriss ‘903 Lane Oba Combination teaches the method of claim 13 substantially as is claimed,
wherein Oba further teaches the anterior and posterior clips are symmetrically spaced from each other and located on opposite sides of the valve frame (Annotated Figure 5).
Regarding claim 15 the Moriss Moriss ‘903 Lane Oba Combination teaches the method of claim 14 substantially as is claimed,
wherein Oba further teaches the medial/lateral strut anchors are each spaced from the anterior leaflet clip by a maximum of 75 degrees (Figure 5 shows one medial and one lateral strut that are spaced from the anterior leaflet clips by 45 degrees).
Regarding claim 28 the Moriss Moriss ‘903 Lane Combination teaches the method of claim 1 substantially as is claimed,
wherein Moriss further discloses the advancement of the deployment catheter occurs across a puncture in a native septum (Figure 1f; [0136], [0165]) into a native left atrium (Figure 1f),
the valve frame being self-expandable ([0166]),
but is silent with regards to the valve frame being advanced out of the delivery catheter and into the left atrium, testing the path across the native valve by lowering the advanced portion of the valve frame past the valve into the native left ventricle, moving the advanced portion of the valve frame back into the left atrium, and then lowering the advanced portion of the valve frame back into the ventricle.
However, regarding claim 28 Oba teaches a method of deploying a valve in which a valve frame is advanced out of a delivery catheter and into the left atrium (Figure 56a-b), a path is tested across the native mitral valve for the valve frame by lowering the body past the valve into a native left ventricle (Figure 56d), moving the advanced valve frame back into the left atrium (Figures 56e shows how the frame is positioned slightly higher in the atrium than in Figure 56d), and then lowering the advanced valve frame back into the ventricle (Figure 56f). Moriss and Oba are involved in the same field of endeavor, namely methods of deploying valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Moriss Moriss ‘903 Lane Combination by testing the path before deployment as is taught by Oba in order to ensure the deployment and alignment of the valve will be successful before completely releasing the valve, thus resulting in a more accurate positioning and placement.
Regarding claim 29 the Moriss Moriss ‘903 Lane Oba Combination teaches the method of claim 28 substantially as is claimed,
wherein Moriss further discloses securing the anterior clip in an A2 region of the native anterior leaflet by sliding the anterior clip across a surface of the A2 region, and securing the posterior clip in a P2 region of the native posterior leaflet by sliding the posterior clip across a surface of the P2 region ([0212] the tips of clips 120 are passed easily behind the anterior and posterior leaflets near a middle portion of the native leaflet (A2 and P2 regions are in the middle of the leaflet)).
Claims 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss, Moriss ‘903, Lane, and Oba as is applied above, further in view of Alleleyn et al. (US 20220031452 A1), hereinafter known as Alleleyn.
Regarding claim 16 the Moriss Moriss ‘903 Lane Oba Combination teaches the method of claim 15 substantially as is claimed,
but is silent with regards to the valve frame comprises a helically braided nitinol wire frame.
However, regarding claim 16 Alleleyn teaches a frame of a valve (Figure 1 item 4) which comprises a helically braided ([0055]; Figures 3, 7 show how the wire extends helically) Nitinol wire frame ([0147]). Moriss and Alleleyn 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 valve of the Moriss Moriss ‘903 Lane Oba Combination so that the valve frame is made of a helically braided Nitinol wire frame as is taught by Alleleyn in order to ensure the valve conforms with the native heart valve tissue, which eliminates the possible need to reposition the stent after deployment ([0005]-[0006]).
Regarding claim 17 the Moriss Moriss ‘903 Lane Oba Alleleyn Combination teaches the method of claim 16 substantially as is claimed,
wherein Alleleyn further teaches the frame of the valve frame is deformable ([0110]) thereby preserving natural basal left ventricle function when deployed in the native mitral valve.
Claims 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss, Moriss ‘903, Lane, Oba, and Alleleyn as is applied above, further in view of Hoang et al. (US 20220296367 A1) hereinafter known as Hoang.
Regarding claim 18 the Moriss Moriss ‘903 Lane Oba Alleleyn Combination teaches the method of claim 17 substantially as is claimed,
but is silent with regards to whether the frame of the valve frame is shape set to be more than 10% larger than the annulus.
However, regarding claim 18 Hoang teaches that self-expanding valves are designed to be no more than 10% larger than the native annulus ([0171] the annulus is 30 mm, and the frame is 32 mm (2mm oversize). 3mm would be a 10% oversize)). Moriss and Hoang are involved in the same field of endeavor, namely self-expanding mitral valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Moriss Moriss ‘903 Oba Alleleyn Combination so that the frame is oversized in relation to the native annulus as is taught by Hoang in order to ensure the frame exserts a constant outward force to maintain the valve in place after expansion, thus preventing migration.
Regarding claim 19 the Moriss Moriss ‘903 Lane Oba Alleleyn Hoang Combination teaches the method of claim 18 substantially as is claimed,
wherein The Combination further teaches a native left ventricular outflow tract is preserved in part by the valve frame being shape set to more than 10% larger than the native annulus, (see the rejection to claim 18 above; the LVOT is preserved by maintaining the valve in place and preventing migration).
Claims 21-24, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss, Moriss ‘903, and Lane as is applied above, further in view of Thambar et al. (US 20120101571 A1) hereinafter known as Thambar.
Regarding claim 21 the Moriss Moriss ‘903 Lane Combination teaches the method of claim 20 substantially as is claimed,
wherein Moriss further discloses the valve which is separate and removeable from the valve frame when deployed in the native valve ([0166]),
but is silent with regards to the valve including a frame.
However, regarding claim 21 Thambar teaches a mitral valve replacement ([0047]) in which a valve frame (130) is separate from a replacement valve (110). Moriss and Thambar 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 method of the Moriss Moriss ‘903 Lane Combination by having the valve include a separate frame as is taught by Thambar in order to enable the two-part structure to isolate the valve from native heart movements upon implantation, which can lengthen the lifespan of the valve due to reduced forces, or to act as an anchoring structure to help anchor the valve in place.
Regarding claim 22 the Moriss Moriss ‘903 Lane Thambar Combination teaches the method of claim 21 substantially as is claimed,
wherein Moriss further discloses the valve frame and replacement valve each comprise a material covering (Tubular body: [0167] Dacron; Replacement valve: [0205], [0206], [0208] the membrane can be integral with the sealing skirts and thus made of the same material(s) which includes polymer).
Regarding claim 23 the Moriss Moriss ‘903 Lane Thambar Combination teaches the method of claim 22 substantially as is claimed,
wherein Moriss further discloses the strut anchors and clips are part of the valve frame and not the valve ([0166] the leaflet structure can be separate from the tubular body).
Regarding claim 24 the Moriss Moriss ‘903 Lane Thambar Combination teaches the method of claim 23 substantially as is claimed,
wherein Moriss further discloses the clips and strut anchors are inclined in an atrial direction (Figure 2A1, Figure 2E).
Regarding claim 27 the Moriss Moriss ‘903 Lane Thambar Combination teaches the method of claim 23 substantially as is claimed,
wherein Moriss teaches the valve frame is self-expanding ([0166]), and wherein Thambar teaches the valve is self-expanding ([0117]).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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 03/02/26