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 11/26/25 have been fully considered but they are not persuasive.
On page 11 regarding claim priority to claim 5, Applicant argues [0119] has priority for the subject matter of claim 5.
The Examiner respectfully points out that noting [0119] in the application as filed does not mention anything about 150 degrees. However, the Examiner notes that claim 5 has not been rejected as having new matter, and thus support in the instant application is not required.
On page 11 regarding claim priority to claims 8-9, Applicant argues support for the amended claims is in [0197]. On page 11 regarding claim priority to claim 11, Applicant argues support for the claim is in [0120]. On page 11 regarding priority to claim 24, Applicant argues support for the claim is in [0197] and [0200]).
The Examiner respectfully notes that claims 8-9, 11, and 24 has not been rejected as having new matter, and thus support in the instant application is not required. The claims are simply given the priority date of the filing of the instant application, since priority is not found in previous applications in the priority chain.
On page 11, Applicant argues support for the subject matter of all the above claims can also be found in 18/028212 and 18/694897, and presumably suggests a priority date for these claims to be 03/23/2023 and 03/22/2024, the filing date of each of these applications.
The Examiner respectfully agrees that [0049] of 18/028212 includes support for “stabilization anchors” to be “disposed symmetric to the P2 anchors with a span of 150 degrees”, but notes no support in the disclosure for “medial and lateral anchor struts” to be “spaced from each other by no more than 150 degrees” as would be required to support the subject matter of claim 5. Paragraph [0050] also does not appear to reference medial and lateral anchor struts being spaced no more than 150 degrees from one another. The Examiner notes further that those two paragraphs do not appear to address any of the subject matter of claims 8-9 or 24 (the Examiner points out the complete change in subject matter of claim 11 made in amendments, and as such is not relevant here).
Regarding the supposed support in US 18/694897, the Examiner notes that [0112] only includes the words “Flanges and Anchors of the Braided Wire Frame” and as such does not have support for any of the subject matter of claims 5, 8-9, or 24.
The Examiner respectfully agrees 18/694897 has support in [0205] for leaflet anchors or clips to hang on native leaflets, but notes that this is not understood to be the same scope as claims 8-9, which require a specific clip hanging onto a specific A2 or P2 region.
Paragraphs [0119]-[0120], [0206], [0219]-[0222], [0232], [0256]-[0257], and the discussed figures of 18/694897 appear to have nothing to do with the subject matter of any of the claims having later priority.
On pages 12-13 regarding prior art rejections, Applicant argues amendments overcome the rejection of record since Moriss ‘903 teaches a retainer 110 that is for engaging/conforming with tissue in a subannular region of the mitral valve ([0147], Figure 10b). Applicant argues modification of Moriss ‘903 would not result in the claimed features of claim 1, but would rather result in a valve that is positioned entirely subannularly.
The Examiner respectfully points out that Applicant’s arguments appear to be directed towards modification of a reference (Moriss ‘903) which is not actually modified. The rejection of record is based on the modification or Moriss (US 20150327994), and not Moriss (US 20150351093). Applicant’s arguments are accordingly not persuasive.
On pages 13-14 Applicant argues further that modification of Moriss ‘903 would “render the prior art invention” to be “unsatisfactory for its intended purpose”, and would “change the principle of operation” of the prior art, since Moriss ‘903’s “sole purpose” is “to provide subannular anchoring while absorbing distorting forces imparted by the native annulus and leaving the valve support 120 substantially unaffected”.
The Examiner again respectfully points out that Applicant’s arguments appear to be directed towards a prior art reference which is not modified (but instead, was used in the rejection of record to modify the reference of Moriss (US 20150327994), making Applicant’s arguments unpersuasive.
Drawings
The drawings are objected to because they fail to show the following claimed subject matter: the leaflet assembly.
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 5-13 have a priority date of 10/08/2024, since the following subject matter was first presented in the claims filed on this date:
“the medial and lateral anchor struts are spaced from each other by no more than 150 degrees.”
Claims 8-13 have a priority date of 10/08/2024, since the following subject matter was first presented in the claims filed on this date:
“the posterior clip is configured to be positioned behind a P2 region of a native mitral posterior leaflet…”.
Claims 9-13 have a priority date of 10/08/2024, since the following subject matter was first presented in the claims filed on this date:
“the anterior clip is configured to be positioned behind an A2 region of a native anterior leaflet…”.
Claim 24 has a priority date of 10/08/2024, since the following subject matter was first presented in the claims filed on this date:
“the prosthetic mitral valve is configured to preserve a native left ventricle outflow tract when deployed in the native mitral valve in part by a combination the prosthetic mitral valve being shape set to no more than 10% larger than the native mitral annulus of the native mitral valve, the prosthetic mitral valve being deformable, and the anterior clip hanging behind, but not pinching, an A2 region of the native mitral anterior leaflet.”
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) 1-4, 14-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss et al. (US 20150327994 A1) hereinafter known Moriss in view of Tuval et al. (US 20110208298 A1) hereinafter known as Tuval.
Regarding claim 1 Moriss discloses a prosthetic mitral valve ([0009]) comprising:
a self-expandable tubular body ([0067] nitinol support 110) having an inflow end (Figure 2a1 item 112) and an outflow end (Figure 2a1 item 114);
a flange extending radially outwardly from the inflow end (Figure 2h-1 item 165) which minimizes paravalvular leaks (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Moriss discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example [0217] the flange prevents atrial movement and encourages ingrowth, both of which will contribute to minimizing leaks) and resists migration of the valve towards the outflow end when deployed in a mitral valve (this is also stated as a “functional limitation” (See the explanation above). See also [0217]),
wherein the flange comprises a first portion with a perimeter configured to rest on top of a native mitral annulus for supra-annular securement (This is stated as an “intended use” (intended location of implantation) 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 Moriss was considered capable of performing the cited intended location of implantation. See, for example, [0217] the “first portion” is understood to be a top-most half of the flange 165), and a second portion extending from the first portion towards the outflow end (Figure 2h item 165 the bottom-most half of the flange) which has a contoured funnel-like shape (see Figure 2h-1 which shows the flange 165 in its entirety being a funnel-like shape (see [0237] of Applicant’s specification, which defines a funnel-like shape as one without a right-angle transition)) configured to radially push into the native mitral annulus (this is stated as a functional limitation which depends entirely upon the valve into which the claimed device is implanted, and the method upon which it is implanted (see the explanation regarding functional limitations above). The second portion of the flange is understood to be capable of pushing radially into a relatively small -radiused native annulus, for example. See also/alternatively [0217] which states that the flange 165 acts “to compress the annulus between the tip portions 122 and the flange 165”, indicating the intent for the entirety of the flange to press into the annulus.);
a medial anchor strut extending medially from the outflow end of the tubular body (Figures 2a1-2a2 shows at least one strut 120 which extends in a direction that could be considered at least medial of the outflow end);
a lateral anchor strut extending laterally from the outflow end of the tubular body (Figures 2a1-2a2 shows at least one strut 120 which extends in a direction that could be considered at least lateral of the outflow end);
a posterior clip extending posteriorly from the outflow end of the tubular body (Figures 2a1-2a2 shows at least one clip 120 which extends in a direction that could be considered at least posterior of the outflow end); and
an anterior clip extending anteriorly from the outflow end of the tubular body (Figures 2a1-2a2 shows at least one clip 120 which extends in a direction that could be considered at least anterior of the outflow end); and
wherein the medial and lateral anchor struts permit movement of the
the anchor struts and clips resist migration of the valve toward the atrial end (this is also a functional limitation (see the explanations above). See also [0217]),
but is silent with regards to the first portion having, as fabricated, a D-shaped perimeter.
However, regarding claim 1, Tuval teaches that a mitral valve (Abstract) frame flange (Figure 6b item 116) can have a top, as-fabricated, D-shaped perimeter ([0127]-[0128]) for supra-annular securement (Figure 6b). Moriss and Tuval 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 Tuval, since this shape mimics the natural shape of a native mitral valve and accounts for the anterior horn of the atrium. Further, 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 shape of a mitral valve implant would have been considered obvious to try to mimic the natural shape of the valve.
Regarding claim 2 the Moriss Tuval Combination teaches the valve of claim 1 substantially as is claimed,
wherein Moriss further discloses a fabric surrounding a portion of the tubular body ([0167] Dacron).
Regarding claim 3 the Moriss Tuval Combination teaches the valve of claim 1 substantially as is claimed,
wherein Moriss further discloses the clips and anchor struts are inclined in an atrial direction (Figure 2e).
Regarding claim 4 the Moriss Tuval Combination teaches the valve of claim 3 substantially as is claimed,
wherein Moriss further discloses the medial anchor strut are configured to extend within native chordae into a medial area of a native heart when deployed and the lateral anchor strut are configured to extend within the native chordae into a lateral area of the native heart when deployed (this is stated as an “intended use” of the medial and lateral anchor struts, which depends on their method of implantation (see explanation above). See also Figure 2a6; [0159]).
Regarding claim 14 the Moriss Tuval Combination teaches the valve of claim 1 substantially as is claimed,
wherein Moriss further discloses the flange’s second portion comprises a circular perimeter (Figure 2h item 165 the bottom-most half of the flange) which is configured to rest in an intra-annular area of the native mitral annulus when deployed (this is stated as an intended location of implantation (see the explanation regarding “intended uses” above. See also Moriss Figure 2H-1 item 165 and [0217]. See also Tuval [0127]-[0128] the upper part of the frame (Figure 6a-b item 116) has a D-shaped perimeter, but the lower part of the frame (Figure 6a-b item 112 has a circular shape, which indicates a second, lower part of the flange transitions from D-shaped to circular at the junction between the two sections 112, 116).
Regarding claim 15 the Moriss Tuval Combination teaches the valve of claim 14 substantially as is claimed,
wherein Tuval further teaches the flange being configured to radially conform to the native mitral annulus when deployed in the native mitral valve ([0120]).
Regarding claim 16 the Moriss Tuval Combination teaches the valve of claim 15 substantially as is claimed,
wherein the Combination further teaches the clips and anchor struts are configured to permit movement of the native mitral annulus (this is stated as a functional limitation of the anchor struts (see the explanation above), which appears to depend on the method of implantation, and/or the annulus into which the valve in question is implanted into, as opposed to structurally distinguishing the clips and anchor struts.).
Regarding claim 17 the Moriss Tuval Combination teaches the valve of claim 1 substantially as is claimed,
wherein Moriss further discloses a leaflet assembly configured to be received within the tubular body (Figure 2f item 152; [0155]).
Regarding claim 18 the Moriss Tuval Combination teaches the valve of claim 17 substantially as is claimed,
wherein Moriss further the leaflet assembly (Figure 2f item 150) is cooperatively sized with and configured to seat within the tubular body when deployed (see [0155]; Figure 2f or 2a1).
Regarding claim 19 the Moriss Tuval Combination teaches the valve of claim 18 substantially as is claimed,
wherein Moriss further discloses the leaflet assembly is separate and removeable from the tubular body when deployed ([0166]).
Regarding claim 20 the Moriss Tuval Combination teaches the valve of claim 19 substantially as is claimed,
wherein Moriss further discloses the leaflet assembly is part of a valve assembly ([0166] the valve assembly 150 is coupled to the support 110 after implantation).
Regarding claim 21 the Moriss Tuval Combination teaches the valve of claim 19 substantially as is claimed,
wherein Moriss further discloses the tubular body comprises a plurality of tabs at the inflow end (Figure 2H-2 item 165pf; [0270]).
Regarding claim 22 the Moriss Tuval Combination teaches the valve of claim 21 substantially as is claimed,
wherein Moriss further discloses the anchor struts and clips are part of the tubular body and not part of the leaflet assembly ([0166] the leaflet structure can be separate from the tubular body).
Regarding claim 23 the Moriss Tuval Combination teaches the valve of claim 22 substantially as is claimed,
wherein Moriss further discloses the prosthetic mitral valve is configured to preserve a native left ventricular outflow tract when deployed in the native valve in part by multi-point securement of the anchor struts and clips (this limitation appears to be met since there are multiple securement points).
Regarding claim 24 the Moriss Tuval Combination teaches the valve of claim 1 substantially as is claimed,
wherein Moriss further discloses the prosthetic mitral valve is configured to preserve a native left ventricle outflow tract by the valve when deployed in the native valve in part by a combination of the valve being shape set to no more than 10% larger than the native mitral annulus of the native valve (this appears to be related to the size of the valve the valve is implanted into, as opposed to being a feature of the valve itself), the valve being deformable ([0150] the frame is made of a deformable material; [0167], [0173] the arms of the valve are also deformable), and the anterior clip hanging behind but not pinching an A2 region of a native anterior leaflet (This is stated as an “intended use” (intended location of implantation) of the claimed device (see the explanation above). In this case, the structure of the Moriss Tuval Combination was considered capable of performing the cited intended location of implantation.).
Claim(s) 10-11, 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss in view of Tuval as is applied above, further in view of Alleleyn et al. (US 20220031452 A1) hereinafter known as Alleleyn.
Regarding claim 10 the Moriss Tuval Combination teaches the valve of claim 1 substantially as is claimed,
wherein Moriss further discloses a valve assembly (150) attached within the tubular body to the frame ([0166] the valve 150 is coupled to the support after implantation), wherein the frame is configured to act on the valve assembly due to the movement of the native mitral annulus (this is stated as a functional limitation (see the explanation above) which depends mostly on how the device in question is implanted, and also the valve into which the device is implanted. However, see also [0007] which states the annulus changes shape based on heart movement, [0198] which states how the apparatus as a whole 100 experiences a hemodynamic load with each heartbeat, and [0180] which indicates how the arms (which are a part of the frame) are purposedly designed flexible to they experience force from the cyclic bearing of the heart),
and wherein Tuval further teaches a tubular body (Figure 6a-b item 100) which includes a valve assembly attached therein ([0072]), wherein the tubular body is configured to act on the valve assembly due to movement of the native mitral annulus ([0110]),
but is silent with regards to the tubular body including at least one helically braided wire.
However, regarding claim 10 Alleleyn teaches that a stent frame of a valve (Figure 1 item 4) can comprise a helically braided ([0055]; Figures 3, 7 show how the wire extends helically) wire frame ([0147]). Moriss and Alleleyn 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 Moriss Tuval Combination so that the tubular body is made of a helically braided 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 11 the Moriss Tuval Alleleyn Combination teaches the valve of claim 10 substantially as is claimed,
wherein Moriss further discloses the valve assembly comprises leaflets (152), and wherein the leaflets are attached directly to the tubular body ([0166] the valve 150 is coupled to the support 110; [0205] the material of the valve 150 is attached directly or integrally formed with the cover 151 of the support 110, which is attached to the outside of support 110.),
and wherein Tuval also further teaches the valve assembly includes leaflets which are attached directly to the tubular body ([0072]).
Regarding claim 25 the Moriss Tuval Combination teaches the valve of claim 1 substantially as is claimed,
but is silent with regards to the tubular body of the valve comprises a helically braided nitinol wire frame which is deformable.
However, regarding claim 25 Alleleyn teaches that a stent frame of a valve (Figure 1 item 4) can comprise a helically braided ([0055]; Figures 3, 7 show how the wire extends helically) Nitinol wire frame ([0147]) which is deformable (see the explanations above). See also [0110], [0014]). 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 Tuval Combination so that it has 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 26 the Moriss Tuval Alleleyn Combination teaches the valve of claim 25 substantially as is claimed,
wherein the Combination further teaches the wire is shape set to no more than 10% larger than the native mitral annulus of the native annulus (this appears to be related to the size of the annulus into which the valve is implanted as opposed to the structure of the valve itself).
Regarding claim 27 the Moriss Tuval Alleleyn Combination teaches the valve of claim 25 substantially as is claimed,
wherein Alleleyn further teaches the wire frame comprises a braid pattern that repeats around a circle (Figures 3, 7).
Claims 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss and Tuval as is applied above, further in view of Oba et al. (US 20180055629 A1) hereinafter known as Oba.
Regarding claim 5 the Moriss Tuval Combination teaches the valve of claim 4 substantially as is claimed,
but is silent with regards to the medial and lateral anchor strut placement.
However, regarding claim 5 Oba teaches a valve with medial and lateral struts extending from a downstream end (Figures 5-6 shows medial/lateral struts, and anterior/posterior clips extending around the circumference of the frame. The annotated figure shows how medial and lateral struts extend 90 degrees from one another at the least, around either the posterior or anterior clips). 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 location of the medial and lateral anchor strut placements as is taught by Oba 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 situation, the use of arms positioned at any known location around the perimeter of the valve would have been considered obvious to try.
PNG
media_image1.png
542
614
media_image1.png
Greyscale
Regarding claim 6 the Moriss Tuval Oba Combination teaches the valve of claim 5 substantially as is claimed,
wherein Oba further teaches the clips are symmetrically spaced from each other and located on opposite sides of the tubular body (see the annotated figure 5 above).
Regarding claim 7 the Moriss Tuval Oba Combination teaches the valve of claim 6 substantially as is claimed,
wherein Oba further teaches the medial and lateral anchor struts are each spaced from the anterior or posterior 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 8 the Moriss Tuval Oba Combination teaches the valve of claim 7 substantially as is claimed,
wherein the Combination further teaches the posterior clip is configured to be positioned behind a P2 region of a native mitral posterior leaflet when deployed therein (This is stated as an “intended” location of implantation) of the claimed device. The posterior clips are understood capable of being implanted accordingly, if desired).
Regarding claim 9 the Moriss Tuval Oba Combination teaches the valve of claim 8 substantially as is claimed,
wherein the Combination further discloses the anterior clip is configured to be positioned behind an A2 region of a native mitral anterior leaflet when deployed therein (This is stated as an “intended” location of implantation) of the claimed device. The anterior clips are understood capable of being implanted accordingly, if desired).
Claims 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss, Tuval, and Oba as, further in view of Allelyn as are applied above.
Regarding claim 12 the Moriss Tuval Oba Combination teaches the valve of claim 9 substantially as is claimed,
but is silent with regards to the body of the valve comprises a helically braided nitinol wire frame.
However, regarding claim 12 Alleleyn teaches that a stent frame of a valve (Figure 1 item 4) can comprise 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 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 Tuval Oba Combination so that the tubular body 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 13 the Moriss Tuval Oba Alleleyn Combination teaches the valve of claim 12 substantially as is claimed,
wherein the Combination further teaches the wire frame is shape set to more than 10% larger than the native mitral annulus of the native mitral valve (this would depend entirely on the size of the heart into which the valve is implanted, and does not appear to materially change its structure).
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 12/08/25