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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/20/25 has been entered.
Response to Arguments
Applicant's arguments filed 10/20/25 have been fully considered but they are not persuasive.
On page 9 regarding drawing objections, Applicant argues the “helically braided wire” is seen in figures 8c-f, and the “inner fabric” and “outer fabric” are shown in figures 11a-b and 2a-d.
The Examiner respectfully points out that Figure 8c-f shows only 810, described as a “frame”, and item 805, “the valve replacement”. No “helically braided wire” is seen in these figures. As regards figures 11a-b, this figure apparently shows only items 1110, 1105, 1120, 1115, 1125, and 1130, described as a flange rim material, flange outer material, inner adapter cuff material, outer adapter cuff material, inner valve cuff material, and outer adapter cuff material. The Examiner sees no mention of an “inner fabric” or “outer fabric” as Applicant argues.
On page 9 regarding specification objections, Applicant argues “inner fabric” and “outer fabric” is mentioned in various paragraphs, and then admits the terms are not used.
The Examiner respectfully reminds Applicant that proper antecedent basis for claim terms needs to be present in the specification, and that this is not a 112a rejection (which would require proving “support” for the limitations). This objection is accordingly maintained.
On page 10 regarding prior art rejections, Applicant argues amendments overcome the prior art of record, since Moriss ‘903 teaches a valve that is intended to engage a subannular region of the mitral valve. Applicant concludes this would position the valve of the Combination in a location other than suprannularly, as the claims now require.
The Examiner respectfully notes arguments are moot since Moriss ‘903 is not used in the prior art rejection.
On page 11 Applicant argues that Moriss’ 903 would “change the principle of operation” of the modifying reference.
The Examiner respectfully notes arguments are moot since they depend on a reference not used in the rejection of record.
On page 13 regarding the given priority to the claims, Applicant states the subject matter of the claims can be found in various paragraphs of the “original priority application”.
The Examiner respectfully is unclear with what the “original priority application” is considered to be by the Applicant, and so is unable to assess whether or not those paragraphs support all the claimed subject matter deemed to be new with the filing of the instant application. Notably, it may be that Applicant is referring to one of the provisional applications this application has support for (e.g. 63/015353), but this is unclear since there are no paragraph numbers in that application above [00071]. Alternatively, it is possible the Applicant may be referring to one of the original PCT applications, such as PCT/US21/32817, but this again, does not have any paragraph numbers above [0060]. It is unclear how any subsequently filed applications could be considered the “original priority application”, since they are simply one of about 40 applications in the continuity chain, and wouldn’t be able to be considered an “original” priority application. The Examiner accordingly maintains the priority date(s) listed.
Election/Restrictions
Newly submitted claim 32 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the originally filed/examined invention (see claim 27) indicates the presence of an inner fabric extending over an inside portion of the tubular frame. However, newly presented claim 32 states that the leaflets of the valve assembly are “attached directly” to the braided wire, to which the inner fabric is supposedly attached. Notably, the inner fabric cannot be present on the inside of the frame without having the leaflets attached thereto instead of the frame (evidenced by the specification [0160], [0166], [0198]). Accordingly, the “direct” attachment of the leaflets to the frame instead of an inner fabric constitutes a non-originally presented and examined species. If this had been originally presented, the Examiner would have restricted these as alternative, mutually exclusive species.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 32 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Further, newly submitted claim 33 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the originally presented claim 1 is drawn towards an implant for transcatheter deployment with a valve assembly attached within the tubular frame comprising a helically braided wire, and spaced radially inwardly, whereas the newly presented claim 33 is drawn towards an implant for replacement of a native mitral valve which has a valve assembly with leaflets extending from the braided wire structure. Notably, claim 33 is drawn towards a combination compared to the originally filed subcombination. The combination does not require the particulars of the subcombination, since it does not require the implant to be transcatheterly deployed, and the subcombination has separate utility such as acting as a transcatheter implant. Accordingly, if originally presented, the claims would have been restricted from one another.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 33 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Claim 34 is withdrawn for depending on claim 33.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Priority
Claims 4-30 have a priority date of 07/15/2024, since the following subject matter was first presented in the claims filed on this date:
“the posterior leaflet clip is configured to be positioned behind a P2 region of a native mitral leaflet..and the anterior leaflet clip is configured to be positioned behind an A2 region of a native leaflet…”.
Claims 5-30 have a priority date of 07/15/2024, since the following subject matter was first presented in the claims filed on this date:
the implant comprises “a medial anchor strut and a lateral anchor strut carried by the tubular body and configured for sub-annular ventricular deployment, wherein the medial and lateral anchor struts are configured to permit movement of the native mitral annulus in the medial and lateral directions and resist migration of the prosthetic implant towards the native atrium when deployed…”.
Claims 7-30 have a priority date of 07/15/2024, since the following subject matter was first presented in the claims filed on this date:
“the medial anchor strut extends into a medial sub-annular commissural area of the native heart…and wherein the lateral anchor strut extends into a lateral sub-annular commissural area of the native heart…”.
Claims 14-30 have a priority date of 07/15/2024, since the following subject matter was first presented in the claims filed on this date:
“the implant does not obstruct a left ventricle outflow tract (LVOT) when deployed in the mitral valve in part by one or more of the tubular frame being no more than 10% larger than the native mitral annulus of the native mitral valve, the implant being deformable, and an anterior leaflet clip configured to hang behind, but not pinch, an A2 region of the anterior mitral leaflet.”
Claims 21-25 have a priority date of 07/15/2024, since the following subject matter was first presented in the claims filed on this date:
“the tabs resist migration of the replacement valve in an atrial direction when deployed within the implant’s tubular body in the mitral valve.”
Claims 23-25 have a priority date of 07/15/2024, since the following subject matter was first presented in the claims filed on this date:
“the implant does not obstruct the LVOT…by multi-point securement of one or more of the medial and lateral anchor struts and the posterior and anterior leaflet clips.”
Claims 27-30 have a priority date of 07/15/2024, since the following subject matter was first presented in the claims filed on this date:
“an inner fabric extending over an inside portion of the tubular frame”.
Claims 29-30 have a priority date of 07/15/2024, since the following subject matter was first presented in the claims filed on this date:
“the at least helically braided wire comprises a first wire, and wherein the flange comprises the second wire.”
Drawings
The drawings are objected to because they fail to show all the claimed subject matter. The following should be shown by the drawings: the helically braided wire, the inner fabric, the outer fabric.
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 specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
the inner fabric, the outer fabric.
Appropriate correction is required.
Claim Objections
Claim 13, 31 are objected to because of the following informalities:
Claim 13 is objected to for appearing to miss a word after “10% larger than a diameter”.
Claim 31 is objected to for claiming “the at least on helical wire” but this is considered to have a typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 31 is rejected for having new matter, since the originally filed application fails to have support for the helical wire being configured to “act on the valve assembly due to movement of the native mitral annulus”. There is no support in the original disclosure for the helical wire to “act” on the valve assembly, and this is not mentioned or discussed anywhere.
Remaining claims are rejected for depending on a claim with new matter.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-15, 17-25, 27-31 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 Tuval et al. (US 20110208298 A1) hereinafter known as Tuval, and further in view of Alleleyn et al. (US 20220031452 A1) hereinafter known as Alleleyn.
Regarding claim 1 Moriss discloses an implant (abstract: valve) configured for transcatheter deployment within a mitral valve (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 Moriss was considered capable of performing the cited intended use. See, for example [0087], [0003]), within a native mitral valve comprising a native mitral annulus, a native posterior mitral leaflet and a native anterior mitral leaflet, the native mitral valve being within a native heart comprising a native left atrium, and a native left ventricle (these details are related to the intended location of implantation of the claimed implant, as opposed to the implant itself. The implant of Moriss is understood to be capable of being implanted within a native mitral valve with the above features, if desired),
the implant comprising:
a tubular frame (Figure 2a1) with an inflow end (Figure 2a1 item 112) and outflow end (Figure 2a1 item 114), the frame being formed from at least one wire (c) and a valve assembly attached within the frame ([0155]) and configured to be spaced inwardly (See Figure 2f regarding the location of the leaflet assembly within the valve itself and relative to the surrounding annulus A);
a flange comprising a contoured funnel shape (Figure 2h-1 item 165; [0217]), and a perimeter (Figure 2h-1), and a circular cross-section (the bottom-most half of the flange 165 where it joins to the circular frame), wherein the flange is configured to extend towards the native left ventricle and against the native annulus into an intra-annular space of the native heart when deployed within the native mitral valve, wherein the circular cross-section is smaller than the perimeter (Figure 2H-1 shows the uppermost half of the flange 165 extending at a larger perimeter than the lower half),
wherein the flange is configured to resist migration of the implant toward the native ventricle (this is also stated as a functional limitation. Also see [0217]) and resist paravalvular leaks when deployed within the native valve (this is also stated as a functional limitation. See [0217] the flange has a cover which will resist leaks);
at least one leaflet clip (Figure 2a1 item 120) extending radially outwardly from the outflow end (Figure 2a1), which permits movement of the implant and the native annulus and resists migration of the implant toward the native atrium when deployed in the valve (This is stated as a functional limitation of the clip (see explanation above). See also [0151] and Figure 2a6);
but is silent with regards to the frame being formed from a helically braided wire so it is capable of conforming to movement of the native heart,
and the flange’s perimeter being D-shaped.
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]) configured to be positioned on tissue above the native mitral annulus for supra-annular securement (This is stated as an intended use of the perimeter (see the explanation regarding intended uses above). See also 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.
Further, regarding claim 1 Alleleyn teaches that a stent frame of a valve can be made of wire can be made from a helical braided wire ([0055]; Figures 3, 7 show how the wire extends helically), that conforms to the native heart anatomy and adapts to movement of the heart (this is stated as a functional limitation, which a helically braided wire with slidable crossing points is understood to be capable of doing as it moves with the heart ([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 frame of Moriss so it is made of a helically braided wire 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 2 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein Moriss further discloses the leaflet clip comprises a posterior leaflet clip extending radially outwardly from the outflow end of the tubular frame (Figure 2a1 shows at least one clip which can be described as being “posterior”).
Regarding claim 3 the Moriss Tuval Alleleyn Combination teaches the implant of claim 2 substantially as is claimed,
wherein Moriss further discloses the clip comprises an anterior leaflet clip extending radially outwardly from the outflow end of the tubular frame (Figure 2a1 shows the at least one clip which can be described as being “anterior”).
Regarding claim 4 the Moriss Tuval Alleleyn Combination teaches the implant of claim 3 substantially as is claimed,
wherein Moriss further discloses the posterior leaflet clip is configured to be positioned behind a P2 region of the native posterior leaflet when deployed and the anterior leaflet clip is configured to be positioned behind an A2 region of the native anterior leaflet when deployed (this is stated as an “intended use” (see the explanation above). At least one of the arms is understood to be able to be positioned behind a p2 region of a posterior leaflet, and at least one other is understood to be able to be positioned behind an a2 region of an anterior leaflet, if located to do so. See also [0213].).
Regarding claim 5 the Moriss Tuval Alleleyn Combination teaches the implant of claim 4 substantially as is claimed,
wherein Moriss further discloses a medial anchor strut and a lateral anchor strut (Figure 2a1 at least two other of arms 120 are understood to be medial and lateral anchor struts) carried by the tubular frame configured for sub-annular ventricular deployment (this is stated as an “intended use” (see the explanation above). See also [0151], [0213]),
wherein the anchor struts are configured to permit movement of the native annulus in medial and lateral directions (this is stated as a “functional limitation”, which depends entirely on the annulus into which the implant is implanted and its size) and resist migration of the implant toward the native atrium when deployed (this is stated as a “functional limitation”. See [0151], [0213]).
Regarding claim 6 the Moriss Tuval Alleleyn Combination teaches the implant of claim 5 substantially as is claimed,
wherein Moriss further discloses the leaflet clips and anchor struts are inclined in the atrial direction (Figure 2a1 shows the clips and struts extending upward toward the atrial end 112).
Regarding claim 7 the Moriss Tuval Alleleyn Combination teaches the implant of claim 6 substantially as is claimed,
wherein Moriss further discloses the anchor struts extend into a sub-annular commissural area of the heart when deployed (this is stated as an “intended use” (see the explanation above). See also [0026], [0151]).
Regarding claim 8 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein Tuval further teaches the D-shaped perimeter of the flange comprises a straight side (a D-shape is understood to inherently or obviously have a straight side, in order to assume the shape “D”.).
Regarding claim 9 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein the Combination further teaches the contoured funnel shape of the flange is configured to promote sealing, anchoring, and a vortex flow through the implant (this is stated as a “functional limitation” (see the explanation above). Since the Combination teaches the contoured funnel shape, it is understood to promote the same functional features as Applicant’s flange’s shape).
Regarding claim 10 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein the Combination further teaches the flange is configured to fill in the gaps along a transition zone between the native left atrium and the native mitral annulus (this is stated as a “functional limitation” (see the explanation above). Since the Combination teaches the contoured funnel shape, it is understood to promote the same functional features as Applicant’s flange’s shape).
Regarding claim 11 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein Moriss further discloses the frame is capable of self-expanding, provided in part by the wire of the frame, when deployed within the native valve (this is believed to be a functional limitation (See the explanation above). See also [0166] the implant is self-expanding).
Regarding claim 12 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein the Combination further teaches the helically braided wire of the frame is capable of self-expanding, provided in part by the wire of the frame (this is believed to be a functional limitation (See the explanation above). See also [0166] of Moriss the implant is self-expanding, along with the rejection to claim 1 above in light of Allelyen’s helically braided wire).
Regarding claim 13 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein Moriss further discloses the frame is sized to have a diameter in an expanded state no more than 10% larger than a diameter [of] the native valve (this limitation appears to relate to the size of the heart into which the implant is intended to be implanted, as opposed to being a feature of the claimed implant).
Regarding claim 14 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein Moriss further discloses the implant does not obstruct a left ventricular outflow tract when deployed in the native valve by either the frame’s size compared to the native valve, the implant being deformable, or the anterior leaflet clip being configured to hang behind but not pinch an A2 region of the anterior mitral leaflet (Applicant indicates preservation is based on the frame’s size compared to the native valve, which does not materially alter the frame in any way, but instead depends on the specific annulus into which the claimed implant is implanted).
Regarding claim 15 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein Moriss further discloses a fabric attached to the frame ([0167] fabric).
Regarding claim 17 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein Moriss further discloses a replacement valve assembly configured to be received within the frame ([0155], [0166]).
Regarding claim 18 the Moriss Tuval Alleleyn Combination teaches the implant of claim 17 substantially as is claimed,
wherein Moriss further discloses the replacement valve is cooperatively sized with and configured to seat within the tubular frame when deployed (see [0155]; Figure 2f or 2a1).
Regarding claim 19 the Moriss Tuval Alleleyn Combination teaches the implant of claim 18 substantially as is claimed,
wherein Moriss further discloses the replacement valve is removeable from the tubular frame after being deployed ([0166]).
Regarding claim 20 the Moriss Tuval Alleleyn Combination teaches the implant of claim 19 substantially as is claimed,
wherein Moriss further discloses the replacement valve further comprises a fabric ([0205], [0206], [0208]).
Regarding claim 21 the Moriss Tuval Alleleyn Combination teaches the implant of claim 17 substantially as is claimed,
wherein Moriss further discloses the tubular frame further comprises a plurality of tabs at the inflow end (Figure 2H-2 item 165pf; [0270]) which resist migration of the replacement valve in an atrial direction when deployed in the frame (this is stated as a “functional limitation” of the tabs. See also [0218]).
Regarding claim 22 the Moriss Tuval Alleleyn Combination teaches the implant of claim 21 substantially as is claimed,
wherein Moriss further discloses anchor struts and leaflet clips extending from the frame ([0166] the leaflet structure can be separate from the tubular body).
Regarding claim 23 the Moriss Tuval Alleleyn Combination teaches the implant of claim 22 substantially as is claimed,
wherein Moriss further discloses the implant does not obstruct the LVOT when deployed in the native valve in part by multi-point securement of the anchor struts and leaflet clips (this is stated as a functional limitation (See explanation above). Since Moriss teaches the implant’s anchor struts and leaflet clips having multiple locations where they can be secured to native anatomy, this limitation is understood to be met).
Regarding claim 24 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein Moriss further discloses the implant is self-expandable ([0166]).
Regarding claim 25 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein the Combination further teaches the helically braided wire of the frame comprises a nitinol wire wound in a helical spiral (Moriss [0166] the frame is made of nitinol; Alleleyn [0147]; Alleleyn teaches the helical spiral braid/weave Figure 3; [0115], [0110]).
Regarding claim 27 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein Moriss further discloses an inner fabric extending over the inside of the tubular frame ([0148], [0167] Dacron fabric).
Regarding claim 28 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein Moriss further discloses an outer fabric extending over the outside of the frame ([0208] a cover and sealing skirt can be sewn together; [0167] Dacron fabric).
Regarding claim 29 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein Tuval further teaches the helically braided wire comprises a first wire ([0055]),
and wherein Alleleyn further teaches a heart valve comprising a helically braided wire mesh can comprise a first wire and a second wire ([0148]). 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 Alleleyn Combination so that the implant of the Combination is made of two wires as is taught by Alleleyn (e.g. so the helically braided wire and the flange are both formed of two wires) since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. See MPEP 2144.04(VI)(B). In this case, the duplication of the number of wires used would have been obvious to one of ordinary skill.
Regarding claim 30 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein Alleleyn further teaches the tubular frame is woven in an over-under fashion (Figure 3: at least some of the strands are over and some of the strands are under; [0110]).
Regarding claim 31 the Moriss Tuval Alleleyn Combination teaches the implant of claim 1 substantially as is claimed,
wherein the Combination further teaches the helical wire is configured to act on the valve assembly due to movement of the native mitral annulus (this is stated as a functional limitation of the helical wire (see the explanation in the rejection to claim 1 above). The helical wire of the Combination is understood to be capable of performing in the same way as Applicant’s helical wire if implanted in a similar way.).
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 01/29/26
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