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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
The amendment filed 08/11/2026 has been entered. Claims 1-8 and 10-13 remain pending in the application. Claim 9 has been cancelled. New claims 14-20 have been added.
Response to Arguments
Applicant's arguments filed 08/11/2026 have been fully considered but they are not persuasive.
The argument that the metal struts of the annular metal frame 32 do not expand in a direction that is perpendicular to the radial direction of the cylinder, and therefore the prior art does not read on the newly claimed language of “wires which are free to move relative to each other”, the Examiner respectfully disagrees. The prior art, Basude, specifically discloses the material of the frame being able to be elastic, and therefore could be compressed and expanded in any direction as the frame material is made of a flexible material capable of such movement (see paragraph [0281] denoting the frame can be made of elastic material that can be compressed, and elastically recoiled (expanded)).
Applicant’s additional argument that the prior art fails to disclose “wherein the structure is curved in two directions perpendicular to each other in the expanded configuration,” the Examiner respectfully disagrees. The shutter of embodiment 600 is curved in two directions as shown by annotated Figures 19 and 21 below. The reasoning that the prior art only discloses that the shutter can expand in the lateral direction, and doesn’t explicitly say that is can expand along its length, is not a sufficient enough argument as if the shutter is made of a material that is capable of being compressed and expanded in one direction, it would be capable of expanding and compressing at least a little bit in a differing direction. Additionally, the process of expansion upon the length of the device is not a claimed feature in the claim. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., expansion along the device's length) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Objections
Claim 20 objected to because of the following informalities: Claim 20 should be dependent on claim 18. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim 1-5, 7-18, and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 20200138569 A1 (hereafter --Basude--).
Regarding Claim 1, Basude discloses an implant (20) for heart valve repair, the implant comprising: a clamp (24, 26) movable between an open position and a closed position in which the clamp is able to grasp a leaflet of a heart valve (see paragraph [0275], so as to fix the implant on the leaflet, and a shutter (32, 22) comprising a meshed structure (32) (see paragraph [0279]), adapted to pass automatically from a contracted configuration to an expanded configuration (see paragraph [0281]) in which the shutter is able to fill at least partially an opening portion remaining between the leaflet and at least one further leaflet of the heart valve of the heart valve, when the implant is attached to one leaflet (see paragraph [0280], so as to limit a backflow of blood through the opening portion when the heart valve closes (see Abstract denoting that the device reduces regurgitation), wherein the structure is curved in the expanded configuration (see annotated first curved direction in Figure 6 below), the shutter comprises wires which are free to move relative to each other when the meshed structure passes from the contracted configuration to the expanded configuration (see paragraph [0279] denoting the frame has interconnected struts being wires that can “move relative to one another”, see paragraph [0281] denoting the frame can be made of elastic material that can be compressed, and elastically recoiled (expanded)), the implant further comprising a sleeve enclosing end portions of the wires (see annotated sleeve in Figure 6 below, see also paragraph [0279] and [0280] denoting that both ends of the body can be covered by the fabric of the sleeve 28). It is to be noted that any area of the frame can be considered an “end portion,” as this limitation is very broad.
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This embodiment of Basude fails to disclose wherein the meshed structure is curved in two directions perpendicular to each other in the expanded configuration.
Another embodiment of Basude discloses an implant (600) for heart valve repair, the implant comprising: a clamp (see annotated clamp in Figures 19 and 21 below) movable between an open position and a closed position in which the clamp is able to grasp a leaflet of a heart valve (see paragraph [0289], so as to fix the implant on the leaflet, and a shutter (602) comprising a structure (see annotated structure in Figures 19 and 21 below) adapted to pass automatically from a contracted configuration to an expanded configuration (see paragraph [0287]) in which the shutter is able to fill at least partially an opening portion remaining between the leaflet and at least one further leaflet of the heart valve of the heart valve, when the implant is attached to one leaflet (see paragraph [0289], so as to limit a backflow of blood through the opening portion when the heart valve closes (see Abstract denoting that the device reduces regurgitation). This embodiment of Basude teaches wherein the structure is curved in two directions perpendicular to each other in the expanded configuration (one curve direction is about the circumference and then the ends of the device at 602 curve in perpendicular direction).
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Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to have the structure is curved in two directions perpendicular to each other in the expanded configuration, as taught by the alternate embodiment of Basude, it is contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the present disclosure, and therefore it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the present disclosure (see paragraph [0675]).
Regarding Claim 2, Basude as modified discloses the implant of claim 1, wherein the meshed structure is a metallic mesh (see paragraph [0279]).
Regarding Claim 3, Basude as modified discloses the implant of claim 1, wherein the meshed structure is made of a polymer selected from the group consisting of polyolefin, vinyl polymer, saturated polyester, polyurethane or any other biocompatible polymer (see paragraph [0281] denoting a material option is a polymer).
Regarding Claim 4, Basude as modified discloses the implant of claim 1, wherein the shutter comprises a membrane (28) at least partially covering the meshed structure (see paragraph [0279]).
Regarding Claim 5, Basude as modified discloses the implant of claim 1, wherein: the shutter defines a first bearing surface, and the clamp comprises a fastening arm defining a second bearing surface capable of facing the first bearing surface when the clamp is in the closed position, such that the first bearing surface and the second bearing surface enclose the leaflet (see annotated first bearing surface and fastening arm/second bearing surface in Figure 6 above, see also paragraph [0275]).
Regarding Claim 7, Basude as modified discloses the implant of claim 5, wherein the fastening arm is rotatable about an axis of rotation relative to the meshed structure and has a zig zag shape (see annotated fastening arm in Figure 6 above, the fastening arm being capable of rotation about the structure as it can open and close).
Regarding Claim 8, Basude as modified discloses the implant of claim 4, wherein the clamp comprises at least one further fastening arm (26) defining a third bearing surface capable of facing the first bearing surface when the clamp is in the closed position, such that the first bearing surface, the second bearing surface and the third bearing surface enclose the first leaflet therebetween (see annotated “further” fastening arm and third bearing surface in Figure 7 below).
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Regarding Claim 10, Basude as modified discloses the implant of claim 9, wherein the clamp comprises a fastening arm, and the sleeve encloses an end portion the fastening arm (see annotated fastening arm, fastening arm “end portion”, and sleeve in Figure 6 above).
Regarding Claim 11, Basude as modified discloses the implant of claim 9, wherein the sleeve has an opening, the wires and the fastening arm protruding out of the sleeve through the opening (see annotated sleeve opening in Figure 6 above, see paragraph [0264] denoting that the body can be hollow).
Regarding Claim 12, Basude as modified discloses the implant of claim 9, wherein the sleeve has a first opening and a second opening opposite the first opening, the wires protrude out of the sleeve through the first opening and the fastening arm protrudes out of the sleeve through the second opening (see annotated first and second opening, fastening arm “end portion” protruding from the second opening, and the wires “protruding” outwardly from the sleeve as they indent the sleeve in an outward direction from the first opening).
Regarding Claim 13, Basude as modified discloses the implant of claim 1, wherein the meshed structure and the clamp are parts of a single piece (see annotated structure and clamp in Figure 6 above).
Regarding Claim 14, Basude discloses an implant (20) comprising: a clamp (24,26) movable between an open position and a closed position in which the clamp is able to grasp a leaflet of a heart valve (see paragraph [0275]), so as to fix the implant on the leaflet, and a shutter (32, 22) comprising a structure (32) (see paragraph [0279]), adapted to pass automatically from a contracted configuration to an expanded configuration (see paragraph [0281]) in which the shutter is able to fill at least partially an opening portion remaining between the leaflet and at least one further leaflet of the heart valve (see Abstract) , when the implant is attached to one leaflet (see paragraph [0280]), so as to limit a backflow of blood through the opening portion when the heart valve closes (see Abstract denoting that the device reduces regurgitation), and wherein the structure is curved in the expanded configuration (see annotated first curved direction in Figure 6 below), the shutter comprises wires which are free to move relative to each other when the structure passes from the contracted configuration to the expanded configuration (see paragraph [0279] denoting the frame has interconnected struts being wires that can “move relative to one another”, see paragraph [0281] denoting the frame can be made of elastic material that can be compressed, and elastically recoiled (expanded)), the implant further comprising a sleeve enclosing end portions of the wires (see annotated sleeve in Figure 6 below, see also paragraph [0279] and [0280] denoting that both ends of the body can be covered by the fabric of the sleeve 28). It is to be noted that any area of the frame can be considered an “end portion,” as this limitation is very broad.
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This embodiment of Basude fails to disclose wherein the structure is curved in two directions perpendicular to each other in the expanded configuration.
Another embodiment of Basude discloses an implant (600) for heart valve repair, the implant comprising: a clamp (see annotated clamp in Figures 19 and 21 below) movable between an open position and a closed position in which the clamp is able to grasp a leaflet of a heart valve (see paragraph [0289], so as to fix the implant on the leaflet, and a shutter (602) comprising a structure (see annotated structure in Figures 19 and 21 below) adapted to pass automatically from a contracted configuration to an expanded configuration (see paragraph [0287]) in which the shutter is able to fill at least partially an opening portion remaining between the leaflet and at least one further leaflet of the heart valve of the heart valve, when the implant is attached to one leaflet (see paragraph [0289], so as to limit a backflow of blood through the opening portion when the heart valve closes (see Abstract denoting that the device reduces regurgitation). This embodiment of Basude teaches wherein the structure is curved in two directions perpendicular to each other in the expanded configuration (one curve direction is about the circumference and then the ends of the device at 602 curve in perpendicular direction).
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Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to have the structure is curved in two directions perpendicular to each other in the expanded configuration, as taught by the alternate embodiment of Basude, it is contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the present disclosure, and therefore it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the present disclosure (see paragraph [0675]).
Regarding Claim 15, Basude discloses the implant of claim 14, wherein the structure is a metallic mesh (see paragraph [0279]).
Regarding Claim 16, Basude discloses the implant of claim 14, wherein the structure is made of a polymer selected from the group consisting of polyolefin, vinyl polymer, saturated polyester, polyurethane or any other biocompatible polymer (see paragraph [0281] denoting a material option is a polymer).
Regarding Claim 17, Basude discloses the implant of claim 14, wherein the shutter comprises a membrane (28) at least partially covering the structure (see paragraph [0279]).
Regarding Claim 18, Basude discloses the implant of claim 14, wherein: the shutter defines a first bearing surface, and the clamp comprises a fastening arm defining a second bearing surface capable of facing the first bearing surface when the clamp is in the closed position, such that the first bearing surface and the second bearing surface enclose the leaflet (see annotated first bearing surface and fastening arm/second bearing surface in Figure 6 above, see also paragraph [0275]).
Regarding Claim 20, Basude discloses the implant of claim 5, wherein the fastening arm is rotatable about an axis of rotation relative to the structure and has a zig zag shape (see annotated fastening arm in Figure 6 above, the fastening arm being capable of rotation about the structure as it can open and close).
Claims 6 and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 20200138569 A1 (hereafter --Basude--), as applied to claims 5 and 14 above, in view of US 20210022850 A1 (hereafter --Basude 2--).
Regarding Claim 6, Basude as modified discloses the implant of claim 5.
Basude fails to disclose wherein at least one of a first bearing surface and or a second bearing surface is serrated or corrugated.
Basude 2 discloses an implant (1175) for heart valve repair, the implant comprising: a clamp (1176, 1177) movable between an open position and a closed position in which the clamp is able to grasp a leaflet of a heart valve so as to fix the implant on the leaflet (see paragraphs [0012], [0013], and [0016], see also Figure 40) and a shutter (1267) comprising a structure adapted to pass automatically from a contracted configuration to an expanded configuration (see paragraph [0058]) in which the shutter is able to fill at least partially an opening portion remaining between the leaflet and at least one further leaflet of the heart valve of the heart valve (see Figure 44), when the implant is attached to one leaflet (see Figure 40), so as to limit a backflow of blood through the opening portion when the heart valve closes (see Abstract denoting that the device reduces regurgitation, see also paragraph [0033]), and wherein the structure is curved in two directions perpendicular to each other in the expanded configuration (one curve direction is about the circumference and then the ends of the device at 1267 curve in perpendicular direction).
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Basude 2 teaches wherein at least one of a first bearing surface and or a second bearing surface is serrated or corrugated (see annotated first serrated bearing surface in Figure 42 above).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the implant to have the first bearing surface and or a second bearing surface is serrated or corrugated, as taught by Basude 2, as by doing so enables the leaflets to be grasped in a spaced-apart relationship and then drawn together in a coapted relationship while keeping the leaflets vertical (aligned with blood flow) to achieve the optimal coapted configuration (see paragraph [0013]).
Regarding Claim 19, Basude discloses the implant of claim 14.
Basude fails to disclose wherein at least one of a first bearing surface and or a second bearing surface is serrated or corrugated.
Basude 2 discloses an implant (1175) for heart valve repair, the implant comprising: a clamp (1176, 1177) movable between an open position and a closed position in which the clamp is able to grasp a leaflet of a heart valve so as to fix the implant on the leaflet (see paragraphs [0012], [0013], and [0016], see also Figure 40) and a shutter (1267) comprising a structure adapted to pass automatically from a contracted configuration to an expanded configuration (see paragraph [0058]) in which the shutter is able to fill at least partially an opening portion remaining between the leaflet and at least one further leaflet of the heart valve of the heart valve (see Figure 44), when the implant is attached to one leaflet (see Figure 40), so as to limit a backflow of blood through the opening portion when the heart valve closes (see Abstract denoting that the device reduces regurgitation, see also paragraph [0033]), and wherein the structure is curved in two directions perpendicular to each other in the expanded configuration (one curve direction is about the circumference and then the ends of the device at 1267 curve in perpendicular direction).
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Basude 2 teaches wherein at least one of a first bearing surface and or a second bearing surface is serrated or corrugated (see annotated first serrated bearing surface in Figure 42 above).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the implant to have the first bearing surface and or a second bearing surface is serrated or corrugated, as taught by Basude 2, as by doing so enables the leaflets to be grasped in a spaced-apart relationship and then drawn together in a coapted relationship while keeping the leaflets vertical (aligned with blood flow) to achieve the optimal coapted configuration (see paragraph [0013]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
