DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-10) and the further election of Species A (Claims 3 and 4) in the reply filed on July 8th, 2026 is acknowledged.
Response to Amendment
The claims filed on July 8th, 2026 have been entered. Claims 1- 15 are pending in the application. Claims 5, 6, and 11- 15 are withdrawn for being drawn to an unelected invention.
Claim Objections
Claims 4, 8, and 9 are objected to because of the following informalities:
Claim 4, Line 5 states “to tighten as two jaws a flap of a heart valve”, it is suggested to change this to “to tighten as two jaws the flap of the heart valve”.
Claim 8, Lines 2-3 state “pierce a flap of a heart valve”, it is suggested to change this to “pierce the flap of the heart valve”.
Claim 9, Line 3 states “connected to an inlet hole”, it is suggested to change this to “connected to the inlet hole”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 and 7- 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hart et al. (US 5,954,732) in view of Goldfarb et al. (US 2002/0013571) and in view of Buelna et al. (US 5,836,956).
Regarding claim 1, Hart (Hart et al.) teaches a device (10)(abstract)(Figs. 1- 15) for joining tissue (As Hart teaches that the device is capable of being inserted into a vessel and suturing tissue together (Column 7, Lines 1-20), then the device would be capable of joining heart valve flaps.), comprising: a cylindrical proximal body (sheath 47), defining a central axial cavity which runs in the cylindrical proximal body from a first base surface to a second base surface (see annotated Fig. 11 below), a cylindrical distal body (distal portion of tube 87), having a rigid coaxial shaft (rest of tube 87) which is fixed and rises from a central position of a base surface of the cylindrical distal body, in which said coaxial shaft is threaded slidingly in said central axial cavity of the cylindrical proximal body (Column 7, Line 62- Column 8, Line 12), a plurality of arms (expandable structure 92, each filament of the structure is an arm), each arm of the plurality of arms having a first end attached to the second base surface of the cylindrical proximal body and a second end attached to said cylindrical distal body (Column 8, Lines 1- 10), wherein each arm is configured to assume a radially position expanded with an elbow bend when outside said external catheter (see Fig. 6), and to assume an extended position parallel to said rigid coaxial shaft when the cylindrical distal body is inside said external catheter (see Fig. 4), in which said arms are configured so that, when they are in said radially expanded position with an elbow bend, they define radially oriented supports to support flaps of a heart valve (see annotated Fig. 7 below)(Column 8, Lines 1- 12), wherein said cylindrical proximal body defines a plurality of through channels (50 and 52) which run in the cylindrical proximal body from as many inlet holes in the first base surface of the cylindrical proximal body, to as many outlet holes in a lateral surface of the cylindrical proximal body (Column 7, Lines 38- 46), a plurality of internal catheters (needles 70 and 72), each internal catheter of said internal catheters is connected to a respective inlet hole of said inlet holes and is configured to convey a respective suture thread to a respective through channel of said through channels wherein said internal catheters are further configured to let said suture thread come out from the respective outlet hole from the lateral surface of the cylindrical proximal body and to direct it partially in said radial direction when said suture thread is pushed (Column 7, Lines 46- 58), a plurality of suture threads (32 and 34), in which each suture thread of said suture threads is inserted into a respective internal catheter of said internal catheters (Column 7, Lines 46- 52).
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Regarding wherein the plurality of arms define radially oriented supports to support flaps of a heart valve without interfering with chordae tendineae of the heart valve located on opposite sides with respect to the arms in said radially expanded position, as this language is functional, the structure of the device only needs to be able to accomplish the function. Therefore, as Hart teaches that the plurality of arms define radially oriented supports to support tissue within the body (Column 8, Lines 1- 10) and as the chordae tendineae can be of a size where the plurality of arms do not interfere with the chordae tendineae, then the plurality of arms as taught by Hart can accomplish this function.
Hart does not teach an external catheter adapted to be inserted into a patient’s blood vessel, wherein the plurality of arms are configured to assume an extended position parallel to said rigid coaxial shaft when both the cylindrical proximal body and the cylindrical distal body are inside said external catheter, wherein said internal catheter are further configured to direct the suture thread partially in said radial direction between the arms in said radially expanded position or wherein said suture threads having terminations with hooking elements configured in such a way as to hook the flaps of said heart valve when made to come out of the holes of the cylindrical proximal body and in such a way as to expand autonomously in the radial direction after having harpooned said flaps so that, by pulling the suture threads, the valve flaps are dragged by said hooking elements, approaching one another towards a central longitudinal axis of the device.
Goldfarb teaches a similar device (interventional tool 100)(Figs. 22- 23B and 27C- 27D) for joining heart valve flaps (abstract and Paragraph 0109) with an external catheter (125) adapted to be inserted into a patient’s blood vessel (Paragraph 0086), with a cylindrical body (308) with a plurality of arms (302), and a suture thread (322) having a hooking element (800) configured in such a way as to expand and secure the tissue (Paragraph 0113).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by Hart to have an external sheath and a hooking element on the suture as taught by Goldfarb, since Goldfarb teaches that the catheter “affords subsequent access to permit introduction of the tool(s) which will be used for performing the valve or tissue modification” and that the hooking element “provides a broad surface to rest against the leaflets” (Paragraphs 0086 and 0113).
Regarding wherein the plurality of arms are configured to assume an extended position parallel to said rigid coaxial shaft when both the cylindrical proximal body and the cylindrical distal body are inside said external catheter, as the combination teaches a sheath disposed over the device and as the plurality of arms are taught to be collapsible (Column 7, Lines 64- 67 and Column 9, Lines 31- 37), when the cylindrical proximal body and the cylindrical distal body are inserted into the external sheath, then the plurality of arms would assume an extended position parallel to the coaxial shaft, as shown in Fig. 4 of Hart.
Regarding wherein the combination teaches that the hooking element hooks the flaps of said heart valve and expand autonomously in the radial direction after having harpooned the flaps so that, by pulling the suture threads, the valve flaps are dragged by said hooking elements, approaching one another towards a central longitudinal axis of the device, as the combination teaches a suture thread being put into tissue (Hart, Column 7, Lines 1- 20), and a hooking element that hooks the flaps of the heart valve is expands in the radial direction (Goldfarb, Paragraph 0113)(see Figs. 27C and 27D), then when the suture threads are pulled the valve flaps are dragged by the hooking elements and will approach one another toward a central longitudinal axis of the device.
The combination does not teach wherein herein said internal catheters are further configured to direct the suture thread partially in said radial direction between the arms in said radially expanded position.
Buelna (Buelna et al.) teaches a similar device (10)(Figs. 1- 8) for joining tissue together (abstract, Column 3, Line 66- Column 4, Line 2) comprising: a cylindrical proximal body, defining a central axial cavity which runs in the cylindrical proximal body from a first base surface to a second base surface, a cylindrical distal body (see annotated Fig. 4 below); a plurality of arms (fingers 118), each arm of the plurality of arms having a first end attached to the second base surface of the cylindrical proximal body and a second end attached to said cylindrical distal body, wherein each arm is configured to assume a radially position expanded with an elbow bend (see annotated Fig. 4 below), in which said arms are configured so that, when they are in said radially expanded position with an elbow bend, they define radially oriented supports to support the tissue (see annotated Fig. 4 below)(Column 7, Lines 38- 47); wherein said cylindrical proximal body defines a plurality of through channels which run in the cylindrical proximal body from as many inlet holes in the first base surface of the cylindrical proximal body, to as many outlet holes (170, 172) in a lateral surface of the cylindrical proximal body (see annotated Fig. 4 below); and a plurality of internal catheters (needles 90, 92), wherein said internal catheters and to direct suture thread (158, 159) partially in said radial direction between the arms in said radially expanded position when said suture thread is pushed (Column 7, Line 56- Column 8, Line 2; Column 8, Lines 38- 56).
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It would have been obvious to one of ordinary skill in the art to modify the plurality of arms as taught by the combination to be the plurality of arms as taught by Buelna for the purpose of support tissue during a suturing procedure (Hart, Column 8, Lines 1- 12; Buelna, Column 7, Lines 38- 47). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one plurality of arms for another because both are disclosed as equivalent structures for supporting tissue during a suturing procedure (Hart, Column 8, Lines 1- 12; Buelna, Column 7, Lines 38- 47) and substitution of one for the other would have resulted in the predictable result of providing a structure that supports tissue and enables the system to suture tissue together (Hart, Column 7, Lines 1-20 and Column 8, Lines 1- 12; Buelna, Column 3, Line 66- Column 4, Line 2 and Column 7, Lines 38- 47). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Therefore, within the combination, the internal catheters are further configured to direct the suture thread partially in said radial direction between the arms in said radially expanded position.
Regarding claim 2, Hart, Goldfarb and Buelna make obvious the device as discussed above, including the plurality of arms.
The combination further teaches wherein each arm of the plurality of arms defines coplanar supports (see annotated Fig. 4 of Buelna below).
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Regarding claim 3, Hart, Goldfarb and Buelna make obvious the device as discussed above, including the plurality of arms.
The combination further teaches wherein each arm of the plurality of arms is integral (Column 5, Lines 23- 40 of Buelna).
The combination is silent to wherein each arm of the plurality of arms consists either of a shape memory material or an elastically deformable material.
Goldfarb teaches a similar device (interventional tool 100)(Figs. 10A- 10C)(abstract) with an external catheter (125) adapted to be inserted into a patient’s blood vessel (Paragraph 0086), with a cylindrical body (210) with a plurality of arms (212), wherein the plurality of arms are integral and consist of a shape memory material (Paragraph 0091).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plurality of arms as taught by the combination to be made of a shape memory material as taught by Goldfarb, since Goldfarb teaches that this material is preferable and known in the art to be used for a plurality of arms that support tissue (Paragraph 0091).
Regarding claim 4, Hart, Goldfarb and Buelna make obvious the device as discussed above, including the plurality of arms.
The combination further teaches wherein each arm of the plurality of arms is configured so that, by progressively approaching the cylindrical proximal body to the cylindrical distal body, the arm passes from said extended position to said radially expanded position with said elbow bend and further to a closed position in which said elbow bend is functionally configured to cooperate with said coaxial shaft to tighten like two jaws on a flap of a heart valve (see annotated Fig. 5 of Buelna below)(As Buelna teaches that the arms can be further compressed during the procedure (Column 8, Lines 14- 22) and that tissue is between the plurality of arms and the coaxial shaft, then the plurality of arms can be compressed further to a closed position and would be capable of cooperating with the coaxial shaft to tighten on the tissue.).
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Regarding claim 7, Hart, Goldfarb and Buelna make obvious the device as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by Hart to have the hooking elements on the suture as taught by Goldfarb, since Goldfarb teaches that the hooking element “provides a broad surface to rest against the leaflets” (Paragraph 0113).
The combination further teaches wherein each hooking elements of said hooking elements is composed of a tubular body partially cut into longitudinal strips, in which said longitudinal strips are made of elastic or shape memory material and are configured to remain extended longitudinally when they are in the respective internal catheter and to expand autonomously in the radial direction when they are outside the respective internal catheter (Paragraph 0113)(see Figs. 27C and 27D).
Regarding claim 8, Hart, Goldfarb and Buelna make obvious the device as discussed above.
Hart further teaches wherein said internal catheter have terminations shaped like a tip of a syringe needle (see annotated Fig. 11 below) and are configured to pierce a flap of a heart valve (As this language is functional, the structure of the device only needs to be able to accomplish the function, as Hart teaches that the tips of the internal catheters pierce tissue (Column 8, Lines 9- 12), they would be capable of piercing a flap of a heart valve.).
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Regarding claim 9, Hart, Goldfarb and Buelna make obvious the device as discussed above.
The combination does not teach wherein said plurality of through channels comprises three through channels and said plurality of internal catheters comprises three internal catheters each of which is connected to an inlet hole of the respective through channel.
Buelna (Buelna et al.) teaches in another embodiment a similar device ()(Fig. 10) for joining tissue together (abstract, Column 3, Line 66- Column 4, Line 2) comprising: a cylindrical proximal body, a cylindrical distal body (see annotated Fig. 10 below); a plurality of arms (fingers 118); wherein said cylindrical proximal body defines a plurality of through channels which run in the cylindrical proximal body from as many inlet holes in the first base surface of the cylindrical proximal body, to as many outlet holes in a lateral surface of the cylindrical proximal body (see annotated Fig. 10 below); wherein said plurality of through channels comprises three through channels and a plurality of internal catheters (needles 90, 92, 201, and 203) comprises three internal catheters (needles 90, 92, and 201) each of which is connected to an inlet hole of the respective through channel (Column 9, Lines 33- 42).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plurality of through channels and the plurality of inner catheters of the combination to be three through channels and three inner catheters as taught by the second embodiment of Buelna, since Buelna teaches that it is a known alternative to having only two suturing internal catheters and that this configuration allows for suturing more tissue with the extra needles (Column 9, Lines 33- 68).
Regarding claim 10, Hart, Goldfarb and Buelna make obvious the device as discussed above.
The combination does not teach the device comprising cutting means configured for cutting said suture threads.
Goldfarb teaches in a different embodiment a similar device (Fixation device 532)(Fig. 50- 51)(abstract) for deploying suture threads into tissue wherein the device comprises cutting means configured for cutting said suture threads (Paragraph 0135).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of the combination to have a cutting means as taught by Goldfarb, since Goldfarb teaches that doing so allows for the removal of the device after fixing the leaflets (Paragraph 0135).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.R.R./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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