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 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
Acknowledgement is made to the amendment received 01/29/2026.
Acknowledgement is made to the amendment of claims 1 and 15.
Claims 1-20 are pending. A complete action on the merits appears below.
Claim Rejections - 35 USC § 103
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.
Claim 1-7 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Nicholas (US 5514157 A) in view of Smith (US 20130190562 A1).
Regarding claim 1, Nicholas teaches a leaflet laceration device (Fig. 1-2; surgical instrument 10), comprising:
an elongated shaft (Fig. 1-2; elongated fixed tubular section 20);
a moveable arm (Fig. 1-2; tool head 28) coupled to the elongated shaft and pivotable relative thereto between an open condition and a closed condition (Col. 7, Lines 7-11); and
a cutting element coupled to at least one of the elongated shaft and the moveable arm (Col. 3, Lines 32-42), the cutting element being configured and arranged to contact a first surface of an anterior mitral leaflet (In accordance with MPEP 2114 this currently taught structure of the cutting element coupled to at least one of the elongated shaft and the moveable arm, would perform the function of contracting a surface of an anterior mitral leaflet, as this limitation is a recitation of the intended use of the claimed invention, and as this prior art structure is capable of performing this intended use based on the recited characteristics of this element, currently reads on the provided claim limitation, unless otherwise shown that the prior art does not possess these characteristics.).
However, Nicholas fails to teach the leaflet laceration device as comprising: a flexible outer sheath wherein the elongated shaft is moveable within the flexible outer sheath.
Nicholas does teach the surgical instrument as being provided for use in endoscopic or laparoscopic procedures, where a small incision or puncture is made in the patient’s body to provide access for a tube or cannula device, the cannula allowing the insertion of various surgical instruments to perform the surgery (Abstract, Col. 1, Lines 15-30), such as the surgical instrument having a tool head having pivotable end effectors (Col. 5, Lines 40-55).
Smith teaches an endoscopic instrument having a movable distal tool ([0002]), where the tool is connected to a flexible elongate member near a pivot (Abstract).
Smith further teaches the flexible elongate member, also referred to as the treatment device, as being inserted into an endoscope having a flexible outer tube so as to provide for positioning of the treatment instrument during a medical procedure ([0061]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the treatment device having a pivoting distal tool as being inserted into an endoscope during an endoscopic procedure, as is taught by Smith, into the surgical instrument for use in endoscopic procedures as is taught by Nicholas, to produce the predictable result of positioning the treatment instrument within a patient during an endoscopic medical procedure, as is taught by Smith, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 2, Nicholas teaches the leaflet laceration device of claim 1, wherein the cutting element is coupled to the elongated shaft (Fig. 7, the tool head 28 is connected to the fixed section 20 by the articulating section 22 further it should be understood within a broadest reasonable interpretation that all elements of an embodiment of an apparatus are “coupled to” all other elements, either directly, indirectly, electrically, etc.) and configured to lacerate a ventricular surface of the anterior mitral leaflet (In accordance with MPEP 2114 this currently taught structure of the cutting element being coupled to the elongated shaft, would perform the function of lacerating a ventricular surface of the anterior mitral leaflet, as this limitation is a recitation of the intended use of the claimed invention, and as this prior art structure is capable of performing this intended use based on the recited characteristics of this element, currently reads on the provided claim limitation, unless otherwise shown that the prior art does not possess these characteristics).
Regarding claim 3, Nicholas teaches the leaflet laceration device of claim 2, further comprising a first intermediate linkage (Fig. 2; elongated push rod 78) coupled to the elongated shaft via a first pin (Fig. 2; pin 24), and a second intermediate linkage (Fig. 2; link rod 94) coupled to the first intermediate linkage via a second pin (Fig. 2; pin 92) and to the moveable arm via a third pin (Fig. 2; pin 100).
Regarding claim 4, Nicholas teaches the leaflet laceration device of claim 3, wherein the first intermediate linkage is translatable relative to the elongated shaft (Col. 6, Lines 32-62 & Col. 7, Lines 32-46).
Regarding claim 5, Nicholas teaches the leaflet laceration device of claim 4, wherein the first intermediate linkage defines an elongated slot (Fig. 2; aperture 90), the first pin being movable within the elongated slot (Fig. 2; aperture 90 receives articulating section 92).
Regarding claim 6, Nicholas teaches the leaflet laceration device of claim 2, wherein the movable arm defines a pull- hole (Fig. 2; articulating section 22 contains yoke 56 to which the distal portion of flexible cable 58 is mounted), and further comprising a pull-wire (Fig. 2; flexible cable 58) coupled through the pull-hole and extending parallel with the elongated shaft.
Regarding claim 7, Nicholas teaches the leaflet laceration device of claim 6. wherein actuating the pull-wire transitions the moveable arm to the open condition (Col. 3, Lines 37-40 and Col. 6, Lines 11-31).
Regarding claim 9, Nicholas teaches the leaflet laceration device of claim 1, wherein the cutting element is coupled to the moveable arm (Col. 3, Lines 32-42 further it should be understood within a broadest reasonable interpretation that all elements of an embodiment of an apparatus are “coupled to” all other elements, either directly, indirectly, electrically, etc.) and configured to lacerate an atrial surface of the anterior mitral leaflet (In accordance with MPEP 2114 this currently taught structure of the cutting element being coupled to the movable arm, would perform the function of lacerating an atrial surface of the anterior mitral leaflet, as this limitation is a recitation of the intended use of the claimed invention, and as this prior art structure is capable of performing this intended use based on the recited characteristics of this element, currently reads on the provided claim limitation, unless otherwise shown that the prior art does not possess these characteristics).
Regarding claim 10, Nicholas teaches the leaflet laceration device of claim 9, further comprising a first intermediate linkage (Fig. 2; elongated push rod 78) coupled to the elongated shaft via a first pin (Fig. 2; pin 24), and a second curved linkage (Fig. 2; link rod 94) coupled to the first intermediate linkage via a second pin (Fig. 2; pin 92) and to the moveable arm via a third pin (Fig. 2; pin 100).
Regarding claim 11, Nicholas teaches the leaflet laceration device of claim 10, wherein the cutting element is coupled to the second curved linkage (Fig. 7; tool head 28 is connected to the link rod 94 by pin 100), and the cutting element is only exposed to the anterior mitral leaflet when the moveable arm is in the closed condition (Col. 3, Lines 35-50).
Regarding claim 12, Nicholas teaches the leaflet laceration device of claim 10, wherein the first intermediate linkage defines an elongated slot (Fig. 2; aperture 90), the first pin being movable within the elongated slot, and wherein the moveable arm defined a curved slot, the third pin being moveable within the curved slot (Fig. 2; aperture 90 receives articulating section 92).
Regarding claim 13, Nicholas teaches the leaflet laceration device of claim 1, wherein the cutting mechanism comprises a blade having a sharp edge (Col. 3, Lines 32-42).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Nicholas (US 5514157 A) in view of Smith (US 20130190562 A1) and Jen (US 20220008093 A1).
Regarding claim 8, Nicholas teaches the leaflet laceration device of claim 6.
However, Nicholas fails to teach the device further comprising a spring configured to keep the moveable arm in the closed condition when no tension is applied to the pull-wire.
Jen teaches a device for using in a patient body having opposing jaws at a distal end of an elongated shaft member and an actuating wire for controlling actuation between the open and closed jaw configurations (Abstract).
Jen further teaches that continuously requiring a pressure to maintain the jaws closed may be undesirable as this pressure can increase hang fatigue and/or limit operator capabilities during clinical procedures, leading to undesirable consequences and therefore provides a device with a bias to apply a closing force ([0005]- [0007]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the jaw as being held in the closed position unless actuated open, as is taught by Jen, into the jaws which open and close, as is taught by Nicholas, to produce the predictable result of a jaw device which enables a single user to use the device with reduced hand fatigue, as is taught by Jen, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Nicholas (US 5514157 A) and Smith (US 20130190562 A1).
Regarding claim 14, Nicholas teaches the leaflet laceration device of claim 1.
Nicholas further teaches the device wherein the cutting mechanism comprises an electrosurgical wire in electrical communication with a generator (Col. 2, Lines 10-15, Col. 8, Lines 18-25, and Col. 17, Lines 25-36 teach the endoscopic surgical instrument as being used to perform electrocauterization without departing from the scope of the invention).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the element for treating tissue as being used to perform electrocauterization, as is taught by Nicholas, into the tool head of the embodiment of Fig. 1 as is taught by Nicholas, to produce the predictable result of performing electrocauterization with the toolhead as is taught by Nicholas, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claim 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nicholas (US 5514157 A) in view of Smith (US 20130190562 A1) and Orlov (US 20100204662 A1).
Regarding claim 15, Nicholas teaches a method of treatment, comprising:
providing a leaflet laceration device (Fig. 1-2; surgical instrument 10) including an elongated shaft, a moveable arm coupled to the elongated shaft (Fig. 1-2; elongated fixed tubular section 20) and pivotable relative thereto between an open condition and a closed condition (Col. 7, Lines 7-11), and a cutting element coupled to at least one of the elongated shaft and the moveable arm (Col. 3, Lines 32-42);
transitioning the cutting element from the closed condition to the open position (Col. 7, Line 60-Col. 8, Line 5 discusses the device as being moved into an open position once in the desired position).
However, Nicholas is silent upon the method as comprising:
advancing the leaflet laceration device to an anterior mitral leaflet in a procedure; and
cutting the anterior mitral leaflet with the cutting element.
Orlov teaches a device and method for treating mitral valve insufficiency using a device having a catheter and a cutting element (Abstract, [0002], [0010]- [0011]).
Orlov further teaches the method as including the device being provided at and cutting an atrioventricular valve leaflet, such as the anterior mitral leaflet, so as to improve coaptation ([0019], [0024]- [0026], [0284]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the method of advancing the leaflet laceration device to the anterior mitral leaflet and cutting the anterior mitral leaflet, as is taught by Orlov, into the method of using the surgical instrument, as is taught by Nicholas, to produce the predictable result of improving coaptation while treating mitral valve insufficiency, as is taught by Orlov, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Nicholas as modified further fails to teach the leaflet laceration device as including a flexible outer sheath, the elongated shaft as being flexible and moveable within the flexible outer sheath and the procedure as being a transcatheter procedure.
Nicholas does teach the surgical instrument as being provided for use in endoscopic or laparoscopic procedures, where a small incision or puncture is made in the patient’s body to provide access for a tube or cannula device, the cannula allowing the insertion of various surgical instruments to perform the surgery (Abstract, Col. 1, Lines 15-30), such as the surgical instrument having a tool head having pivotable end effectors (Col. 5, Lines 40-55).
Smith teaches an endoscopic instrument having a movable distal tool ([0002]), where the tool is connected to a flexible elongate member near a pivot (Abstract).
Smith further teaches the flexible elongate member, also referred to as the treatment device, as being inserted into an endoscope having a flexible outer tube so as to provide for positioning of the treatment instrument during a medical procedure ([0061]).
Nicholas does teach the surgical instrument as being provided for use in endoscopic or laparoscopic procedures, where a small incision or puncture is made in the patient’s body to provide access for a tube or cannula device, the cannula allowing the insertion of various surgical instruments to perform the surgery (Abstract, Col. 1, Lines 15-30), such as the surgical instrument having a tool head having pivotable end effectors (Col. 5, Lines 40-55).
Smith teaches an endoscopic instrument having a movable distal tool ([0002]), where the tool is connected to a flexible elongate member near a pivot (Abstract).
Smith further teaches the flexible elongate member, also referred to as the treatment device, as being inserted into an endoscope having a flexible outer tube so as to provide for positioning of the treatment instrument during a medical procedure ([0061]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the treatment device having a pivoting distal tool as being inserted into an endoscope during an endoscopic procedure, as is taught by Smith, into the surgical instrument for use in endoscopic procedures as is taught by Nicholas, to produce the predictable result of positioning the treatment instrument within a patient during an endoscopic medical procedure, as is taught by Smith, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 16, in accordance with the above incorporation, Orlov further teaches the method of claim 15, wherein advancing the leaflet laceration device to an anterior mitral leaflet comprises steering the leaflet laceration device through a femoral artery, via and through an aorta, to the anterior mitral leaflet ([00168]- [00170]).
Claim 17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Nicholas (US 5514157 A) in view of Smith (US 20130190562 A1), Orlov (US 20100204662 A1) and Bishop (US 20180185153 A1).
Regarding claim 17, Nicholas as modified teaches the method of claim 15.
However, Nicholas fails to teach the method wherein advancing the leaflet laceration device to an anterior mitral leaflet comprises steering the leaflet laceration device through a femoral vein, a right atrium, across a septum to a left atrium and through a previously implanted prosthetic valve to the anterior mitral leaflet.
Bishop teaches a method and device for advancing a catheter to the mitral valve for prosthetic implantation (Abstract).
Bishop further teaches the prosthetic valve as being capable of being implanted before or after cutting the mitral valve ([0112], [0296]) and that the catheter may be delivered to the mitral valve leaflets through the femoral vein and traversed up into the inferior vena cava and trans-septal to the left atrium ([0110]- [0011]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the method of delivering the catheter to the anterior mitral leaflet by the femoral vein and traversing up the inferior vena cava and trans-septal to the left atrium, as is taught by Bishop, into the method of delivering a catheter to a mitral valve as is taught by Nicholas as modified, to produce the predictable result of utilizing a known route to insert a catheter to a mitral valve of a patient to deliver a catheter to the mitral valve of the patient, as is taught by Bishop, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 19, Bishop teaches the method of claim 15, further comprising the step of implanting a prosthetic heart valve prior to advancing the leaflet laceration device to the anterior mitral leaflet ([0296], [0335]).
Regarding claim 20, Bishop teaches the method of claim 15, further comprising the step of implanting a prosthetic heart valve after advancing the leaflet laceration device to the anterior mitral leaflet ([0296], [0335]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nicholas (US 5514157 A) in view of Smith (US 20130190562 A1), Orlov (US 20100204662 A1) and Spenser (US 20120010700 A1).
Regarding claim 18, Nicholas as modified teaches the method of claim 15.
However, Nicholas fails to teach the method wherein advancing the leaflet laceration device to an anterior mitral leaflet comprises advancing the leaflet laceration device through an apex of a heart.
Spenser teaches a method for treating a dysfunctional mitral valve by the implantation of a prosthetic replacement valve ([0038]).
Spenser further teaches a number of possible percutaneous routes to access the mitral valve, such as transapically, i.e. via the heart apex ([0081]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the method of delivering the catheter to the anterior mitral leaflet via the heart apex, as is taught by Spenser, into the method of delivering a catheter to a mitral valve as is taught by Nicholas as modified, to produce the predictable result of utilizing a known route to insert a catheter to a mitral valve of a patient to deliver a catheter to the mitral valve of the patient, as is taught by Spenser, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the Nicholas reference are moot in view of the new rejections under Nicholas and Smith.
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 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 date of this final action.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794