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.
Status of the Claims
The current office action is made responsive to claims filed 11/21/2024.
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.
Claims 1, 3-9, 12-13, 15-16, 19-20 rejected under 35 U.S.C. 103 as being unpatentable over Vardi (US 20160270810 A1) in view of Ducharme (US 8454584 B2).
Regarding claim 1, Vardi teaches a medical device (Abstract), the device comprising:
an incision device (Fig. 3; catheter 100) structured to be operably coupled to a distal end of a catheter, wherein the incision device comprises an incision channel (Fig. 3; sheath 150) defined along the incision device, wherein the incision channel defines an open channel top and a channel bottom (the sheath is taught as having an inner portion and an open outer portion, therefore, as broadly as is claimed as there are currently no limitations which define the orientation of top and bottom, this limitation is taught as broadly as is currently claimed); and
a retractable cutting apparatus (Fig. 3; catheter shaft 110) disposed within the incision channel, wherein the retractable cutting apparatus comprises:
a first cutting apparatus link (Fig. 3; blade 116a) defining a first link distal end and a first link proximal end, wherein the first link distal end is rotatably fixed proximate to a distal end of the incision channel ([0129]);
a second cutting apparatus link (Fig. 3; blade 116b) defining a second link distal end and a second link proximal end, wherein the second link distal end is attached to the first link proximal end of the first cutting apparatus link ([0129]); and
wherein the first cutting apparatus comprises a first cutting surface proximate to the first link proximal end of the first cutting apparatus link, wherein the first cutting surface is structured to protrude from the incision channel in an instance in which the retractable cutting apparatus is in the deployed position ([0010], [0012]- [0013], [0129]),
wherein the second cutting apparatus link comprises a second cutting surface ([0010], [0012]- [0013], [0129]).
However, Vardi fails to teach a medical device comprising: a guide member coupled to the second link proximal end, wherein the guide member is structured to move the first cutting apparatus link and the second cutting apparatus link and cause the retractable cutting apparatus to move between a retracted position and a deployed position,
wherein in an instance in which the guide member is moved in a first direction of the first cutting apparatus link and the second cutting apparatus link, the first link proximal end of the first cutting apparatus link and the second link distal end of the second cutting apparatus link are structured to move in a direction of the open channel top to the deployed position, and
wherein in an instance in which the guide member is moved in a second direction opposite of the first cutting apparatus link and the second cutting apparatus link, the first link proximal end of the first cutting apparatus link and the second link distal end of the second cutting apparatus link are structured to move in a direction of the channel bottom to the retracted position.
Vardi does however teach the known use of a pull-wire being attached to an actuator within a handle to control the position of the sheath and therefore the blades between extended and withdrawn positions ([0021], [0078], [0095], [0128]).
Ducharme teaches a medical device (Fig. 1A-C; device 100) having a tubular outer body (Fig. 1A-C; body 102), a pair of linkages (Fig. 1A-C; linkages 122, 126) which may expand and be deployed through an aperture (Fig. 1A-C; aperture 103) within the body (Fig. 1A-C; body 102), the linkages containing a protruding portion wherein the protruding portion contains a section for anchoring within tissue (Fig. 1A-C; extension 124).
Ducharme further teaches the positions of the linkages as being controlled by an elongate inner body (Fig. 1A-C; elongate inner body 112), where the inner body is pivotably attached to the proximal linkage member and the proximal and distal movements of the inner body control the actuation of the linkages and therefore the anchoring extension (Col. 3, Lines 5-55).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the control of the position of the blades by a pull-wire which distally and proximally positions the sheath, as is taught by Vardi with element which controls the position of the linkages between a position within the outer body and extended outside of the outer body as being an elongate inner body which is attached to the proximal linkage, as is taught by Ducharme, to produce the predictable result of controlling the position of the linkages, as is taught by Ducharme, as it has been held that the substitution of one known element for another according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 3, Vardi teaches the medical device of claim 1, wherein upon movement to the deployed position, the first cutting surface is structured to make an incision along a pericardium upon movement of the catheter (In accordance with MPEP 2114 this currently taught structure of first cutting surface, would perform the function of making an incision along a pericardium, 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 4, Vardi teaches the medical device of claim 1, wherein at least one of the first cutting surface and the second cutting surface comprise at least one of a blade or an electrode ([0129]).
Regarding claim 5, Vardi teaches the medical device of claim 1, wherein the incision channel comprises a channel protrusion structured to prevent the first cutting surface and a second cutting surface from being parallel along the incision channel (Fig. 3; biasing arm 117).
Regarding claim 6, Vardi teaches the medical device of claim 1, wherein the channel protrusion causes an angle between the first cutting surface and a secondary cutting surface to be less than 180 degrees to assist the movement between the retracted position and the deployed position (Fig. 3; biasing arm 117).
Regarding claim 7, Vardi teaches the medical device of claim 1, wherein the first cutting surface remains stationary along the incision channel in an instance in which the catheter is being moved ([0126]).
Regarding claim 8, Vardi teaches the medical device of claim 1, wherein the first cutting surface is located on a bottom surface of the first cutting apparatus link and the second cutting surface is located on a top surface of the second cutting apparatus link ([0010], [0015], [00135]- [00137]).
Regarding claim 9, Vardi teaches the medical device of claim 8, wherein the first and second cutting surfaces are angled relative to each other to create opposing cutting surfaces ([0129]- [0131]).
Regarding claim 12, Vardi teaches the medical device of claim 1, wherein the first cutting surface is a blade rigidly attached to the first cutting apparatus link and the second cutting surface is a blade rigidly attached to the second cutting apparatus link ([0010], [0015], [00135]- [00137]).
Regarding claim 13, Vardi teaches the medical device of claim 1, wherein the first cutting surface defines a blade height that is defined by the amount the first cutting surface protrudes from the incision channel in the deployed position, wherein the blade height is adjustable ([0010], [0128]- [0131]).
Regarding claim 15, Vardi teaches the medical device of claim 1, further comprising a guide member movement actuator attached to the guide member, wherein the guide member movement actuator is manipulated to move the guide member ([0021], [0078], [0095], [0128]).
Regarding claim 16, Vardi teaches a medical device (Abstract)., the device comprising:
an incision device (Fig. 3; catheter 100) structured to be operably coupled to a distal end of a catheter, wherein the incision device comprises an incision channel (Fig. 3; sheath 150) defined along the incision device, wherein the incision channel defines an open channel top and a channel bottom (the sheath is taught as having an inner portion and an open outer portion, therefore, as broadly as is claimed as there are currently no limitations which define the orientation of top and bottom, this limitation is taught as broadly as is currently claimed); and
a retractable cutting apparatus (Fig. 3; catheter shaft 110) disposed within the incision channel, wherein the retractable cutting apparatus comprises:
a first cutting apparatus link (Fig. 3; blade 116a) defining a first link distal end and a first link proximal end, wherein the first link distal end is rotatably fixed proximate to a distal end of the incision channel ([0129]);
a second cutting apparatus link (Fig. 3; blade 116a) defining a second link distal end and a second link proximal end, wherein the second link distal end is attached to the first link proximal end of the first cutting apparatus link ([0129]); and
wherein the first cutting apparatus comprises a first cutting surface proximate to the first link proximal end of the first cutting apparatus link, wherein the first cutting surface is structured to protrude from the incision channel in an instance in which the retractable cutting apparatus is in the deployed position ([0010], [0012]- [0013], [0129]),
wherein the second cutting apparatus link comprises a second cutting surface ([0010], [0012]- [0013], [0129]),
wherein the first and second cutting surfaces are positioned in an angled configuration relative to each other to thereby create opposing cutting surfaces ([0129]- [0131]).
However, Vardi fails to teach a medical device comprising: a guide member coupled to the second link proximal end, wherein the guide member is structured to move the first cutting apparatus link and the second cutting apparatus link and cause the retractable cutting apparatus to move between a retracted position and a deployed position, and
wherein in an instance in which the guide member is moved in a first direction of the first cutting apparatus link and the second cutting apparatus link, the first link proximal end of the first cutting apparatus link and the second link distal end of the second cutting apparatus link are structured to move in a direction of the open channel top to the deployed position.
Vardi does however teach the known use of a pull-wire being attached to an actuator within a handle to control the position of the sheath and therefore the blades between extended and withdrawn positions ([0021], [0078], [0095], [0128]).
Ducharme teaches a medical device (Fig. 1A-C; device 100) having a tubular outer body (Fig. 1A-C; body 102), a pair of linkages (Fig. 1A-C; linkages 122, 126) which may expand and be deployed through an aperture (Fig. 1A-C; aperture 103) within the body (Fig. 1A-C; body 102), the linkages containing a protruding portion wherein the protruding portion contains a section for anchoring within tissue (Fig. 1A-C; extension 124).
Ducharme further teaches the positions of the linkages as being controlled by an elongate inner body (Fig. 1A-C; elongate inner body 112), where the inner body is pivotably attached to the proximal linkage member and the proximal and distal movements of the inner body control the actuation of the linkages and therefore the anchoring extension (Col. 3, Lines 5-55).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the control of the position of the blades by a pull-wire which distally and proximally positions the sheath, as is taught by Vardi with element which controls the position of the linkages between a position within the outer body and extended outside of the outer body as being an elongate inner body which is attached to the proximal linkage, as is taught by Ducharme, to produce the predictable result of controlling the position of the linkages, as is taught by Ducharme, as it has been held that the substitution of one known element for another according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 19, Vardi teaches the medical device of claim 16, wherein the incision channel comprises a channel protrusion structured to prevent the first cutting surface and a second cutting surface from being parallel along the incision channel (Fig. 3; biasing arm 117).
Regarding claim 20, Vardi teaches the medical device of claim 16, wherein the first cutting surface is a blade rigidly attached to the first cutting apparatus link and the second cutting surface is a blade rigidly attached to the second cutting apparatus link ([0010], [0015], [00135]- [00137]).
Claims 2, 10-11, 14, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Vardi (US 20160270810 A1) in view of Ducharme (US 8454584 B2) further in view of Edwards (US 20080097422 A1).
Regarding claim 2, Vardi teaches the medical device of claim 1.
However Vardi fails to teach the medical device wherein the second cutting apparatus link defines a first blade receiving aperture that is structured to receive the first cutting surface in an instance in which the retractable cutting apparatus is in the retracted position.
Edwards teaches an expandable catheter treatment device ([0126]) wherein the expandable structures are provided for damaging patient tissue ([0021], [0150]- [0151]), such as in the form of an electrode along the flat edge portion (Fig. 41-43; electrode 166).
Edwards further teaches the expandable structure (Fig. 41-43; operative element 146) as comprising links (Fig. 41-43; spines 150) having distal and proximal portions (Fig. 41-43; distal portion 158 and proximal portion 160), the distal portion comprising the portion for penetrating tissue (Fig. 41-43; electrode 166) being positioned within a slot of the proximal portion (Fig. 41-43; flexible joint 156).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the position of an element which punctures patient tissue into a slot for receiving said element within elongated distal and proximal portions of an expandable structure, as is taught by Edwards, into the expandable elements for cutting patient tissue having elongated distal and proximal portions, as is taught by Vardi, to produce the predictable result puncturing tissue and containing an element which punctures patient tissue when in a non-fully expanded position, as is taught by Edwards, 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 10, in accordance with the above rejection, Edwards teaches the medical device of claim 1, wherein at least one of the first cutting surface and the second cutting surface comprises an electrode (Fig. 41-43; electrode 166).
Regarding claim 11, Vardi teaches the medical device of claim 1, wherein the second cutting surface comprises a mechanical blade ([0129]).
In accordance with the above rejection, Edwards teaches the first cutting surface is taught as comprising an electrode (Fig. 41-43; electrode 166).
Regarding claim 14, in accordance with the above rejection, Edwards the medical device of claim 1, wherein the first cutting apparatus link further comprises a puncturing tip adjacent to the first link proximal end (Fig. 41-43; electrode 166).
Regarding claim 17, Vardi as modified teaches the medical device of claim 16.
However, Vardi fails to teach the medical device wherein the first cutting apparatus link further comprises a puncturing tip adjacent to the first link proximal end.
Edwards teaches an expandable catheter treatment device ([0126]) wherein the expandable structures are provided for damaging patient tissue ([0021], [0150]- [0151]), such as in the form of an electrode along the flat edge portion (Fig. 41-43; electrode 166).
Edwards further teaches the expandable structure (Fig. 41-43; operative element 146) as comprising links (Fig. 41-43; spines 150) having distal and proximal portions (Fig. 41-43; distal portion 158 and proximal portion 160), the distal portion comprising the portion for penetrating tissue (Fig. 41-43; electrode 166) being positioned within a slot of the proximal portion (Fig. 41-43; flexible joint 156).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the position of an element which punctures patient tissue into a slot for receiving said element within elongated distal and proximal portions of an expandable structure, as is taught by Edwards, into the expandable elements for cutting patient tissue having elongated distal and proximal portions, as is taught by Vardi, to produce the predictable result puncturing tissue and containing an element which punctures patient tissue when in a non-fully expanded position, as is taught by Edwards, 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 18, in accordance with the above rejection, Edwards teaches the medical device of claim 16, wherein the first cutting apparatus link further comprises a puncturing tip adjacent to the first link proximal end (Fig. 41-43; electrode 166), and wherein the first cutting surface comprises an electrode (Fig. 41-43; electrode 166)
Vardi further teaches the second cutting surface comprises a mechanical blade ([0129]).
Conclusion
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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