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 06/29/2026.
Acknowledgement is made to the amendment of claim 1.
Claims 1-12 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 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20120184980 A1) in view of Gandhi (US 20160256218 A1), Huffmaster (US 20160008141 A1), Weadock (US 20150141810 A1), and Siegal (US 20100262147 A1).
Regarding claim 1, Anderson teaches an apparatus (Abstract) for nerve denervation or modulation ([0005] teaches modulation within the body as broadly as is claimed by controlling the occlusive effect on a vessel within the body) in a body, comprising:
a main body (Fig. 1; vessel occlusive device 1) including a shaft (Fig. 1; conduit 9);
a unit (Fig. 1; outer sheath 12) formed to be drawn out from one end of the shaft and configured to denervate or modulate at least some of nerves on a tube in the body; and
a guide (Fig. 1; inner occlusive tape 13) deformed into a wound state to bring the unit into contact with the tube in the body, wherein the guide includes:
a body portion (Fig. 1; flexible sizing band of outer surface 17) which is spaced apart from the unit to enclose the circumference of the tube in the wound state; and
a coupling portion (Fig. 1; terminal end 14) which is connected to the end of the body portion and to which an end of the unit is fixed,
wherein the body portion includes a first body group (Fig. 2B; flexible sizing band of outer surface 17 is shown as having a distal portion and a proximal portion, the distal portion being closer to terminal end 14) located closer to the coupling portion and a second body group (Fig. 2B; flexible sizing band of outer surface 17 is shown as having a distal portion and a proximal portion, the proximal portion being closer to proximal end 16) located closer to the shaft.
However, Anderson fails to teach the apparatus as being an electrode apparatus, the unit as being an electrode unit and the guide as being an electrode guide.
Anderson instead teaches an apparatus for wrapping an elongated element around a vessel within the body so as to provide treatment to a patient ([0005], [0014]).
Gandhi teaches a tissue treatment device having a shaft and a flat configuration for wrapping around a vessel within a body of a patient (Abstract, [0035]).
Gandhi further teaches the flat portion which contacts the vessel within the patient as being an electrode pad for treating the tissue of the patient ([0035]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of a flat distal portion for wrapping around the vessel of a patient as containing electrodes to treat patient tissue as is taught by Gandhi, into the flat occlusive tape of Anderson for wrapping around a vessel of a patient, to produce the predictable result of treating a vessel within a patient, as is taught by Gandhi 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)
Anderson further teaches the device as having a tape which is disposed within an occlusive sheath so as to apply a tension to the sheath and provide a tension to the body vessel ([0010]).
Anderson as modified further fails to teach apparatus wherein the guide is configured to be spaced apart from the unit in remaining sections except the coupling portion in the wound state.
Huffmaster teaches a device having a deployment cannula which may be inserted in a patient body having an elongated member having a distal end which is formed to be in a generally circular configuration for use in a patient during tissue treatment (Abstract, [0113]).
Huffmaster further teaches the elongated member as being shaped, specifically with regard to the circular configuration, by a tether which is tensioned to form the distal end portion into a desired shape ([0114]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the position of the tape for providing tension to the sheath, relative to said sheath, as is taught by Anderson with the position of the tether for providing tension to the elongated member as is taught by Huffmaster, to produce the predictable result of forming a distal end of an elongated member with a circular configuration for use during tissue treatment, as is taught by Huffmaster, 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).
Anderson as modified by Gandhi teaches the body as wrapping around a vessel (Anderson, [0010]; Gandhi, [0035]) and delivering energy (Gandhi, [0035]).
However, Anderson as currently modified does not teach the first body group as forming a smaller radius of curvature than the second body group in the wound state and the body portion forming an overall spiral shape in the wound state.
Weadock teaches a device for wrapping around a vessel and delivering energy when delivered from a loading device ([0051]- [0054]).
Weadock further teaches the configuration of this device for wrapping around this vessel as being any of a variety of configurations depending on the surgeon’s desired placement of the energy deliver component, such as a spiral when wound around the vessel, where the portion of the device which is closer to the elongated catheter is shown as having a larger radius of curvature than the distal portion ([0051]- [0054]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the device which wraps around a vessel as being a spiral shape where the portion which is closer to the shaft has a larger radius of curvature than the portion which extends to wrap around the vessel, as is taught by Weadock, into the device which wraps around a vessel and delivers energy as is taught by Anderson as modified, to produce the predictable result of wrapping around a vessel to deliver energy in any placement which is desirable to the surgeon, as is taught by Weadock, 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).
Anderson as modified further fails to teach the body portion as including a plurality of joint units the plurality of joints including the first body group and the second body group, wherein each of the first body group and the second body group includes joint units having different lengths, and the joint units of the first body group being shorter than the joint units of the second body group.
Siegal teaches a medical device which includes an elongated element for deployment from a delivery device (Abstract, Fig. 2) having a deployed state as it extends from the delivery element which is a spiral ([0053]). This elongated element which forms a spiral being formed from hollow segments sequentially interconnected at effective hinges (Abstract).
Siegal further teaches these segments which form a spiral as not all being the same size so as to achieve the desired expanding form ([0047], [0050]- [0052]).
For more information regarding the known relationship between the radius of curvature and the size of hinged segments and/or width of slots, see the reference provided in the conclusion section which teaches the known relationship of the smaller section length having a smaller radius of curvature.
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of a variety of segments sequentially interconnects at hinges, wherein the segments have sizes based on the desired expanding form, as is taught by Siegal, into the device which produces a spiral having a radius of curvature which increased along the length of the spiral from a proximal to distal end, as is taught by the above incorporation of Weadock into Anderson, to produce the predictable result of providing an arrangement for forming a spiral of a desired form, as is taught by Siegal, 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 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20120184980 A1) in view of Gandhi (US 20160256218 A1), Huffmaster (US 20160008141 A1), Weadock (US 20150141810 A1), and Siegal (US 20100262147 A1) further in view of Clement (US 20140371855 A1).
Regarding claim 2, Anderson as modified teaches the electrode apparatus of Claim 1.
However, Anderson fails to teach the electrode apparatus, wherein the coupling portion includes: a first clamping piece fixed to the body portion; and a second clamping piece coupled to the first clamping piece with a portion of the electrode unit interposed therebetween.
Clement teaches a medical device for providing artificial contractile forces to organ structures within a body of a patient (Abstract, [0087], [0206]).
Clement further teaches the device as having a first end and a second which click together so as to lock as a band and control the position of the device while being capable of applying pressure around the organ ([0208]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the coupling structure having two ends which connect so as to close the band which wraps around a vessel of patient tissue, as is taught by Clement, into the modified apparatus of Anderson to have produced the predictable result of providing the band with a locking mechanism for control of positioning, as is taught by Clement 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 3, Clement further teaches the electrode apparatus of Claim 2,
wherein any one of the first clamping piece and the second clamping piece includes a protrusion (Fig. 2; silicone lip 110) protruding in one direction,
the other one of the first clamping piece and the second clamping piece includes a fastening groove (Fig. 2; grid 107) recessed corresponding to the protrusion, and
a through-hole through (Fig. 2; locking member 108) which the protrusion penetrates is formed at a portion of the electrode unit.
Regarding claim 4, the modified teaching of Anderson teaches the electrode apparatus of claim 2, in accordance with the above modification of Clement into Anderson, Clement further teaches the unit (Clement teaches the inner member of the U-band as being the unit element as is relevant based on the currently provided modification) as extending to enclose the second clamping piece (the inner portion of the U-band surrounds, or encloses as broadly as is claimed, the distal portion 106b) and inserted between the first clamping piece and the second clamping piece (the inner portion of the U-band is shown as being inserted at the point which is referred to as the locking member, this is located between the first end and the free end of the U-bend).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20120184980 A1) in view of Gandhi (US 20160256218 A1), Huffmaster (US 20160008141 A1), Weadock (US 20150141810 A1), and Siegal (US 20100262147 A1), further in view of Banik (US 20040199052 A1).
Regarding claim 5, Anderson further teaches the electrode apparatus of Claim 2, wherein the electrode guide further includes a joint wire which penetrates the body portion and is coupled to the second clamping piece to guide the body portion to be in the wound state (Fig. 2; proximal end 10).
However, Anderson as modified fails to teach the second clamping piece includes: a wire groove formed to allow insertion of an end of the joint wire; and a fixing plate configured to close a portion of the wire groove in order to suppress deviation of the end of the joint wire from the wire groove.
Banik teaches a mechanism for connecting and controlling the movement of an elongated catheter for insertion into the body comprising a plurality of discs (Abstract, [0092]- [0094]).
Banik further teaches the discs which are stacked to cooperatively control positioning as having a groove which is formed to allow the insertion of a wire and a base which is configured to close the wire groove and provide support to the discs while stacking ([0094]).
Therefore, it would have been obvious to a person having incorporated a known articulation joint for connecting two mechanisms of which are coupled to control the position of a device within the body, as is taught by Banik, into the modified teaching of Anderson to produce the predictable result of controlling the articulation of a device using a plurality of movable mechanisms which are coupled together, as is taught by Banik 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 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20120184980 A1) in view of Gandhi (US 20160256218 A1), Huffmaster (US 20160008141 A1) Weadock (US 20150141810 A1), and Siegal (US 20100262147 A1) further in view of Schuettler (US 20190059820 A1).
Regarding claim 6, Anderson as modified teaches the electrode apparatus of Claim 1.
However, Anderson fails to teach the apparatus wherein the electrode unit includes: a base layer; an electrode layer disposed on the base layer; and a top layer disposed to overlap a portion of the electrode layer with the electrode layer interposed therebetween.
Schuettler teaches an electrode device having a plurality of layers for fabricating an electrode (Abstract).
Schuettler further teaches the electrode including a bottom layer (Fig. 1-2; first layer 40); a metal foil (Fig. 1-2; foil 10); and a top layer (Fig. 1-2; second layer) disposed to overlap a portion of the metal layer with the metal layer interposed in between ([0045]- [0046]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the structure of the electrode layers as is taught by Schuettler into the electrode apparatus as is taught by the modified teaching of Anderson, so as to produce the predictable result of producing an electrode with a structure which provides energy to tissue of the body 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 7, in accordance with the above incorporation of Clement into the modified device of Anderson of claim 2, Clement further teaches the electrode apparatus of Claim 6, wherein the coupling portion ([0206]- [0208]) includes:
a first clamping piece (Fig. 1-3; first end 106a) fixed to the body portion; and
a second clamping piece (Fig. 1-3; second end 106b) coupled to the first clamping piece with a portion the electrode unit interposed therebetween ([0206]- [0208]).
In accordance with the above incorporation of Schuettler into the modified device of Anderson of claim 6, Schuettler further teaches the electrode unit comprising of at least one of the base layer and the top layer.
Regarding claim 8, Clement further teaches the electrode apparatus of Claim 7, wherein any one of the first clamping piece and the second clamping piece includes a protrusion (Fig. 2; silicone lip 110) protruding in one direction,
the other one of the first clamping piece and the second clamping piece includes a fastening groove (Fig. 2; grid 107) recessed corresponding to the protrusion, and
at least the unit includes a through-hole (Fig. 2; locking member 108) through which the protrusion penetrates.
In accordance with the above incorporation of Schuettler into the modified device of Anderson of claim 6, Schuettler further teaches the electrode unit comprising of at least one of the base layer and the top layer.
Regarding claim 9, Anderson teaches the electrode apparatus of claim 6, in accordance with the above modification of Clement into Anderson, Clement further teaches the unit (Clement teaches the inner member of the U-band, as the unit is taught to be the inner member of the device by the base reference of the modification) as extending to enclose a part of the coupling portion (the inner portion of the U-band surrounds, or encloses, the distal portion 106b) and inserted and fixed in the coupling portion (the inner portion of the U-band is shown as being inserted at a point, which is referred to as the locking member, which is located between the first end and the free end of the U-bend, [0100], [0209]).
In accordance with the above incorporation of Schuettler into the modified device of Anderson of claim 6, Schuettler further teaches the electrode unit comprising of at least one of the base layer and the top layer.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20120184980 A1) in view of Gandhi (US 20160256218 A1), Huffmaster (US 20160008141 A1), Weadock (US 20150141810 A1), Siegal (US 20100262147 A1), and Schuettler (US 20190059820 A1) further in view of Wilson (US 20130150940 A1).
Regarding claim 10, the modified device of Anderson teaches the electrode apparatus of Claim 6.
However, Anderson as modified fails to teach the apparatus wherein the electrode unit further includes a reinforcing layer of which a part is coupled to the base layer and the other part is inserted and fixed in the coupling portion.
Wilson teaches an electrode of a cuff body which contains reinforcing elements to accommodate movements of biological structures (Abstract).
Wilson further teaches a layer of reinforcing elements, the layer comprising two portions on either end of the unit which are coupled to the base layer ([0103]). Incorporating this layer of reinforcement elements of an electrode unit into the unit of Clement, which is taught based on the modification of Clement into Anderson as being the inner portion of the U-bend would produce a reinforcement layer which is contains one part which is inserted and fixed in the coupling portion of the modified base and another portion which is coupled as broadly as is claimed to all other elements of the electrode unit and is not inserted and fixed to the coupling portion.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the reinforcing elements of Wilson, into the electrode unit of Anderson as is currently is modified, to produce the predictable result of reinforcing an electrode so as to accommodate biological structures, as is taught by Wilson 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 11, Anderson teaches the electrode apparatus of claim 10, in accordance with the above modification of Clement into Anderson, Clement further teaches the unit (Clement teaches the inner member of the U-band, as the unit is taught to be the inner member of the device by the base reference of the modification) as extending to enclose the coupling portion (the inner portion of the U-band surrounds, or encloses, the distal portion 106b) and inserted and fixed in the coupling portion in an opposite direction of insertion of the other part of the coupling portion (the inner portion of the U-band is shown as being inserted at a point, which is referred to as the locking member, which is located between the first end and the free end of the U-bend, [0100], [0209]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over (US 20120184980 A1) in view of Gandhi (US 20160256218 A1), Huffmaster (US 20160008141 A1), Weadock (US 20150141810 A1), Siegal (US 20100262147 A1), and Schuettler (US 20190059820 A1) further in view of Aujla (US 20170156784 A1).
Regarding claim 12, the modified device of Anderson teaches the electrode apparatus of Claim 6.
However, Anderson fails to teach the electrode apparatus wherein the electrode unit further includes a sensor unit disposed on the base layer and configured to sense a temperature.
Aujla teaches an electrode device having multiple layers containing a temperature sensor so as to prevent excessive heating of tissue during the use of the electrode (Abstract, [0004]).
Aujla further teaches the temperature sensor as being disposed on the base layer of the electrode unit ([0043]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the temperature sensor being located on the base layer of the electrode as is taught by Aujla into the electrode unit of the modified device of Anderson to produce the predictable result of sensing an electrode temperature during use, as is taught by Aujla 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 Anderson/Gandhi/Huffmaster reference are moot in view of the new rejections under Anderson/Gandhi/Huffmaster and Anderson/Gandhi/Huffmaster/Weadock/Siegal.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
US 20170095138 A1- [0056] discusses the known relationship between segments which form a curvature and the radius of a curvature, specifically with relation to endoscope tube bending rigidity and the length of the sections of the tube between slits, which function as hinging portions, where smaller intervals, and therefore smaller length sections, provide for lower bending rigidity, and therefore a smaller radius of curvature than the section with larger length sections
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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