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 .
Response to Amendment
The preliminary amendments filed 07/08/2024 have been entered. Currently, claims 9 and 12 have been amended, and claims 1-15 are pending in the application.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase, “a plurality groups of base body groups” is suggested to be further amended to read, “a plurality of groups of base body groups”. Appropriate correction is required.
Claims 3, 7-8 are objected to because of the following informalities: the phrase, “the plurality groups of base body groups” is suggested to be further amended to read, “the plurality of groups of base body groups”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the base body" in line 8. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner if this base body is the same as the “two or more base bodies” or the same as the “base body group”. For examination purposes, Examiner will treat the base body as the two or more base bodies. Claims 2-15 are also rejected because they are dependent on claim 1.
Claim 1 recites the limitation “the base body group” in line 6. There is insufficient antecedent basis for this limitation in the claim. Claims 2-15 are also rejected because they are dependent on claim 1.
Claim 1 recites the limitation “the base body group” in line 6. The recitation renders the scope of the claim as indefinite because it is unclear if the base body group is intended to reference each of the base body groups of the plurality of groups, or if such is directed towards a single base body group of the plurality of groups. The Examiner respectfully suggests that Applicant clearly delineate the desired structural relationship between the plurality of groups of the base body groups and the remaining recitations in the claim of the various “base body groups”. Claims 2-15 are also rejected because they are dependent on claim 1.
Claim 2 recites the limitation "the base body" in line 5. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner if this base body is the same as the “two or more base bodies” or the same as the “base body group” already cited in claim 1. For examination purposes, Examiner will treat the base body as the two or more base bodies. Claims 3-11 are also rejected because they are dependent on claim 2.
Claim 9 recites the limitation "two base bodies " in line 3. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner if these base bodies are the same as the “two or more base bodies” already cited in claim 1. For examination purposes, Examiner will treat the two base bodies the same as the two or more base bodies on a given base body group. Claims 10-11 are also rejected because they are dependent on claim 9.
Claims 10 recites the limitation “the base body group” in line 5. The recitation renders the scope of the claim as indefinite because it is unclear if the base body group is intended to reference each of the base body groups of the plurality of groups, or if such is directed towards a single base body group of the plurality of groups. The Examiner respectfully suggests that Applicant clearly delineate the desired structural relationship between the plurality of groups of the base body groups from independent claim 1 and the base body groups of the dependent claim.
Claims 11 recites the limitation “the base body group” in line 5. The recitation renders the scope of the claim as indefinite because it is unclear if the base body group is intended to reference each of the base body groups of the plurality of groups, or if such is directed towards a single base body group of the plurality of groups. The Examiner respectfully suggests that Applicant clearly delineate the desired structural relationship between the plurality of groups of the base body groups from independent claim 1 and the base body groups of the dependent claim.
Claim 12 recites the limitation "the base body" in line 2. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner if this base body is the same as the “two or more base bodies” or the same as the “base body group” already cited in claim 1. For examination purposes, Examiner will treat the base body as the two or more base bodies.
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.
Claims 1-9, 12-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Waldhauser (W.O. Application No. 2017156039 A1), and further in view of Basu (U.S. Application No. 20170164858 A1).
Regarding independent claim 1, Waldhauser discloses an electrophysiology catheter (3700), comprising an inner tube (3728) and an outer tube (3706) connected in a sleeving mode (pa. 0850 & Fig. 37A), wherein the inner tube and the outer tube are movably relative to each other (pa. 0873), and the inner tube and the outer tube are connected with each other by an electrode assembly (3720) (via proximal hub 3740 and distal hub 3750, pa. 0863, 0873 & Fig. 37B) which comprises:
a plurality groups of base body groups (3727) which are arranged in a circumferential direction of the inner tube (pa. 0855 & Fig. 37D), wherein the base body group connects the inner tube with the outer tube and comprises two or more base bodies (3722A, 3722B) distributed at intervals in the circumferential direction of the inner tube (pa. 0855), the base body is deformable (pa. 0870), and includes a plurality of electrodes (3724) (pa. 0854).
However, Waldhauser does not disclose the base body comprising a first segment and a second segment connected with each other, the first segment and the second segment having a first connecting point, the first connecting points of a same base body group are in contact connection with each other to form a junction, and electrodes which are at least disposed at the junctions.
Basu, in the same field of endeavor, teaches an electrophysiologic catheter (10) with an electrode array assembly (16) (pa. 0033 & Fig. 1), wherein the electrode array assembly comprises an interconnected framework (18) formed from a plurality of individual spines/base bodies (combination of substrate 22 and polymeric layer 24) and electrodes (20) disposed on top (pa. 0034). The base body comprises a first segment (see annotated Fig. 1 below) and a second segment (see annotated Fig. 1 below) connected with each other, the first segment and the second segment having a first connecting point (see annotated Fig. 1 below), the first connecting points of a same base body group (i.e., combination of the front two spines/base bodies seen in Fig. 1) are in contact connection with each other to form a junction (see annotated Fig. 1 below), and electrodes are at least disposed at the junctions (pa. 0034 & Fig. 2). Examiner is interpreting “junction” as an act of joining; the state of being joined; and/or a
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region of transition that is not limited to a single point.
It would have been an obvious matter of design choice to one having ordinary skill in the art at the time of filing of the claimed invention to have substituted the structural arrangement/design of the base body groups in the electrode assembly of Waldhauser with the structural arrangement/design of the electrode array assembly as taught by Basu since it appears that the invention would perform equally as well with either structure and they both would yield the same predictable results holding a plurality of electrodes for the purpose of treating tissue.
Moreover, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the location of the electrodes of Waldhauser to be disposed on the junctions, as taught by Basu, since the specific location/spacing of the electrodes aids the catheter perform its desired functionalities.
Regarding claim 2, Waldhauser discloses wherein the electrode assembly at least has a first state (a state where the base bodies do not experience any counter forces against them) and a second state (an expanded state where the base bodies bend radially outward, pa. 0870), and the relative movement between the inner tube and the outer tube can drive the connected electrode assembly to switch between the first state and the second state (pa. 0870),
wherein in the first state, the base body is attached to an outer wall of the inner tube in the circumferential direction of the inner tube, and an extension direction of the base body is parallel to an axis direction of the inner tube (see Fig. 37B);
wherein in the second state, the base body bendingly deform to outwardly bulge relative to the inner tube (pa. 0870).
However, Waldhauser does not disclose each adjacent first segments of a same base body group enclose to form a first closed shape and each adjacent second segments enclose to form a second closed shape, and each adjacent base body groups enclose to form a third closed shape.
Basu, in the same field of endeavor, teaches each adjacent first segments of a same base body group enclose to form a first closed shape (see annotated Fig. 1 below) and each adjacent second segments enclose to form a second closed shape (see annotated Fig. 1 below), and each adjacent base body groups enclose to form a third closed shape (see annotated Fig. 1 below).
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It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have substituted the structural arrangement/design of the base body groups in the electrode assembly of Waldhauser with the structural arrangement/design of the electrode array assembly as taught by Basu, which includes the first, second, and third encloses shapes, since it appears that the invention would perform equally as well with either structure and they both would yield the same predictable results holding a plurality of electrodes for the purpose of treating tissue.
Regarding claim 3, Waldhauser discloses wherein in the second state, the plurality groups of base body groups circumferentially distributed around the inner tube have a largest diameter (located at in the middlemost section of the electrode assembly).
However, Waldhauser does not disclose wherein in the second state, the junctions are located at one side of a plane where the largest diameter is located away from the outer tube.
Basu, in the same field of endeavor, teaches wherein in the second state, the plurality groups of base body groups circumferentially distributed around the inner tube have a largest diameter (i.e., in a middlemost section, see Fig. 1), and the junctions are located at one side (i.e., in a distalmost section) of a plane where the largest diameter is located away from the outer tube.
It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have substituted the structural arrangement/design of the base body groups in the electrode assembly of Waldhauser with the structural arrangement/design of the electrode array assembly as taught by Basu, which includes the largest diameter and the location of the junctions, since it appears that the invention would perform equally as well with either structure and they both would yield the same predictable results holding a plurality of electrodes for the purpose of treating tissue.
Regarding claim 4, Waldhauser discloses the electrodes being a plurality of electrodes (see Fig. 37B).
However, Waldhauser does not disclose wherein the electrodes at least comprise first electrodes and second electrodes, wherein the first electrodes are located at the junctions, the second electrodes are disposed at the second segments, and the second electrodes are located at the positions with the largest diameter, or the second electrodes are located between the positions with the largest diameter and the junctions.
Basu, in the same field of endeavor, teaches wherein the electrodes at least comprise first electrodes and second electrodes, wherein the first electrodes are located at the junctions, the second electrodes are disposed at the second segments (pa. 0033-0034 & Figs. 1-2), and the second electrodes are located at the positions with the largest diameter (see Fig. 1).
It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have substituted the structural arrangement/design of the base body groups in the electrode assembly of Waldhauser with the structural arrangement/design of the electrode array assembly as taught by Basu, which includes the specific locations of the of the first and second electrodes, since it appears that the invention would perform equally as well with either structure and they both would yield the same predictable results holding a plurality of electrodes for the purpose of treating tissue.
Regarding claim 5, Waldhauser/Basu combination discloses wherein the first electrodes and the second electrodes are electrode rings in an annular structure, and following the circumferential direction of the inner tube, a circumferential area of the first electrodes is greater than a circumferential area of the second electrodes (in an embodiment where the electrodes can be a variety configurations and sizes such as ring electrodes that fully enclose the body on which they are located or partially encircle the body on which they are located) (Waldhauser pa. 0699).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a configuration where the first electrodes are ring electrodes with a full circumference (with a large circumferential area) and the second electrodes are ring electrodes with a partial circumference (with a smaller circumferential area) since this configuration may help to localize the stimulation electrical energy into the target tissue and away from the blood (Waldhauser pa. 0699).
Regarding claim 6, Waldhauser discloses the invention substantially as claimed in claims 1 and 4 discussed above.
However, Waldhauser does not disclose wherein, along the axis direction of the inner tube, the first electrodes circumferentially arranged have a first diameter, and the second electrodes circumferentially arranged have a second diameter which is greater than the first diameter.
Basu, in the same field of endeavor, teaches wherein, along the axis direction of the inner tube, the first electrodes circumferentially arranged have a first diameter (see first diameter represented by an upper horizontal dash line on annotated Fig. 1 below), and the second electrodes circumferentially arranged have a second diameter (see second diameter represented by a lower horizontal dash line on annotated Fig. 1 below) which is greater than the first diameter (difference illustrated by the vertical dash line on annotated Fig. 1 below).
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It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have substituted the structural arrangement/design of the base body groups in the electrode assembly of Waldhauser with the structural arrangement/design of the electrode array assembly as taught by Basu, which includes the first and the second diameters, since it appears that the invention would perform equally as well with either structure and they both would yield the same predictable results holding a plurality of electrodes for the purpose of treating tissue.
Regarding claim 7, Waldhauser/Basu combination discloses wherein the electrode assembly comprises a plurality of first base seats (i.e., distal ends of the two or more base bodies 3722A and 3722B, as seen in Fig. 37F of the Waldhauser reference) which are circumferentially arranged on the inner tube (as seen in Fig. 37J, the distal ends of the two or more base bodies are circumferentially arranged around a central lumen 3753 configured to receive the inner tube 3728) and configured to connect the plurality groups of base body groups with the inner tube (pa. 0872), and the base bodies of a same base body group are connected to different said first base seats respectively (Waldhauser, Figs. 37B, 37J).
Regarding claim 8, Waldhauser/Basu combination discloses wherein the electrode assembly comprises a plurality of second base seats (i.e., proximal ends/bends 3725 of the two or more base bodies 3722A and 3722B, as seen in Figs. 37E and 37G of the Waldhauser reference) which are circumferentially arranged between the inner tube and the outer tube at one side near the outer tube and configured to connect the plurality groups of base body groups with the outer tube (as seen in Fig. 37G, the proximal ends/bends of the two or more base bodies are circumferentially arranged around a central lumen 3743 configured to receive the inner tube 3728), and the base bodies of a same base body group are connected to different said second base seats respectively (Waldhauser, pa. 0855 & Figs. 37B, 37G).
Regarding claim 9, Waldhauser discloses wherein the second base seat and the second segment have a second connecting point at a connecting position (located in the straight section of the two or more base bodies, as seen in Figs. 37C and 37G of the Waldhauser reference), the base body group comprises two base bodies, and the second connecting points at the connecting positions of adjacent base body groups with the same second base seat are in contact fit with each (see Figs. 37C, 37G).
However, Waldhauser does not disclose wherein the electrodes further comprise third electrodes, and the third electrode is located at the second connecting points which are in contact fit with each other.
Basu, in the same field of endeavor, teaches any number of the electrodes (20) may be readily positioned at any location on interconnected framework (18) (pa. 0034).
It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have added and located the third electrodes on any position of the electrode assembly of Waldhauser, including at the second connecting points which are in contact fit with each other, in order to increase the area of treatment for the target tissue.
Regarding claim 12, Waldhauser/Basu combination discloses wherein the base body comprises a support rod (i.e., a wire material that composes the two or more base bodies 3722A, 3722B) (Waldhauser, pa. 0855 & Fig. 37D) and an insulating layer (3829) (Waldhauser, pa. 0859 & Fig. 37F), the support rod is a metal member with deformation ability, and the insulting layer covers a surface of the metal member.
Regarding claim 13, Waldhauser/Basu combination discloses wherein the electrophysiology catheter has a head end (3704) and a tail end (3702) in an extension direction thereof, the electrode assembly is located at the head end (Waldhauser, pa. 0850 & Fig. 37A), and the tail end is provided with an adjusting part (handle 3710, including securing member 3774, which is fixably coupled to actuator 3780, and actuator tube assembly 3790, pa. 0882 & Figs. 37Li-37Lii) which connects the sleeved inner tube and the outer tube and can control and drive the inner tube to move relative to the outer tube in the axis direction of the catheter (Waldhauser, pa. 0882).
Regarding claim 15, Waldhauser/Basu combination discloses wherein the electrophysiology catheter further comprises wires (3712) (Waldhauser, pa. 0871, 0900), the electrophysiology catheter is provided with a power source (a neurostimulator) at the tail end (Waldhauser, pa. 0850), and the wires are connected with the electrodes and extend to the tail end to be electrically connected with the power source (Waldhauser, pa. 0900).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Waldhauser and Basu as applied to claims 1 and 9 above, and further in view of Viswanathan (U.S. Patent No. 10660702 B2).
Regarding claim 10, Waldhauser/Basu combination discloses the invention substantially as claimed in claims 1 and 9 discussed above.
However, they do not disclose wherein the electrode assembly has a third state which is formed by a relative movement between the inner tube and the outer tube on the basis of the second state; wherein in the third state, the third electrodes are circumferentially arranged in interspaces between the base body groups, the electrode assembly forms an umbrella structure, and along the axis direction of the inner tube the plane defined by the third electrodes is at least between the first electrodes and the second electrodes.
Viswanathan, in the same field of endeavor, teaches an electrode assembly (3600) (Col. 30, lines 9-15) configured in a third state (i.e. a flower shape formed by the twisting and bending of flexible spline members (3630) as they bias away from the longitudinal axis of the electrode assembly at an acute angle) which is formed by a relative movement between an inner tube (3620) and an outer tube (3610) (Col. 30, lines 24-33; Col. 31, lines 6-21);
wherein in the third state, the third electrodes are circumferentially arranged in interspaces between the base body groups/spline members, the electrode assembly forms an umbrella structure (see Fig. 36A), and along an axis direction (i.e., a longitudinal axis (3650)) of the inner tube the plane defined by the third electrodes (3640) is at least between the first electrodes and the second electrodes (Col. 32, lines 20-27 & Fig. 36A).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bending and twisting motion of the electrode assembly of Waldhauser in order to form a third state, as taught by Viswanathan, so as to reduce trauma to tissue, aid positioning, and allowing the base body groups to more easily conform to the geometry of the targeted tissue (Viswanathan, Col. 30, lines 9-15).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Waldhauser and Basu as applied to claims 1 and 9 above, and further in view of Novichenok (U.S. Patent No. 9351789 B2).
Regarding claim 11, Waldhauser discloses the invention substantially as claimed in claims 1 and 9 discussed above.
Basu teaches any number of the electrodes (20) may be readily positioned at any location on interconnected framework (18) (pa. 0034).
However, they do not disclose wherein the electrode assembly has a fourth state which is formed by the relative movement between the inner tube and the outer tube on the basis of the second state; wherein in the fourth state, the third electrodes are circumferentially arranged in the interspaces between the base body groups and at least the first electrodes, the second electrodes and the third electrodes are in a same plane.
Novichenok, in the same field of endeavor, teaches an electrode assembly (28) configured in a fourth state (i.e., in a radially expanded configuration formed by the twisting of base body groups/arms 30, 32) which is formed by the relative movement between an inner tube (36) and an outer tube (18) on the basis of the second state (Col. 6, lines 48-59 & Figs. 3A-3C); and
at least the first electrodes (24), the second electrodes (24), and the third electrodes (24) are in a same plane (see Fig. 3C).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the location/position of the third electrodes of Novichenok in order to be circumferentially arranged in the interspaces between the base body groups/arms in order to increase the area of treatment.
Moreover, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bending and twisting motion of the electrode assembly of Waldhauser in order to form a fourth state, as taught by Novichenok, in order to allow the base body groups to more easily conform to the geometry of the targeted tissue (Novichenok, Col. 6, lines 43-47).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Waldhauser and Basu as applied to claims 1 and 13 above, and further in view of Waldstreicher (U.S. Application No. 20190201089 A1).
Regarding claim 14, Waldhauser/Basu combination discloses wherein the adjusting part comprises a sliding component (3790) slidably connecting the inner tube with the outer tube (Waldhauser, pa. 0882 & Figs. 37Li-37Lii).
However, they do not disclose wherein the adjusting part comprises a button.
Waldstreicher, in the same field of endeavor, teaches a catheter (102) comprising a handle (110) (analogous to the adjusting part of Waldhauser), wherein when the catheter is successfully positioned within the target area, the one or more energy delivery bodies can be expanded, deployed or otherwise positioned into tissue contact via a mechanism in the catheter handle (e.g. lever, slider, plunger, button) operatively connected to an electrode assembly (108) via a pull/push tubing/wire or by other mechanisms (pa. 0409-0410).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the button of Waldstreicher to be operatively connect to the adjusting mechanism, specifically the sliding component of Waldhauser for the purpose of easing actuation mechanism of the electrode assembly for the user.
Conclusion
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794