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.
Response to Amendment
The Amendments filed June 11, 2026 have been entered. Applicant’s amendments have overcome the claim objections, and 112(b) rejections previously set-forth in the Non-Final Office Action mailed on 03/13/2026. Currently, claims 1-3, 6-12 have been amended, claims 4-5 have been cancelled, and claims 1-3, 6-15 are pending in the application.
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 1-3, 6-15 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 positions" in line 14. There is insufficient antecedent basis for this limitation in the claim. Claims 2-3, 6-15 are also rejectedbecause they are dependent on claim 1.
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 1-3, 6-9, 12-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Waldhauser (W.O. Application No. 2017156039 A1), in view of Basu (U.S. Application No. 20170164858 A1), and further in view of Lopes (U.S. Application No. 20130190587 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 of groups (3727) of base body groups which are arranged in a circumferential direction of the inner tube (pa. 0855 & Fig. 37D), wherein each 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 two or more base bodies are deformable (pa. 0870) and includes a plurality of electrodes (3724), which includes two or more electrodes (pa. 0854);
wherein the plurality of the electrodes discussed herein can be ring-electrodes that, when following a circumferential direction of the inner tube, fully encircle the base bodies on which they are located (i.e., these set of electrodes have a large circumferential area), or the electrodes can be a partial ring, where the electrode only partially encircles the base bodies on which they are located (i.e., these sets of electrodes have a smaller circumferential area when compared to the electrodes that fully encircle the base bodies) (pa. 0699).
However, Waldhauser does not disclose the two or more base bodies at least comprise 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.
Furthermore, 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 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 bodies comprise 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 region of transition that is not limited to a single point.
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Furthermore, Basu 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 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.
However, Waldhauser/Basu combination are not explicit about the first and the second electrodes having different circumferential areas, specifically no embodiment in either reference teaches a catheter using a combination of differently sized electrodes in tandem.
Lopes, in the same field of endeavor, teaches an ablation structure (308) comprising a catheter body (314) and a set of splines/elongate members (304) (pa. 0087 & Figs. 3A-3E), wherein each spline includes a plurality of electrodes (315) with respective conductive surfaces (e.g., energy transmission surfaces 319) (pa. 0118). In various embodiments, one or more dimensions or sizes of the various conductive surfaces of the various electrodes vary depending on their mounted location on the ablation structure (pa. 0118), or in order to control the depth of ablation and running time of an ablation procedure (pa. 0124).
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 sizes/shapes of the electrodes of Waldhauser, so that they can be a combination of differently sized electrodes (i.e., a combination of electrodes which fully encircle the base bodies/have a large circumferential area, and electrodes which partially encircles the base bodies/have a smaller circumferential area), as taught by Lopes, in order to control the depth of ablation and running time of an ablation procedure (Lopes, pa. 0124).
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 two or more base bodies are attached to an outer wall of the inner tube in the circumferential direction of the inner tube, and an extension direction of the two or more base bodies are parallel to an axis direction of the inner tube (see Fig. 37B);
wherein in the second state, the two or more base bodies bendingly deform to outwardly bulge relative to the inner tube (pa. 0870).
However, Waldhauser/Lopes combination do 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.
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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).
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 of 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/Lopes combination do 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 6, Waldhauser discloses the invention substantially as claimed in claim 1 discussed above.
However, Waldhauser/Lopes combination do 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/Lopes 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 of 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/Lopes 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 of 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 the two or more 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/Lopes combination do 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/Lopes combination discloses wherein the two or more base bodies comprise a support rod (i.e., a wire material) (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/Lopes 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/Lopes 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, Basu, and Lopes 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/Lopes 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 plurality of groups of 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 plurality of groups of 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, Basu, and Lopes as applied to claims 1 and 9 above, and further in view of Novichenok (U.S. Patent No. 9351789 B2).
Regarding claim 11, Waldhauser/Lopes combination 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 plurality of groups of 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, Basu, and Lopes 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/Lopes 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.
Response to Arguments
Applicant's arguments filed 06/11/2926 have been fully considered but they are partially persuasive.
With regards to newly amended independent claim 1, Applicant argues that the Waldhauser reference does not disclose a circumferential area of the first electrodes is greater than a circumferential area of the second electrodes. Specifically, Applicant contends that pa. 0699 of Waldhauser only discloses 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. However, this is merely a generic concept and does not take into consideration of purposefully employ a larger-area electrode for the specific structure of the junction to solve the specific technical problem of maximizing the use of its exposed area and compensating for the structural interspace. Examiner finds these arguments to be partially persuasive.
Examiner concedes to the fact that the Waldhauser reference merely discloses the generic concept of electrodes having a variety of shapes/sizes, and that such recitation lacks a specific teaching of using differently sized electrodes in tandem. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-3, 6-10, 12-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Waldhauser (W.O. Application No. 2017156039 A1), in view of Basu (U.S. Application No. 20170164858 A1), and further in view of Lopes (U.S. Application No. 20130190587 A1).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Waldhauser, Basu, and Lopes as applied to claims 1 and 9 above, and further in view of Viswanathan (U.S. Patent No. 10660702 B2).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Waldhauser, Basu, and Lopes as applied to claims 1 and 9 above, and further in view of Novichenok (U.S. Patent No. 9351789 B2).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Waldhauser, Basu, and Lopes as applied to claims 1 and 13 above, and further in view of Waldstreicher (U.S. Application No. 20190201089 A1).
It is the Examiner’s position that the newly filed rejections based on the combination of references are tenable for at least the reasoning set forth in the action above.
However, in response to applicant's argument that a specific functional purpose for solving a specific technical problem must be explicitly disclosed in the prior art in order to justify the choice of having different sets of ring electrodes having different circumferential areas, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the Waldhauser reference discloses the plurality of the electrodes can be ring-electrodes that fully encircle the base bodies, or they can be a partial ring that partially encircles the base bodies (pa. 0699). The Lopes reference is then used to teach the one or more dimensions or sizes of the various conductive surfaces of the various electrodes can vary depending on their mounted location on the ablation structure (pa. 0118), or in order to control the depth of ablation and running time of an ablation procedure (pa. 0124). Therefore, the prior art meets the structural claim limitation requirements of claim 1, without needing to explicitly solve the specific technical problem presented by Applicant. Furthermore, the claim language is broad and does not require the prior art to disclose a specific structure that solves the specific technical problem of maximizing the use of its exposed area and compensating for the structural interspace. Therefore, for the reasonings set-forth above, the pending claims are rejected under a new combination of references.
Conclusion
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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