DETAILED ACTION
The following is a Non-Final Office Action on the merits.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
Acknowledgment is made to the amendment received 10/7/2025.
Applicant’s amendments are sufficient to overcome the 35 USC 112(b)/second paragraph rejections set forth in the previous office action.
Response to Arguments
Applicant’s arguments filed 10/7/2025 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as set forth below.
The Examiner notes the claims fail to recite in combination the one or more control units configured to control navigation of the catheter, movement of the internal element within an inflatable device, activating selected electrodes to create one of the claimed ablation patterns that is formed while the catheter is ablating,
Claim Objections
Claim 16 is objected to because of the following informalities: amend “longitudinal body” to -the longitudinal body- in ll. 4. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: amend “electrical energy” to -the electrical energy- in ll. 3. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: amend “electrical energy” to -the electrical energy- in ll. 2. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: amend “electrical energy” to -the electrical energy- in ll. 8. Appropriate correction is required.
Claim 30 is objected to because of the following informalities: amend “electrical energy” to -the electrical energy- in ll. 2. Appropriate correction is required.
Claim 36 is objected to because of the following informalities: amend “electrical energy” to -the electrical energy- in ll. 15. Appropriate correction is required.
Claim 37 is objected to because of the following informalities: amend “each electrode” to -each electrode of the plurality of electrodes- in ll. 3. Appropriate correction is required.
Claim 39 is objected to because of the following informalities: amend “electrical energy” to -the electrical energy- in ll. 3. 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.
Claim 33 is 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 33 recites the limitations of “supply electrical energy to each of the plurality of electrodes independently” and “a power generator…for providing electrical power to each of the plurality of electrodes”. It is unclear if the “electrical power” is the same as the “electrical energy” previously recited. For purposes of examination, “electrical power” will be interpreted as -the electrical energy-.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “control units” in claims 16-22, 30-31, 36 & 38-39 and “drive system” in claims 17 & 38.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 16-17, 20, 23, 27-28, 30-31 & 36-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman (2002/0099428) in view of Hastings et al. (WO 03/086190).
Concerning claim 16, as illustrated in at least Figs. 1 & 8E-F, Kaufman discloses a medical system (Fig. 1), comprising:
a catheter for ablating tissue (catheter 20; [0054]) including:
a flexible longitudinal body including a distal end (catheter 20 has a body that has a distal end; [0054]); and
a distal portion extending distally from the distal end of longitudinal body, the distal portion including a plurality of electrodes (distal portion 24 extends from distal end of the body and includes electrodes 26; [0054]); and
one or more control units coupled to the catheter and configured to (1) control a supply of electrical energy to each of the plurality of electrodes (sliding contacts 44, 44’ on distal tip of the conductor 28 can contact an inner surface of the electrodes such that an energy or current can be delivered from a power source 30 to the selected electrode, where the sliding contacts 44, 44’ can be driven manually or mechanically under a computer control; [0054-0055], [0060-0061], [0062]).
Kaufman fails to disclose the one or more control units configured to also automatically control a position of the distal portion of the catheter. However, Hastings et al. disclose a medical system (20) comprising a catheter (22) and one or more control units (72) configured to automatically control a position of the distal portion of the catheter (22). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Kaufman such that the one or more control units configured to also automatically control a position of the distal portion of the catheter in order to provide the benefit of remote operation as taught by Hastings et al. ([0006], [0027], [0031]; Fig. 1-2)
Concerning claim 17, Hastings et al. further disclose a drive system (170) configured to move the catheter (22) proximally and distally, wherein the drive system (170) is in communication with and controlled by the one or more control units (6) ([0009-0010]; Fig. 8A-B).
Concerning claim 20, Kaufman fails to disclose a graphical user interface configured to allow a user to select an area of tissue targeted for ablation by the plurality of electrodes. However, Hastings et al. further disclose a graphical user interface (tissue image) configured to allow a user to select an area of tissue targeted for ablation by the plurality of electrodes ([0060-0063], [0067-0068]). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Kaufman such that the graphical user interface is configured to allow a user to select an area of tissue targeted for ablation by the plurality of electrodes in order to provide the benefit of the catheter converging on physician-specified targets for treatment as taught by Hastings et al. ([0059-0062]).
Concerning claim 23, Kaufman discloses the catheter (20) includes an internal element (51) extending from a proximal portion of the catheter to the distal portion, and wherein: the internal element (51) includes a distal protrusion (44) with a radially-outermost surface in contact with a radially-inner surface of the distal portion, the internal element (51) is positioned within, and moveable relative to, the distal portion and the longitudinal body (20) and the internal element (51) is configured to transfer electrical energy to each of the plurality of electrodes (26) independently of others of the plurality of electrodes (26) ([0060], [0063]; Fig. 8E-F).
Concerning claim 27, Kaufman discloses the distal protrusion (44) is configured to activate each of the plurality of electrodes (26) independently when in contact with each electrode (26), and wherein the distal protrusion (44) is configured to translate longitudinally and rotate relative to the distal portion ([0060], [0063]; Fig. 8E-F).
Concerning claim 28, Kaufman discloses each of the plurality of electrodes (26) is not connected to a proximal lead; and wherein the distal protrusion (44) is curved ([0060], [0063]; Fig. 8E-F).
Concerning claim 30, Kaufman discloses the one or more control units (46) is configured to independently supply electrical energy to each of the plurality of electrodes (22, 88/314) ([0069]; Fig. 1).
Concerning claim 31, as illustrated in at least Figs. 1 & 8E-F, Kaufman discloses a medical system (Fig. 1), comprising:
a catheter for ablating tissue (catheter 20; [0054]) including:
a flexible longitudinal body including a distal end (catheter 20 has a body that has a distal end; [0054]); and
a distal portion extending distally from the distal end of longitudinal body, the distal portion including a plurality of electrodes (distal portion 24 extends from distal end of the body and includes electrodes 26; [0054]);
one or more control units coupled to the catheter and configured to (1) supply electrical energy to each of the plurality of electrodes independently (electronic actuator 46 couples to conductor 28 to move sliding contact(s) 44 into engagement with a selected electrode 26 to activate the electrode, where sliding contacts can be driven manually or mechanically under a computer control; [0061], [0063], [0069]);
a power generator coupled to and controlled by the one or more control units for providing electrical power to each of the plurality of electrodes (sliding contacts 44, 44’ on distal tip of the conductor 28 can contact an inner surface of the electrodes such that an energy or current can be delivered from a power source 30 to the selected electrode, where the sliding contacts 44, 44’ can be driven manually or mechanically under a computer control; [0054-0055], [0060-0061], [0062]).
Kaufman fails to disclose the one or more control units configured to also automatically control a position of the distal portion of the catheter. However, Hastings et al. disclose a medical system (20) comprising a catheter (22) and one or more control units (72) configured to automatically control a position of the distal portion of the catheter (22). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Kaufman such that the one or more control units configured to also automatically control a position of the distal portion of the catheter in order to provide the benefit of remote operation as taught by Hastings et al. ([0006], [0027], [0031]; Fig. 1-2)
Concerning claim 36, as illustrated in at least Figs. 14-15, Bencini discloses as illustrated in at least Figs. 1 & 8E-F, Kaufman discloses a medical system (Fig. 1), comprising:
a catheter for ablating tissue (catheter 20; [0054]) including:
a flexible longitudinal body including a distal end (catheter 20 has a body that has a distal end; [0054]); and
a distal portion extending distally from the distal end of longitudinal body, the distal portion including a plurality of electrodes (distal portion 24 extends from distal end of the body and includes electrodes 26; [0054]); and
one or more control units coupled to the catheter and configured to (1) control a supply of electrical energy to each of the plurality of electrodes (sliding contacts 44, 44’ on distal tip of the conductor 28 can contact an inner surface of the electrodes such that an energy or current can be delivered from a power source 30 to the selected electrode, where the sliding contacts 44, 44’ can be driven manually or mechanically under a computer control; [0054-0055], [0060-0061], [0062]);
wherein the catheter includes an internal element extending from a proximal portion of the catheter to the distal portion (sliding contacts 44, 44’ on distal tip of the conductor 28 extend from the proximal end to the distal end; [0054-0055], [0061]), and wherein:
the internal element includes a distal protrusion with a radially-outermost surface in contact with a radially-inner surface of the distal portion, the internal element is positioned within, and moveable relative to, the distal portion and the longitudinal body, and the internal element is configured to transfer electrical energy to each of the plurality of electrodes independently of others of the plurality of electrodes (conductor 26 can be longitudinally movable and rotatable about longitudinal axis 31 until the sliding contacts 44, 44' contact electrode 26 to deliver energy or current from the power source 30; [0054-0055], [0060-0061], [0062]).
Kaufman fails to disclose the one or more control units configured to also automatically control a position of the distal portion of the catheter. However, Hastings et al. disclose a medical system (32) comprising a catheter (22) and one or more control units (72) configured to automatically control a position of the distal portion of the catheter (22). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Kaufman such that the one or more control units configured to also automatically control a position of the distal portion of the catheter in order to provide the benefit of remote operation as taught by Hastings et al. ([0006], [0027], [0031]; Fig. 1-2)
Claim 37 is rejected upon the same rationale as applied to claim 27.
Claim 38 is rejected upon the same rationale as applied to claim 17.
Claim(s) 16, 18, 20, 23, 27-28, 30-32, 36-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bencini (6,666,864) in view of Hastings et al. (WO 03/086190).
Concerning claim 16, as illustrated in at least Figs. 14-15, Bencini discloses a medical system (Fig. 14-15), comprising:
a catheter for ablating tissue (catheter 104; Col. 10-11, ll. 44-2) including:
a flexible longitudinal body including a distal end (flexible catheter body 106 is formed from a proximal member 108 and a distal member 112; Col. 10-11, ll. 44-2); and
a distal portion extending distally from the distal end of longitudinal body, the distal portion including a plurality of electrodes (distal member 112 carries a plurality of spaced electrodes 114; Col. 10-11, ll. 44-2); and
one or more control units coupled to the catheter and configured to (1) control a supply of electrical energy to each of the plurality of electrodes (power motor supply and control or mapping device and/or PC board in handle 110 controls motor 132 and electrical contacts 136 to deliver energy to electrodes 114 from connector 142/52 from a power source; Col. 6, ll. 27-45, Col. 11, ll. 41-55).
Bencini fails to disclose the one or more control units configured to also automatically control a position of the distal portion of the catheter. However, Hastings et al. disclose a medical system (20) comprising a catheter (22) and one or more control units (72) configured to automatically control a position of the distal portion of the catheter (22). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Kaufman such that the one or more control units configured to also automatically control a position of the distal portion of the catheter in order to provide the benefit of remote operation as taught by Hastings et al. ([0006], [0027], [0031]; Fig. 1-2)
Concerning claim 18, Bencini discloses a power generator (power supply) coupled to and controlled by the one or more control units (PC board) for providing electrical energy to each of the plurality of electrodes (114) (Col. 6, ll. 27-45, Col. 11, ll. 41-55); and a scanner (128) configured to create images of a patient's anatomy (Col. 11, ll. 28-40; Fig. 14-15).
Concerning claim 20, Bencini fails to disclose a graphical user interface configured to allow a user to select an area of tissue targeted for ablation by the plurality of electrodes. However, Hastings et al. further disclose a graphical user interface (tissue image) configured to allow a user to select an area of tissue targeted for ablation by the plurality of electrodes ([0060-0063], [0067-0068]). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Bencini such that the graphical user interface is configured to allow a user to select an area of tissue targeted for ablation by the plurality of electrodes in order to provide the benefit of the catheter converging on physician-specified targets for treatment as taught by Hastings et al. ([0059-0062]).
Concerning claim 23, Bencini discloses the catheter (104) includes an internal element (130) extending from a proximal portion of the catheter to the distal portion, and wherein: the internal element (130) includes a distal protrusion (136) with a radially-outermost surface in contact with a radially-inner surface of the distal portion, the internal element (130) is positioned within, and moveable relative to, the distal portion and the longitudinal body (112) and the internal element (130) is configured to transfer electrical energy to each of the plurality of electrodes (114) independently of others of the plurality of electrodes (114) (Col. 7, ll. 29-26, Col. 11, ll. 41-55; Fig. 14-15).
Concerning claim 27, Bencini discloses the distal protrusion (44) is configured to activate each of the plurality of electrodes (26) independently when in contact with each electrode (26), and wherein the distal protrusion (44) is configured to translate longitudinally and rotate relative to the distal portion (Col. 7, ll. 29-26, Col. 11, ll. 41-55; Fig. 14-15).
Concerning claim 28, Bencini discloses each of the plurality of electrodes (118) is not connected to a proximal lead; and wherein the distal protrusion (136) is curved (Col. 7, ll. 29-26, Col. 11, ll. 41-55; Fig. 14-15).
Concerning claim 30, Bencini discloses the one or more control units (PC board) is configured to independently supply electrical energy to each of the plurality of electrodes (22, 88/314) (Col. 6, ll. 27-45, Col. 11, ll. 41-55; Fig. 14-15).
Concerning claim 31, as illustrated in at least Figs. 14-15, Bencini discloses a medical system (Fig. 14-15), comprising:
a catheter for ablating tissue (catheter 104; Col. 10-11, ll. 44-2) including:
a flexible longitudinal body including a distal end (flexible catheter body 106 is formed from a proximal member 108 and a distal member 112; Col. 10-11, ll. 44-2); and
a distal portion extending distally from the distal end of longitudinal body, the distal portion including a plurality of electrodes (distal member 112 carries a plurality of spaced electrodes 114; Col. 10-11, ll. 44-2);
one or more control units coupled to the catheter and configured to (1) supply electrical energy to each of the plurality of electrodes independently; a power generator coupled to and controlled by the one or more control units for providing electrical power to each of the plurality of electrodes (power supply and control or mapping device and/or PC board in handle 110 controls motor 132 and electrical contacts 136 to deliver energy to electrodes 114 from connector 142/52 from a power source; Col. 6, ll. 27-45, Col. 11, ll. 41-55).
Bencini fails to disclose the one or more control units coupled to the catheter and configured to also automatically control a position of the distal portion of the catheter; and a motor system configured to move the catheter proximally and distally, wherein the motor system is in communication with and controlled by the one or more control units. However, Hastings et al. disclose a medical system (20) comprising a catheter (22) coupled to one or more control units (72) configured to automatically control a position of the distal portion of the catheter (22), and a motor system (170) configured to move the catheter proximally and distally, wherein the motor system (170) is in communication with and controlled by the one or more control units (72). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Bencini such that the one or more control units configured to also automatically control a position of the distal portion of the catheter in order to provide the benefit of remote operation as taught by Hastings et al. ([0006], [0027], [0031]; Fig. 1-2)
Concerning claim 32, Bencini discloses the distal portion of the catheter (104) includes an interior portion and an exterior surface, wherein each of the plurality of electrodes (114) extends from the interior portion to the exterior surface, wherein an exterior surface of each electrode (114) is flush with the exterior surface of the distal portion (112) , and an interior surface of each electrode (114) faces the interior portion of the catheter (104) (Fig. 15).
Concerning claim 36, as illustrated in at least Figs. 14-15, Bencini discloses a medical system (Fig. 14-15), comprising:
a catheter for ablating tissue (catheter 104; Col. 10-11, ll. 44-2) including:
a catheter for ablating tissue (catheter 104; Col. 10-11, ll. 44-2) including:
a flexible longitudinal body including a distal end (flexible catheter body 106 is formed from a proximal member 108 and a distal member 112; Col. 10-11, ll. 44-2); and
a distal portion extending distally from the distal end of longitudinal body, the distal portion including a plurality of electrodes (distal member 112 carries a plurality of spaced electrodes 114; Col. 10-11, ll. 44-2); and
one or more control units coupled to the catheter and configured to (1) control a supply of electrical energy to each of the plurality of electrodes (power motor supply and control or mapping device and/or PC board in handle 110 controls motor 132 and electrical contacts 136 to deliver energy to electrodes 114 from connector 142/52 from a power source; Col. 6, ll. 27-45, Col. 11, ll. 41-55);
wherein the catheter includes an internal element extending from a proximal portion of the catheter to the distal portion (rotatable cable 130 is both rotatable and longitudinally translatable within catheter body 108, 112; Col. 11, ll. 28-40), and wherein:
the internal element includes a distal protrusion with a radially-outermost surface in contact with a radially-inner surface of the distal portion, the internal element is positioned within, and moveable relative to, the distal portion and the longitudinal body, and the internal element is configured to transfer electrical energy to each of the plurality of electrodes independently of others of the plurality of electrodes (spring-like electrical contacts 136 being curved to facilitate rotation form an actuator that may be moved from electrode 114 to electrode 114 by moving the slidable handle 134 to create lesions; Col. 7, ll. 29-26, Col. 11, ll. 41-55; Fig. 14-15).
Bencini fails to disclose the one or more control units configured to also automatically control a position of the distal portion of the catheter. However, Hastings et al. disclose a medical system (20) comprising a catheter (22) and one or more control units (72) configured to automatically control a position of the distal portion of the catheter (22). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Bencini such that the one or more control units configured to also automatically control a position of the distal portion of the catheter in order to provide the benefit of remote operation as taught by Hastings et al. ([0006], [0027], [0031]; Fig. 1-2)
Claim 37 is rejected upon the same rationale as applied to claim 27.
Claim 38 is rejected upon the same rationale as applied to claim 17.
Claim 39 is rejected upon the same rationale as applied to claim 18.
Claim(s) 16-21, 24-25 & 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (6,006,755) in view of Hastings et al. (WO03/086190).
Concerning claim 16, as illustrated in at least Figs. 2a, 2e & 14-16, Edwards et al. discloses a medical system (Fig. 2a), comprising:
a catheter for ablating tissue (apparatus 10 used to deliver energy to treatment site 12 to produce lesions 14; Col. 5, ll. 8-14) including:
a flexible longitudinal body including a distal end (shaft 18 has a distal end; Col. 5, ll. 8-45); and
a distal portion extending distally from the distal end of longitudinal body, the distal portion including a plurality of electrodes (basket assembly 20 is located at the distal end of shaft 18 and includes electrodes 22/122; Col. 7, ll. 22-43); and
one or more control units (controller 138/microprocessor 136; Col. 13, ll. 10-19 & Col. 14, ll. 22-50) coupled to the catheter and configured to (1) control a supply of electrical energy to each of the plurality of electrodes (each RF electrode 22/122 is connected to resources which generate an independent output; Col. 11, ll. 62-13, Col. 13, ll. 10-42, Col. 14, ll. 11-21).
Edwards fails to disclose the one or more control units configured to also automatically control a position of the distal portion of the catheter. However, Hastings et al. disclose a medical system (20) comprising a catheter (22) and one or more control units (72) configured to automatically control a position of the distal portion of the catheter (22). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Edwards such that the one or more control units configured to also automatically control a position of the distal portion of the catheter in order to provide the benefit of remote operation as taught by Hastings et al. ([0006], [0027], [0031]; Fig. 1-2)
Concerning claim 17, Hastings et al. further disclose a drive system (60) configured to move the catheter (22) proximally and distally, wherein the drive system (60) is in communication with and controlled by the one or more control units (72) ([0030-0031]; Fig. 1-2).
Concerning claim 18, Edwards discloses a power generator (24/124) coupled to and controlled by the one or more control units for providing electrical energy to each of the plurality of electrodes (22/122) (Col. 12, ll. 63-8); and a scanner (scanner) configured to create images of a patient's anatomy (Col. 12, ll. 28-38).
Concerning claim 19, Edwards discloses the one or more control units (136/138) are configured to monitor an impedance of each of the plurality of electrodes (22/122) and adjust the electrical energy supplied to each of the plurality of electrodes (22/122) based on the monitored impedance (Col. 14, ll. 36-50).
Concerning claim 20, Edwards discloses a graphical user interface (146) (Col. 14, ll. 29-35). Edwards fails to disclose the graphical user interface configured to allow a user to select an area of tissue targeted for ablation by the plurality of electrodes. However, Hastings et al. further disclose a graphical user interface (tissue image) configured to allow a user to select an area of tissue targeted for ablation by the plurality of electrodes ([0060-0063], [0067-0068]). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Edwards such that the graphical user interface is configured to allow a user to select an area of tissue targeted for ablation by the plurality of electrodes in order to provide the benefit of the catheter converging on physician-specified targets for treatment as taught by Hastings et al. ([0059-0062]).
Concerning claim 21, Edwards discloses the one or more control units (136/138) are configured to adjust an amount of electrical energy supplied to at least one of the plurality of electrodes (22/122) based on at least one image created by a scanner (22, 88/314) (Col. 12, ll. 29-63).
Concerning claim 24, Edwards discloses the catheter (10) includes an ultrasound probe (transducer) positioned within the distal portion; and a scanner is configured to detect the position of the ultrasound probe (any of imaging system can detect position of the catheter, and thus the ultrasound probe) (Col. 12, ll. 29-38 & Col. 13-14, ll. 65-3). In the alternative, Hastings et al. disclose the catheter includes an ultrasound probe (ultrasonic localization sensors or transmitters on catheter tip) positioned within the distal portion; a scanner (external transmitters or receivers) is configured to detect the position of the ultrasound probe. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Edwards to further comprise a scanner is configured to detect the position of the ultrasound probe in order to provide the benefit of a device localization system as taught by Hastings et al. ([0037]; Fig. 1).
Concerning claim 25, Edwards discloses the distal portion of the catheter is expandable (25) and includes an interior portion and an exterior surface, wherein each of the plurality of electrodes (22/122) extends from the interior portion to the exterior surface (Col. 7, ll. 22-43; Fig. 2e).
Concerning claim 30, Edwards discloses the one or more control units (136/138) is configured to independently supply electrical energy to each of the plurality of electrodes (22/122) (Col. 12, ll. 29-63).
Claim(s) 16-17, 22 & 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Utely et al. (2009/0012512) in view of Hastings et al. (WO03/086190).
Concerning claim 16, as illustrated in at least Figs. 1A, 5-8D & 48-50A, Utely et al. discloses a medical system (system for ablation; [0123]), comprising:
a catheter for ablating tissue including: a flexible longitudinal body including a distal end (ablation catheter 41 comprises a flexible longitudinal body including a distal end; [0105]); and
a distal portion extending distally from the distal end of longitudinal body, the distal portion including a plurality of electrodes (ablation structure 101 is located at the body distal end can have various electrode patterns; [0105], [0134]); and
one or more control units (computer controller; [0143]) coupled to the catheter and configured to (1) control a supply of electrical energy to each of the plurality of electrodes (computer controller has the capability of directing the generator to deliver energy to all the electrodes or to a subset of the electrodes for a specific time that allow the formation of patterns that, when the pattern is in therapeutic contact with a target surface, can ablate a portion of tissue in the target area, and leave a portion of the tissue in the target area non-ablated; [0143-0145]).
Utely fails to disclose the one or more control units configured to also automatically control a position of the distal portion of the catheter. However, Hastings et al. disclose a medical system (20) comprising a catheter (22) and one or more control units (72) configured to automatically control a position of the distal portion of the catheter (22). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Utely such that the one or more control units configured to also automatically control a position of the distal portion of the catheter in order to provide the benefit of remote operation as taught by Hastings et al. ([0006], [0027], [0031]; Fig. 1-2)
Concerning claim 17, Hastings et al. further disclose a drive system (60) configured to move the catheter (22) proximally and distally, wherein the drive system (60) is in communication with and controlled by the one or more control units (72) ([0030-0031]; Fig. 1-2).
Concerning claim 22, Utely discloses the one or more control units include a plurality of stored ablation patterns (Fig. 48A-55), wherein each stored ablation pattern (Fig. 48A-55) includes output energy levels for each of the p0lurality of electrodes (60), the plurality of stored ablation patterns (Fig. 48A-55) comprising at least one of a central-and-lateral pattern with a central region having a greater ablation depth relative to a lateral region; an eccentric ablation pattern with zones on opposite sides; a helical ablation pattern with a helically shaped ablation zone; or a gradient controlled ablation pattern with an ablation zone that increases radially outward along the distal portion relative to a longitudinal axis of the catheter when the catheter is oriented along the longitudinal axis after ablating (Fig. 55) ([0022], [0024], [0143-0144], [0146-0154]).
Concerning claim 24, Utely fails to disclose the catheter includes an ultrasound probe positioned within the distal portion; and a scanner is configured to detect the position of the ultrasound probe. However, Hastings et al. disclose the catheter includes an ultrasound probe (ultrasonic localization sensors or transmitters on catheter tip) positioned within the distal portion; a scanner (external transmitters or receivers) is configured to detect the position of the ultrasound probe. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Utely such that the catheter includes an ultrasound probe positioned within the distal portion and a scanner that is configured to detect the position of the ultrasound probe in order to provide the benefit of a device localization system as taught by Hastings et al. ([0037]; Fig. 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Salahieh et al. (2017/0296266) teaches a longitudinally movable conductor on the interior of an expandable element (Fig. 9A-11).
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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