DETAILED ACTION
The amendment filed May 19, 2025, has been entered and is fully considered. Claims 1-20 are pending. Claim 1 is amended.
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 3-14, 16, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hauck et al., (hereinafter 'Hauck,' U.S. PGPub. No. 2009/0062642) in view of Visram et al., (hereinafter 'Visram,' U.S. PGPub. No. 2005/0159738 ) and further in view of Clare et al., (hereinafter 'Clare,' U.S. Pat. 5,540,722) and McGee et al., (hereinafter ‘McGee,’ U.S. Pat. 5,673,695).
Regarding claim 1, Hauck (Fig. 1-6) discloses a method for gaining access to a region of a heart (Fig.1; [0033]), the method comprising the steps of (a) advancing an electrosurgical device into the heart (see heart 16, catheter 14 in Fig. 3; [0013], “a catheter or another device may puncture this location in a transseptal procedure.”); (b) visualizing a position of a tip of the electrosurgical device using an electroanatomical mapping system (see [0040]-[0041], tip electrode 20, catheter 14 is visualized utilizing the three-dimensional models to properly locate target tissue and create lesions); (c) positioning the tip of the electrosurgical device at a target tissue ([0040]-[0041]); and (e) delivering energy from the electrical generator (40) through an electrode (20) at a tip of the electrosurgical device (14) ([0013]; see [0034] for tissue ablation).
Hauck is silent regarding the electrosurgical device is a puncturing device, and delivering energy to puncture the target tissue.
However, in the same field of endeavor, Visram teaches a similar method for gaining access to a region of a heart (heart 800 in Fig. 8) comprising advancing an electrosurgical puncturing device (120) into the heart ([0058]) and positioning the tip of the electrosurgical puncturing device at a target tissue (Fig. 8; [0059]-[0061]). Visram further teaches (e) delivering energy from the electrical generator (128) through an electrode (112) at a tip of the electrosurgical puncturing device to puncture the target tissue ([0061], “energy may be delivered to create the perforation. For example, generator 128 is activated and RF energy is delivered through device 102 to make a perforation (step 910).”). This configuration allows the user “to remove or perforate unwanted tissue in a controlled manner in any location in the body, particularly in the atrial septum for controlled transeptal puncture” (abstract), thereby improving safety and accuracy. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck to include wherein the electrosurgical device is a puncturing device, and the step of delivering energy to puncture the target tissue, as taught by Visram, in order “to remove or perforate unwanted tissue in a controlled manner in any location in the body” (abstract), thereby improving safety and accuracy.
Although Hauck discloses switching between a mapping and ablation mode, wherein the mapping occurs separate from the ablation ([0039]-[0041]), Hauck in view of Visram are silent regarding (d) actuating a switch to electrically decouple the electrosurgical puncturing device from the electroanatomical mapping system while electrically coupling the electrosurgical puncturing device to an electrical generator independent of operation of the electroanatomical mapping system and the electrical generator.
However, in the same field of endeavor, Clare teaches a similar device comprising a switch apparatus that can be utilized for switching between multiple electrodes for performing diagnostic and therapeutic procedures on a patient (abstract, col. 1, ll. 5-33). Clare teaches that the switch apparatus (11) is adapted to be used with various medical apparatuses, such as a defibrillator (26), and another medical device such as electrosurgical unit (31) and ablation electrode (39). The switch is operable between first and second positions, wherein one or the other of the medical devices connected to the switch is exclusively in use in either the first or second position, respectively (col. 3, line 7- col. 6, line 34). This switch configuration allows for two independent medical devices to be utilized together, reducing the need for additional components such as electrodes, thereby minimizing cost and increasing efficiency and optimization (abstract; col. 1, ll. 5-31; col. 6, ll. 21-34). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram to include actuating a switch to electrically decouple the electrosurgical puncturing device from the electroanatomical mapping system while electrically coupling the electrosurgical puncturing device to an electrical generator independent of operation of the electroanatomical mapping system and the electrical generator, as taught by Clare. Doing so allows for two independent medical devices to be utilized together, reducing the need for additional components such as electrodes, thereby minimizing cost and increasing efficiency and optimization (abstract; col. 1, ll. 5-31; col. 6, ll. 21-34).
Although Hauck in view of Visram and Clare teach the method of actuating a switch, Hauck in view of Visram and Clare are silent regarding manually actuating the switch, (e) delivering energy from the electrical generator through an electrode at a tip of the electrosurgical puncturing device to puncture the target tissue while the electrical generator is electrically coupled to the electrode and the electroanatomical mapping system is electrically decoupled from the electrosurgical puncturing device; and (f) receiving electrical or electrophysiological signals from the electrode at the tip of the electrosurgical puncturing device while the electrosurgical mapping system is electrically coupled to the electrode and the electrical generator is electrically decoupled from the puncturing device.
However, in the same field of endeavor, McGee teaches a similar system comprising a mechanical switch (68 in Fig. 5) which is configured to be manually switched between a first position and a second position (col. 7, ll. 41-45, “for selecting either the signal monitor module 60 or the energy generator module 64, thereby choosing between operating the electrodes in a SENSING MODE and an ABLATING MODE (as FIG. 5 shows).”). McGee teaches that “using the switch 68, the physician can successively toggle between the SENSING MODE and the ABLATING MODE until the elimination of the accessory pathway has been confirmed” (col. 11, ll. 27-30). It is well known in the art (as can be seen in McGee) to utilize a manual switch, which is configured to be physically switched between a first position and a second position, in order to easily toggle between different operations or modes of treatment, such that the modes of treatment are effectuated exclusive of the other. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram and Clare to include the manually actuating the switch, (e) delivering energy from the electrical generator through an electrode at a tip of the electrosurgical puncturing device to puncture the target tissue while the electrical generator is electrically coupled to the electrode and the electroanatomical mapping system is electrically decoupled from the electrosurgical puncturing device; and (f) receiving electrical or electrophysiological signals from the electrode at the tip of the electrosurgical puncturing device while the electrosurgical mapping system is electrically coupled to the electrode and the electrical generator is electrically decoupled from the puncturing device, as taught by McGee. Doing so allows the user to easily toggle between different and exclusive operations or modes of treatment, thereby providing greater control and accuracy of treatment. Further, this modification would have merely comprised a simple substitution of one well known switching means for another in order to produce a predictable result, MPEP 2143(1)(B).
Regarding claim 3, Hauck discloses wherein step (c) further comprises advancing a tip (20) of the electrosurgical puncturing device (14) outside of a tubular support member (8), the tip comprising an electrode (tip electrode 20) ([0033], “The catheter system 10 may include a guiding introducer having a sheath 8, which may be inserted into the patient 12. The sheath 8 may provide a lumen for the introduction of a catheter 14 which may be disposed beyond the distal insertion end of the sheath 8.” Also see [0034]).
Regarding claim 4, Hauck discloses further comprising using the electroanatomical mapping system for electrically-based monitoring wherein the electrically-based monitoring includes measuring current, impedance, and/or voltage ([0004], electrical mapping; [0033], electro-anatomical mapping; see [0040] for process for internal mapping and modeling).
Regarding claim 5, Hauck discloses further comprising, prior to step (a), advancing a guidewire and a sheath through a right femoral vein and inferior vena cava, and into a right atrium (see [0005], for use of guide wire; and [0043], “As may be appreciated, cardiac access is often provided by inserting the sheath 8 in the femoral vein in the right leg. The sheath is then maneuvered up to the inferior vena cava 52 and into the right atrium 54. See FIG. 3A.”).
Further, in view of the prior modification of Hauck in view of Visram and further in view of Clare and McGee, Visram teaches performing such methods while using intracardiac echocardiography for visualization ([0061]). This allows the user to confirm placement of the device, by relying on “visualization of important anatomical landmarks and structures,” ([0003], thereby improving accuracy and safety). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram and further in view of Clare and McGee to include using intracardiac echocardiography for visualization as taught by Visram. Doing allows for confirmation of the placement of the device by relying on “visualization of important anatomical landmarks and structures,” ([0003]), thereby improving accuracy and safety.
Regarding claim 6, Hauck in view of Visram and further in view of Clare and McGee teach all of the limitations of the method according to claim 1. In view of the prior modification of Hauck in view of Visram and further in view of Clare and McGee, Visram teaches further comprising, prior to step (a), mapping a right atrium of the heart using intracardiac echocardiography ([0003]; [0062]). This allows the user to confirm placement of the device, by relying on “visualization of important anatomical landmarks and structures,” ([0003], thereby improving accuracy and safety). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram and further in view of Clare and McGee to include prior to step (a), mapping a right atrium of the heart using intracardiac echocardiography as taught by Visram. Doing allows for confirmation of the placement of the device by relying on “visualization of important anatomical landmarks and structures,” ([0003]), thereby improving accuracy and safety.
Regarding claim 7, Hauck in view of Visram and further in view of Clare and McGee teach all of the limitations of the method according to claim 6. In view of the prior modification of Hauck in view of Visram and further in view of Clare and McGee, Visram teaches further comprising using a mapping catheter ([0003]; [0061], “The position of functional tip region 110 and active electrode 112 may be additionally confirmed using an imaging modality such as fluoroscopy or intracardiac echocardiography”).
Regarding claim 8, Hauck in view of Visram and further in view of Clare and McGee teach all of the limitations of the method according to claim 1. Hauck further discloses comprising, prior to step (a), mapping a right side of the heart ([0034]; see [0040] for mapping of cardiac chamber, including a right side of the heart).
In view of the prior modification of Hauck in view of Visram and further in view of Clare and McGee, Visram teaches further mapping using intracardiac echocardiography ([0003]; [0062]). This allows the user to confirm placement of the device, by relying on “visualization of important anatomical landmarks and structures,” ([0003], thereby improving accuracy and safety). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram and further in view of Clare and McGee to include prior to step (a), mapping a right side of the heart using intracardiac echocardiography as taught by Visram. Doing allows for confirmation of the placement of the device by relying on “visualization of important anatomical landmarks and structures,” ([0003]), thereby improving accuracy and safety.
Regarding claim 9, Hauck in view of Visram and further in view of Clare and McGee teach all of the limitations of the method according to claim 8. In view of the prior modification of Hauck in view of Visram and further in view of Clare and McGee, Visram teaches further comprising using a mapping catheter for the step of mapping a right side of the heart ([0003]; [0061], “The position of functional tip region 110 and active electrode 112 may be additionally confirmed using an imaging modality such as fluoroscopy or intracardiac echocardiography”).
Regarding claim 10, Hauck in view of Visram and further in view of Clare and McGee teach all of the limitations of the method according to claim 1. In view of the prior modification of Hauck in view of Visram and further in view of Clare and McGee, Visram teaches further comprising identifying one or more key anatomical features using intracardiac echocardiography and displaying the key anatomical features on a display of the electroanatomical mapping system ([0003]; [0062]). This allows the user to confirm placement of the device, by relying on “visualization of important anatomical landmarks and structures,” ([0003], thereby improving accuracy and safety). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram and further in view of Clare and McGee to include further comprising identifying one or more key anatomical features using intracardiac echocardiography and displaying the key anatomical features on a display of the electroanatomical mapping system, as taught by Visram. Doing allows for confirmation of the placement of the device by relying on “visualization of important anatomical landmarks and structures,” ([0003]), thereby improving accuracy and safety.
Regarding claim 11, Hauck in view of Visram and further in view of Clare and McGee teach all of the limitations of the method according to claim 10. In view of the prior modification of Hauck in view of Visram and further in view of Clare and McGee, Visram teaches “transesophageal echocardiography, intracardiac echocardiography and the use of other devices in the heart [can be used] to identify certain landmarks. … [and] provides potentially useful information for electrophysiological studies and pacemaker implantation by visualization of important anatomical landmarks and structures” ([0003]). Visram teaches wherein the key anatomical features (i.e., landmarks) include: (b) a fossa ovalis ([0004]).
Hauck in view of Visram and further in view of Clare and McGee are silent regarding wherein the key anatomical features include: (a) an aortic root, and (c) a coronary sinus. However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram and further in view of Clare and McGee to include wherein the key anatomical features include: (a) an aortic root, and (c) a coronary sinus. This modification would have merely comprised a simple substitution of one well known element for another in order to produce a predictable result. MPEP 2143(I)(B).
Regarding claim 12, Hauck in view of Visram and further in view of Clare and McGee teach all of the limitations of the method according to claim 1. Hauck (Fig. 3) further discloses advancing the electrosurgical puncturing device through the transseptal sheath (sheath 8, catheter 14).
Further, in view of the prior modification of Hauck in view of Visram and further in view of Clare and McGee, Visram teaches performing such methods while using intracardiac echocardiography for visualization ([0061]). This allows the user to confirm placement of the device, by relying on “visualization of important anatomical landmarks and structures,” ([0003], thereby improving accuracy and safety). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram and further in view of Clare and McGee to include tracking and clocking down the electrosurgical puncturing device to the target tissue as taught by Visram. Doing allows for confirmation of the placement of the device by relying on “visualization of important anatomical landmarks and structures,” ([0003]), thereby improving accuracy and safety.
Hauck in view of Visram and further in view of Clare and McGee are silent regarding wherein step (c) includes: advancing a transseptal sheath through a superior vena cava to a brachiocephalic vein. However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram and further in view of Clare and McGee to include advancing a transseptal sheath through a superior vena cava to a brachiocephalic vein, since this modification would have merely comprised a simple substitution of one well known method of entry into a heart to reach a targeted location for another in order to produce a predictable result. MPEP 2143(I)(B).
Regarding claim 13, Hauck further discloses wherein the target tissue is a septum ([0046]-[0047], interatrial septum 24), and confirming a location of a tip (20) of the electrosurgical puncturing device using the electroanatomical mapping system (see [0040]-[0041], tip electrode 20, catheter 14 is visualized utilizing the three-dimensional models to properly locate target tissue and create lesions). In view of the prior modification of Hauck in view of Visram and further in view of Clare and McGee, Clare further teaches the method further comprises the steps of setting the switch to a mode for sensing or mapping (col. 3, line 7- col. 6, line 34). See obviousness rejection of claim 1 above.
Regarding claim 14, Hauck further discloses wherein the target tissue is a septum ([0046]-[0047], interatrial septum 24), and wherein the method further comprises the steps of advancing a sheath (sheath 8) into a left atrium through the puncture ([0043], “In what is typically referred to as a transseptal approach, the sheath and/or a catheter extending through the sheath is passed through the interatrial septum 24 between the right atrium 54 and left atrium 56. This provides access to the left atrium 56 as well as the pulmonary veins.” Also see [0044] where sheath 8 provides access to the left atrium 56).
In view of the prior modification of Hauck in view of Visram and further in view of Clare and McGee, Visram teaches performing such methods while using intracardiac echocardiography for visualization ([0061]). This allows the user to confirm placement of the device, by relying on “visualization of important anatomical landmarks and structures,” ([0003], thereby improving accuracy and safety). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram and further in view of Clare and McGee to include confirming the position of the sheath using intracardiac echocardiography following the advancement as taught by Visram. Doing allows for confirmation of the placement of the device by relying on “visualization of important anatomical landmarks and structures,” ([0003]), thereby improving accuracy and safety.
Regarding claim 16, Hauck further discloses wherein the target tissue is a septum ([0046]-[0047], interatrial septum 24), and wherein the method further comprises a step of advancing a catheter into a left atrium through the puncture ([0043], “In what is typically referred to as a transseptal approach, the sheath and/or a catheter extending through the sheath is passed through the interatrial septum 24 between the right atrium 54 and left atrium 56. This provides access to the left atrium 56 as well as the pulmonary veins.” Also see [0044] where sheath 8 provides access to the left atrium 56).
In view of the prior modification of Hauck in view of Visram and further in view of Clare and McGee, Visram teaches further comprising using a mapping catheter ([0003]; [0061], “The position of functional tip region 110 and active electrode 112 may be additionally confirmed using an imaging modality such as fluoroscopy or intracardiac echocardiography”).
Regarding claim 17, Hauck further discloses wherein the target tissue is a septum ([0046]-[0047], interatrial septum 24), and wherein the method further comprises a step of advancing an ablation catheter into a left atrium through the puncture ([0043], “In what is typically referred to as a transseptal approach, the sheath and/or a catheter extending through the sheath is passed through the interatrial septum 24 between the right atrium 54 and left atrium 56. This provides access to the left atrium 56 as well as the pulmonary veins.” Also see [0044] where sheath 8 provides access to the left atrium 56).
Regarding claim 20, Hauck further discloses wherein the electrosurgical puncturing device comprises a wire operable to delivery RF energy ([0058]. “The exemplary system 10 may include a generator 40, such as, e.g., AC current generator and/or a radio frequency (RF) generator, which in the present embodiment provides an electrical signal(s) to the electrode(s) of the catheter 14 as well as to the force transducer 22 (as illustrated by wires 44).” ).
Claims 2 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hauck in view of Visram and further in view of Clare and McGee as applied to claim 1 above, and further in view of Roelle et al., (hereinafter ‘Roelle,’ U.S. PGPub. No. 2011/0295268).
Regarding claim 2, Hauck in view of Visram and further in view of Clare and McGee teach all of the limitations of the method according to claim 1. Hauck in view of Visram and further in view of Clare and McGee are silent regarding wherein step (c) further comprises tenting the target tissue with the electrosurgical puncturing device.
However, in the same field of endeavor, Roelle teaches a similar method including tenting the target tissue with the electrosurgical puncturing device (74) (see Figs. 8A-8C). Roelle teaches “[t]enting may be desirable to assist with positioning and vectoring the instrument assembly distal portion (56) and to temporarily alter the mechanical properties of the tissue structure (for example, in tension, a thinned wall is not as likely to continue to deform and move away from the instrument assembly when a traversing instrument is advanced toward and into such wall relative to the rest of the instrument assembly…)” ([0040]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram and further in view of Clare and McGee to include wherein step (c) further comprises tenting the target tissue with the electrosurgical puncturing device, as taught by Roelle, in order to temporarily alter the mechanical properties of the tissue structure, thereby maintaining and improving contact between the device and the target tissue, and increasing accuracy of treatment.
In view of the prior modification of Hauck in view of Visram and further in view of Clare and McGee, Visram teaches performing such methods while using intracardiac echocardiography for visualization ([0061]). This allows the user to confirm placement of the device, by relying on “visualization of important anatomical landmarks and structures,” ([0003], thereby improving accuracy and safety). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram and further in view of Clare and McGee to include using intracardiac echocardiography to confirm tenting of the target tissue as taught by Visram. Doing allows for confirmation of the placement of the device by relying on “visualization of important anatomical landmarks and structures,” ([0003]), thereby improving accuracy and safety.
Regarding claim 19, Hauck in view of Visram and further in view of Clare and McGee teach all of the limitations of the method according to claim 1, but are silent wherein the electrosurgical puncturing device is an RF needle.
However, in the same field of endeavor, Roelle teaches a similar method wherein the electrosurgical puncturing device is an RF needle (tool 74, sharpened tip 76) (see Figs. 3B and 8A-8C; [0034]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram and further in view of Clare and McGee to include wherein the electrosurgical puncturing device is an RF needle as taught by Roelle, in order to provide a clean puncture to the targeted tissue, thereby increasing accuracy and efficiency. Further, this modification would have merely comprised a simple substitution of one well known puncturing device for another in order to produce a predictable result. MPEP 2143(I)(B).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hauck in view of Visram and further in view of Clare and McGee as applied to claim 1 above, and further in view of Brenneman et al., (hereinafter ‘Brenneman,’ U.S. PGPub. No. 2016/0058452).
Regarding claim 15, Hauck further discloses wherein the target tissue is a septum. Hauck in view of Visram and further in view of Clare and McGee are silent regarding wherein the method further comprises the steps of creating a second puncture and advancing a second sheath through the second puncture.
However, in the same field of endeavor, Brenneman teaches a similar method of forming fistulas within the body to gain access and deliver treatment to various locations ([0099]-[0101]). Brenneman teaches after the creation of a first fistula, “a second clinical procedure can be performed (e.g. the creation of a second fistula at a different anatomical location).” ([0101]). Brennan teaches a second fistula may be created due to inadequate therapy provided by the first fistula or in the case of stenosis of the first fistula ([0104]), thereby providing continued treatment and improved safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram and further in view of Clare and McGee to include wherein the method further comprises the steps of creating a second puncture and advancing a second sheath through the second puncture, as taught by Brenneman, in order to obviate inadequacies in the first puncture and allow for continued treatment, thereby improving efficiency and safety.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hauck in view of Visram and further in view of Clare and McGee as applied to claim 1 above, and further in view of Keller et al., (hereinafter ‘Keller,’ U.S. PGPub. No. 2002/0045925).
Regarding claim 18, Hauck in view of Visram and further in view of Clare and McGee teach all of the limitations of the method according to claim 1, but are silent regarding wherein the method further comprises the steps of inserting an esophageal probe through an esophagus and monitoring a temperature in the esophagus during the step of ablating to prevent undesired tissue damage.
However, in the same field of endeavor, Keller teaches “[t]emperature probes 608, 610 are placed on or in the patient so that they generate a signal that represents the temperature of the patient of the portion of the patient that is controlled by the system.” ([0135]). A variety of probes may be used to obtain such measurements, including esophageal probes ([0135]). The esophageal probes will generate a signal representative of the temperature sought to be controlled by the system which may be, for example, a temperature of a target tissue or core body temperature.” ([0135]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Hauck in view of Visram and further in view of Clare and McGee to include wherein the method further comprises the steps of inserting an esophageal probe through an esophagus and monitoring a temperature in the esophagus during the step of ablating to prevent undesired tissue damage, as taught by Keller. Doing so provides the user with accurate temperature feedback, such that the user is able to maintain a desired temperature, thereby increasing control and safety.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the amendment has necessitated a new ground of rejection.
Applicant’s argument (p. 7) that the combination does not teach the amendments is not found persuasive. In particular, applicant contends “[t]he switching device of Clare involves coupling four components (defibrillator, generator, reference electrode, defibrillation electrodes) rather than (1) the electroanatomical mapping system, (2) electric generator, and (3) tip electrode of the amended claims. Further, Clare does not teach coupling to one device at the patient, such as the puncture device as set forth in the claims, and instead teaches coupling to multiple devices spread around the patient. Still further, Clare does not teach or make obvious a device to decouple the generator from the electrodes or to couple the defibrillator to the electrodes independent of operation of the electroanatomical mapping system and the electrical generator as required by the claims because operation of the generator automatically decouples the defibrillator from the electrodes and automatically couples the generator to the electrodes.” Firstly, it is noted that claim 1 recites “comprising” and is therefore open ended. The prior art is not required to be limited only to the invention as claimed, i.e., the three components of “(1) the electroanatomical mapping system, (2) electric generator, and (3) tip electrode” as Applicant contends. Clare teaches a switch apparatus that is adapted to be used with various medical apparatuses – any number of medical devices – including those claimed. The switch is operable between first and second positions, wherein one or the other of the medical devices connected to the switch is exclusively in use in either the first or second position, respectively (col. 3, line 7- col. 6, line 34). This switch configuration allows for two independent medical devices to be utilized together, reducing the need for additional components such as electrodes, thereby minimizing cost and increasing efficiency and optimization (abstract; col. 1, ll. 5-31; col. 6, ll. 21-34). Clare teaches a switch that provides decoupling of the various medical devices to be used in isolation.
Further, McGee teaches the additional limitations as amended, curing any perceived deficiencies of Clare. See above for further clarification.
Applicant states (p. 7) “Visram contradicts any suggestion that an electroanatomical mapping system and electric generator should not be coupled to an electrosurgical device at the same time.” In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Further, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
No further arguments have been set forth regarding the dependent claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.A.D./Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
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