DETAILED ACTION
This action is pursuant to the claims filed on December 26, 2024. Claims 21-40 are pending. Claims 1-20 are canceled. A first action on the merits of claims 1-20 is as follows.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21-23, 25-29, 32-33, and 36-37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cosman (U.S. Pat. No. 6,241,725), and further in view of Lee et al. (hereinafter ‘Lee’, U.S. PGPub. No. 2007/0016183).
In regards to independent claim 21 and claims 34-35, Cosman discloses a system for use during a surgical procedure (electrode system in Fig. 7), the system comprising:
an ablation device having a sharp tip configured for conducting radiofrequency (RF) energy (electrode 701 comprising a metal cannula and a sharpened trocar conductive distal tip);
a controller (computer graphic workstation 731 inherently comprises a processor); and
the controller configured to provide a real-time ultrasound imaging during an ablation mode and coagulation mode (graphic display 741 shows the actual lesion process as it is proceeding in real-time; the ultrasound image is used to render the anatomy and the tumor volume of 751; col. 9, ln. 3-10: the merged image 751 between the rendered electrodes and the rendered anatomical image based upon the real-time ultrasound probe imaging).
However, Cosman fails to disclose that the ablation device comprises a plurality of stylets, wherein the stylets are moveable with respect to the sharp tip.
Lee teaches an ablation device comprising a trocar or sharp tip and a plurality of stylets (ablation instrument in Figs.1-5: trocar 10 and a plurality of stylets 224, [0025]).
Lee teaches an ablation device comprising a trocar and a plurality of stylets (ablation instrument in Figs.1-5: trocar 10 and a plurality of stylets 224, [0025]). In a first geometry, the stylets are fully deployed from the trocar for delivering ablation energy to cause ablation of tumor or tissue ([0085]). In a second geometry, the stylets are fully retracted and the tip of the trocar is configured to deliver coagulation energy to prevent blood loss along the track formed by the trocar during the withdrawal ([0025]), thus meeting claims 34-35. Given that Cosman does contemplates that any geometries of electrodes can be used with the system (col. 9, ln. 31-36), it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the ablation device and incorporate a plurality of stylets extending from the trocar or sharp tip as taught by Lee so that the modified ablation device assumes a plurality of geometries, including ablation and coagulation modes, respectively as needed for the clinical procedure.
Since Cosman discloses a rendered ablation device represented in rendered image view during real-time ultrasound imaging (col. 9, ln. 3-10: the merged image 751 between the rendered electrodes and the rendered anatomical image based upon the real-time ultrasound probe imaging), the modified ablation device of Cosman/Lee provides for 1) a first device image and a first indication indicating that the system is in an ablation mode when the ablation device has a first geometry ready for delivering ablation energy which is a merged image between the rendered plurality of stylets fully deployed from the sharp tip on the rendered anatomical ultrasound probe image and 2) a second device image and a second indication indicating that the system is in a coagulation mode when the ablation device has a second geometry ready for delivering coagulation energy which is a merged image between the rendered plurality of stylets fully retracted in the sharp tip on the rendered anatomical ultrasound probe image, where the second geometry is different from the first geometry. Note that the first device image is different from the second device image because these two images will be taken at different time points during real-time ultrasound imaging.
In regards to claim 22, Cosman/Lee combination further discloses wherein the first indication and the second indication are respective pre-determined graphical objects (as noted above, Cosman discloses that the first indication and second indication are rendered images of the modified sharp tip and the plurality of stylets and given that the indications are rendered by the display 741 and workstation 731, it is inherently predetermined graphical objects on the ultrasound images).
In regards to claims 25-29, Cosman/Lee combination further discloses that any functionality feature such as buttons, menus and submenus on a graphical user interface/display/screen to monitor or control the system and ablation process can be provided on the same computer graphic workstation (col. 10-29). Given that the claimed menus and submenus are merely a list of buttons without a specific detail as to the functionality associated with selecting the buttons, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provide any menus or submenus as desired as doing so involves routine skilled in the art.
In regards to claim 32-33, Cosman/Lee combination further discloses wherein the ultrasound image of the desired anatomical structure comprises an intraabdominal ultrasound image (the final image displayed on the display is a merge of rendered electrodes, rendered anatomy and tumor volume for real-time display of any anatomical region); wherein the ultrasound probe and the ablation device are moveable independent of each other (electrode 701 and probe 721 are independent probes).
In regards to claim 23 and 36, Cosman/Lee combination further discloses both the first indication and the second indication are different from a power-level indicator (window 743 discloses digital displays of power level on the electrode or electrodes as shown in Fig. 7 which is different from the rendered electrodes as represented as 741 in Fig. 7; note that the digital display for power level graph is within a rectangular profile or object, thus meeting claim 23).
In regards to claim 37, Cosman/Lee combination further discloses wherein the first indication comprises a first ready indicator (the workstation 731 provides a display window 742 along the display of the workstation 731 which reads on ‘the first indication’ as claim 37/21 does not specifically provide any specific recitation in regards to the first ready indicator; note that the first ready indicator reads on ‘On’ function along the screen when the plurality of stylets are fully deployed from the trocar tip), wherein the second indication comprises a second ready indicator that is different from the first ready indicator (the workstation 731 provides a display window 742 along the display of the workstation 731 which reads on ‘the first indication’ as claim 37/21 does not specifically provide any specific recitation in regards to the first ready indicator; note that the first ready indicator reads on ‘On’ function along the screen when the plurality of stylets are retracted from the trocar tip), and wherein the controller is configured to provide a temperature value in association with the first ready indicator, and to provide a coagulation power level in association with the second ready indicator (on the same display window 742, the temperature of each of the electrodes and the power level are shown in a graphical form, col. 8, ln. 26-65).
Claims 24, 30 and 38-40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cosman and Lee as applied to claim 21 above, and further in view of Edwards et al (hereinafter ‘Edwards’, U.S. Pat No. 6,258,087).
In regard to claims 24, and 38-40, Cosman/Lee combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, Cosman/Lee combination does not disclose a foot-operated input device such that the system is configured to start delivery of the ablation energy in response to an actuation of a foot pedal of the foot-operated input device and start delivery of the coagulation energy in response to an actuation of a foot pedal of the foot-operated input device.
Edwards teaches a foot pedal that allows the practitioner to send a radiofrequency radiation through a plurality of stylets in order to ablate or coagulate the tissue mass of the patient (col. 39, ln. 58-62: "when the physician is ready to apply energy to the targeted tissue region, the physician presses the foot pedal”; col. 11, ln. 1-19). Edwards further teaches terminating the radiofrequency radiation by pressing the foot pedal as needed (col. 41, ln. 40-43). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Cosman/Lee combination and incorporate a manual foot pedal for activating and terminating RF energy delivery to the plurality of stylets as taught by Edwards. Doing so would allow hands-free activation and deactivation of energy delivery to target tissue.
In regards to claim 30, Cosman/Lee combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, Cosman/Lee combination does not disclose the controller configured to determine a respective temperature associated with each of the stylets of the ablation device.
Edwards teaches regulating RF energy to a plurality of electrodes so as to achieve a target tissue temperature at each electrode (temperature information 466 in exemplary Fig. 73; col. 24, ln. 22-24 & col. 36, ln. 47). Edwards further teaches calculating an average temperature from the respective temperatures (col. 24, ln. 22-24: “the controller thus receives as input a temperature that is approximately the average of the temperature sensed by the sensors 80”). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of Cosman/Lee combination and adjust the delivery of RF energy based upon the temperature of the stylets as taught by Edwards, as doing so involves routine in the art and a predictable result of temperature feedback energy control would ensue.
Claim 31 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cosman and Lee as applied to claim 21, and further in view of Lee (U.S. Pat. No. 6,840,935).
In regards to claim 31, Cosman/Lee combination discloses the invention substantially as claimed in claim 21 and discussed above.
However, Cosman/Lee combination fail to disclose a second imaging device comprising a laparoscopic camera.
Lee teaches an ablation system comprising a first imaging device comprising an ultrasound probe having a first image output (ultrasound probe 24 is inserted into a patient as shown in Fig. 1; col. 6, ln. 9-11); a second imaging device comprising a laparoscopic camera (laparoscope 12 is inserted into the patient as shown in Fig. 1). Cosman already discloses the use of additional imaging modalities to better display the anatomical region of interest including CT, MRI, SPECT, or other scanning means (col. 8, ln. 37-43), therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of Cosman/Lee combination and provide an additional imaging device such as laparoscopic camera as taught by Lee, thereby arriving at the claimed invention. The use of multiple imaging modalities for 3-D graphic rendering of the anatomical region of interest provides a more accurate image for better viewing during ablation procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 5/28/2026
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