DETAILED ACTION
Applicant's preliminary amendments and remarks, filed 12/30/24, are fully acknowledged by the Examiner. Currently, claims 76-88 are pending with claims 1-75 and 89-90 canceled, and claims 78-82, 84-86 amended. The following is a complete response to the 12/30/24 communication.
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 Objections
Claim 81 is objected to because of the following informalities: a electroporation should be "an electroporation". Appropriate correction is required.
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.
Claim(s) 76-80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque (US 2011/0137156) in view of Bliweis (US 2009/0292279).
Regarding claim 76, Razzaque teaches an ablation system comprising:
an ablation needle configured to be inserted into the tissue of a patient and adjust the temperature of the patient tissue via an ablation process (needle as in par. [0181] to ablate tissue);
an imaging system configured to generate a plurality of two-dimensional images of the patient tissue (image data as in par. [0179]);
a display (display 2420 as in Fig. 24); and
a processing system configured to:
receive a plurality of two-dimensional images of the patient tissue (par. [0181] 2d slices);
generate volumetric image data of the patient's tissue based on the received plurality of two- dimensional images (2d slices to see 3d volumetric data as in par. [0181] and Fig. 36);
segment the ablation needle within the volumetric image data of the patient's tissue (segmenting the needle as in par. [0177]);
Razzaque is not explicit regarding during an ablation process, predict a temperature profile of the patient's tissue proximate the ablation needle;
identify one or more volumetric isotherm boundaries based on the predicted temperature profile; and
display a cross-sectional image of the volumetric image data on the display (display image 2460 as in Fig. 26, 24, 36D), the cross-sectional image showing a plane that includes an axis defined by the ablation needle (par. [0177] plane of orientation axis through the needle) and including the needle and one or more of the identified one or more volumetric isotherm boundaries.However, Bliweis teaches calculating values and displaying from thermal information in the form of isotherm volumes (par. [0109]).It would have been obvious to one of ordinary skill in the art to predict a temperature profile and display an isotherm as in Bliweis, as a way to visualize treatment.
Regarding claim 77, Razzaque teaches wherein the processing system is further configured to segment one or more lesions within the volumetric image data (segmenting lesion from volumetric image data as in par. [0058]); and wherein the cross-sectional image includes a representation of one or more segmented lesions (par. [0182]).
Regarding claim 78, Razzaque teaches wherein the system comprises a cryoablation system (par. [0107]).
Regarding claim 79, Razzaque teaches wherein the system comprises a microwave ablation system (par. [0107]).
Regarding claim 80, Razzaque teaches wherein the system comprises a radiofrequency ablation system (par. [0107]).
Claim(s) 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque in view of Bliweis, in view of Mayse (US 2016/0278845).
Regarding claim 81, Razzaque is silent wherein the system comprises an electroporation system.However, Mayse teaches catheter based electroporation as a similar energy modality as microwave or RF energy delivery (par. [0146]).It would have been obvious to one of ordinary skill in the art to modify Razzaque with the electroporation energy for ablation as in Mayse, as a known alternative ablation technique that is used by a probe to destroy tissue.
Claim(s) 82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque in view of Bliweis, in view of Bar-Tal (US 2015/0057652).
Regarding claim 82, Razzaque is silent wherein the system comprises an ultrasound ablation system.However, Bar-Tal teaches using ultrasound energy (par. [0049]).It would have been obvious to one of ordinary skill in the art to modify Razzaque with the ultrasound energy for ablation as in Bar-Tal, as a known ablation technique that is used by a probe to destroy tissue.
Claim(s) 83, 85 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque in view of Bliweis, in view of Sahay (US 2017/0209218).
Regarding claim 83, Razzaque is silent wherein the one or more volumetric isotherm boundaries includes at least an isotherm at 0, -20, or -40 degrees Celsius.However, Sahay teaches isotherms at -20 or 0 degrees Celsius (par. [0043]).It would have been obvious to one of ordinary skill in the art to modify Razzaque with the isotherms of Sahay, to have boundaries for a lethal ice zone when undergoing cryoablation.
Regarding claim 85, wherein the one or more volumetric isotherm boundaries includes at least an isotherm corresponding to the extent of a volume within which tissue death is predicted.However, Sahay teaches isotherms at -20 or 0 degrees Celsius (par. [0043]), at a lethal ice zone.It would have been obvious to one of ordinary skill in the art to modify Razzaque with the isotherms of Sahay, to have boundaries for a lethal ice zone when undergoing cryoablation.
Claim(s) 84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque in view of Bliweis, in view of Townley (US 2018/0133460).
Regarding claim 84, wherein the one or more volumetric isotherm boundaries includes at least an isotherm at 60 degrees Celsius.However, Townley teaches an isotherm at 60 degrees Celsius (par. [0051]).It would have been obvious to one of ordinary skill in the art to modify Razzaque with the isotherms of Townley, to have boundaries for an ablation region when undergoing ablation.
Claim(s) 86-88 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque in view of Bliweis, in view of Strehl (US 2012/0089008).
Regarding claim 86, Razzaque wherein the cross-sectional image showing the plane comprises a first cross-sectional image showing a first plane (planar image 2460), but is not explicit wherein the processing system is further configured to display a second cross-sectional image of the volumetric image data on the display, the second cross-sectional image showing a second plane that includes the axis defined by the ablation needle and including the needle and one or more of the identified one or more volumetric isotherm boundaries.However, Strehl teaches a cross-sectional, two-dimensional view showing a second plane through a volume in which the longitudinal axis defined by a needle lies, the second plane different from a first plane, intersecting the first plane at an angle so as to be non-coplanar with the first plane, and being coaxial with the first plane along the longitudinal axis of the virtual needle (Fig. 16 and par. [0113]; multiple planes along 161, 162 coplanar and coaxial with the first plane are imaged and displayed).
It would have been obvious to one of ordinary skill in the art to modify Razzaque with the imaging planes of Strehl, allowing for viewing in multiple planes.
Regarding claim 87, Razzaque teaches further comprising a user interface in communication with the processing system (par. [0246]), and wherein the processing system is configured to transition between the first cross-sectional image and the second cross-sectional image in response to a command received via the user interface (par. [0246]).
Regarding claim 88, Razzaque teaches wherein the processing system is configured to receive a command from the user interface to rotate the volumetric image data about the axis defined by the needle to transition between the first cross-sectional image and the second cross-sectional image (rotating the needle to rotate the image as in par. [0050]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Deinzer (US 2007/0055131), Green (US 2013/0197357) were cited in related 16/283,354.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
