DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/29/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 6/29/2026.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Previously, claims 1 and 14 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kustra. Now, based on amendments to the claim language, claims 1 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kustra in view of Choi and are rejected under 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 9-19, and 22-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claims 1 and 14, there is not support for the claim language “wherein the characterizing information includes stored empirically-sensed temperature information for an ultrasonic gel proxy medium”. While paragraph [0019] of applicant’s specification states “that stored empirically-sensed temperature information can correspond, at least in part, to thermal results of the particular thermal ablation apparatus in a proxy medium”, this means that the thermal results are of the thermal ablation apparatus, not an ultrasonic gel proxy medium. Additionally, paragraph [0049] of applicant’s specification states that “the temperatures achieved within the gel 302 by the foregoing are sensed by the various thermocouples and collected, for example, by the aforementioned data acquisition circuit 107.” Once again, the temperatures of the gel are not being sensed, only the temperature of “the foregoing”, which is cryotherapy needle/probe 307 is sensed. Thus, there is no support for the claim language “wherein the characterizing information includes stored empirically-sensed temperature information for an ultrasonic gel proxy medium” because the specification does not disclose sensing the temperature of an ultrasonic gel or of a proxy medium.
Regarding dependent claims 2-6, 9-13, 15-19, and 22-26, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, 6, 9-15, 17, 19, and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Kustra et al., US 20210137606, herein referred to as “Kustra”, in view of Choi, KR 20250037045, herein referred to as “Choi”.
Regarding claim 1, Kustra discloses a method to facilitate administering thermal ablation to a patient’s target volume (Figure 2), the method comprising: by a control circuit (Figure 1: planning unit 5 and evaluation unit 6): accessing characterizing information for a particular thermal ablation apparatus (Figure 2: step 201 and [0067]: “In step 201, the current position of the thermal ablation device 1 is determined.” And [0052]); and before and/or after administering the thermal ablation to the patient’s target volume ([0067]: “Then, information about the determined optimum thermal dose distribution and about the cost assigned to the computed path are presented to the interventionist in step 206. The information about the determined optimum thermal dose distribution may comprise a visualization of the dose distribution and/or the cost assigned to the dose distribution. On the basis of the presented information, the interventionist may decide whether to perform the ablation from the current position of the thermal ablation device 1 or to steer the thermal ablation device 1 to the planned position.”), generating a temperature volume histogram as a function of the characterizing information for the particular thermal ablation apparatus ([0054]). Kustra does not explicitly disclose a method wherein the characterizing information includes stored empirically-sensed temperature information for an ultrasonic gel proxy medium.
However, Choi teaches a method (Figure 4 and Abstract) wherein the characterizing information includes stored empirically-sensed temperature information for an ultrasonic gel proxy medium (Page 5, first paragraph).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Kustra so that the characterizing information includes stored empirically-sensed temperature information for an ultrasonic gel proxy medium as taught by Choi so that the operation of the heating device can be controlled to maintain a temperature in a desired range (Choi, page 5, first paragraph).
Regarding claim 2, Kustra in view of Choi discloses the method of claim 1, and Kustra further discloses a method wherein accessing the characterizing information for the particular thermal ablation apparatus comprises accessing characterizing information for a particular thermal ablation needle ([0034]: “the thermal ablation device 1 may be configured as a needle-like device which may be inserted into the patient body 2 by an interventionist within the scope of a minimally invasive intervention.”).
Regarding claim 4, Kustra in view of Choi discloses the method of claim 1, and Kustra further discloses a method wherein the thermal ablation comprises cryotherapy ([0033]: “In this embodiment, the thermal ablation device 1 may be configured as a cryoprobe for delivering a cooling fluid to the target tissue.”).
Regarding claim 6, Kustra in view of Choi discloses the method of claim 1, and Kustra further discloses a method further comprising: by the control circuit: presenting, via a user interface, a graphic depiction of the temperature volume histogram (Figure 1: display 4 and [0054]).
Regarding claim 9, Kustra in view of Choi discloses the method of claim 1, and Kustra further discloses a method wherein the characterizing information for the particular thermal ablation apparatus includes at least one of: a thermal fluid that effects a desired thermal ablation result ([0033]); a flow rate of the thermal fluid; and at least one physical dimension of the particular thermal ablation apparatus ([0034]).
Regarding claim 10, Kustra in view of Choi discloses the method of claim 1, and Kustra further discloses a method wherein generating the temperature volume histogram further comprises generating the temperature volume histogram as a further function of modeling content ([0054]).
Regarding claim 11, Kustra in view of Choi discloses the method of claim 1, and Kustra further discloses a method wherein the modeling content represents at least one of patient thermal states, patient blood flow, and patient anatomy ([0042]: “On the basis of anatomy as shown in the patient image, an optimization procedure may be performed in order to find the ablation position(s).” and [[0041]).
Regarding claim 12, Kustra in view of Choi discloses the method of claim 1, and Kustra further discloses a method wherein generating the temperature volume histogram further comprises generating the temperature volume histogram as a further function of information regarding a patient’s geometry ([0054] and [0043]).
Regarding claim 13, Kustra in view of Choi discloses the method of claim 12, and Kustra further discloses a method wherein the information regarding the patient's geometry comprises at least one of a specified patient volume of interest, a particular thermal ablation needle orientation/location/depth with respect to patient geometry, and/or a particular plan or pattern of administering and using treatment accoutrements ([0040] and [0044]).
Regarding claim 14, Kustra discloses an apparatus to facilitate administering thermal ablation to a patient’s target volume (Figure 1), the apparatus comprising: a memory having stored therein characterizing information for a particular thermal ablation apparatus (Figure 1: planning unit 5 and evaluation unit 6); a control circuit (Figure 1: planning unit 5 and evaluation unit 6) operably coupled to the memory and configured to: access the characterizing information for the particular thermal ablation apparatus ([0052]); and before and/or after administering the thermal ablation to the patient’s target volume ([0067]: “Then, information about the determined optimum thermal dose distribution and about the cost assigned to the computed path are presented to the interventionist in step 206. The information about the determined optimum thermal dose distribution may comprise a visualization of the dose distribution and/or the cost assigned to the dose distribution. On the basis of the presented information, the interventionist may decide whether to perform the ablation from the current position of the thermal ablation device 1 or to steer the thermal ablation device 1 to the planned position.”), generate a temperature volume histogram as a function of the characterizing information for the particular thermal ablation apparatus ([0054]). Kustra does not explicitly disclose a system wherein the characterizing information includes stored empirically-sensed temperature information for an ultrasonic gel proxy medium.
However, Choi teaches a system (Figure 4) wherein the characterizing information includes stored empirically-sensed temperature information for an ultrasonic gel proxy medium (Page 5, first paragraph).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Kustra so that the characterizing information includes stored empirically-sensed temperature information for an ultrasonic gel proxy medium as taught by Choi so that the operation of the heating device can be controlled to maintain a temperature in a desired range (Choi, page 5, first paragraph).
Regarding claim 15, Kustra in view of Choi discloses the apparatus of claim 14, and Kustra further discloses a system wherein the control circuit is(Figure 1: planning unit 5 and evaluation unit 6) configured to access the characterizing information for the particular thermal ablation apparatus by accessing characterizing information for a particular thermal ablation needle ([0034]: “the thermal ablation device 1 may be configured as a needle-like device which may be inserted into the patient body 2 by an interventionist within the scope of a minimally invasive intervention.”).
Regarding claim 17, Kustra in view of Choi discloses the apparatus of claim 14, and Kustra further discloses a system wherein the thermal ablation comprises cryotherapy ([0033]: “In this embodiment, the thermal ablation device 1 may be configured as a cryoprobe for delivering a cooling fluid to the target tissue.”).
Regarding claim 19, Kustra in view of Choi discloses the apparatus of claim 14, and Kustra further discloses a system further comprising: a user interface that is operably coupled to the control circuit (Figure 1: display 4); and wherein the control circuit is further configured to present, via the user interface, a graphic depiction of the temperature volume histogram (Figure 1: display 4 and [0054]).
Regarding claim 22, Kustra in view of Choi discloses the apparatus of claim 14, and Kustra further discloses a system wherein the characterizing information for the particular thermal ablation apparatus includes at least one of: a thermal fluid that effects a desired thermal ablation result ([0033]); a flow rate of the thermal fluid; and at least one physical dimension of the particular thermal ablation apparatus ([0034]).
Regarding claim 23, Kustra in view of Choi discloses the apparatus of claim 14, and Kustra further discloses a system wherein the control circuit is further configured to generate the temperature volume histogram by generating the temperature volume histogram as a further function of modeling content ([0054]).
Regarding claim 24, Kustra in view of Choi discloses the apparatus of claim 14, and Kustra further discloses a system wherein the modeling content represents at least one of patient thermal states, patient blood flow, and patient anatomy ([0042]: “On the basis of anatomy as shown in the patient image, an optimization procedure may be performed in order to find the ablation position(s).” and [[0041]).
Regarding claim 25, Kustra in view of Choi discloses the apparatus of claim 14, and Kustra further discloses a system wherein the control circuit is further configured to generate the temperature volume histogram by generating the temperature volume histogram as a further function of information regarding a patient’s geometry ([0054] and [0043]).
Regarding claim 26, Kustra in view of Choi discloses the apparatus of claim 25, and Kustra further discloses a system wherein the information regarding the patient's geometry comprises at least one of a specified patient volume of interest, a particular thermal ablation needle orientation/location/depth with respect to patient geometry, and/or a particular plan or pattern of administering and using treatment accoutrements ([0040] and [0044]).
Claims 3, 5, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kustra in view of Choi, further in view of Baissalov et al., "A semi-empirical treatment planning model for optimization of multiprobe cryosurgery", 2000, Engineering in Medicine and Biology Society, Vol. 1, pages 714-717, herein referred to as “Baissalov”.
Regarding claim 3, Kustra in view of Choi discloses the method of claim 2, but does not explicitly disclose a method wherein accessing the characterizing information for the particular thermal ablation needle comprises accessing characterizing information for the particular thermal ablation needle from amongst a plurality of different candidate thermal ablation needles.
However, Baissalov teaches a method wherein accessing the characterizing information for the particular thermal ablation needle comprises accessing characterizing information for the particular thermal ablation needle from amongst a plurality of different candidate thermal ablation needles (Page 714, Col. 2, lines 14-20).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Kustra so that it includes accessing characterizing information for the particular thermal ablation needle from amongst a plurality of different candidate thermal ablation needles as taught by Baissalov so that a variety of dimensions for a treatment device can be used (Baissalov Page 714, Col. 2, lines 11-20).
Regarding claim 5, Kustra in view of Choi discloses the method of claim 1, but does not explicitly disclose a method further comprising: by the control circuit: determining a zone of lethality as a function of the temperature volume histogram.
However, Baissalov teaches a method further comprising: by the control circuit: determining a zone of lethality as a function of the temperature volume histogram (Figures 2-4).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Kustra so that it includes determining a zone of lethality as a function of the temperature volume histogram as taught by Baissalov to avoid treatment complications by having 100% of a tumor enclosed by a critical isotherm and all normal healthy tissue left unfrozen (Baissalov Page 716, Second paragraph under ‘IV. Discussion’ ).
Regarding claim 16, Kustra in view of Choi discloses the apparatus of claim 15, but does not explicitly disclose an apparatus wherein accessing the characterizing information for the particular thermal ablation needle comprises accessing characterizing information for the particular thermal ablation needle from amongst a plurality of different candidate thermal ablation needles.
However, Baissalov teaches an apparatus wherein accessing the characterizing information for the particular thermal ablation needle comprises accessing characterizing information for the particular thermal ablation needle from amongst a plurality of different candidate thermal ablation needles (Page 714, Col. 2, lines 14-20).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Kustra so that it includes accessing characterizing information for the particular thermal ablation needle from amongst a plurality of different candidate thermal ablation needles as taught by Baissalov so that a variety of dimensions for a treatment device can be used (Baissalov Page 714, Col. 2, lines 11-20).
Regarding claim 18, Kustra in view of Choi discloses the apparatus of claim 14, but does not explicitly disclose an apparatus wherein the control circuit is further configured to determine a zone of lethality as a function of the temperature volume histogram.
However, Baissalov teaches an apparatus wherein the control circuit is further configured to determine a zone of lethality as a function of the temperature volume histogram (Figures 2-4).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Kustra so that the control circuit is further configured to determine a zone of lethality as a function of the temperature volume histogram as taught by Baissalov to avoid treatment complications by having 100% of a tumor enclosed by a critical isotherm and all normal healthy tissue left unfrozen (Baissalov Page 716, Second paragraph under ‘IV. Discussion’ ).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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