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 .
Response to Amendment
Acknowledgment is made to the amendment received 3/30/2026.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Response to Arguments
Applicant's arguments filed 3/30/2026 have been fully considered but they are not persuasive. Regarding claims 1 and 14, applicant argues that Kustra does not disclose the claim language “before and/or after administering the thermal ablation to the patient's target volume, generating a temperature volume histogram as a function of the characterizing information for the particular thermal ablation apparatus” because the device of Kustra is placed in the patient before the histogram is generated. However, the claim language does not require that the histogram be generated before and/or after the device is placed in a patient. Rather, the claim language requires that the histogram is generated before and/or after administering the thermal ablation to the patient's target volume. Administering thermal ablation is a different step in the process than inserting the device in the patient. As paragraph [0067] of Kustra describes, the histogram is generated before ablation occurs to determine whether the position of the device is optimal for the procedure or whether it should be moved. Thus, Kustra does disclose the amended claim language. Therefore, applicant’s arguments have been fully considered but they are not persuasive and the previous rejections of claims 1 and 14 stand.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4, 6-7, 9-15, 17, 19-20, and 22-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kustra et al., US 20210137606, herein referred to as “Kustra”.
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]).
Regarding claim 2, Kustra discloses the method of claim 1, 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 discloses the method of claim 1, 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 discloses the method of claim 1, 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 7, Kustra discloses the method of claim 1, wherein generating the temperature volume histogram further comprises generating the temperature volume histogram as a further function of stored empirically-sensed temperature information ([0052]-[0053]).
Regarding claim 9, Kustra discloses the method of claim 1, 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 discloses the method of claim 1, 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 discloses the method of claim 1, 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 discloses the method of claim 1, 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 discloses the method of claim 12, 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]).
Regarding claim 15, Kustra discloses the apparatus of claim 14, 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 discloses the apparatus of claim 14, 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 discloses the apparatus of claim 14, 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 20, Kustra discloses the apparatus of claim 14, wherein the control circuit is further configured to generate the temperature volume histogram as a further function of stored empirically-sensed temperature information ([0052]-[0053]).
Regarding claim 22, Kustra discloses the apparatus of claim 14, 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 discloses the apparatus of claim 14, 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 discloses the apparatus of claim 14, 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 discloses the apparatus of claim 14, 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 discloses the apparatus of claim 25, 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]).
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 3, 5, 8, 16, 18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kustra 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 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 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 8, Kustra discloses the method of claim 1, but does not explicitly disclose a method wherein the stored empirically-sensed temperature information corresponds to thermal results of the particular thermal ablation apparatus in a proxy medium.
However, Baissalov teaches a method wherein the stored empirically-sensed temperature information corresponds to thermal results of the particular thermal ablation apparatus in a proxy medium (Page 715, Col 1, first full 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 stored empirically-sensed temperature information corresponds to thermal results of the particular thermal ablation apparatus in a proxy medium as taught by Baissalov to optimize the shape of predicted isotherms (Baissalov Page 715, Col. 2) 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 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 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’ ).
Regarding claim 21, Kustra discloses the apparatus of claim 20, but does not explicitly disclose an apparatus wherein the stored empirically-sensed temperature information corresponds to thermal results of the particular thermal ablation apparatus in a proxy medium.
However, Baissalov teaches an apparatus wherein the stored empirically-sensed temperature information corresponds to thermal results of the particular thermal ablation apparatus in a proxy medium (Page 715, Col 1, first full 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 apparatus disclosed by Kustra so that the stored empirically-sensed temperature information corresponds to thermal results of the particular thermal ablation apparatus in a proxy medium as taught by Baissalov to optimize the shape of predicted isotherms (Baissalov Page 715, Col. 2) 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
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.
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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/NORA W RHODES/Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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