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 .
Claim Objections
Claims 2-3, 6, 15 & 19 objected to because of the following informalities:
Claim 2, line 2: “the portions” should read --the portions of the needle tract--,
Claim 3, line 4: “the portions” should read --the portions of the needle tract--,
Claim 6, line 3: “the first portions” should read --the first portions of the needle tract--,
Claim 6, line 5: “the second portions” should read --the second portions of the needle tract--,
Claim 15, line 2 (second occurrence): “the portions” should read --the portions of the needle tract--,
Claim 19, line 3: “the first portions” should read --the first portions of the needle tract--,
Claim 19, line 5: “the second portions” should read --the second portions of the needle tract--,
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the patient” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, the claim recites “energy” in line 9 and it is unclear if this is the same energy or a different energy from that recited in line 7. For examination purposes, these are the same energy and the limitation will be interpreted as “the energy”.
Claims 2-7 are also rejected by virtue of their dependency on claim 1.
Regarding claim 2, the claim recites “the portions” line 1 and it is unclear if these are the same portions as the potions of the needle tract as recited in claim 1, from which claim 2 depends, or are different portions. For examination purposes, these are the same portions and the limitation will be interpreted as “the portions of the needle tract”. For other recitations, see Claim Objections for correction.
Regarding claim 6, the claim recites “the first portions” line 2 and it is unclear if these are the same first portions as the potions of the needle tract as recited in claim 3, from which claim 6 depends, or are different first portions. For examination purposes, these are the same first portions and the limitation will be interpreted as “the first portions of the needle tract”. For other recitations, see Claim Objections for correction.
Regarding claim 6, the claim recites “the second portions” line 4 and it is unclear if these are the same second portions as the potions of the needle tract as recited in claim 3, from which claim 6 depends, or are different second portions. For examination purposes, these are the same second portions and the limitation will be interpreted as “the second portions of the needle tract”. For other recitations, see Claim Objections for correction.
Regarding claim 7, the claim recites “energy” in line 5 and it is unclear if this is the same energy or a different energy from that recited claim 1, from which claim 7 depends. For examination purposes, these are the same energy and the limitation will be interpreted as “the energy”.
Regarding claim 8, the claim recites “energy” in line 11 and it is unclear if this is the same energy or a different energy from that recited in line 8. For examination purposes, these are the same energy and the limitation will be interpreted as “the energy”.
Claims 9-13 are also rejected by virtue of their dependency on claim 8.
Regarding claim 9, the claim recites “energy” in line 2 and it is unclear if this is the same energy or a different energy from that recited claim 8, from which claim 9 depends. For examination purposes, these are the same energy and the limitation will be interpreted as “the energy”.
Regarding claim 10, the claim recites “energy” in line 5 and it is unclear if this is the same energy or a different energy from that recited claim 8, from which claim 10 depends. For examination purposes, these are the same energy and the limitation will be interpreted as “the energy”.
Claims 11-13 are also rejected by virtue of their dependency on claim 10.
Regarding claim 14, the claim recites “energy” in line 8 and it is unclear if this is the same energy or a different energy from that recited in line 5. For examination purposes, these are the same energy and the limitation will be interpreted as “the energy”.
Claims 15-20 are also rejected by virtue of their dependency on claim 8.
Regarding claim 15, the claim recites “the portions” line 2 (first occurrence) and it is unclear if these are the same portions as the potions of the needle tract as recited in claim 14, from which claim 15 depends, or are different portions. For examination purposes, these are the same portions and the limitation will be interpreted as “the portions of the needle tract”. For other recitations, see Claim Objections for correction.
Regarding claim 16, the claim recites “the portions” line 5 and it is unclear if these are the same portions as the potions of the needle tract as recited in claim 14, from which claim 16 depends, or are different portions. For examination purposes, these are the same portions and the limitation will be interpreted as “the portions of the needle tract”.
Claims 17-19 are also rejected by virtue of their dependency on claim 16.
Regarding claim 19, the claim recites “the first portions” line 2 and it is unclear if these are the same first portions as the potions of the needle tract as recited in claim 16, from which claim 19 depends, or are different first portions. For examination purposes, these are the same first portions and the limitation will be interpreted as “the first portions of the needle tract”. For other recitations, see Claim Objections for correction.
Regarding claim 19, the claim recites “the second portions” line 4 and it is unclear if these are the same second portions as the potions of the needle tract as recited in claim 16, from which claim 19 depends, or are different second portions. For examination purposes, these are the same second portions and the limitation will be interpreted as “the second portions of the needle tract”. For other recitations, see Claim Objections for correction.
Regarding claim 20, the claim recites “energy” in line 6 and it is unclear if this is the same energy or a different energy from that recited claim 14, from which claim 20 depends. For examination purposes, these are the same energy and the limitation will be interpreted as “the energy”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 & 14-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jester et al. (U.S. Pub. No. 20250107845, earliest effective filing date), herein referred to as “Jester”.
Regarding claim 1, Jester teaches a system (Abstract: A microwave ablation apparatus; [0159]: Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described), comprising:
an ablation probe (ablation probe 110) including an antenna ([0068]: an antenna in an ablation probe 110); and
a controller (computing device 500) in operable communication with the ablation probe and a display (display 516; [0085]: The base unit 102 may include one or more computing devices 500; see Figs. 1 & 5), wherein the controller is operable to:
display, on the display, an image of the ablation probe in a needle tract in the patient (see Fig. 9; [0110]: the needle display 906 displays a size of the ablation zone that will be created using the settings of the needle user interface 900);
control the antenna to emit energy in the needle tract ([0114]: Referring now to FIG. 11, an example energy user interface 1100 is illustrated. The energy user interface 1100 may provide information regarding energy delivered during an ablation treatment … The energy user interface 1100 may also include a power setting 1108 that may also have been selected or controlled using the needle user interface 900); and
display, on the image, portions of the needle tract expected to have failed to receive energy from the antenna ([0116]: The ablation cycle user interface 1300 may include a needle display 1302 that displays a graphical illustration of the needle and the current temperature at one or more positions on the needle or where temperature sensors have been positioned; wherein in Fig. 13, the segments T2 and T3 at 39C and 38C, respectively, are seen as expecting to have failed to receive energy from the antenna as they are below the T1 temperature of 49C and only a degree or two higher than basal body temperature).
Regarding claim 2, Jester teaches wherein to display the portions, the controller is operable to highlight the portions on the image ([0116]: The needle display 1302 may also display a halo or other visual indicator that indicates that the antenna in the needle is energized and the needle is currently heating the target tissue).
Regarding claim 3, Jester teaches wherein the ablation probe is operable in:
an ablation mode in which the antenna generates an ablation zone (Fig. 8, “Ablate”; [0106]: an ablation start selector 816. The ablation start selector 816 may initiate an ablation cycle using the current parameters being displayed in the needle user interface 800); and
a cauterization mode in which the antenna emits cauterization energy (Fig. 8, “Track Ablate”; [0108]: a track ablate selector 818. The track ablate selector 818 may allow a user to perform a track ablate procedure. The track ablate procedure may deliver a power signal to the needle to cause burning, cauterization, or other heating to occur proximate the needle in the tissue),
wherein to display the portions, the controller is operable to display first portions of the needle tract not expected to have been encompassed by the ablation zone and thereby failed to receive cauterization energy from the antenna ([0116]: The ablation cycle user interface 1300 may include a needle display 1302 that displays a graphical illustration of the needle and the current temperature at one or more positions on the needle or where temperature sensors have been positioned; wherein in Fig. 13, the segments T2 and T3 at 39C and 38C, respectively, are seen as expecting to have failed to receive energy from the antenna as they are below the T1 temperature of 49C and only a degree or two higher than basal body temperature).
Regarding claim 14, Jester teaches a non-transitory computer readable medium storing instructions that, when executed by a processor, causes the processor to ([0083]: The base unit 102 may include one or more computing devices that can operate to execute the instructions provided in the operating platform 402. The computing devices may also include memory on which the operating platform 402 may be stored. The memory may also record other information and measurements regarding operation of the ablation apparatus 100. The one or more computing devices in the base unit 102 may have the structure and/or functionality described below and shown in FIG. 5. In other examples, the computing devices may be configured as other devices, hardware or the like, such as by application-specific circuits; [0159]: Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described):
display, on a display (display 516), an image of an ablation probe (ablation probe 110) in a needle tract in a patient (see Fig. 9; [0110]: the needle display 906 displays a size of the ablation zone that will be created using the settings of the needle user interface 900);
control an antenna of the ablation probe to emit energy in the needle tract ([0114]: Referring now to FIG. 11, an example energy user interface 1100 is illustrated. The energy user interface 1100 may provide information regarding energy delivered during an ablation treatment … The energy user interface 1100 may also include a power setting 1108 that may also have been selected or controlled using the needle user interface 900); and
display, on the image, portions of the needle tract expected to have failed to receive energy from the antenna ([0116]: The ablation cycle user interface 1300 may include a needle display 1302 that displays a graphical illustration of the needle and the current temperature at one or more positions on the needle or where temperature sensors have been positioned; wherein in Fig. 13, the segments T2 and T3 at 39C and 38C, respectively, are seen as expecting to have failed to receive energy from the antenna as they are below the T1 temperature of 49C and only a degree or two higher than basal body temperature).
Regarding claim 15, Jester teaches wherein to display the portions, the processor is operable to highlight the portions on the image ([0116]: The needle display 1302 may also display a halo or other visual indicator that indicates that the antenna in the needle is energized and the needle is currently heating the target tissue).
Regarding claim 16, Jester teaches wherein the ablation probe is operable in:
an ablation mode in which the antenna generates an ablation zone (Fig. 8, “Ablate”; [0106]: an ablation start selector 816. The ablation start selector 816 may initiate an ablation cycle using the current parameters being displayed in the needle user interface 800); and
a cauterization mode in which the antenna emits cauterization energy (Fig. 8, “Track Ablate”; [0108]: a track ablate selector 818. The track ablate selector 818 may allow a user to perform a track ablate procedure. The track ablate procedure may deliver a power signal to the needle to cause burning, cauterization, or other heating to occur proximate the needle in the tissue),
wherein to display the portions, the processor is operable to display first portions of the needle tract not expected to have been encompassed by the ablation zone and thereby failed to receive cauterization energy from the antenna ([0116]: The ablation cycle user interface 1300 may include a needle display 1302 that displays a graphical illustration of the needle and the current temperature at one or more positions on the needle or where temperature sensors have been positioned; wherein in Fig. 13, the segments T2 and T3 at 39C and 38C, respectively, are seen as expecting to have failed to receive energy from the antenna as they are below the T1 temperature of 49C and only a degree or two higher than basal body temperature).
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 4-5 & 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Jester as applied to claims 1 & 14, above, and further in view of Brannan et al. (U.S. Pub. No. 20230020183), herein referred to as “Brannan”.
Regarding claim 4, Jester fails to disclose wherein the controller is further operable to display, on the image, second portions of the needle tract not expected to have been encompassed by the ablation zone, but expected to have received cauterization energy from the antenna.
However, Brannan discloses wherein the controller (computing device 100) is further operable to display (user interface 800), on the image ([0068]: a user interface 800 displayable by the system during a tract ablation procedure that assist a clinician in visualizing the actual rate of withdrawal relative to a recommended/preconfigured rate of withdrawal), second portions of the needle tract (trajectory rings 815) not expected to have been encompassed by the ablation zone, but expected to have received cauterization energy from the antenna ([0039]: To mitigate risk of a bleeding needle tract, users will coagulate the tract using the energized ablation needle. Currently, to do this successfully (minimize over-ablation of healthy tissue along the tract while ensuring full coagulation of the tract); [0068]: The guidance marker 805 is initially oriented over the needle tip of the graphical representation of the ablation probe 801; see rest of [0068] discussing the process such that the trajectory rings are seen as the energy application sites). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Jester to include the controller of Brannan for the purpose of providing the clinician with insight into whether the clinician is retracting the ablation probe at the correct rate and to mitigate the risk of a bleeding needle track, coagulating the tract using the energized ablation needle to minimize over-ablation of healthy tissue along the tract while ensuring full coagulation of the tract (Brannan: [0038], [0039]).
Regarding claim 5, Jester in view of Brannan discloses wherein the controller is operable to:
display the first portions of the needle tract in a first manner (Brannan: ablation zone 515, Fig. 5); and
display the second portions of the needle tract in a second manner different than the first manner (trajectory rings 815, Fig. 8).
Regarding claim 17, Jester fails to disclose further storing instructions that, when executed by the processor, causes the processor to display, on the image, second portions of the needle tract not expected to have been encompassed by the ablation zone, but expected to have received cauterization energy from the antenna.
However, Brannan discloses further storing instructions that, when executed by the processor (computing device 100), causes the processor to display (user 800), on the image ([0068]: a user interface 800 displayable by the system during a tract ablation procedure that assist a clinician in visualizing the actual rate of withdrawal relative to a recommended/preconfigured rate of withdrawal), second portions of the needle tract (trajectory rings 815) not expected to have been encompassed by the ablation zone, but expected to have received cauterization energy from the antenna ([0039]: To mitigate risk of a bleeding needle tract, users will coagulate the tract using the energized ablation needle. Currently, to do this successfully (minimize over-ablation of healthy tissue along the tract while ensuring full coagulation of the tract); [0068]: The guidance marker 805 is initially oriented over the needle tip of the graphical representation of the ablation probe 801; see rest of [0068] discussing the process such that the trajectory rings are seen as the energy application sites). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the processor of Jester to include the processor of Brannan for the purpose of providing the clinician with insight into whether the clinician is retracting the ablation probe at the correct rate and to mitigate the risk of a bleeding needle track, coagulating the tract using the energized ablation needle to minimize over-ablation of healthy tissue along the tract while ensuring full coagulation of the tract (Brannan: [0038], [0039]).
Regarding claim 18, Jester in view of Brannan discloses further storing instructions that, when executed by the processor, causes the processor to:
display the first portions of the needle tract in a first manner (Brannan: ablation zone 515, Fig. 5); and
display the second portions of the needle tract in a second manner different than the first manner (trajectory rings 815, Fig. 8).
Claims 6 & 19 are rejected under 35 U.S.C. 103 as being unpatentable over Jester as applied to claims 1 & 14, above, and further in view of Green et al. (U.S. Pub. No. 20130197357), herein referred to as “Green”.
Regarding claim 6, Jester in view of Brannan fail to disclose wherein:
to display the first portions in the first manner, the controller is operable to display the first portions in a first color; and
to display the second portions in the second manner, the controller is operable to display the second portions in a second color different than the first color.
However, Greene disclose wherein:
to display the first portions in the first manner, the controller is operable to display the first portions in a first color; and to display the second portions in the second manner, the controller is operable to display the second portions in a second color different than the first color ([0112] In some embodiments, each medical device and its associated image guidance cues (e.g. trajectory rings, intersection square, text, etc.) can be associated with a color. In some embodiments, each medical device with its associated image guidance cues is associated with a different color. For example, the first medical device 1212 and image guidance cues related to it can be drawn in pink, a second medical device 1214 and its associated image guidance cues can be drawn in green, and a third medical device 1216 and its associated image guidance cues can be drawn in blue; wherein in this combination, the portions are still that of Jester in view of Brannan, but the depiction of various features in different colors is taught by Green). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Jester in view of Brannan to include the controller of Green for the purpose of enabling the medical devices and associated image guidance cues to be distinguished (Green: [0112]).
Regarding claim 19, Jester in view of Brannan fail to disclose wherein:
to display the first portions in the first manner, the processor is operable to display the first portions in a first color; and
to display the second portions in the second manner, the processor is operable to display the second portions in a second color different than the first color.
However, Green discloses wherein:
to display the first portions in the first manner, the processor is operable to display the first portions in a first color; and to display the second portions in the second manner, the processor is operable to display the second portions in a second color different than the first color ([0112]: In some embodiments, each medical device and its associated image guidance cues (e.g. trajectory rings, intersection square, text, etc.) can be associated with a color. In some embodiments, each medical device with its associated image guidance cues is associated with a different color. For example, the first medical device 1212 and image guidance cues related to it can be drawn in pink, a second medical device 1214 and its associated image guidance cues can be drawn in green, and a third medical device 1216 and its associated image guidance cues can be drawn in blue; wherein in this combination, the portions are still that of Jester in view of Brannan, but the depiction of various features in different colors is taught by Green). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the processor of Jester in view of Brannan to include the processor of Green for the purpose of enabling the medical devices and associated image guidance cues to be distinguished (Green: [0112]).
Allowable Subject Matter
Claims 7 & 20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 8-13 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571) 272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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