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 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 (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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim(s) 1-3, 5-7, and 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brannan (US 2017/0319276 A1, Nov. 9, 2017) (hereinafter “Brannan”) in view of Munrow et al. (US 2014/0073911 A1, Mar. 13, 2014) (hereinafter “Munrow”).
Regarding claim 1: Brannan discloses a console of a medical system for treating tissue (fig. 1, computing device 100), the console comprising: a transducer interface configured to couple with an ultrasound transducer (fig. 1, ultrasound workstation 150 and ultrasound sensor 140); an ablative energy source configured to couple with an ablative instrument ([0030]-[0031]); and a video interface configured to communicate with a monitor (fig. 1, display 110); wherein the console is configured to generate an avatar of the ablative instrument and a representation of an ultrasound imaging plane associated with the ultrasound transducer, and to provide the avatar of the ablative instrument and the representation of the ultrasound imaging plane via the video interface for display by the monitor (fig. 7, [0052]-[0053]).
Brannan does not disclose that the ablative instrument has one or more stylets that are deployable.
Munrow, in the same field of endeavor, discloses a console of a medical system for treating tissue (fig. 1, system controller 12), the console comprising: a transducer interface configured to couple with an ultrasound transducer ([0054]-[0055], system controller 12 with imaging component 28); and an ablative energy source configured to couple with an ablative instrument having one or more stylets that are deployable ([0054], controller 12, treatment probe 16 with needle 56 and tines 57). Munrow further discloses that this structure is suitable for treating uterine fibroids ([0005], [0014], [0017]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide an ablative instrument with one or more deployable stylets as taught by Munrow with the console of Brannan in order to effectively treat uterine fibroids.
Further regarding claim 1: Brannan and Munrow disclose wherein the console is also configured to determine a deployment state of the one or more stylets and generate a representative ablation border or expected treatment zone via the video interface for display by the monitor (Munrow - [0015], [0032], [0089]-[0091], fig. 15A, virtual boundaries TB and SB; Brannan - fig. 7, [0052]-[0053], zones 718 and 720). Brannan further discloses wherein a size of the representative ablation border or expected treatment zone is function of a predetermined target temperature, and a predetermined target time ([0028], [0043]-[0045], [0052] - "a total ablation zone 720 showing the area which will be ablated if the ablation procedure is allowed to run to completion", [0054]) while Munrow further discloses that the treatment boundary must be sufficient to cover the entire treatment area ([0079]-[0080] - i.e. the treatment boundary must cover the area to be heated over time for treatment) and that the console (“controller”) is configured to determine a size the representative ablation border or expected treatment zone (“treatment boundary”) as a function of the deployment state and the energy delivery parameters ([0015], [0018] – “a treatment boundary which is calculated by the system controller based upon the needle structure deployment configuration (either as set by the "stops" or as calculated in real-time as the needle structure is deployed)”, [0019], [0026], [0032] – “At least one of a treatment boundary and a safety boundary are projected onto the display in response to the tine deployment.”).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to determine the treatment plan, including the console calculating the treatment boundary, as a function of a predetermined target temperature, and a predetermined target time as taught by Brannan while also considering the structure and deployment state of the instrument as taught by Munrow in order to achieve a treatment boundary sufficient to treat the entire fibroid area.
Regarding claim 2: Brannan and Munrow disclose the console of claim 1, wherein the avatar comprises a virtual representation of the one or more stylets in the deployment state (Munrow - [0082] - "FIG. 15A mixes both the virtual image which would be present on the display 14 as well as the physical presence of the treatment probe 16", where the needle and tines are shown in fig. 15A).
Regarding claim 3: Brannan and Munrow disclose the console of claim 2, wherein the representative ablation border or the expected treatment zone surrounds the virtual representation of the one or more stylets in the deployment state (Brannan - fig. 7, boundaries 718 and 720; Munrow - fig. 15A, boundaries TB and SB).
Regarding claim 5: Brannan and Munrow disclose the console of claim 1, wherein the console is configured to generate the representative ablation border or the expected treatment zone in real time during deployment of the one or more stylets (Munrow - [0032]).
Regarding claim 6: Brannan and Munrow disclose the console of claim 1, wherein the console is configured to provide (1) the representative ablation border or the expected treatment zone, and (2) the representation of the ultrasound imaging plane, via the video interface for simultaneous presentation by the monitor (Brannan - fig. 7).
Regarding claim 7: Brannan and Munrow disclose the console of claim 1, wherein the console is configured to provide (1) the representative ablation border or the expected treatment zone, and (2) the predetermined target time, via the video interface for simultaneous presentation by the monitor (Brannan - fig. 7, [0052] - "a time remaining until the ablation procedure is complete" and "duration of ablation at a specific temperature" are predetermined target times).
Regarding claim 9: Brannan and Munrow disclose the console of claim 1, wherein the console is configured to provide a timer for simultaneous display with the predetermined target time ([0052] - status messages may include "duration of ablation at a specific temperature, elapsed time of the ablation and/or a time remaining until the ablation procedure is complete").
Regarding claim 10: Brannan and Munrow disclose the console of claim 9, wherein the deployment state comprises a deployment length (Munrow - see at least figs. 3 and 15A - the deployable tines/”stylets” have a “deployment length” relative to the central shaft), and wherein the representative ablation border or the expected treatment zone has a length and a width that are both pre-determined based on a value of the deployment length of the one or more stylets, a value of the predetermined target time, and a value of the predetermined target temperature (both the displayed boundaries of Brannan and Munrow have “a length and a width” by virtue of being 2D geometric shapes; Brannan - [0028], [0043]-[0045], [0052] - "a total ablation zone 720 showing the area which will be ablated if the ablation procedure is allowed to run to completion", [0054], fig. 8; Munrow - [0015] - calculates based on the stop positions, [0018], [0019], [0026]
Regarding claim 11: Brannan and Munrow disclose the console of claim 1, wherein the console is configured to provide a first display area defined by a first display frame, and a second display area defined by a second display frame (Brannan - fig. 7, at least views 702 and 712).
Regarding claim 13: Brannan and Munrow disclose the console of claim 12, wherein the console is configured to provide another representation of the ultrasound imaging plane for display in the second display area (Brannan - fig. 7 - the display of the ultrasound plane in view 702 differs from the display in view 712).
Regarding claim 14: Brannan and Munrow disclose the console of claim 13, wherein the representation of the ultrasound image plane and the other representation of the ultrasound imaging plane shows different respective orientations of the ultrasound imaging plane (Brannan - fig. 7 - the display of the ultrasound plane in view 702 differs in perspective from the display in view 712).
Regarding claim 15: Brannan and Munrow disclose the console of claim 1 wherein the console is also configured to provide a representation of the ultrasound transducer via the video interface for display by the monitor (Brannan - fig. 7, [0052]).
Claim(s) 4 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brannan and Munrow as applied to claim 1 above, and further in view of Girotto et al. (US 2017/0135760 A1, May 18, 2017) (hereinafter “Girotto”).
Regarding claim 4: Brannan and Munrow disclose the console of claim 1 but are silent on wherein the representative ablation border or the expected treatment zone has an asymmetric configuration.
Girotto, in the same field of endeavor, discloses displaying an expected treatment zone with an asymmetric configuration (fig. 6A - projected ablation zone 330a is asymmetric about at least one axis). Girotto further teaches that the disclosed display style allows the user to ascertain with greater clarity the effects of the planned treatment ([0074]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide 3D perspective display of the projected ablation zone as taught by Girotto in order to allow the user to more easily ascertain the effects of the planned treatment.
Regarding claim 8: Brannan and Munrow disclose the console of claim 1, but are silent on wherein the representation of the ultrasound imaging plane comprises a three-dimensional representation of the ultrasound imaging plane. It is noted that a plane cannot be represented as three-dimensional, so it is assumed that Applicant intends to claim a perspective view of the plane in a three-dimensional space.
Girotto, in the same field of endeavor, discloses displaying a three-dimensional representation of the ultrasound imaging plane (figs. 6A-6D - the plane is shown in perspective in different 3D positions, [0084]-[0087]; fig. 3E, [0074]). Girotto further teaches that the disclosed display style allows the user to ascertain with greater clarity the effects of the planned treatment ([0074]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide 3D perspective display of the projected ablation zone as taught by Girotto in order to allow the user to more easily ascertain the effects of the planned treatment.
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brannan and Munrow as applied to claim 1 above, and further in view of Pelissier et al. (US 2018/0220995 A1, Aug. 9, 2018) (hereinafter “Pelissier”).
Regarding claims 16 and 18: Brannan and Munrow disclose the console of claim 1 but are silent on an ultrasound depth adjustment control for adjusting an ultrasound depth to one of a plurality of pre-determined reference depths, and wherein the pre-determined reference depths comprise two or more of: 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, or 9 cm; or an ultrasound focus adjustment control for adjusting an ultrasound focal depth to one of a plurality of pre-determined reference focal depths, and wherein the pre-determined reference focal depths comprise two or more of: 0.2 cm, 0.4 cm, 0.7 cm, 1.0 cm, 1.4 cm, 1.8 cm, 2.3 cm, 3.0 cm, 4.0 cm, 5.0 cm, 6.0 cm, or 8.0 cm.
Pelissier, in the same field of ultrasound imaging, discloses that conventional ultrasound systems provide depth and focus adjustment controls configured to adjust the depth and focus to a series of predetermined values (figs. 3A-3D show a depth scale with 11 marks corresponding to predetermined depth values of 0cm - 10cm indicated by markers 114 and 314, where 114a and 114b are shown in figs. 3A and 3B indicating a depth of 2cm while marker 314 is shown in figs. 3C and 3D as indicating a depth of 5cm, see [0036], [0039], with a control 312 for adjusting the depth and a control 330 for adjusting focus). Pelissier further teaches that such controls are conventional ([0032], [0035]) and that changing the imaging depth and focal position (depth) improves image quality based on the location of the feature of interest ([0039]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the console of Brannan and Munrow with conventional imaging controls as taught by Pelissier so that the image quality may be optimized for a particular imaging target.
Regarding claim 17: Brannan and Munrow disclose the console of claim 1 but are silent on an ultrasound frequency adjustment control for adjusting an ultrasound frequency to one of a plurality of pre-determined reference frequencies, and wherein the pre-determined reference frequencies comprise two or more of: 5 MHz, 6 MHz, 9 MHz, or 12 MHz.
Pelissier, in the same field of ultrasound imaging, discloses that conventional ultrasound systems provide controls configured to adjust an ultrasound frequency to one of a plurality of pre-determined reference frequencies (figs. 3A-3D show three predetermined frequency settings: RES, GEN, and PEN which represent high, mid, and low frequencies as described in [0033]).
Pelissier further discloses that frequency is a results-effective variable ([0033] - “resolution (‘RES’) providing the highest frequency and lowest penetration, penetration (‘PEN’) providing the lowest frequency and highest penetration, and general (‘GEN’) providing mid-range frequencies that balance resolution with penetration”). While Pelissier does not explicitly state the values of these predetermined frequency settings, conventional ultrasound frequency settings include 5 MHz, 6 MHz, 9 MHz, or 12 MHz (as evidenced by Carovac, Aladin, Fahrudin Smajlovic, and Dzelaludin Junuzovic. "Application of ultrasound in medicine." Acta Informatica Medica 19.3 (2011): 168) where a given frequency value or range is appropriate for various imaging targets (see pg. 169, column 3 - pg. 170, column 1).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the console of Brannan and Munrow with conventional imaging controls as taught by Pelissier so that the image quality may be optimized for a particular imaging target. It would further be prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to select a frequency setting of 5 MHz, 6 MHz, 9 MHz, or 12 MHz because frequency is a results-effective variable which is selected based on the desired imaging target and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brannan and Munrow as applied to claim 1 above, and further in view of Epstein et al. (US 2015/0190206 A1, Jul. 9, 2015) (hereinafter “Epstein”).
Regarding claim 19: Brannan and Munrow disclose the console of claim 1, but are silent on wherein the console is configured to provide a proximity meter via the video interface for display by the monitor, the proximity meter indicating a position of a distal end of the ablative instrument relative to the ultrasound imaging plane.
Epstein, in the same field of endeavor, discloses a console for an ablation system wherein the console is configured to provide a proximity meter via the video interface for display by the monitor, the proximity meter indicating a position of a distal end of the ablative instrument relative to the ultrasound imaging plane (fig. 3, meter 124, [0027]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a proximity meter as taught by Epstein with the console of Brannan and Munrow in order to allow the user to quickly and easily ascertain the relative position between the imaging plane and the ablative instrument.
Regarding claim 20: Brannan, Munrow and Epstein disclose the console of claim 19, wherein the proximity meter comprises bars in a first color indicating that the distal end of the ablative instrument is in front of the ultrasound imaging plane (Epstein - [0027] - yellow); wherein proximity meter comprises bars in a second color indicating that the distal end of the ablative instrument is behind the ultrasound imaging plane, the second color being different from the first color (Epstein - [0027] - blue); and wherein the proximity meter comprises a bar in a third color indicating that the distal end of the ablative instrument is on the ultrasound imaging plane, the third color being different from the first color and from the second color (Epstein - [0027] - green).
Response to Arguments
Double patenting rejections are withdrawn in light of the terminal disclaimer filed 07/15/2026.
Applicant’s arguments with respect to prior art rejection of all pending claims, filed 07/15/2026, have been fully considered but are not persuasive.
Applicant argues that the representation of the ablation probe as shown in fig. 7 and described in [0052]-[0053] of Brannan is not an avatar of the probe but the actual ablation device itself.
Examiner respectfully disagrees. The interaction of the ablation probe and the ultrasound plane is shown in fig. 7. The ultrasound plane intersects with only a small portion of the instrument. It is unclear how Applicant is suggesting that an image of the entirety of the ablation probe, while it is inserted inside the patient’s tissue, is acquired. It can’t be a live image of the entire probe captured by the live ultrasound imaging, including the portion of the probe extending in front of and behind the plane of the ultrasound image, because there isn’t sufficient coverage by the imaging plane to acquire the entire instrument as it is shown in fig. 7.
Additionally, figure 7 includes a representation 714 of the portion of the ablation probe that lies under (behind) the ultrasound plane. Even if Applicant does not accept that the representation of the probe is not a live image of the entire probe (which, again, could not be captured by a 2D ultrasound plane positioned as shown relative to the probe), at least the indicator 714 is reasonably considered an “avatar” of the probe. It is further noted that the portion of example screen 700 that contains the representation of the probe is described as the “navigation view 712, in which ablation probe 130 as well as a shadow indicator 714 representing the portion of ablation probe 130 which lies below the ultrasound imaging plane, a vector line 716 representing the trajectory of the ablation probe 130, a current ablation zone 718 showing the area which is currently being ablated, and a total ablation zone 720 showing the area which will be ablated if the ablation procedure is allowed to run to completion, are shown.” In order for Applicant’s assertion to be true, the system of Brannan would be required to acquire a live ultrasound image of the entire ablation probe, segment the probe from the whatever live imaging source was used (again, including the portions of the probe that do not intersect with the ultrasound plane) and then superimpose that segmented representation onto a navigation view with the additional elements such as the indicator 714 and trajectory line 716. Additionally, one could argue that even a live image of the actual probe which was segmented and then superimposed in a field with other graphical elements could reasonably be considered an “avatar” in that context.
Moreover, Brannan contains an extensive description of how EM tracking is used to track the relative positions between the ultrasound probe (140) and the ablation probe (130) inside the body of the patient ([0032]) and displaying the tracked location of the ablation probe (130) relative to a model of the patient’s body ([0041]). There is no disclosure of obtaining a live image of the entire ablation probe (130) while it is inserted within the patient’s body.
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 CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799
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