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 3 and 7 are objected to because of the following informalities:
In claim 3, the “matching” should read “that is configured to match”.
In claim 3, the “delivers” should read “is configured to deliver”.
In claim 7, “the position” should read “a position”.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12465434, in view of Trovato et al (US20100063496), hereinafter Trovato.
Although the claims at issue are not identical, they are not patentably distinct from each other because limitations of Claim 3 of the instant application correspond to the limitations of the parent claim 1 and additional limitations of the parent claim 4. In particular, claim 1 of the U.S. Patent No. 12465434 recites the “patient-specific device for guiding resection of a tumor located in a tissue of a patient, comprising: a locator form having a locator-form surface matching a surface of the tissue near the tumor's location when the tissue is imaged in a first position of the patient in which the surface of the tissue has a first shape, such that the locator form, when fit to the surface of the tissue when the patient is in a second position in which the surface of the tissue has a second shape, restores the tissue to the first shape”.
Claim 3 of the instant application
a locator form having a locator-form surface matching a surface of the local tissue near the tumor when the local tissue is imaged in a preoperative position corresponding to a first shape of the surface of the local tissue, such that the locator form, when fit to the surface of the local tissue, restores the local tissue to the preoperative position and the first shape;
US 12465434
1. A patient-specific device for guiding resection of a tumor located in a tissue of a patient, comprising: a locator form having a locator-form surface matching a surface of the tissue near the tumor's location when the tissue is imaged in a first position of the patient in which the surface of the tissue has a first shape, such that the locator form, when fit to the surface of the tissue when the patient is in a second position in which the surface of the tissue has a second shape, restores the tissue to the first shape; and a surgical guidance cue integrally formed with the locator form and based on images including only images of the tissue in the first position, to indicate a spatial property of the tumor in the first position; wherein the second position differs from the first position, and the second shape differs from the first shape.
Claim 3 of the instant application
when the locator form is fit to the surface of the local tissue
US 12465434
4. The patient-specific device of claim 1, the surgical guidance cue including a raised needle port having shape and position to passively direct a needle to one of (i) a location associated with the tumor and (ii) a margin of the tumor, when the patient-specific device is placed on the surface of the tissue.
The U.S. Patent No. 12465434 does not teach that the robotic delivery device delivers the therapeutic agent and the system of claim 1.
However, in the surgery planning field of endeavor, Trovato discloses RF ablation planner, which is analogous art. Trovato teaches a surgical navigation system (10) (“These specific values can be used to guide the surgeon” [0012]; “a tracking or robotic system” [0042]), comprising:
a robotic delivery device (“Another advantage is that specific, quantitative target locations and orientations are determined These specific values can be used to guide the surgeon with tracking devices, such as magnetic trackers. They Trovato also be used to control other devices such as robots, which require quantitative data.” [0012]. “Since the plan is quantitative, it can be carried out using a robot and/or by using registered image guidance, such as by quantitatively tracking the ablation probe.” [0030]; “a robot can be given the target point and can carry out the maneuver, with feedback from the tracking system” [0042]);
a processor (21) communicatively coupled to the robotic delivery device (“optimization component 14 includes a processor 21 for performing various analytical actions, executing one or more routines…such as those described with regard to FIGS. 2, 5, and 10.” [0031]; Fig. 1); and
a memory (20) communicatively coupled to the processor and storing (i) a surgical guidance cue (70) (102) indicating a three-dimensional spatial property (“3-D ellipsoidal ablation volumes” [0041]) associated with a tumor (68) within a local tissue (“According to the method, at 24, a tumor volume is segmented and identified.” [0036]. “At 28, a set of ellipse centers is defined, such that a plurality of 3-D ellipsoidal ablation volumes corresponding to respective ellipse centers collectively envelope the entire tumor mass.” [0041]; “A tumor mass volume 68 is segmented and enveloped by the planned target volume (PTV) 70, which is the visualized or otherwise calculated tumor mass 68 volume” [0047]; Fig. 2; “FIG. 6A image 100 illustrates a 3D segmented, irregular shape tumor with margin defining a PTV 102.” [0062]), and (ii) machine-readable instructions that, when executed by the processor (“executing one or more routines…such as those described with regard to FIGS. 2, 5, and 10.” [0031]; Fig. 1):
control the robotic delivery device, according to the surgical guidance cue (“a robot can be given the target point and can carry out the maneuver, with feedback from the tracking system” [0042]), to deliver a therapeutic agent (“saline” [0066]) into an interior of the local tissue (“to control other devices such as robots, which require quantitative data.” [0012] “In image 132 (FIG. 9B), the unablatable areas are presented to a surgeon (e.g., via the GUI 18 or the like) as being highlighted so that the surgeon can take appropriate action…the surgeon injects saline into a space between the tumor and the critical region 136 to separate the tumor from the critical region 136.” [0066]; Figs. 9A-B. Note that the “robot can be given the target point and can carry out the maneuver” [0042], including injections, because robots are disclosed as an alternative to guiding the surgeon [0012]).
Therefore, based on Trovato’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the outer diameter of the second portion of U.S. Patent No. 12465434 to employ the robotic delivery device that delivers the therapeutic agent and the system of claim 1, as taught by Trovato, in order to facilitate surgical procedures based on preoperative imaging data.
Claims 8 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11931116.
Although the claims at issue are not identical, they are not patentably distinct from each other because limitations of Claim 8 of the instant application correspond to the limitations of the parent claim 6. In particular, claim 6 of the U.S. Patent No. 11931116 recites the “patient-specific device for guiding resection of a tumor located in a tissue of a patient, comprising: a locator form having a locator-form surface matching a surface of the tissue near the tumor's location when the tissue is imaged in a first position of the patient in which the surface of the tissue has a first shape, such that the locator form, when fit to the surface of the tissue when the patient is in a second position in which the surface of the tissue has a second shape, restores the tissue to the first shape”.
Instant application
8. A surgical navigation method for resecting a tumor, comprising:
generating a preoperative image of local tissue in a preoperative position of the local tissue, the local tissue having a local tissue surface;
Claim 6 of US 11931116
6. A method for guiding resection of a tumor comprising: generating a supine image of a breast in a supine position, the breast having a breast surface;
Instant application
generating, from the preoperative image, a first surface model of the local tissue surface and a second surface model of the tumor;
Claim 6 of US 11931116
generating, from the supine image, a surface model of the breast surface and a surface model of the tumor;
Instant application
determining, based at least in part upon the first surface model and the second surface model, a surgical guidance cue indicating a three-dimensional spatial property associated with the tumor;
Claim 6 of US 11931116
determining, based at least in part upon the surface model of the breast surface and the surface model of the tumor, a plurality of surgical guidance cues indicating three-dimensional spatial properties associated with the tumor;
Instant application
generating a visualization of the surgical guidance cue relative to the local tissue surface at least in part by
superimposing the surgical guidance cue on the first surface model to enable transfer of the surgical guidance cue to the local tissue; and
transferring the surgical guidance cue to the local tissue surface.
Claim 6 of US 11931116
generating a visualization of the surgical guidance cues relative to the breast surface at least in part by superimposing the surgical guidance cues on the surface model of the breast surface to enable transfer of the surgical guidance cues to the breast;
Claim 13 of the instant application
manufacturing a locator form that fits the local tissue, when in the preoperative position, and includes features indicating at least a portion of the surgical guidance cue; and
restoring the local tissue to its position in the preoperative image by aligning the locator form with respect to the local tissue.
Claim 6 of
US 11931116
manufacturing a locator form that fits the breast, when in the supine position, and an adjoining anatomical structure at least partially surrounding the breast, the locator form including features indicating at least a portion of the surgical guidance cues; and
restoring the breast to its position in the supine image by aligning the locator form with respect to the breast and the adjoining anatomical structure.
Claim Rejections - 35 USC § 103
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.
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 1-2 are rejected under 35 U.S.C. 102(a)(1) over Trovato et al (US20100063496), hereinafter Trovato in view of Hauck et al (US 20070185485), hereinafter Hauck.
Regarding claim 1, Trovato teaches a surgical navigation system (10) (“These specific values can be used to guide the surgeon” [0012]; “a tracking or robotic system” [0042]), comprising:
a robotic delivery device (“Another advantage is that specific, quantitative target locations and orientations are determined These specific values can be used to guide the surgeon with tracking devices, such as magnetic trackers. They may also be used to control other devices such as robots, which require quantitative data.” [0012]. “Since the plan is quantitative, it can be carried out using a robot and/or by using registered image guidance, such as by quantitatively tracking the ablation probe.” [0030]; “a robot can be given the target point and can carry out the maneuver, with feedback from the tracking system” [0042]);
a processor (21) communicatively coupled to the robotic delivery device (“optimization component 14 includes a processor 21 for performing various analytical actions, executing one or more routines…such as those described with regard to FIGS. 2, 5, and 10.” [0031]; Fig. 1); and
a memory (20) communicatively coupled to the processor and storing (i) a surgical guidance cue (70) (102) indicating a three-dimensional spatial property (“3-D ellipsoidal ablation volumes” [0041]) associated with a tumor (68) within a local tissue (“According to the method, at 24, a tumor volume is segmented and identified.” [0036]. “At 28, a set of ellipse centers is defined, such that a plurality of 3-D ellipsoidal ablation volumes corresponding to respective ellipse centers collectively envelope the entire tumor mass.” [0041]; “A tumor mass volume 68 is segmented and enveloped by the planned target volume (PTV) 70, which is the visualized or otherwise calculated tumor mass 68 volume” [0047]; Fig. 2; “FIG. 6A image 100 illustrates a 3D segmented, irregular shape tumor with margin defining a PTV 102.” [0062]), and (ii) machine-readable instructions that, when executed by the processor (“executing one or more routines…such as those described with regard to FIGS. 2, 5, and 10.” [0031]; Fig. 1):
deliver a therapeutic agent (“saline” [0066]) into an interior of the local tissue (“to control other devices such as robots, which require quantitative data.” [0012] “In image 132 (FIG. 9B), the unablatable areas are presented to a surgeon (e.g., via the GUI 18 or the like) as being highlighted so that the surgeon can take appropriate action…the surgeon injects saline into a space between the tumor and the critical region 136 to separate the tumor from the critical region 136.” [0066]; Figs. 9A-B).
While teaching the use of robots (“These specific values can be used to guide the surgeon with tracking devices, such as magnetic trackers. They may also be used to control other devices such as robots, which require quantitative data.” [0012]; “a robot can be given the target point and can carry out the maneuver, with feedback from the tracking system” [0042]), Trovato does not explicitly teach controlling the robotic delivery device, according to the surgical guidance cue, to deliver a therapeutic agent into an interior of the local tissue.
However, in the robotic surgical systems field of endeavor, Hauck discloses robotic surgical system and method for automated creation of ablation lesions, which is analogous art. Hauck teaches controlling the robotic delivery device, according to the surgical guidance cue, to deliver a therapeutic agent into an interior of the local tissue ("Robotic surgical system 10 may be adapted for automated delivery of therapy, such as ablation of cardiac or other tissue or the delivery of a therapeutic agent to a cardiac or other tissue surface. As shown in FIG. 16, user interface 166 permits the user to define a navigation path 200 (also referred to herein as a "predetermined path" or "treatment path") on tissue surface 82, preferably by utilizing input devices 158 to designate navigation path 200 " [0111]).
Therefore, based on Hauck’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Trovato to employ machine-readable instructions that, when executed by the processor, control the robotic delivery device, according to the surgical guidance cue, to deliver a therapeutic agent into an interior of the local tissue as taught by Hauck, in order to facilitate automated delivery of therapy.
Regarding claim 2, Trovato modified by Hauck teaches the system of claim 1.
Trovato teaches the memory further storing the surgical guidance cue generated by fusing models from pre-operative (“the model …a registered patient image.” [0042]) and intraoperative imagery (“visual feedback … in real-time. The target can be displayed along with the live tracked location,” [0042]) (“The system 10 generates a quantitative ablation plan, including target positions and orientations for each ablation. It may optionally identify the entry point or points on the outside of the body that lead to the target(s)…Since the plan is quantitative, it can be carried out using a robot and/or by using registered image guidance, such as by quantitatively tracking the ablation probe.” [0030]. “At 30, the identified ellipse centers for the given probe size are output to a user, such as a surgeon or the like, via the graphical user interface such as is illustrated in FIG. 7, to permit the user to evaluate and/or execute the model… A tracking system provides visual feedback to the surgeon on the position and orientation of the tool, or tool-tip in real-time. The target can be displayed along with the live tracked location, often along with a registered patient image.” [0042]).
Allowable Subject Matter
Claims 4-7, 9-12, and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXEI BYKHOVSKI whose telephone number is (571)270-1556. The examiner can normally be reached on Monday-Friday: 8:30am - 5:00pm.
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798
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