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
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 1-5, 8-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over DeFreitas (US 20110087132 A1) further in view of Stolka (US 20120253200 A1).
Regarding Claim 1: DeFreitas discloses (in at least figures 1-5 and 7-9, the description, and the claims) a method for projecting an incision indicator onto a breast of a patient (fig. 1, fig. 9, par.’s 24-26, and par. 42: needle breast biopsy system and method for use), the method comprising:
compressing the breast (fig. 9 and par. 37: “At step 91 the biopsy compression paddle moves down towards the compression platform, compressing the patient's breast, and the process of visualizing the lesion is initiated at step 92.”);
acquiring, while compressing the breast, an x-ray image of the breast (fig. 9 and par. 37: “[…] visualization of the lesion may be performed using a scout image, a mammogram, acquired stereotactic images, acquired tomosynthesis projection images, tomosynthesis reconstructed images, or any combination thereof […] an x-ray imaging system having tomosynthesis capabilities may be adapted to include a `stereotactic mode`, which, when selected, causes the x-ray imaging system to automatically retrieve the typical +/-15 degree stereotactic images and performs appropriate imaging processing on the stereotactic images to derive a stereotactic volume.” See also fig. 1 and par. 25: x-ray imaging assembly 2);
receiving an indication identifying at least one target region in the breast, based at least on the x-ray image (fig. 9 and par. 38: “[…] at step 93 the lesion is targeted. Targeting the lesion involves identifying the coordinates of the lesion using image data, and converting the coordinates from the Cartesian coordinate system of the images to the angular coordinate system of the tilted biopsy assembly […] depending upon the capabilities of the x-ray imaging system, the lesion target coordinates may be derived using a scout image, a mammogram, acquired stereotactic images, acquired tomosynthesis projection images, tomosynthesis reconstructed images, or any combination thereof”);
detecting that an arm securing an interventional element (fig.’s 1-2 and par.’s 25-27: needle biopsy assembly 10) is positioned such that a path of the interventional element intersects with the breast at the at least one target region and intersects at a surface of the breast at a target incision point (fig. 9 and par. 39: “At step 94, once the target coordinates are derived the medical professional can being the biopsy procedure by pressing control buttons required to move the biopsy needle […] The control panel may also provide other helpful information to the user, such as warning indicators when the needle is too close to the breast platform, chest wall or skin line […], the warning indicators may be color coded or may provide other visual or audible indicators of undesirable conditions”); and
DeFreitas does not explicitly disclose projecting an incision indicator onto the breast at the target incision point.
Stolka discloses an analogous method (fig.’s 7-9, par.’s 10-12, par. 76, and par. 120: image guided navigation and intervention system. See also fig. 12 and par. 140: intervention system utilized for projecting an incision indicator onto a breast of a patient) comprising projecting an incision indicator onto the surface of the breast at the target incision point while illuminating the at least a portion of the breast with task lighting (fig.’s 7-9 and par. 78: “[…] one possible approach to display needle guidance information to the user by means of direct projection onto the surface in the region of interest in a parallax-independent fashion […] Using e.g. a combination of moving, potentially color/size/thickness/etc.-coded circles and crosses, the five degrees of freedom governing a needle insertion (two each for insertion point location and needle orientation, and one for insertion depth and/or target distance) can be intuitively displayed to the user […] the position and color of a projected circle on the surface indicate the intersection of the line between the current needle position and the target location with the patient surface, and said intersection point's distance from a planned insertion point.”).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for DeFreitas to, taught by Stolka, project an incision indicator onto the breast at the target incision point thereby increasing the amount of guidance information provided to the user at the location and improving the accuracy and safety of the incision process (Stolka par. 78).
Regarding Claim 2: DeFreitas in view of Stolka discloses the method of claim 1, and Stolka discloses the method further comprising:
adjusting the projected incision indicator based on a change in a distance between the surface of the breast and a projector projecting the incision indicator (Stolka fig.’s 7-9 and par. 78: “Using e.g. a combination of moving, potentially color/size/thickness/etc.-coded circles and crosses, the five degrees of freedom governing a needle insertion (two each for insertion point location and needle orientation, and one for insertion depth and/or target distance) can be intuitively displayed to the user […] the position and color of a projected circle on the surface indicate the intersection of the line between the current needle position and the target location with the patient surface, and said intersection point's distance from a planned insertion point.” See also par. 78: “The position, color, and size of a projected cross can encode the current orientation of the needle with respect to the correct orientation towards the target location, as well as the needle's distance from the target. The orientation deviation is also indicated by an arrow pointing towards the proper position/orientation configuration […] guidance information necessary to adjust the needle orientation can be projected as a virtual shadow onto the surface next to the needle insertion point, prompting the user to minimize the shadow length to properly orient the needle for insertion”).
The rationale to combine is the same as for claim 1.
Regarding Claim 3: DeFreitas in view of Stolka discloses the method of claim 2, and Stolka discloses the method further comprising:
adjusting the projected incision indicator to counteract a parallax effect (fig.’s 7-9 and par. 78: “[…] one possible approach to display needle guidance information to the user by means of direct projection onto the surface in the region of interest in a parallax-independent fashion […]”)
The rationale to combine is the same as for claim 1.
Regarding Claim 4: DeFreitas in view of Stolka discloses the method of claim 1, and DeFreitas discloses wherein the at least one target region includes a first target region and a second target region (fig. 9 and par. 42: “[…] steps 95 and 96 may be repeated to verify excision of the entire lesion.” That is, step 95 (verify target localization) and step 96 (excise tissue) may be repeated for a first, second, and any additional target localizations to excise the entire lesion), and the method further comprising:
receiving a selection of the first target region (fig. 9 and par. 38: “[…] at step 93 the lesion is targeted. Targeting the lesion involves identifying the coordinates of the lesion using image data, and converting the coordinates from the Cartesian coordinate system of the images to the angular coordinate system of the tilted biopsy assembly […] depending upon the capabilities of the x-ray imaging system, the lesion target coordinates may be derived using a scout image, a mammogram, acquired stereotactic images, acquired tomosynthesis projection images, tomosynthesis reconstructed images, or any combination thereof”);
receiving a selection of the second target region (fig. 9 and par. 38: “[…] at step 93 the lesion is targeted. Targeting the lesion involves identifying the coordinates of the lesion using image data, and converting the coordinates from the Cartesian coordinate system of the images to the angular coordinate system of the tilted biopsy assembly […] depending upon the capabilities of the x-ray imaging system, the lesion target coordinates may be derived using a scout image, a mammogram, acquired stereotactic images, acquired tomosynthesis projection images, tomosynthesis reconstructed images, or any combination thereof” NOTE: As stated in paragraph 42, step 95 (verify target localization) and step 96 (excise tissue) may be repeated for additional target localizations. Accordingly, the target coordinates received in step 93 include the first, second, and any additional target regions required to excise the entire lesion.);
detecting that the arm is repositioned such that the path of the interventional element intersects with the second target region (fig. 9 and par. 39: “At step 94, once the target coordinates are derived the medical professional can being the biopsy procedure by pressing control buttons required to move the biopsy needle […] The control panel may also provide other helpful information to the user, such as warning indicators when the needle is too close to the breast platform, chest wall or skin line […], the warning indicators may be color coded or may provide other visual or audible indicators of undesirable conditions.” NOTE: As stated in paragraph 42, step 95 (verify target localization) and step 96 (excise tissue) may be repeated for additional target localizations. Accordingly, detections and indications of the biopsy needle’s proper positioning are still provided according to the received target coordinates of the first, second, and any additional target regions.);
Stolka discloses wherein an incision indicator is projected based on the path of the interventional element intersecting the first target region (fig.’s 7-9 and par. 78: “[…] one possible approach to display needle guidance information to the user by means of direct projection onto the surface in the region of interest in a parallax-independent fashion […] Using e.g. a combination of moving, potentially color/size/thickness/etc.-coded circles and crosses, the five degrees of freedom governing a needle insertion (two each for insertion point location and needle orientation, and one for insertion depth and/or target distance) can be intuitively displayed to the user […] the position and color of a projected circle on the surface indicate the intersection of the line between the current needle position and the target location with the patient surface, and said intersection point's distance from a planned insertion point.”) and adjusting the projection of the incision indicator to intersect the path of the interventional element at a second target region on the surface of the breast (par. 78: “The position, color, and size of a projected cross can encode the current orientation of the needle with respect to the correct orientation towards the target location, as well as the needle's distance from the target. The orientation deviation is also indicated by an arrow pointing towards the proper position/orientation configuration […] guidance information necessary to adjust the needle orientation can be projected as a virtual shadow onto the surface next to the needle insertion point, prompting the user to minimize the shadow length to properly orient the needle for insertion”).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to receive selections and detect that the arm is repositioned for multiple target regions, as is taught by DeFreitas, and to align the projection of the incision indicator at each target region, as is taught by Stolka, thereby increasing the capability of the system and to ensure proper treatment of the entire effected area (DeFreitas fig. 9 and par. 42. See also Stolka par. 78)
Further, it would have been obvious to one of ordinary skill in the art to duplicate the method steps (including at least the receiving a selection from a target region, the projection of the incision indicator, detection of the arm repositioning, and adjusting of the projection indicator each of which is rejected over DeFreitas and Stolka as cited) for multiple target regions.
Regarding Claim 5: DeFreitas in view of Stolka discloses the method of claim 1, and Stolka disclose wherein projecting the incision indicator is automatic based on detecting that the arm is positioned such that the path of the insertion element intersects with the breast at the at least one target region (Stolka fig.’s 7-9 and par. 78: “Using e.g. a combination of moving, potentially color/size/thickness/etc.-coded circles and crosses, the five degrees of freedom governing a needle insertion (two each for insertion point location and needle orientation, and one for insertion depth and/or target distance) can be intuitively displayed to the user […] the position and color of a projected circle on the surface indicate the intersection of the line between the current needle position and the target location with the patient surface, and said intersection point's distance from a planned insertion point.” See also par. 78: “The position, color, and size of a projected cross can encode the current orientation of the needle with respect to the correct orientation towards the target location, as well as the needle's distance from the target. The orientation deviation is also indicated by an arrow pointing towards the proper position/orientation configuration […] guidance information necessary to adjust the needle orientation can be projected as a virtual shadow onto the surface next to the needle insertion point, prompting the user to minimize the shadow length to properly orient the needle for insertion” That is, Stolka’s method automatically adjust the orientation of the projected incision indicator based on the needle’s detected orientation.).
The rationale to combine is the same as for claim 1.
Regarding Claim 8: DeFreitas in view of Stolka discloses the method of claim 1, and Stolka discloses wherein the incision indicator is at least one of: a crosshair; a dot; an oval; a rectangle; and a line (fig.’s 7-9 and par. 78: “Using e.g. a combination of moving, potentially color/size/thickness/etc.-coded circles and crosses, the five degrees of freedom governing a needle insertion (two each for insertion point location and needle orientation, and one for insertion depth and/or target distance) can be intuitively displayed to the user […] the position and color of a projected circle on the surface indicate the intersection of the line between the current needle position and the target location with the patient surface, and said intersection point's distance from a planned insertion point.”).
The rationale to combine is the same as for claim 1.
Regarding Claim 9: DeFreitas in view of Stolka discloses the method of claim 8, and Stolka discloses wherein the incision indicator comprises a selectable color (fig.’s 7-9 and par. 78: “Using e.g. a combination of moving, potentially color/size/thickness/etc.-coded circles and crosses, the five degrees of freedom governing a needle insertion (two each for insertion point location and needle orientation, and one for insertion depth and/or target distance) can be intuitively displayed to the user […] the position and color of a projected circle on the surface indicate the intersection of the line between the current needle position and the target location with the patient surface, and said intersection point's distance from a planned insertion point.”).
The rationale to combine is the same as for claim 1.
Regarding Claim 10: DeFreitas discloses (in at least figures 1-5 and 7-9, the description, and the claims) an apparatus for projecting an incision indicator onto a breast of a patient (fig. 1, fig. 9, par.’s 24-26, and par. 42: needle breast biopsy system and method for use), the apparatus comprising:
an x-ray source capable of selectively moving relative to the breast (fig. 1: x-ray imaging assembly 2. See par. 25: “[…] gantry 1 supports a C-arm that can move up or down along the gantry to a selected height, driven by motor(s) controlled by a health professional operating the system. C-arm carries an x-ray tube 2a at an upper end and a breast tray 2b at a lower end.”);
an x-ray detector (fig. 1: x-ray imaging assembly 2. See par. 25: “Tray 2b covers a flat panel x-ray image receptor 2c, spaced from the tray by a focused anti-scatter grid 2d (which may be retractable so that it can be removed from the space between tray 2b and receptor 2c).”);
a compression system for compressing the breast, the compression system disposed between the x-ray source and the x-ray detector (fig. 1: x-ray imaging assembly 2. See par. 25: “The C-arm also carries a compression paddle 2e that is between source 2a and breast tray 2b and is motorized to move away from tray 2b so a patient's breast can fit between tray 2b and paddle 2e, and closer to tray 2b so the patient's breast can be compressed and immobilized.”);
an arm for securing an interventional element (fig.’s 1-2 and par.’s 25-27: needle biopsy assembly 10);
a task lighting source disposed between the x-ray source and the compression system (fig. 1 and par. 25: Task lighting as claimed is standard and well known to be included in the mammography/tomosynthesis system disclosed by DeFreitas, wherein gantry 1 supporting imaging assembly 2 is attended to be a medical professional at acquisition work station 4);
a processor; and memory storing instructions that, when executed by the processor, cause the apparatus to perform a set of operations comprising (fig. 1, fig.’s 10-11, and par. 25: acquisition work station 4 with display interface used by a medical professional to operate the imaging and intervention system. Work station 4 comprised a processor and memory as is standard and well known in the art.):
illuminating at least a portion of the breast with the task lighting source (fig. 1 and par. 25: Task lighting as claimed is standard and well known to be included in the mammography/tomosynthesis system disclosed by DeFreitas, wherein gantry 1 supporting imaging assembly 2 is attended to be a medical professional at acquisition work station 4);
detecting that the arm is in a position such that a path of the interventional element intersects with a surface of the breast at a target incision point (fig. 9 and par. 39: “At step 94, once the target coordinates are derived the medical professional can being the biopsy procedure by pressing control buttons required to move the biopsy needle […] The control panel may also provide other helpful information to the user, such as warning indicators when the needle is too close to the breast platform, chest wall or skin line […], the warning indicators may be color coded or may provide other visual or audible indicators of undesirable conditions”); and
DeFreitas does not explicitly disclose an indicator source or projecting an incision indicator from an indicator source.
Stolka discloses an analogous art (fig. 3A, fig.’s 7-9, par.’s 10-12, par. 76, and par. 120: image guided navigation and intervention system. See also fig. 12 and par. 140: intervention system utilized for projecting an incision indicator onto a breast of a patient) comprising an indicator source disposed between the x-ray source and the compression system, wherein the indicator source is coupled to the arm (fig. 3A, fig.’s 7-9 and par. 68: “[…] augmentation device 200 attached to the C-arm 202 of an x-ray imaging system […], the augmentation device 200 is illustrated as having a projector 204, a first camera 206 and a second camera 208”) and a set of operations comprising projecting an incision indicator from the indicator source onto the surface of the breast at the target incision point (fig.’s 7-9 and par. 78: “[…] one possible approach to display needle guidance information to the user by means of direct projection onto the surface in the region of interest in a parallax-independent fashion […] Using e.g. a combination of moving, potentially color/size/thickness/etc.-coded circles and crosses, the five degrees of freedom governing a needle insertion (two each for insertion point location and needle orientation, and one for insertion depth and/or target distance) can be intuitively displayed to the user […] the position and color of a projected circle on the surface indicate the intersection of the line between the current needle position and the target location with the patient surface, and said intersection point's distance from a planned insertion point.”).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for DeFreitas to, taught by Stolka, include an indicator source and project an incision indicator onto the breast at the target incision point thereby increasing the amount of guidance information provided to the user at the location and improving the accuracy and safety of the incision process (Stolka par. 78).
Regarding Claim 11: DeFreitas in view of Stolka discloses the system of claim 10, and Stolka further discloses wherein the tasking lighting source and the indicator source are the same (fig. 3A, fig.’s 7-9 and par. 68: “[…] augmentation device 200 attached to the C-arm 202 of an x-ray imaging system […], the augmentation device 200 is illustrated as having a projector 204, a first camera 206 and a second camera 208.” See fig.’s 8A-8B: projector comprising multiple light sources including task lighting and indicator source.).
The rationale to combine is the same as for claim 10.
Regarding Claim 12: DeFreitas in view of Stolka discloses the system of claim 10, and Stolka discloses wherein the tasking lighting source and the indicator source are a projector (fig. 3A, fig.’s 7-9 and par. 68: “[…] augmentation device 200 attached to the C-arm 202 of an x-ray imaging system […], the augmentation device 200 is illustrated as having a projector 204, a first camera 206 and a second camera 208.” See fig.’s 8A-8B: projector comprising multiple light sources including task lighting and indicator source.).
The rationale to combine is the same as for claim 10.
Regarding Claim 13: DeFreitas in view of Stolka discloses the system of claim 12, and Stolka discloses the set of operations further comprising: determining a location of the incision indicator in a projection image of the projector, based on a distance between the projector and the surface of the breast (fig.’s 7-9 and par. 78: “[…] one possible approach to display needle guidance information to the user by means of direct projection onto the surface in the region of interest in a parallax-independent fashion […] Using e.g. a combination of moving, potentially color/size/thickness/etc.-coded circles and crosses, the five degrees of freedom governing a needle insertion (two each for insertion point location and needle orientation, and one for insertion depth and/or target distance) can be intuitively displayed to the user […] the position and color of a projected circle on the surface indicate the intersection of the line between the current needle position and the target location with the patient surface, and said intersection point's distance from a planned insertion point.”).
The rationale to combine is the same as for claim 10.
Regarding Claim 14: DeFreitas in view of Stolka discloses the system of claim 13, and Stolka discloses wherein the distance between the projector and the surface of the breast is based on the position of the arm (Stolka fig.’s 7-9 and par. 78: “Using e.g. a combination of moving, potentially color/size/thickness/etc.-coded circles and crosses, the five degrees of freedom governing a needle insertion (two each for insertion point location and needle orientation, and one for insertion depth and/or target distance) can be intuitively displayed to the user […] the position and color of a projected circle on the surface indicate the intersection of the line between the current needle position and the target location with the patient surface, and said intersection point's distance from a planned insertion point.” See also par. 78: “The position, color, and size of a projected cross can encode the current orientation of the needle with respect to the correct orientation towards the target location, as well as the needle's distance from the target. The orientation deviation is also indicated by an arrow pointing towards the proper position/orientation configuration […] guidance information necessary to adjust the needle orientation can be projected as a virtual shadow onto the surface next to the needle insertion point, prompting the user to minimize the shadow length to properly orient the needle for insertion” That is, Stolka’s method automatically adjust the orientation of the projected incision indicator based on the needle’s detected orientation.).
The rationale to combine is the same as for claim 10.
Regarding Claim 15: DeFreitas in view of Stolka discloses the system of claim 10, and Stolka discloses wherein the indicator source is calibrated based on a calibration position of the arm (Stolka fig.’s 7-9 and par. 78: “Using e.g. a combination of moving, potentially color/size/thickness/etc.-coded circles and crosses, the five degrees of freedom governing a needle insertion (two each for insertion point location and needle orientation, and one for insertion depth and/or target distance) can be intuitively displayed to the user […] the position and color of a projected circle on the surface indicate the intersection of the line between the current needle position and the target location with the patient surface, and said intersection point's distance from a planned insertion point.” See also par. 78: “The position, color, and size of a projected cross can encode the current orientation of the needle with respect to the correct orientation towards the target location, as well as the needle's distance from the target. The orientation deviation is also indicated by an arrow pointing towards the proper position/orientation configuration […] guidance information necessary to adjust the needle orientation can be projected as a virtual shadow onto the surface next to the needle insertion point, prompting the user to minimize the shadow length to properly orient the needle for insertion” That is, Stolka’s method automatically adjust the orientation of the projected incision indicator based on the needle’s detected orientation.).
The rationale to combine is the same as for claim 10.
Regarding Claim 18: DeFreitas in view of Stolka discloses the system of claim 10, and Stolka discloses wherein the indicator source is positioned at an end of the arm (fig. 3A, fig.’s 7-9 and par. 68: “[…] augmentation device 200 attached to the C-arm 202 of an x-ray imaging system […], the augmentation device 200 is illustrated as having a projector 204, a first camera 206 and a second camera 208”).
The rationale to combine is the same as for claim 10.
Regarding Claim 19: DeFreitas in view of Stolka discloses the system of claim 10, and DeFreitas discloses wherein the interventional element is a needle or a wire (fig.’s 1-2 and par.’s 25-27: needle biopsy assembly 10).
Regarding Claim 20: DeFreitas discloses (in at least figures 1-5 and 7-9, the description, and the claims) an apparatus for projecting an incision indicator onto a breast of a patient fig. 1, fig. 9, par.’s 24-26, and par. 42: needle breast biopsy system and method for use), the apparatus comprising:
an x-ray source capable of selectively moving relative to the breast (fig. 1: x-ray imaging assembly 2. See par. 25: “[…] gantry 1 supports a C-arm that can move up or down along the gantry to a selected height, driven by motor(s) controlled by a health professional operating the system. C-arm carries an x-ray tube 2a at an upper end and a breast tray 2b at a lower end.”);
an x-ray detector(fig. 1: x-ray imaging assembly 2. See par. 25: “Tray 2b covers a flat panel x-ray image receptor 2c, spaced from the tray by a focused anti-scatter grid 2d (which may be retractable so that it can be removed from the space between tray 2b and receptor 2c).”);
a compression system for compressing the breast, the compression system disposed between the x-ray source and the x-ray detector (fig. 1: x-ray imaging assembly 2. See par. 25: “The C-arm also carries a compression paddle 2e that is between source 2a and breast tray 2b and is motorized to move away from tray 2b so a patient's breast can fit between tray 2b and paddle 2e, and closer to tray 2b so the patient's breast can be compressed and immobilized.”);
an arm for securing an interventional element, the arm disposed between the x-ray source and the compression system (fig.’s 1-2 and par.’s 25-27: needle biopsy assembly 10).
DeFreitas does not explicitly disclose a projector coupled to an end of the arm.
Stolka discloses an analogous art (fig. 3A, fig.’s 7-9, par.’s 10-12, par. 76, and par. 120: image guided navigation and intervention system. See also fig. 12 and par. 140: intervention system utilized for projecting an incision indicator onto a breast of a patient) comprising a projector coupled to an end of the arm (fig. 3A, fig.’s 7-9 and par. 68: “[…] augmentation device 200 attached to the C-arm 202 of an x-ray imaging system […], the augmentation device 200 is illustrated as having a projector 204, a first camera 206 and a second camera 208”), the projector capable of selectively projecting task lighting (See fig.’s 8A-8B: projector comprising multiple light sources including task lighting and indicator source.) and an incision indicator onto a surface of the breast based at least on a position of the arm and a target incision point (fig.’s 7-9 and par. 78: “[…] one possible approach to display needle guidance information to the user by means of direct projection onto the surface in the region of interest in a parallax-independent fashion […] Using e.g. a combination of moving, potentially color/size/thickness/etc.-coded circles and crosses, the five degrees of freedom governing a needle insertion (two each for insertion point location and needle orientation, and one for insertion depth and/or target distance) can be intuitively displayed to the user […] the position and color of a projected circle on the surface indicate the intersection of the line between the current needle position and the target location with the patient surface, and said intersection point's distance from a planned insertion point.”).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for DeFreitas to, taught by Stolka, include a projector and project an incision indicator onto the breast at the target incision point thereby increasing the amount of guidance information provided to the user at the location and improving the accuracy and safety of the incision process (Stolka par. 78).
Claims 6-7 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over DeFreitas and Stolka as applied to claims 1 and 10 above, and further in view of Moctezuma De La Barrera (US 20050195587 A1), hereinafter referred to as Moctezuma.
Regarding Claim 6: DeFreitas in view of Stolka discloses the method of claim 1, and Stolka further discloses the method further comprising: receiving an indication to review projection of the incision indicator (Stolka par.’s 78-79. The projected indicator as disclosed by Stolka provides multiple visual means as well as display information to inform the user of the projection’s orientation and to review its alignment.);
DeFreitas and Stolka do not explicitly disclose terminating projection of the incision indicator.
Moctezuma discloses an analogous method (fig.’s 3-6E and par.’s 27-28: device and method for illumination of a surgical site) comprising terminating a projection of an incision indicator (par. 32: “When the instrument 456 is at the proper point and on the proper trajectory as illustrated in FIG. 6b, the line disappears and is replaced by a circle of light 462 having an outer ring 464. The outer ring 464 can be distinguished from the circle of light 462 in any manner such as by a difference in brightness or color […] The outer ring 464 is moved toward the incision point 458 as the instrument proceeds toward the target point 452, the circle of light 462 changes character, either by brightness change, color change or some other change to indicate that the instrument 456 is at the proper depth as shown in FIG. 6d.”).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for DeFreitas and Stolka’s incision indicator to, as taught by Moctezuma, terminate after review thereby providing a clear and intuitive verification that an instrument as been aligned with the proper trajectory and allowing the user to continue the procedure with enhanced accuracy and confidence (Moctezuma par. 32).
Regarding Claim 7: DeFreitas and Stolka in view of Moctezuma disclose the method of claim 6, and Moctezuma further discloses wherein the task lighting is illuminated subsequent to terminating projection of the incision indicator (par. 32: “When the instrument 456 is at the proper point and on the proper trajectory as illustrated in FIG. 6b, the line disappears and is replaced by a circle of light 462 having an outer ring 464. The outer ring 464 can be distinguished from the circle of light 462 in any manner such as by a difference in brightness or color […]”).
The rationale to combine is the same as for claim 6.
Regarding Claim 16: DeFreitas in view of Stolka discloses the system of claim 10, and Stolka discloses wherein the indicator source is a micro electrical mechanical system (MEMS) (par. 62: “the local sensor system 112 has a three-axis gyro system that provides rotation information about three orthogonal axes of rotation. The three-axis gyro system can be a micro-electromechanical system (MEMS) three-axis gyro system, for example. The local sensor system 112 can alternatively, or in addition, include one or more linear accelerometers that provide acceleration information along one or more orthogonal axes in an embodiment of the current invention. The linear accelerometers can be, for example, MEMS accelerometers.” See also par.’s 81-82.)
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the indicator source as taught by DeFreitas and Stolka to, as further taught by Stolka, comprise a micro electrical system thereby contributing to an overall compact, accurate, and maneuverable projector that works in conjunction with the imaging of the imaging system (Stolka par.’s 10-12. See also par. 62 and 72).
DeFreitas and Stolka do not explicitly disclose the micro electrical system including a mirror that is adjustable to control reflection of a laser beam to project the incision indicator onto the surface of a breast.
Moctezuma discloses an analogous art (fig.’s 1-6E and par.’s 27-28: device and method for illumination of a surgical site) including a mirror that is adjustable to control reflection of a laser beam to project the incision indicator onto the surface of a breast (fig. 1 and par. 24: “ […] navigation camera system has two CCD camera arrays 118, and 120, capable of detecting light either reflected or emitted from position sensors 124 on a tracking device 126 […] the minimum number of arrays will be able to maintain a line of sight to the tracking devices 126 at all times […] a variety of well-known position-sensing devices 124 can be used as the position sensors 124. These include both active and passive or reflective optical sensors, magnetic sensors, sonic sensors or projectors, inertial sensors or combination systems […] These tracking devices can be attached or associated with the anatomy of the patient 108 or associated or integrated into tools or instruments 128 to be used during the procedure.” See par. 31: “The combination of the motorized joints 404 and the external tracking system 412 can enable the system to automatically adjust the operating room light 400 to maintain the optimum projection angles for data projection” That is, on of ordinary skill in the art would understand that Moctezuma standard teaching of active, adjustable, and reflective optical sensors to align a projected incision indicator anticipates the mirror as claimed. See also fig.’s 4-4, par. 22, and par.’s 28-31.)
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the MEMS indicator source as taught by DeFreitas and Stolka to, as taught by Moctezuma, comprise mirror for adjustable control of a laser beam to thereby contributing to an overall compact, accurate, and maneuverable projector that works in conjunction with the imaging of the imaging system (Stolka par.’s 10-12. See also par. 62 and 72).
Regarding Claim 17: DeFreitas and Stolka in view of Moctezuma disclose system of claim 16, and Moctezuma further discloses wherein the mirror of the MEMS is adjusted based on a distance between the indicator source and the surface of the breast (fig. 1 and par. 24: “[…] tracking devices can be attached or associated with the anatomy of the patient 108 or associated or integrated into tools or instruments 128 to be used during the procedure.” See fig. 4 and par. 30: “surgical site 305 is modified during the procedure by incisions, retractions, or other aspects of the surgical procedure, the system will self calibrate to enable the system to modify the data light projected so that the images are clear and undistorted.” See also par. 31: “The combination of the motorized joints 404 and the external tracking system 412 can enable the system to automatically adjust the operating room light 400 to maintain the optimum projection angles for data projection.”).
The rationale to combine is the same as for claim 16.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure includes:
Meurer (US 20120179038 A1) discloses certain limitations of the method and apparatus of claims 1-2, 5, 8-15, 19, and 20.
Wells (US 20210401381 A1) discloses certain limitations of the method and apparatus of claims 1-2, 5, 8-15, 19, and 20.
Vancamberg (US 20160183899 A1) discloses certain limitations of the method and apparatus of claims 1-2, 5, 10, 19, and 20.
Kukuk (US 8265731 B2) discloses certain limitations of the method and apparatus of claims 1-2, 5, 8-15, 19, and 20.
Weese (US 20090216111 A1) discloses certain limitations of the method and apparatus of claims 1-2, 5, 8-15, 19, and 20.
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/EVAN MANCINI/Examiner, Art Unit 2855
/KRISTINA M DEHERRERA/Supervisory Patent Examiner, Art Unit 2855 5/15/26
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