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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
An aiming apparatus in claim 1
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the published specification shows that the following appears to be the corresponding structure describe in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
An aiming apparatus is described as markers in paragraphs 40-42.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 2 is objected to because of the following informalities:
In claim 2 “the alignment the within the permitted error limits” should be changed to “the alignment .
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.
Claim 2 is 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.
Regarding claim 2, the claim recites the limitation “the device of claim 1”. This limitation lacks antecedent basis. No device has previously been set forth. For examination purposes, this limitation will be interpreted as reciting “the apparatus of claim 1”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5-7, are rejected under 35 U.S.C. 103 as being unpatentable over Bauer et al. (US5488951, hereafter Bauer) and Case et al. (US20130317363, hereafter Case).
Regarding claim 1, Bauer discloses an X-Ray guided focused ultrasound (FUS) treatment apparatus (Bauer, Col 1, lines 7-9; “The invention relates to an extracorporeal treatment apparatus having an electroacoustic transducer for producing focused sound waves”), the apparatus comprising:
a FUS transducer having a central axis (Bauer, transducer 4) (Bauer, Figures 5 and 8-10), the FUS transducer being configured to transmit a FUS therapeutic energy beam to a treatment location (Bauer, Col 1, lines 7-9; “The invention relates to an extracorporeal treatment apparatus having an electroacoustic transducer for producing focused sound waves”); and
an aiming apparatus comprising (Bauer, spot film marker 22, telescope device 29, guide tube 31, and rod 32) (Bauer, Col 6, lines 51-58; “An alternative device for introducing the spot film marker 22 is shown in FIG. 8. A telescope device 29, by means of which the spot film marker 22 can be positioned in the focus of the transducer by means of the telescope 29 which can be driven out, is provided there within the dome of the transducer 4. The telescope 29 may be actuated mechanically, pneumatically or hydraulically.”) (Bauer, Col 6, lines 60-63; “the spot film marker 22 can be positioned in the focus 6 of the transducer by means of a guide tube 31 on a rod 32 arranged laterally of the transducer”).
Bauer does not clearly and explicitly disclose wherein the aiming apparatus comprises a first x-ray aiming marker and a second x-ray aiming marker disposed along an axis coinciding with the central axis of the FUS transducer, the first x-ray aiming marker and the second x-ray aiming marker having different sizes, wherein a difference between the sizes of the first x-ray aiming marker and the second x-ray aiming marker is indicative of an alignment within permitted error limits of the apparatus.
In an analogous surgical x-ray navigation field of endeavor Case discloses wherein an aiming apparatus comprises a first x-ray aiming marker and a second x-ray aiming marker disposed along an axis coinciding an ablation device, the first x-ray aiming marker and the second x-ray aiming marker having different sizes, wherein a difference between the sizes of the first x-ray aiming marker and the second x-ray aiming marker is indicative of an alignment within permitted error limits of the apparatus (Case, Para 116; "A navigation guide screen 448 is provided on display screen 440 to assist in navigating the ablation needle to the target “T”. Based on the data received from the navigation system 406, the controller can determine if the surgical device 424 is aligned with target “T”. If the surgical device 424 is not aligned with target “T”, the circle 454 would be off-centered from outer circle 453. The user would then adjust the angle of entry for the surgical device 424 until the center of circle 454 is aligned with the center of outer circle 453. In some embodiments, circle 454 may be displayed as a red circle when the center of circle 454 is not aligned with the center of outer circle 453 or circle 454 may be displayed as a green circle when the center of circle 454 is aligned with the center of outer circle 453. Additionally, controller 408 may calculate the distance between the target “T” and the surgical device 424.") (Case, Para 15; “As used in this description, the term “ablation procedure” generally refers to any ablation procedure, such as microwave ablation, radio frequency (RF) ablation or microwave ablation-assisted resection. As it is used in this description, “energy applicator” generally refers to any device that can be used to transfer energy from a power generating source, such as a microwave or RF electrosurgical generator, to tissue.”) (Case, Para 30; “In an aspect of the present disclosure, an ablation planning and navigation system is provided”).
Case is interpreted as disclosing this limitation in the claim because it is analogous to what is described in paragraph 47 of the published application which describes this limitation in the claims.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bauer wherein the aiming apparatus comprises a first x-ray aiming marker and a second x-ray aiming marker disposed along an axis coinciding with the central axis of the FUS transducer, the first x-ray aiming marker and the second x-ray aiming marker having different sizes, wherein a difference between the sizes of the first x-ray aiming marker and the second x-ray aiming marker is indicative of an alignment within permitted error limits of the apparatus as taught by Case in order to use an easily understood and intuitive visual method of aiming a device.
Regarding claim 2, Bauer as modified by Case above discloses all of the limitations of claim 1 as discussed above.
Bauer does not clearly and explicitly disclose wherein a gap between the first x-ray aiming marker and the second x-ray aiming marker visible in an x-ray image is indicative of the alignment the within the permitted error limits.
Case further discloses wherein a gap between the first x-ray aiming marker and the second x-ray aiming marker visible in an x-ray image is indicative of the alignment the within the permitted error limits (Case, Para 116; "A navigation guide screen 448 is provided on display screen 440 to assist in navigating the ablation needle to the target “T”. Based on the data received from the navigation system 406, the controller can determine if the surgical device 424 is aligned with target “T”. If the surgical device 424 is not aligned with target “T”, the circle 454 would be off-centered from outer circle 453. The user would then adjust the angle of entry for the surgical device 424 until the center of circle 454 is aligned with the center of outer circle 453. In some embodiments, circle 454 may be displayed as a red circle when the center of circle 454 is not aligned with the center of outer circle 453 or circle 454 may be displayed as a green circle when the center of circle 454 is aligned with the center of outer circle 453. Additionally, controller 408 may calculate the distance between the target “T” and the surgical device 424.") (Case, Para 15; “As used in this description, the term “ablation procedure” generally refers to any ablation procedure, such as microwave ablation, radio frequency (RF) ablation or microwave ablation-assisted resection. As it is used in this description, “energy applicator” generally refers to any device that can be used to transfer energy from a power generating source, such as a microwave or RF electrosurgical generator, to tissue.”) (Case, Para 30; “In an aspect of the present disclosure, an ablation planning and navigation system is provided”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bauer wherein a gap between the first x-ray aiming marker and the second x-ray aiming marker visible in an x-ray image is indicative of the alignment the within the permitted error limits as taught by Case in order to use an easily understood and intuitive visual method of aiming a device.
Regarding claim 3, Bauer as modified by Case above discloses all of the limitations of claim 1 as discussed above.
Bauer does not clearly and explicitly disclose wherein the first x-ray aiming marker and second x-ray aiming marker are rings.
Case further discloses wherein the first x-ray aiming marker and second x-ray aiming marker are rings (Case, Para 116; "A navigation guide screen 448 is provided on display screen 440 to assist in navigating the ablation needle to the target “T”. Based on the data received from the navigation system 406, the controller can determine if the surgical device 424 is aligned with target “T”. If the surgical device 424 is not aligned with target “T”, the circle 454 would be off-centered from outer circle 453. The user would then adjust the angle of entry for the surgical device 424 until the center of circle 454 is aligned with the center of outer circle 453. In some embodiments, circle 454 may be displayed as a red circle when the center of circle 454 is not aligned with the center of outer circle 453 or circle 454 may be displayed as a green circle when the center of circle 454 is aligned with the center of outer circle 453. Additionally, controller 408 may calculate the distance between the target “T” and the surgical device 424.") (Case, Para 15; “As used in this description, the term “ablation procedure” generally refers to any ablation procedure, such as microwave ablation, radio frequency (RF) ablation or microwave ablation-assisted resection. As it is used in this description, “energy applicator” generally refers to any device that can be used to transfer energy from a power generating source, such as a microwave or RF electrosurgical generator, to tissue.”) (Case, Para 30; “In an aspect of the present disclosure, an ablation planning and navigation system is provided”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bauer wherein the first x-ray aiming marker and second x-ray aiming marker are rings as taught by Case in order to use an easily understood and intuitive visual method of aiming a device.
Regarding claim 5, Bauer as modified by Case above discloses all of the limitations of claim 1 as discussed above.
Bauer further discloses wherein the aiming apparatus is disposed within a socket of the FUS transducer (Bauer, Figure 5 showing spot film marker 22 and telescope device 29 in a socket of the transducer) (Bauer, Col 6, lines 51-58; “An alternative device for introducing the spot film marker 22 is shown in FIG. 8. A telescope device 29, by means of which the spot film marker 22 can be positioned in the focus of the transducer by means of the telescope 29 which can be driven out, is provided there within the dome of the transducer 4. The telescope 29 may be actuated mechanically, pneumatically or hydraulically.”).
Regarding claim 6, Bauer as modified by Case above discloses all of the limitations of claim 1 as discussed above.
Bauer further discloses a cradle, wherein the FUS transducer is configured to be disposed within the cradle (Bauer, Figure 1; showing a cradle holding the components of apparatus).
Regarding claim 7, Bauer as modified by Case above discloses all of the limitations of claim 6 as discussed above.
Bauer further discloses wherein the aiming apparatus is configured to be disposed within the cradle (Bauer, Figure 5 showing spot film marker 22 and telescope device 29 in the cradle) (Bauer, Col 6, lines 51-58; “An alternative device for introducing the spot film marker 22 is shown in FIG. 8. A telescope device 29, by means of which the spot film marker 22 can be positioned in the focus of the transducer by means of the telescope 29 which can be driven out, is provided there within the dome of the transducer 4. The telescope 29 may be actuated mechanically, pneumatically or hydraulically.”).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bauer and Case as applied to claim 1 above, and further in view of Chernyak et al. (US20030151720, hereafter Chernyak).
Regarding claim 4, Bauer as modified by Case above discloses all of the limitations of claim 1 as discussed above.
Bauer does not clearly and explicitly disclose wherein the first x-ray aiming marker and second x-ray aiming marker are asymmetric.
In an analogous diagnostic imaging system field of endeavor Chernyak discloses wherein at least two markers are asymmetrical (Chernyak, Para 17; “A calibration apparatus, such as a body comprising a rotationally asymmetric aperture may be positioned in an optical path of the Hartmann-Shack camera and pupil camera. A control system is coupled to the Hartmann-Shack camera and pupil camera to determine the relative position of the calibration apparatus in the images taken with each of the cameras so as to determine the misalignment between the two cameras”) (Chernyak, Para 11; “the present invention provides a calibration apparatus for determining a relative positional and rotational offset between a Hartmann-Shack camera and a pupil camera. The apparatus comprises a body having an aperture. In some embodiments, the aperture is rotationally asymmetric. The rotationally asymmetrical aperture may take a variety of asymmetric forms”) (Chery yak, claim 13; “wherein the control system in the first mode superimposes a marker in a nominal position over an image of the calibration apparatus taken with the Hartmann-Shack camera and an image taken with the pupil camera and allows the marker to be moved into substantial alignment with the image of the asymmetric aperture, wherein the control system in the second mode compares the type of movement of the marker in the image taken with the Hartmann-Shack camera with the type of movement of the marker in the image taken with the pupil camera so as to determine the positional and rotational offset between the Hartmann-Shack camera and the pupil camera”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bauer wherein the x-ray markers are asymmetric x-ray markers in order to allow for a determination of misalignment between the two imaging devices as taught by Chernyak (Chernyak, Para 11 -17) which improves accuracy.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Bauer and Case as applied to claim 1 above, and further in view of Boctor et al. (US20130218024, hereafter Boctor).
Regarding claim 8, Bauer as modified by Case above discloses all of the limitations of claim 1 as discussed above.
Bauer does not clearly and explicitly disclose wherein the aiming apparatus comprises a depth camera disposed on one of the FUS transducer or a cradle configured to affix the FUS transducer.
In an analogous image guided ultrasound therapy system field of endeavor Boctor discloses in Figure 3a a depth camera (Boctor, Para 69; “A depth imaging system composed from more than two cameras. For example with three cameras where camera 1 and 2 are optimized for far range, camera 2 and 3 for mid-range, and camera 1 and 3 for close range.”) disposed on one of the FUS transducer or a cradle configured to affix the FUS transducer (Boctor, Figure 3a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bauer wherein the aiming apparatus comprises a depth camera disposed on one of the FUS transducer or a cradle configured to affix the FUS transducer in order to provide depth guidance as needed while taking into account the viewing position as taught by Boctor (Boctor, Para 46, 222, and 170).
Regarding claim 9, Bauer as modified by Case above discloses all of the limitations of claim 1 as discussed above.
Bauer does not clearly and explicitly disclose wherein the aiming apparatus comprises at least two distance sensors and a camera disposed on one of the FUS transducer or a cradle configured to affix the FUS transducer.
In an analogous image guided ultrasound therapy system field of endeavor Boctor discloses in Figure 3a at least two distance sensors (Boctor, Para 222; “In this case, it may be useful to have multiple depth ranging configurations built into the same head, mount, or bracket assembly), e.g. using […] multiple depth sensors, additionally at different relative orientations and/or set to different focal lengths.”) and a camera (Boctor, Para 69; “A depth imaging system composed from more than two cameras. For example with three cameras where camera 1 and 2 are optimized for far range, camera 2 and 3 for mid-range, and camera 1 and 3 for close range.”) disposed on one of the FUS transducer or a cradle configured to affix the FUS transducer (Boctor, Figure 3a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bauer wherein the aiming apparatus comprises at least two distance sensors and a camera disposed on one of the FUS transducer or a cradle configured to affix the FUS transducer in order to provide depth guidance as needed while taking into account the viewing position as taught by Boctor (Boctor, Para 46, 222, and 170).
Regarding claim 10, Bauer as modified by Case above discloses all of the limitations of claim 1 as discussed above.
Bauer does not clearly and explicitly disclose wherein the aiming apparatus comprising at least two angular sensors and a camera disposed on one of the FUS transducer or a cradle configured to affix the FUS transducer.
In an analogous image guided ultrasound therapy system field of endeavor Boctor discloses in Figure 3a at least two angular sensors (Boctor, Para 170; “In some embodiments, the local sensor system 112 includes an inertial sensor component 114 which can include one or more gyroscopes”) (Boctor, Para 183; “The tracking accuracy for such screens could be improved by attaching (at least inertial) local sensor systems to said screens, allowing better orientation estimation that using visual clues alone.”) (Boctor, Para 193-194; “The local sensor system can include inertial sensors 506, such as a three-axis gyro system, for example. […] Some embodiments of the current invention can provide an augmentation of existing devices which comprises a combination of different sensors: an inertial measurement unit based on a 3-axis accelerometer”) and a camera (Boctor, Para 69; “A depth imaging system composed from more than two cameras. For example with three cameras where camera 1 and 2 are optimized for far range, camera 2 and 3 for mid-range, and camera 1 and 3 for close range.”) disposed on one of the FUS transducer or a cradle configured to affix the FUS transducer (Boctor, Figure 3a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bauer wherein the aiming apparatus comprising at least two angular sensors and a camera disposed on one of the FUS transducer or a cradle configured to affix the FUS transducer in order to provide depth guidance as needed while taking into account the viewing position as taught by Boctor (Boctor, Para 46, 222, and 170).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bauer and Case as applied to claim 1 above, and further in view of Gorek et al. (US20100312103, hereafter Gorek).
Regarding claim 11, Bauer as modified by Case above discloses all of the limitations of claim 1 as discussed above.
Bauer does not disclose a radio opaque marker configured to be disposed at a center of an X-Ray intensifier; and a marker configured to be disposed on a skin of a patient above the treatment location.
In an analogous x-ray guided medical procedure field of endeavor Gorek discloses at least one radio opaque marker (laser reticle 18) configured to be placed at a center of an X-ray intensifier (Gorek, Para 66; “laser reticle 18 comprising a reticle frame 1152, radiopaque cross hair marker 1154, radiolucent front cover 1158, radiolucent back plate 1159, adjustable clamps 1160, sensor tilt LED indicators 1164, and an adjustable laser emitter system 96. FIG. 14 illustrates an exploded view of laser reticle 18. The reticle 18 is configured to generate a reference cross-hair viewable in fluoroscopic images generated by C-arm 20”) (Gorek, Para 17; “Radiopaque markers are also integrated into the reticle. The markers provide a reference for properly aligning the fluoroscopic images”), and a marker configured to be placed on a skin of a patient (Gorek, Para 66; “Other benefits may also be gained by using laser reticle 18, such as the benefit of producing a laser cross-hair target on the skin of the patient.”) above a treatment location (Gorek, Para 70; “Laser reticle 18 also includes an adjustable laser cross hair emitter, which may generate a cross-haired target onto the patient's skin at the surgical access site. […] Thus, a perfect vector will be created down the central axis 85 of the x-ray beam 85, which may assist the surgeon in determining a preferred starting point for skin penetration when performing”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bauer to include a radio opaque marker configured to be disposed at a center of an X-Ray intensifier; and a marker configured to be disposed on a skin of a patient above the treatment location in order to accurately align the imaging device as taught by Gorek (Gorek, Para 17).
Regarding claim 12, Bauer as modified by Case and Gorek above disclose all of the limitations of claim 11 as discussed above.
Bauer does not clearly and explicitly disclose wherein the marker that is configured to be disposed on the skin is a visual marker.
Gorek further discloses wherein the marker that is configured to be disposed on the skin is a visual marker (Gorek, Para 66; “Other benefits may also be gained by using laser reticle 18, such as the benefit of producing a laser cross-hair target on the skin of the patient.”) (Gorek, Para 70; “Laser reticle 18 also includes an adjustable laser cross hair emitter, which may generate a cross-haired target onto the patient's skin at the surgical access site. […] Thus, a perfect vector will be created down the central axis 85 of the x-ray beam 85, which may assist the surgeon in determining a preferred starting point for skin penetration when performing”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bauer wherein the marker that is configured to be disposed on the skin is a visual marker in order to accurately align the imaging device as taught by Gorek (Gorek, Para 17).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bauer, Case, and Gorek as applied to claim 11 above, and further in view of Gilboa (US20080208041, hereafter Gilboa).
Regarding claim 13, Bauer as modified by Case and Gorek above disclose all of the limitations of claim 11 as discussed above.
Bauer does not clearly and explicitly disclose wherein the marker that is configured to be disposed on the skin is a radio opaque marker.
In an analogous surgical navigation field of endeavor Gilboa discloses wherein the marker that is configured to be disposed on the skin is a radio opaque marker (Gilboa, Para 75; “According to one particularly preferred methodology, at the beginning of the procedure, a coordinator sticker or other "patch" made of a block or layer of material that contains the fiducial markers is attached to skin of the patient above the target. A CT (or other volume imaging) scan is performed. Locations of the markers and the target are determined and fed to computer 200, for instance via disk-on-key memory 220. Based on this data, navigation of the tool towards the target can be determined.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bauer wherein the marker that is configured to be disposed on the skin is a radio opaque marker in order to navigate the surgical device with greater accuracy as taught by Gilboa (Gilboa, Para 74).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John Li whose telephone number is (313)446-4916. The examiner can normally be reached Monday to Thursday; 5:30 AM to 3:30 PM Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN D LI/Primary Examiner, Art Unit 3798
Prosecution Insights