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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 28, 2025 has been entered.
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.
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.
Claims 1, 9-12, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. PG Pub. No. 2021/0298832 A1 to Govari in view of U.S. PG Pub. No. 2008/0275339 A1 to Thiemann et al.
Regarding claim 1, Govari discloses an apparatus, comprising: (a) a body having a distal end; (b) a first position sensor, the first position sensor being fixedly positioned relative to the distal end, the first position sensor being configured to generate a signal indicating a real-time position of the first position sensor within three-dimensional space; (c) an ultrasonic assembly, the ultrasonic assembly being fixedly positioned relative to the position sensor, the ultrasonic assembly comprising a transducer operable to generate ultrasonic waves, the distal end being configured to emit the ultrasonic waves generated by the transducer, the ultrasonic assembly being configured to generate ultrasonic images; and (d) a processor configured to register a patient with one or more preoperative images based at least in part on one or more two-dimensional ultrasonic images generated by the ultrasonic assembly and the signal indicating a real-time position of the first position sensor within three-dimensional space (see Figs. 1-3, abstract, and para 4-9, 15-21, 26-31, 33-38, 47-52, 56, and 62-66).
It appears Govari discloses 2D images.
However, in the alternative Thiemann discloses a similar ultrasound, CT bone imaging system, wherein two-dimensional ultrasound images are used for registration with CT images (see Figs. 1 and 4, abstract, and para 31, 36, 38, 42-55, and 62).
It would have been an obvious substitute to use 2D images instead of the generic ultrasound images of Govari because doing so would predictably allow for registration between CT and ultrasound images. Further, the combination with Thiemann would allow for the added benefit of enhanced scaling and imaging using ultrasound.
Regarding claim 9, Govari discloses a device, wherein the processor being further configured to identify structural features of bone in the one or more two-dimensional ultrasonic images generated by the ultrasonic assembly through one or more image processing algorithms (see Figs. 1-3, abstract, and para 4-9, 15-21, 26-31, 33-38, 47-52, 56-60, and 62-66).
Regarding claim 10, Govari discloses a device, wherein the processor being further configured to correlate the structural features of bone identified from the one or more two- dimensional ultrasonic images with corresponding structural features of bone in one or more preoperative images (see Figs. 1-3, abstract, and para 4-9, 15-21, 26-31, 33-38, 47-52, 56-60, and 62-66).
Regarding claim 11, Govari discloses a device, wherein the processor being further configured to map a plurality of registration points from bone in the one or more two- dimensional ultrasonic images with corresponding points in the one or more preoperative images (see Figs. 1-3, abstract, and para 4-9, 15-21, 26-31, 33-38, 47-52, 56-60, and 62-66).
Regarding claim 21, Govari discloses a device, the processor being further configured to map the plurality of registration points from bone to the corresponding points in the one or more preoperative images with only one two-dimensional ultrasonic image (see Figs. 1-3, abstract, and para 4-9, 15-21, 26-31, 33-38, 47-52, 56-60, and 62-66).
Regarding claim 12, Govari discloses an apparatus, comprising: (a) a body having a distal end; (b) a first position sensor, the first position sensor being fixedly positioned relative to the distal end by a first distance, the first position sensor being configured to generate a signal indicating a real-time position of the first position sensor within three-dimensional space;
(c) an imaging module, the imaging module being fixedly positioned relative to the first position sensor, the imaging module being operable to capture images of soft tissue, bone, and the transition point between soft tissue and bone (see Figs. 1-3, abstract, and para 4-9, 15-21, 26-31, 33-38, 47-52, 56, and 62-66).
It appears Govari discloses 2D images.
However, in the alternative Thiemann discloses a similar ultrasound, CT bone imaging system, wherein two-dimensional ultrasound images are used for registration with CT images (see Figs. 1 and 4, abstract, and para 31, 36, 38, 42-55, and 62).
It would have been an obvious substitute to use 2D images instead of the generic ultrasound images of Govari because doing so would predictably allow for registration between CT and ultrasound images. Further, the combination with Thiemann would allow for the added benefit of enhanced scaling and imaging using ultrasound.
Further, Thiemann discloses a similar device, comprising (d) a patient tracking assembly, the patient tracking assembly configured to be fixedly positioned to the head of a patient, the patient tracking assembly including a second position sensor configured to generate a signal indicating a real time position of the patient tracking assembly within three-dimensional space (see Figs. 1 and 4, abstract, and para 31, 36, 38, 42-55, and 62 noting element 15 is attached to the bone of interest and the bone of interest in some embodiments is the skull or head).
It would have been obvious and predictable to have included a patient tracking assembly with the system of Govari because doing so would provide an additional frame of reference and fiducial point for registration. Further, a patient tracking assembly would also be useful for tracking patient movement relative to either or both of the ultrasound device and the CT imaging device in both references.
Claims 2-6 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Govari and Thiemann as applied to claims 1 and 12 above, and further in view of U.S. PG Pub. No. 2018/0098816 A1 to Govari et al. (hereinafter Govari II).
Regarding claim 2, Govari discloses a device, wherein the ultrasonic assembly being configured to determine a depth of soft tissue between bone in a patient and an outer surface of the patient (see Figs. 1-3, abstract, and para 4-9, 15-21, 26-31, 33-38, 47-52, 56, and 62-66).
However, Govari doesn’t disclose contact with the patient but does suggest that light-touch registration is possible and beneficial.
Govari II discloses a similar US CT registration system, wherein the ultrasound device is in contact with the distal end (see Fig. 2, abstract, and para 40-43).
It would have been an obvious and predictable substitution to substitute a light-touch registration for a no touch registration because both would predictably provide registration. Further, a light-touch registration is easier for a user to implement because the probe can be predictably and repeatedly placed on known locations of the head.
Examiner notes the claims are obvious over Govari II and Govari as well.
Regarding claim 3, Govari discloses a device, further comprising a processor configured to determine a distance between the first position sensor and the bone in the patient based at least in part on a combination of a known distance between the first position sensor and the distal end and the depth of soft tissue determined by the ultrasonic assembly (see Figs. 1-3, abstract, and para 4-9, 15-21, 26-31, 33-38, 47-52, 56, and 62-66).
Regarding claim 4, Govari discloses a device, further comprising an image guided surgery system external to the body, the processor being contained in the image guided surgery system (see Figs. 1-3, abstract, and para 4-9, 15-21, 26-31, 33-38, 47-52, 56, and 62-66).
Regarding claim 5, Govari discloses a device, the image guided surgery system further comprising a field generator assembly, the field generator assembly being operable to generate an electromagnetic field, the first position sensor being configured to generate a signal indicating a real-time position of the first position sensor within three- dimensional space in response to the electromagnetic field (see Figs. 1-3, abstract, and para 4-9, 15-21, 26-31, 33-38, 47-52, 56, and 62-66).
Regarding claim 6, Govari discloses a device, the processor being further configured to register a patient with one or more preoperative images based at least in part on the determined distance between the first position sensor and the bone in the patient and the signal indicating a real-time position of the first position sensor within three-dimensional space (see Figs. 1-3, abstract, and para 4-9, 15-21, 26-31, 33-38, 47-52, 56, and 62-66).
Regarding claim 13, Govari II in combination with Govari discloses a similar US CT registration system, further comprising a processor, the processor being configured to determine a real-time distance from the first position sensor to the bone in the patient underlying the contact point based on a combination of the first distance and a second distance determined from the difference in a depth of the soft tissue between the bone and a contact point (see Govari II Fig. 2, abstract, and para 40-43 and citations to Govari for claim 12).
It would have been an obvious and predictable substitution to substitute a light-touch registration for a no touch registration because both would predictably provide registration. Further, a light-touch registration is easier for a user to implement because the probe can be predictably and repeatedly placed on known locations of the head.
Regarding claim 14 Govari discloses a device, wherein the processor being further configured to register a patient with one or more preoperative images based at least in part on the determined real-time distance and the signal indicating a real-time position of the first position sensor within three-dimensional space (see Figs. 1-3, abstract, and para 4-9, 15-21, 26-31, 33-38, 47-52, 56, and 62-66).
Regarding claim 15 Govari discloses a device, wherein the imaging module being operable to: (i) emit ultrasonic energy through tissue between the outer surface of the patient and the bone in the patient, and (ii) receive ultrasonic energy reflected by the bone in the patient to thereby determine the second distance (see Figs. 1-3, abstract, and para 4-9, 15-21, 26-31, 33-38, 47-52, 56, and 62-66).
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Govari and Thiemann as applied to claim 12 above, and further in view of either or both of U.S. PG Pub. No. 2016/0361070 A1 to Ardel and U.S. Patent No. 5,871,445 A to Bucholz.
Regarding claims 16-18, Ardel and Bucholz discloses similar surgical range finders, wherein the imaging module being operable to: (i) emit light through tissue between the outer surface of the patient and the bone in the patient, and (ii) receive light reflected by the bone in the patient to thereby determine the second distance; the emitted light being within the infrared spectrum; and the emitted light comprising laser light (see Ardel Figs. 5 and 8 and para 240 and Bucholz Fig. 8 and col 15 ln 65-col 16 ln 34).
It would have been an obvious and predictable substitute to use infrared lasers for the ultrasound of Govari because doing so would predictably provide the same measurements as already required in Govari. Alternatively, adding a laser range finder could also provide redundant measurements for increased accuracy.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Govari and Thiemann as applied to claim 12 above, and further in view of U.S. PG Pub. No. U.S. PG Pub. No. 2008/0039718 A1 to Drinan et al.
Regarding claim 19, Drinan discloses a similar depth finding tissue imaging device, wherein the depth finding module being operable to determine the second distance via ultra-wideband radar (see Figs. 3-5 and para 45-58).
It would have been an obvious and predictable substitute to use UWB radar for the ultrasound of Govari because doing so would predictably provide the same measurements with a small number of inexpensive components enabling low power, portable applications.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Govari II and either or both of U.S. PG Pub. No. 2016/0361070 A1 to Ardel and U.S. Patent No. 5,871,445 A to Bucholz.
Regarding claim 20, Govari II discloses a method, comprising: (a) positioning a registration probe against an outer surface of a patient at a first contact point; (b) capturing position data via a position sensor of the registration probe while the registration probe is positioned against the outer surface of the patient at the first contact point, the position data indicating a real-time position of the position sensor within three-dimensional space (see Figs. 1-3, abstract, and para 6-12, 22-25, 29, 30, and 32-48).
Further, Ardel and Bucholz discloses similar surgical range finders, (c) emitting light from a depth-finding module of the registration probe through soft tissue underlying the outer surface of the patient, the emitted light being reflected by bone under the soft tissue; and (d) capturing data from the reflected light, the captured data representing an image of the bone (see Ardel Figs. 5 and 8 and para 240 and Bucholz Fig. 8 and col 15 ln 65-col 16 ln 34).
It would have been an obvious and predictable substitute to use infrared lasers for the ultrasound of Govari II because doing so would predictably provide the same measurements as already required in Govari II. Alternatively, adding a laser range finder could also provide redundant measurements for increased accuracy.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot in view of the new grounds of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJEEV P SIRIPURAPU whose telephone number is (571)270-3085. The examiner can normally be reached 9-5 M-F.
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 is Keith Raymond. 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.
/RAJEEV P SIRIPURAPU/Primary Examiner, Art Unit 3798
Prosecution Insights