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
Claim 10 is objected to because of the following informalities: In claim 10, line 2, “patent” needs to be changed to “patient”. Appropriate correction is required.
Election/Restrictions
Applicant’s election without traverse of species a) of the 1st set and species a) from the 2nd set (claims 2, 3, 5-8, 10-15, 17-21) in the reply filed on 04/28/2026 is acknowledged.
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.
Claim(s) 2, 3, 5-8, 10-11, 13-15, 17-, 19, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cosman (US 2004/0122311) in view of Yared (US 2007/0238957).
With respect to claim 2, Cosman discloses a method for confirming positioning of a patient for scanning in a system, the method comprising:
capturing at least one 3D optical image of the patient via at least one 3D optical imaging device of the system; based on the at least one 3D optical image, identifying a position of the patient with respect to the system (see para. 0037, 0038 “Regarding the camera system C, the individual optical cameras 17, 18 and 19 essentially "look" at the position and orientation of the patient P, that is, viewing the volume containing the patient P and the apparatus as explained above. The markers 20, 21, 23 and 24 can be "seen" by the cameras to track marker positions relative to the isocenter point 7 and the beam B. By way of a disclosing reference, see U.S. Pat. No. 5,446,548, entitled "Patient Positioning and Monitoring System", L. H. Garrick and S. F. El-Hakim, issued Aug. 29, 1995; as well as an operating system identified as the OTS Optical Tracking System produced by Radionics, Inc. of Burlington, Mass. or a Motion Tracking System available from Oxford Metronics, Oxford, England. [0033] As indicated, the optical signal outputs from the cameras 17, 18 and 19 are supplied to an optical image tracking processor 34 (FIG. 1, upper right) as well known in the field. In the operation of the processor 34, the individual camera data signals are translated into three-dimensional position data (in the camera coordinate space) related to objects in the cameras' collective field of view and including the identifying index markers 20, 21, 23 and 24. The resulting positional data defines the position of the patient P relative to objects in the field of view of the camera system C (in camera coordinate space). ;
comparing the identified patient position to one or more acceptance criteria; and determining acceptance of the identified position, wherein based on acceptance of the identified patient position (see para. 0045, 0046, “the marker positions are thereby determined in three-dimensional space relative to the camera system. Further, the marker positions on the patient's body are also determined relative to markers on the LINAC itself such as 30, 31, 32 on the couch 11 or 40A, 40B, and 40C on the gantry 1. Data from the camera system C is provided from the processor 34 to the comparator/computer 37 where the index marker locations are compared to marker positions determined from imaging data to accomplish a "best fit" as well known. Accordingly, the image data defining the patient is transformed to camera space. Thus, a target coordinate is determined from the treatment planning system 36 involving the explicit location of the target in relation to objects in the camera field of view including the collimator 5 and accordingly the beam B. [0046] In a dynamic mode of the system, corrections may be provided for patient movement during treatment along with continual confirmation of the patient's body position relative to the LINAC machine. If there is respiratory body movement of the patient P, as would typically occur in the torso region, the tidal movement can be observed by the camera system C tracking the index markers 20, 21, 23 and 24. Synchronizing the radiation from the LINAC machine L can assure that the anatomical target is impacted by the beam 6 even though the patient's internal organs are moving. This too can be controlled by the controller 38 with feedback to the optical tracking processor 34 through the comparator 37. Consequently, the comparator 37 enables streamlining certain complex procedures and even routine procedures”;
a scan of the patient is performed via the at least one 3D optical imaging device and a x-ray source of the system (see para. 0063) After the treatment planning, the patient is put on the couch F with an appropriate setup as illustrated by the step of block 73. Alternatively, during the step of block 73, the patient could be placed on a diagnostic apparatus such as an interoperative CT or MRI scanner. By use of an optical tracking system, as described above, further reference data is taken on the treatment machine, e.g., machine L (FIG. 1) in a step illustrated by block 74 (FIG. 4). Also within the step, a transformation can be made via a computer or comparator (e.g., comparator 37, FIG. 1) to establish the position of treatment plan targets relative to the coordinate space of the camera system..
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However, Cosman fails to explicitly teach that the x-ray system is a dual energy x-ray system.
Yared discloses a combined x-ray and optical tomographic imaging system in which, “The configuration between the optical and x-ray axes is not limited to quadrature mounting, but could be based on any arbitrary angle, for example, in the system 300 shown in FIG. 3. Furthermore, as FIG. 3 indicates, more than one x-ray axis could be provided, for example, a dual-energy x-ray subsystem employing two x-ray sources (142, 347) and two x-ray detectors (144, 348) may be used. Advantages of such a system include the use of different x-ray beam energies simultaneously for different contrast levels, in addition to improved scan speed and temporal resolution. The object 132 under study or evaluation is positioned on a sliding support 236 such that the isocenter of the gantry 240 is contained within the object 132.” See para. 0098.
It would have been obvious to one skilled in the art before the effective filling date to have a dual x-ray system as disclosed by Yared because doing so will allow for improved temporal resolution.
With respect to claims 3, 15 Cosman in view of Yared disclose the method of claim wherein the one or more acceptance criteria includes the patient being entirely within a scanning field of the at least one 3D optical imaging device and the dual-energy x-ray source (see Cosman Fig. 1, body position within the scanning area).
With respect to claims 5, 17 Cosman in view of Yared disclose wherein based on a non-acceptance of the identified patient position, the patient is repositioned (see Cosman Fig. 4, repositioning of the patient).
With respect to claims 6, 18 Cosman in view of Yared disclose urther comprising presenting an alert on the system when non-acceptance of the identified patient position occurs (see para. 0076 the target coordinates are display in the user interface for alignment).
With respect to claim 7, Cosman in view of Yared disclose the method of claim 6, wherein the alert includes a reason for non-acceptance and instructions for repositioning the patient towards an acceptable position. (see para. 0076 the target coordinates are display in the user interface for alignment)
With respect to claim 8, Cosman in view of Yared disclose the method of claim 2, wherein the determination of acceptance of the identified patient position occurs prior to the scan of the patient (Cosman describes imaging feedback to positioning of the target, the scanning of optical and x-ray occurs dynamically to provide target data, 0046).
With respect to claim 10, Cosman in view of Yared disclose the method of claim 2, further comprising during the scan of the patient, repeating confirmation of patent positioning by capturing at least one second 3D optical image, identifying a second position of the patient, comparing the second identified patient position to the one or more acceptance criteria, and determining acceptance of the second identified patent position (see Cosman para. 0045,0046 multiple targets)
With respect to claim 11, Cosman in view of Yared disclose the method of claim 10, wherein the repeated confirmation of patent positioning is performed continuously or in predetermined intervals (see Cosman para. 0046).
With respect to claims 13, 21, Cosman in view of Yared disclose wherein the at least one 3D optical image is obtained from a stereoscopic device, a laser scanning device, a structured light device, a modulated light device, or a combination of at least some thereof. (see Cosman para. 0028).
With respect to claim 14, Cosman in view of Yared disclose A system comprising:a support structure configured to move along an axis of a patient; a dual-energy x-ray source mounted to the support structure, the dual energy x-ray source configured to emit dual-energy x-rays towards the patient along a scan path; (see Fig. 1, Fig. 2 yared) an x-ray detector configured to detect the dual-energy x-rays emitted from the dual- energy x-ray source after passing through the patient; (see para. 0098) at least one 3D optical imaging device mounted to the support structure and configured to obtain at least one 3D optical image of the patient; (see Fig. 3, element 124)
and a processing device communicatively coupled to the support structure, the dual-energy x- ray source, the x-ray detector, and the at least one 3D optical imaging device, the processing device configured to:capture at least one 3D optical image of the patient via the at least one 3D optical imaging device;based on the at least one 3D optical image, identify a position of the patient with respect to the system;compare the identified patient position to one or more acceptance criteria; and determine acceptance of the identified patient position, wherein based on acceptance of the identified patient position, a scan of the patient is performed via the support structure (see Cosman, see para. 0045, 0046, “the marker positions are thereby determined in three-dimensional space relative to the camera system. Further, the marker positions on the patient's body are also determined relative to markers on the LINAC itself such as 30, 31, 32 on the couch 11 or 40A, 40B, and 40C on the gantry 1. Data from the camera system C is provided from the processor 34 to the comparator/computer 37 where the index marker locations are compared to marker positions determined from imaging data to accomplish a "best fit" as well known. Accordingly, the image data defining the patient is transformed to camera space. Thus, a target coordinate is determined from the treatment planning system 36 involving the explicit location of the target in relation to objects in the camera field of view including the collimator 5 and accordingly the beam B. [0046] In a dynamic mode of the system, corrections may be provided for patient movement during treatment along with continual confirmation of the patient's body position relative to the LINAC machine. If there is respiratory body movement of the patient P, as would typically occur in the torso region, the tidal movement can be observed by the camera system C tracking the index markers 20, 21, 23 and 24. Synchronizing the radiation from the LINAC machine L can assure that the anatomical target is impacted by the beam 6 even though the patient's internal organs are moving. This too can be controlled by the controller 38 with feedback to the optical tracking processor 34 through the comparator 37. Consequently, the comparator 37 enables streamlining certain complex procedures and even routine procedures”;).
However, Cosman fails to explicitly teach that the x-ray system is a dual energy x-ray system.
Yared discloses a combined x-ray and optical tomographic imaging system in which, “The configuration between the optical and x-ray axes is not limited to quadrature mounting, but could be based on any arbitrary angle, for example, in the system 300 shown in FIG. 3. Furthermore, as FIG. 3 indicates, more than one x-ray axis could be provided, for example, a dual-energy x-ray subsystem employing two x-ray sources (142, 347) and two x-ray detectors (144, 348) may be used. Advantages of such a system include the use of different x-ray beam energies simultaneously for different contrast levels, in addition to improved scan speed and temporal resolution. The object 132 under study or evaluation is positioned on a sliding support 236 such that the isocenter of the gantry 240 is contained within the object 132.” See para. 0098.
It would have been obvious to one skilled in the art before the effective filling date to have a dual x-ray system as disclosed by Yared because doing so will allow for improved temporal resolution.
With respect to claim 19, Yared discloses The system of claim 14, further comprising an optically translucent patient support table or wall on which the patient is positioned. (see Fig. 3, emitter 122 send optical signal to detector 124).
Claim(s) 12, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cosman (US 2004/0122311) in view of Yared (US 2007/0238957), as applied to claims 2, 14, in view of Malkov et al. ( “Combining 3D optical imaging and dual energy absorptiometry to measure three compositional components” Proc SPIE Int Soc Opt Eng., Feb. 2014).
With respect toclaims 12, 20, Cosman in view of Yared disclose further comprising scanning the patient via:moving the dual-energy x-ray source, an x-ray detector, and the at least one 3D optical imaging device along a scan path of the patient;emitting x-rays from the dual-energy x-ray source;detecting the x-rays at the x-ray detector after the x-rays have passed through at least a portion of the patient;capturing, substantially concurrently with the emission of the x-rays, 3D optical images of the patient (see For example Yared, Fig. 1 and its corresponding description);
However Cosman in view of Yared fails to teach determining on a per-pixel basis, amounts of at least three of: bone, fat tissue, lean tissue, dehydrated lean tissue, and water of the patient.
Malkov, in the same field of endeavor in the subject of combining 3D optical imaging and dual energy absorptiometry to measure three compositional components discloses having a dual energy absorptiometry body scanner in combination with a 3D optical imaging device (e.g. Kinect imaging system) (see abstract, see section 3.2, section 3.3).
Malkov discloses the system of claim 53, further comprising a processing device, wherein the x-ray detector and the first 3D optical imaging device are communicatively coupled to the processing device, and wherein the processing device is configured to compute a thickness of the scanning target on a per pixel basis ( section 3.3 3D optical imaging “The end result is a unqiue and accurate total tissue thickness, T, for each pixel”).
It would have been obvious to one skilled in the art at the time of the invention to modify Berger in view of Navab to further include a 3D optical imaging system as disclosed by Malkov in order to estimate body are compositions such as water, bone lipid and protein (see abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M SANTOS RODRIGUEZ whose telephone number is (571)270-7782. The examiner can normally be reached Monday-Friday 8:30am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M. Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
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