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.
Claim(s) 1, 4-5, 8-9, 11-20 and 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ren et al. (US 20090268865) in view of Lebovic et al. (US 6577702).
Regarding claim 1, Ren teaches a method of imaging a breast compressed with a paddle comprising a foam compressive element, the method comprising:
emitting an x-ray energy from an x-ray source 16 towards the breast 12 and the paddle compressive element 10 and a marker 22 disposed adjacent the paddle compressive element, wherein the x-ray energy is emitted over a predetermined time period, and wherein the marker comprises a physical characteristic;
detecting the x-ray energy at a detector 20 disposed opposite the breast from the x-ray source;
generating an image of the compressed breast and the marker based on the detected x-ray energy, wherein the marker in the generated image comprises an image characteristic associated with the physical characteristic; comparing the image characteristic to the physical characteristic; and sending a signal when the image characteristic deviates from the physical characteristic by a threshold (correlation analysis and gray level within system tolerance, para 35-36).
However Ren fails to teach the paddle is foam.
Lebovic teaches a paddle foam 6.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adapt the paddle of Ren with the foam as taught by Lebovic, since it would better patient comport.
Regarding claim 4, Ren as modified teaches the marker is disposed on a surface of a foam compressive element that contacts the breast during the emission of the x-ray energy (on the skin).
Regarding claim 5, Ren teaches the marker is adhered to the breast (on the skin).
Regarding claim 8, Ren teaches processing the image of the breast and the marker to generate an analysis image; and displaying the analysis image, wherein the marker is not visible in the analysis image (para 35-36).
Regarding claim 9, Ren teaches the physical characteristic comprises a radiopacity (at least 100%), and wherein the image characteristic corresponds to an attenuation of the x-ray energy passing through the marker during the emission of the x-ray energy (para 35-36).
Regarding claim 11, Ren teaches sending the signal comprises displaying a notification (para 54).
Regarding claim 12, Ren teaches an apparatus comprising:
an x-ray source; an x-ray detector; a breast support platform for supporting a breast during an imaging procedure; a breast compression paddle movably disposed between the x-ray source and the x-ray detector, the breast compression paddle comprising a rigid substrate and a marker disposed in contact with the paddle (marker on the skin), wherein the marker comprises a plurality of markers arranged in at least one row foam compressive element; at least one processor; and a memory storing instructions that, when executed by the at least one processor, cause the apparatus to perform operations comprising: emitting an x-ray energy from the x-ray source and though the breast and the marker; receiving the emitted x-ray energy; generating an image from the received x-ray energy, wherein the image depicts the breast and the marker; analyzing the image to identify a movement of the marker; and sending a signal when the movement exceeds a threshold (correlation analysis and gray level within system tolerance, para 35-36).
However Ren fails to teach the paddle is foam.
Lebovic teaches a paddle foam 6.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adapt the paddle of Ren with the foam as taught by Lebovic, since it would better patient comport.
Regarding claim 13, Ren teaches analyzing the image comprises identifying the marker in the image (para 35-36).
Regarding claim 14, Ren teaches the marker comprises a physical characteristic and wherein analyzing the image comprises comparing the physical characteristic of the marker to an imaged characteristic of the marker in the image (para 35-36).
Regarding claim 15, Ren teaches the physical characteristic comprises a dimension of the marker (para 35-36).
Regarding claim 16, Ren teaches the physical characteristic comprises a radiopacity of the marker (at least 100%).
Regarding claim 17, Ren teaches the operations further comprise: processing the image of the breast and the marker to generate an analysis image; and displaying the analysis image and teaches the marker is not visible in the analysis image (para 35-36).
Regarding claim 18, Ren teaches sending the signal comprises displaying a notification (para 31-32).
Regarding claim 19, Ren teaches the marker is disposed on a surface of a foam compressive element that is configured to contact the breast during the emission of the x-ray energy (para 26, skin line).
Regarding claim 20, Ren teaches the breast compression paddle comprises the marker is integral with the paddle (when compressed).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ren et al. (US 20090268865) in view of Rusin (US 6412491).
Regarding claim 21, Ren fails to teach the marker is disposed on a sheet adhered to the breast.
Rusin teaches a marker is disposed on a sheet adhered to the breast (figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adapt the marker of Ren with the marker, since it would better marker positioning.
Regarding claim 23, Ren teaches the at least one row comprises a plurality of rows (figure 5c).
Regarding claim 24, Ren teaches the row is disposed substantially parallel to a chest wall of the patient (figure 5c).
Regarding claim 25, Ren fails to teach the row is disposed substantially orthogonal to a chest wall of the patient.
However it would have been obvious to one having ordinary skill in the art at the time the invention was made to adapt the orthogonal direction, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Regarding claim 27, Ren teaches an apparatus comprising:
an x-ray source; an x-ray detector; a breast support platform for supporting a breast during an imaging procedure; a breast compression paddle movably disposed between the x-ray source and the x-ray detector, the breast compression paddle comprising: a rigid substrate; and a marker disposed in contact with the foam compressive element; at least one processor; and a memory storing instructions that, when executed by the at least one processor, cause the apparatus to perform operations comprising: emitting an x-ray energy from the x-ray source and though the breast and the marker; receiving the emitted x-ray energy; generating an image from the received x-ray energy, wherein the image depicts the breast and the marker; analyzing the image to identify a movement of the marker; and sending a signal when the movement exceeds a threshold (correlation analysis and gray level within system tolerance, para 35-36).
However Ren fails to teach the paddle is foam.
Lebovic teaches a paddle foam 6.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adapt the paddle of Ren with the foam as taught by Lebovic, since it would better patient comport.
Allowable Subject Matter
Claim 2-3, 6-7, 10 and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 2-3, 6-7 and 10, the prior art fails to teach the physical characteristic comprises a physical dimension, and wherein the image characteristic depicts a movement of the marker during the emission of the x-ray energy as claimed in claim 2.
Regarding claim 26, the prior art fails to teach a first row of the plurality of rows is disposed substantially orthogonal to a second row of the plurality of rows.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOON K SONG whose telephone number is (571)272-2494. The examiner can normally be reached M to Th 10am to 7pm.
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/HOON K SONG/Primary Examiner, Art Unit 2884
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