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 23 is objected to because of the following informalities: “the pattern is one or a grid pattern” should read –the pattern is one of a grid pattern--.
Appropriate correction is required.
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 8-11 & 22-31 are rejected under 35 U.S.C. 103 as being unpatentable over Fisher (US 2011/0087098) in view of Morita (US 2015/0093013) and Erhard (US 2014/0328458).
Regarding claim 8, Fisher teaches an imaging system, comprising:
a breast compression paddle (compression plate 52, [0036]);
an imaging detector (imaging panels 38, 39, [0033]);
at least one sensor (2D matrices of sensors 40, 41, [0033]) incorporated into at least one of the breast compression paddle (Figure 2) or the imaging detector ([0033] & Figures 1-2);
Per Figure 2, the combination of the 2D matrix of sensors and compression plate comprise the imaging panel. Thus, the sensors are incorporated into both the breast compression paddle and the imaging detector.
at least one processor (computer units 16, 18, [0032]); and
memory (memory, [0067]), operatively coupled to the at least one processor, storing instructions that when executed by the at least one processor, cause the system to perform a set of operations, comprising:
generating, based on data captured by the at least one sensor, spatial data (image data, [0032]) for a breast compressed between the breast compression paddle and the imaging detector ([0048]).
However, Fisher fails to disclose generating, based on the spatial data, at least one of a contact map or positional data for the compressed breast.
Morita teaches generating, based on the spatial data (radiation image of the breast M, [0165]), at least one of a contact map or positional data (Figure 17) for the compressed breast.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Fisher to include generating, based on the spatial data, at least one of a contact map or positional data for the compressed breast, as taught by Morita. Measuring the proportion of the breast that contacts the paddle allows for the degree of compression to be gauged, as a higher compression will result in a higher breast contact area.
However, Fisher in view of Morita fail to disclose based on the at least one of the contact map or positional data, generating a notification that the breast is in an at least one of an improper compression or an improper position.
Erhard teaches based on the at least one of the contact map or positional data (breast contact area, [0056]), generating a notification (output signal 17, [0080]) that the breast is in an improper compression ([0080] & Figure 12C).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Fisher and Morita to include based on the at least one of the contact map or positional data, generating a notification that the breast is in an improper compression, as taught by Erhard. Proper compression is important during a mammogram, as an overly-compressed breast can cause discomfort in a patient, and insufficient compression can lower image quality while increasing the radiation dose to the patient.
Regarding claim 9, Fisher in view of Morita and Erhard teach the system of claim 8, and Fisher further teaches that the at least one sensor includes at least one of an optical sensor (optical panels, Abstract), an infrared sensor (Abstract), or an ultrasonic sensor (ultrasound panels, Abstract).
Although Fisher does not explicitly teach infrared sensors, the Abstract teaches that the imaging panels “may include panels using any form of…electromagnetic energy” and lists several of these types of sensors. Because infrared imaging is well-known in the art, especially in the field of breast imaging, Examiner asserts that one having ordinary skill in the art would understand that the teachings of Fisher can apply to an infrared sensor.
Regarding claim 10, Fisher in view of Morita and Erhard teach the system of claim 8, and Fisher further teaches that the at least one sensor includes a set of sensors incorporated into the breast compression paddle and the imaging detector (Figures 1-2).
Regarding claim 11, Fisher in view of Morita and Erhard teach the system of claim 8, and Morita further teaches that the contact map includes a skin line for the breast (portion M2, [0165], Figure 17), an uncompressed breast line (portion M1, [0165], Figure 17), and a roll-off region between the uncompressed breast line and the skin line (Figure 17).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Fisher such that the contact map includes a skin line for the breast, an uncompressed breast line, and a roll-off region between the uncompressed breast line and the skin line, as taught by Morita. The relative area of the roll-off region can be observed in order to determine the degree of breast compression, as the roll-off region decreases as the compression increases.
Regarding claim 22, Fisher in view of Morita and Erhard teach the system of claim 10, and Fisher further teaches that the set of sensors are disposed in a pattern throughout at least one of the breast compression paddle and the imaging detector (Figures 1, 6-10, & 12-13).
Regarding claim 23, Fisher in view of Morita and Erhard teach the system of claim 22, and Fisher further teaches that the pattern is one of a grid pattern (2D matrices of sensors 40, 41, [0033]; Figures 1, 6-10, & 12-13) and the set of sensors being disposed around the periphery of the at least one of the breast compression paddle and the imaging detector (Figure 1).
Per Figure 1, it appears as if the sensors 40, 41 comprise the entirety of the imaging panels 38, 39; thus, there would be sensors disposed around the periphery of the compression plate and imaging panel.
Regarding claim 24, Fisher in view of Morita and Erhard teach the system of claim 10, and Fisher further teaches that the set of sensors include one or more of force sensors (piezoelectric transducers (PZTs) and/or piezoelectric micromachines ultrasonic transducers (pMUTs), [0004]), photo sensors (optical panels, Abstract), infrared sensors (See rejection of claim 9), and ultrasonic sensors (ultrasound panels, Abstract).
Regarding claim 25, Fisher in view of Morita and Erhard teach the system of claim 24, and Fisher further teaches that the set of sensors comprises a force sensor, and the force sensor comprises a piezoelectric sensor ([0004]).
Regarding claim 26, Fisher in view of Morita and Erhard teach the system of claim 25, and Fisher further teaches that the force sensor comprises one or more of an analog filter (filtering, [0068]), gain circuits for signal conditioning (amplification, [0068]), and an analog-to-digital converter for signal capture (analog-to-digital controls, [0068]).
Regarding claim 27, Fisher in view of Morita and Erhard teach the system of claim 24, and Fisher further teaches that the set of sensors comprise a combination of force sensors, photo sensors, infrared sensors, and ultrasonic sensors (Abstract).
The Abstract of Fisher teaches that the imaging panels may be a combination of the different modalities.
Regarding claim 28, Fisher in view of Morita and Erhard teach the system of claim 27, and Fisher further teaches that the set of sensors generate a plurality of signals indicative of the breast tissue compressed between the breast compression paddle and the imaging detector ([0048] & Figure 2).
Regarding claim 29, Fisher in view of Morita and Erhard teach the system of claim 8, and Morita further teaches that the at least one of the contact map or positional data corresponds with a time of compression ([0165] & Figure 17).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Fisher such that the at least one of the contact map or positional data corresponds with a time of compression, as taught by Morita. Intuitively, obtaining the contact map when the breast is being compressed allows the degree of compression to be gauged.
Regarding claim 30, Fisher in view of Morita and Erhard teach the system of claim 8, and Fisher further teaches that the imaging detector is disposed a distance away from and parallel to the breast compression paddle (Figure 2).
Regarding claim 31, Fisher in view of Morita and Erhard teach the system of claim 11, and Morita further teaches that the contact map is created based on the spatial data ([0165]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Fisher in view of Morita and Erhard, as applied to claim 8, above, in further view of Kontos (US 2009/0324049).
Regarding claim 21, Fisher in view of Morita and Erhard teach the system of claim 8.
However, Fisher in view of Morita and Erhard fail to disclose that the positional data includes data based on at least one of a position of a pectoral muscle and a position of a posterior nipple line.
Kontos teaches that the positional data (image of a breast 550, [0035], Figure 5c) includes data based on at least one of a position of a pectoral muscle (pectoral muscle, [0035]) and a position of a posterior nipple line (line 562, [0035], Figure 5c).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Fisher, Morita, and Erhard such that the positional data includes data based on at least one of a position of a pectoral muscle and a position of a posterior nipple line, as taught by Kontos. The pectoral muscle and posterior nipple line are well-known landmarks in breast imaging, ensuring adequate imaging of the breast.
Claims 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Ren (US 2012/0033868) in view of Erhard.
Regarding claim 32, Ren teaches a method of imaging breast tissue to ensure adequate compression of the breast tissue, the method comprising:
generating, based on data captured by at least one sensor (receptor 110, [0022]) integrated with one of a breast compression paddle (compression paddle 104 & breast platform 106, [0022]) and an imaging detector (housing, [0022]), spatial data (image data, [0022]) for a breast (breast 102, [0022]) compressed between the breast compression paddle and the imaging detector; and
generating, based on the spatial data, at least one of a contact map or positional data for the compressed breast ([0028] & Figures 5-6).
However, Ren fails to disclose based on the at least one of the contact map or positional data, generating a notification that the breast is in an at least one of an improper compression or an improper position.
Erhard teaches based on the at least one of the contact map or positional data (breast contact area, [0056]), generating a notification (output signal 17, [0080]) that the breast is in an improper compression ([0080] & Figure 12C).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Ren to include based on the at least one of the contact map or positional data, generating a notification that the breast is in an improper compression, as taught by Erhard. Proper compression is important during a mammogram, as an overly-compressed breast can cause discomfort in a patient, and insufficient compression can lower image quality while increasing the radiation dose to the patient.
Regarding claim 33, Ren in view of Erhard teach the method of claim 32, and Ren further teaches performing, based on the at least one of the contact map or positional data, a corrective action ([0032]-[0033]).
Regarding claim 34, Ren in view of Erhard teach the method of claim 33, and Ren further teaches that the corrective action comprises one or more of discarding one or more acquired images collected by the imaging detector ([0032]-[0033]), correcting one or more acquired images collected by the imaging detector ([0032]-[0033]), and generating a correction map ([0033]).
Paragraph [0033] teaches that correcting the images “may include proper global and local adjustment, transformation, and shift back to correct the motion amount”. Applied to the motion map, this constitutes a correction map.
Allowable Subject Matter
Claims 12-13 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.
Claim 12 recites “comparing the determined value for the roll-of region to a predetermined threshold for the roll-off region”. No prior art has been found that teaches this limitation; thus, claim 12 contains allowable subject matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798