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 16 is objected to because of the following informalities:
In claim 16, in line 11, “a cavity” should be changed to --- the cavity ---.
In claim 16, in line 13, “the breast” should be replaced with --- of the breast ---.
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.
Claims 1-7 and 9-16 are 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.
Claim 1 recites the limitation "the breast" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the mammographic image" in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the ultrasonic image" in line 15. There is insufficient antecedent basis for this limitation in the claim.
With regards to claim 1, in line 19, it is unclear as to whether the “a breast” is referring to the same “breast” set forth in line 9 or referring to a different breast. For examination purposes, Examiner assumes the former.
With regards to claim 1, in line 23, it is unclear whether the “a mammographic image” is referring to the same “mammographic image” set forth in line 13 or referring to a different image. For examination purposes, Examiner assumes the former.
With regards to claim 1, in line 24, it is unclear whether the “an ultrasonic probe” is referring to the same probe (i.e. “ultrasound probe”) set forth in line 14, or referring to a different probe. For examination purposes, Examiner assumes the former.
With regards to claim 1, in line 26, it is unclear whether the “an ultrasonic image” is referring to the same “ultrasonic image” set forth in line 15 or referring to a different image. For examination purposes, Examiner assumes the former.
With regards to claims 3, 4 and 7, in line 2, it is unclear as to whether the “ultrasonic images” are referring to the same “at least one ultrasound image” as set forth in line 14 of claim 1 or referring to different images. For examination purposes, Examiner assumes the former.
With regards to claim 7, in line 4, it is unclear as to whether “the ultrasound image” is referring to the same “at least one ultrasound image” as set forth in line 14 of claim 1 or referring to a different image. For examination purposes, Examiner assumes the former. Claim 9 is similarly rejected (see line 2).
With regards to claim 10, in line 3, it is unclear as to whether the “an ultrasound image” is referring to the same “at least one ultrasound image” as set forth in line 14 of claim 1 or referring to a different image. For examination purposes, Examiner assumes the former.
Claim 16 recites the limitation "the breast" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the mammographic image" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the ultrasonic image" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the patient’s habitus" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the image field" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
With regards to claim 16, in line 10, it is unclear as to whether the “a breast” is referring to the same “breast” set forth in line 3 or referring to a different “breast”.
With regards to claim 16, in line 14, it is unclear as to whether the “a mammographic image” is referring to the same “mammographic image” set forth in lines 3-4 or referring to a different “mammographic image”.
With regards to claim 16, in line 17, it is unclear as to whether the “an ultrasonic image” is referring to the same “ultrasound image” set forth in line 4 or referring to a different “ultrasonic image”.
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.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dederichs et al. (US Pub No. 2019/0090828) in view of Davis et al. (US Pub No. 2016/0166217) and Eberhard et al. (US Pub No. 2003/0194050), as evidenced by Nelson et al. (US Pub No. 2003/0205675).
With regards to claim 1, Dederichs et al. disclose a method of performing a breast cancer detection procedure comprising:
providing a system (1) for compressing and stabilizing the breast (paragraphs [0040]-[0042]; Figures 2-3), acquiring the mammographic image (paragraphs [0046]-[0047], referring to the 2D X-ray images) and acquiring the ultrasonic image (paragraph [0047], referring to the ultrasound recordings), the system comprising:
an x-ray device (3,4) configured to generate at least one mammography image, including the mammographic image (paragraphs [0040]-[0041]; Figures 2-3); and
a concavely shaped X-ray imaging screen and supporting table (4, 18) configured to accommodate the patient’s habitus and capture all breast tissues in the image field for generating the at least one mammography image (paragraphs [0048]-[0055]; Figures 2-3).
compressing and stabilizing a breast within a cavity using a compression plate (9 or 4, referred to as the “compression units (detector 4 and compression trough 9”), the cavity at least partially defined by a side wall forming a top opening of the cavity (paragraphs [0029], [0042], [0048], referring to the “compression trough 9…arranged on a vertical support element (17)…The compression units (…compression trough 9) are mounted on the support element (17) such that the compression trough 9 can be lowered to compress a breast 8…The detector 4…can also be mounted in a vertically adjustable manner”; paragraphs [0053], [0055], referring to the air cushion (18) arranged to the sides of the breast (8), wherein filling of the chambers of the aid cushion (18) shape and form the chest wall regions, and thus the air cushion (18) forms at least one side wall of the cavity within which the breast is positioned within; paragraph [0060], referring to chambers achieving a height corresponding at least to the distance between the X-ray detector (4) and the compression unit (9) in completely compressed final state, wherein in its final recording position, the breast (8) can be completely surrounded by the chambers of the air cushion (18) and acted upon by the contact surfaces (19) thereof; Figures 2-3, wherein, as depicted in Figures 2-3 [in particular in Fig. 3], the air cushion (18), including the filled chambers (i.e 32, 33, 30, 31) form side walls of the cavity within which the breast is positioned within and further form a top opening of the cavity);
acquiring a mammographic image of the breast within the cavity (paragraphs [0040]-[0041], [0044]-[0045], [0079], referring to the use of the X-ray tube (3) and detector (4) to record x-ray images of the breast; Figures 2-3);
docking an ultrasonic probe (5) onto the compression plate (paragraphs [0040], [0044]-[0046]; [0079], referring to the ultrasound transducer (5) which transmits and receives the ultrasound waves and wherein ultrasound images are recorded; paragraphs [0049]-[0050], referring to the ultrasound transducer being placed to rest/”dock” on the compression surface (16) of the compression trough (9) and is guided over the fabric (11), wherein an ultrasound coupling gel (contact gel) can be applied to the respective compression element “here the fabric 11”, which would thus result in the ultrasound probe (5) being docked upon the fabric/coupling gel; Figure 3);
providing a coupling fluid (paragraph [0050], referring to an ultrasound coupling gel (contact gel) being applied to the respective compression element (11) by means of a dispensing unit; Figures 2-3); and
acquiring an ultrasonic image of the breast (paragraphs [0040], [0044]-[0046]; [0079], referring to the ultrasound transducer (5) which transmits and receives the ultrasound waves and wherein ultrasound images are recorded).
However, though Dederichs et al. does disclose that a coupling fluid can be provided by applying the coupling fluid (i.e. “ultrasound coupling gel”) to the respective compression element (11), wherein the compression element (11) can be fabric or gauze (and therefore porous) (paragraphs [0050], [0054]), Dederichs et al. do not specifically disclose that the cavity is at least partially filled with the coupling fluid.
Further, Dederichs et al. do not specifically disclose that the side wall forming the top opening is a “rigid” side wall, wherein an edge of a bottom surface of the compression plate fits entirely within the top opening for the compressing and stabilizing the breast.
Davis et al. disclose a non-rigid breast compression paddle, wherein the compression paddle (152) has a mesh material (212) forming the primary interface with patient tissue (Abstract; paragraph [0042]; Figures 3-4). An acoustic coupling gel or lotion may be applied, wherein the mesh structure (212) allows passage of the acoustic gel to facilitate acoustic coupling of the probe (160) through paddle (152) and with the breast tissue (paragraph [0041]; Figures 1-4).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the coupling fluid of Dederichs et al. be applied in a sufficient amount such that the coupling fluid passes through the fabric/gauze/mesh material of the compression plate [thereby resulting in the cavity of Dederichs et al. being at least partially filled with the coupling fluid], as taught by Davis et al., in order to effectively facilitate acoustic coupling of the probe through the paddle/compression plate and with the breast tissue (paragraph [0041]).
However, the above combined references do not specifically disclose that the side wall forming the top opening is a “rigid” side wall, wherein an edge of a bottom surface of the compression plate fits entirely within the top opening for the compressing and stabilizing the breast.
Eberhard et al. disclose a multimodality imaging system containing an X-ray imaging subsystem and a nuclear medicine imaging subsystem, as well as a third modality, such as an ultrasound modality (Abstract; paragraph [0038], [0049], [0065]). A nuclear medicine subsystem (5) includes a mammo compression paddle (41), along with two nuclear medicine detectors (82, 83) located on opposite sides of the detection volume (i.e. breast volume) below the breast compression paddle (41) (paragraph [0051]; Figures 9-10, wherein the detectors (82,83), as depicted in Figure 9, forms a top opening of a cavity for the detection volume/breast and further an edge of a bottom surface of the compression plate/paddle (41) fits entirely within the top opening for the compressing and stabilizing the breast). The detectors (82, 83, 84) located on the sides of the breast (i.e., on the sides of the detection volume) provide useful depth information (paragraph [0052]). The detector may be a solid state detector array, such as a semiconductor photodiode or charge coupled device array or a vacuum position sensitive radiation detector, such as a position sensitive photomultiplier tube (paragraph [0041]; note that such radiation detectors would inherently be rigid in order to effectively detect the radiation in a desired position, as evidenced by Nelson et al. (i.e. see paragraph [0003] of Nelson et al., which discloses commercial nuclear medicine detectors being rigid); Figures 9-10).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the cavity of the above combined references be at least partially defined by a “rigid” side wall forming the top opening, wherein an edge of a bottom surface of the compression plate fits entirely within the top opening for the compressing and stabilizing the breast, as taught by Eberhard et al., in order to provide a multi-modality imaging system that further includes a nuclear medicine imaging subsystem, thereby providing further diagnostic information (Abstract;
Allowable Subject Matter
Claims 1-7 and 9-15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
With regards to claim 1, the prior art does not teach or suggest a method further comprising providing a system for compressing and stabilizing the breast comprising an examination box comprising a side wall surrounding a cavity and forming a perimeter of a top opening, wherein the side wall comprises a side opening connected to the cavity, and wherein at least a portion of the side wall extends above the side opening to the perimeter, in combination with the other claimed elements.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7 and 9-15 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. Claims 1, etc. have been rejected under 35 USC 112(b). Note that claim 1 is not rejected under prior art as it contains the allowable subject matter which was indicated in the previous Office action.
With regards to claim 16, Applicant's arguments filed June 11, 2026 have been fully considered but they are not persuasive.
With regards to claim 16, Applicant argues that Dederich fails to disclose or suggest “a concavely shaped X-ray imaging screen and supporting table” as Dederich discloses a conventional planar or flat support structure (i.e. table 10), wherein the table (10) is planar and Dederichs offers no suggestion of a concavely shaped X-ray imaging screen and supporting table.
However, claim 16 requires “a concavely shaped X-ray imaging screen” and a supporting table, wherein a “concavely” supporting table is not recited. Therefore, Dederich’s disclosure of a planar table/support structure meets the “supporting table” limitation. With regards to the concavely shaped X-ray imaging screen, the positioning element (18) which receives x-rays beams (and thus serves as an X-ray imaging screen) is viewed as corresponding to the claimed “X-ray imaging screen” and, as depicted in Figure 2, can assume a concave shape and therefore meets the “concavely shaped X-ray imaging screen” limitation.
Claim 16 therefore remains rejected under the previously applied prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
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