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 .
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 8/4/2026, with respect to the rejection(s) of claim(s) 2-21 under 35 U.S.C. 102 and 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Smith (US 2012/0238870 A1 in view of Petrick et al (DE 202019106995 U1), Komardin (US 6,054,712 A) and Smith et al (US 8787522 B2).
Response to Amendment
The amendment submitted 8/4/2026 has been accepted and entered. Claims 12, 17 are amended. No claims are further cancelled. No new claims are added. Thus, claims 2-21 are examined.
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) 2-9, 11, 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2012/0238870 A1 in view of Petrick et al (DE 202019106995 U1) and Komardin (US 6,054,712 A).
Regarding claims 2, Smith et al discloses an x-ray breast imaging system (multi-mode mammography/tomosynthesis system)(See Figs. 1, 2 and paragraph [0014], [0036]) comprising: a breast support platform (116) comprising an x-ray receptor (502) (paragraph [0036]) (i.e. "an upper surface 116 serving as a breast plate or platform and enclosing an image detector subsystem system 117 comprising a flat panel x-ray imaging receptor 502") (See Figs. 1, 2); and an x-ray tube head (108) (Figs. 1-2, 3A and paragraphs [0036])) comprising: an x-ray source (108a) configured to emit an x-ray beam (108b) in a direction towards the x-ray receptor (paragraph [0061]); a collimator (108e); a filter assembly (108c) comprising a plurality of specimen imaging filters selectively positionable adjacent to the collimator (108e) (paragraph [0061]), wherein the collimator (108e) is configured to block a portion of the specimen imaging filter to define an x-ray beam path (108b) towards the x-ray receptor (paragraph [0061]). Smith further discloses "Variable filter arrangement [sic] are known in the field, as they are used in a variety of systems" (paragraph [0061]). Smith et al does not disclose: the plurality of filters are disposed within a respective plurality of filter slots; and the specimen imaging filter comprises at least one aperture defined therein, such the at least one aperture defines the x-ray beam path towards the x-ray receptor. Petrick et al discloses a filter assembly (10) comprising a plurality of slots (four rectangles shown in Fig. 4) in which a respective plurality of specimen imaging filters (19) are disposed. Komardin et al discloses a specimen imaging filter (diaphragm 102 formed of lead functions as a spatial filter by spatially filtering X-rays from source 101) comprising an aperture (103) defined therein, and a collimator (diaphragm 106, comprising alternating regions 107 and 108 that are respectively transparent and opaque to x-rays, collimates X-rays; in Fig. 1, the diaphragm 106 is mistakenly labeled "100", but the alternating regions 107 and 108 are labeled correctly) configured to block a portion of the specimen imaging filter (102) so that the at least one aperture defines an x-ray beam path towards an x-ray receptor (113); (See Fig. 1 and col. 8, lines 1 - col. 9, line 61). The specimen imaging filter (102 with aperture 103) of Komardin (col. 8, lines 58-63) ("diaphragm 102 is a sheet of a material such as tungsten or lead that is opaque to the penetrating radiation. In diaphragm 102, an orifice 103, which may be a slit, circular, or any desired shape, limits the divergence of radiation 104"). Thus, as Smith discloses variable filter arrangements were known, and Petrick et al discloses a known variable filter arrangement, it would have been obvious to one of ordinary skill in the art at the time Applicant's invention was effectively filed to modify the invention of Smith et al in view of the teachings of the Petrick et al to use a slotted assembly to provide a convenient means for changing filters in the X-ray beam path. As Smith et al discloses a filter and collimator used together to define an x-ray beam path and Komardin discloses a particular type of filter and collimator for the same purpose, it would have been obvious to one of ordinary skill in the art at the time Applicant's invention was effectively filed to modify the invention of Smith et al in view of the teachings of the Komardin et al to use a filter with an aperture such the at least one aperture defines the x-ray beam path towards the x-ray receptor to limit the divergence of the x-ray beam that reaches the collimator and to provide desired collimation as disclosed by Komardin (Komardin, col. 8, line 1 - col. 9, line 61).
Regarding claim 3, Smith et al discloses wherein the x-ray tube head (108) (Figs. 1-2, 3A and paragraphs [0036])) is rotatably supported on the imaging system (multi-mode mammography/tomosynthesis system)(See Figs. 1, 2 and paragraph [0014], [0036]), and wherein the x-ray tube head is configured to tilt (paragraph [0038]) relative to the breast support platform (116) during emission of the x-ray beam (108b) through the specimen imaging filter (paragraph [0060]).
Regarding claim 4, Smith et al discloses wherein the x-ray tube head (108) (Figs. 1-2, 3A and paragraphs [0036])) is tiltable in both right and left directions (paragraph [0038]).
Regarding claim 5, Smith et al in view of Petrick et al discloses wherein the at least one aperture is substantially rectangular-shaped (four rectangles shown in Fig. 4).
Regarding claim 6, Smith et al in view of Komardin et al discloses wherein the at least one aperture comprises a pair of apertures (103) and the collimator (diaphragm 106, comprising alternating regions 107 and 108 that are respectively transparent and opaque to x-rays, collimates X-rays; in Fig. 1) comprises at least one collimator blade, and wherein the at least one collimator blade is configured to selectively cover one of the pair of apertures (the specimen imaging filter (102 with aperture 103) of Komardin (col. 8, lines 58-63) ("diaphragm 102 is a sheet of a material such as tungsten or lead that is opaque to the penetrating radiation. In diaphragm 102, an orifice 103, which may be a slit, circular, or any desired shape, limits the divergence of radiation 104").
Regarding claim 7, Smith et al discloses wherein the filter assembly comprises a rotatable filter wheel having plurality of slots (paragraph [0060]).
Regarding claim 8, Smith et al discloses wherein the x-ray source comprises three or more focal spot sizes (paragraph [0036]).
Regarding claim 9, Smith et al discloses wherein one of the focal spot sizes is less than or equal to 50 mm (paragraph [0036]).
Regarding claim 11, Smith et al discloses wherein further comprising a vacuum assisted biopsy assembly configured to capture one or more tissue specimens (paragraphs [0046]-[0047]).
Regarding claim 20, Smith et al discloses an x-ray breast imaging system (multi-mode mammography/tomosynthesis system) (See Figs. 1, 2 and paragraph [0014], [0036]), comprising: a compression paddle (122) (paragraph [0036]); a breast support platform (116) comprising an x-ray receptor (502) (paragraph [0036]); and an x-ray tube head (108) (Figs. 1-2, 3A and paragraphs [0036])) configured to selectively tilt relative to the breast support platform (paragraph [0038]), the x-ray tube head comprising: an x-ray source (108a) configured to emit an x-ray beam (108b) in a direction towards the x-ray receptor; a collimator (108e) (paragraph [0061]). Petrick et al discloses a filter assembly (10) comprising a plurality of slots (four rectangles shown in Fig. 4) in which a respective plurality of specimen imaging filters (19) are disposed. Komardin et al discloses a specimen imaging filter (diaphragm 102 formed of lead functions as a spatial filter by spatially filtering X-rays from source 101) comprising an aperture (103) defined therein, and a collimator (diaphragm 106, comprising alternating regions 107 and 108 that are respectively transparent and opaque to x-rays, collimates X-rays; in Fig. 1, the diaphragm 106 is mistakenly labeled "100", but the alternating regions 107 and 108 are labeled correctly) configured to block a portion of the specimen imaging filter (102) so that the at least one aperture defines an x-ray beam path towards an x-ray receptor (113); (See Fig. 1 and col. 8, lines 1 - col. 9, line 61). The specimen imaging filter (102 with aperture 103) of Komardin (col. 8, lines 58-63) ("diaphragm 102 is a sheet of a material such as tungsten or lead that is opaque to the penetrating radiation. In diaphragm 102, an orifice 103, which may be a slit, circular, or any desired shape, limits the divergence of radiation 104"). Thus, as Smith et al discloses variable filter arrangements were known, and Petrick et al discloses a known variable filter arrangement, it would have been obvious to one of ordinary skill in the art at the time Applicant's invention was effectively filed to modify the invention of Smith et al in view of the teachings of the Petrick et al to use a slotted assembly to provide a convenient means for changing filters in the X-ray beam path. As Smith et al discloses a filter and collimator used together to define an x-ray beam path and Komardin et al discloses a particular type of filter and collimator for the same purpose, it would have been obvious to one of ordinary skill in the art at the time Applicant's invention was effectively filed to modify the invention of Smith et al in view of the teachings of the Komardin et al to use a filter with an aperture such the at least one aperture defines the x-ray beam path towards the x-ray receptor to limit the divergence of the x-ray beam that reaches the collimator and to provide desired collimation as disclosed by Komardin et al (Komardin, col. 8, line 1 - col. 9, line 61).
Regarding claim 21, Smith et al discloses wherein the imaging system is configured to acquire one or more tissue specimen images whereby the x-ray tube head is tilted (paragraph [0038]). Komardin et al discloses a specimen imaging filter (diaphragm 102 formed of lead functions as a spatial filter by spatially filtering X-rays from source 101) comprising an aperture (103) defined therein, and a collimator (diaphragm 106, comprising alternating regions 107 and 108 that are respectively transparent and opaque to x-rays, collimates X-rays; in Fig. 1, the diaphragm 106 is mistakenly labeled "100", but the alternating regions 107 and 108 are labeled correctly) configured to block a portion of the specimen imaging filter (102) so that the at least one aperture defines an x-ray beam path towards an x-ray receptor (113); (See Fig. 1 and col. 8, lines 1 - col. 9, line 61). The specimen imaging filter (102 with aperture 103) of Komardin (col. 8, lines 58-63). As Smith et al discloses a filter and collimator used together to define an x-ray beam path and Komardin discloses a particular type of filter and collimator for the same purpose, it would have been obvious to one of ordinary skill in the art at the time Applicant's invention was effectively filed to modify the invention of Smith et al in view of the teachings of the Komardin et al to use a filter with an aperture such the at least one aperture defines the x-ray beam path towards the x-ray receptor to limit the divergence of the x-ray beam that reaches the collimator and to provide desired collimation as disclosed by Komardin (Komardin, col. 8, line 1 - col. 9, line 61).
Claim(s) 10, 12-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2012/0238870 A1 in view of Petrick et al (DE 202019106995 U1) and Komardin (US 6,054,712 A), as applied to claim 2 above, and further in view of Smith et al (US 8787522 B2).
Regarding claim 10, Smith et al, Petrick et al and Komardin et al disclose all of the limitations of parent claim 2, as described supra however, Smith et al, Petrick et al and Komardin et al are silent with regards to specimen container as claimed. Smith et al (522) discloses a specimen container configured to retain one or more tissue specimens, the specimen container either removably couplable to the imaging system or configured to be disposed directly on the support platform or on a compression paddle ( breast tissue can be pulled away from patient's chest wall and securely retained in unit 104 for imaging) (col. 6, lines 40-46). Thus, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith et al (870) of an x-ray breast imaging system (multi-mode mammography/tomosynthesis system) with Smith et al (522) of a multi-mode system and method for imaging a patient's breast with x-rays in one or more of a CT mode. A person of ordinary skill in the art would have been motivated to do this to optimize clinical efficiency, image quality, and patient comfort during biopsy or surgical procedures.
Regarding claim 12, Smith et al (870) discloses a method of acquiring a tissue specimen image on an x-ray breast imaging system (multi-mode mammography/tomosynthesis system)(See Figs. 1, 2 and paragraph [0014], [0036]), the method comprising: compressing a patient's breast between a compression paddle and a support platform (a breast support platform (116) comprising an x-ray receptor (502) (paragraph [0036]) (i.e. "an upper surface 116 serving as a breast plate or platform and enclosing an image detector subsystem system 117 comprising a flat panel x-ray imaging receptor 502") (See Figs. 1, 2)); imaging the patient's breast via an x-ray source (108a) disposed in an x-ray tube head (108) (Figs. 1-2, 3A and paragraphs [0036])) and an X- ray receptor (paragraph [0061]) disposed in the support platform; obtaining one or more tissue specimens from the patient's breast; a filter assembly (108c) comprising a plurality of specimen imaging filters selectively positionable adjacent to the collimator (108e) (paragraph [0061]), wherein the collimator (108e) is configured to block a portion of the specimen imaging filter to define an x-ray beam path (108b) towards the x-ray receptor (paragraph [0061]). Smith further discloses "Variable filter arrangement [sic] are known in the field, as they are used in a variety of systems" (paragraph [0061]). Smith et al does not disclose: tissue sample container, the plurality of filters are disposed within a respective plurality of filter slots; and the specimen imaging filter comprises at least one aperture defined therein, such the at least one aperture defines the x-ray beam path towards the x-ray receptor. Petrick et al discloses a filter assembly (10) comprising a plurality of slots (four rectangles shown in Fig. 4) in which a respective plurality of specimen imaging filters (19) are disposed. Komardin et al discloses a specimen imaging filter (diaphragm 102 formed of lead functions as a spatial filter by spatially filtering X-rays from source 101) comprising an aperture (103) defined therein, and a collimator (diaphragm 106, comprising alternating regions 107 and 108 that are respectively transparent and opaque to x-rays, collimates X-rays; in Fig. 1, the diaphragm 106 is mistakenly labeled "100", but the alternating regions 107 and 108 are labeled correctly) configured to block a portion of the specimen imaging filter (102) so that the at least one aperture defines an x-ray beam path towards an x-ray receptor (113); (See Fig. 1 and col. 8, lines 1 - col. 9, line 61). The specimen imaging filter (102 with aperture 103) of Komardin (col. 8, lines 58-63) ("diaphragm 102 is a sheet of a material such as tungsten or lead that is opaque to the penetrating radiation. In diaphragm 102, an orifice 103, which may be a slit, circular, or any desired shape, limits the divergence of radiation 104"); Smith et al (522) discloses a specimen container configured to retain one or more tissue specimens, the specimen container either removably couplable to the imaging system or configured to be disposed directly on the support platform or on a compression paddle ( breast tissue can be pulled away from patient's chest wall and securely retained in unit 104 for imaging) (col. 6, lines 40-46). Thus, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith et al (870) of an x-ray breast imaging system (multi-mode mammography/tomosynthesis system) with Smith et al (522) of a multi-mode system and method for imaging a patient's breast with x-rays in one or more of a CT mode. A person of ordinary skill in the art would have been motivated to do this to optimize clinical efficiency, image quality, and patient comfort during biopsy or surgical procedures. Thus, as Smith discloses variable filter arrangements were known, and Petrick et al discloses a known variable filter arrangement, it would have been obvious to one of ordinary skill in the art at the time Applicant's invention was effectively filed to modify the invention of Smith et al in view of the teachings of the Petrick et al to use a slotted assembly to provide a convenient means for changing filters in the X-ray beam path. As Smith et al discloses a filter and collimator used together to define an x-ray beam path and Komardin discloses a particular type of filter and collimator for the same purpose, it would have been obvious to one of ordinary skill in the art at the time Applicant's invention was effectively filed to modify the invention of Smith et al in view of the teachings of the Komardin et al to use a filter with an aperture such the at least one aperture defines the x-ray beam path towards the x-ray receptor to limit the divergence of the x-ray beam that reaches the collimator and to provide desired collimation as disclosed by Komardin (Komardin, col. 8, line 1 - col. 9, line 61).
Regarding claim 13, Smith et al (870) discloses further comprising tilting the x-ray tube head relative to the breast support platform during the imaging of the one or more tissue specimens (paragraph [0038]).
Regarding claim 14, Smith et al (870) in view of Smith et al (522) discloses wherein the x-ray tube tilts in a direction that is towards a position of the container that is disposed on the imaging system (See Fig. 6).
Regarding claim 15, Smith et al (870) discloses wherein imaging the patient's breast and imaging the one or more tissue specimens are performed under the same breast compression procedure (See Figs. 1, 2 and paragraph [0014], [0036]).
Regarding claim 16, Smith et al (870) in view of Smith et al (522) discloses further comprising placing the container on the support platform or the compression paddle ( breast tissue can be pulled away from patient's chest wall and securely retained in unit 104 for imaging) (col. 6, lines 40-46).
Regarding claim 17, Smith et al (870) discloses wherein obtaining the one or more tissue specimens comprises excising the one or more tissue specimens via a vacuum assisted biopsy assembly (paragraphs [0046]-[0047]).
Regarding claim 18, Smith et al (870) discloses wherein breast imaging occurs at a first focal spot size of the x-ray source and tissue imaging occurs at a second focal spot size, and wherein the first focal spot size is greater than the second focal spot size (paragraph [0036]).
Regarding claim 19, Smith et al (870) discloses wherein one of the focal spot sizes is less than or equal to 50 mm (paragraph [0036]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ozcan (US 2013/0280752 A1) discloses a specimen imaging filter (22) comprises at least one aperture (24) (See Fig. 1C and paragraph [0092]) used for the purpose of spatial filtering.
Lou et al (US 10,709,396 B2) discloses a filter set of a CT scanning device and control method thereof are provided. An example of the CT scanning device includes a gantry, an X-ray generator, a filter set, a detector, and a drive motor. The filter set includes a disc, a filter disposed on the disc and having a substantially annular groove structure, and a drive shaft connected to the disc. A body thickness of the annular groove structure varies in a circumferential direction and a radial direction. A shaft axis of the drive shaft is parallel to a radiation direction of X-ray. As the drive shaft is driven by the drive motor, the disc rotates around the shaft axis, such that a region of the filter is aligned with the radiation direction of the X-ray, and a body thickness of the region corresponds to a respective X-ray attenuation for an examination region of a subject.
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/F.P.B./Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884
