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 .
Election/Restrictions
Newly submitted claim 21 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Original claims 1-12 and newly submitted claim 21are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because original claims 1-12 do not require the particulars of moving a linear transducer, that dynamically conforms… to a plurality of positions on the surface of the breast tissue and obtaining one or more ultrasound images at each position. The subcombination has separate utility such as acquisition of ultrasound images from different positions in an uncompressed breast which may be used for comparison or finding an ROI.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
In this case, the invention of original claims 1-12 require search strategy including CPC and text queries related to obtaining ultrasound images of the breast while compressing the breast tissue at a second compression force which is not required of the search strategy for newly submitted claim 21 and newly submitted claim 21 would require search strategy including CPC and text queries related to a linear transducer moved to a plurality of positions and obtaining one or more ultrasound images at each position which is not required of the search strategy for original claims 1-12. Furthermore, newly submitted claim 21 would appear to introduce additional new matter by claiming a linear transducer which dynamically conforms to the breast for which there is insufficient written description for in the application as originally filed, thus introducing further burden.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 21 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Regarding 35 U.S.C. 112
Applicant's arguments filed 12/15/2025 have been fully considered but they are not persuasive. For example, applicant argues “at 512, once positioned, the ultrasound transducer may be mechanically or electromechanically driven along a defined path and may while driven, acquire ultrasound image data of the underlying breast tissue at 514” and “meanwhile fig. 1 clearly shows an ultrasound transducer 104 placed on a membranous sheet 106. Paragraph [0046] and see fig. 1 below” (REMARKS pg. 4-5). As noted in the previous Office Action mailed on 09/15/2025, Examiner respectfully disagrees in that claim 1 is specifically directed to a method which uses the alternative embodiment system as depicted in fig. 7A and disclosed in [0029] and [0062] with an alternative flexible transducer disclosed in [0063] and that the disclosure of the method of fig. 5 is directed specifically to the previous figs. 1-4C. As noted in the previous rejection, while there is disclosure of one embodiment in which the transducer is driven across a membrane while obtaining ultrasound images, such disclosure is not provided with respect to a transducer which dynamically conforms to the breast. In other words, there is no such disclosure of moving a flexible transducer such as that depicted in fig. 7A and disclosed in [0062]-[0063] and no corresponding disclosure of the two embodiments (i.e. the system of fig. 1 in which the transducer is driven and the system of fig. 7A in which the transducer dynamically conforms) used together. Examiner further notes that fig. 7A specifically depicts a transducer directly on the breast without a flexible membrane and further depicts the membrane over the entire breast without any explanation for how such a transducer would move across the breast nor why it would need to move across the breast. For at least the reasons listed above, applicant’s arguments are not found persuasive.
Regarding Prior Art
Applicant’s arguments with respect to claim 1 have been considered but are moot in view of the new grounds of rejection necessitated by amendment.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6-8, 10-12 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “wherein the obtaining the ultrasound image further includes scanning the breast tissue with the transducer as the transducer is moving from the first position to the second position along the breast tissue and is dynamically conforming to the breast tissue curvature”. Examiner notes examiner notes that the transducer which dynamically conforms to the breast is directed to the alternative embodiment of fig. 7A disclosed in at least [0062]-[0063], however, the cited limitation is directed to an embodiment of fig. 1, 2B, and/or 7B directed to mechanically or electrically driving an ultrasound transducer along the membranous sheet. The disclosure related to 7A does not provide sufficient support that the dynamically conforming transducer is moved from a first position to as second position while obtaining ultrasound images and the disclosure related to the embodiments of fig. 1, 2B, and/or 7B in which the transducer is moved see at least [0046], [0049], does not provide sufficient support that the transducer which is moved dynamically conforms to the breast. There is further no disclosure of the two different embodiments being usable together. Further, examiner notes that [0073] of applicant’s specification does not explicitly state figures that are combinable but is rather generic and not specific enough to support a conclusion that any figure can be combined with any other embodiment and new matter would not result. It is reasonably clear that based on the shape of the transducer in fig. 7A and further the dynamically conformable transducer disclosed as an alternative would not be reasonably combined with the moving configuration depicted in at least fig. 1. For example, fig. 7A depicts the transducer covering the entire breast and directly in contact with the breast where such a configuration would not require movement and further would not reasonably be moved across the membranous sheet as depicted in fig. 1 due to its material/direct contact with the breast as depicted nor is there sufficient disclosure for how such a transducer would be moved. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing and the limitation therefore constitutes new matter.
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.
Claims 1, 4, and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US 20160166217 A1), hereinafter Davis in view of Zhang et al. (US 20160166234 A1), hereinafter Zhang.
Regarding claim 1,
Davis teaches a method for imaging (at least fig. 2) comprising:
Compressing breast tissue (at least fig. 2 (180) and corresponding disclosure in at least [0037]-[0038]) with a compression paddle (at least fig. 1, 3, or 4 (152) and corresponding disclosure in at least [0027]) with a compression surface made of a membranous sheet (at least fig. 3 or 4 (212) and corresponding disclosure in at least [0042]. See also [0027] which discloses the upper paddle may be at least partly formed using a flexible non-rigid mesh material (i.e. formed as a mesh paddle) where a mesh paddle is considered a membranous sheet in its BRI) at a first compression force ([0054] which discloses in some embodiments where differing imaging modalities may benefit from different degrees of compression the amount of compression applied may be changed between imaging protocols for example an initial compression (i.e. first compression) may be automatically applied followed by acquisition of the tomosynthesis image data) ;
Obtaining x-ray images of the breast tissue while compressing the breast tissue at the first compression force (at least fig. 2 (182) and corresponding disclosure in at least [0041]);
and
Obtaining ultrasound images of the breast tissue (at least fig. 2 (194) and corresponding disclosure in at least [0041]) while compressing the breast tissue at the second compression force ([0054] which discloses the amount of compression applied may be changed (increased or decreased) between imaging protocols and Upon completion of the tomosynthesis acquisition, the compression may be reduced or lessened to a level (a second compression force) determined to be appropriate for ultrasound imaging (e.g., to a different point on a suitable compression curve selected based on the patient's characteristics). Examiner notes that in such an embodiment a person having ordinary skill in the art would have recognized the ultrasound imaging (i.e. 194) occurs at the reduced level of compression (thus at the second compression force)); and
Wherein obtaining ultrasound images of the breast while compressing the breast tissue at the second compression force includes scanning the breast tissue with a transducer (at least fig. 1 (160) and corresponding disclosure in at least [0032]);
Wherein the obtaining the ultrasound images further includes scanning the breast tissue with the transducer as the transducer is moving from the first position to the second position along the breast tissue ([0034] which discloses In these embodiments, the ultrasound probe 160 may be manually or automatically brought into contact with the tissue being imaged or with the overlying sonolucent paddle structure 152 compressing the breast tissue and the ultrasound probe 160 (i.e. transducer) may then be moved via a mechanical subsystem to move with respect to the breast tissue while acquiring ultrasound image data)
Davis fails to explicitly teach the transducer dynamically conforms to the breast tissue curvature when the transducer is moving from a first position to a second position along the breast tissue and wherein the ultrasound images further includes scanning the breast tissue with the transducer as the transducer is dynamically conforming to the breast tissue curvature.
Zhang discloses a method for imaging (see at least fig. 3) comprising:
obtaining ultrasound images of a breast while compressing the breast tissue (at least fig. 3 (194) and corresponding disclosure in at least [0045]) includes scanning the breast tissue with a transducer (at least fig. 6 (160) and corresponding disclosure in at least [0054]) that dynamically conforms to the breast tissue curvature ([0054] which discloses can be seen in FIG. 6, both the patient-contacting surfaces of the paddle 152 and of the probe 160 may be curved so as to conform to the shape of the tissue surfaces to be imaged and the curvature of the ultrasound probe to enable better tissue contact with the ultrasound probe) when the transducer is moving from a first position to a second position along the breast (examiner notes that a curved patient contacting surface of the probe would dynamically conform to the breast tissue curvature as disclosed in at least [0054] while moving from a first position to a second position)
and wherein the obtaining the ultrasound images further includes scanning the breast tissue with the transducer as the transducer is moving from the first position to the second position along the breast tissue ([0021] which discloses Further, the ultrasound probe and associated components may be configured to as to move and scan the breast tissue under compression. See also [0025]) and is dynamically conforming to the breast tissue curvature ([0054] which discloses can be seen in FIG. 6, both the patient-contacting surfaces of the paddle 152 and of the probe 160 may be curved so as to conform to the shape of the tissue surfaces to be imaged and the curvature of the ultrasound probe to enable better tissue contact with the ultrasound probe)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Davis to include scanning the breast tissue with a transducer that conforms to the breast tissue curvature as taught by Zhang in order to enable better tissue contact with the ultrasound probe (Zhang [0054]) while acquiring ultrasound image data, thus enhancing the quality of imaging in Davis. Additionally/alternatively, such a modification amounts to merely a simple substitution of one known transducer for another yielding predictable results with respect to ultrasound imaging of the breast thus rendering the claim obvious (MPEP 2143).
Regarding claim 4,
Davis, as modified, teaches the elements of claim 1 as previously stated. Davis further teaches further comprising:
determining the first compression with a sensor ([0039] which discloses in certain embodiments, one or more sensors (such as strain sensors provided on the edge of the paddle 152 or at the paddle mount on compression mechanism 128) may be monitored for an indication that the desired force threshold is reached, stopping compression [0040] which discloses Based on these examination specific factors, the appropriate curves may be queried to provide the correct compression threshold values. In such embodiments, the force sensors may provide measures of the trajectory of the paddle 152 on the breast and consultation with the appropriate table or curves may be used to establish when the curve is optimized and [0054] which discloses In some embodiments where differing imaging modalities may benefit from different degrees of compression, the amount of compression applied may be changed (increased or decreased) between imaging protocols. For example, in a tomosynthesis/ultrasound implementation, an initial compression may be automatically applied followed acquisition of the tomosynthesis image data. Examiner thus notes that the initial compression (i.e. the first compression force) is determined with the sensor as disclosed for compressing to the desired compression); and
varying the first compression force on the breast tissue to provide the second compression force based on the first compression force determined by the sensor ([0054] which discloses upon completion of the tomosynthesis acquisition, the compression may be reduced or lessened to a level. Thus examiner notes that the varying of the first compression force to provide the second compression force is necessarily based on the first compression force determined by the sensor in its BRI. In other words, varying the compression force to provide the second compression force is necessarily based on the first compression force which is varied).
Regarding claim 6,
Davis, as modified, teaches the elements of claim 1 as previously stated. Davis further teaches wherein obtaining the ultrasound images includes mechanically driving the ultrasound transducer along the membranous sheet to obtain ultrasound image data ([0034] which discloses In these embodiments, the ultrasound probe 160 may be manually or automatically brought into contact with the tissue being imaged or with the overlying sonolucent paddle structure 152 compressing the breast tissue and the ultrasound probe 160 (i.e. transducer) may then be moved via a mechanical subsystem to move with respect to the breast tissue while acquiring ultrasound image data, thus the transducer 160 is mechanically driven along the membranous sheet of the paddle 152 to obtain ultrasound image data).
Examiner notes that in the modified system the ultrasound transducer of Zhang is driven in the same manner accordingly.
Additionally/alternatively, Zhang further teaches wherein the obtaining the ultrasound images includes mechanically or electrically driving the transducer along a membranous sheet (at least fig. 10 (330) and corresponding disclosure in at least [0061]) to obtain ultrasound image data ([0048] which discloses once positioned, the ultrasound probe 160 may be mechanically or electromechanically driven (block 224) along a defined path and may, while driven, acquire ultrasound image data of the underlying breast tissue)
Regarding claim 7,
Davis, as modified, teaches the elements of claim 6 as previously stated. Davis further teaches wherein the ultrasound images are based on the ultrasound image data (Examiner notes that the ultrasound images are based on ultrasound image data acquired by the ultrasound transducer as it is moved along the membranous sheet during the ultrasound acquisition).
Regarding claim 21,
Davis, as modified, teaches the elements of claim 1 as previously stated. Davis further teaches wherein the obtaining the ultrasound images further includes the transducer following the breast tissue curvature and remaining orthogonal to a surface of the breast at all points along the breast tissue while scanning (See at least fig. 1 and 5. Examiner notes that the transducer movement would follow the breast tissue curvature and remain orthogonal to the surface of the breast at all points along the breast tissue while scanning)
Additionally/alternatively Zhang further teaches wherein the obtaining the ultrasound images further includes the transducer following the breast tissue curvature and remaining orthogonal to a surface of the breast at all points along the breast tissue while scanning ([0048] which discloses in certain embodiments, the probe 160 may be driven toward or away from the patient chest wall. Conversely, in other embodiments the probe 160 may be driven in a direction generally parallel to the chest wall (e.g., from left to right or vice versa with respect to the patient). From this acquired ultrasound image data one or more ultrasound images 196 may be generated. Examiner notes that such movement would follow the breast tissue curvature and remain orthogonal to a surface of the breast at all points along the breast tissue while scanning accordingly).
Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over Davis and Zhang as a applied to claim 1 above and as evidenced by NPL Cleveland Clinic (“Tomosynthesis”), hereinafter Cleveland Clinic.
Regarding claim 2,
Davis further discloses wherein the x-ray images obtained are at least one of planar (2D) images or 2D images for tomosynthesis (fig. 2 (182) and [0041] which discloses X-ray tomosynthesis is perform and a resulting volumetric rendering is generated. Examiner notes that tomosynthesis acquisition necessarily means that the obtained/acquired data are 2D images for tomosynthesis as evidenced by Cleveland Clinic which discloses Breast tomosynthesis also known as 3D mammography because it uses a series of two-dimensional images to build a three-dimensional image of your breast)
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Davis and Zhang as applied to claim 1 above and further in view of Evans et al. (US 20140180082 A1), hereinafter Evans.
Regarding claim 3,
Davis teaches the elements of claim 1 as previously stated. Davis fails to explicitly teach wherein obtaining ultrasound images of the breast tissue includes obtaining a plurality of two-dimensional ultrasound images of the breast tissue, and forming a three-dimensional image based on the plurality of two-dimensional images of the breast tissue.
Evans, in a similar field of endeavor involving breast imaging, teaches wherein obtaining ultrasound images of the breast tissue includes obtaining a plurality of two-dimensional ultrasound images of the breast tissue, and forming a three-dimensional image based on the plurality of two-dimensional images of the breast tissue ([0082] which discloses the linear ultrasound transducer generates two-dimensional images for each position of the transducer across the scanning surface. It is able to capture multiples 2D images which, when fed into the image reconstruction processor, generates 3D ultrasound images of the breast).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Davis to include obtaining a plurality of two-dimensional ultrasound images and forming a three-dimensional image as taught by Evans in order to provide a three-dimensional image of the breast, such that the whole breast may be visualized (Evans [0006]). Such a modification would further allow for registration of the volumetric image generated from the tomosynthesis data of Davis and the 3D image of Evans accordingly (Evans [0007]), thereby providing enhanced breast evaluation by providing for registered image data of the two imaging modalities.
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Davis and Zhang in view of Entrekin (US 2008025452 A1), hereinafter Entrekin.
Regarding claim 5,
Davis teaches the elements of claim 1 as previously stated. Davis further teaches applying a gel to the membranous sheet prior to obtaining the ultrasound images (at least fig. 2 (190) and corresponding disclosure in at least [0041] which discloses an acoustic coupling gel is applied prior to ultrasound imaging and the mess structure allows passage of the acoustic gel to facilitate acoustic coupling of the probe 160 through paddle 152. Thus the gel is necessarily applied to the membranous sheet to some degree in order for the gel to pass through accordingly)
Davis fails to explicitly teach wherein the ultrasound images of the breast tissue includes transvers image of the breast tissue, and the method further comprising: obtaining the transverse images of the breast tissue by scanning at least one of the medial margins of the breast tissue or the lateral margins of the breast tissue as a transducer moves between the compression paddle and a breast plate.
Entrekin, in a similar field of endeavor involving ultrasound breast imaging, teaches obtaining transverse images of the breast tissue by scanning the lateral margins of breast tissue as a transducer (at least fig. 5 (68) and corresponding disclosure in at least [0030]) moves between the compression paddle and a breast plate (at least fig. 5 (66 or bottom portion of housing 66) and corresponding disclosure in at least [0023]) ([0052] which discloses if the scanning transducer is rotated 90 degrees and moved front-to-back instead of left-to-right, the same improvement in visualizing the lateral margins (as previously discussed with respect to visualizing the nipple and chest wall) would occur. Examiner notes that the transducer is between the compression paddle 12 and the breast plate 24 and moves therebetween accordingly)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Davis to include obtaining transverse images as taught by Entrekin in order to provide for enhanced applications of whole breast ultrasound, such that areas of non-contact such as the lateral edges of the breast may be visualized (Entrekin [0052])
Regarding claim 8,
Davis teaches the elements of claim 1 as previously stated. Davis fails to explicitly teach wherein obtaining the ultrasound images includes providing more than one pass over the breast tissue with an ultrasound transducer while compressing the breast tissue at the second compression.
Entrekin teaches obtaining ultrasound images includes providing more than one pass over the breast tissue ([0019] which discloses a two pass linear scan is used for conventional, nonsteered rectangular volumetric image)with an ultrasound transducer (at least fig. 1 (26) and corresponding disclosure in at least [0018]) while compressing the breast ([0033] which discloses a two pass linear scan is used for obtaining a steered trapezoidal volumetric image. Image data representative of the breast is then acquired as the ultrasound transducer array traverses the path. Acquiring image data for the two-pass 3D scan uses steered trapezoidal image frames to image the breast)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Davis to include providing more than one pass over the breast tissue with an ultrasound transducer while compressing the breast as taught by Entrekin in order to allow for 3D imaging of the breast with enhanced visualization of breast tissue by allowing more tissue adjacent to the chest wall and near the nipple to simultaneously be imaged even with some loss of contact due to curvature at the edge of the breast (Entrekin [0034]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Davis and Zhang as applied to claim 1 above and further in view of Yu et al. (US 20060173303 A1), hereinafter Yu.
Regarding claim 10,
Davis teaches the elements of claim 1 as previously stated. Davis further teaches wherein the first compression force is an initial compression for tomosynthesis imaging and the second compression force is a level determined to be appropriate for ultrasound imaging ([0054]), however, it is unclear if the initial compression force is at or greater than 20-pounds-force and the second compression force is less than 20 pounds-force.
Yu, in a similar field of endeavor involving breast imaging, teaches wherein full-field breast ultrasound usually involves as an example 8 pounds of breast compression and x-ray mammography involves as an example 20 pounds or more ([0023])
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Davis to provide the first compression force (for X-ray mammography) at or greater than 20-pounds-force and the second compression force (for breast ultrasound) less than 20 pounds-force as taught by Yu in order to provide the appropriate compression force for the different imaging modalities accordingly where such differing imaging modalities may benefit from the different degrees of compression accordingly as taught by Davis in [0054]. Furthermore such a modification amounts to merely routine optimization of the compression force for each imaging modality having a reasonable expectation that the acquisitions of each imaging modality would be improved by providing a corresponding optimized compression force.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Davis and Zhang as applied to claim 1 above and further in view of Konno (US 20220133247 A1), hereinafter Konno.
Regarding claim 11,
Davis teaches the elements of claim 1 as previously stated. Davis fails to explicitly teach further comprising varying the first compression force on the breast tissue to provide the second compression force that is different than the first compression force including moving a tensioning lever of compression mechanism from a first position to a second position.
Konno, in a similar field of endeavor involving medical breast imaging, teaches varying a first compression force on breast tissue to provide a second compression force that is different than the first compression force including moving a tensioning lever (at least figs. 1-3 (40) and corresponding disclosure in at least [0075] which discloses the operation portion 40 is a cantilever type lever) of a compression mechanism (at least fig. 3 (50 and 40) and corresponding disclosure in at least [0078] where the lever and drive mechanism in combination are considered the compression mechanism in its BRI) from a first position to a second position (See at least figs. 2-3 and [0074] disclosing that operation (i.e. rotation/movement) of the operation portion compresses and releases the compression of the breast and [0087] which discloses in a case in which the displacement direction of the operation portion is in an upward direction, the compression plate movement controller 62 controls the drive mechanism to raise the compression plate. Thus movement from a first position (i.e. neutral) to a second position (i.e. in an upward direction) is included in varying the first compression force to provide a second compression force that is different form the first compression force (i.e. a reduced/lowered level of force))
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Davis to include moving a tensioning level of a compression mechanism from a first position to a second position as taught by Konno in order to allow for enhanced operability of the compression plate by a user (Konno [0027]), such that a user may change the compression of the breast as desired, thereby enhancing a user’s experience when performing breast imaging in the system of Davis when modified by Konno.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Davis and Zhang as applied to claim 1 above and further in view of Choi et al. (US 20180161010 A1), hereinafter Choi.
Regarding claim 12,
Davis teaches the elements of claim 1 as previously stated. Davis fails to explicitly teach further comprising determining missing voxel value or signal to noise ratio below a threshold of the ultrasound images obtained for scanned areas; and
Alerting a user of the scanned areas wherein the missing voxel values are presented or the signal to noise ratio is below the threshold.
Choi, in a similar field of endeavor involving ultrasound imaging, teaches determining signal to noise ratio below a threshold of the ultrasound images obtained for scanned areas ([0119] which discloses the ultrasound image processing apparatus 300 detects an ultrasound image having a low quality from among the detected ultrasound images 510 (Poor View Detection) and [0116] which discloses reference measures such as a signal-to-noise ratio (SNR) and a peak signal-to-noise ratio (PSNR) may be used to perform the image quality analysis and [0155] which discloses A target region of which imaging is omitted or of which imaging has an image quality lower than a threshold may be represented by an indicator 1125d. Examiner thus notes that an areas with low quality or quality below a threshold has signal to noise ratio below a threshold since the signal to noise ratio is used for determining the quality); and
Alerting a user of the scanned areas wherein the signal to noise ratio is below the threshold ([0155] which discloses a target region of which imaging is omitted or of which imaging has an image quality lower than a threshold may be represented by an indicator 1125d and [0134] which discloses when a quality value of an acquired ultrasound image corresponding to a target region is determined to be less than the first reference value, the ultrasound image processing apparatus 300 may output a notification window indicating that the user may repeat imaging on the target region)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Davis to include determining signal to noise ratio below a threshold of the ultrasound images and altering a user as taught by Choi in order to improve the imaging of Davis by indicating to a user that he or she may repeat imaging on the target region having a low quality (Choi [0134]). Such a modification thereby ensures the images are thoroughly captured for accurate health diagnosis (Choi [0005]).
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 BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached on 5712700552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LYN KLEIN/Examiner, Art Unit 3797