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
Claims 1-11 are objected to because of the following informalities: claim 1, the term “comprising” should have a colon after the term to denote the end of the preamble. Claims 1 and 11 states “a second ultrasound canning” which should state “a second ultrasound scanning”. Claim 8 states “data sequence” in line 4 which should state “a data sequence”. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,419,614. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim 1 of the present application and the patent are related to an ultrasound diagnostic apparatus including processing circuitry configured to: perform a first, second and third ultrasound scanning in a time-division manner during a scan sequence, acquired, based on a result of the first ultrasound scanning, blood flow information, acquire, based on a result of the second ultrasound scanning, morphological information, acquired, based on a result of the third ultrasound scanning, tissue property information as well as generating a first superimposed image, a second superimposed image as well as a first look-up table related to a blood flow and a second look-up table related to tissue properties. Claim 1 of the present application additionally discloses the option of a third superimposed image which is a feature set forth in claim 2 of the patent. Examiner notes the generation step of claim 1 allows the selection of only one of (i), (ii), or (iii) which is anticipated by the requirement of all three limitations in the patent. Claims 2 and 3 are anticipated by claim 1 of the patent. Claim 4 is anticipated by claim 4 of the patent. Claim 5 is anticipated by claim 3 of the patent. Claim 8 is anticipated by claim 6 of the patent. Claim 9 is anticipated by claim 7 of the patent. Claim 10 is anticipated by claim 8 of the patent. Claim 11 is the corresponding method to the apparatus as set forth in claim 1 of the present application and anticipated by claim 1 of the patent. Claim 6 discloses the feature of a power image as set forth in claim 5 of the patent. Claim 6 further discloses a first index value representing signal intensity of the blood flow which is an obvious variant of the blood flow information as set forth in the patent as signal intensity is a well-known and conventional method for determining blood flow parameters in a patient. Claim 7 discloses the feature of the second LUT as set forth in the patent. The claim further discloses features of elasticity of a tissue which is an obvious variant of displacement based on shear waves as set forth in the patent as shear waves are well-known and conventional in the art to provide elasticity information.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 4, 8, 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sato (2014/0039317).
Regarding claim 1, Sato discloses an ultrasound diagnostic apparatus, comprising:
processing circuitry configured to:
perform a first ultrasound scanning (color Doppler image data – [0055]), a second ultrasound scanning (B-mode image data – [0055]), and a third ultrasound scanning on a subject (elastography mode – [0045]) in a time-division manner during a scan sequence (abstract);
acquire, based on a result of the first ultrasound scanning, blood flow information at each position within a first region of the subject (color Doppler image data that is blood stream image data – [0055]);
acquire, based on a result of the second ultrasound scanning, morphological information at each position within a second region which overlaps with at least a part of the first region of the subject (B-mode image data that is tissue image data - [0055]; fig.9a);
acquire, based on a result of the third ultrasound scanning, tissue property information at each position within a third region which overlaps with at least a part of an overlapped region between the first region and the second region of the subject (ultrasound scans performed in the Doppler mode or the elastography mode – [0045]);
generate (i) a first superimposed image in which a blood flow image and a morphologic image are overlapped, the blood flow image having a pixel value corresponding to the blood flow information allocated to each position, and the morphologic image having a pixel value corresponding to the morphologic information allocated to each position (tissue Doppler image and B-mode image are superimposed – [0121]; fig.14a) or (ii) a second superimposed image in which a tissue property image and a morphological image are overlapped, the tissue property image having a pixel value corresponding to the tissue property information allocated to each position (elastography image and B-mode image are superimposed – [0122]; fig.14b).
Sato fails to explicitly disclose display the first and second superimposed images side by side.
However, Sato discloses, a first image and a second image to be displayed side by side (it is possible to improve the image quality of the images indicating the motion information of the tissue and the tissue images that are displayed at the same time – [0123]; figs. 14a and 14b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first and second superimposed images and the side by side display of images of Sato with displaying the first and second superimposed images side by side as it would provide the user with simultaneous viewing of images focusing on different enhanced portions of a region of interest.
Regarding claim 2, Sato discloses acquire, based on the result of the first ultrasound scanning, the blood flow information at each position within the first region of the subject (color Doppler image – figs.9A and 9B); acquire, based on the result of the second ultrasound scanning, the morphological information at each position within the second region that includes at least a part of the first region of the subject and is larger than the first region (B-Mode image – figs.9A and 9B); and acquire, based on the result of the third ultrasound scanning, the tissue property information at each position within the third region that includes at least a part of the first region of the subject and is smaller than the second region (Elastography image – figs.14A and 14B).
Regarding claim 4, Sato discloses the invention as claimed and discussed above, but fail to explicitly display the first superimposed image and the second superimposed image at different positions of the display.
However, Sato discloses display a first image and a second image at different positions of the display (it is possible to improve the image quality of the images indicating the motion information of the tissue and the tissue images that are displayed at the same time – [0123]; figs. 14a and 14b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first superimposed image and the second superimposed image and the display of a first image and a second image at different positions of the display of Sato with displaying the first and second superimposed images at different positions of the display as it would provide the user with simultaneous viewing of images focusing on different enhanced portions of a region of interest.
Regarding claim 8, Sato discloses wherein the first ultrasound scanning includes repeating ultrasound scanning over the first region for a plurality of times, and the processing circuitry acquires, for each position within the first region, a data sequence consisting of received data collected by the plurality of times of ultrasound scanning, and acquires the blood flow information based on the data sequence ([0057]).
Regarding claim 10, Sato discloses wherein the morphologic image is an image based on B-mode data (B-mode image data that is tissue image data - [0055]; fig.9a).
Regarding claim 11, Sato discloses an image processing method comprising:
performing a first ultrasound scanning (color Doppler image data – [0055]), a second ultrasound scanning (B-mode image data – [0055]), and a third ultrasound scanning on a subject (elastography mode – [0045]) in a time-division manner during a scan sequence (abstract);
acquiring, based on a result of the first ultrasound scanning, blood flow information at each position within a first region of the subject (color Doppler image data that is blood stream image data – [0055]);
acquire, based on a result of the second ultrasound scanning, morphological information at each position within a second region which overlaps with at least a part of the first region of the subject (B-mode image data that is tissue image data - [0055]; fig.9a);
acquiring, based on a result of the third ultrasound scanning, tissue property information at each position within a third region which overlaps with at least a part of an overlapped region between the first region and the second region of the subject (ultrasound scans performed in the Doppler mode or the elastography mode – [0045]);
generating (i) a first superimposed image in which a blood flow image and a morphologic image are overlapped, the blood flow image having a pixel value corresponding to the blood flow information allocated to each position, and the morphologic image having a pixel value corresponding to the morphologic information allocated to each position (tissue Doppler image and B-mode image are superimposed – [0121]; fig.14a) or (ii) a second superimposed image in which a tissue property image and a morphological image are overlapped, the tissue property image having a pixel value corresponding to the tissue property information allocated to each position (elastography image and B-mode image are superimposed – [0122]; fig.14b); and
displaying the first and second superimposed images side by side (it is possible to improve the image quality of the images indicating the motion information of the tissue and the tissue images that are displayed at the same time – [0123]; figs. 14a and 14b).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sato (2014/0039317) as applied to claim 1 above, and further in view of Cain et al (2013/0102932).
Regarding claim 3, Sato discloses the invention as claimed and discussed above, but fail to explicitly disclose wherein the tissue property information is information based on propagation of shear waves in the subject induced by acoustic radiation force applied to the subject; and the third ultrasound scanning applies the acoustic radiation force to the subject so as to generate the shear wave, and each position within the third region is observed for a displacement based on the shear wave.
However, Cain et al teach in the same medical field of endeavor, wherein a tissue property information is information based on propagation of shear waves in a subject induced by acoustic radiation force applied to the subject (tissue lesion elasticity wave measured with shear wave elastography, wherein a quasi-planar shear wave was induced by acoustic radiation force - abstract); and the third ultrasound scanning applies the acoustic radiation force to the subject so as to generate the shear waves, and each position within the third region is observed for a displacement based on the shear waves (the ability of tissue to rebound from externally induced displacements by whatever means (acoustic radiation force induced displacements) – [0018]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the elastography mode of Sato with the explicit disclosure of ultrasound shear wave elastography to generate displacements using acoustic radiation force as this is a well-known and conventional elastography means to provide elasticity measurements of tissue to a user.
Claim(s) 5 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sato (2014/0039317) as applied to claim 1 above, and further in view of Kato et al (JP 2012061075).
Regarding claim 5, Sato discloses the invention as claimed and discussed above, but fail to explicitly disclose wherein the third superimposed image includes the blood flow image arranged in an uppermost layer, the tissue property image arranged in an intermediate layer, and the morphologic image arranged in a lowermost layer.
However, Kato et al teach in the same medical field of endeavor, a third superimposed image includes a blood flow image arranged in an uppermost layer, a tissue property image arranged in an intermediate layer and a morphologic image arranged in a lowermost layer (the color Doppler image DG is superimposed on the B-mode image BG and the elastic image EG, and is displayed with priority over the B-mode image BG and the elastic image EG. The elastic image EG is displayed in a translucent state through which the background B-mode image BG is added by being added to the B-mode image BG (p.5, para. 4, fig.7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the superimposed image with the blood flow image arranged in an uppermost layer and the morphologic image arranged in a lowermost layer of the superimposed image of Sato with generating a superimposed image obtained by arranged the blood flow image in an uppermost layer, the tissue property image in the intermediate layer and the morphologic image in the lowermost layer of Kato et al as it would provide simultaneous viewing of a field of view of interest while prioritizing the blood flow.
Regarding claim 9, Sato discloses the invention as claimed and discussed above, but fail to explicitly disclose wherein an amount of time required for performing the first ultrasound scanning in the scan sequence is greater than an amount of time required for performing the third ultrasound scanning in the scan sequence.
However, Kato et al teach in the same medical field of endeavor, wherein an amount of time required for performing a first scanning in a scan sequence is greater than an amount of time required for performing a third ultrasound scanning in the scan sequence (the blood flow image corresponds to the color Doppler data processing unit creates color Doppler data based on the echo data e1 to e4, while the elastography image is acquired using the physical quantity data which is only based on e1 and e4 – p.4, para.5).
It would have been obvious to one of ordinary still in the art before the effective filing date of the invention to modify the scanning sequence time of the first ultrasound scanning and the third ultrasound scanning of Sato with time required for performing first scanning is greater than the amount of time require for performing third ultrasound scanning in the scanning sequence as it would provide accurately reflecting elasticity (p.4, para.6 – Kato et al).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sato (2014/0039317) as applied to claim 1 above, and further in view of Inoue (2013/0177229).
Regarding claim 7, Sato discloses the invention as claimed and discussed above, but fail to explicitly disclose wherein a tissue property information includes a second index value representing elasticity of a tissue at each position within a third region, and a tissue property image is an elastography image in which a color corresponding to the second index value is allocated to each position, and a second LUT displayed on a display shows correspondence between the second index value and the color in the elasticity image.
However, Inoue teaches in the same medical field of endeavor, wherein a tissue property information includes a second index value representing elasticity of a tissue at each position within a third region, and a tissue property image is an elastography image in which a color corresponding to the second index value is allocated to each position (color image provide by converting the elasticity values into hue information – [0051]), and a second LUT displayed on a display shows correspondence between the second index value and the color in the elasticity image (color conversion table – [0051]; fig.4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tissue property information and elasticity imaging of Sato with a second index value representing elasticity of a tissue at each position within a third region which is a color allocated to each position and the second LUT displayed to show correspondence between the second index value and the color in the elasticity as it would provide the user with an image which can be easily interpreted to detect changes in elasticity which are different than the expected range of the tissue.
Allowable Subject Matter
Claim 6 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims as well as obviating the Double Patenting Rejection.
Conclusion
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/ROCHELLE D TURCHEN/ Primary Examiner, Art Unit 3797
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