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 1-9 and 17-20 are objected to because of the following informalities: “one or more processor” in claims 1, 5, 7-9 and 17 should state “one or more processors”. 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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,226,259. Although the claims at issue are not identical, they are not patentably distinct from each other because the independent claims of both the present application and the patent are directed to an ultrasound imaging system and method comprising a processor comprising hardware, generate data of an ultrasound image of a subject, set a first boundary in the ultrasound image…, set, based on the first boundary set, a second boundary…, invert a magnitude and delete a region between the first boundary and the second boundary. The patent claims include additional feature of the inverting occurring after the deleting and generating data of a three-dimensional ultrasound image; however, the claims anticipate independent claims 1, 10 and 17 of the present application. Dependent claims 2, 3, 11 and 12 are anticipated by the independent claims of the patent. Dependent claims 4-9 and 13-16 are anticipated by at least claims 2-4 of the patent. Claims 18 and 19 are anticipated by claim 16 of the patent. Claim 20 is anticipated by the independent claims of the patent.
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 1-20 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.
Claims 1, 10 and 17 recite the limitation "the first boundary set" in line 9, 8 and 9, respectively. There is insufficient antecedent basis for this limitation in the claim.
Claims 5 and 14 recite the limitation “the second ultrasound image set” in line 16 and 14, respectively. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas in the form of mental processes without significantly more.
The claim(s) recite(s) the following abstract ideas:
“set a first boundary…” (claims 1, 10 and 17);
“set, based on the first boundary set, a second boundary…” (claims 1, 10 and 17);
“invert a magnitude relationship of a luminance value of each pixel in the ultrasound image” (claims 1, 10 and 17);
“delete a region between the first boundary and the second boundary” (claims 1, 10 and 17).
The cited limitations, under their broadest reasonable interpretation, cover performance in the mind in that nothing precludes them from being practically performed in the mind, or with the assistance of basic physical aids. See MPEP 2106.04(a)(2)(III)(B). In this case, the setting of a first and second boundary, inverting a magnitude relationship and deleting a region are simply calculations which constitute a mental process regardless of whether performed with the assistance of pen/paper. Generating data of an ultrasound image of a subject as provided is a pre-solution activity and the claims only disclose this step with a high level of generality. This feature does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps are based on generic data gathering and merely specifies the nature of the data exploited in executing the abstract ideas and only generally links to a particular technological environment or field of use. See MPEP 2106.05(g) on pre-solution activity and its failure to constitute significantly more. The steps set forth above, allows for them to be practically performed in the mind, or with the assistance of basic physical aids.
The judicial exception is not integrated into a practical applications because while the cited steps (claims 1, 10 and 17) are optionally associated with one or more processors (claims 1 and 17), this is generic computer hardware and simply represents implementing the abstract ideas with a computer. MPEP 2106.05(f) notes that “using a computer as a tool to perform the abstract idea” is not sufficient to integrate a judicial exception into a practical application as interpreted by the court(s). Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972) held that “simply implementing a mathematical principle on a physical machine, namely a computer, wave not a patentable application of that principle” and Intellectual Ventures LLC v. Symantec Corp., 838 F.3D 1307, 1318 (Fed.Cir. 2016) established that mental processes encompass acts which, absent anything beyond generic computer components, may be “performed by a human, mentally or with pen and paper.” Intellectual Ventures additionally established that if a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category of abstract ideas unless the claim cannot be practically performed in the mind or with the aid of basic physical aids in the ways elaborated.
Dependent claims 2-9, 11-16 and 18-20 further define the mathematical concepts used to perform the steps outlined above and do not provide any active steps or functions to amount to significantly more than the judicial exception.
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) 1-4, 9-13 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murishita et al (2005/0267366) in view of Liew et al (2004/0242987) and further in view of Sato et al (2015/0338492).
Regarding claim 1, Murashita et al disclose an ultrasound imaging system (ultrasonic diagnostic apparatus – [0009]) comprising:
one or more processor comprising hardware (executed in an ultrasonic diagnostic apparatus or by operating a computer using a program – [0016]) and configured to:
generate data of an ultrasound image of a subject (an image data generation unit – [0009]);
set a first boundary in the ultrasound image across with luminance values of pixels in the ultraosund image changes by a predetermined amount (boundary 62 is extracted using the first threshold value in regions other than the debris portion – [0065]); and
set, based on the first boundary set, a second boundary in the ultrasound image (the second threshold value is suitably set in the debris portion to extract the actual boundary 72 – [0065]);
invert a magnitude relationship of a luminance value of each pixel in the ultrasound image (a brightness inversion unit 20 applies to the image data…a process of inverting the brightness value…as a result, the portion of the liver cyst which has a low reflection is converted to a high level, and the region outside the liver cyst which has a high reflection is converted to a low level – [0035]);
and delete a region (3D region-of-interest generator unit 42 generates a plurality of two-dimensional regions 80 – [0051]. Examiner notes the image is only of the region of interest 80 and the external portion as seen in figure 4 has been deleted; noise removal unit 22 – [0037]).
Murashita et al fail to explicitly disclose a second boundary from within the first boundary in the ultrasound image.
However, Liew et al teach in the same medical field of endeavor, a secondary boundary from within a first boundary in an ultrasound image (as will be appreciated by those of skill in the art, where multiple ROI are used any or all of the ROI can be organized such that it does not overlap, it abuts without overlapping, it overlaps partially, it overlaps completely (a first ROI is located completely within a second identified ROI) – [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the abutting first and second boundaries of Murashita et al with the second boundary from within the first boundary in the ultrasound image as it would provide for any configuration of regions of interest (boundaries) which are present within the image of the patient.
Murashita et al as modified by Liew et al fail to explicitly disclose delete a region between the first boundary and the second boundary.
However, Sato et al teach in the same medical field of endeavor, delete a region between a first boundary and a second boundary (processing for removing the boundary region between the brain and air from the phase image subjected to the noise mask processing is performed – [0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the deleting of Murashita et al s modified by Liew et al with deleting a region between a first boundary and a second boundary as it would provide deleting data which is not of a region of interest.
Regarding claims 2 and 3, Murashita et al as modified by Liew et al and Sato et al disclose the invention as claimed and discussed above. Liew et al further teaches wherein the first boundary represents a boundary between a first portion of a subject and an external portion of a first boundary, and wherein a second boundary represents a boundary between the first portion of the subject external of the second boundary and a second portion of the subject external of the second boundary and a second portion of the subject internal of the second boundary (fig.2A and [0057]).
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 boundary and second boundary of Murashita et al with representing a boundary between a first portion of the subject and an external portion external of the first boundary and a boundary between the first portion of the subject external of the second boundary and a second portion of the subject internal the second boundary, respectively, as it would provide for any configuration of regions of interest (boundaries) which are present within the image of the patient.
Regarding claim 4, Murashita et al disclose wherein deleting the region is executed after inverting the magnitude relationship of the luminance value of each pixel in the ultrasound image (brightness value inversion unit 20 occurs before noise removal unit 24 – fig.1).
Regarding claim 9, Murashita et al disclose wherein the one or more processor is further configured to: cause a display to display an image of the subject based on the ultrasound image generate (display image generation unit 32 – [0040]); and calculate a distance between two points that are specified in the image of the subject display on the display (a distance between the plurality of two-dimensional regions of interest generated as a result of the reduction process, that is a distance between a plurality of planes – [0056]; fig.7; [0062]; fig. 10).
Regarding claim 10, Murashita et al disclose a method of an ultrasound imaging system (ultrasonic diagnostic apparatus – [0009]) comprising:
generating data of an ultrasound image of a subject (an image data generation unit – [0009]);
setting a first boundary in the ultrasound image across with luminance values of pixels in the ultraosund image changes by a predetermined amount (boundary 62 is extracted using the first threshold value in regions other than the debris portion – [0065]); and
setting, based on the first boundary set, a second boundary in the ultrasound image (the second threshold value is suitably set in the debris portion to extract the actual boundary 72 – [0065]);
inverting a magnitude relationship of a luminance value of each pixel in the ultrasound image (a brightness inversion unit 20 applies to the image data…a process of inverting the brightness value…as a result, the portion of the liver cyst which has a low reflection is converted to a high level, and the region outside the liver cyst which has a high reflection is converted to a low level – [0035]);
and deleting a region (3D region-of-interest generator unit 42 generates a plurality of two-dimensional regions 80 – [0051]. Examiner notes the image is only of the region of interest 80 and the external portion as seen in figure 4 has been deleted; noise removal unit 22 – [0037]).
Regarding claims 11 and 12, Murashita et al as modified by Liew et al and Sato et al disclose the invention as claimed and discussed above. Liew et al further teaches wherein the first boundary represents a boundary between a first portion of a subject and an external portion of a first boundary, and wherein a second boundary represents a boundary between the first portion of the subject external of the second boundary and a second portion of the subject external of the second boundary and a second portion of the subject internal of the second boundary (fig.2A and [0057]).
Regarding claim 13, Murashita et al disclose wherein deleting the region is executed after inverting the magnitude relationship of the luminance value of each pixel in the ultrasound image (brightness value inversion unit 20 occurs before noise removal unit 24 – fig.1).
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 boundary and second boundary of Murashita et al with representing a boundary between a first portion of the subject and an external portion external of the first boundary and a boundary between the first portion of the subject external of the second boundary and a second portion of the subject internal the second boundary, respectively, as it would provide for any configuration of regions of interest (boundaries) which are present within the image of the patient.
Regarding claims 17-19, Murashita et al disclose an ultrasound imaging system (ultrasonic diagnostic apparatus – [0009]) comprising:
one or more processor comprising hardware (executed in an ultrasonic diagnostic apparatus or by operating a computer using a program – [0016]) and configured to:
generate data of an ultrasound image of a subject (an image data generation unit – [0009]);
set a first boundary in the ultrasound image across with luminance values of pixels in the ultraosund image changes by a predetermined amount, wherein the first boundary is a first outline of a first portion of the subject (boundary 62 is extracted using the first threshold value in regions other than the debris portion – [0065]); and
set, based on the first boundary set, a second boundary in the ultrasound image, wherein the second boundary is a second outline of a second portion of the subject (the second threshold value is suitably set in the debris portion to extract the actual boundary 72 – [0065]);
delete a region (3D region-of-interest generator unit 42 generates a plurality of two-dimensional regions 80 – [0051]. Examiner notes the image is only of the region of interest 80 and the external portion as seen in figure 4 has been deleted; noise removal unit 22 – [0037]); and
invert a magnitude relationship of a luminance value of each pixel in the ultrasound image (a brightness inversion unit 20 applies to the image data…a process of inverting the brightness value…as a result, the portion of the liver cyst which has a low reflection is converted to a high level, and the region outside the liver cyst which has a high reflection is converted to a low level – [0035]).
Allowable Subject Matter
Claims 5-8, 14-16 and 20 are allowable over the prior art but are dependent upon a rejected base claim and are currently rejected under Double Patenting and under 35 U.S.C. 101.
Conclusion
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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797