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
New 112(a) rejection necessitated by amendment.
Regarding prior art
Applicant's arguments filed 01/26/2026 been fully considered but they are not persuasive. For example, applicant argues that “Specht does not disclose that the region-of-interest suggestion lines includes the first line, and the second line is excluded from the region-of-interest suggestion line among the first, second, third, and fourth lines” (REMARKS pg. 6). Examiner respectfully disagrees in that fig. 6 of Specht depicts what is considered a region of interest suggestion line 324 including a first line (i.e. line located shallower than the detection target) and the line 324 does not include (thus excludes) the second line (i.e. the line located deeper than the detection target). Examiner notes that the claim therefore broadly refers to a line as excluding the second line and does not preclude an interpretation in which the second line is displayed, but is not considered a part of the region of interest suggestion line. For at least these reasons, applicant’s arguments against the teachings of Specht are not found persuasive.
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.
Claim 3 is 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 3 recites the limitation “the region of interest suggestion line consists of four discrete line segments, each of which corresponds to a portion of the contour line at a respective vertex of the quadrangle, and wherein the four discrete line segments collectively form only a part of the contour, such that remaining portions of the contour line, including the portion of the contour line located deeper than the detection target are excluded from the region-of-interest suggestion line”. Examiner notes that the limitation is directed to the embodiment depicted in fig. 11 and further would include at least a portion of the second line in the region of interest suggestion line (e.g. a portion of the quadrangle at the vertices that are deeper than the region of interest). Claim 1 is directed to an embodiment in which the first line as recited is shallower than the detection target and excludes the second line which is deeper than the detection target as depicted in at least fig. 10. There is insufficient support for an embodiment which includes the first line excludes the second line and consists of four discrete line segments that correspond to portions of the contour line at respective vertex of the quadrangle. For at least these reasons, claim 3 is directed to new matter as 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.
Claim Rejections - 35 USC § 112(b)
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.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation “the region of interest suggestion line consists of four discrete line segments, each of which corresponds to a portion of the contour line at a respective vertex of the quadrangle, and wherein the four discrete line segments collectively form only a part of the contour, such that remaining portions of the contour line, including the portion of the contour line located deeper than the detection target are excluded from the region-of-interest suggestion line”. The limitation is first unclear as to how the region of interest suggestion line includes the first line and excludes the second line as recited in claim 1 and further consists of four discrete line segments which correspond to a portion of the contour line at a respective vertex of the quadrangle. The limitation is further unclear as to whether any of the four discrete line segments correspond to any of the first, second, third, or fourth lines recited previously. Finally, there is antecedent basis for the limitation ”the portion of the contour line located deeper than the detection target” and it is unclear if this is or relates to the second line or if this is a different portion which is located deeper than the detection target. For examination purposes, it has been interpreted to mean a different region of interest suggestion line which consists of four discrete line segments corresponding to vertices of the quadrangle, however, clarification is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 6, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Specht et al. (US 202002352548 A1 and cited in applicant’s IDS filed 01/24/2024), hereinafter Specht.
Regarding claims 1 and 20,
Specht discloses an ultrasound diagnostic apparatus (at least fig. 1 (100) and corresponding disclosure in at least [0020]) comprising:
A monitor (at least fig. 1 (118) and corresponding disclosure in at least [0022]); and
A processor (at least fig. 1 (116) and corresponding disclosure in at least [0022]) configured to
Detect a detection target captured in an ultrasound image (at least fig. 3 (302) and corresponding disclosure in at least [0039] and [0039] which discloses the ROI 306 may be automatically positioned by the processor based on pulse wave Doppler data and/or image data from the B-mode image 302. The processor 116 may determine the ROI 306 placement by identifying the ROI placement on the image 302 that yields pulse wave Doppler values that are consistent with the structure being analyzed. According to an embodiment, The processor may position the ROI 306 on a portion of the image representing the left ventricle outflow tract. Such ROI placement requires the processor to detect a detection target (i.e. the structure or other region in the ultrasound image) for placing the ROI accordingly);
Set, on the ultrasound image, a region of interest (at least figs. 3 and 6 (306) and corresponding disclosure in at least [0039]) including the detection target which is detected ([0039] which discloses the ROI 306 may be automatically positioned by the processor based on pulse wave Doppler data and/or image data from the B-mode image 302. The processor 116 may determine the ROI 306 placement by identifying the ROI placement on the image 302 that yields pulse wave Doppler values that are consistent with the structure being analyzed. According to an embodiment, The processor may position the ROI 306 on a portion of the image representing the left ventricle outflow tract), the region-of-interest suggestion line being automatically set based on a detected depth position of the detection target ([0039] which discloses the ROI 306 may be automatically positioned by the processor based on pulse wave Doppler data and/or image data from the B-mode image 302. The processor 116 may determine the ROI 306 placement by identifying the ROI placement on the image 302 that yields pulse wave Doppler values that are consistent with the structure being analyzed. According to an embodiment, The processor may position the ROI 306 on a portion of the image representing the left ventricle outflow tract. Thus is based on any detected depth position of the detection target (i.e. region of interest position)) and
Display, on the monitor, a region of interest suggestion line (at least fig. 6 (324) and corresponding disclosure in at least [0046]), consisting of only a part of a contour line (at least fig. 3 (304) and corresponding disclosure in at least [0039]) of the region of interest (306), wherein the contour of the region-of interest is consisted of a first line located at shallower than the detection target, a second line, located at deeper than the detection target, a third line that connects one end of the first line and one end of the second line, and a fourth line that connects the other end of the first line and the other end of the second line (see annotated fig. 3 below)
the region-of-interest suggestion line (324) includes the first line (see at least fig. 6),
the second line is excluded from the region-of-interest suggestion line (324) (Examiner notes that the region of interest suggestion line is considered to be line 324 which is the first line, but does not include (thus excludes) the second line).
And the region-of-interest suggestion line is dynamically generated in response to the depth position of the detection target ([0035] which discloses If it is desired to continue acquiring ultrasound data, the method 200 may repeat steps 202, 204, 206, 208, 210, 211, 212, and 214. According to an embodiment where the ultrasound image is a live image, the steps 202, 204, 206, 208, 210, 211, 212, 214 and 216 may be iterated many times during the acquisition and display of the live image) so as to avoid obscuring the region located deeper than the detection target in the ultrasound image where the at least one posterior acoustic feature is to be confirmed by the user (Examiner notes that such generation of the border/region of interest suggestion line as depicted in at least figs. 6 would avoid obscuring the region located deeper than the detection target in the ultrasound image where the at least one posterior acoustic feature is to be confirmed by the user. See also [0042] which discloses the border 304 is unobtrusive and does not block structures within the B-mode image 302)
Examiner notes that the system of Specht, as modified, would perform the method of claim 20 having corresponding method steps.
PNG
media_image1.png
710
674
media_image1.png
Greyscale
Regarding claim 3,
Specht further discloses wherein the region of interest (306) has a shape of a quadrangle (see at least fig. 3 depicting a quadrangle); and
Where the region-of-interest suggestion line consists of four discrete line segments (see at least fig. 5 (320)), each of which corresponds to a portion of the contour line at a respective vertex of the quadrangle, and wherein the four discrete line segments collectively form only a part of the contour line, such that remaining portions of the contour line, including the portion of the contour line located deeper than the detection target, are excluded from the region-of-interest suggestion line (see at least fig. 5 in which only four segments 320)
Regarding claims 6,
Specht further discloses wherein the region of interest (306) has two sides that extend along a sound line in the ultrasound image and that face each other (see at least fig. 3 depicting two sides (i.e. left and right side) extending along a sound line in the ultrasound image, where they are considered facing each other in its broadest reasonable interpretation)
Regarding claim 19,
Specht further discloses further comprising:
an ultrasound probe (at least fig. 1 (106) and corresponding disclosure in at least [0020]);
Wherein the processor (116) is further configured to acquire the ultrasound image using the ultrasound probe (106) ([0022] which discloses the processor 116 is in electronic communication with the probe 106. The processor 116 may control the probe 106 to acquire ultrasound data. The processor 116 controls which of the elements 104 are active and the shape of a beam emitted from the probe 106. The processor 116 is also in electronic communication with a display device 118, and the processor 116 may process the ultrasound data into images for display on the display device 118).
Regarding claim 21,
The limitation “wherein the at least one posterior acoustic feature includes a posterior acoustic shadow or an enhanced posterior echo” is directed towards limitations included in intended use limitations (i.e. where at least one posterior acoustic feature is to be confirmed). It is thus noted that the system of Specht would thus would allow any region located deeper than the detection target including a posterior acoustic shadow or an enhanced posterior echo to be confirmed by a user accordingly.
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Specht in view of Tsutaoka (US 20210219941 A1), hereinafter Tsutaoka.
Regarding claim 8,
Specht teaches the elements of claim 1 as previously stated. Specht fails to explicitly teach wherein the detection target is a feces.
Tsutaoka, in a similar field of endeavor involving ultrasound imaging, teaches wherein a detection target is feces ([0073] which discloses the rectal stool evaluation unit 22 extracts the rectum from the ultrasound image in the region of interest A2 and the rectal stool evaluation unit 22 (i.e. processor) evaluates, for example, whether the rectal stool present inside the extracted rectum is loose stool or hard stool where evaluation of the rectal stool (i.e. feces) requires detection of the stool (i.e. feces) and where the ROI (A2) includes the stool (i.e. feces))
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Specht to include the feces as a detection target as taught by Tsutaoka in order to allow for additional uses of the ultrasound system such as for rectal evaluation using the ultrasound system of Specht. Furthermore, such a modification amounts to merely a simple substitution of one known detection target for another yielding predictable results with respect to ultrasound image analysis, thereby rendering the claim obvious (MPEP 2143).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Specht.
Regarding claim 10,
Specht teaches the elements of claims 1 and 2 as previously stated. Specht further teaches an embodiment in which the detection target is a B-line ([0053] which discloses the B-mode image includes a plurality of B lines 504. A border 506 is shown to indicate the ROI from which the processor 116 calculates the number of B lines 504 present in the image) in a lung echo (Examiner notes that the system of Specht teaches wherein the detection target is a B-line as noted above regarding fig. 9 and [0053], where in a lung echo is considered an intended use of the claimed invention. A limitation directed towards intended use must result in a structural difference between the prior art and the claimed invention and the prior art must merely be capable of being used to detect the detection target which is a B-line in a lung echo. Therefore, since Specht teaches the detection target as a B-line, the system is therefore capable of use with detecting a B-line in any instance including in a lung echo, thus the system of Specht would function accordingly in a lung echo and therefore reads on the claimed invention)
However, Specht fails to explicitly teach in the embodiment in which the detection target is a B-line, that a region-of-interest suggestion line includes a first line that is located shallower than the detection target that is a B-line.
Nonetheless, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Specht to include the region of interest suggestion line of fig. 6 in the embodiment in which the detection target is a B-line as depicted in fig. 9 in order to define an upper border of the ROI (Specht [0046]) which includes the B lines. Such a modification would make clear to a user where an upper border of such an ROI exists accordingly and further amounts to merely a combination of known elements yielding predictable results with respect to ROI display, thereby rendering the claim Obvious (MPEP 2143).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Specht in view of Imai (US 20210113196 A1), hereinafter Imai.
Regarding claims 12,
Specht teaches the elements of claim 1 as previously stated. Specht fails to explicitly teach wherein the detection target is a cyst.
Imai, in a similar field of endeavor involving ultrasound imaging, teaches wherein a detection target is a cyst ([0061] which discloses the measurement target recognition unit of the processor recognizes a measurement target included in the ultrasound image. The measurement target can include a part to be a target of measurement, such as a cyst).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Specht to include a cyst as a detection target as taught by Imai, in order to allow for additional uses of the ultrasound system, such as for measurement of anatomical structures of the patient such as a cyst. Furthermore, such a modification amounts to merely a simple substitution of one known detection target for another yielding predictable results with respect to ultrasound image analysis, thereby rendering the claim obvious (MPEP 2143).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Specht in view of Kang et al. (US 20190209134 A1), hereinafter Kang.
Regarding claims14,
Specht teaches the elements of claim 1 as previously stated. While Specht teaches the processor is further configured to set the region of interest which is manually positioned ([0039] which discloses according to other embodiments, the ROI may be manually positioned on the B-mode image 302), Specht fails to explicitly teach wherein the region of interest has at least one of a shape or a size which is input by a user.
Nonetheless, Kang, in a similar field of endeavor involving ultrasound imaging, teaches wherein a processor is further configured to set a region of interest having a shape or a size which is input by a user ([0081] In operation 410, the ultrasound imaging apparatus 300 sets an ROI in an ultrasound image of an object. The setting of the ROI may be performed based on a user's input for a size and a shape of the ROI).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Specht to include setting the region of interest having a shape or a size which is input by a user as taught by Kang in order to allow for more enhanced control by the user, where a user may wish to provide an ROI having a different shape or size than the ROI provided by the system. Such a modification therefore enhances the user experience of the system of Specht by providing a more customizable ROI accordingly.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
Prosecution Insights