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 Amendment
Applicant’s amendment filed 7/23/2026 is acknowledged.
Claims 1-14 remain pending in the current application.
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.
Claim 10 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 10 includes the limitation “the visual information is detachably attached to the probe”. It is unclear the manner in which the visual information is to be attached to the probe. It is the interpretation of the office that the visual information claimed is virtual information displayed on a screen and as such physically cannot be detached from the physical structure that is the probe. For the purposes of this office action, visual information which can be removed in any manner will be considered analogous to the limitation in question.
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) 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over McLaughlin (US 20240057976 A1) in view of Nikou (US 20240081784 A1).
Regarding claim 1, McLaughlin teaches an ultrasonic diagnostic apparatus ([0005] performing ultrasound imaging includes collecting ultrasound information of a subject region in response to ultrasound pulses transmitted toward the subject region; [0032] allow doctors to more easily diagnose diseases and provide treatments for the diseases based on their diagnoses)
an ultrasonic probe that transmits and receives ultrasonic waves ([0051] At step 202, ultrasound information of a subject region is collected; [0048] transducer 110 can be an array transducer that includes an array of transmitting and receiving elements for transmitting and receiving ultrasound waves)
a simulated ultrasonic image generator that generates a simulated ultrasonic image simulating ultrasonic waves emitted from by using ultrasonic waves received by the ultrasonic probe and based on different-device information on ultrasonic irradiation of the different device ([0059] At step 204, one or more ultrasound images of at least a portion of the subject region are formed from the reflectivity information. Ultrasound images formed at step 204 can be generated from the reflectivity information using an applicable technique. Specifically, B-Mode ultrasound images can be formed from the reflectivity information through one or more applicable B-Mode imaging techniques. Examples of B-Mode imaging techniques include a fundamental imaging technique, a fundamental spatial compounding imaging technique, a harmonic imaging technique, a harmonic spatial compounding imaging technique, a fundamental and harmonic compounding imaging technique, and a fundamental and harmonic spatial compounding imaging technique)
an image combiner that combines the ultrasonic image generated by the ultrasonic image generator and the simulated ultrasonic image generated by the simulated ultrasonic image generator ([0060] At step 206, the one or more ultrasound images are modified based on the complementary information to the reflectivity information to generate one or more enhanced ultrasound images. Specifically, the ultrasound images can be modified to present information related to the subject region in a more clear and accurate manner; [0076] FIG. 7 is a composite image 700 including the B-Mode phantom and the sound speed map 600 overlaid with the mean propagation speed value removed)
and a hardware processor that outputs a composite image obtained by combining by the image combiner ([0047] a display 116, such as a computer monitor, may display ultrasound images created by the image processor 112 and/or images using data stored in the cine memory 114).
McLaughlin fails to teach a different device different from the ultrasonic diagnostic apparatus.
However, Nikou teaches a different device different from the ultrasonic diagnostic apparatus ([0058] the Display 125 overlays image information collected from various modalities (e.g., CT, MRI, X-ray, fluorescent, ultrasound, etc.) collected pre-operatively or intra-operatively to give the surgeon various views of the patient's anatomy as well as real-time conditions).
McLaughlin and Nikou are considered analogous because they both disclose ultrasonic diagnostic devices. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use a different device other than an ultrasound diagnostic device such as an X-Ray, CT, or MRI device to aid in diagnosis in order to isolate the shape and location, or outline, of bone tissue (Nikou [0009]).
Regarding claim 2, McLaughlin fails to teach an ultrasonic bone fracture treatment device.
However, Nikou teaches an ultrasonic bone fracture treatment device ([0041] Resection Equipment 110 (not shown in FIG. 1) performs bone or tissue resection using, for example, mechanical, ultrasonic, or laser techniques).
McLaughlin and Nikou are considered analogous because they both disclose ultrasonic diagnostic devices. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to utilize resection equipment that provides ultrasonic treatment to bone in order to isolate the shape and location, or outline, of bone tissue (Nikou [0009])
Regarding claim 3, McLaughlin teaches the information includes at least one or more of a waveform, an intensity, and an irradiation range of ultrasonic waves to be emitted ([0108] FIG. 13A shows a grey-scale map reprinting the sound speed as a function of both horizontal and vertical (range) positions. FIG. 13B shows the horizontal averaged sound speed as a function range, including a horizontally averaged accumulated sound speed from the transducer up to the range value).
McLaughlin fails to teach a different device.
However, Nikou teaches a different device ([0058] the Display 125 overlays image information collected from various modalities (e.g., CT, MRI, X-ray, fluorescent, ultrasound, etc.) collected pre-operatively or intra-operatively to give the surgeon various views of the patient's anatomy as well as real-time conditions).
McLaughlin and Nikou are considered analogous because they both disclose ultrasonic diagnostic devices. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use a different device other than an ultrasound diagnostic device such as an X-Ray, CT, or MRI device to aid in diagnosis in order to isolate the shape and location, or outline, of bone tissue (Nikou [0009]).
Regarding claim 4, McLaughlin teaches a transmitter that generates a transmission signal simulating an ultrasonic wave of the different device based on the different-device information ([0059] Ultrasound images formed at step 204 can be generated from the reflectivity information using an applicable technique).
Regarding claim 5, McLaughlin teaches a receiver that generates, from an ultrasonic wave received by the ultrasonic probe, a reception signal simulating an ultrasonic wave of the different device based on the different-device information ([0071] At step 360, a B-Mode image is generated based on the backscatter from the Tx/Rx sequence. At step 370, the B-Mode image is adaptively processed using the sound speed map)
Regarding claim 6, McLaughlin teaches the image combiner combines the ultrasonic image and the simulated ultrasonic image based on irradiation range information of the ultrasonic waves in the different-device information ([0060] At step 206, the one or more ultrasound images are modified based on the complementary information to the reflectivity information to generate one or more enhanced ultrasound images. Specifically, the ultrasound images can be modified to present information related to the subject region in a more clear and accurate manner).
Regarding claim 7, McLaughlin teaches a display part that displays the composite image output by the hardware processor on a screen ([0071] At step 380, the processed image is displayed).
Regarding claim 8, McLaughlin teaches the ultrasonic probe is provided with visual information visually indicating a size of an ultrasonic irradiator of the different device ([0105] As illustrated in FIG. 11A, the zeroth region can be a portion of the subject 1120 between the transducer 1110 and the ROI 1130. The ROI 1130 is subdivided into sub-image regions that each having the same dimensions (e.g., being defined by a uniform grid), with characteristic size Δr).
Regarding claim 9, McLaughlin fails to teach the ultrasonic probe is provided with a posture acquirer that acquires information on a posture of the ultrasonic probe.
However, Nikou teaches the ultrasonic probe is provided with a posture acquirer that acquires information on a posture of the ultrasonic probe ([0190] The position data for the transducer assembly 10 can include orientation and location information for the transducer assembly 10, for example, although other types of positioning information can also be included. In some examples, a spatial tracking device (not shown) is coupled to the transducer assembly 10 and is configured to track the orientation and location of the transducer assembly 10. The position data can be obtained by the spatial tracking device using a reference (not shown) at a known location relative to the transducer assembly 10).
McLaughlin and Nikou are considered analogous because they both disclose ultrasonic diagnostic devices. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to track the orientation of the ultrasound transducer assembly with a tracking device in order to isolate the shape and location, or outline, of bone tissue (Nikou [0009]).
Regarding claim 10, McLaughlin teaches the visual information is detachably attached to the ultrasonic probe ([0076] FIG. 7 is a composite image 700 including the B-Mode phantom and the sound speed map 600 overlaid with the mean propagation speed value removed)
Regarding claim 11, McLaughlin teaches an ultrasonic diagnostic method ([0005] performing ultrasound imaging includes collecting ultrasound information of a subject region in response to ultrasound pulses transmitted toward the subject region; [0032] allow doctors to more easily diagnose diseases and provide treatments for the diseases based on their diagnoses)
ultrasonic image generating that is generating an ultrasonic image by using ultrasonic waves received by an ultrasonic probe ([0051] At step 202, ultrasound information of a subject region is collected; [0048] transducer 110 can be an array transducer that includes an array of transmitting and receiving elements for transmitting and receiving ultrasound waves)
simulated image generating that is generating a simulated ultrasonic image simulating an irradiation signal of ultrasonic waves emitted by using the ultrasonic waves received by the ultrasonic probe and based on different-device information on ultrasonic irradiation of the different device ([0059] At step 204, one or more ultrasound images of at least a portion of the subject region are formed from the reflectivity information. Ultrasound images formed at step 204 can be generated from the reflectivity information using an applicable technique. Specifically, B-Mode ultrasound images can be formed from the reflectivity information through one or more applicable B-Mode imaging techniques. Examples of B-Mode imaging techniques include a fundamental imaging technique, a fundamental spatial compounding imaging technique, a harmonic imaging technique, a harmonic spatial compounding imaging technique, a fundamental and harmonic compounding imaging technique, and a fundamental and harmonic spatial compounding imaging technique)
combining that is combining the generated ultrasonic image and the generated simulated ultrasonic image ([0060] At step 206, the one or more ultrasound images are modified based on the complementary information to the reflectivity information to generate one or more enhanced ultrasound images. Specifically, the ultrasound images can be modified to present information related to the subject region in a more clear and accurate manner; [0076] FIG. 7 is a composite image 700 including the B-Mode phantom and the sound speed map 600 overlaid with the mean propagation speed value removed)
and outputting that is outputting a composite image obtained by combining ([0047] a display 116, such as a computer monitor, may display ultrasound images created by the image processor 112 and/or images using data stored in the cine memory 114)
McLaughlin fails to teach a different device different from the ultrasonic diagnostic apparatus.
However, Nikou teaches a different device different from the ultrasonic diagnostic apparatus ([0058] the Display 125 overlays image information collected from various modalities (e.g., CT, MRI, X-ray, fluorescent, ultrasound, etc.) collected pre-operatively or intra-operatively to give the surgeon various views of the patient's anatomy as well as real-time conditions).
McLaughlin and Nikou are considered analogous because they both disclose ultrasonic diagnostic devices. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use a different device other than an ultrasound diagnostic device such as an X-Ray, CT, or MRI device to aid in diagnosis in order to isolate the shape and location, or outline, of bone tissue (Nikou [0009]).
Regarding claim 12, McLaughlin teaches non-transitory computer-readable storage medium storing a program causing a computer to perform ultrasonic image generating ([0005] performing ultrasound imaging includes collecting ultrasound information of a subject region in response to ultrasound pulses transmitted toward the subject region)
ultrasonic image generating that is generating an ultrasonic image by using ultrasonic waves received by an ultrasonic probe ([0051] At step 202, ultrasound information of a subject region is collected; [0048] transducer 110 can be an array transducer that includes an array of transmitting and receiving elements for transmitting and receiving ultrasound waves)
simulated image generating that is generating a simulated ultrasonic image simulating an irradiation signal of ultrasonic waves emitted by using the ultrasonic waves received by the ultrasonic probe and based on different-device information on ultrasonic irradiation of the different device ([0059] At step 204, one or more ultrasound images of at least a portion of the subject region are formed from the reflectivity information. Ultrasound images formed at step 204 can be generated from the reflectivity information using an applicable technique. Specifically, B-Mode ultrasound images can be formed from the reflectivity information through one or more applicable B-Mode imaging techniques. Examples of B-Mode imaging techniques include a fundamental imaging technique, a fundamental spatial compounding imaging technique, a harmonic imaging technique, a harmonic spatial compounding imaging technique, a fundamental and harmonic compounding imaging technique, and a fundamental and harmonic spatial compounding imaging technique)
combining that is combining the generated ultrasonic image and the generated simulated ultrasonic image ([0060] At step 206, the one or more ultrasound images are modified based on the complementary information to the reflectivity information to generate one or more enhanced ultrasound images. Specifically, the ultrasound images can be modified to present information related to the subject region in a more clear and accurate manner; [0076] FIG. 7 is a composite image 700 including the B-Mode phantom and the sound speed map 600 overlaid with the mean propagation speed value removed)
and outputting that is outputting a composite image obtained by combining ([0047] a display 116, such as a computer monitor, may display ultrasound images created by the image processor 112 and/or images using data stored in the cine memory 114)
McLaughlin fails to teach a different device different from the ultrasonic diagnostic apparatus.
However, Nikou teaches a different device different from the ultrasonic diagnostic apparatus ([0058] the Display 125 overlays image information collected from various modalities (e.g., CT, MRI, X-ray, fluorescent, ultrasound, etc.) collected pre-operatively or intra-operatively to give the surgeon various views of the patient's anatomy as well as real-time conditions).
McLaughlin and Nikou are considered analogous because they both disclose ultrasonic diagnostic devices. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use a different device other than an ultrasound diagnostic device such as an X-Ray, CT, or MRI device to aid in diagnosis in order to isolate the shape and location, or outline, of bone tissue (Nikou [0009]).
Regarding claim 13, McLaughlin fails to teach the visual information is a mark on a surface of the probe or on an attachment that is attached to the probe.
However, Nikou teaches the visual information is a mark on a surface of the probe or on an attachment that is attached to the probe ([0043] Tracking System 115 may use a tracker array attached to the End Effector 105B to determine the location and orientation of the End Effector 105B. The position of the End Effector 105B may be inferred based on the position and orientation of the Tracking System 115 and a known relationship in three-dimensional space between the Tracking System 115 and the End Effector 105B. Various types of tracking systems may be used in various embodiments of the present invention including, without limitation, Infrared (IR) tracking systems, electromagnetic (EM) tracking systems, video or image based tracking systems, and ultrasound registration and tracking systems)
McLaughlin and Nikou are considered analogous because they both disclose ultrasonic diagnostic devices. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to provide a tracker array that can be attached or detached from the probe that assists with a visual tracking system in order to isolate the shape and location, or outline, of bone tissue (Nikou [0009]).
Regarding claim 14, McLaughlin fails to teach the visual information is a mark on an attachment that is attached to the probe.
However, Nikou teaches the visual information is a mark on an attachment that is attached to the probe ([0043] Tracking System 115 may use a tracker array attached to the End Effector 105B to determine the location and orientation of the End Effector 105B. The position of the End Effector 105B may be inferred based on the position and orientation of the Tracking System 115 and a known relationship in three-dimensional space between the Tracking System 115 and the End Effector 105B. Various types of tracking systems may be used in various embodiments of the present invention including, without limitation, Infrared (IR) tracking systems, electromagnetic (EM) tracking systems, video or image based tracking systems, and ultrasound registration and tracking systems)
McLaughlin and Nikou are considered analogous because they both disclose ultrasonic diagnostic devices. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to provide a tracker array that can be attached or detached from the probe that assists with a visual tracking system in order to isolate the shape and location, or outline, of bone tissue (Nikou [0009]).
Response to Arguments
Applicant's arguments filed 7/23/2026 have been fully considered but they are not persuasive. In response to the rejection of dependent claim 10 under 35 USC 112(b), applicant points to paragraphs [0047] and [0049] of the specification and states that the visual information should be interpreted as a mark on a surface of an attachment to the probe and adds two new claims which narrow this down further. However, claim 10 as it is currently written remains indefinite, seeing as the visual information itself is not what is removably connected to the probe, but rather the visual information is incorporated into a separate attachment to the probe, the attachment is a feature which remains unclaimed in claim 10 and as such the claim is not definite. More structure regarding the attachment to the probe which comprises the visual information should be added to the claim to overcome the indefiniteness rejection.
In regards to the rejection under 35 USC 103 applicant alleges that McLaughlin in view of Nikou fails to obviate the independent claim arguing that Nikou does not explicitly simulate ultrasound waves. This is not found persuasive due to the fact that Nikou is not relied upon to teach simulated ultrasound waves, but rather just a combination of outputs from two separate devices. The primary McLaughlin reference already teaches simulated ultrasound waves as required by the claim, the only deficiency of the McLaughlin reference in anticipating the claim is that the two manners of ultrasound waves originate from the same device. As a result, the Nikou reference is brought in simply to explain the possibility of combining outputs from two separate devices. Given the use of standard and simulated ultrasound waves in McLaughlin, one of ordinary skill in the art could easily arrive at the conclusion of utilizing two separate devices for these measurements as disclosed in Nikou. In this argument, applicant simply addresses the deficiency of the Nikou reference while failing to consider the holistic combination of prior art that is used in making an obviousness rejection of the claim. the applicant is pointed to MPEP section 2145, IV which reads:
One cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because "[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012).
For at least the aforementioned reasons, the independent claim remains rejected under 35 USC 103 and dependent claims remain rejected at least by virtue of their dependency.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sakai (US 20190216429 A1) teaches [0097] identifiers 26A and 26C may be respectively configured by red and green seals or covers (adapters) having red and green portions detachably attached to the case 25. Further, the identifiers 26A and 26C may be configured to be identifiable by each other by feeling with an operator's hand or may be configured to form the identifier 26A as a projection and form the identifier 26C as a recess, for example; [0152] The configuration enables an operator to intuitively and easily recognize the front and the back of the ultrasound image by visual observation by respectively associating the front and the back of the ultrasound image with positions (positions on the front side and the back side) in the short axis direction of the ultrasound probe 2 using the ultrasound image, the identifiers 26A and 26C, and the identification mark or the probe mark. The identification mark may have an identifier on the front side or the back side.
THIS ACTION IS MADE FINAL. 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 GABRIEL VICTOR POPESCU whose telephone number is (571)272-7065. The examiner can normally be reached M-F 8AM-5PM.
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 at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GABRIEL VICTOR POPESCU/Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
