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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 02, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on April 28, 2025 are accepted.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4, 7 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 4 and 15 recite “the first registration minimizes a similarity metric between a second predicted projection of the probe device based on the first registration and the actual projection of the probe device”. This limitation s a computer/processor-implemented functional claim limitation as it is directed to an operation performed by one or more processors. Yet the specification does not disclose the computer and the algorithm in sufficient details (e.g., the necessary steps and/or flowcharts) that perform the claimed functions, i.e., how does a processor minimize a similarity metric in order to generate a registration between the predicted projection and the actual projection, such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. The specification merely discloses in [0065] (PG Pub US 2025/0248769 A1) that “an optimizer may be used to generate a registration that minimizes a similarity metric (e.g., providing a scalar value that describes the similarity) between the predicted projection 650 and the actual projection of the probe device 220.
Claim 7 recites “the initial registration is determined based on kinematics of the imaging device and kinematics of an instrument controlling the probe device”. This limitation s a computer/processor-implemented functional claim limitation as it is directed to an operation performed by one or more processors. Yet the specification does not disclose the computer and the algorithm in sufficient details (e.g., the necessary steps and/or flowcharts) that perform the claimed functions, i.e., how does a processor determine the kinematics of the instrument that appears to be not part of the claimed system? Further, since claim 7 depends on claim 1, and claim 1 recites that the initial registration is determined between a probe device space and an imaging device space, how does a processor relate the kinematics of the instrument to the probe device? Note that depending on what kind of instrument it is, the kinematics of the instrument and the kinematics of the probe device are not necessarily identical or translatable. For example, the instrument may control the movement of the probe device but the instrument itself remains static. Further, how does a processor use the kinematic data of the imaging device and of the instrument to perform registration between the imaging device space and the probe device space, such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. The specification discloses that the initial registration is determined “based on” the kinematics in [0058], [0061] and [0062] yet no further disclosure can be identified in regard to how kinematics of the imaging device and the instrument that controls the probe device is used to arrive the registration.
It is not enough to disclose that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015). As the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention, these claims are rejected for lack of written description. For more information regarding the written description requirement, see MPEP §§ 2161, 2162-2163.07(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.
Claims 4, 7 and 15 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 pre-AIA the applicant regards as the invention.
Claim 4 recites “the first registration minimizes a similarity metric between a second predicted projection…and the actual projection of the probe device” that renders the scope of the claim indefinite. A registration in medical imaging is to align images or imaging data by transforming them into a common coordinate system. Hence, it would be expected that the difference or the offset of the images/imaging data should be brought to minimum, i.e., to enhance their similarity. It is unclear how a registration may be done by minimizing the similarity (i.e., to make them more different) between the two. Further it is unclear what the “similarity” refers to, i.e., what aspect of the predicted projection and the actual projection that the similarity is determined and minimized. Clarification is required. The same rejection applies to claim 15 for the substantially identical limitation recited in the claim. For examination purpose, claim 4 is interpreted to minimize the offset to increase the similarity.
Claim 7 recites that the initial registration is determined based on kinematics of the imaging device and kinematics of an instrument controlling the probe device. “instrument”. Claim 7 depends on claim 1, and claim 1 recites that the initial registration is determined between a probe device space and an imaging device space. The “instrument” is not an actively recited element of the claimed system and it appears to be a separate component of the probe device. Hence, it is unclear whether the initial registration is determined between the probe device space and the imaging device space in claim 1, then determined again based on the kinematics of the imaging device and the instrument. Clarification is required.
Claim Rejections - 35 USC § 103
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 10, 13-16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gogin et al., EP 2509507 B1, hereinafter Gogin, in view of Lang et al., US 2021/0192759 A1, hereinafter Lang, further in view of Behrendt et al., US 2020/0240790 A1, hereinafter Behrendt.
Claims 1, 13 and 20. Gogin teaches a medical system, a method, and a non-transitory machine-readable medium comprising a plurality of machine-readable instructions which when executed by one or more processors associated with a medical device are adapted to cause the one or more processors to perform a method ([0001]: a system comprising an x-ray system as well as an ultrasound system, wherein the system is equipped with a computer program for performing the method), comprising:
one or more processors configured to perform operations ([0001]: a system comprising an x-ray system as well as an ultrasound system, wherein the system is equipped with a computer program for performing the method) comprising:
determining an initial registration between a probe device space and an imaging device space (Claim 1: registering the detected ultrasound probe with a 3D model of the probe by matching a digitally rendered radiograph of the 3D model with a projection of the probe in the 2D x-ray image; and [0023]: a 2D x-ray image of an ultrasound probe may be registered with a 3D model of the probe which can be either a 3D acquisition of the probe or a computer-aided design. This registration is performed by matching a digitally rendered radiograph of the probe and the real x-ray projection of the probe) – the “3D model of the probe” is considered the “probe device space” as claimed, and the “detected ultrasound probe in the 2D x-ray image” is considered the “imaging device space” as claimed,
the probe device space being associated with a probe device coupled to the medical system, the imaging device space being associated with an imaging device coupled to the medical system (Claim 1: detecting an ultrasound probe in the 2D x-ray image; registering the detected ultrasound probe with a 3D model of the probe by matching a digitally rendered radiograph of the 3D model with a projection of the probe in the 2D x-ray image; and [0001]: a system comprising an x-ray system as well as an ultrasound system) - the “3D model of the probe” is considered the “probe device space” as claimed and it is associated with the probe device (i.e., the ultrasound probe or the ultrasound system), and the “detected ultrasound probe in the 2D x-ray image” is considered the “imaging device space” as claimed and it is associated with the imaging device (i.e., imaged by the x-ray system);
receiving imaging data from the imaging device (Claim 1: receiving a 2D x-ray image);
generating a predicted projection of the probe device relative to the image data based on the initial registration (Claim 1: estimating a position and an orientation of the ultrasound probe relative to a reference coordinate system based on the registration) – the estimated position and orientation of the ultrasound probe is considered “a prediction projection of the probe device” as claimed.
As considered above, Gogin teaches the predicted projection (Claim 1: estimating a position and an orientation of the ultrasound probe relative to a reference coordinate system based on the registration), the actual projection (Claim 1: detecting an ultrasound probe in the 2D x-ray image), and the registration being between the probe device space and the imaging device space (Claim 1 and [0023], see above).
Gogin does not teach updating the initial registration by comparing the predicted information to the actual information in the image data to generate a first registration.
In regard to updating the initial registration to generate a first registration, in an analogous imaging registration based medical procedure guidance field of endeavor, Lang teaches updating the initial registration to generate a first registration ([0717]: modify the registration of the virtual data of the patient in relationship to live data of the patient. The operator or surgeon can optionally repeat the registration procedure using any of the techniques described in the specification or known in the art for registering the virtual data of the patient, including, for example the virtual surgical plan, relationship to the live data of the patient after the physical surgical alteration).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the one or more processors of Gogin employ such a feature associated with updating the initial registration to generate a first registration as taught in Lang for the advantage of allowing all subsequent virtual medical steps to be referenced off the re-registration of the virtual and live data, as suggested in Lang, [0717].
In regard to the re-registration being performed by comparing the predicted information to the actual information in the image data, in an analogous registration updating field of endeavor, Behrendt teaches that
the predicted information and the actual information is compared to update the initial registration to generate a first registration ([0055]: FIGS.4A: the map image 400 includes map features, such as lane-markings 400A; FIG.4B: a visualization image 402, which includes a set of localization features, such as detections of lane-markings 401A; FIG.4C: the map image 400 is offset from the visualization image 402 by a fist offset value 406 along an x-axis and a second offset value 408 along a y-axis; and [0056]: FIG.4D: when the map image 400 is optimally registered with the visualization image 402, the map features 400A are aligned with the localization features 402A. In this case, the localization update data includes offset data, which indicates an offset between a position of the map image, as aligned via the localization estimate, relative to a position fo the map image, as optimally registered) – the visualization image 402 is considered the actual information and the map image 400 is considered the predicted information.
Hence, when Gogin, Lang and Behrendt are combined, the offset of the predicted information being the predicted projection and the actual information being the actual projection is determined and used to generate an optimizing registration that is the first registration as claimed.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the one or more processors of Gogin and Lang combined employ such a feature associated with the predicted information and the actual information is compared to update the initial registration to generate a first registration as taught in Behrendt for the advantage of determining localization information in a high level of accuracy, as suggested in Behrendt, [0002].
Claims 2 and 14. Gogin, Lang and Behrendt combined teaches all the limitations of claim 1.
As applied to claim 1, Gogin teaches the predicted projection (Claim 1: estimating a position and an orientation of the ultrasound probe relative to a reference coordinate system based on the registration) and the actual projection (Claim 1: detecting an ultrasound probe in the 2D x-ray image).
Behrendt also teaches predicted information and actual information, and Behrendt further teaches aligning the two information ([0055]: the visualization image 402 is considered the actual information and the map image 400 is considered the predicted information).
Hence, when Gogin, Lang and Behrendt are combined, it teaches the claimed feature of aligning the predicted projection with the actual projection.
Claim 3. Gogin, Lang and Behrendt combined teaches all the limitations of claim 1, including the projection of the probe device (Gogin, claim 1).
Lang further teaches a second predicted projection of the probe device based on the first registration matches the actual projection of the probe device ([0717]: all subsequent virtual surgical steps displayed by the OHMD and any related virtual surgical plan can be referenced off the re-registration of the virtual and live data of the patient. For example, the OHMD can then be used after the re-registration for projecting all subsequent virtual surgical steps, e.g., by projecting one or more of virtual surgical tool…).
Claims 4 and 15. Gogin, Lang and Behrendt combined teaches all the limitations of claim 1, including a second predicted projection of the probe device, the actual projection of the probe device, and the first registration (Gogin: claim 1 and Lang: [0717]).
Behrendt further teaches
the first registration minimizes a similarity metric between a predicted projection and the actual projection ([0031]: the map alignment module is configured to obtain the localization estimate. Upon receiving the localization estimate, the map alignment module is configured to use this localization estimate to obtain a map region…In FIG.2A, the map alignment module is configured to align the map region such that the localization estimate is positioned at a predetermined area of the map region).
To align such that the estimate is positioned at a predetermined area is considered “minimizing a similarity metric” as claimed. Note that the term “minimizing a similarity metric” renders the scope of the claim indefinite in the rejection under 35 U.S.C. 112(b) and is interpreted as minimizing the offset to increase the similarity.
Claims 5 and 16. Lang further teaches that
the actual projection of the probe device comprises an outline of the probe device in the image data ([0915]: the projection can be a 2D outline similar to radiographic templates, optionally derived from radiographic templates, oral 3D image, e.g., a 3D CAD file of the…virtual medical device and virtual instrument).
Claim 10. As applied to claim 1, Gogin teaches that the probe device is an ultrasound probe. It is known in the field of art that an ultrasound probe requires an manipulator, either manually or robotically, to move it, i.e., an ultrasound probe “lacking independent movement capacities” as claimed.
Claims 6, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gogin et al., EP 2509507 B1, hereinafter Gogin, in view of Lang et al., US 2021/0192759 A1, hereinafter Lang, further in view of Behrendt et al., US 2020/0240790 A1, hereinafter Behrendt, further in view of Popovic et al., US 2019/0290247 A1, hereinafter Popovic.
Claims 6, 17 and 18. Gogin, Lang and Behrendt combined teaches all the limitations of claim 1.
Gogin further teaches
determining a probe area; and providing one or more instructions to a user to position the probe device to obtain a scan of the probe area ([0043]: An ultrasound acquisition system with for example a TEE ultrasound probe, is configured to produce images of the anatomy. This ultrasound acquisition system is assumed to lie aet least partially in the field of view of the x-ray acquisition system with sufficient information that it is enough to recover the coordinate system of the images produced by this system; and [0055]: the probe steering module, based on the ultrasound/x-ray registration information will determine and apply the relevant set parameters enabling this device-driven steering).
Neither of Gogin, Lang and Behrendt teaches that the probe area is determined to be associated with one or more anatomic features identified in an anatomic model.
However, in an analogous proper probe device placement field of endeavor, Popovic teaches
identifying one or more anatomic features in an anatomic model; determining a probe area associated with the one or more anatomic features; and providing one or more instructions to a user to position the probe device to obtain a scan of the probe area ([0091]: In order to visualize desired anatomical regions or lesions, a laparoscopic probe must be placed in the specific positions and orientations…This display embodiment helps alleviate this difficulty by presenting an anatomical model of an anatomical organ along with an overlay of probe positions and orientations that would achieve the relevant views, such as, for example, a current position 110 and projected position 111a-111d relative to anatomical model image shown in FIG.15).
In regard to the recited feature of claim 18 “controlling the probe device using a manipulator, to scan the probe area”, as applied to claim 1, Gogin teaches that the probe device is an ultrasound probe. It is known in the field of art that an ultrasound probe lacks independent movement capacities and requires an manipulator, either manually or robotically, to control the scanning operation of the device move it.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the one or more processors of Gogin. Lang and Behrendt combined employ such a feature associated with identifying one or more anatomic features in an anatomic model; determining a probe area associated with the one or more anatomic features; and providing one or more instructions to a user to position the probe device to obtain a scan of the probe area as taught in Popovic for visualizing desired anatomical regions or lesions by presenting this relevant view, as suggested in Popovic, [0091].
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gogin et al., EP 2509507 B1, hereinafter Gogin, in view of Lang et al., US 2021/0192759 A1, hereinafter Lang, further in view of Behrendt et al., US 2020/0240790 A1, hereinafter Behrendt, further in view of Mozes et al., US 20180008355 A1, hereinafter Mozes.
Claim 11. Gogin, Lang and Behrendt combined teaches all the limitations of claim 1.
Neither of Gogin, Lang and Behrendt teaches a manipulator configured to control the probe device by controlling an end effector to grip the probe device.
However, in an analogous ultrasound imaging-based registration field of endeavor, Mozes teach
a manipulator configured to control the probe device by controlling an end effector to grip the probe device ([0069]: A suitable scanning device (i.e.,.. other imaging device such as an ultrasound transducer…) scanner may be attached to an end effector (i.e., tip) of the arm member 350…as administered, for example, via the controller device 450) – the ultrasound transducer is considered the “probe device” as claimed; and the controller device is considered the “manipulator” as claimed. To be attached to the end effector is consider that the end effector grips the ultrasound transducer.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the probe device of Gogin, Lang and Behrendt combined employ such a feature of being controlled by a manipulator via controlling an end effector to grip the probe device, as taught in Mozes for the advantage of capable of scanning the patient’s structure to surface match the captured and manipulated image with an actual scan without necessarily requiring a fiducial marker”, as suggested in Mozes, [0069].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gogin et al., EP 2509507 B1, hereinafter Gogin, in view of Lang et al., US 2021/0192759 A1, hereinafter Lang, further in view of Behrendt et al., US 2020/0240790 A1, hereinafter Behrendt, further in view of Eibye et al., US 2015/0369915 A1, hereinafter Eibye.
Claim 12. Gogin, Lang and Behrendt combined teaches all the limitations of claim 1.
As applied to claim 1, Gogin teaches the initial registration and updating the initial registration to generate the first registration (Gogin: Claim 1, [0023]; and Lang: [0717]).
Neither Popovic not Mozes teaches that the registration is performed in response to the probe device being determined to be in an activated state.
However, in an analogous ultrasound imaging device registration field of endeavor, Eibye teaches
the registration is performed in response to the probe device being determined to be in an activated state ([0051]: registration can be achieved for an ultrasound input device 104 merely by activating the ultrasound input device 104).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the registration of Gogin, Lang and Behrendt combined employ such a feature of being performed in response to the probe device being determined to be in an activated state, as taught in Eibye, for the advantage of limiting the registration to be performed only when the imaging device is activated, as suggested in Eibye, [0052]: transmission of the signal may be deactivated to that described for activation, for example, tiered down after a preconfigured duration of time of activation.
Allowable Subject Matter
Claims 8-9 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The limitations recited in claims 8 and 19 in regard to the features of “transforming, based on the second registration, the anatomic model to the probe device space to generate a first transformed anatomic model; and transforming, based on the first registration, the first transformed anatomic model to the first imaging device space to generate a second transformed anatomic model, the first registration is between the probe device space and the imagine device space, and the second registration is between a model space of the anatomic model and the probe device space", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
Dependent claim 9 is allowable solely by virtue of their respective dependency upon an allowable claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal M Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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