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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Drawings
The drawings filed on November 20, 2024 are accepted.
Claim Objections
Claims 1, 6, 9, 16, 25 are objected to because of the following informalities:
In claims 1, 6, 16 and 25, the term “tomosynthesis imaging system” recited in these claims should be corrected to –the cone beam tomosynthesis imaging system-- for claim language consistency purpose.
Claim 9, the term “the user interface system” should be corrected to –the interface system-- for claim language consistency purpose.
Appropriate correction is required.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 5: “positional encoders configured to track a position and orientation” does not have its corresponding disclosure in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1: the claim limitation of “an interface system configured to accept the initiation input” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “system” coupled with functional language “to accept” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “system”.
Claim 5: the claim limitation of “positional encoders configured to track a position and orientation” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “encoder” coupled with functional language “to track” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “encoder”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claim 1: “an input interface” refers to the specification, PG Pub US 2-25/0186013 A1, [0038]: The interface system 114 can be any suitable input device. Non-limiting examples of suitable input devices can include keyboard, touchscreen, manual button.
Claim 5: “positional encoder” does not have structural information disclosed in the specification.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
Claim 5 is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, yet neither the claim nor the specification provides the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
As discussed above, the claim limitations below are interpreted under 35 U.S.C. 112 (f).
Claim 5: Claim limitation “positional encoders configured to track a position and orientation”.
The specification does not provide any disclosure in regard to the positional encoder and the function it performs. One of ordinary skill in the art would not understand the specification, the drawing and the original claims to disclose any particular structure that achieves the disclosed functionality.
This limitation fails to comply with the written description requirement as the limitations are unbound functional imitations which cover all ways of performing the respective functions and inventor has not provided sufficient disclosure to show possession of such an invention. The limitations therefore fails to comply with the written description requirement. See MPEP 2181.II.A.
Further because claims including a 112(f)-invoking term are interpreted as requiring the disclosed corresponding structure for that term, absent the disclosure of any such corresponding structure, the written description is insufficient to show that Applicant was in possession of the invention as claimed at the time of the invention, and such a claim must be rejected under 35 USC 112(a). (MPEP 2181.IV).
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.
The following claim limitations invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph:
Claim 5: the limitations of “positional encoders”.
A claim with a 112(f)-invoking term must be construed as requiring the corresponding structure for that term, or its equivalents. Consequently, absent the disclosure of such corresponding structure, the metes and bounds of the claim cannot be determined, and the claim must be rejected under 112(b) as being indefinite. (MPEP 2181.III)
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 12 and 23 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 12 recites “highlights of features that differ” that renders the scope of the claim indefinite. It is unclear what objects the features are associated with or referring to. It is also unclear what scope the term “differ” is about – for example, do features that show in only one of the 3D image and the prior 3D images get highlighted, or do features that show on both but with different orientation or different intensity get highlighted, or any other interpretation? Clarification with proper claim amendment is required.
Claim 23 recites “a prior 3D image” that renders the scope of the claim indefinite. It is unclear whether it refers to the same as the identical term recited in cliam22, line 4.
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 1-2, 4, 11-12, 16, 18-21 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al., US 2025/0295289 A1, hereinafter Zhao, in view of Ng et al., US 2017/0164931 A1, hereinafter Ng.
Claims 1, 22 and 23. Zhao teaches an imaging system and a method of surgical navigation of a patient using distributed patient reference tracking of a patient anatomy ([0005]: a need exists for methods and systems capable of determining whether a tool is within a target (e.g., lesion) with improved accuracy or efficiency. The present disclosure addresses the above need by providing a tomosynthesis-based tool-in-lesion decision method with improved accuracy and efficiency), comprising
a cone beam tomosynthesis imaging system that includes at least one rotatable tomosynthesis x-ray source and is configured to create a 3D image of a patient anatomy upon an initiation input ([0161]: the systems, methods and techniques described herein may be implemented at least in part with the use of a user interface that may be presented on a graphical user interface…At a high level, the user interfaces may be used for performing and interpreting tomosynthesis and augmented fluoroscopy; [0008]: During a CBCT scan, a CBCT scanner may acquire projections along a rotation of 180-360 degrees angle (i.e. a full rotation of x-ray source and detector) over the region of interest to obtain a volumetric data set…Tomosynthesis is similar to CBCT scan but uses a limited rotation angle (e.g., 15-60 degrees) thus it has a reduced scanning time as compared to CBCT; [0113]: imaging systems such as a fluoroscopy imaging system for providing real-time imaging of a target site (e.g., comprising lesion). Multiple 2D fluoroscopy images may be used to create tomosynthesis or Con Beam CT (CBCT) reconstruction to better visualize and provide 3D coordinates of the anatomical structures. FIG.13 shows an example of a fluoroscopy (tomosynthesis) imaging system 1300; and [0187]: in some embodiments, the fluoroscopic images for the tomosynthesis and augmented fluoroscopy model may be acquired utilizing a Cone Beam CT (CBCT)) – any imaging acquisition requires acquisition setting parameters that is considered the “initiation input” as claimed;
at least one memory device including instructions that, when executed by at least one processor, cause the tomosynthesis imaging system to ([0178]: The CPU 2705 can execute instructions on computer-readable media, which can be embodied in a program or software. The instructions may be stored in a memory location, such as the memory 2710. The instructions can be directed to the CPU 2705, which can subsequently program or otherwise configure the CPU 2705 to implement methods of the present disclosure):
obtain the 3D image from the tomosynthesis imaging system ([0113]: imaging systems such as a fluoroscopy imaging system for providing real-time imaging of a target site (e.g., comprising lesion). Multiple 2D fluoroscopy images may be used to create tomosynthesis or Con Beam CT (CBCT) reconstruction to better visualize and provide 3D coordinates of the anatomical structures. FIG.13 shows an example of a fluoroscopy (tomosynthesis) imaging system 1300);
obtain a prior 3D image of the patient anatomy, wherein the prior 3D image is at least one of a higher quality produced by the cone beam tomosynthesis imaging system, or is produced via a different imaging system than the 3D image; produce a composite 3D image ([0116]: in some cases, the segmented and reconstructed images (e.g., CT images as described elsewhere) provided prior to the operation of the systems described herein may be overlaid on the real time image) – the CT images provided prior to the operation is considered the “prior 3D image produced via a different imaging system” as claimed. The overlaid image is considered the “composite 3D image” as claimed; and
an interface system configured to accept the initiation input to obtain the 3D image and to render at least a portion of the composite 3D image for review by a supervisor ([0116]:…This may allow operators or users to visualize the accurate location of the lesion as well as a planned path; and [0118]: the navigation and localization subsystem may be configured to construct a virtual airway model based on the pre-operative image (e.g., pre-op CT image or tomosynthesis). The navigation and localization subsystem may be configured to identify the segmented lesion location in the 3D rendered airway model and…may generate an optimal path from the main bronchi to the lesions with a recommended approaching angle toward th lesion for performing surgical procedures) - since the 3D image has already been acquired and obtained, it at least implicitly teaches that the initial input has been accepted (such that the 3D image may be acquired. To identify the lesion and generate an optimal path is considered to “review the 3D image” as claimed. Either the user or the navigation and localization subsystem is the claimed supervisor.
Zhao does not teach that the composite 3D image is produced by registering the 3D image and the prior 3D image.
However, in an analogous imaging registration and fusion-based treatment planning field of endeavor, Ng teaches
register the 3D image with the prior 3D image to produce a composite 3D image ([0025]: for procedure guidance where multiple planes of live ultrasound are fused with the corresponding CT slice and these multiple displays of the planes are used for procedure guidance; and [0037]: Orthogonal X-planes may be employed to generate live fusion overlay views on the display that can provide very accurate tracking of needle placement in lesions or other instrument placement) – the fusion overlay view on the display is considered the “composite 3D image” 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 system and method of Zhao employ such a feature of registering the 3D image with the prior 3D image to produce a composite 3D image as taught in Ng for the conventionally recognized advantage for imaging registration that is to properly align images to ensure accurate analysis and interpretation for treatment planning and surgical tool navigation and tracking.
Claim 2. Zhao further teaches that
the cone beam tomosynthesis imaging system is a hybrid system that is configured to produce either of fluoroscopic images and cone beam computed tomography (CBCT) images ([0161]: the systems, methods and techniques described herein may be implemented at least in part with the use of a user interface that may be presented on a graphical user interface…At a high level, the user interfaces may be used for performing and interpreting tomosynthesis and augmented fluoroscopy).
Claim 4. Zhao further teaches that
the hybrid system further includes at least one central x-ray source, wherein the at least one central x-ray source is used to produce one or both of the fluoroscopic images and the CBCT images ([0130]: …a mobile C-arm fluoroscopy…The C-arm imaging system may comprise a source (e.g., an X-ray source) and a detector (e.g., an X-ray detector or X-ray imager). The X-ray detector may generate an image presenting the intensities of received x-rays. The imaging system may reconstruct 3D image based on multiple 2D image).
Claim 11. Zhao and Ng combined teaches all the limitations of claim 1, including the registration of a 3D CT image and a prior 3D image (Zhao: [0116]; and Ng: [0025]).
Ng further teaches
registering the 3D image with the prior 3D image includes image-based registration, wherein common features between the 3D image and the prior 3D image are correlated ([0005]: registration is the correlation of spatial locations in the CT images to the same spatial locations in the ultrasound images…One method is called plane registration…A common anatomical point is then marked in the CT and in the ultrasound. This combination of a common plane and a common point is sufficient to register the CT image to the ultrasound image).
Claim 12. Zhao and Ng combined teaches all the limitations of claim 1, including the registration of a 3D CT image and a prior 3D image (Zhao: [0116]; and Ng: [0025]).
Ng further teaches
the composite 3D image is an overlay of the two images including highlights of features that differ ([0035]: images that are overlaid, fused or otherwise registered between two imaging modalities; and [0047]: if there were any error in the head-toe direction, the sagittal plane would highlight that offset and allow the user to correct for it).
Claim 16. Zhao further teaches that
the prior 3D image is obtained from a prior CT imaging session or is the composite 3D image from an earlier iteration ([0116]: in some cases, the segmented and reconstructed images (e.g., CT images as described elsewhere) provided prior to the operation of the systems described herein may be overlaid on the real time image); and
the 3D image from the tomosynthesis imaging system is obtained using a short-angle acquisition ([0008]: Tomosynthesis is similar to CBCT scan but uses a limited rotation angle (e.g., 15-60 degrees) thus it has a reduced scanning time as compared to CBCT).
Claim 18. Zhao further teaches that
the supervisor is a user and the interface system is a display onto which the composite 3D image is rendered for the user ([0161]: the systems, methods, and techniques described herein may be implemented at least in part with the use of a user interface; and [0116]:…This may allow operators or users to visualize the accurate location of the lesion as well as a planned path).
Claim 19. The imaging system of claim 1, wherein the supervisor is a coded decision maker, and the interface system renders the composite 3D image to the coded decision maker ([0118]: the navigation and localization subsystem may be configured to construct a virtual airway model based on the pre-operative image (e.g., pre-op CT image or tomosynthesis). The navigation and localization subsystem may be configured to identify the segmented lesion location in the 3D rendered airway model and…may generate an optimal path from the main bronchi to the lesions with a recommended approaching angle toward th lesion for performing surgical procedure) – the navigation and localization subsystem are the “coded decision maker” as claimed.
Claim 20. Zhao further teaches that
the initiation input is configured to be manually generated by a user or automatically generated by a coded decision maker ([0079]: The smTomo may retrieve and process fluoroscopy images from smFluoroFrameGrabber of the Vision subsystem. The smTomo may receive user commands and may call tomosynthesis dynamic link library modules to process and generate intermediate files before tomosynthesis reconstruction).
Claim 21. Zhao further teaches
a robotic arm configured to manipulate a surgical instrument which includes a command input which is operatively connected to the supervisor and configured to accept instructions from the supervisor ([0060]: A system as described herein, includes an elongate portion or elongate member…The system may further include a support apparatus such as a robotic manipulator (e.g., robotic arm)…the system may further include peripheral devices and subsystems such as imaging systems that would assist or facilitate the navigation of the elongate member to the target site; and [0118]: the navigation and localization subsystem may be configured to construct a virtual airway model based on the pre-operative image (e.g., pre-op CT image or tomosynthesis). The navigation and localization subsystem may be configured to identify the segmented lesion location in the 3D rendered airway model and…may generate an optimal path from the main bronchi to the lesions with a recommended approaching angle toward th lesion for performing surgical procedure).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al., US 2025/0295289 A1, hereinafter Zhao, in view of Ng et al., US 2017/0164931 A1, hereinafter Ng, in view of Wang et al., US 2015/0043712 A1, hereinafter Wang.
Claim 3. Zhao and Ng combined teaches all the limitations of claim 1.
Zhao further teaches that
a common x-ray source is used to generate the CBCT images or the fluoroscopic images ([0063]: the tomosynthesis imaging mode and the augmented fluoroscopy mode; [0064]: the C-arm or O-arm imaging system may comprise a source (e.g., an X-ray source) and a detector (e.g., an X-ray detector or X-ray imager) and [0113]: imaging systems such as a fluoroscopy imaging system for providing real-time imaging of a target site (e.g., comprising lesion). Multiple 2D fluoroscopy images may be used to create tomosynthesis or Cone Beam CT (CBCT) reconstruction to better visualize and provide 3D coordinates of the anatomical structures. FIG.13 shows an example of a fluoroscopy (tomosynthesis) imaging system 1300).
Neither Zhao nor Ng does not teach that the x-ray source is configured to be fixed in a parked position during at least one of fluoroscopic imaging or CBCT imaging.
However, in an analogous x-ray-based imaging modality configuration field of endeavor, Wang teaches such a feature in claim 14: stereo fluoroscopy of a subject comprises an x-ray source array having three or more x-ray sources, each x-ray source having a fixed position within the array and having a corresponding collimator and independently energizable to emit radiation toward the subject.
To cover a regions to be scanned, a rotatable single x-ray source or multiple x-ray sources each at a fixed position may be used. Either configuration would be able to achieve the same goal.
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 x-ray source of the Zhao and Ng combined employ such a feature of being configured to be fixed in a parked position during at least one of fluoroscopic imaging or CBCT imaging as taught in Wang as an alternative configuration of the x-ray source in an x-ray-based imaging modality.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al., US 2025/0295289 A1, hereinafter Zhao, in view of Ng et al., US 2017/0164931 A1, hereinafter Ng, further in view of Sun et al., US 2008/0095421 A1, hereinafter Sun.
Claim 5. Zhao and Ng combined teaches all the limitations of claim 1, including registering the 3D image and the prior 3D image (Ng: [0025] and [0037]).
Neither Zhao nor Ng teaches positional encoders configured to track a position and orientation of the 3D image relative to the prior 3D image.
However, in an analogous medical imaging data registration field of endeavor, Sun teaches
positional encoders configured to track a relative position and orientation between the two images to be registered (Claim 7: registering the fluoroscopy image with the data representing the volume as a function of the registrations of the fluoroscopy image with the ultrasound data and the ultrasound data with the data representing the volume comprises determining a position and orientation of the fluoroscopy image relative to the data representing the volume as a function of a position and orientation of the fluoroscopy image relative to the ultrasound data and a position and orientation of the ultrasound data relative to the data representing the volume; and claim 20: the processor is operable to register the region with the scanned volume) – the processor is the “positional encoder” 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 registration of the two images of Zhao and Ng combined employ such a feature of positional encoders configured to track a relative position and orientation between the two images to be registered as taught in Sun for the conventionally recognized advantage of properly aligning the two images for image registration.
Claims 6-7 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al., US 2025/0295289 A1, hereinafter Zhao, in view of Ng et al., US 2017/0164931 A1, hereinafter Ng, further in view of Frielinghaus et al., US 2019/0369717 A1, hereinafter Frielinghaus.
Claims 6 and 24. Zhao and Ng combined teaches all the limitations of claims 1 and 22, respectively.
Zhao further teaches
a camera that tracks via at least one reference marker positioned at fixed locations on at least one of the patient and the tomosynthesis imaging system ([0009]: the methods herein may employ pose estimation methods to obtain the relative pose of the camera…when markers (e.g., an array of artificial markers with known positions…) are captured within the images, then the relative positions of the markers to one another within the 2D projection may be processed using computer vision methods to estimate the pose of the camera in the 3D world reference frame).
Neither Zhao nor Ng teaches that the camera is a stereotactic tracking camera.
However, in an analogous imaging-based fiducial marker tracking field of endeavor, Frielinghaus teaches
a stereotactic tracking camera, wherein the stereotactic tracking camera tracks via at least one reference marker positioned at fixed locations on at least one of the patient and the tomosynthesis imaging system ([0031]: the object is at least a physical object and the position tracking system is an infra-red tracking system and an infrared-reflective marker device is attached to the physical object in a predetermined (at least one of known or fixed) position relative to the physical object for allowing tracking of the physical object by the position tracking system; and [0097]: a navigation system (within the disclosure also called position tracking system),…for example the infrared-sensitive stereotactic camera or array of resonant coil circuits).
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 camera of Zhao and Ng combined employ such a feature of being a stereotactic tracking camera as taught in Frielinghaus for the conventionally recognized advantage of comprising two or more image sensors to simulate human binocular vision that provides the ability to perceive depth for a better performance when used for tracking purpose.
Claim 7. Frielinghaus further teaches
the stereotactic tracking camera is further configured to track at least one surgical instrument ([0097]: a navigation system (within the disclosure also called position tracking system), such as a surgical navigation system…for example the infrared-sensitive stereotactic camera or array of resonant coil circuits).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al., US 2025/0295289 A1, hereinafter Zhao, in view of Ng et al., US 2017/0164931 A1, hereinafter Ng, further in view of Frielinghaus et al., US 2019/0369717 A1, hereinafter Frielinghaus, further in view of Chiou et al., US 12,211,151 B1.
Claim 9. Zhao, Ng and Frielinghaus combined teaches all the limitations of claim 7, including displaying in a user interface a composite image of the 3D image and the prior 3D image (Zhao: [0116] and Ng: [0025]).
Neither of them teaches that the user interface system displays the location of the at least one surgical instrument overlaid over the prior 3D image.
However, in an analogous imaging-based device tracking and navigation field of endeavor, Chiou teaches that
the user interface system displays the location of the at least one surgical instrument overlaid over the image (Col.38: list of commands that can be executed by the tracking system: overlay images, fuse images, register images, turn surgical instrument on, turn surgical instrument off…).
Since the surgical instrument can be turned on and off on the display of the overlaid/fused/registered images, and Zhao teaches that the overlaid/fused/registered images are between the 3D image and the prior 3D image, when Zhao and Chiou are combined, it teaches that the surgical instrument is overlaid with the prior 3D image.
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 user interface of the modified Zhao employ such a feature of displaying the location of the at least one surgical instrument overlaid over the image as taught in Chiou for the conventionally recognized advantage of displaying the object being tracked on the image for visualization purpose.
Allowable Subject Matter
Claims 8, 10, 13-15, 17 and 25 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 following is a statement of reasons for the indication of allowable subject matter:
The limitations recited in claim 8 in regard to the features of “the cone beam tomosynthesis imaging system periodically creates a new 3D image of the patient anatomy, re-registers the new 3D image with the composite 3D image creating an updated registration, and allowing the at least one surgical instrument to be tracked based on the updated registration", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
The limitations recited in claim 10 in regard to the features of “registering the 3D image with the prior 3D image includes camera-based registration which includes at least one of a pre-calibrated camera position registration and an object-based registration using an optical image obtained using the stereotactic tracking camera", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
The limitations recited in claim 13 in regard to the features of “the composite 3D image is an integrated 3D image produced by morphing the prior 3D image onto the 3D image to match an updated anatomical condition of the patient", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
The limitations recited in claim 14 in regard to the features of “the composite 3D image is an integrated 3D image produced by morphing the prior 3D image onto the 3D image to match an updated anatomical condition of the patient", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
The limitations recited in claim 13 in regard to the features of “the composite 3D image is an integrated 3D image produced by morphing the prior 3D image onto the 3D image to match an updated anatomical condition of the patient", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
The limitations recited in claim 17 in regard to the features of “defining a selected local portion of the prior 3D image such that the prior 3D image is only modified within the selected local portion to produce the composite 3D image using a local matching metric", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
The limitations recited in claim 25 in regard to the features of “the composite 3D image is produced by morphing the prior 3D image onto the 3D image to match an updated anatomical condition of the patient; and a user interface system configured to accept the initiation input and obtain the 3D image and to render at least a portion of the composite 3D image for review by a supervisor, wherein registering the prior 3D image onto the 3D image further adapted to define a selected local portion of the prior 3D image such that the prior 3D image is only modified within the selected local portion to produce the composite 3D image using a local matching metric", in combination with the other claimed elements, are not taught or disclosed in the prior arts.
Dependent claims 14-15 are allowed at least by virtue of their respective dependency upon an allowable claim.
Conclusion
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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