DETAILED ACTION
Remarks
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The preliminary amendment filed 1/31/23 is entered. Accordingly, claims 1-15 are pending and under examination.
Information Disclosure Statement
The information disclosure statements filed 1/31/23 and 7/17/24 fail to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Specifically, the Applicant has not filed English translations for the references indicated by strikethrough on the annotated information disclosure statements. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Rejections - 35 USC § 103 (AIA )
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4, 11, and 14 are rejected under 35 U.S.C. 103 as being obvious over US 2017/0217102 A1 to MANSI in view of US 2017/0032703 A1 to SEKINO.
Regarding claim 1, MANSI teaches a three-dimensional object (Abstract: system and method for multi-modality fusion for 3D printing of a patient-specific organ model is disclosed; par. 0017: 3D printed model), wherein the three-dimensional object is produced based on biological property information indicating a biological property obtained by magnetic resonance elastography(MRE) measurement of an organism; and the three-dimensional object has a distribution of a … property corresponding to a distribution of the biological property (par. 0018: Tissue substrate and properties are estimated through direct imaging measurement, e.g., MR, elastography, and this information is mapped to the holistic model as spatially varying, potentially dynamic mesh data. The holistic model is then 3D-printed; par. 0019: generates a 3D printed model of a target organ (or other anatomical structure)… and can be similarly applied to generate a patient-specific 3D printed model for any anatomical structure or a 3D printed model including multiple organs or anatomical structures; par. 0031: Tissue properties can also be estimated and mapped to the holistic mesh model. For example, spatially varying biomechanical properties like stiffness can be mapped to the holistic mesh model. Stiffness can be measure directly using elastography techniques, such as … MR elastography), but does not expressly disclose the three-dimensional object has a distribution of a strength property corresponding to a distribution of the biological property.
Regarding claim 11, MANSI further teaches an object producing method (Abstract: system and method for multi-modality fusion for 3D printing of a patient-specific organ model is disclosed), comprising: producing a three-dimensional object using a 3D printer based on medical 3D data of an organism (par. 0035: the 3D printer prints the patient-specific anatomy (shape) of the target organ defined in the 3D holistic model with materials having material properties, colors, and textures that represent various physiological and/or anatomical parameters of interest), wherein the medical 3D data includes biological property information indicating a biological property obtained by MRE measurement of the organism; and the three-dimensional object has a distribution of a … property corresponding to a distribution of the biological property (par. 0018: Tissue substrate and properties are estimated through direct imaging measurement, e.g., MR, elastography, and this information is mapped to the holistic model as spatially varying, potentially dynamic mesh data. The holistic model is then 3D-printed; par. 0019: generates a 3D printed model of a target organ (or other anatomical structure)… and can be similarly applied to generate a patient-specific 3D printed model for any anatomical structure or a 3D printed model including multiple organs or anatomical structures; par. 0031: Tissue properties can also be estimated and mapped to the holistic mesh model. For example, spatially varying biomechanical properties like stiffness can be mapped to the holistic mesh model. Stiffness can be measure directly using elastography techniques, such as … MR elastography), but does not expressly disclose the three-dimensional object has a distribution of a strength property corresponding to a distribution of the biological property.
However, SEKINO teaches a simulated organ and the manufacturing thereof, wherein the simulated organ is produced, using 3D printing, to have a specific value range for various physical properties, including strength values (Abstract; par. 0110; 0112).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate additional physical properties of an actual organ, including strength values, as taught by SEKINO, into the simulated 3D printed organ of MANSI, in order to provide a more accurate simulation of an actual organ, thereby providing a more realistic experience to the end user.
Regarding claim 2, MANSI further teaches wherein the three-dimensional object is produced based on medical 3D data including the biological property information (par. 0018: holistic 3D mesh model of the organ of interest… holistic model is then 3D-printed); and the medical 3D data is generated based on medical image data obtained by capturing an image of the organism with a medical image capturing device and on the biological property (par. 0018: different images from multiple imaging modalities used to build holistic 3D mesh model; par. 0020: medical images from multiple medical imaging modalities are received. The medical images can include a medical images of the target organ acquired using a plurality of medical imaging modalities. For example, medical images from a plurality of medical imaging modalities, such as CT, MR, ultrasound, positron emission tomography (PET), Dyna-CT, x-ray, etc., can be received. In an advantageous embodiment, the medical images received from the various medical imaging modalities are 3D medical images and/or 4D (3D+t) medical image data (i.e., a time-sequence of 3D medical images); par. 0029: Various tissue properties, tissue dynamics, and tissue activity can be estimated through direct measurement from the medical images (e.g., ultrasound, MR, elastography)).
Regarding claim 4, MANSI further teaches wherein the biological property information is individual biological property information indicating an individual biological property obtained by MRE measurement of one organism (Abstract: The estimated one or more spatially varying physiological parameter can be represented in the 3D printed model using a spatially material property; par. 0019: FIG. 2 illustrates a method for multi-modality image fusion for 3D printing of a holistic patient-specific organ model according to an embodiment of the present invention; par. 0031: For example, stiffness can be measured directly using elastography techniques, such as MR elastography).
Regarding claim 14, MANSI further teaches the elements above, but does not expressly disclose wherein the 3D printer is a material jetting type. However, SEKINO further teaches producing the simulated organ using 3D printing using an ink jet method (par. 0108). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an ink jet 3D printing method, as taught by SEKINO, into the method of making the device of MANSI, as doing so is applying a known technique to a known method ready for improvement to yield predictable results. Additionally, using the 3D printing method of SEKINO in the method of MANSI would have been obvious to try based on the finite number of 3D printing methods known in the art, and doing so is a predictable solution, with a reasonable expectation of success.
Claims 3, 12, and 13 are rejected under 35 U.S.C. 103 as being obvious over MANSI in view of SEKINO, as applied to claim 2 and 11, respectively, in further view of US 2013/0218002 A1 to KIRALY.
Regarding claim 3, MANSI further teaches wherein the medical 3D data includes a plurality of voxels generated based on the medical image data (par. 0022: the registration can be based on voxels inside the organ in the medical images), but does not expressly disclose the medical 3D data includes image density information indicating an image density in the medical image data and allocated to each voxel, and the biological property information allocated to each voxel.
Regarding claim 12, MANSI further teaches wherein the medical 3D data further includes a plurality of voxels generated based on a medical image data (par. 0022: the registration can be based on voxels inside the organ in the medical images), but does not expressly disclose the medical 3D data includes image density information indicating an image density in the medical image data and allocated to each voxel.
Regarding claim 13, MANSI further teaches wherein the medical 3D data further includes a plurality of voxels generated based on a medical image data (par. 0022: the registration can be based on voxels inside the organ in the medical images), but does not expressly disclose the medical 3D data includes image density information indicating an image density in the medical image data and allocated to each voxel, and the biological property information indicating the biological property and allocated to each voxel.
Regarding claims 3, 12 and 13, KIRALY teaches a method of using magnetic resonance (MR) elastography, wherein MR imaging system acquires the data by scanning the patient (par. 0032) which provides tissue characteristic information, such as elastic modulus, velocity, or stiffness, and that indicates a density or viscosity for allowing simulation with MR acquired data (Abstract; par. 0005; 0063). KIRALY discloses storing the medical image data (e.g., ultrasound, MR anatomy data, and/or MR elastography data), and further includes associating each datum with a different volume location (voxel) in the patient volume (par. 0039; 0060). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the method of processing MR elastography data including associating tissue characteristic information and density information to different volume locations, i.e., voxels, as taught by KIRALY, into the modified invention of MANSI, as doing so is applying a known technique of processing MR elastography data to improve similar system and methods of generating a simulated anatomical model in the same way.
Claim 5 is rejected under 35 U.S.C. 103 as being obvious over MANSI in view of SEKINO, as applied to claim 1, respectively, in further view of US 6,957,961 B1 to OWENS.
Regarding claim 5, MANSI teaches the elements above, but does not expressly disclose wherein the biological property information is average biological property information indicating an average biological property obtained by averaging a plurality of individual biological properties obtained by MRE measurement of a plurality of organisms. OWENS teaches a manikin and method of making the manikin made from bio-simulating material (Abstract) which comprises body parts comprising physical characteristics of the subject they are simulating, e.g., a human child, wherein measurements of the actual body parts are taken and average characteristic measurements of each body part are calculated and used to construct each body part (col. 5, lines 11-20). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate using average values of each physical characteristic of a given body part, as taught by OWENS, into the modified invention of MANSI, in order to apply a known technique of producing bio-simulating materials using average measured values for each physical characteristic of a given body part.
Claims 7-8 are rejected under 35 U.S.C. 103 as being obvious over MANSI in view of SEKINO, as applied to claim 1, respectively, in further view of EP3496073A1 to MATSUMURA.
Regarding claim 7, MANSI teaches the elements above, but does not expressly disclose wherein the three-dimensional object comprises a hydrogel as a material constituting the three-dimensional object.
Regarding claim 8, MANSI teaches the elements above, but does not expressly disclose wherein the hydrogel contains water, a polymer, and a mineral.
However, MATSUMURA teaches an ultrasonic phantom used in puncture treatment training (Abstract; Title), the phantom mimicking a living tissue (par. 0015), the phantom manufactured by a 3D printer, e.g., inkjet printer (par. 0085-0086), and the phantom comprising a hydrogel comprising water, polymer, and mineral (par. 0017).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a hydrogel comprising water, polymer, and mineral, as taught by MATSUMURA, into the modified invention of MANSI, in order to provide a material that mimics living tissue, as doing so is applying a known technique to a known method ready for improvement to yield predictable results.
Claims 9-10 are rejected under 35 U.S.C. 103 as being obvious over MANSI in view of SEKINO, as applied to claim 1, respectively, in further view of US 2015/0279237 A1 to SUGIYAMA.
Regarding claim 9, MANSI teaches the elements above, but does not expressly disclose a housing that houses the three-dimensional object.
Regarding claim 10, MANSI teaches the elements above, but does not expressly disclose wherein the housing is an imitation imitating a structure of at least part of the organism.
However, SUGIYAMA teaches a mannequin that houses simulated human organs, e.g., simulated heart, veins for training of cardiac massage by cardiopulmonary resuscitation (Abstract; par. 0004; 0010; 0032). SUGIYAMA teaches that cardiopulmonary resuscitation can be realistically practiced in a state close to the actual state using the mannequin simulating a human body (par. 0009; 0066). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a mannequin in the shape of a human configured to house simulated human organs, as taught by SUGIYAMA, into the invention of MANSI, in order to provide a more realistic model with the simulated organs in a simulated human body, thereby allowing for training on the assembly of simulated anatomy to be performed.
Claims 6 and 15 are rejected under 35 U.S.C. 103 as being obvious over MANSI in view of SEKINO, as applied to claim 1, in further view of US 2018/0345583 A1 to LENG.
Regarding claim 6, MANSI teaches the elements above including a focus on improving accuracy (par. 0021), but does not expressly disclose wherein a difference of a three-dimensional object property obtained by MRE measurement of the three-dimensional object from the biological property is within 5%. However, LENG teaches a method for performing quality control assessments of a three dimensional (3D) printing system (Abstract). LENG further discloses that it is critical to have the models accurately represent patient anatomy and pathology, and that in medical applications, it is imperative that parts created meet the stringent requirements and have all dimensions fall within acceptable tolerances (par. 0025). LENG discloses that accuracy, precision, and shape fidelity of 3D printed parts produced are important for patient safety and optimal patient care, and the features of the phantom 100 have been chosen to inspect these qualities, such that proper adjustments to the 3D printing system can be made when unacceptable measurements are observed, which is accomplished in part by calculating distances between the original model and the scanned model on a point by point basis to provide easy identification of areas of the part that deviate furthest from the desired dimensions (par. 0035; 0046). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to improve model accuracy through a quality control process ensuring qualities of the model match the actual patient anatomy and pathology, as taught by LENG, into the modified invention of MANSI, in order to produce the most accurate model possible, thereby providing a more realistic model organ to the end user. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to achieve a tolerance of less than 5% as claimed using the quality control process of LENG, through routine optimization, to further the objective of providing the most accurate model as possible.
Regarding claim 15, MANSI as modified by SEKINO teaches … a three- dimensional object, … comprising: wherein the three-dimensional object is the three-dimensional object according to claim 1 (see product claim 1 and method of manufacturing claim 11 above), but does not expressly disclose a method for evaluating accuracy of the three-dimensional object, the method comprising: evaluating accuracy of property based on biological property information indicating a biological property obtained by MRE measurement of an organism and three-dimensional object property information indicating a property of a three-dimensional object obtained by MRE measurement of the three-dimensional object. However, LENG teaches a method for performing quality control assessments of a three dimensional (3D) printing system (Abstract). LENG further discloses that the quality control includes testing accuracy of final 3D printed parts, including in medical applications, and that for models involving patients, it is critical to have the models accurately represent patient anatomy and pathology (par. 0025; FIG. 5). LENG discloses the accuracy is determined based on a comparison of physical measurements of the 3D printed part to the 3D model (par. 0048; 0065; FIG. 5). LENG discloses that when accuracy falls outside predetermined tolerances, the part can be discarded or adjusted appropriately to meet a desired specification, and when the accuracy is acceptable, the part can be used for its intended purpose (par. 0065; FIG. 5). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the process of evaluating the accuracy of a 3D printed part to a 3D model, as taught by LENG, to the modified method of manufacturing of MANSI, in order to ensure the 3D printed part accurately represents patient anatomy and pathology, so that unacceptable 3D parts may be discarded and 3D models may be adjusted to meet quality control requirements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Hull whose telephone number is 571-272-0996. The examiner can normally be reached on Monday-Friday from 8:00am to 5:00pm MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached at telephone number 571-272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES B HULL/Primary Examiner, Art Unit 3715