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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The Amendment filed 6/15/26 has been entered. Claim(s) 1-5 and 8-21 are pending in the application and are under examination.
Claim Rejections - 35 USC § 103 (AIA )
Claims 1, 2, 4, 8, 11, 14, 15 and 16 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, US 2018/0345583 A1 to LENG, and EP3496073A1 to MATSUMURA.
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).
To the extent MANSI does not expressly disclose the three-dimensional object has a distribution of a strength property corresponding to a distribution of the biological property, 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.
Although MANSI discloses a focus on improving accuracy (par. 0021), MANSI 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.
To the extent MANSI does not expressly disclose wherein the three-dimensional object comprises a hydrogel capable of MRE measurements as a material constituting the three-dimensional object, 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). The phrase “capable of MRE measurements” is interpreted under the broadest reasonable interpretation as any hydrogel as the neither the claims or specification impose any structural limitations based on this phrase to the hydrogel. Accordingly, the hydrogel of MATSUMURA is interpreted as capable of MRE measurements. 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/device ready for improvement to yield predictable results.
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 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/device ready for improvement to yield predictable results.
Regarding claim 16, MANSI further teaches wherein the object is an organ model (par. 0019: model of a target organ).
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/device 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.
Regarding claim 15, MANSI, as modified above, teaches the three-dimensional object according to claim 1 (rejection of claim 1 incorporated herein by reference), 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.
Claims 3, 12, and 13 are rejected under 35 U.S.C. 103 as being obvious over MANSI in view of SEKINO, LENG, and MATSUMURA, 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, LENG, and MATSUMURA, 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 9-10 are rejected under 35 U.S.C. 103 as being obvious over MANSI in view of SEKINO, LENG, and MATSUMURA, 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 17-21 are rejected under 35 U.S.C. 103 as being obvious over MANSI in view of SEKINO, LENG, and MATSUMURA, as applied to claim 8, respectively, in further view of US 2018/0061279 to NIIMI.
Regarding claim 17, MANSI teaches the elements above, but does not expressly disclose wherein the polymer is formed from a monomer containing a (meth)acrylamide group. However, NIIMI also teaches using hydrogel for medical models (par. 0035; 0119) as the hydrogel has a composition extremely close to a human body (par. 0255). NIIMI teaches the hydrogel includes a polymer, water, and mineral (par. 0137), wherein the polymer formed by a monomer containing methacrylamide (par. 0083). 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 hydrogel comprising a polymer formed by a monomer containing methacrylamide, as taught by NIIMI, into the modified invention of MANSI, as doing so is applying a known technique of manufacturing a hydrogel in an anatomical model to a known method/device ready for improvement to yield predictable results.
Regarding claim 18, MANSI teaches the elements above, but does not expressly disclose wherein the hydrogel contains 30.0% by mass or greater but 90.0% by mass or less of water. However, NIIMI also teaches using hydrogel for medical models (par. 0035; 0119) as the hydrogel has a composition extremely close to a human body (par. 0255). NIIMI teaches the hydrogel includes a polymer, water, and mineral (par. 0137), wherein the moisture/water content of the hydrogel is 70% by mass or greater (par. 0046; 0092). The moisture/water content of NIIMI is within the claimed range, and 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 the moisture/water content, as taught by NIIMI, into the modified invention of MANSI, in order to provide a composition that is considered extremely close to a human body, thereby producing a more accurate training model.
Regarding claim 19, MANSI teaches the elements above, but does not expressly disclose wherein the mineral is a water-swellable layered clay mineral. However, NIIMI also teaches using hydrogel for medical models (par. 0035; 0119) as the hydrogel has a composition extremely close to a human body (par. 0255). NIIMI teaches the hydrogel includes a mineral, including a water swellable clay (par. 0088-0090). NIIMI teaches that it is desirable for a clay mineral to be uniformly dispersible in water, and thus water swellable clay is preferred (par. 0088). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate water swellable clay as the mineral in hydrogel, as taught by NIIMI, into the modified invention of MANSI, as doing so is applying a known technique of manufacturing a hydrogel in an anatomical model to a known method/device ready for improvement to yield predictable results, e.g., uniformly dispersible in water.
Regarding claim 20, MANSI teaches the elements above, but does not expressly disclose wherein the hydrogel contains 10.0% by mass or greater but 50.0% by mass or less of organic solvent. However, NIIMI further teaches the hydrogel contains an organic solvent to enhance moisture retention of the hydrogel structure (par. 0096-0098) wherein the organic solvent is preferably from 10 to 50 percent by mass to the total of the hydrogel structure (par. 0100). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate organic solvent of 10 to 50% by mass of the total hydrogel structure, as taught by NIIMI, into the modified invention of MANSI, as doing so is applying a known technique of manufacturing a hydrogel in an anatomical model to a known method/device ready for improvement to yield predictable results, e.g., enhanced moisture retention.
Regarding claim 21, MANSI teaches the elements above, but does not expressly disclose wherein the mineral is hectorite and the polymer is formed from dimethylacrylamide and polyethylene glycol diacrylate. However, NIIMI teaches the hydrogel is produced using a mineral, preferably hectorite (par. 0090). Further, NIIMI teaches the hydrogel is produced using a polymer, including dimethylacrylamide and polyethylene glycol 200 di(meth)acrylate (par. 0083; 0148; 0369). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate hectorite, dimethylacrylamide and polyethylene glycol 200 di(meth)acrylate, as taught by NIIMI, into the modified invention of MANSI, as doing so is applying a known technique of manufacturing a hydrogel in an anatomical model to a known method/device ready for improvement to yield predictable results.
RESPONSE TO ARGUMENTS
35 USC § 103 – Rejections
Applicant's arguments filed 6/15/26 have been fully considered but they are not persuasive.
Applicant argues there is no suggestion to use such a hydrogel (of MATSUMURA) in a system as instantly claimed. Applicant’s argument is conclusory, and therefore, not persuasive.
Applicant argues it is not believed that LENG discloses or suggests measurements of MRE in objects as claimed. Applicant’s argument is conclusory and thus not persuasive. Further, LENG is not relied upon to teach MRE measurements. Rather, MANSI discloses a 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 (par. 0018), and that stiffness can be measured directly using elastography techniques, such as … MR elastography (par. 0031). Therefore, Applicant’s argument is not persuasive.
Applicant further argues that the art of record does not teach the new limitations of claim 1 (i.e., hydrogel capable of MRE measurement and obtaining a difference of the three-dimensional object from the biological property of within 5%). However, MANSI discloses the importance of an accurate model (par. 0021), and the hydrogel of MANSI is interpreted as capable of being measured by MRE. The claims do not impose any structure limitations further defining the structure of the hydrogel that results in it being capable of MRE measurements. Further, LENG is relied upon in the rejection for it’s approach to improving accuracy of a model (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)). As indicated in the rejection, LENG provides the motivation to make the model of MANSI as accurate as possible, which one of ordinary skill in the art would understand to be as close to 100% accurate as possible, i.e., within 5% of the actual anatomy. Therefore, Applicant’s argument is not persuasive.
Applicant argues the specific components of the hydrogel are not disclosed or suggested in MANSI or the other cited art. Applicant’s argument is conclusory, and therefore, not persuasive.
Applicant argues new claims 16-21 are further patenable. However, Applicant is directed to the new grounds of rejection, as necessitated by claim amendment. Therefore, Applicant’s argument is not persuasive.
Conclusion
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 extension fee 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 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
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