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 .
Claim Objections
Claims objected to because of the following informalities:
In claim 1, line 8, “and from different” should read “and different”.
In claim 2, line 1, “A method” should read “The method”.
In claim 3, line 7, “structure and foam” should read “structure, and foam”.
In claim 5, line 2, “claim 1,” should read “claim 1, further comprising”
In claim 9, line 4, “structure; and” should read “structure, and”.
In claim 10, line 6, “structure and foam” should read “structure, and foam”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 16 recites a process, the process including the steps of providing a medical simulator; and training medical staff with the simulator. The recited steps, under their broadest reasonable interpretation, are providing a medical simulator and training staff with the simulator. The recited steps, as drafted, are a process that is a method of applying an abstract idea, specifically certain methods of organizing human activity in the form of teaching (providing a simulator and training staff with the simulator). If claim limitations, under their broadest reasonable interpretation, include certain methods of organizing human activity, the limitations fall under the abstract ideas judicial exception and therefore recite ineligible subject matter. Accordingly, claim 16 recites an abstract idea.
The judicial exception is not integrated into a practical application because the claims do not recite additional elements that are significantly more than the judicial exception or meaningfully limit the practice of the judicial exception. The additional elements are the simulator having at least two additively manufactured foam components, wherein the foam components differ in at least one of the following features: foam structure and material. The additional elements are merely generally linking the process with the field of additive manufacturing and defining the structure of the simulator in a general manner. Accordingly, the additional elements and steps do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. Therefore, the claim is directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as discussed above, the additional elements of the simulator having at least two additively manufactured foam components, wherein the foam components differ in at least one of the following features: foam structure and material are merely generally linking the process with the field of additive manufacturing. Further, the limitations, taken in combination, add nothing that is not already present when looking at the elements taken individually. As such, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, under their broadest reasonable interpretation, the additional elements do not meaningfully limit the practice of the abstract idea and do not amount to significantly more than the judicial exceptions. Therefore, claim 16 is not directed to eligible subject matter as it is directed to an abstract idea without significantly more.
Claim 17 is dependent from claim 16 and includes all the limitations of the independent claim. Therefore, the dependent claim recites the same abstract idea. The limitations of the dependent claims fail to amount to significantly more than the judicial exception as the limitations are functional limitations that do not provide further specificity to the structure or composition of the apparatus or device used as the resistances would be different based on the different structure or material and are not specifically defined in the claim. Therefore, the claim provides no patentable weight and the limitations are not evidence of a practical application or significantly more. Therefore, the analysis of the independent claim can be applied to this dependent claim.
Accordingly, claims 16-17 are directed to abstract ideas without significantly more and are not drawn to eligible subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 9, 16, 18, and 22 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Loguda-Summers et al. (US PGPub 20210104176), hereinafter referred to as Loguda.
With regard to claim 1, Loguda teaches a method for producing a medical simulator (Abstract; Paragraphs 0028, 0031 teach a process for medical training including manufacturing, using 3D printing, an anatomical model (medical simulator)), having at least two foam components (Paragraphs 0028, 0031, 0042 teach the process can manufacture a plurality of components including at least a first and second set of structures composed of different materials wherein TPU and ABS are two different foam components), wherein the method comprises the steps of:
additive manufacturing of a first foam component (Paragraphs 0028, 0031, 0038, 0042; manufacturing the first set of structures or for instance a vertebrae); and
additive manufacturing of at least one further foam component (Paragraphs 0028, 0031, 0038, 0042; manufacturing the second set of structures or for instance a disc),
wherein the first foam component and the at least one further foam component are configured so as to have at least one of different foam structures and from different materials (Paragraphs 0028, 0031-0032 teach the anatomical structures can be formed of any form of additive manufacturing technique employing a material wherein the first and second sets of structures are made of different materials and have different structure (disc v. vertebrae) and different stiffness).
With regard to claim 9, Loguda teaches a medical simulator (Abstract; Paragraphs 0028, 0031 teach a process for medical training including manufacturing, using 3D printing, an anatomical model (medical simulator)), having at least two additively manufactured foam components (Paragraphs 0028, 0031, 0042 teach the process can manufacture a plurality of components including at least a first and second set of structures composed of different materials wherein TPU and ABS are two different foam components), wherein the foam components differ in at least one of the following features: foam structure, and material (Paragraphs 0028, 0031-0032 teach the anatomical structures can be formed of any form of additive manufacturing technique employing a material wherein the first and second sets of structures are made of different materials and have different structure (disc v. vertebrae) and different stiffness).
With regard to claim 16, Loguda teaches a medical simulator method (Abstract; Paragraph 0009; “method for injection placement training”) comprising the steps of:
providing a medical simulator having at least two additively manufactured foam components (Abstract; Paragraphs 0028, 0031 teach a process for medical training including manufacturing, using 3D printing, an anatomical model (medical simulator)), wherein the foam components differ in at least one of the following features: foam structure and material (Paragraphs 0028, 0031-0032 teach the anatomical structures can be formed of any form of additive manufacturing technique employing a material wherein the first and second sets of structures are made of different materials and have different structure (disc v. vertebrae) and different stiffness); and
training medical staff with the simulator (Paragraphs 0009, 0029, 0044 teach the model can be used to train a student, resident, or intern (staff) for performing injections such as lumbar punctures or spinal anesthesiology).
With regard to claims 18 and 22, Loguda further teaches wherein the medical simulator is an epidural anaesthesia simulator (Paragraphs 0029, 0044 teach the model is used for injection training of a user wherein the procedure can include spinal anesthesia (epidural anaesthesia)).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claim(s) 2-3, 8, 10, 15, 17, 19, 20, 23, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loguda in view of Bohl (US PGPub 20200078093).
With regard to claim 2, Loguda may not explicitly teach wherein in that at least one of the at least two foam components is configured so as to have at least one of a predetermined geometry of the elementary cells, orientation of the elementary cells, size of the elementary cells, and cell wall structure. However, Bohl teaches a system and method for constructing an anatomical model using 3D printing wherein the model includes a plurality or components and layers wherein the printed model can be made of various materials in order to replicate biomechanical, anatomical, and/or physiological properties and include printing parameters including in-fill density (size of elementary cells), in-fill pattern (geometry and orientation), print orientation, and number of print shells (cell wall structure) wherein different printing parameters are used to replicate component or predefined anatomical properties of different components or pieces of the model (Paragraphs 0039-0040, 0049, 0055).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Bohl by applying the technique of generating printing parameters including in-fill density and pattern, print orientation, and number of print shells of Bohl for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical simulator models for training medical staff/users. One of ordinary skill in the art would modify Loguda by coding the system to include printing parameters including in-fill density and pattern, print orientation, and number of print shell based on desired properties for different components or sets of components such that different components can be printed with different materials (e.g., foam, TPU, ABS, Styrofoam) and have predefined in-fill structure corresponding to the properties. Upon such modification, the method and system of Loguda would include wherein in that at least one of the at least two foam components is configured so as to have at least one of a predetermined geometry of the elementary cells, orientation of the elementary cells, size of the elementary cells, and cell wall structure. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Bohl with Loguda’s system and method in order to better simulate the biomechanical, anatomical, and physiological properties of the desired medical simulator/model.
With regard to claim 3, Loguda further teaches teach wherein in that the first foam component and the at least one further foam component are configured so as to have different foam structures (Paragraphs 0028, 0031-0032 teach the anatomical structures can be formed of any form of additive manufacturing technique employing a material wherein the first and second sets of structures are made of different materials and have different structure (disc v. vertebrae) and different stiffness (foam structure)), but may not explicitly teach wherein the different foam structures differ by at least one of the following foam structure parameters: geometry of the elementary cells, orientation of the elementary cells, average size of the elementary cells, pore structure, and foam density. However, as discussed above, Bohl teaches a system and method for constructing an anatomical model using 3D printing wherein the model includes a plurality or components and layers wherein the printed model can be made of various materials in order to replicate biomechanical, anatomical, and/or physiological properties and include printing parameters including in-fill density (size of elementary cells), in-fill pattern (geometry, orientation, pore structure, and foam density), shape, porosity, composition, and print orientation wherein different printing parameters are used to replicate component or predefined anatomical properties of different components or pieces of the model such that different components differ based on the printing parameters (Paragraphs 0039-0040, 0049, 0055-0056).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Bohl by applying the technique of generating printing parameters including in-fill density and pattern, print orientation, shape, porosity, and composition of Bohl for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical simulator models for training medical staff/users. One of ordinary skill in the art would modify Loguda by coding the system to include printing parameters including in-fill density and pattern, print orientation, porosity, shape, and composition based on desired properties for different components or sets of components such that different components can be printed with different materials (e.g., foam, TPU, ABS, Styrofoam) and different structure including geometry, orientation, size, porosity, and density. Upon such modification, the method and system of Loguda would include wherein the different foam structures differ by at least one of the following foam structure parameters: geometry of the elementary cells, orientation of the elementary cells, average size of the elementary cells, pore structure, and foam density. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Bohl with Loguda’s system and method in order to better simulate the biomechanical, anatomical, and physiological properties of the desired medical simulator/model.
With regard to claim 8, Loguda may not explicitly teach wherein the at least two foam components are adapted to a tissue structure of a patient. However, Bohl teaches the 3D printed model may be based an image dataset of a patient or designed to be representative of a particular patient or patient-specific disease (Paragraphs 0040, 0047-0048).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Bohl by applying the technique of generating 3D model based on a particular patient or patient-specific disease of Bohl for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical simulator models for training medical staff/users. One of ordinary skill in the art would modify Loguda by coding the system to include printing parameters that generate the model based on a particular patient such that the model is reflective of the patient’s anatomy such as a spinal column including the corresponding anatomical and biomechanical parameters (tissue structure). Upon such modification, the method and system of Loguda would include wherein the at least two foam components are adapted to a tissue structure of a patient. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Bohl with Loguda’s system and method in order to train staff on a particular patient or to treat a patient-specific disease or structure.
With regard to claim 10, Loguda may not explicitly teach wherein the foam structures of the first foam component and of the at least one further foam component differ by at least one of the following foam structure parameters: geometry of the elementary cells, orientation of the elementary cells, average size of the elementary cells, pore structure, and foam density. However, as discussed above, Bohl teaches a system and method for constructing an anatomical model using 3D printing wherein the model includes a plurality or components and layers wherein the printed model can be made of various materials in order to replicate biomechanical, anatomical, and/or physiological properties and include printing parameters including in-fill density (size of elementary cells), in-fill pattern (geometry, orientation, pore structure, and foam density), shape, porosity, composition, and print orientation wherein different printing parameters are used to replicate component or predefined anatomical properties of different components or pieces of the model such that different components differ based on the printing parameters (Paragraphs 0039-0040, 0049, 0055-0056).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Bohl by applying the technique of generating printing parameters including in-fill density and pattern, print orientation, shape, porosity, and composition of Bohl for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical simulator models for training medical staff/users. One of ordinary skill in the art would modify Loguda by coding the system to include printing parameters including in-fill density and pattern, print orientation, porosity, shape, and composition based on desired properties for different components or sets of components such that different components can be printed with different materials (e.g., foam, TPU, ABS, Styrofoam) and different structure including geometry, orientation, size, porosity, and density. Upon such modification, the method and system of Loguda would include wherein the foam structures of the first foam component and of the at least one further foam component differ by at least one of the following foam structure parameters: geometry of the elementary cells, orientation of the elementary cells, average size of the elementary cells, pore structure, and foam density. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Bohl with Loguda’s system and method in order to better simulate the biomechanical, anatomical, and physiological properties of the desired medical simulator/model.
With regard to claim 15, Loguda may not explicitly teach wherein at least one of the at least two foam components has at least one of a predetermined geometry of the elementary cells, orientation of the elementary cells, size of the elementary cells, and cell wall structure. However, Bohl teaches a system and method for constructing an anatomical model using 3D printing wherein the model includes a plurality or components and layers wherein the printed model can be made of various materials in order to replicate biomechanical, anatomical, and/or physiological properties and include printing parameters including in-fill density (size of elementary cells), in-fill pattern (geometry and orientation), print orientation, and number of print shells (cell wall structure) wherein different printing parameters are used to replicate component or predefined anatomical properties of different components or pieces of the model (Paragraphs 0039-0040, 0049, 0055).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Bohl by applying the technique of generating printing parameters including in-fill density and pattern, print orientation, and number of print shells of Bohl for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical simulator models for training medical staff/users. One of ordinary skill in the art would modify Loguda by coding the system to include printing parameters including in-fill density and pattern, print orientation, and number of print shell based on desired properties for different components or sets of components such that different components can be printed with different materials (e.g., foam, TPU, ABS, Styrofoam) and have predefined in-fill structure corresponding to the properties. Upon such modification, the method and system of Loguda would include wherein at least one of the at least two foam components has at least one of a predetermined geometry of the elementary cells, orientation of the elementary cells, size of the elementary cells, and cell wall structure. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Bohl with Loguda’s system and method in order to better simulate the biomechanical, anatomical, and physiological properties of the desired medical simulator/model.
With regard to claim 17, Loguda may not explicitly teach wherein different needle penetration resistances and different fluid penetration resistances are simulated by means of the at least two foam components. Examiner notes that limitations of claim 17 are functional limitations of the structure of the simulator and, per page 6, line 24 – page 7, line 15 of the specification of the instant application, are results of varying the foam structure including geometry, orientation, and size of the cells. As discussed above, Bohl teaches a system and method for constructing an anatomical model using 3D printing wherein the model includes a plurality or components and layers wherein the printed model can be made of various materials in order to replicate biomechanical, anatomical, and/or physiological properties and include printing parameters including in-fill density (size of elementary cells), in-fill pattern (geometry and orientation), print orientation, and number of print shells (cell wall structure) wherein different printing parameters are used to replicate component or predefined anatomical properties of different components or pieces of the model (Paragraphs 0039-0040, 0049, 0055). While Bohl may not explicitly teach the resulting layers/prints based on different print parameters would have different needle and fluid penetration resistances, per the instant application, the resulting model would have different needle and fluid penetration resistances by having different in-fill density, patterns, and orientations.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Bohl by applying the technique of generating printing parameters including in-fill density and pattern, print orientation, and number of print shells of Bohl for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical simulator models for training medical staff/users. One of ordinary skill in the art would modify Loguda by coding the system to include printing parameters including in-fill density and pattern, print orientation, and number of print shell based on desired properties for different components or sets of components such that different components can be printed with different materials (e.g., foam, TPU, ABS, Styrofoam) and have predefined in-fill structure corresponding to the properties thereby resulting in different needle and fluid penetration resistances based on the different print parameters. Upon such modification, the method and system of Loguda would include wherein different needle penetration resistances and different fluid penetration resistances are simulated by means of the at least two foam components. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Bohl with Loguda’s system and method in order to better simulate the biomechanical, anatomical, and physiological properties of the desired medical simulator/model.
With regard to claims 19 and 25, Loguda may not explicitly teach wherein at least one of the at least two foam components has at least one of a predetermined orientation of the elementary cells and size of the elementary cells. However, as discussed above, Bohl teaches a system and method for constructing an anatomical model using 3D printing wherein the model includes a plurality or components and layers wherein the printed model can be made of various materials in order to replicate biomechanical, anatomical, and/or physiological properties and include printing parameters (predetermined features) including in-fill density (size of elementary cells) and in-fill pattern (geometry, orientation, pore structure, and foam density) wherein different printing parameters are used to replicate component or predefined anatomical properties of different components or pieces of the model such that different components differ based on the printing parameters (Paragraphs 0039-0040, 0049, 0055-0056).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Bohl by applying the technique of generating printing parameters including in-fill density and pattern and print orientation of Bohl for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical simulator models for training medical staff/users. One of ordinary skill in the art would modify Loguda by coding the system to include printing parameters including in-fill density and pattern and print orientation based on desired properties for different components or sets of components such that different components can be printed with different materials (e.g., foam, TPU, ABS, Styrofoam) and different structure including geometry, orientation, size, porosity, and density. Upon such modification, the method and system of Loguda would include wherein at least one of the at least two foam components has at least one of a predetermined orientation of the elementary cells and size of the elementary cells. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Bohl with Loguda’s system and method in order to better simulate the biomechanical, anatomical, and physiological properties of the desired medical simulator/model.
With regard to claims 20 and 23, Loguda may not explicitly teach wherein the foam structures of the first foam component and of the at least one further foam component differ by porosity. However, Bohl further teaches the print parameters can include altering the porosity of the component such that two components can differ by porosity (Paragraph 0056).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Bohl by applying the technique of generating printing parameters including porosity of the component of Bohl for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical simulator models for training medical staff/users. One of ordinary skill in the art would modify Loguda by coding the system to include printing parameters including porosity based on desired properties for different components or sets of components such that different components can be printed with different materials (e.g., foam, TPU, ABS, Styrofoam) and different structure including porosity. Upon such modification, the method and system of Loguda would include wherein the foam structures of the first foam component and of the at least one further foam component differ by porosity. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Bohl with Loguda’s system and method in order to better simulate the biomechanical, anatomical, and physiological properties of the desired medical simulator/model.
Claim(s) 4, 11, 21, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loguda in view of Green et al. (US PGPub 20180208706), hereinafter referred to as Green.
With regard to claim 4, Loguda may not explicitly teach wherein the first foam component and the at least one further foam component are manufactured from the same base material with different additivation in each case though Loguda further teaches the different components can be different colors to distinguish the components (Paragraph 0038). However, Green teaches methods for creating a composition made of TPU using additive manufacturing including artificial organs and medical models wherein additional additives can be added to the TPU including colorants, dyes, pigments, stabilizers, and other agents and modifiers to provide desired properties to the composition (Paragraphs 0002, 0028, 0070, 0075-0077, 0093).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Green by applying the technique of incorporating additives to the additive manufacturing material such as TPU to affect the properties of the material of Green for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical models. One of ordinary skill in the art would modify Loguda by including additives to the material such as dyes and pigments such that one set of components would have different properties such as color compared to the second set of components such that the vertebrae and disks could be made of the same material, e.g., TPU, but include different dyes/pigments to render different colors. Upon such modification, the method and system of Loguda would include wherein the first foam component and the at least one further foam component are manufactured from the same base material with different additivation in each case. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Green with Loguda’s system and method in order to provide desired properties and, in the case of dyes/pigments, provide user’s a visual contrast between layers/components (Loguda paragraph 0038).
With regard to claim 11, Loguda may not explicitly teach wherein the first foam component and the at least one further foam component have the same base material with different additivation in each case though Loguda further teaches the different components can be different colors to distinguish the components (Paragraph 0038). However, Green teaches methods for creating a composition made of TPU using additive manufacturing including artificial organs and medical models wherein additional additives can be added to the TPU including colorants, dyes, pigments, stabilizers, and other agents and modifiers to provide desired properties to the composition (Paragraphs 0002, 0028, 0070, 0075-0077, 0093).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Green by applying the technique of incorporating additives to the additive manufacturing material such as TPU to affect the properties of the material of Green for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical models. One of ordinary skill in the art would modify Loguda by including additives to the material such as dyes and pigments such that one set of components would have different properties such as color compared to the second set of components such that the vertebrae and disks could be made of the same material, e.g., TPU, but include different dyes/pigments to render different colors. Upon such modification, the method and system of Loguda would include wherein the first foam component and the at least one further foam component have the same base material with different additivation in each case. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Green with Loguda’s system and method in order to provide desired properties and, in the case of dyes/pigments, provide user’s a visual contrast between layers/components (Loguda paragraph 0038).
With regard to claims 21 and 24, Loguda may not explicitly teach wherein the first foam component and the at least one further foam component are manufactured from the same base polymer, with different additivation in each case though Loguda further teaches the different components can be different colors to distinguish the components (Paragraph 0038). However, Green teaches methods for creating a composition made of TPU (polymer) using additive manufacturing including artificial organs and medical models wherein additional additives can be added to the TPU including colorants, dyes, pigments, stabilizers, and other agents and modifiers to provide desired properties to the composition (Paragraphs 0002, 0028, 0070, 0075-0077, 0093).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Green by applying the technique of incorporating additives to the additive manufacturing material such as TPU (a polymer) to affect the properties of the material of Green for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical models. One of ordinary skill in the art would modify Loguda by including additives to the material such as dyes and pigments such that one set of components would have different properties such as color compared to the second set of components such that the vertebrae and disks could be made of the same material, e.g., TPU, but include different dyes/pigments to render different colors. Upon such modification, the method and system of Loguda would include wherein the first foam component and the at least one further foam component are manufactured from the same base polymer, with different additivation in each case. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Green with Loguda’s system and method in order to provide desired properties and, in the case of dyes/pigments, provide user’s a visual contrast between layers/components (Loguda paragraph 0038).
Claim(s) 5-6, 12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loguda in view of Champ et al. (US PGPub 20190355280), hereinafter referred to as Champ.
With regard to claim 5, Loguda may not explicitly teach additive manufacturing of a transition region between two adjacent foam components, wherein the transition region comprises a gradual transition between at least one of the different foam structures and materials of the adjacent foam components. However, Champ teaches a method of manufacturing a medial model/organ using additive manufacturing wherein gradients (transition region) between two regions/components can be created by depositing increasing or decreasing density of a second material on a first material in order to provide realism when using ultrasound (Abstract; Paragraphs 0035-0036, 0038).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Champ by applying the technique of layering increasing or decreasing density of a second material on the first material of Green for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical models. One of ordinary skill in the art would modify Loguda by manufacturing the model by adding increasing or decreasing density/amounts of the second material for the second layer, component, or set of components on the first material/first component thereby creating a “transition region” between the two materials and components. Upon such modification, the method and system of Loguda would include additive manufacturing of a transition region between two adjacent foam components, wherein the transition region comprises a gradual transition between at least one of the different foam structures and materials of the adjacent foam components. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Champ with Loguda’s system and method in order to provide more realistic ultrasound responses and provide echogenicity to the models as Loguda is intended for use with ultrasounds.
With regard to claim 6, Loguda may not explicitly teach wherein the at least two foam components are manufactured integrally. Examiner notes that per MPEP 2144.04 and In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) making the components integral would be merely a matter of obvious engineering choice to one of ordinary skill and could be accomplished by printing the different components together thereby layering one component onto another. However, for the sake of compact prosecution, Champ also teaches additive manufacturing of models including a spinal column using a plurality of materials with differing physical properties by sequentially layering and/or joining the plurality of materials such that one material/component would be layered into the second or another material/component (Paragraphs 0038, 0043-0044).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Champ by applying the technique of layering a plurality of materials into a model of Green for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical models. One of ordinary skill in the art would modify Loguda by manufacturing the model by layering one material/component such as the disk into the next component/material such as the vertebrae thereby making the model, a spinal column, integrally. Upon such modification, the method and system of Loguda would include wherein the at least two foam components are manufactured integrally. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Champ with Loguda’s system and method in order to provide more realistic ultrasound responses and provide echogenicity to the models as Loguda is intended for use with ultrasounds.
With regard to claim 12, Loguda may not explicitly teach further comprising a transition region between two adjacent foam components, wherein the transition region comprises a gradual transition between at least one of the different foam structures and materials of the adjacent foam components. However, Champ teaches a method of manufacturing a medial model/organ using additive manufacturing wherein gradients (transition region) between two regions/components can be created by depositing increasing or decreasing density of a second material on a first material in order to provide realism when using ultrasound (Abstract; Paragraphs 0035-0036, 0038).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Champ by applying the technique of layering increasing or decreasing density of a second material on the first material of Green for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical models. One of ordinary skill in the art would modify Loguda by manufacturing the model by adding increasing or decreasing density/amounts of the second material for the second layer, component, or set of components on the first material/first component thereby creating a “transition region” between the two materials and components. Upon such modification, the method and system of Loguda would include further comprising a transition region between two adjacent foam components, wherein the transition region comprises a gradual transition between at least one of the different foam structures and materials of the adjacent foam components. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Champ with Loguda’s system and method in order to provide more realistic ultrasound responses and provide echogenicity to the models as Loguda is intended for use with ultrasounds.
With regard to claim 14, Loguda may not explicitly teach wherein the at least two foam components are manufactured integrally. Examiner notes that per MPEP 2144.04 and In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) making the components integral would be merely a matter of obvious engineering choice to one of ordinary skill and could be accomplished by printing the different components together thereby layering one component onto another. However, for the sake of compact prosecution, Champ also teaches additive manufacturing of models including a spinal column using a plurality of materials with differing physical properties by sequentially layering and/or joining the plurality of materials such that one material/component would be layered into the second or another material/component (Paragraphs 0038, 0043-0044).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda to incorporate the teachings of Champ by applying the technique of layering a plurality of materials into a model of Green for 3D printing the models of Loguda, as both references and the claimed invention are directed to 3D printing medical models. One of ordinary skill in the art would modify Loguda by manufacturing the model by layering one material/component such as the disk into the next component/material such as the vertebrae thereby making the model, a spinal column, integrally. Upon such modification, the method and system of Loguda would include wherein the at least two foam components are manufactured integrally. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Champ with Loguda’s system and method in order to provide more realistic ultrasound responses and provide echogenicity to the models as Loguda is intended for use with ultrasounds.
Claim(s) 7 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loguda in view of Bohl and Rolland et al. (US PGPub 20190283316), hereinafter referred to as Rolland.
With regard to claim 7, as discussed in the prior art rejection of claim 2 above, Loguda in view of Bohl teaches a method for manufacturing a medical model using additive manufacturing wherein the in-fill pattern can be set as a print parameter (Bohl Paragraphs 0039-0040, 0049, 0055) but may not explicitly teach wherein at least one of the foam components is manufactured so as to have a foam structure in the form of a rod structure, wherein the edges of the elementary cells are formed by rods. However, Rolland teaches a method of forming a 3D object by additive manufacturing wherein the 3D object may include one or more repeating structural elements (in-fill pattern) including tubes, beams, or struts (rods) (Abstract; Paragraphs 0408, 0410).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda in view of Bohl to incorporate the teachings of Rolland by incorporating tubes, beams, or struts as repeating structural elements (infill pattern) as taught by Rolland for 3D printing the models of Loguda in view of Bohl, as, while Rolland is directed to more generic additive manufacturing, the references and the claimed invention are directed to 3D printing models and one of ordinary skill would have found it obvious to apply the teachings of Rolland for general 3D printing/additive manufacturing to the process of Loguda to improve Loguda in the same way. One of ordinary skill in the art would modify Loguda in view of Bohl by coding the system to include tubes, beams, or struts (types of rods) as the in-fill pattern of the printing parameters such that a component could be printed with a rod structure forming the edges of the cells. Upon such modification, the method and system of Loguda in view of Bohl would include wherein at least one of the foam components is manufactured so as to have a foam structure in the form of a rod structure, wherein the edges of the elementary cells are formed by rods. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Rolland with Loguda in view of Bohl’s system and method in order to manufacture complex models and provide desired properties.
With regard to claim 13, as discussed in the prior art rejection of claim 2 above, Loguda in view of Bohl teaches a method for manufacturing a medical model using additive manufacturing wherein the in-fill pattern can be set as a print parameter (Bohl Paragraphs 0039-0040, 0049, 0055) but may not explicitly teach wherein at least one of the different foam structures has a rod structure, wherein the edges of the elementary cells are formed by rods. However, Rolland teaches a method of forming a 3D object by additive manufacturing wherein the 3D object may include one or more repeating structural elements (in-fill pattern) including tubes, beams, or struts (rods) (Abstract; Paragraphs 0408, 0410).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Loguda in view of Bohl to incorporate the teachings of Rolland by incorporating tubes, beams, or struts a