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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show “a metallic electrode” of claim 14 as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 10 objected to because of the following informalities:
In claim 1, line 4, “3 D data” should read “3D data” or “3-D data”.
In claim 10, line 3, “as living tissue” should read “as a living tissue”.
In claim 10, line 3, “in its interior” should read “in the interior of the thorax imitation”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “An ex vivo biophantom comprising or consisting of” (emphasis added). The recitation of both the exclusionary, consisting of, and the inclusionary, comprising of, renders the claim indefinite as the recitations are contradictory, and it is unclear which interpretation the applicant is attempting to use. Further, if interpreted as “consisting of”, several dependent claims would be rejected for including additional elements and limitations. For the sake of compact prosecution, the recitation is interpreted as “comprising”.
Claims 2-15 are rejected by virtue of their dependency from claim 1.
Claim 9 recites the limitation “wherein said modular construction preferably comprises a whole thorax module, a half thorax module, and a chest wall section module”. It is unclear how the construction includes both a whole thorax and a half thorax or if the whole thorax is comprised of two half thorax modules. The issue arises as the specification only defines the half thorax as a thorax cut parallel to the spine and does not provide detail of how the modules are connected with each other or their relative placement and use together. Further, based on the specification, it appears the modules are separate modifications such that the limitation should be a selection of one of the modules rather than a construction of all three, but the wording of the limitation does not match this interpretation and leads to further lack of clarity. Finally, if the embodiment is meant to be interpreted as any one of the modules, the half thorax module by itself would raise further issues under 35 U.S.C. 112(d) as it would not include all the elements of claim 1 (i.e., rib pairs and shoulder blades (plural)). Therefore, this lack of clarity renders the claim indefinite as one of ordinary skill in the art would not be able to determine what the inventor or a joint inventor regards as the claimed invention.
Claim 9 recites the limitation "the spine" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the base" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the connectors" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the front and rear ends" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the accommodation" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the pleural space" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the use of electrical surgical instrument" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the development and optimization of implants" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the development and optimization of surgical operation instruments" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the development and optimization of exoskeletons" in line 7. There is insufficient antecedent basis for this limitation in the claim.
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) 1, 3-7, and 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mele et al. (US PGPub 20200043371), hereinafter referred to as Mele, in view of Moore et al. (US PGPub 20170076636), hereinafter referred to as Moore, and further in view of Crabtree (US PGPub 20120288839).
Regarding claim 1, Mele teaches an ex vivo biophantom (Abstract; Paragraphs 0009, 0016, 0036; “anatomically correct model capable of simulating bodily structures” comprising or consisting of:
an anatomically realistic thorax imitation with a sternum, thoracic vertebrae, rib pairs, shoulder blades, and clavicles (Figs. 1, 7A; Paragraphs 0010, 0016, 0036-0037 teach the anatomical model includes a thorax having ribs and a sternum) produced using additive manufacturing processes based on 3D data of real patients (Paragraphs 0036, 0065 teach the thorax is formed using manufacturing processes know by one of ordinary skill in the art including additive manufacturing based on clinical measurements (3D data) of human subjects (real patients));
wherein said thorax imitation comprises in its interior:
(i) at least one chamber that comprises a thorax organ or a thorax functional tissue to simulate a thorax organ (Paragraphs 0012, 0035, 0051-0052, 0060 teach the model can include structure for emulating organs including a heart, lungs, and a trachea); and
(ii) a perfusion system connected to said at least one chamber sets said biophantom in motion to simulate real physiological breathing (Paragraphs 0052, 0054, 0057, 0070 teaches the system can be pressurized with gas and/or fluid to simulate a pericardial sac and pressurized to emulate the movements of a breathing subject).
Mele may not explicitly teach the imitation with thoracic vertebrae, shoulder blades, and clavicles; at least one living tissue chamber that comprises a living tissue of a thorax organ or a thorax functional tissue to simulate a thorax organ or a thorax functional tissue of a patient; a perfusion system connected to said at least one living tissue chamber which supplies said living tissue with oxygen and nutrients. However, Moore teaches a surgical simulation device including a simulated human skeleton including a spinal column (vertebrae) and clavicles and including an organ tray supporting animal/porcine or human cadaver organs (living tissue) wherein the organs can be perfused with blood (nutrients) and/or air (oxygen) to simulate biological processes (Paragraphs 0056, 0063-0066, 0073-0074, 0080-0081).
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 Mele to incorporate the teachings of Moore by applying the teaching of the model including a spinal column and clavicles and including an organ tray supporting animal or cadaver organs of Moore to the model of Mele, as both references and the claimed invention are directed to surgical/medical simulator models manufactured using additive manufacturing/3D printing. One of ordinary skill in the art would modify Mele by including clavicles and vertebrae to the model and substituting the interior organs with an organ tray supporting animal or cadaver (living tissue) organs and connecting the organs to tubing to perfuse the organs with fluid and air to simulate breathing and other processes. Upon such modification, the method and system of Mele would include the imitation with thoracic vertebrae and clavicles; at least one living tissue chamber that comprises a living tissue of a thorax organ or a thorax functional tissue to simulate a thorax organ or a thorax functional tissue of a patient; a perfusion system connected to said at least one living tissue chamber which supplies said living tissue with oxygen and nutrients. 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 Moore with Mele’s system and method in order to create a more realistic medical model (Moore Paragraphs 0065, 0067).
Mele in view of Moore may not explicitly teach the imitation with shoulder blades. However, Crabtree teaches a surgical training simulation anatomical model including shoulder blades (Abstract; Paragraph 0034).
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 Mele in view of Moore to incorporate the teachings of Crabtree by applying the teaching of the model including shoulder blades of Crabtree to the model of Mele, as both references and the claimed invention are directed to surgical/medical simulator models. One of ordinary skill in the art would modify Mele in view of Moore by including shoulder blades to the model by printing the model with shoulder blades. Upon such modification, the method and system of Mele in view of Moore would include the imitation with shoulder blades. 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 Crabtree with Mele in view of Moore’s system and method in order to create a more realistic medical model and as shoulder blades are well-known portions of a skeletal system to be replicated for a surgical model.
Regarding claim 3, Mele further teaches wherein said thorax imitation is made from a material suitable for computer tomography (CT) and/or magnetic resonance (MR), wherein said material is preferably selected from the group consisting of silicone (Paragraphs 0036, 0042, 0062 teach the thorax can be made of silicone material. It is noted that Mele does not explicitly state the material is “suitable for CR and/or MR” but as the material is one of the listed materials for preferably being suitable, the recitation of Mele teaches the claimed limitation without further modification).
Regarding claim 4, Mele further teaches wherein said thorax limitation comprises on its inner surface a skin imitation, optionally comprising additional layers for imitation of fat and muscle layers, that simulates the real skin pleura distances of a patient (Fig. 2A,B; Paragraphs 0017, 0042-0045, 0047 teach the model includes a membranous layer including skin, subcutaneous, adipose, and muscle layers wherein the layers have thickness to mimic the density, elasticity, and structure of human tissue thereby simulating a pleural cavity).
Regarding claim 5, Mele further teaches wherein said thorax imitation comprises a diaphragm imitation at its lower aperture (Fig. 12; Paragraphs 0057, 0070 teach the model includes a diaphragm located within the internal cavity of the thorax at the lower point of the model).
Regarding claim 6, Mele further teaches wherein said at least one living tissue chamber is made from a material suitable for computer tomography and/or magnetic resonance (MR), wherein said material is preferably selected from the group consisting of silicone (Paragraphs 0036, 0042, 0062 teach the thorax can be made of silicone material. It is noted that Mele does not explicitly state the material is “suitable for CR and/or MR” but as the material is one of the listed materials for preferably being suitable, the recitation of Mele teaches the claimed limitation without further modification).
Regarding claim 7, Mele may not explicitly teach wherein said at least one living tissue chamber comprises living tissue selected from the group consisting of lung tissue, heart tissue, thymus tissue, esophagus tissue, and trachea tissue. However, Moore further teaches the organ blocks can include heart, lung, esophagus, and trachea (Paragraphs 0055, 0075-0076).
As discussed above, 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 Mele to incorporate the teachings of Moore by applying the teaching of the model including an organ tray supporting animal or cadaver organs including heart, lung, esophagus, and/or trachea of Moore to the model of Mele, as both references and the claimed invention are directed to surgical/medical simulator models manufactured using additive manufacturing/3D printing. One of ordinary skill in the art would modify Mele by substituting the interior organs with an organ tray supporting animal or cadaver (living tissue) organs and connecting the organs to tubing to perfuse the organs with fluid and air to simulate breathing and other processes wherein the organs could include heart, lung, esophagus, and trachea. Upon such modification, the method and system of Mele would include wherein said at least one living tissue chamber comprises living tissue selected from the group consisting of lung tissue, heart tissue, esophagus tissue, and trachea tissue. 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 Moore with Mele’s system and method in order to create a more realistic medical model (Moore Paragraphs 0065, 0067).
Regarding claim 10, Mele may not explicitly teach wherein the thorax imitation of the biophantom comprises an organ tray and/or a net for organ support as living tissue chamber in its interior for the accommodation and/or support of natural organs or parts thereof and/or artificial organs. However, as discussed above, Moore teaches a surgical simulation device including an organ tray supporting animal/porcine or human cadaver organs (living tissue) wherein the organs can be perfused with blood (nutrients) and/or air (oxygen) to simulate biological processes (Paragraphs 0056, 0063-0066, 0073-0074, 0080-0081).
As discussed above, 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 Mele to incorporate the teachings of Moore by applying the teaching of the model including an organ tray supporting animal or cadaver organs of Moore to the model of Mele, as both references and the claimed invention are directed to surgical/medical simulator models manufactured using additive manufacturing/3D printing. One of ordinary skill in the art would modify Mele by including clavicles and vertebrae to the model and substituting the interior organs with an organ tray supporting animal or cadaver (living tissue) organs and connecting the organs to tubing to perfuse the organs with fluid and air to simulate breathing and other processes. Upon such modification, the method and system of Mele would include wherein the thorax imitation of the biophantom comprises an organ tray for organ support as living tissue chamber in its interior for the accommodation and/or support of natural organs or parts thereof and/or artificial organs. 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 Moore with Mele’s system and method in order to create a more realistic medical model (Moore Paragraphs 0065, 0067).
Regarding claim 11, Mele, as modified, further teaches wherein said organ tray is airtight sealable and allows the implementation of negative pressure for a simulation of the pleural space (Paragraphs 0052-0054 teach the model can include the internal cavity being substantially surrounded by a pericardial sac emulating a pleural cavity wherein the sack can be pressurized to simulate the pericardial sac).
Regarding claim 12, Mele, as modified, further teaches wherein said organ tray comprises at least one sealable opening through which tubing systems for ventilation and perfusion of the organs can be introduced into the organ tray (Fig. 12; Paragraphs 0050, 0054 teach the model can be pressurized and includes tubing as shown for pumping air or fluid into the model such that the subcutaneous layer would “seal” the opening to create a simulated subcutaneous tunnel).
Regarding claim 13, Mele further teaches the model including tubing for interacting with the model and simulated organs (Paragraphs 0038, 0046, 0054, 0057), and Moore further teaches fluid being pumped into the organ through tubing (Paragraphs 0073-0074), but Mele in view of Moore may not explicitly teach wherein said organ tray comprises a tubing system with a pump through which an open fluid circuit can be induced in the organ tray. However, Crabtree further teaches the model including a pump and reservoir for pumping fluid or air through the model and organs thereby creating a fluid circuit (Paragraphs 0023-0025, 0038, 0040).
As discussed above, 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 Mele in view of Moore to incorporate the teachings of Crabtree by applying the teaching of the model including a pump and reservoir for pumping the fluid through the organ of Crabtree using the tubing and organs of Mele in view of Moore, as both references and the claimed invention are directed to surgical/medical simulator models. One of ordinary skill in the art would modify Mele in view of Moore by including a pump and reservoir for pumping fluid such as a liquid or air through the tubing creating a fluid circuit to the organs and organ tray. Upon such modification, the method and system of Mele in view of Moore would include wherein said organ tray comprises a tubing system with a pump through which an open fluid circuit can be induced in the organ tray. 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 Crabtree with Mele in view of Moore’s system and method in order to create a more realistic medical model and control the fluid and air flow through the organs to better simulate respiration and other biological processes.
Regarding claim 14, Mele further teaches wherein said organ tray comprises a metallic electrode allowing the use of electrical surgical instruments (Paragraph 0056 teaches the model can include a metal support structure; it is noted that the instant specification does not define or show the “metallic electrode” or provide details for how the electrode “allows the use of electrical surgical instruments”, while the specification is sufficient to support the recitation, the broadness of the limitation is taught by the teachings of Mele as Mele includes a metal support structure and can be used for training procedures using surgical instruments).
Regarding claim 15, Mele, as modified, further teaches a method for: (i) ex vivo training of surgical and minimally-invasive surgical procedures as well as for research purposes (Paragraph 0038 teaches the model can be used for training procedures (surgical procedures)), ii) the development and optimization of implants, iii) the development and optimization of surgical operation instruments, or iv) the development and optimization of exoskeletons (The listed “methods” are intended uses for the biophantom of claim 1 as the limitations do not include any steps or specific details for performing the “development and optimization”, as claimed, the limitations provide no patentable weight as the limitations are intended uses/purposes for the biophantom and the biophantom could perform the limitations without further modification (see MPEP 2111.02, 2112, and 2114)), wherein the biophantom of claim 1 is used (see prior art rejection of claim 1 above).
Claim(s) 2 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mele in view of Moore and Crabtree as applied to claim 1 above, and further in view of Sakezles (US PGPub 20080187895).
Regarding claim 2, Mele in view of Moore and Crabtree may not explicitly teach wherein said thorax imitation is produced by an additive manufacturing process selected from the group consisting of fused deposition modeling (FDM), selective laser sintering (SLS), selective laser melting (SLM), and stereolithography (SLA). However, Sakezles teaches methods for creating synthetic anatomical models wherein the models include skin, fat, muscle, and bone wherein the models are manufactured using rapid prototyping techniques such as stereolithography, selective laser sintering, and fused deposition modeling (Paragraphs 0098, 0128, 0147, 0155, 0216).
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 Mele in view of Moore and Crabtree to incorporate the teachings of Sakezles by applying the technique of manufacturing the anatomical model using rapid prototyping including stereolithography, selective laser sintering, and/or fused deposition modeling of Sakezles as the additive manufacturing technique of Mele, as both references and the claimed invention are directed to surgical/medical simulator models created using additive manufacturing. One of ordinary skill in the art would modify Mele in view of Moore and Crabtree using one of the rapid prototyping/additive manufacturing techniques of stereolithography, selective laser sintering, and/or fused deposition modeling as the process for manufacturing the model as the techniques are well-known in the art and would be obvious to one of ordinary skill in the art to use in order to achieve the expected result of manufacturing the model. Upon such modification, the method and system of Mele in view of Moore and Crabtree would include wherein said thorax imitation is produced by an additive manufacturing process selected from the group consisting of fused deposition modeling (FDM), selective laser sintering (SLS), selective laser melting (SLM), and stereolithography (SLA). 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 Sakezles with Mele in view of Moore and Crabtree’s system and method as the techniques are well-known in the art and can be used to achieve a desired design result with the expected result of manufacturing the desired model.
Regarding claim 15, Mele in view of Moore and Crabtree as discussed above teach wherein the biophantom of claim 1 is used (see prior art rejection of claim 1 above), but may not explicitly teach a method for: ii) the development and optimization of implants, iii) the development and optimization of surgical operation instruments, or iv) the development and optimization of exoskeletons. However, Sakezles further teaches using the anatomical models for simulated use testing of medical devices including implants and instruments (Abstract; Paragraphs 0136-0137, 0141, 0159).
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 Mele in view of Moore and Crabtree to incorporate the teachings of Sakezles by applying the teaching of using the anatomical model to test and develop medical tools of Sakezles using the model of Mele, as both references and the claimed invention are directed to surgical/medical simulator models created using additive manufacturing. One of ordinary skill in the art would modify Mele in view of Moore and Crabtree by using the model to test medical devices including implants and tools/instruments. Upon such modification, the method and system of Mele in view of Moore and Crabtree would include a method for: ii) the development and optimization of implants, or iii) the development and optimization of surgical operation instruments. 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 Sakezles with Mele in view of Moore and Crabtree’s system and method as the techniques are obvious to try as an intended use of the model and would provide a practical use for the models to improve medical device testing and improvement.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mele in view of Moore and Crabtree as applied to claim 1 above, and further in view of Tassone et al. (US PGPub 20190287423), hereinafter referred to as Tassone.
Regarding claim 8, Mele in view of Moore and Crabtree may not explicitly teach wherein said biophantom has a modular construction for coupling to other biophantom modules, wherein said other biophantom modules are preferably selected from the group consisting of modules for the imitation of a human abdomen, neck/head, and female breasts. However, Tassone teaches a surgical simulation system including an anatomical model wherein the model is modular and can include one or more anatomical structures including a chest, an abdomen, a pelvis, legs, arms, and a skull (head) which can be connected and coupled together (Paragraphs 0063, 0079, 0084, 0086).
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 Mele in view of Moore and Crabtree to incorporate the teachings of Tassone by applying the technique of including multiple anatomical structures which can be coupled together to form an anatomical model of Tassone to the model of Mele in view of Moore and Crabtree, as both references and the claimed invention are directed to surgical/medical simulator models created using additive manufacturing/3D printing. One of ordinary skill in the art would modify Mele in view of Moore and Crabtree to include additional anatomical structures including a head/skull and abdomen which can be connected to the chest/thorax to build a fuller/larger anatomical model wherein the support of the thorax would include the connectivity to couple with the other modules. Upon such modification, the method and system of Mele in view of Moore and Crabtree would include wherein said biophantom has a modular construction for coupling to other biophantom modules, wherein said other biophantom modules are preferably selected from the group consisting of modules for the imitation of a human abdomen and neck/head. 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 Tassone with Mele in view of Moore and Crabtree’s system and method in order to create a more realistic medical model and provide users the ability to customize the model for desired procedures and simulations.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mele in view of Moore and Crabtree as applied to claim 1 above, further in view of Barsness et al. (US PGPub 20140329217), hereinafter referred to as Barsness, and further in view of Lavell et al. (US PGPub 20220327964), hereinafter referred to as Lavell.
Regarding claim 9, Mele further teaches wherein said modular construction preferably comprises a whole thorax module (Fig. 1; Paragraphs 0035-0037 teach the model includes a whole thorax), and Moore further teaches a half thorax module (Figs. 14-16; Paragraphs 0068-0069), but Mele in view of Moore and Crabtree may not explicitly teach wherein the thorax imitation of the biophantom has a modular construction, wherein said modular construction preferably comprises a chest wall section module comprising at least two ribs with fixation to the spine and the base of the sternum, and wherein said modular construction preferably comprises a plug-in system with the connectors inserted a the front and rear ends of the ribs. However, Barsness teaches surgical simulators and methods wherein the simulator may be 3D printed including a simulated rib cage and thorax wherein the ribs are selectively removable and replaceable by connectors at the sternum and spine (front and rear) of the ribs (Abstract; Paragraphs 0108-0110) and Lavell teaches a medical simulation and training system including an anatomical model wherein the model includes removable modules and units including a removable chest and ribs (Paragraphs 0124, 0153, 0247, 0271, 0289).
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 Mele in view of Moore and Crabtree to incorporate the teachings of Barsness and Lavell by applying the teaching of making the anatomical model modular including removable ribs via connectors at the sternum and spine of Barsness and a removable chest and ribs of Lavell to the anatomical model of Mele in view of Moore and Crabtree, as the references and the claimed invention are directed to surgical/medical simulator models. One of ordinary skill in the art would modify Mele in view of Moore and Crabtree by modifying the skeletal structure to be printed to include removable ribs attached via connectors at the sternum and spine and having the skin/chest be removable in order to improve Mele in view of Moore and Crabtree in the same way by allowing easier access to the interior of the model. Upon such modification, the method and system of Mele in view of Moore and Crabtree would include wherein the thorax imitation of the biophantom has a modular construction, wherein said modular construction preferably comprises a chest wall section module comprising at least two ribs with fixation to the spine and the base of the sternum, and wherein said modular construction preferably comprises a plug-in system with the connectors inserted a the front and rear ends of the ribs. 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 Barsness and Lavell with Mele in view of Moore and Crabtree’s system and method in order to improve access to the interior of the model for a user to access the internal organs (Lavell Paragraphs 0113, 0153).
Conclusion
Accordingly, claims 1-15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CORRELL T FRENCH whose telephone number is (571)272-8162. The examiner can normally be reached M-Th 7:30am-5pm; Alt Fri 7:30am-4pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kang Hu can be reached at (571)270-1344. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CORRELL T FRENCH/Examiner, Art Unit 3715
