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
Claim 18 objected to because of the following informalities:
Claim 18, line 2, “the shape of a human organ” should read “a shape of a human organ”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Daniel Schaller (US 20080299529 A1; hereinafter Schaller).
Regarding claims 1 and 18, Schaller discloses an anatomical model (Shown in Fig 1) comprising: an artificial organ frame (frame around the hollow organ 1 as shown in Fig 1) including a hollow body defining a cavity (this is a hollow organ, a cavity it's inherent to a hollow organ) therein and including windows defined through the hollow body (an inlet 20 acting as a window; Fig 1), the hollow body shaped like a human organ (See Fig 1); and an artificial tissue disposed within the cavity of the hollow body (simulated tissue is part of this model for HF surgical procedures; ¶5) and accessible through the windows of the hollow body (inlet 20 provides access to the hollow organ 1; ¶35), the artificial tissue having mechanical (this type of hollow organ has mechanical properties as stated in the background of invention; ¶3) and electrical properties that mimic the human organ (tissue of foreign bodies and hollow organ are electrically conductive; ¶5 and ¶19). Schaller does not explicitly disclose windows defined through the hollow body of the anatomical model.
However, Schaller does disclose a window in the form of an inlet 20 in Fig 1. and the structure of the windows is the same. Furthermore, Schaller mentions that the invention must have at least one inlet but there is no limit as to how many it can have.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller with a second inlet since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04, VI, B Duplication of Parts. In this case there is no new and unexpected result.
Regarding claim 2, Schaller discloses wherein the hollow body of the artificial organ frame is shaped like a stomach (shaped like a stomach, see Fig 1).
Regarding claim 3, Schaller discloses wherein the artificial organ frame includes a tubular section (quick change device has a tubular section; Fig 1) extending from the hollow body and defining a lumen therethrough (it is extending from the hollow organ as shown in Fig 1), the lumen in open communication with the cavity of the hollow body (lumen is the channel created by the tubular section and is in direct communication with the hollow organ; ¶39 and Fig 1).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller in view of Tassone et al. (US 20180144662 A1; hereinafter Tassone).
Regarding claim 4, Schaller does not explicitly disclose wherein the tubular section includes fasteners extending from a terminal end of the tubular section.
However, Tassone focuses on creating modular, high fidelity anatomical models for surgical training, which relates to Schaller because they are both models trying to create anatomical models for surgical training. Tassone teaches wherein the tubular section includes fasteners extending from a terminal end of the tubular section (there is a fastening mechanism here, such as hooks or fasteners, on a tubular structure; ¶93).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Tassone for the benefit of implementing modularity in these parts. By making this model modular, they can quickly attach and detach these parts in case they need to be replaced or swapped in the training environment.
Regarding claim 5, Schaller does not explicitly disclose further including an artificial intestine connected to the tubular section of the artificial organ frame.
However, Tassone focuses on creating modular, high fidelity anatomical models for surgical training, which relates to Schaller because they are both models trying to create anatomical models for surgical training. Tassone teaches further including an artificial intestine connected to the tubular section of the artificial organ frame (the structures being connected through a tubular structure can be the stomach and the intestine; ¶63).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Tassone for the benefit of implementing modularity in these parts. By making this model modular, they can quickly attach and detach these parts in case they need to be replaced or swapped in the training environment.
Regarding claim 6, Schaller does not explicitly disclose wherein the artificial tissue is a hydrogel.
However, Tassone focuses on creating modular, high fidelity anatomical models for surgical training, which relates to Schaller because they are both models trying to create anatomical models for surgical training. Tassone teaches wherein the artificial tissue is a hydrogel (the artificial tissue in the anatomical structure can be made of hydrogel; abstract).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Tassone because hydrogels have high water content, biocompatibility, and structural similarity to the natural extracellular matrix (ECM), which supports cell survival and growth. Furthermore, hydrogels provide similar mechanical properties that mimic human tissue.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller in view of Tassone in view of Tejo-Otero et al. (Soft-Tissue-Mimicking Using Hydrogels for the Development of Phantoms; hereinafter Tejo-Otero).
Regarding claim 7, Schaller does not explicitly disclose wherein the artificial tissue is formed from polyvinyl alcohol and gellan gum.
However, Tassone focuses on creating modular, high fidelity anatomical models for surgical training, which relates to Schaller because they are both models trying to create anatomical models for surgical training. Tassone teaches wherein the artificial tissue is formed from polyvinyl alcohol (PVA can be used to create this model; ¶154).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Tassone because PVA is a hydrogel that can be used with freeze-thaw cycles to customize stiffness and elasticity, allowing it to mimic different tissues and pathologies (e.g., tumors or blood vessels).
Tejo-Otero focuses on soft-tissue-mimicking through the use of hydrogels, which relates to Schaller because they both want to simulate artificial tissue. Tejo-Otero teaches the use of gellan gum to create artificial tissue (Phytagel/PHY is a brand name for gellan gum and is used to mimic mechanical properties of soft living tissue; abstract).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Tejo-Otero because Gellan Gum is biodegradable, biocompatible, and a non-toxic hydrogel to mimic human tissue. This allows it to mimic the extracellular matrix (ECM) to support cellular activity and can be tuned to match the stiffness of tissues like brain, skin, or adipose tissue.
Regarding claim 8, Schaller does not explicitly disclose wherein the artificial tissue includes about 10-28% polyvinyl alcohol and about 1-4% gellan gum.
Tejo-Otero focuses on soft-tissue-mimicking through the use of hydrogels, which relates to Schaller because they both want to simulate artificial tissue. Tejo-Otero teaches wherein the artificial tissue includes about 10-28% polyvinyl alcohol (introduction of this article mentions that studies have been done to mimic liver tissue with 14% PVA; Page 2 paragraph 4) and about 1-4% gellan gum (introduction of this article mentions that studies have been done to mimic liver tissue with 2% PHY; Page 2 paragraph 4).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Tejo-Otero because hydrogels have high water content, biocompatibility, and structural similarity to the natural extracellular matrix (ECM), which supports cell survival and growth. Furthermore, hydrogels provide similar mechanical properties that mimic human tissue.
Claims 9-11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller in view of OKAYAMA et al. (US 20190244544 A1; hereinafter Okayama).
Regarding claim 9, Schaller does not explicitly disclose further including an artificial blood assembly including an artificial blood reservoir containing artificial blood and at least one artificial blood vessel fluidly coupled to the artificial blood reservoir.
However, Okayama focuses on an organ model created for surgery simulation, which relates to Schaller because it also focuses on a model created for surgery training and simulation. Okayama teaches further including an artificial blood assembly including an artificial blood reservoir (pump 60 acts a reservoir; ¶25 and Fig 1) containing artificial blood (pump 60 causes liquid to flow in ¶25 and the liquid is simulated blood in ¶3) and at least one artificial blood vessel (organ model has simulated blood vessels; ¶35) fluidly coupled to the artificial blood reservoir (liquid, which is simulated blood flows through blood vessels and this liquid also circulates through the pump 60; ¶41).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Okayama for the benefit of having the surgical training be as realistic as possible. By having artificial blood pumped through blood vessels, the training environment can make the training as realistic as possible.
Regarding claim 10, Schaller does not explicitly disclose wherein the artificial blood reservoir is a pump and the at least one artificial blood vessel is a tube.
However, Okayama focuses on an organ model created for surgery simulation, which relates to Schaller because it also focuses on a model created for surgery training and simulation. Okayama teaches wherein the artificial blood reservoir is a pump (pump 60 acts a reservoir; ¶25 and Fig 1) and the at least one artificial blood vessel is a tube (subclavian artery 34 is a blood vessel and is a tube; See Fig 2).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Okayama for the benefit of having the surgical training be as realistic as possible. By having artificial blood pumped through blood vessels, the training environment can make the training as realistic as possible.
Regarding claim 11, Schaller does not explicitly disclose wherein the at least one artificial blood vessel is disposed within the artificial tissue.
However, Okayama focuses on an organ model created for surgery simulation, which relates to Schaller because it also focuses on a model created for surgery training and simulation. Okayama teaches wherein the at least one artificial blood vessel is disposed within the artificial tissue (blood vessels laid along the surface of the main body of the heart in ¶35 which has artificial tissue, such as PVA in ¶34).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Okayama for the benefit of having the surgical training be as realistic as possible. By having artificial blood pumped through blood vessels, the training environment can make the training as realistic as possible.
Regarding claim 20, Schaller does not explicitly disclose further including forming at least one artificial blood vessel within the artificial tissue and fluidly connecting the at least one artificial blood vessel to an artificial blood reservoir containing artificial blood.
However, Okayama focuses on an organ model created for surgery simulation, which relates to Schaller because it also focuses on a model created for surgery training and simulation. Okayama teaches further including forming at least one artificial blood vessel within the artificial tissue (organ model has simulated blood vessels; ¶35) and fluidly connecting the at least one artificial blood vessel to an artificial blood reservoir containing artificial blood (liquid, which is simulated blood flows through blood vessels and this liquid also circulates through the pump 60 and the pump here acts as a reservoir; ¶41).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Okayama for the benefit of having the surgical training be as realistic as possible. By having artificial blood pumped through blood vessels, the training environment can make the training as realistic as possible.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Schaller in view of Felsinger et al. (US 20190085162 A1; hereinafter Felsinger).
Regarding claim 12, Schaller discloses a tumor can be required in the anatomical model (tumor in the form of foreign bodies; ¶5), but Schaller does not explicitly disclose further including an artificial tumor having a hard body and a channel extending through the hard body.
However, Felsinger focuses on creating synthetic tissue for electrosurgical training and simulation, which relates to Schaller because their anatomical model is also used for training in surgical procedures. Felsinger teaches further including an artificial tumor having a hard body and a channel extending through the hard body (using hydrogel to create this model in ¶2 and simulated organ model with tubular structure in ¶25 and this structure can simulate other artificial models, such as a tumor in ¶36).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Felsinger for the benefit of using hydrogel for creating tissue that emulates mechanical properties of real tissue, such as elasticity, toughness, saturability, tactility, color and texture.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Schaller in view of Felsinger in view of Junichi KOGISO (US 20160314714 A1 see-IDS; hereinafter Kogiso).
Regarding claim 13, Schaller does not explicitly disclose wherein the artificial organ frame includes a peg extending from an inner surface of the hollow body, and the peg extends through the channel of the artificial tumor.
However, Kogiso focuses on a human stomach model that has a holding tissue portion, which relates to Schaller because Schaller also shows a stomach model that can simulate areas with tumors. Kogiso teaches wherein the artificial organ frame includes a peg extending from an inner surface of the hollow body, and the peg extends through the channel of the artificial tumor (a peg is used to hold tumor like a fastener and Kogiso has a tissue holding portion 20 to hold or fasten tissue on the simulated human stomach; Fig 1 and ¶18-19).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Kogiso since it has been held that simple substitution of one known element for another yields predictable results. In this case the tissue holding portion achieves the same role of a peg and in ¶58 of the specification of the present invention we can see that multiple types of fastening mechanisms are used, such as pegs, fasteners, or flanges. See MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller in view of Jarc et al. (US 20140051049 A1; hereinafter Jarc).
Regarding claim 14, Schaller discloses the anatomical model including: an artificial organ frame (frame around the hollow organ 1 as shown in Fig 1) including a hollow body defining a cavity therein (this is a hollow organ, a cavity it's inherent to a hollow organ) and including windows defined through the hollow body (inlet 20 provides access to the hollow organ 1; ¶35), the hollow body shaped like a human organ (See Fig 1); and an artificial tissue disposed within the cavity of the hollow body (simulated tissue is part of this model for HF surgical procedures; ¶5) and accessible through the windows of the hollow body (inlet 20 provides access to the hollow organ 1; ¶35), the artificial tissue having mechanical (this type of hollow organ has mechanical properties as stated in the background of invention; ¶3) and electrical properties that mimic the human organ (tissue of foreign bodies and hollow organ are electrically conductive; ¶5 and ¶19). Schaller does not explicitly disclose a surgical training and testing system comprising: a surgical instrument; a training dome including ports, each of the ports configured to allow passage of a portion of the surgical instrument through the port and into a cavity of the training dome; and an anatomical model positioned within the cavity of the training dome; and windows defined through the hollow body of the anatomical model.
However, Jarc focuses on anatomical models and surgical training with the implementation of robotics, which relates to Schaller because they both implement anatomical models for training in surgery. Jarc teaches a surgical training and testing system comprising: a surgical instrument (cannulas 322; Fig 3C); a training dome including ports (the model of abdomen 101 disclosed here acts as a dome with multiple ports/holes; ¶31 and Fig 1), each of the ports configured to allow passage of a portion of the surgical instrument through the port and into a cavity of the training dome (holes 103 can accommodate cannulas, which are surgical instruments; ¶33); and an anatomical model positioned within the cavity of the training dome (there is platform 106 inside the training dome that can be configured to place a simulated surgical site at various depths within the model, a surgical site will simulate all the elements required for surgery, including a stomach because the abdomen houses multiple organs, including the stomach; ¶59).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Jarc because the implementation of robotics in the surgery training allows trainees to practice complex procedures, such as suturing and dissection, multiple times, allowing them to make and learn from mistakes without risking patient harm. Furthermore, robotic surgery provides high precision for difficult procedures.
In regards to “windows defined through the hollow body of the anatomical model”, Schaller does not explicitly disclose windows, but it does disclose a window in the form of an inlet 20 in Fig 1. and the structure of the windows is the same. Furthermore, Schaller mentions that the invention must have at least one inlet (¶8) but there is no limit as to how many it can have.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller with a second inlet to allows access to the model from a second inlet since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04, VI, B Duplication of Parts. In this case there is no new and unexpected result.
Regarding claim 15, Schaller does not disclose wherein the surgical instrument is a robotic surgical instrument.
However, Jarc focuses on anatomical models and surgical training with the implementation of robotics, which relates to Schaller because they both implement anatomical models for training in surgery. Jarc teaches wherein the surgical instrument is a robotic surgical instrument (cannulas are surgical instruments implemented with the robot; ¶11 and Fig 6).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Jarc because the implementation of robotics in the surgery training allows trainees to practice complex procedures, such as suturing and dissection, multiple times, allowing them to make and learn from mistakes without risking patient harm. Furthermore, robotic surgery provides high precision for difficult procedures.
Regarding claim 16, Schaller does not disclose a robotic surgical system comprising: the surgical training and testing system of claim 14; and a robotic arm operably coupled to the surgical instrument.
However, Jarc focuses on anatomical models and surgical training with the implementation of robotics, which relates to Schaller because they both implement anatomical models for training in surgery. Jarc teaches a robotic surgical system comprising: the surgical training and testing system of claim 14 (this surgical system is implemented with robotics; ¶11); and a robotic arm operably coupled to the surgical instrument (robotic arms implemented with the cannula; ¶11 and Fig 6).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Jarc because the implementation of robotics in the surgery training allows trainees to practice complex procedures, such as suturing and dissection, multiple times, allowing them to make and learn from mistakes without risking patient harm. Furthermore, robotic surgery provides high precision for difficult procedures.
Regarding claim 17, Schaller does not disclose further including a control device and an operating console, the robotic arm connected to the control device and tele-operable by the operating console.
However, Jarc focuses on anatomical models and surgical training with the implementation of robotics, which relates to Schaller because they both implement anatomical models for training in surgery. Jarc teaches further including a control device (the robotic manipulator acts as a control device; ¶56) and an operating console (separate console; ¶57), the robotic arm connected to the control device and tele-operable by the operating console (a trainee can teleoperate the surgical instrument from a separate console; ¶57).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Jarc because the implementation of robotics in the surgery training allows trainees to practice complex procedures, such as suturing and dissection, multiple times, allowing them to make and learn from mistakes without risking patient harm. Furthermore, robotic surgery provides high precision for difficult procedures.
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over Schaller in view of Fergal Kerins (US20160027341 A1; hereinafter Kerins).
Regarding claim 19, Schaller does not disclose wherein forming the artificial tissue includes pouring a liquid solution of the artificial tissue into the cavity of the hollow body of the artificial organ frame and subjecting the artificial organ frame and the liquid solution of the artificial tissue to a freeze- thaw cycle to cure the artificial tissue within the artificial organ frame.
However, Kerins focuses on creating artificial anatomical compositions, such as tissue, through the use of hydrogel (such as polyvinyl alcohol that can mimic mechanical properties of tissue) and the use of the thaw/freeze cycle, which relates to Schaller because it uses artificial tissue with mechanical and electrical features for their anatomical model. Kerins teaches wherein forming the artificial tissue includes pouring a liquid solution of the artificial tissue into the cavity of the hollow body of the artificial organ frame (liquid being poured into the mold of the anatomical part to create an structural component, such as tumors or other different tissue; ¶60-61) and subjecting the artificial organ frame and the liquid solution of the artificial tissue to a freeze- thaw cycle to cure the artificial tissue within the artificial organ frame (liquid solution subjected to a freeze/thaw cycle; ¶62).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schaller to implement the teachings of Kerins because it allows for the creation of biocompatible, durable, and tunable material without resorting to toxic chemical crosslinking agents. By manipulating the cycles and freezing temperature, you can fine-tune the hydrogel to have the desired strength and porosity for specific applications, such as wound dressings, cartilage, or soft tissue substitutes.
Conclusion
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/JOSE ANGELES/Examiner, Art Unit 3715
/DMITRY SUHOL/Supervisory Patent Examiner, Art Unit 3715