DETAILED ACTION
Remarks
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections – 35 USC 102 (AIA )
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)(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.
Claims 1-7, 10-17, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2022/0372293 to RAJAGOPALAN.
Regarding claim 1, RAJAGOPALAN teaches a surgical trainer to facilitate training of a medical practitioner in one or more surgical procedures (Abstract: medical training simulators and mannequins; par. 0014: surgical simulators for training; par. 0110: elastomeric materials or compositions and skin-like materials described herein may be used in high-fidelity three-dimensional surgical training models (e.g., mannequin) for demonstrating or practicing surgical techniques), the surgical trainer comprising: one or more layers of healable synthetic tissues, wherein the healable synthetic tissue includes healable material configured to facilitate a re-bonding of the healable synthetic tissues to their original shape after an incision is made to the healable synthetic tissues (par. 0013: self-healing elastomeric materials that can simulate skin and can be repaired after use, allowing repeated use of the materials in medical training simulators and mannequins. Elastomeric materials provided herein can not only replicate the texture, viscoelastic properties and/or feel of real skin, including the three layers of skin, fat and muscle, but in addition they can be repaired after use . . . autonomously by bringing together the jagged ends of a cut or incision (intrinsic self-healing) . . . There are also provided elastomeric material compositions, and uses thereof, including multi-use medical training simulators and mannequins that have self-healing properties; par. 0052: The term “self-healing” is used herein to refer to polymeric materials that can repair themselves after mechanical damage such as cracks, cuts, lesions, wounds, scars, and the like).
Regarding claim 12, RAJAGOPALAN teaches a modular manikin for surgical training simulation (Abstract: medical training simulators and mannequins; par. 0014: surgical simulators for training; par. 0110: elastomeric materials or compositions and skin-like materials described herein may be used in high-fidelity three-dimensional surgical training models (e.g., mannequin) for demonstrating or practicing surgical techniques), the modular manikin comprising: at least one synthetic body part comprising one or more layers of healable synthetic tissues, wherein the healable synthetic tissues include healable material configured to facilitate a re-bonding of the healable synthetic tissues to their original shape after an incision is made to the healable synthetic tissues (par. 0013: self-healing elastomeric materials that can simulate skin and can be repaired after use, allowing repeated use of the materials in medical training simulators and mannequins. Elastomeric materials provided herein can not only replicate the texture, viscoelastic properties and/or feel of real skin, including the three layers of skin, fat and muscle, but in addition they can be repaired after use . . . autonomously by bringing together the jagged ends of a cut or incision (intrinsic self-healing) . . . There are also provided elastomeric material compositions, and uses thereof, including multi-use medical training simulators and mannequins that have self-healing properties; par. 0052: The term “self-healing” is used herein to refer to polymeric materials that can repair themselves after mechanical damage such as cracks, cuts, lesions, wounds, scars, and the like).
Regarding claim 2 and 13, RAJAGOPALAN further teaches wherein the healable synthetic tissues are self-healable synthetic tissues comprising at least one selected from hydrogen bonding, ionic bonding, van der Waal forces, covalent bonding, dynamic hydrogen bonding, hydrophobic interactions, dynamic covalent bonds or Schiff base, disulfide bonds, and Diels-Alder reactions, or a combination of intermolecular interactions (par. 0015: the elastomeric material is thermally self-healing, and comprises thermoreversible disulphide bonds; par. 0021: the elastomeric material is self-healable due to thermoreversible disulphide bonds and/or hydrogen bonds; par. 0063: hydrogen bonds, covalent bonds, ionic bonds).
Regarding claim 3 and 14, RAJAGOPALAN further teaches wherein the healable synthetic tissues comprise at least a supermolecular, a reversible covalent bond, or a combination thereof (par. 0053: Intrinsic self-healing materials generally achieve repair through the inherent reversibility of chemical bonds and physical interactions between the damaged interfaces, for example, reversible covalent bonds; par. 0063: covalent bonds).
Regarding claim 4 and 15, RAJAGOPALAN further teaches wherein the healing of the healable synthetic tissue is activated by exposing said healable synthetic tissue to at least one factor selected from heat, pH changes, pressure, energy, hydration, dehydration, water diffusion, surface modification treatment, or a combination thereof (par. 0013: Elastomeric materials provided herein … can be repaired after use, either autonomously by bringing together the jagged ends of a cut or incision (intrinsic self-healing) or through thermal healing, e.g., by heating a cut and applying a gentle mechanical pressure (thermo self-healing).).
Regarding claim 5 and 16, RAJAGOPALAN further teaches wherein the at least one synthetic body part comprises one or more layers of non-healable synthetic tissues (claim 16: The high-fidelity skin-simulating layer … further comprising a skeleton-simulating structure, the high-fidelity skin simulating layer being disposed upon the skeleton-simulation structure, and the skeleton-simulating structure being shaped to simulate at least one human body part; FIG. 9A-9C: a model of a foot (i.e., non-healable synthetic tissue) with simulated skin (yellow) attached).
Regarding claim 6 and 17, RAJAGOPALAN further teaches wherein the healable synthetic tissues comprise one or more self-healing additives to initiate the re-bonding of synthetic tissue material (par. 0096: an additive is included in a polymer to improve the … self-healing properties).
Regarding claim 7, RAJAGOPALAN further teaches wherein the self-healing additives initiate rebonding of synthetic tissue material via at least one selected from dynamic hydrogen bonding, ionic bonding, van der Waal forces, hydrophobic interactions, dynamic covalent bonds or bidirectional reactions such as Schiff base, disulfide bonds, and Diels-Alder reactions, or a combination of intermolecular interactions (par. 0015: the elastomeric material is thermally self-healing, and comprises thermoreversible disulphide bonds; par. 0021: the elastomeric material is self-healable due to thermoreversible disulphide bonds and/or hydrogen bonds; par. 0023: self-healing through chemical interactions (hydrogen bonding and/or thermoreversible disulfide bond re-formation or metathesis); par. 0070: the elastomeric materials and compositions thereof are cross-linked chemically and are intrinsically self-healing due to chemical interactions that occur between monomers (e.g., Hydrogen (H) bonding, disulfide linkages); par. 0073: skin-like material that is capable of thermal self-healing, the material comprising a polysiloxane derivative, e.g., PDMS, with thermoreversible disulphide bonds).
Regarding claim 10 and 20, RAJAGOPALAN further teaches wherein, the healable synthetic tissue further comprises at least one selected from a colorant, a gelling agent, a plasticizer, a humectant, a preservative, or a combination thereof (par. 0095: elastomeric materials and compositions comprise one or more additive to improve various properties of the compositions. Examples of suitable classes of additives include without limitation plasticizers … paints (e.g., acrylic paint), dyes, and other colouring agents).
Regarding claim 11, RAJAGOPALAN further teaches wherein the healable synthetic tissue has a tensile strength in the range of 1kPa to 100 MPa (par. 0023: the elastomeric material is used to prepare an artificial skin or skin-like material. In some embodiments, a simulated skin provided herein has one or more of the following performance characteristics: … substantially the same or similar tensile strength; par. 0120: the epidermis simulating layer may be comprised of an elastomeric material having a tensile strength from about 150 psi (about 1.0 MPa) to about 500 psi (about 3.4 MPa), in another embodiment from about 225 psi (about 1.5 MPa) to about 500 psi (about 3.4 MPa), in another embodiment from about 300 psi (about 2.1 MPa) to about 500 psi (about 3.4 MPa), in still another embodiment from about 400 psi (about 2.8 MPa) to about 500 psi (about 3.4 MPa), and still yet another embodiment from about 450 psi (about 3.1 MPa) to about 500 psi (about 3.4 MPa); par. 0131: a subcutaneous-simulating layer, of an embodiment of the surgical training model has a tensile strength of from about 16 MPa to about 20 MPa).
Claim Rejections - 35 USC § 103 (AIA )
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 8-9 and 18-19 are rejected under 35 U.S.C. 103 as being obvious over RAJAGOPALAN, as applied to claim 1 and 12, in view of US 2016/0140879 to HANANEL.
Regarding claim 8 and 18, RAJAGOPALAN further teaches a plurality of sensors (par. 0141: wearable circuitry including electronic sensors (e.g., force and otherwise) may be formed using the self-healing elastomer materials or compositions and skin-like materials of the present technology.), but does not expressly teach the sensors as positioned within at least one layer of the healable synthetic tissues configured to detect both the magnitude and relative position of an external force and incision applied to the healable synthetic tissue.
Regarding claim 9 and 19, RAJAGOPALAN further teaches wherein the sensors are at least one selected from a pressure sensor, a force sensor, a cut sensor, or a combination thereof (par. 0141: wearable circuitry including electronic sensors (e.g., force and otherwise) may be formed using the self-healing elastomer materials or compositions and skin-like materials of the present technology.).
However, HANANEL teaches an anatomical simulation model (Abstract) configured to provide for training of … making an incision (par. 0028; par. 0066). HANANEL teaches sensors can be positioned on or between a layer or layers of the organosilicate tissue model or imbedded within one or more layers of the tissue model for measuring deformation of the tissue model upon contact or collision with objects such as surgical instruments, hands of a medical practitioner or other organs such as bones (par. 0061), e.g., a piezoresistive sensor can be used to measure deformation of the tissue model material at a particular location (par. 0064), including sensors at an incision site where the sensors measure the depth, pressure, and forces (with direction) of any movement of the tissue (par. 0066). HANANEL teaches placing the sensors at such expected deformation sites because these locations are known as collision sites where damage has occurred by improper technical or procedural technique (par. 0066). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate embedded sensors at expected deformation sites, including incision sites, within a layer or layers of a tissue model, as taught by HANANEL, into the simulated tissue layer(s) of RAJAGOPALAN, in order to measure depth, pressure, and forces (with direction) of the simulated tissue for each sensor location, thereby detecting when improper technical or procedural technique occurs at particular locations of the simulated tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Hull whose telephone number is 571-272-0996. The examiner can normally be reached on Monday-Friday from 8:00am to 5:00pm MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached at telephone number 571-272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES B HULL/Primary Examiner, Art Unit 3715