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 .
Status of Claims
This office action is in response to the patent application 18/279,572 originally filed on August 30, 2023. Claims 1-75 were originally presented for examination.
In the Preliminary Amendment filed August 30, 2023, claims 1-75 were canceled and claims 76-95 were introduced as new claims. Claim 76 is independent. Claims 76-95 remain pending.
Information Disclosure Statement
The Information Disclosure Statement filed on August 30, 2023 has been considered. Non-patent Literature Document Cite No 5 could not be considered because the provided text is illegible. An initialed copy of the Form 1449 is enclosed herewith.
Priority
This application is a 371 of PCT/CA2022/050281, filed February 28, 2022. This application claims priority of US Provisional Application 63/154,904, filed March 1, 2021.
Drawings
Regarding FIGS. 1-9, 37 CFR 1.84(b)(1), stated in part, indicates that black and white photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention. The photographs must be of sufficient quality so that all details in the photographs are reproducible in the printed patent. Therefore, the use of a black and white photographs lacking sufficient reproducible quality prevents FIGS. 1-9 from complying with 37 CFR 1.84(b)(1).
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.
Claims 92 and 93 are rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 92, and substantially similar limitations in claim 93, recites the limitation “the biopolymer.” The limitation is not previously introduced in claim 76, 92, or 93, respectively. As such, the limitation lacks antecedent basis. Therefore, claims 92 and 93 are rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim Rejections - 35 USC § 102
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.
Claims 76, 77, 83, 85, and 88 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Black et al. (hereinafter “Black,” US 2020/0335012).
Regarding claim 76, Black discloses a tissue simulating structure for use in surgical training (Black Abstract, “A simulated dissectible tissue model for practicing surgical skills is provided”), the structure comprising at least two of:
a) a polymer (Black [0064], “The invention is not limited to embedding vasculature but may include other anatomical landmarks and structures including but not limited to vasculature, tumors, pathologies, organs and tissue structures and the material from which these are fabricated include but are not limited to any polymer material, silicone, KRATON and the like,” any polymer material is used as a base simulated tissue),
b) a lubricant (Black [0063], “The one or more outer silicone layers of the simulated dissectible tissue is made from a two-part RTV 10A durometer silicone mixed with a silicone deadener at 33% of the total weight, leading to a 2:1 ratio of the total silicone used to deadener. The deadener is a silicone oil that softens the properties of the curing silicone it is added too [sic],” silicone oil is a type of lubricant),
c) a porous material (Black [0082], “The simulated seminal vesicles 256 are made of urethane foam other foam or material over molded onto the simulated vas deferens. The simulated prostate 254 is made of urethane foam or other foam or material over molded onto the simulated urethra,” foams are porous materials),
d) elongated fibers (Black [0078], “one strand of fiber may be connected to the first layer at one location and then connected to the first layer again at another location along the length of the fiber or to the second layer and its free ends may or may not be embedded in the first or second layer… Although the word polyfill is used throughout the specification, the composition is not limited to polyester. The fibers are selected from any suitable material such as polyester, polyamide, acrylic, acetate, polyolefin, cotton, fiberfill, batting, polyethylene terephthalate, polyethylene naphthalate, nylon, polyfill, fiberfill, polymer, plastic, spandex or other suitable fiber, natural fiber, non-absorbent fiber, synthetic fiber or fiber-like material and still be called polyfill,” the polyfill fibers are elongated fibers), and
e) an extension-limiting component (Black [0078], “A layer of polyfill comprises a plurality of one or more non-aligned, randomly arranged, nonwoven fiber which may or may not be connected to one or more adjacent silicone layer at one or more location along the length of the fiber(s). The fiber is connected to one or more of the first layer and the second layer by being embedded into the one or more of the first layer and the second layer during the manufacturing process which will be described in greater detail below. Each fiber may be in the form of a strand, filament, yarn, micro-fiber and the like and has a length and at least a first end and a second end,” the fibers and/or yarn is an extension-limiting component).
Regarding claim 77, Black discloses wherein the polymer is selected from polyurethane rubber, silicone, silicone rubber, a biopolymer, or combinations thereof (Black [0064], “The invention is not limited to embedding vasculature but may include other anatomical landmarks and structures including but not limited to vasculature, tumors, pathologies, organs and tissue structures and the material from which these are fabricated include but are not limited to any polymer material, silicone, KRATON and the like,” silicone or any polymer material can be used).
Regarding claim 83, Black discloses wherein the porous material is one or more layers of open-cell polyurethane foam, another synthetic foam, natural fabric, natural felt, or combinations thereof (Black [0082], “The simulated seminal vesicles 256 are made of urethane foam other foam or material over molded onto the simulated vas deferens. The simulated prostate 254 is made of urethane foam or other foam or material over molded onto the simulated urethra,” foams are porous materials).
Regarding claim 85, Black discloses wherein the elongated fibers comprise animal fiber, silk, human hair, non-human animal hair, synthetic fiber, acrylic, polyester, polyvinyl chloride (PVC), organic fibers, cotton, hemp, bamboo, or combinations thereof (Black [0078], “one strand of fiber may be connected to the first layer at one location and then connected to the first layer again at another location along the length of the fiber or to the second layer and its free ends may or may not be embedded in the first or second layer… Although the word polyfill is used throughout the specification, the composition is not limited to polyester. The fibers are selected from any suitable material such as polyester, polyamide, acrylic, acetate, polyolefin, cotton, fiberfill, batting, polyethylene terephthalate, polyethylene naphthalate, nylon, polyfill, fiberfill, polymer, plastic, spandex or other suitable fiber, natural fiber, non-absorbent fiber, synthetic fiber or fiber-like material and still be called polyfill”).
Regarding claim 88, Black discloses wherein the extension- limiting component is braided thread, braided multifilament thread, monofilament thread, suture material, wire, fishing line, yarn, rope, fabric, a minimally-extensible plastic or combinations thereof (Black [0078], “A layer of polyfill comprises a plurality of one or more non-aligned, randomly arranged, nonwoven fiber which may or may not be connected to one or more adjacent silicone layer at one or more location along the length of the fiber(s). The fiber is connected to one or more of the first layer and the second layer by being embedded into the one or more of the first layer and the second layer during the manufacturing process which will be described in greater detail below. Each fiber may be in the form of a strand, filament, yarn, micro-fiber and the like and has a length and at least a first end and a second end”).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 78 is rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Hendrickson et al. (hereinafter “Hendrickson,” US 2012/0015337).
Regarding claim 78, Black does not explicitly teach wherein the polymer is polyurethane rubber having a Shore hardness between 5A and 90A.
However, Hendrickson discloses wherein the polymer is polyurethane rubber having a Shore hardness between 5A and 90A (Hendrickson [0044], “the artificial epidermis-dermis layer 15 is formed of a combination of platinum cured room temperature vulcanization silicone rubber… As can be understood by those skilled in the art, the Shore durometer numbers provided above represent the Shore durometer of the respective cured material. The two Shore durometer scales are "A" and "OO", with the "A" scale going from A10 to A40 for either polyurethane or silicone rubber.”).
Hendrickson is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein the polymer is polyurethane rubber having a Shore hardness between 5A and 90A, as taught by Hendrickson, since using polyurethane rubber as the polymer would have been a simple substitution of one known element for another to obtain predictable results. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Claims 79-81 are rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Iverson et al. (hereinafter “Iverson,” US 2018/0075777).
Regarding claim 79, Black does not explicitly teach wherein the lubricant is mineral oil, glycerin, jojoba oil, olive oil, polyurethane softening agent, or combinations thereof.
However, Iverson discloses wherein the lubricant is mineral oil, glycerin, jojoba oil, olive oil, polyurethane softening agent, or combinations thereof (Iverson [0014], “a synthetic tissue phantom is provided that includes: a first semi-anatomic skin layer including from about 0.1% to about 10% mineral oil by volume of that layer, from about 0.1% to about 0.75% by volume of that layer of at least one pigment, from about 0.0% to about 0.15% by volume of that layer of a thickener, and further consisting essentially of a single silicone rubber in an amount of from about 89.0% to about 99.8% by volume of that layer”).
Iverson is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein the lubricant is mineral oil, glycerin, jojoba oil, olive oil, polyurethane softening agent, or combinations thereof, as taught by Iverson, since using mineral oil as the lubricant would have been a simple substitution of one known element for another to obtain predictable results. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 80, Black does not teach wherein the lubricant is about 5% wt/wt to about 50% wt/wt, relative to the total amount of polymer.
However, Iverson discloses wherein the lubricant is about 5% wt/wt to about 50% wt/wt, relative to the total amount of polymer (Iverson [0017], “there is contemplated a synthetic tissue phantom comprising: a first layer of silicone rubber in an amount of from about 89% to about 99.9% by volume; a second layer including from about 15% to about 30% mineral oil by volume, from about 15% to about 30% of at least one softener and silicone rubber in an amount of from about 35% to about 55% by volume”).
Iverson is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein the lubricant is about 5% wt/wt to about 50% wt/wt, relative to the total amount of polymer, as taught by Iverson, since using mineral oil as the lubricant would have been a simple substitution of one known element for another to obtain predictable results. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 81, Black does not explicitly teach wherein the lubricant is mineral oil.
However, Iverson discloses wherein the lubricant is mineral oil (Iverson [0012], “One or more of these layers may also consist essentially of a single silicone rubber. The preferred oil is a mineral oil.”).
Iverson is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein the lubricant is mineral oil, as taught by Iverson, since using mineral oil as the lubricant would have been a simple substitution of one known element for another to obtain predictable results. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Claim 82 is rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Hananel et al. (hereinafter “Hananel,” US 2016/0140879).
Regarding claim 82, Black does not explicitly teach wherein the lubricant is glycerin.
However, Hananel discloses wherein the lubricant is glycerin (Hananel [0060], “Additives can be added to reduce tackiness, decrease cross linking of the polymers (which makes them more fragile), increase lubricity (for a more viscous “feeling”), or increase the electrical conductive nature of the materials… In an example, the additives can be at least one of petroleum jelly, glycerin, baby oil, talcum powder, colors, tints, dyes, metal wires, metal powders, nanotubes, theromochromatic pigments, slurries, water, and ink.”).
Hananel is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein the lubricant is glycerin, as taught by Hananel, since using glycerin as the lubricant would have been a simple substitution of one known element for another to obtain predictable results. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Claims 84, 89-91, 94, and 95 are rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Toly (US 2004/0126746).
Regarding claim 84, Black does not explicitly teach wherein the porous material comprises one or more layers of 1/16" to 1/2" open-cell polyurethane foam.
However, Toly discloses wherein the porous material comprises one or more layers of 1/16" to 1/2" open-cell polyurethane foam (Toly [0093], “Preferably, a polyurethane foam, such as TC-265 A/B.TM., available from BJB Enterprises Incorporated, is used to fabricate the abdominal member.”; also Toly [0079], “for any given surgical area, simulated human tissue 200 layers can vary in thickness.”; also Toly [0085], “Preferably, the extraperitoneal layer 218 is about 4 to about 10 millimeters thick.”).
Toly is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein the porous material comprises one or more layers of 1/16" to 1/2" open-cell polyurethane foam, as taught by Toly, since using polyurethane foam as the porous material would have been a simple substitution of one known element for another to obtain predictable results. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 89, Black does not teach wherein the extension-limiting component is positioned inside or outside the polymer, mimicking the anatomic behaviour of ligaments positioned between bones and restricting movement of the bones relative to each other.
However, Toly discloses wherein the extension-limiting component is positioned inside or outside the polymer, mimicking the anatomic behaviour of ligaments positioned between bones and restricting movement of the bones relative to each other (Toly [0168], “Simulated knee 424 accurately represents an actual knee and the tissue adjacent thereto. Elastomers are used as described above, to simulate tissues such as skin, muscle, and fat. More rigid polymers can be employed to simulate bone, cartilage, tendons and or ligaments associated with the knee. Simulated knee 424 includes an evaluation circuit 426 configured to evaluate aspiration of the simulated knee.”).
Toly is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein the extension-limiting component is positioned inside or outside the polymer, mimicking the anatomic behaviour of ligaments positioned between bones and restricting movement of the bones relative to each other, as taught by Toly, in order to accurately represent anatomical structures such as a knee and the tissue adjacent thereto (Toly [0168]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 90, Black does not explicitly teach wherein the polymer comprises a skin-like texture to mimic Langer's lines.
However, Toly discloses wherein the polymer comprises a skin-like texture to mimic Langer's lines (Toly [0080], “As the silicone formulation cures, the pre-formed fibrous layer is bonded thereto. However, the silicone-coated fibrous layer need not be bonded to the silicone blend layer. The silicone-coated fibrous layer 204 imparts a realistic resistance to cutting, similar to the resistance of real human skin,” Toly aims to provide realistic skin textures for surgical training; also Toly [0123], “elastomeric materials can be employed to realistically simulate many physiological elements, such as skin, tissue, membranes, fat, muscle an organs,” realistically simulating all types of physiological elements for surgical simulation).
Toly is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein the polymer comprises a skin-like texture to mimic Langer's lines, as taught by Toly, in order to realistically represent skin for surgical practice (Toly [0080]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 91, Black does not explicitly teach wherein the structure further comprises one or more anchors disposed on an outer surface of the tissue-simulating structure for connecting the structure to at least one bone.
However, Toly discloses wherein the structure further comprises one or more anchors disposed on an outer surface of the tissue-simulating structure for connecting the structure to at least one bone (Toly [0168], “Simulated knee 424 accurately represents an actual knee and the tissue adjacent thereto. Elastomers are used as described above, to simulate tissues such as skin, muscle, and fat. More rigid polymers can be employed to simulate bone, cartilage, tendons and or ligaments associated with the knee. Simulated knee 424 includes an evaluation circuit 426 configured to evaluate aspiration of the simulated knee,” the cartilage, tendons, and ligaments anchor bones in the knee).
Toly is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein the structure further comprises one or more anchors disposed on an outer surface of the tissue-simulating structure for connecting the structure to at least one bone, as taught by Toly, in order to accurately represent anatomical structures such as a knee and the tissue adjacent thereto (Toly [0168]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 94, Black does not explicitly teach wherein the structure is configured to form at least one tendon-like structure, and a muscle-like structure, wherein the tendon-like structure and the muscle-like structure are connected by embedded elongated fibers to form a musculotendinous junction.
However, Toly discloses wherein the structure is configured to form at least one tendon-like structure, and a muscle-like structure, wherein the tendon-like structure and the muscle-like structure are connected by embedded elongated fibers to form a musculotendinous junction (Toly [0074], “any of the number of fasciae or connective tissues, for example, the deep fascia, which binds muscles such as the anterior and posterior rectus sheath or aponeuroses, ligaments, and tendons. Sub-membranous tissue, such as fat, muscle or extraperitoneal tissue, by comparison, occupies more space and is generally easier to dissect than membranes. However, even in different tissues that are sub-membranous, there can be a great disparity in tissue consistency. For instance, fat is much easier to dissect and has a very different tactile characteristic than muscle. In some instances, only the blunt end of a scalpel can be employed to dissect fat. Given the need to provide realistic simulation and training models, it is therefore appropriate to impart a level of realism to surgical trainers to enable a user to experience the subtle differences between membranous and sub-membranous tissues.”; also Toly [0168], “It should be understood that other joints can be simulated, and the present invention is not intended to be limited in application only to use on simulated knees. A common medical procedure performed on joints is aspirating accumulated fluid from the interior of the joint. This procedure is schematically illustrated in FIG. 17A, with the needle of a syringe 428 being inserted into a simulated knee 424. Simulated knee 424 accurately represents an actual knee and the tissue adjacent thereto. Elastomers are used as described above, to simulate tissues such as skin, muscle, and fat. More rigid polymers can be employed to simulate bone, cartilage, tendons and or ligaments associated with the knee. Simulated knee 424 includes an evaluation circuit 426 configured to evaluate aspiration of the simulated knee.”).
Toly is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein the structure is configured to form at least one tendon-like structure, and a muscle-like structure, wherein the tendon-like structure and the muscle-like structure are connected by embedded elongated fibers to form a musculotendinous junction, as taught by Toly, in order to accurately represent anatomical structures such as a knee and the tissue adjacent thereto (Toly [0168]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 95, Black does not explicitly teach wherein a first at least one tendon-like structure is positioned at a first end of the muscle-like structure for connecting the muscle-like structure to at least one bone.
However, Toly discloses wherein a first at least one tendon-like structure is positioned at a first end of the muscle-like structure for connecting the muscle-like structure to at least one bone (Toly [0074], “any of the number of fasciae or connective tissues, for example, the deep fascia, which binds muscles such as the anterior and posterior rectus sheath or aponeuroses, ligaments, and tendons. Sub-membranous tissue, such as fat, muscle or extraperitoneal tissue, by comparison, occupies more space and is generally easier to dissect than membranes. However, even in different tissues that are sub-membranous, there can be a great disparity in tissue consistency. For instance, fat is much easier to dissect and has a very different tactile characteristic than muscle. In some instances, only the blunt end of a scalpel can be employed to dissect fat. Given the need to provide realistic simulation and training models, it is therefore appropriate to impart a level of realism to surgical trainers to enable a user to experience the subtle differences between membranous and sub-membranous tissues.”; also Toly [0168], “It should be understood that other joints can be simulated, and the present invention is not intended to be limited in application only to use on simulated knees. A common medical procedure performed on joints is aspirating accumulated fluid from the interior of the joint. This procedure is schematically illustrated in FIG. 17A, with the needle of a syringe 428 being inserted into a simulated knee 424. Simulated knee 424 accurately represents an actual knee and the tissue adjacent thereto. Elastomers are used as described above, to simulate tissues such as skin, muscle, and fat. More rigid polymers can be employed to simulate bone, cartilage, tendons and or ligaments associated with the knee. Simulated knee 424 includes an evaluation circuit 426 configured to evaluate aspiration of the simulated knee.”).
Toly is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein a first at least one tendon-like structure is positioned at a first end of the muscle-like structure for connecting the muscle-like structure to at least one bone, as taught by Toly, in order to accurately represent anatomical structures such as a knee and the tissue adjacent thereto (Toly [0168]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Claims 86 and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Rowan (US 3,775,865).
Regarding claim 86, Black does not teach wherein the elongated fibers are silk fibers.
However, Rowan discloses wherein the elongated fibers are silk fibers (Rowan col. 1 line 59 through col. 2 line 7, “The material of which the tube is made can be silicone (silastic rubber), latex, natural rubber, polyurethane plastics, woven fibers of cotton, silk or other materials. The materials and the dimensions, such as thickness, diameter and distance between edges, must be selected and matched to the tensile strength and consistency of the various body tissues that are to be simulated. Thus, for example, if the human skin is to be simulated a strong material must be selected, while a simulation of the kidney or the eye would require the selection of a very delicate material.”).
Rowan is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein the elongated fibers are silk fibers, as taught by Rowan, since using silk as the elongated fibers would have been a simple substitution of one known element for another to obtain predictable results. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 87, Black does not teach wherein the elongated fibers are oriented according to the structure or tensile or normal forces, in a substantially parallel direction or substantially perpendicular direction or substantially cross-hatched pattern or substantially fanned layout or substantially at the periphery of the tissue-simulating structure or in random directions or combinations thereof.
However, Rowan discloses wherein the elongated fibers are oriented according to the structure or tensile or normal forces, in a substantially parallel direction or substantially perpendicular direction or substantially cross-hatched pattern or substantially fanned layout or substantially at the periphery of the tissue-simulating structure or in random directions or combinations thereof (Rowan col. 1 line 59 through col. 2 line 7, “The material of which the tube is made can be silicone (silastic rubber), latex, natural rubber, polyurethane plastics, woven fibers of cotton, silk or other materials. The materials and the dimensions, such as thickness, diameter and distance between edges, must be selected and matched to the tensile strength and consistency of the various body tissues that are to be simulated. Thus, for example, if the human skin is to be simulated a strong material must be selected, while a simulation of the kidney or the eye would require the selection of a very delicate material.”).
Rowan is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein the elongated fibers are oriented according to the structure or tensile or normal forces, in a substantially parallel direction or substantially perpendicular direction or substantially cross-hatched pattern or substantially fanned layout or substantially at the periphery of the tissue-simulating structure or in random directions or combinations thereof, as taught by Rowan, in order to adequately simulate various body tissues (Rowan col. 1 line 59 through col. 2 line 7). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Claims 92 and 93 are rejected under 35 U.S.C. 103 as being unpatentable over Black in view of McCullen et al. (hereinafter “McCullen,” US 2019/0000602).
Regarding claim 92, Black discloses wherein the biopolymer is gelatin, alginate, or kappa carrageenan.
However, McCullen discloses wherein the biopolymer is gelatin, alginate, or kappa carrageenan (McCullen [0059], “The base layer may have a roughened surface by the inclusion of porogenic materials which can include poly(ethers), poly(ether esters), sulfopolyesters, salts, sugars, inorganic bases such as sodium or potassium phosphate, biomolecules such as gelatin, collagens, peptides, oligosaccharides, and polysaccharides such as hyaluronic acid and its derivatives, chondroitin sulfate and dermatan sulfate. These can be included by direct addition and intermixing with the major synthetic component of the base layer. The addition of such components can provide desired properties such as hydration, delivery of desired biomolecules, material recognition for cells, and tissue adherence.”).
McCullen is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein the biopolymer is gelatin, alginate, or kappa carrageenan, as taught by McCullen, in order to provide desired properties such as hydration, delivery of desired biomolecules, material recognition for cells, and tissue adherence (McCullen [0059]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 93, Black discloses wherein, when the biopolymer is alginate or kappa carrageenan, the structure further comprises a hardener.
However, McCullen discloses wherein, when the biopolymer is alginate or kappa carrageenan, the structure further comprises a hardener (McCullen [0059], “The base layer may have a roughened surface by the inclusion of porogenic materials which can include poly(ethers), poly(ether esters), sulfopolyesters, salts, sugars, inorganic bases such as sodium or potassium phosphate, biomolecules such as gelatin, collagens, peptides, oligosaccharides, and polysaccharides such as hyaluronic acid and its derivatives, chondroitin sulfate and dermatan sulfate. These can be included by direct addition and intermixing with the major synthetic component of the base layer. The addition of such components can provide desired properties such as hydration, delivery of desired biomolecules, material recognition for cells, and tissue adherence,” some materials are included to create a “roughened surface”).
McCullen is analogous to Black, as both are drawn to the art of artificial tissue. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Black, to include wherein, when the biopolymer is alginate or kappa carrageenan, the structure further comprises a hardener, as taught by McCullen, in order to provide desired properties such as hydration, delivery of desired biomolecules, material recognition for cells, and tissue adherence (McCullen [0059]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stephen Alvesteffer whose telephone number is (571)272-8680. The examiner can normally be reached M-F 8:00-6:00.
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/STEPHEN ALVESTEFFER/Examiner, Art Unit 3715