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 arguments and amendments entered on April 17, 2026 for the patent application 18/279,572 originally filed on August 30, 2023. Claims 76 and 92-94 are amended. Claims 1-75 are canceled. Claims 76-95 remain pending. The first office action of December 17, 2025 is fully incorporated by reference into this office action.
Information Disclosure Statement
The Information Disclosure Statement filed on April 21, 2026 has been considered. An initialed copy of the Form 1449 is enclosed herewith.
Response to Amendment
Applicant’s amendments to the claims have been noted by the Examiner.
Applicant has amended claims 92 and 93 to depend from claim 77, providing proper antecedence for “the biopolymer.” Accordingly, the 35 USC 112 rejections of claims 92 and 93 are withdrawn. However, new rejections under 35 USC 112 are applied in this office action.
Applicant’s amendments to the claims are sufficient to overcome the outstanding rejections under 35 USC 102 and 35 USC 103. However, new rejections under 35 USC 103 are applied in this office action.
Drawings
Applicant has submitted replacement drawings for FIGS. 1-9. The replacement drawings filed April 17, 2026 are acknowledged and accepted by the Examiner. All outstanding objections to the drawings are withdrawn.
Claim Objections
Claims 94 and 95 are objected to because of the following informalities: typographical errors.
Claim 94 recites “The tissue simulating structure of claim 76, wherein the structure is configured to form at least one tendon-like structure, a muscle-like structure, and an interface region between the at least one tendon-like structure and the muscle-like structure are formed by embedded elongated fibers to form a musculotendinous junction. the tendon-like structure and the muscle-like structure are by embedded elongated fibers to form a musculotendinous junction.” The Examiner reasonably believes that the last portion of the claim was erroneously included, and that the claim should be amended to “The tissue simulating structure of claim 76, wherein the structure is configured to form at least one tendon-like structure, a muscle-like structure, and an interface region between the at least one tendon-like structure and the muscle-like structure are formed by embedded elongated fibers to form a musculotendinous junction.” Appropriate correction is required.
Dependent claim 95 is also objected to based on its dependency to claim 94.
Claim Rejections - 35 USC § 112
Claims rejected under § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 76-95 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claim 76, and substantially similar limitations in claim 94, is recites “an interface region.” This limitation is not adequately described in the specification as originally filed and forms the basis of the rejection. Specifically, the Applicant’s disclosure contains no instances of the word “interface” or the word “region.” As such, the claimed subject matter is not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. Therefore, claims 76 and 94 are deemed to recite new matter and is properly rejected under 35 U.S.C. §112(a). Claims 77-95 are also rejected under 35 U.S.C. §112(a) based on their dependencies to claim 76. Claim 95 is also rejected under 35 U.S.C. §112(a) based on its dependency to claim 94.
Claims rejected under § 112(b)
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 76-95 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 76, and substantially similar limitations in claims 87, 91, and 93, recites the limitation “the structure.” The limitation “a tissue simulating structure,” is originally introduced earlier in claim 76. As such, the subsequent limitations are either (1) not following antecedent basis (i.e. “the tissue simulating structure”); or (2) are intended to be new limitations which ambiguously conflict with the previous limitation of claim 76. Therefore, claims 76, 87, 91, 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. Claims 77-95 are also rejected under 35 U.S.C. § 112(b), based on their respective dependencies to claim 76.
Claim 76 recites the limitation “wherein structure comprises.” The limitation is originally introduced earlier in claim 76. As such, the subsequent limitations are either (1) not following antecedent basis (i.e. “wherein the tissue simulating structure comprises”); or (2) are intended to be new limitations which ambiguously conflict with the previous limitation of claim 76. Therefore, claim 76 is 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. Claims 77-95 are also rejected under 35 U.S.C. § 112(b), based on their respective dependencies to claim 76.
Claim 94 recites the limitation “an interface region.” The limitation is originally introduced in claim 76. As such, the subsequent limitations are either (1) not following antecedent basis (i.e. “[[an]] the interface region”); or (2) are intended to be new limitations which ambiguously conflict with the previous limitation of claim 76. Therefore, claim 94 is 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 95 is also rejected under 35 U.S.C. § 112(b), based on its dependency to claim 94.
Claim 95 recites the limitation “a first at least one tendon-like structure.” The limitation is originally introduced in claim 94. As such, the subsequent limitations are either (1) not following antecedent basis (i.e. “ the at least one tendon-like structure”); or (2) are intended to be new limitations which ambiguously conflict with the previous limitation of claim 94. Therefore, claim 95 is 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 § 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.
Claims 76, 77, 83-85, and 88-91 are rejected under 35 U.S.C. 103 as being unpatentable over Black et al. (hereinafter “Black,” US 2020/0335012) in view of Toly (US 2004/0126746).
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).
Black does not explicitly teach every limitation of wherein structure comprises a muscle-like tissue, a tendon-like tissue, a ligament-like tissue, or an interface region therebetween.
However, Toly discloses wherein structure comprises a muscle-like tissue, a tendon-like tissue, a ligament-like tissue, or an interface region therebetween (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 structure comprises a muscle-like tissue, a tendon-like tissue, a ligament-like tissue, or an interface region therebetween, 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 77, Black in view of Toly 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 in view of Toly 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 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 85, Black in view of Toly 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 in view of Toly 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”).
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.
Claim 78 is rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Toly, and in further view of Hendrickson et al. (hereinafter “Hendrickson,” US 2012/0015337).
Regarding claim 78, Black in view of Toly 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 in view of Toly, 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 in view of Toly, 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 Toly, and in further view of Iverson et al. (hereinafter “Iverson,” US 2018/0075777).
Regarding claim 79, Black in view of Toly 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 in view of Toly, 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 in view of Toly, 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 in view of Toly 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 in view of Toly, 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 in view of Toly, 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 in view of Toly 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 in view of Toly, 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 in view of Toly, 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 Toly, and in further view of Hananel et al. (hereinafter “Hananel,” US 2016/0140879).
Regarding claim 82, Black in view of Toly 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 in view of Toly, 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 in view of Toly, 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 86 and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Toly, and in further view of Rowan (US 3,775,865).
Regarding claim 86, Black in view of Toly 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 in view of Toly, 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 in view of Toly, 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 in view of Toly 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 in view of Toly, 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 in view of Toly, 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 Toly, and in further view of McCullen et al. (hereinafter “McCullen,” US 2019/0000602).
Regarding claim 92, Black in view of Toly does not explicitly teach 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 in view of Toly, 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 in view of Toly, 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 in view of Toly does not explicitly teach 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 in view of Toly, 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 in view of Toly, 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.
Claims 94 and 95 are rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Toly, and in further view of Hall et al. (hereinafter “Hall,” US 4,143,426).
Regarding claim 94, Black in view of Toly does not explicitly teach wherein the structure is configured to form at least one tendon-like structure, a muscle-like structure, and an interface region between the at least one tendon-like structure and the muscle-like structure are formed by embedded elongated fibers to form a musculotendinous junction. [ the tendon-like structure and the muscle-like structure are by embedded elongated fibers to form a musculotendinous junction. (this portion of the claim disregarded because it appears to be entered in error, see objection supra) ]
Black does disclose embedded 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.”). Toly also discloses fasciae connective tissues which interact with the muscles and tendons (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.”)
However, Hall explicitly discloses wherein the structure is configured to form at least one tendon-like structure, a muscle-like structure, and an interface region between the at least one tendon-like structure and the muscle-like structure are formed by embedded elongated fibers to form a musculotendinous junction (Hall col. 4 lines 14-21, “An artificial tendon is attached to the musculotendinous portion of the muscle (or the tendon stump) by using an interfacing material which will distribute the forces over a wide area”; also Hall col. 5 lines 12-30, “The novel means of attachment of the artificial tendon to the musculotendinous portion of a skeletal muscle allow the use of an artificial tendon by itself as a prosthetic tendon or in combination with an external articulating skeletal extension. The artificial tendon 140 may be a seine cord of nylon. A velour laminate is bonded to the end 142 of the artificial tendon 140.”).
Hall is analogous to Black in view of Toly, 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 in view of Toly, to include wherein the structure is configured to form at least one tendon-like structure, a muscle-like structure, and an interface region between the at least one tendon-like structure and the muscle-like structure are formed by embedded elongated fibers to form a musculotendinous junction, as taught by Hall, in order to more evenly distribute the forces on the tendon (Hall col. 4 lines 15-22). 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 in view of Hall 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 in view of Hall, 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 in view of Hall, 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.
Response to Arguments
The Applicant’s arguments filed on April 17, 2026 have been fully considered, and the Examiner’s responses are provided below.
The Applicant respectfully argues “the present amendment further serves to clarify that the claimed structure is not merely a generic composite material, but rather a structure specifically adapted to simulate distinct anatomical tissue types and interfaces therebetween… Although the Black reference describes the use of materials such as polymers, lubricants, porous materials, and fibrous components, these materials are used in a fundamentally different manner.”
The Examiner respectfully disagrees. The Examiner notes that in order to differentiate the claims from the prior art, structural differences must be claimed. The prior art must only be capable of performing the claimed intended uses, which in the case of claim 76, is “surgical training.” The Black reference, though it is directed to training for surgical dissection, is still capable of being used for “surgical training.” Furthermore, surgical dissection training is also a form of “surgical training.”
Although Applicant intends for the structure to be specifically adapted to simulate distinct anatomical tissue types, the claims do not reflect this distinction. No distinct anatomical tissue types are recited in claim 76.
The Applicant further respectfully argues, “Black does not disclose any arrangement of such materials to reproduce differing mechanical behaviours associated with distinct tissue types, nor does Black disclose forming discrete tissue regions such as muscle-like, tendon-like, or ligament-like regions.”
The Examiner respectfully disagrees. The Examiner notes that the claims must be interpreted using the broadest reasonable interpretation in light of the disclosure. The claims do not recite any specific arrangement of materials, mechanical behaviors, distinct tissue types, or discrete tissue regions. Therefore, Black still reads upon the limitations of claim 76.
The Applicant also respectfully argues, “Black fails to disclose or suggest an interface region between different tissue types, as expressly recited in amended independent claim 76… the Black reference does not disclose a structure in which different regions are formed to represent different tissues, let alone an interface region between such tissues.”
The Examiner respectfully disagrees. The Examiner first notes that independent claim 76 recites a “structure comprising at least two of: a) a polymer, b) a lubricant, c) a porous material, d) elongated fibers, and e) an extension-limiting component, wherein structure comprises a muscle-like tissue, a tendon-like tissue, a ligament-like tissue, or an interface region therebetween” (emphasis added). Only two of the elements a) through e) are required as part of the structure. The way the claim is currently written, it appears that the limitation “wherein structure comprises a muscle-like tissue, a tendon-like tissue, a ligament-like tissue, or an interface region therebetween” is a part of e), which means that it is not required unless fewer than two of a) through d) are found in the prior art. Furthermore, “wherein structure comprises a muscle-like tissue, a tendon-like tissue, a ligament-like tissue, or an interface region therebetween” (emphasis added) is written in the alternative using “or,” meaning that the structure only requires the prior art to read on one of “a muscle-like tissue,” “a tendon-like tissue,” “a ligament-like tissue,” or “an interface region therebetween.” Also, as shown above in the 35 USC 112(a) rejection, the meaning of “an interface region therebetween.” Is uncertain because it is not in the original disclosure.
The Examiner further notes that the claims have no limitation reciting “a structure in which different regions are formed to represent different tissues,” as asserted in the arguments.
Regarding the 35 USC 103 rejections applying Hendrickson, the Applicant respectfully argues, “the disclosure of layered constructs formed by sequential deposition in Hendrickson (see, e.g., paragraphs [0032]-[0035]) does not teach or suggest arranging the claimed components, including polymers, lubricants, porous materials, elongated fibers, and extension-limiting components, to form muscle-like, tendon-like, or ligament-like tissue regions, nor does it disclose a biomechanical interface region between such tissues. The mere selection of a polymer having a particular Shore hardness does not teach or suggest the claimed structural arrangement or the formation of distinct tissue analogues. Further, Applicant contends that any ‘interfaces’ taught by Hendrickson are simply boundaries between adjacent layers within a composite structure, and not functional or structural analogues of tissue interfaces.”
The Examiner respectfully disagrees. The Examiner first notes that the independent parent claim 76, as amended, does not require any particular structural arrangement of any distinct tissue analogues. The “interface region” is also not described in the disclosure (see 35 USC 112(a) rejection supra), and therefore must be interpreted under the broadest reasonable interpretation in light of the specification, and using the plain meaning of the words. Claim 76 can reasonably be read to require only a structure comprising a polymer and a lubricant, and capable of use for surgical training to simulate tissue. These features are all taught by Black (see 35 USC 103 rejections supra). Even if read under the interpretation that the limitations of “wherein structure comprises a muscle-like tissue, a tendon-like tissue, a ligament-like tissue, or an interface region therebetween” are required, Black may still disclose these features, since these limitations are recited in the alternative, using “or,” and only one of them is required to be part of the structure. However, the Toly reference is applied to Black in case this narrower interpretation of claim 76 is disputed. Toly, as applied in the 35 USC rejection above, discloses the specific muscle and tendon structures of the amended claim.
The Hendrickson reference is only introduced for its teaching of “wherein the polymer is polyurethane rubber having a Shore hardness between 5A and 90A.” Since Hendrickson is also disclosing simulated tissue structures, it is analogous to Black in view of Toly, and it would have been obvious at the time of filing to combine these features.
Regarding the 35 USC 103 rejections applying Iverson, the Applicant respectfully argues, “While Iverson does disclose the use of lubricants, including oils such as mineral oil, within synthetic tissue phantoms… these materials are incorporated for the purpose of modifying bulk material properties such as softness, lubricity, and tactile response within individual layers. Iverson does not disclose or suggest arranging lubricants in combination with polymers, porous materials, elongated fibers, and extension-limiting components to form discrete tissue regions having differing mechanical behaviours, such as muscle-like, tendon-like, or ligament-like tissue regions, nor does Iverson disclose forming a biomechanical interface region between such tissues.
Rather, as with Black, Iverson is directed to layered constructs in which materials are selected to approximate general tissue characteristics, and any inclusion of lubricants is limited to adjusting the feel or performance of a given layer… The mere identification of specific lubricants, therefore, does not teach or suggest the claimed structural arrangement or the formation of distinct tissue analogues and interface regions.
Accordingly, even if combined with Black, Iverson would at most provide a dissectible or layered model with modified material properties but would still fail to teach or suggest the presently claimed invention, and the amended claims are not rendered obvious.”
The Examiner respectfully disagrees. The Examiner notes that Iverson is only introduced to show that the lubricant used in Black in view of Toly for the tissue simulating structure may be a specific type of lubricant such as mineral oil. Iverson is not relied upon for teaching “arranging lubricants in combination with polymers, porous materials, elongated fibers, and extension-limiting components to form discrete tissue regions having differing mechanical behaviours, such as muscle-like, tendon-like, or ligament-like tissue regions… forming a biomechanical interface region between such tissues,” and many of these cited limitations are not recited in the claims. The Black, Toly, and Iverson references are all directed to tissue simulating structures, and are therefore analogous art with features that would have been obvious to readily combine.
Regarding the 35 USC 103 rejections applying Hananel, the Applicant respectfully argues, “Hananel does not disclose or suggest the use of glycerin, or any lubricant, in combination with polymers, porous materials, elongated fibers, and extension-limiting components arranged to form discrete tissue regions having differing mechanical behaviours, as required by the amended claims. Nor does Hananel disclose forming muscle-like, tendon-like, or ligament-like tissue regions, or a biomechanical interface region therebetween… the mere identification of glycerin as a potential additive or lubricant does not teach or suggest the claimed structural arrangement or the formation of distinct tissue analogues and interface regions.”
The Examiner respectfully disagrees. The Examiner notes that Hananel is only introduced to show that the lubricant used in Black in view of Toly for the tissue simulating structure may be a specific type of lubricant such as glycerin. Hananel is not relied upon for its teaching of “polymers, porous materials, elongated fibers, and extension-limiting components arranged to form discrete tissue regions having differing mechanical behaviours.” Furthermore, these features are not required by the amended claims, since only two of these features is required and Hananel discloses the use of a glycerin lubricant with a polymer. The Black, Toly, and Hananel references are all directed to tissue simulating structures, and are therefore analogous art with features that would have been obvious to readily combine.
Regarding the 35 USC 103 rejections applying Toly, the Applicant respectfully argues, “The Toly reference is directed to a medical physiological simulator incorporating conductive elastomer-based evaluation circuits for providing feedback during simulated procedures, not to the structural configuration of tissue-simulating materials.”
The Examiner respectfully disagrees. The Examiner notes that the claims do not recite any specific structural configuration of tissue-simulating materials. The claims only require that at least two of a list of five materials are present in the structure. No specific configuration of the materials is recited in the claims.
Further regarding the Toly reference, Applicant respectfully argues that “While the reference does disclose layered tissue structures and fibrous reinforcement (see paragraph [0022]), Applicant contends that the layers are described in the context of supporting and housing evaluation circuits, which is entirely non-analogous to materials configured to form distinct tissue regions having differing mechanical behaviours.”
The Examiner respectfully disagrees. The combined references Black in view of Toly disclose all the limitations of independent claim 76. No specific behaviors are recited in the claims. Even if claimed, the intended uses of the claimed invention, if structurally identical to the prior art, cannot be used to differentiate it from the prior art.
Further regarding the Toly reference, Applicant respectfully argues that “the reference does not teach porous materials comprising layers of 1/16 inch to 1/2 inch open-cell polyurethane foam, nor any disclosure of an extension-limiting component positioned within or outside a polymer to mimic ligament behaviour between bones.”
The Examiner respectfully disagrees. As in the previous 35 USC 103 rejection of claim 84, it is clear that Toly (paragraphs [0079], [0085], [0093]) discloses using polyurethane foam to fabricate simulated tissue structures of varying thicknesses. Upon investigation, the TC-265 foam specifically cited by Toly appears to be an open-cell foam as recited in the claims.
As for the extension-limiting component mimicking ligament structures as recited in claim 89, Toly discloses (paragraphs [0168]) these in accurately simulating bone, cartilage, tendons and or ligaments. The intended uses of these features, absent structural differences, do not patentably distinguish from the prior art.
Further regarding the Toly reference, Applicant respectfully argues that “there is no disclosure of a polymer surface having a skin-like texture specifically corresponding to Langer's lines.”
The Examiner respectfully disagrees. Toly discloses realistically simulating skin tissue. Langer’s lines, as known in the art, are largely not visible to the naked eye; they can only be identified by manipulation and observing structural changes in the skin. The claims do not recite how a skin-like texture with Langer’s lines is structurally different from one without Langer’s lines, since the differences are not visible and only structural. Therefore, there is effectively no structural difference between the claimed invention, which does not recite any implications of having Langer’s lines, and a “realistic” skin simulation.
Further regarding the Toly reference, Applicant respectfully argues that “Toly fails to disclose anchors disposed on an outer surface of a tissue-simulating structure for connecting the structure to bone.”
The Examiner respectfully disagrees. Toly paragraph [0168] describes a simulated knee with simulated muscle made from elastomers, connecting to a rigid polymer bone structure by cartilage, tendons, and ligaments (also made from rigid polymers). These features disclose connecting muscle tissue-simulating structures to a simulated bone using simulated tendons as anchors.
Further regarding the Toly reference, Applicant respectfully argues that “While Toly generally references simulated anatomical structures, including tissue layers and joints (see paragraphs [0021]-[0022]), such references are directed to representational anatomical components within a training simulator, and not to structurally engineered tissue analogues formed from specific combinations of materials as now claimed. In particular, Toly does not disclose forming distinct muscle-like and tendon-like regions that are structurally differentiated through the arrangement of components such as polymers, lubricants, porous materials, elongated fibers, and extension-limiting components.”
The Examiner respectfully disagrees. As discussed above, the claims do not specify any structurally engineered tissue analogues formed from specific combinations of materials. Instead, claim 76 is claimed in a generic manner, requiring only two general components to be present, such as a polymer and a lubricant. Black in view of Toly still reads upon claim 72.
Further regarding the Toly reference, the Applicant respectfully argues that “Toly does not disclose an interface region between a muscle-like structure and a tendon-like structure formed by embedded elongated fibers to create a musculotendinous junction, as required by claim 95.”
The currently amended claim 94 is now rejected above under 35 USC 103 as being rendered obvious by Black in view of Toly and Hall. Hall is found to disclose the features of claim 94 that are deficient from Black in view of Toly, and the features disclosed by Hall are found to be obvious when combined with Black in view of Toly.
Further regarding the Toly reference, the Applicant respectfully argues, “Nor does Toly disclose positioning a tendon-like structure at an end of a muscle-like structure for connection to bone in the claimed manner.”
The Examiner respectfully disagrees. As shown in the 35 USC 103 rejection of claim 95 above, Toly paragraph [0168] discloses a simulated knee with simulated muscle, tendons, and bone. These features disclose the limitations of claim 95.
Regarding the 35 USC 103 rejection applying Rowan, the Applicant respectfully argues that Rowan “does not disclose or suggest the use of elongated fibers as a distinct structural component within a composite tissue-simulating structure… Moreover, Rowan does not disclose any arrangement or orientation of fibers within the tubing, let alone the specific orientations recited in claim 87, such as alignment according to tensile or normal forces, substantially parallel or perpendicular directions, cross-hatched patterns, fanned layouts, peripheral arrangements, or random orientations.”
The Examiner respectfully disagrees. The Examiner notes that the Rowan reference is only relied upon for teaching that the elongated fibers can be silk fibers. Rowan is analogous art, disclosing a simulator for teaching suturing techniques.
As for claim 87, while it is true that Rowan does not disclose any particular orientation for the fibers, claim 87 also does not recite any specific orientation for the fibers. The claim language, “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,” appears to cover any possible orientation for the fibers. Therefore, any disclosure of elongated fibers would read on claim 87.
Regarding the 35 USC 103 rejection applying McCullen, the Applicant respectfully argues, “While McCullen generally discloses the inclusion of biomolecules and naturally-derived components within a synthetic mesh construct, such disclosures are limited to the incorporation of additives within a base layer or composite implant material to modify properties such as hydration, wettability, or biological response (see paragraph [0059], which describes inclusion of biomolecules such as gelatin and polysaccharides within the base layer ). These materials are incorporated as minor constituents within a synthetic implant device, and are not disclosed as forming a tissue-simulating structure comprising distinct regions having differing mechanical behaviours as now required by the amended claims.”
The Examiner respectfully disagrees. McCullen is only relied upon for its teaching that gelatin may be added to the base material for replicating natural tissue structures. The claims do not recite any distinct regions having differing mechanical behaviours, and intended uses without structural differences cannot differentiate the instant claimed invention from the prior art.
Further regarding the McCullen reference, the Applicant respectfully argues that “there is no disclosure of alginate or kappa carrageenan being used in the manner claimed, nor any teaching of combining such materials with a "hardener" to form a structurally distinct region within a tissue-simulating of construct.”
The Examiner respectfully disagrees. The Examiner first notes that the claimed “gelatin, alginate, or kappa carrageenan” is recited in the alternative with “or”. Claim 92 only requires that one of the three compounds is present. Furthermore, in claim 93, the hardener is disclosed as materials used to create a “roughened surface”. A “structurally distinct region within a tissue-simulating of construct” is not recited in the claims.
Further regarding the McCullen reference, the Applicant respectfully argues that “the Examiner's reliance on McCullen is directed to general material selection within a fundamentally different class of devices. The mere identification of potential biomaterials, such as gelatin or polysaccharides, does not teach or suggest the claimed arrangement of components forming distinct tissue regions and interface regions therebetween.”
The Examiner respectfully disagrees. McCullen is analogous to Black, Toly, and the instant claimed invention, as all of these are directed to mimicking human tissue. As discussed previously, the claims do not explicitly require an “arrangement of components forming distinct tissue regions and interface regions therebetween.”
The Applicant further respectfully argues, “the Examiner's need to rely upon seven references having unique technical contexts underscores that the claimed invention is not obvious.”
The Examiner respectfully disagrees. In response to Applicant's argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991).
For the reasons provided above, the 35 USC 103 rejections will be maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/STEPHEN ALVESTEFFER/Examiner, Art Unit 3715
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