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 .
Response to Request for Continued Examination
This is a Non-Final Office action in response to the Request for Continued Examination filed on March 3, 2026. Applicant amended claims 1, 10, and 17. Claims 1-20 remain pending in the application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 5-8, 17-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable under US 20180261125 A1 (“Rios”) in view of US 20200100894 A1 (“Woodburn”) and US 20020094926 A1 (“Kling”).
In regards to claim 1, Rios discloses the following limitations with the exception of the underlined limitations.
A muscle block comprising: a plurality of first layers ([0012], “The plastic shell can be covered with layers … simulating human or animal muscle or skin.”), wherein each first layer of the plurality of first layers comprises microstructure including an arrangement of fill material and space defined by a first unit cell repeating in two dimensions within a plane ([0102], “the first layer … may be made of a transparent elastomer layer” Examiner notes that elastomers contain microstructures and that an elastomer layer may contain fill material and can be defined in two dimensions within a plane.);
and a plurality of second layers ([0012], “The plastic shell can be covered with layers … simulating human or animal muscle or skin.”), wherein each second layer of the plurality of second layers comprises microstructures including an arrangement of fill material and space defined by a second unit cell repeating in two dimensions within a plane ([0102], “The second layer … may consist of a transparent elastomer layer” Examiner notes that elastomers contain microstructures and that an elastomer layer may contain fill material and can be defined in two dimensions within a plane.);
wherein the first unit cell and the second unit cell each comprises a doubly periodic or triply periodic arrangement of fill material,
and wherein the plurality of first layers and the plurality of second layers are combined to form the muscle block, in adjacent layers stacked next to each other ([0012], “The plastic shell can be covered with layers … simulating human or animal muscle or skin.”) and defined by the first unit cells and the second unit cells, and wherein the microstructures of the plurality of first layers align with the microstructures of the plurality of second layers such that the space from each of the plurality of first layers and the plurality of second layers align together to form ([0077], “the first layer … may represent the epidermis … The second layer … may represent the dermis”) a three-dimensional arrangement for receiving fluid.
Woodburn discloses
fill material and space ([0035], “fill material ... can be injected”)
a three-dimensional arrangement for receiving fluid ([0013], “FIG. 6 is a … view of a fluid coupling between a fluid injection”)
Rios and Woodburn combined are considered analogous to the claim invention because they are in the fields of practicing injection techniques and inflatable orbital implants. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a muscle block comprising: a plurality of first layers, wherein each first layer of the plurality of first layers comprises an arrangement of fill material defined by a first unit cell repeating in two dimensions within a plane; a plurality of second layers, wherein each second layer of the plurality of second layers comprises an arrangement of fill material defined by a second unit cell repeating in two dimensions within a plane; of fill material, and wherein the plurality of first layers and the plurality of second layers are combined to form the muscle block, in adjacent layers stacked next to each other and defined by the first unit cells and the second unit cells, and wherein the microstructures of the plurality of first layers align with the microstructures of the plurality of second layers such that the space from each of the plurality of first layers and the plurality of second layers align together to form a three-dimensional arrangement for receiving fluid, as disclosed by Rios, fill material and space, a three-dimensional arrangement for receiving fluid, as disclosed by Woodburn, to provide fill material and a fluid injection for an inflatable orbital implant that can reposition an eyeball of a patient. One skilled in the art would recognize the value of the addition of fill material and a fluid injection for an inflatable orbital implant that can reposition an eyeball of a patient.
Kling discloses
wherein the first unit cell and the second unit cell each comprises a doubly periodic or triply periodic arrangement ([0148], “The embeddedness follows immediately from the injectivity hypothesis ... The surface generated will be doubly periodic” Examiner notes that the injectivity hypothesis includes the injective function that maps elements of its domain to elements of its codomain. Examiner notes that an elastomer layer can be doubly periodic.);
Rios and Kling combined are considered analogous to the claim invention because they are in the field of practicing injection techniques and practical procedures for folding tessellations (a repeating, geometric pattern without gaps or overlaps). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a muscle block comprising: a plurality of first layers, wherein each first layer of the plurality of first layers comprises an arrangement of fill material defined by a first unit cell repeating in two dimensions within a plane; a plurality of second layers, wherein each second layer of the plurality of second layers comprises an arrangement of fill material defined by a second unit cell repeating in two dimensions within a plane; of fill material, and wherein the plurality of first layers and the plurality of second layers are combined to form the muscle block, in adjacent layers stacked next to each other and defined by the first unit cells and the second unit cells, and wherein the microstructures of the plurality of first layers align with the microstructures of the plurality of second layers, as disclosed by Rios, wherein the first unit cell and the second unit cell each comprises a doubly periodic or triply periodic arrangement, as disclosed by Kling, to provide the generation of a doubly periodic surface used in practical procedures, functions or techniques for folding tessellations. One skilled in the art would recognize the value of the addition of the generation of a doubly periodic surface used in practical procedures, functions or techniques for folding tessellations.
In regards to claim 3, Rios does not disclose wherein the second unit cell is identical to the first unit cell.
Kling discloses
wherein the second unit cell is identical to the first unit cell ([0148], “The surface generated will be doubly periodic” Examiner notes that in a doubly periodic arrangement cells are identical to each other.).
Rios and Kling combined are considered analogous to the claim invention because they are in the field of practicing injection techniques and practical procedures for folding tessellations (a repeating, geometric pattern without gaps or overlaps). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a muscle block comprising: a plurality of first layers, wherein each first layer of the plurality of first layers comprises an arrangement of fill material defined by a first unit cell repeating in two dimensions within a plane; a plurality of second layers, wherein each second layer of the plurality of second layers comprises an arrangement of fill material defined by a second unit cell repeating in two dimensions within a plane; and of fill material, as disclosed by Rios, wherein the second unit cell is identical to the first unit cell, as disclosed by Kling, to provide the generation of a doubly periodic surface for practical procedures, functions or techniques for folding tessellations.
In regards to claim 5, Rios discloses
wherein the fill material comprises polylactic acid, polypropylene, polyethylene terephthalate, acrylonitrile butadiene styrene polymers, acrylic styrene acrylonitrile polymers, poly(methyl methacrylate), polyoxymethylene, polyetherimide, one or more other thermoplastic polymers, or other material capable of being used in an additive printing application ([0087], “The … layer may be covered with removable layers of elastomer” Examiner notes that elastomers can have fill material comprised of polylactic acid.).
In regards to claim 6, Rios discloses
wherein a Shore hardness of the fill material is approximately 70A to approximately 90A ([0087], “The … layer may be covered with removable layers of elastomer” Examiner notes that the typical Shore hardness range for elastomers is 20A to 90A.).
In regards to claim 7, Rios discloses
wherein an average density of the muscle block is approximately 10% infill to approximately 25% infill ([0087], “The … layer may be covered with removable layers of elastomer” Examiner notes that the typical infill density for an elastomer can range from 10% infill to 100% infill.).
In regards to claim 8, Rios discloses
wherein the first unit cell is a cubic unit cell and has a length of approximately 4 mm to approximately 12 mm ([0087], “The … layer may be covered with removable layers of elastomer” Examiner notes that elastomer cubes can be manufactured with dimensions from 4 mm up to 12 mm in length.).
Claims 2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable under Rios in view of Woodburn, Kling, and US 20200230286 A1 (“Becker”).
In regards to claim 2, Rios does not disclose wherein the first unit cell comprises a triply periodic arrangement of fill material including a gyroid shape.
Becker discloses
wherein the first unit cell comprises a triply periodic arrangement of fill material including a gyroid shape ([0050], “the … polymer matrix may … Gyroid triply periodic minimal surface geometry with a … 83% porosity” Examiner notes that in claimed invention the gyroid shape may allow for fluid to pass through muscle block [0096] and that an 83% porosity in Becker’s disclosure means that 83% of the material’s total volume consists of empty spaces, which would allow for fluid to pass through easily.).
Rios and Becker combined are considered analogous to the claim invention because they are in the field of practicing injection techniques and tissue scaffolds. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a muscle block comprising: a plurality of first layers, wherein each first layer of the plurality of first layers comprises an arrangement of fill material defined by a first unit cell repeating in two dimensions within a plane; a plurality of second layers, wherein each second layer of the plurality of second layers comprises an arrangement of fill material defined by a second unit cell repeating in two dimensions within a plane; and of fill material, as disclosed by Rios, wherein the first unit cell comprises a triply periodic arrangement of fill material including a gyroid shape, as disclosed by Becker, to provide the gyroid triply periodic minimal surface geometry for novel bioactive peptide loaded poly(propylene fumarate) tissue scaffolds and related methods for their making and use. One skilled in the art would recognize the value of the addition of a gyroid triply periodic minimal surface geometry used in novel bioactive peptide loaded poly(propylene fumarate) tissue scaffolds.
In regards to claim 9, Rios does not disclose wherein the muscle block comprises tubules with a minimum diameter of approximately 2 mm to approximately 8 mm.
Becker discloses
wherein the muscle block comprises tubules with a minimum diameter of approximately 2 mm to approximately 8 mm ([0050], “the … polymer matrix may … Gyroid triply periodic minimal surface geometry” Examiner notes that in the claimed invention “the shape of fill material … is referred to as a gyroid, and when repeated in three dimensions it forms several tubules within muscle block” [0098] and that tubules in a gyroid fill can range from 2 mm to 8 mm.).
Rios and Becker combined are considered analogous to the claim invention because they are in the field of practicing injection techniques and tissue scaffolds. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a muscle block comprising: a plurality of first layers, wherein each first layer of the plurality of first layers comprises an arrangement of fill material defined by a first unit cell repeating in two dimensions within a plane; a plurality of second layers, wherein each second layer of the plurality of second layers comprises an arrangement of fill material defined by a second unit cell repeating in two dimensions within a plane; and of fill material, as disclosed by Rios, wherein the muscle block comprises tubules with a minimum diameter of approximately 2 mm to approximately 8 mm, as disclosed by Becker, to provide the gyroid triply periodic minimal surface geometry for novel bioactive peptide loaded poly(propylene fumarate) tissue scaffolds and related methods for their making and use. One skilled in the art would recognize the value of the addition of a gyroid triply periodic minimal surface geometry used in novel bioactive peptide loaded poly(propylene fumarate) tissue scaffolds.
Claim 4, 10-16, and 19 is rejected under 35 U.S.C. 103 as being unpatentable under Rios in view of Kling, Woodburn, and US 11984046 B2 (“Powdrill”).
In regards to claim 4, Rios does not disclose wherein the muscle block has a general geometry that includes a half cylinder.
Powdrill discloses
wherein the muscle block has a general geometry that includes a half cylinder (column 3, lines 4-5, “FIG. 1A is a … view of a first embodiment of the surgical skills training model.” Examiner notes that in Annotated Powdrill FIG. 1A (see below) the model depicts a geometry that resembles a half cylinder.).
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Rios and Powdrill are considered analogous to the claim invention because they are in the field of practicing injection techniques and surgical skills training. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a muscle block comprising: a plurality of first layers, wherein each first layer of the plurality of first layers comprises an arrangement of fill material defined by a first unit cell repeating in two dimensions within a plane; a plurality of second layers, wherein each second layer of the plurality of second layers comprises an arrangement of fill material defined by a second unit cell repeating in two dimensions within a plane; and of fill material, as disclosed by Rios, wherein the muscle block has a general geometry that includes a half cylinder, as disclosed by Powdrill, to provide an embodiment for a surgical skills training model that has an elongated body including muscle, fascia, subcutaneous tissue, connective tissue and skin mimicking layers. One skilled in the art would recognize the value of the addition of a surgical skills training model that has an elongated body including muscle, fascia, subcutaneous tissue, connective tissue and skin mimicking layers.
In regards to claim 10, Rios discloses the following limitations with the exception of the underlined limitations.
An injection trainer comprising: a muscle block ([0012], “The plastic shell can be covered with layers … simulating human or animal muscle or skin.”);
and one or more overlying layers above the muscle block, wherein a region of the muscle block comprises: a plurality of first layers that each comprise microstructures including an arrangement of fill material and space defined by a first unit cell repeating in two dimensions within a plane; and a plurality of second layers that each comprise microstructures including an arrangement of fill material and space defined by a second unit cell repeating in two dimensions within a plane ([0087], “The … layer may be covered with … elastomer” Examiner notes that elastomers contain microstructures and that an elastomer can be a fill material and may contain crystalline portions of polylactic acid ([0088] of claimed invention) which can be defined by a unit cell repeating in three dimensions.), wherein the plurality of first layers and the plurality of second layers are combined to form the region of the muscle block, and the microstructures of the plurality of first layers align with the microstructures of the plurality of second layers such that the space from each align together to form a three-dimensional arrangement that allows for passage of fluid through the muscle block ([0077], “the first layer … may represent the epidermis … The second layer … may represent the dermis … The third layer … may represent the muscle”).
Powdrill discloses
and one or more overlying layers above the muscle block (column 3, lines 44-45, “the subcutaneous tissue layer … overlies the muscle layer”);
Rios and Powdrill are considered analogous to the claim invention because they are in the field of practicing injection techniques and surgical skills training. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for an injection trainer comprising: a muscle block;
wherein a region of the muscle block comprises: a plurality of first layers that each comprise microstructures including an arrangement defined by a first unit cell repeating in two dimensions within a plane; and a plurality of second layers that each comprise microstructures including an arrangement defined by a second unit cell repeating in two dimensions within a plane, wherein the plurality of first layers and the plurality of second layers are combined to form the region of the muscle block, and the microstructures of the plurality of first layers align with the microstructures of the plurality of second layers such that the space from each align together to form a three-dimensional arrangement that allows for passage of fluid through the muscle block, as disclosed by Rios, and one or more overlying layers above the muscle block, as disclosed by Powdrill, to provide a subcutaneous tissue layer and a muscle layer for a surgical skills training model that has an elongated body. One skilled in the art would recognize the value of the addition of a subcutaneous tissue layer and a muscle layer for a surgical skills training model that has an elongated body.
Woodburn discloses
fill material and space ([0035], “fill material ... can be injected”)
Rios and Woodburn combined are considered analogous to the claim invention because they are in the fields of practicing injection techniques and inflatable orbital implants. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for an injection trainer comprising: a muscle block; wherein a region of the muscle block comprises: a plurality of first layers that each comprise microstructures including an arrangement defined by a first unit cell repeating in two dimensions within a plane; and a plurality of second layers that each comprise microstructures including an arrangement defined by a second unit cell repeating in two dimensions within a plane, wherein the plurality of first layers and the plurality of second layers are combined to form the region of the muscle block, and the microstructures of the plurality of first layers align with the microstructures of the plurality of second layers such that the space from each align together to form a three-dimensional arrangement that allows for passage of fluid through the muscle block, as disclosed by Rios, fill material and space, as disclosed by Woodburn, to provide fill material for an inflatable orbital implant that can reposition an eyeball of a patient. One skilled in the art would recognize the value of the addition of fill material for an inflatable orbital implant that can reposition an eyeball of a patient.
In regards to claim 11, Rios discloses
wherein the one or more overlying layers are designed to allow a user to simulate a skin pinch ([0082], “Users of the injection apparatus may be able to pinch the skin, stretch the skin, or grab a portion of the muscle in order to simulate a real injection.”).
In regards to claim 12, Rios does not disclose wherein the one or more overlying layers comprise an intermediate layer and a surface layer.
Powdrill discloses
wherein the one or more overlying layers comprise an intermediate layer and a surface layer (column 3, lines 44-46, “the subcutaneous tissue layer … overlies the muscle layer … and the skin layer … overlies the subcutaneous tissue layer.” Examiner interprets the skin layer as a surface layer and the subcutaneous tissue layer as an intermediate layer.).
Rios and Powdrill are considered analogous to the claim invention because they are in the field of practicing injection techniques and surgical skills training. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for an injection trainer comprising: a muscle block; wherein a region of the muscle block comprises: a plurality of first layers that each comprise microstructures including an arrangement defined by a first unit cell repeating in two dimensions within a plane; and a plurality of second layers that each comprise microstructures including an arrangement defined by a second unit cell repeating in two dimensions within a plane, wherein the plurality of first layers and the plurality of second layers are combined to form the region of the muscle block, and the microstructures of the plurality of first layers align with the microstructures of the plurality of second layers such that the space from each align together to form a three-dimensional arrangement that allows for passage of fluid through the muscle block, as disclosed by Rios, and one or more overlying layers above the muscle block, wherein the intermediate layer comprises a foam rubber, a polyurethane, or a sponge, as disclosed by Powdrill, to provide a subcutaneous tissue layer, a muscle layer, and a skin layer for a surgical skills training model that has an elongated body. One skilled in the art would recognize the value of the addition of a subcutaneous tissue layer and a muscle layer for a surgical skills training model that has an elongated body.
In regards to claim 13, Rios discloses
wherein the intermediate layer comprises a foam rubber, a polyurethane, or a sponge ([0087], “The … layer may be covered with … elastomer” Examiner notes that a foam rubber can be a type of elastomer.).
In regards to claim 14, Rios discloses
wherein the surface layer comprises a silicone rubber, an ethylene propylene rubber, a fluoroelastomer, an olefin-based rubber, a latex rubber, a nitrile rubber, or a butyl rubber ([0087], “The … layer may be covered with … elastomer” Examiner notes that a silicone rubber can be a type of elastomer.).
In regards to claim 15, Rios discloses
wherein the fill material comprises polylactic acid, polypropylene, polyethylene terephthalate, acrylonitrile butadiene styrene polymers, acrylic styrene acrylonitrile polymers, poly(methyl methacrylate), polyoxymethylene, polyetherimide, one or more other thermoplastic polymers, or other material capable of being used in an additive printing application, and has a Shore hardness of approximately 70A to approximately 90A ([0087], “The … layer may be covered with … elastomer” Examiner notes that an elastomer can be a fill material and may contain polylactic acid and that the typical Shore hardness range for elastomers is 20A to 90A.).
In regards to claim 16, Rios discloses
wherein the region of the muscle block comprises at least 80% of a total volume of the muscle block ([0078], “the injectable muscle and skin layers … may be made of an elastomer” Examiner notes that despite its voids and empty spaces an elastomer can be engineered to cover at least 80% of a total volume.).
In regards to claim 19, Rios does not disclose wherein combined thicknesses of the surface layer and the intermediate layer is less than or equal to a height of the muscle block.
Powdrill discloses
wherein combined thicknesses of the surface layer ((column 4, line 63 and column 5, lines 2-3, “The skin layer … … is approximately 1.5 mm thick” Examiner notes that the skin layer represents the surface layer) and the intermediate layer (column 4, line 29 and lines 33-34, “The subcutaneous tissue layer … is … approximately 5 mm thick” Examiner notes that the subcutaneous tissue layer represents the intermediate layer.) is less than or equal to a height of the muscle block (column 6, lines 45-49, “ Muscle layer … The thickness of this layer … is sufficient to fill the mold to the desired height of about 50 mm or less”.). See Annotated Powdrill FIG. 1A. above.)
Rios and Powdrill are considered analogous to the claim invention because they are in the field of practicing injection techniques and surgical skills training. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for an injection trainer comprising: a muscle block comprising a material with a Shore hardness of approximately 70A to approximately 90A; a surface layer comprising a silicone rubber, an ethylene propylene rubber, a fluoroelastomer, an olefin-based rubber, a latex rubber, a nitrile rubber, or a butyl rubber; and an intermediate layer between the muscle block and the surface layer; wherein the muscle block includes a region comprising an arrangement of fill material defined by a first unit cell repeating in three dimensions, and wherein the unit cell has a density of at least approximately 10% infill, as disclosed by Rios, wherein combined thicknesses of the surface layer and the intermediate layer is less than or equal to a height of the muscle block, as disclosed by Powdrill, to provide a subcutaneous tissue layer, a muscle layer, and a skin layer for a surgical skills training model that has an elongated body. One skilled in the art would recognize the value of the addition of a subcutaneous tissue layer and a muscle layer for a surgical skills training model that has an elongated body.
Claims 17-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable under Rios in view of Woodburn.
In regards to claim 17, Rios discloses the following limitations with the exception of the underlined limitations.
An injection trainer comprising: a muscle block comprising a material with a Shore hardness of approximately 70A to approximately 90A ([0087], “The … layer may be covered with … elastomer” Examiner notes that the typical Shore hardness range for elastomers is 20A to 90A.);
a surface layer comprising a silicone rubber, an ethylene propylene rubber, a fluoroelastomer, an olefin-based rubber, a latex rubber, a nitrile rubber, or a butyl rubber ([0087], “The … layer may be covered with … elastomer” Examiner notes that a silicone rubber can be a type of elastomer.);
and an intermediate layer between the muscle block and the surface layer ([0092], “FIG. 4B depicts a … a … removable layer including at least three simulated human skin and muscle layers” Examiner interprets the skin layer as a surface layer and the muscle layer as an intermediate layer.),
wherein the muscle block includes a region comprising: a plurality of first layers that each comprise microstructures including an arrangement of fill material and space defined by a first unit cell repeating in two dimensions in a plane; a plurality of second layers that each comprise microstructures including an arrangement of fill material and space defined by a second unit cell repeating in two dimensions within a plane; wherein the plurality of first layers and the plurality of second layers are combined to form the region of the muscle block, and the microstructures of the plurality of first layers align with the microstructures of the plurality of second layers such that the space from each of the plurality of first layers and the plurality of second layers align together to form a three-dimensional third unit cell that has a density of at least approximately 10% infill ([0087], “The … layer may be covered with removable layers of elastomer” Examiner notes that elastomers contain microstructures and that an elastomer can be a fill material and may contain crystalline portions of polylactic acid ([0088] of claimed invention) which can be defined by a unit cell repeating in three dimensions. Examiner notes that the typical infill density for an elastomer can range from 10% infill to 100% infill.) and that allows for passage of fluid through the muscle block.
Woodburn discloses
fill material and space ([0035], “fill material ... can be injected”)
and that allows for passage of fluid through the muscle block ([0013], “FIG. 6 is a … view of a fluid coupling between a fluid injection”).
Rios and Woodburn combined are considered analogous to the claim invention because they are in the fields of practicing injection techniques and inflatable orbital implants. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for an injection trainer comprising: a muscle block comprising a material with a Shore hardness of approximately 70A to approximately 90A; a surface layer comprising a silicone rubber, an ethylene propylene rubber, a fluoroelastomer, an olefin-based rubber, a latex rubber, a nitrile rubber, or a butyl rubber; and an intermediate layer between the muscle block and the surface layer, wherein the muscle block includes a region comprising: a plurality of first layers that each comprise microstructures including an arrangement defined by a first unit cell repeating in two dimensions in a plane; a plurality of second layers that each comprise microstructures including an arrangement defined by a second unit cell repeating in two dimensions within a plane; wherein the plurality of first layers and the plurality of second layers are combined to form the region of the muscle block, and the microstructures of the plurality of first layers align with the microstructures of the plurality of second layers such that the space from each of the plurality of first layers and the plurality of second layers align together to form a three-dimensional third unit cell that has a density of at least approximately 10% infill and that allows for passage of fluid through the muscle block, as disclosed by Rios, fill material and space, and that allows for passage of fluid through the muscle block, as disclosed by Woodburn, to provide fill material for an inflatable orbital implant that can reposition an eyeball of a patient. One skilled in the art would recognize the value of the addition of fill material for an inflatable orbital implant that can reposition an eyeball of a patient.
In regards to claim 18, Rios discloses
wherein the intermediate layer contacts the muscle block and the surface layer, and the intermediate layer comprises a foam rubber, a polyurethane, or a sponge ([0087], “The … layer may be covered with … elastomer” Examiner notes that a foam rubber can be a type of elastomer.).
In regards to claim 20, Rios discloses
further comprising a slot configured to interface with a base plate ([0088], “The pivotable stand … may be attached to a removable base” Examiner notes that the opening for the pivotable stand can represent the slot and that the removable base can represent the base plate. See Rios Annotated FIG. 4A below.).
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Response to Arguments
Applicant's arguments filed March 3, 2026 have been fully considered, but they are not persuasive. Applicant amended claims 1, 10, and 17. Claims 1-20 remain pending in the application.
With respect to “Section 103 Rejections”, Applicant argues “Rios, Kling, Becker, and Powdrill do not disclose or suggest all elements of the amended claims” (See REMARKS, III. Section 103 Rejections, page 2, lines 6-7). Examiner acknowledges Applicant’s remarks. With respect to claim 1, a muscle block comprising: a plurality of first layers ([0012], “The plastic shell can be covered with layers … simulating human or animal muscle or skin.”), wherein each first layer of the plurality of first layers comprises microstructure including an arrangement defined by a first unit cell repeating in two dimensions within a plane ([0102], “the first layer … may be made of a transparent elastomer layer” Examiner notes that elastomers contain microstructures and that an elastomer layer may contain fill material and can be defined in two dimensions within a plane.); and a plurality of second layers ([0012], “The plastic shell can be covered with layers … simulating human or animal muscle or skin.”), wherein each second layer of the plurality of second layers comprises microstructures including an arrangement defined by a second unit cell repeating in two dimensions within a plane ([0102], “The second layer … may consist of a transparent elastomer layer” Examiner notes that elastomers contain microstructures and that an elastomer layer may contain fill material and can be defined in two dimensions within a plane.); and wherein the plurality of first layers and the plurality of second layers are combined to form the muscle block, in adjacent layers stacked next to each other ([0012], “The plastic shell can be covered with layers … simulating human or animal muscle or skin.”) and defined by the first unit cells and the second unit cells, and wherein the microstructures of the plurality of first layers align with the microstructures of the plurality of second layers such that the space from each of the plurality of first layers and the plurality of second layers align together to form ([0077], “the first layer … may represent the epidermis … The second layer … may represent the dermis”), Woodburn discloses fill material and space ([0035], “fill material ... can be injected”) and a three-dimensional arrangement for receiving fluid ([0013], “FIG. 6 is a … view of a fluid coupling between a fluid injection”), and Kling discloses wherein the first unit cell and the second unit cell each comprises a doubly periodic or triply periodic arrangement ([0148], “The embeddedness follows immediately from the injectivity hypothesis ... The surface generated will be doubly periodic” Examiner notes that the injectivity hypothesis includes the injective function that maps elements of its domain to elements of its codomain. Examiner notes that an elastomer layer can be doubly periodic.). The combination of Rios, Woodburn, and Kling discloses all of the limitations of claim 1.
MPEP § 2111 discusses proper claim interpretation, including giving claims their
broadest reasonable interpretation (“BRI”) in light of the specification during
examination. Under BRI, the words of a claim must be given their plain meaning unless
such meaning is inconsistent with the specification, and it is improper to import claim
limitations from the specification into the claim. Applicant’s argument is not persuasive because the BRI is broader than what is argued. Independent claim 10 “similar features as the muscle block of claim 1” (See REMARKS, Section 103 Rejections, page 2, lines 4-5). Therefore, the rejection of claim 1, as obvious by Rios in view of Woodburn and Kling, is maintained. Consequently, the rejections of dependent claims 2-9 are maintained. Further, the rejections of independent claim 10 and dependent claims 11-16, as obvious by Rios in view of Woodburn, Kling, and Powdrill are maintained.
With respect to “Section 102 Rejections”, Applicant argues “Rios does not disclose each and every element of amended claim 17” (See REMARKS, IV. Section 102 Rejections, page 5, lines 4-5). Examiner acknowledges Applicant’s remarks. With respect to claim 17, Rios discloses an injection trainer comprising: a muscle block comprising a material with a Shore hardness of approximately 70A to approximately 90A ([0087], “The … layer may be covered with … elastomer” Examiner notes that the typical Shore hardness range for elastomers is 20A to 90A.); a surface layer comprising a silicone rubber, an ethylene propylene rubber, a fluoroelastomer, an olefin-based rubber, a latex rubber, a nitrile rubber, or a butyl rubber ([0087], “The … layer may be covered with … elastomer” Examiner notes that a silicone rubber can be a type of elastomer.); and an intermediate layer between the muscle block and the surface layer ([0092], “FIG. 4B depicts a … a … removable layer including at least three simulated human skin and muscle layers” Examiner interprets the skin layer as a surface layer and the muscle layer as an intermediate layer.), wherein the muscle block includes a region comprising: a plurality of first layers that each comprise microstructures including an arrangement defined by a first unit cell repeating in two dimensions in a plane; a plurality of second layers that each comprise microstructures including an arrangement defined by a second unit cell repeating in two dimensions within a plane; wherein the plurality of first layers and the plurality of second layers are combined to form the region of the muscle block, and the microstructures of the plurality of first layers align with the microstructures of the plurality of second layers such that the space from each of the plurality of first layers and the plurality of second layers align together to form a three-dimensional third unit cell that has a density of at least approximately 10% infill ([0087], “The … layer may be covered with removable layers of elastomer” Examiner notes that elastomers contain microstructures and that an elastomer can be a fill material and may contain crystalline portions of polylactic acid ([0088] of claimed invention) which can be defined by a unit cell repeating in three dimensions. Examiner notes that the typical infill density for an elastomer can range from 10% infill to 100% infill.) and Woodburn discloses fill material and space ([0035], “fill material ... can be injected”) and that allows for passage of fluid through the muscle block ([0013], “FIG. 6 is a … view of a fluid coupling between a fluid injection”). The combination of Rios, Woodburn, and Kling discloses all of the limitations of claim 17.
MPEP § 2111 discusses proper claim interpretation, including giving claims their
broadest reasonable interpretation (“BRI”) in light of the specification during
examination. Under BRI, the words of a claim must be given their plain meaning unless
such meaning is inconsistent with the specification, and it is improper to import claim
limitations from the specification into the claim. Applicant’s argument is not persuasive because the BRI is broader than what is argued. Therefore, the rejection of claim 17, as obvious by Rios in view of Woodburn and Kling, is maintained. Consequently, the rejections of dependent claims 18-20, as obvious by Rios in view of Woodburn and Kling, are maintained.
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Any inquiry concerning this communication or earlier communications from the
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(571) 272-4252 and whose email address is lantoine@uspto.gov. The examiner can be reached Monday-Thursday, 7:30 am-5:30 pm CT. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached on (571) 272-7147. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/LISA H ANTOINE/
Examiner, Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715
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