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 .
Applicant’s submission of a Response
Applicant’s submission of a response was received on 06/24/2026. Presently, claims 1, 3-11, 13-17, and 19-29 are pending.
Response to Arguments
Applicant's arguments filed 06/24/2026 have been fully considered but they are not persuasive. Applicant’s representative asserts that the amended claims limitations are not met. However, the rejection of claims 1, 3-11, 13-17, and 19-29 is maintained as presented below.
Applicant’s representative alleges the following:
In regards to claim 1, “the Action somehow jumps to the conclusion, without any rational underpinning, that Black describes a simulated vaginal canal having ‘a second smooth section near a distal end of the simulated vaginal canal ’” (Page 11 of Remarks).
In regards to claim 1, “Miyazaki does not teach ‘a first section comprising a plurality of ridges,’ as alleged in the Action. Rather, Miyazaki in 187 states that the ‘the vaginal wall 820 can be textured. For example, as shown in FIG. 18, the vaginal wall 820 can have one or more ridges to simulate a human vagina.’” (Page 11 of Remarks).
In regards to claim 1, “the Action does not provide any reasoning for why one of ordinary skill would have been motivated to modify ‘a first section’ of the simulated vaginal canal described in Black when Miyazaki does not teach or suggest that the one or more ridges are in a first section of the vaginal wall.” (Page 12 of Remarks).
In regards to claim 1, “Black clearly does not describe or even suggest a cord or a plurality of cords. Black also does not describe or suggest suspending its simulated uterus within its frame via a plurality of cords or that the plurality of cords are configured to allow the simulated cervix to move in response to user interaction.” (Page 13 of Remarks).
In regards to claim 1, “Robbins in the cited passage and Figs. 1 and 2 does not describe or suggest a simulated uterus (being equated in the Action to our claimed ‘support structure’) but rather simulated cysts or tumors 10 suspended by nylon threads 12. Accordingly, Robbins does not teach the support structure or even a supposed simulated uterus, suspended within the frame via a plurality of cords.” (Page 14 of Remarks).
In regards to claim 1, “Robbins does not teach or suggest a plurality of cords that are "configured to allow the simulated cervix to move in response to user interaction." Rather, Robbins describes nylon threads 12 being used to suspend simulated cysts or tumors 10 in a plastic box that is then filled with an ambiance of tissue equivalent material.” (Page 15 of Remarks).
In regards to claim 1, “Replacing Black's fasteners with Robbins' threads 12 is not a ‘simple substitution’ since it is not clear how Robbins' triangulated thread configuration could be used in place of Black's fasteners.” (Page 15 of Remarks).
In regards to claim 3, “Black does not describe or suggest a support structure, or its simulated uterus being equated to our claimed support structure, as being entirely elongate and tubular extending from the proximal most end of the support structure to the distal most end of the support structure as provided by claim 3. Rather, Black describes in 89 a simulated uterus as having ‘a bulbous portion 40 defining a hollow simulated uterine cavity 42. The bulbous portion 40 is connected to a tubular portion 44 defining a vaginal canal 46 having an opening 48.’ As such, Black does not characterize or illustrate the simulated uterus as being tubular, much less being ‘entirely elongate and tubular’ extending from the proximal most end of the simulated uterus to the distal most end of the simulated uterus.” (Page 17 of Remarks).
In regards to claim 11, “Black at most teaches a simulated uterus having a portion made of TPE and a simulated vaginal canal that may have an embedded mesh layer. However, Black does not teach or suggest a support structure that comprises a reinforcement matrix or sleeve to further reinforce or provide tear resistance.” (Page 18 of Remarks).
In regards to claim 13, “Black does not describe or suggest that the frame and the plurality of cords comprises nonconductive material” (Page 19 of Remarks).
In regards to claim 1, “Medina does not teach the support structure or even a supposed simulated uterus, suspend within the frame via a plurality or cords”. (Page 21 of Remarks)
In regards to claim 1, “Medina does not teach or suggest that the elongated wire or thread 36 is ‘configured to allow the simulated cervix to move in response to user interaction’”. (Page 21 of Remarks)
In regards to claim 21, “the claimed support structure having a height smaller than the height of the simulated vaginal canal and the height of the simulated cervix is not ‘merely a design choice’. Rather, the claimed support structure saves resources, reduces waste, and eases assembly and manufacturability of the model compared to the models that include a simulated uterus”. (Page 25 of Remarks)
In regards to claim 21, “one of ordinary skill in the art would not have been motivated to modify Black’s tissue model for the reason provided in the Action, because Black already simulates how a real tissue is suspended by using the sheets and the fasteners and, thus, does not require any modification to provide this benefit”. (Page 27 of Remarks)
In regards to claim 1, “Bust does not teach the support structure or even a supposed simulated uterus, suspended within the frame via a plurality of cords”. (Page 29 of Remarks)
In regards to claim 7, “Black does not describe or suggest a simulated vesicocervical space, the simulated vesicocervical space being positioned outside the distal end of the simulated vaginal canal and comprising at least two layers, wherein a first set or pre-determined locations are connected with an interface material as provided by claim 7”. (Page 36 of Remarks)
In regards to claim 16, “Black fails to describe or suggest ‘all pieces connected together’ are formed as a monolithic piece or structure”. (Page 36 of Remarks)
In regards to claim 8, “Black does not teach or suggest yarn assembled onto a three-dimensional mandrel at all. Much less a support structure formed via yarn that is assembled onto a three-dimensional mandrel and cast within a mold”. (Page 38 of Remarks)
In regards to claim 10, “Black simply does not describe or suggest a color of a material used to cast the support structure that is different from a color of the yarn forming the support structure”. (Page 39 of Remarks)
In regards to claim 14, “modifying Black’s simulated bladder to inflate and deflate would be contrary to Black’s teaching to stuffing the simulated bladder with material to maintain its shape”. (Page 41 of Remarks)
In regards to claim 15, “Black does not describe or suggest the simulated bladder further comprises added batting at a top portion of the simulated bladder or a thickening of a material making up the top portion of the simulated bladder as required by claim 15”. (Page 43 of Remarks)
In regards to claim 19, “Alexander, Black, Miyazaki, Robbins, or any combination thereof, as well as the Action fails to describe or suggest the support structure (being equated in the Action in reference to claim 1 as Black’s simulated uterus) comprising a removable grounding cable required by claim 19 depending from claim 1. In particular, the action states ‘Alexander shows the simulated tissue used with a grounding wire’ which is not the same as a simulated tissue structure comprising a removable grounding cable, unless Applicant’s description is used as a guide”. (Page 44 of Remarks)
In regards to claim 20, “Felsinger, Black, Miyazaki, Robbins, or any combination thereof, as well as the Action fails to describe or suggest the support structure (being equated in the Action in reference to claim 1 as Black’s simulated uterus) comprising a removable grounding pad required by claim 20 depending from claim 1. In particular, the action states ‘simulated tissue is used with a grounding pad’ which is not the same as a simulated tissue structure comprising a ground pad or the support structure comprising a removable grounding pad”. (Page 45 of Remarks)
In regards to claim 22, “None of the applied references teach or suggest a simulated vaginal opening that includes ‘includes a dedicated hole where a filling is inserted’ as recited in claim 22”. (Page 47 of Remarks)
In regards to claim 22, “None of the applied references teach or suggest a simulated vaginal opening that includes ‘includes a dedicated hole where a filling is inserted’ as recited in claim 22”. (Page 47 of Remarks)
Regarding point (1), the examiner respectfully disagrees.
Applicant’s representative argues that “the Action somehow jumps to the conclusion, without any rational underpinning, that Black describes a simulated vaginal canal having ‘a second smooth section near a distal end of the simulated vaginal canal’” (Page 11 of Remarks)
In response to the arguments above, silicone has a smooth texture. Black uses silicone for multiple parts in the prior art, including simulated uterus, fallopian tubes, ovaries (¶90 of Black), simulated cervix (¶110 of Black), and any other portion of the model can be made of silicone (¶128) (See 103 Rejection below)
Regarding point (2), the examiner respectfully disagrees.
Applicant’s representative argues that “Miyazaki does not teach ‘a first section comprising a plurality of ridges,’ as alleged in the Action. Rather, Miyazaki in 187 states that the ‘the vaginal wall 820 can be textured. For example, as shown in FIG. 18, the vaginal wall 820 can have one or more ridges to simulate a human vagina.’” (Page 11 of Remarks).
In response to the arguments above, Miyazaki does teach the claimed limitations. The vaginal wall, as part of a first section will have a one or more ridges to simulate a human vagina (col 25 lines 34-36 and Fig 18 of Miyazaki) (See 103 Rejection below)
Regarding point (3), the examiner respectfully disagrees.
Applicant’s representative argues that “the Action does not provide any reasoning for why one of ordinary skill would have been motivated to modify ‘a first section’ of the simulated vaginal canal described in Black when Miyazaki does not teach or suggest that the one or more ridges are in a first section of the vaginal wall.” (Page 12 of Remarks).
In response to the arguments above, the office action did provide reasoning. Black is simulating a vaginal canal (vaginal canal 218, Fig 14 of Black) and Miyazaki is also simulating the internal space of a vagina that has a plurality of ridges (col 25 lines 34-36 and Fig 18 of Miyazaki). Therefore, one of ordinary skill in the art would come to the conclusion that modifying a vaginal canal to have ridges will be more realistic because there are vaginal rugea formed in the shape of ridges in a real vaginal canal. (See 103 Rejection below)
Regarding point (4), the examiner respectfully disagrees.
Applicant’s representative argues that “Black clearly does not describe or even suggest a cord or a plurality of cords. Black also does not describe or suggest suspending its simulated uterus within its frame via a plurality of cords or that the plurality of cords are configured to allow the simulated cervix to move in response to user interaction.” (Page 13 of Remarks).
In response to the arguments above, Black already discloses suspending simulated organ structures, such as a simulated uterus, within its frame via fasteners (¶110 of Black). However, Black does not mention the use of a plurality of cords, this is why Black is used in combination with Robbins for a simple substitution. The purpose of the plurality of cords is the same as the fasteners, they allow the simulated organ to be in a suspended manner. (See 103 Rejection below)
Regarding point (5), the examiner respectfully disagrees.
Applicant’s representative argues that “Robbins in the cited passage and Figs. 1 and 2 does not describe or suggest a simulated uterus (being equated in the Action to our claimed ‘support structure’) but rather simulated cysts or tumors 10 suspended by nylon threads 12. Accordingly, Robbins does not teach the support structure or even a supposed simulated uterus, suspended within the frame via a plurality of cords.” (Page 14 of Remarks).
In response to the arguments above, the simulated uterus is made of simulated tissue (abstract of Black) and simulated cysts or tumors (abstract of Robbins) are also made of simulated tissue. The simulated uterus has already been disclosed by Black, this is why this is used in combination with Robbins to show that simulated tissue (ex: simulated uterus, cysts, or tumors) are in a suspended state. (See 103 Rejection below)
Regarding point (6), the examiner respectfully disagrees.
Applicant’s representative argues that “Robbins does not teach or suggest a plurality of cords that are "configured to allow the simulated cervix to move in response to user interaction." Rather, Robbins describes nylon threads 12 being used to suspend simulated cysts or tumors 10 in a plastic box that is then filled with an ambiance of tissue equivalent material.” (Page 15 of Remarks).
In response to the arguments above, this limitation is disclosed by Black, not Robbins. Again, Robbins is being used for the plurality of cords. Black does not mention the use of a plurality of cords, this is why Black is used in combination with Robbins for a simple substitution. The purpose of the plurality of cords is the same as the fasteners, they allow the simulated organ to be in a suspended manner. (See 103 Rejection below)
Regarding point (7), the examiner respectfully disagrees.
Applicant’s representative argues that “Replacing Black's fasteners with Robbins' threads 12 is not a ‘simple substitution’ since it is not clear how Robbins' triangulated thread configuration could be used in place of Black's fasteners.” (Page 15 of Remarks).
In response to the arguments above, the claimed subject matter is “wherein the support structure is suspended within the frame via a plurality of cords, and wherein the plurality of cords are configured to allow the simulated cervix to move in response to user interaction.”. This is a simple substitution because the purpose of the plurality of cords is to suspend the structure, which has the exact same result as suspending them with fasteners. There is no mention of a “triangulated thread configuration” in the claim. (See 103 Rejection below)
Regarding point (8), the examiner respectfully disagrees.
Applicant’s representative argues that “Black does not describe or suggest a support structure, or its simulated uterus being equated to our claimed support structure, as being entirely elongate and tubular extending from the proximal most end of the support structure to the distal most end of the support structure as provided by claim 3. Rather, Black describes in 89 a simulated uterus as having ‘a bulbous portion 40 defining a hollow simulated uterine cavity 42. The bulbous portion 40 is connected to a tubular portion 44 defining a vaginal canal 46 having an opening 48.’ As such, Black does not characterize or illustrate the simulated uterus as being tubular, much less being ‘entirely elongate and tubular’ extending from the proximal most end of the simulated uterus to the distal most end of the simulated uterus.” (Page 17 of Remarks).
In response to the arguments above, the support structure is “entirely elongate and tubular” as seen in Fig. 15 of Black and Fig. 4E. It is true that there is also a bulbous portion, but it still doesn’t change the tubular shape of the structure, this is why is better to look at Figs. 4E and 15 of Black to have a view from different perspectives. (See 103 Rejection below)
Regarding point (9), the examiner respectfully disagrees.
Applicant’s representative argues that “Black at most teaches a simulated uterus having a portion made of TPE and a simulated vaginal canal that may have an embedded mesh layer. However, Black does not teach or suggest a support structure that comprises a reinforcement matrix or sleeve to further reinforce or provide tear resistance.” (Page 18 of Remarks).
In response to the arguments above, the distinction applicant made for reinforcement matrix is of a reinforcement material (¶48 of the specification of the present invention). TPE is considered to have this type of reinforcement material because it’s flexible and it provides resistance (¶100-101 of Black). (See 103 Rejection below)
Regarding point (10), the examiner respectfully disagrees.
Applicant’s representative argues that “Black does not describe or suggest that the frame and the plurality of cords comprises nonconductive material” (Page 19 of Remarks).
In response to the arguments above, Black already discloses the frame to comprise nonductive material, and so will the fasteners (¶128 of Black). What Black does not disclose is the plurality of cords, which is why this is a rejection that combines Black with Robbins. (See 103 Rejection below)
Regarding point (11), the examiner respectfully disagrees.
Applicant’s representative argues that “Medina does not teach the support structure or even a supposed simulated uterus, suspend within the frame via a plurality or cords”. (Page 21 of Remarks)
In response to the arguments above, this limitation is disclosed by Black, not Medina. Again, Medina is being used for the plurality of cords. Black does not mention the use of a plurality of cords, this is why Black is used in combination with Medina for a simple substitution. The purpose of the plurality of cords is the same as the fasteners, they allow the simulated organ to be in a suspended manner. (See 103 Rejection below)
Regarding point (12), the examiner respectfully disagrees.
Applicant’s representative argues that “Medina does not teach or suggest that the elongated wire or thread 36 is ‘configured to allow the simulated cervix to move in response to user interaction’”. (Page 21 of Remarks)
In response to the arguments above, this limitation is disclosed by Black, not Medina. Again, Medina is being used for the plurality of cords. Black does not mention the use of a plurality of cords, this is why Black is used in combination with Medina for a simple substitution. The purpose of the plurality of cords is the same as the fasteners, they allow the simulated organ to be in a suspended manner. (See 103 Rejection below)
Regarding point (13), the examiner respectfully disagrees.
Applicant’s representative argues that “the claimed support structure having a height smaller than the height of the simulated vaginal canal and the height of the simulated cervix is not ‘merely a design choice’. Rather, the claimed support structure saves resources, reduces waste, and eases assembly and manufacturability of the model compared to the models that include a simulated uterus”. (Page 25 of Remarks)
In response to the arguments above, the cited paragraph is ¶27 of the present invention for support of “the claimed support structure saves resources, reduces waste, and eases assembly and manufacturability of the model compared to the models that include a simulated uterus”. However, this is in direct connection to a complete simulated part, such as a simulated uterus, this does not mention how certain widths or heights of the simulated components is not a design choice. (See 103 Rejection below)
Regarding point (14), the examiner respectfully disagrees.
Applicant’s representative argues that “one of ordinary skill in the art would not have been motivated to modify Black’s tissue model for the reason provided in the Action, because Black already simulates how a real tissue is suspended by using the sheets and the fasteners and, thus, does not require any modification to provide this benefit”. (Page 27 of Remarks)
In response to the arguments above, this is the reason why it’s used in combination. Black already discloses how a real tissue is suspended by using the sheets and the fasteners, but does not mention the use of a plurality of cords. However, cords have the same purpose of fasteners in order to keep simulated tissue suspended, and they can both be looped. Therefore, someone of ordinary skill in the art would come to the conclusion that modifying Black’s fasteners with wires or threads will lead to the same suspended state. (See 103 Rejection below)
Regarding point (15), the examiner respectfully disagrees.
Applicant’s representative argues that “Bush does not teach the support structure or even a supposed simulated uterus, suspended within the frame via a plurality of cords”. (Page 29 of Remarks)
In response to the arguments above, Black is the art used for the simulated uterus is made of simulated tissue (abstract of Black) suspended within the frame via a plurality of fasteners. Bush is only used to show how nylon threads could be used to substitute the fasteners for the threads. (See 103 Rejection below)
Regarding point (16), the examiner respectfully disagrees.
Applicant’s representative argues that “Black does not describe or suggest a simulated vesicocervical space, the simulated vesicocervical space being positioned outside the distal end of the simulated vaginal canal and comprising at least two layers, wherein a first set or pre-determined locations are connected with an interface material as provided by claim 7”. (Page 36 of Remarks)
In response to the arguments above, the vesicocervical space is a combination of both the silicone layer 228 and fiber layer 229 (Fig 14 of Black) and there is an interface material will be the dissecting layer 226 in the bottom part as shown in Fig 14 and ¶109 or Black. As shown in Fig 14, the dissecting layer 226 is another layer that is shown to be an interface layer between the silicone layer 228 and fiber layer 229. (See 103 Rejection below)
Regarding point (17), the examiner respectfully disagrees.
Applicant’s representative argues that “Black fails to describe or suggest ‘all pieces connected together’ are formed as a monolithic piece or structure”. (Page 36 of Remarks)
In response to the arguments above, these pieces together are “cast as a single piece” as shown by Fig. 2 and 14 of Black and ¶125 that mentions how these parts are joined together with adhesive. In the same way, the present invention has multiple pieces that are cast as a single piece, ¶44 of the present invention mentions how these pieces are connected to each other or formed as a single monolithic piece. (See 103 Rejection below)
Regarding point (18), the examiner respectfully disagrees.
Applicant’s representative argues that “Black does not teach or suggest yarn assembled onto a three-dimensional mandrel at all. Much less a support structure formed via yarn that is assembled onto a three-dimensional mandrel and cast within a mold”. (Page 38 of Remarks)
In response to the arguments above, Black already discloses the support structure assembled onto a three-dimensional mandrel and cast within a mold as previously explained in the Office action. However, it does not disclose the support structure formed via yarn, which is why Souter is being used to show how the support structure, such as the simulated uterus, is formed via fabric mesh made of yarn. (See 103 Rejection below)
Regarding point (19), the examiner respectfully disagrees.
Applicant’s representative argues that “Black simply does not describe or suggest a color of a material used to cast the support structure that is different from a color of the yarn forming the support structure”. (Page 39 of Remarks)
In response to the arguments above, Although Black doesn’t explicitly mention the color of the yarn, it does disclose the color of the support structure changing. Therefore, one of ordinary skill in the art will come to the conclusion that if the support structure does change, it will be different from the color of the yarn. (See 103 Rejection below)
Regarding point (20), the examiner agrees.
Applicant’s representative argues that “modifying Black’s simulated bladder to inflate and deflate would be contrary to Black’s teaching to stuffing the simulated bladder with material to maintain its shape”. (Page 41 of Remarks)
In response to the arguments above, these arguments have been found convincing and thus the rejection on claim 14 has been withdrawn. (See Office action below)
Regarding point (21), the examiner agrees.
Applicant’s representative argues that “Black does not describe or suggest the simulated bladder further comprises added batting at a top portion of the simulated bladder or a thickening of a material making up the top portion of the simulated bladder as required by claim 15”. (Page 43 of Remarks)
In response to the arguments above, since the rejection on claim 14 has been withdrawn and claim 15 depends from claim 14, it will put claim 15 in condition for allowance. (See Office action below)
Regarding point (22), the examiner respectfully disagrees.
Applicant’s representative argues that “Alexander, Black, Miyazaki, Robbins, or any combination thereof, as well as the Action fails to describe or suggest the support structure (being equated in the Action in reference to claim 1 as Black’s simulated uterus) comprising a removable grounding cable required by claim 19 depending from claim 1. In particular, the action states ‘Alexander shows the simulated tissue used with a grounding wire’ which is not the same as a simulated tissue structure comprising a removable grounding cable, unless Applicant’s description is used as a guide”. (Page 44 of Remarks)
In response to the arguments above, again, the support structure is already disclosed by Black. Alex is used in combination with Black in order to show simulated tissue (ex: simulated uterus is a form of simulated tissue) used with a grounding wire. (See 103 Rejection below)
Regarding point (23), the examiner respectfully disagrees.
Applicant’s representative argues that “Felsinger, Black, Miyazaki, Robbins, or any combination thereof, as well as the Action fails to describe or suggest the support structure (being equated in the Action in reference to claim 1 as Black’s simulated uterus) comprising a removable grounding pad required by claim 20 depending from claim 1. In particular, the action states ‘simulated tissue is used with a grounding pad’ which is not the same as a simulated tissue structure comprising a ground pad or the support structure comprising a removable grounding pad”. (Page 45 of Remarks)
In response to the arguments above, again, the support structure is already disclosed by Black. Felsinger is used in combination with Black in order to show simulated tissue (ex: simulated uterus is a form of simulated tissue) used with a removable grounding pad. (See 103 Rejection below)
Regarding point (24), the examiner agrees.
Applicant’s representative argues that “None of the applied references teach or suggest a simulated vaginal opening that includes ‘includes a dedicated hole where a filling is inserted’ as recited in claim 22”. (Page 47 of Remarks)
In response to the arguments above, these arguments have been found convincing and thus the rejection on claim 22 has been withdrawn. (See Office action below)
Regarding claim 21, since they recite similar features to claim 1, same response to arguments is applied.
Applicant’s representative argues that since the references do not disclose the suggested features of claim 1 and so, dependent claims and new claims are patentable. However, in light of the remarks and standing rejection below, the examiner asserts the prior art of record teaches all the elements as claimed and these elements satisfy all structural, functional, operational, and spatial limitations currently in the claims. Therefore, the standing rejections are proper and maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 5, 11, 13, 17, 24, 25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Black et al. (US20180005549A1; hereinafter Black) in view of Douglas Miyazaki (US 20160104394 A1; hereinafter Miyazaki) in view of Robbins et al. (US 4493653 A; hereinafter Robbins).
Regarding claim 1, Black discloses a simulated tissue structure (simulated organ structure 202; Fig 14) comprising: a frame having a top portion, a base and two sidewalls (frame 204 has a top portion, base, and two sidewalls as shown in Fig 9), wherein the frame has an opening at a proximal end of the frame (frame has opening at the proximal end as shown Fig 9); a simulated vaginal canal that defines an internal space within the frame (simulated vaginal canal 218; Fig 14), the internal space having a first section near a proximal end of the simulated vaginal canal (the first section is inside the simulated vaginal canal 218; Fig 14, an opening at the proximal end of the simulated vaginal canal corresponding to the opening at the proximal end of the frame (Opening of simulated vaginal canal in Fig 14 corresponding to the opening of the frame), and a second smooth section near a distal end of the simulated vaginal canal (near the distal end of the simulated vaginal canal we have the beginning of the simulated uterus 216 and inside the uterus we have the simulated cervix made of silicone, which is a smooth surface; ¶110); a simulated cervix located at and is connected to the distal end of the simulated vaginal canal such that a proximal end of the simulated cervix extends inside the simulated vaginal canal and a distal end of the simulated cervix extends past the internal space defined by the simulated vaginal canal (simulated cervix located between simulated uterus 216 and vaginal canal 214 at the proximal end 260 and the simulated cervix extends past the internal space defined by the simulated vaginal canal; ¶110 and Fig 14); and a support structure that is connected to the distal end of the simulated cervix (the simulated uterus acts as the support structure for the simulated cervix because the cervix is located inside the simulated uterus; ¶110), wherein the support structure is suspended within the frame (simulated uterus is suspended within the pelvic frame; ¶101), and wherein the simulated cervix is allowed to move in response to user interaction (simulated uterus will hang and swing in response to being manipulated with surgical instruments; ¶101). Black does not explicitly disclose the internal space having a first section comprising a plurality of ridges. Furthermore, Black discloses the support structure is suspended within the frame (this is already disclosed by a simulated uterus is suspended within the pelvic frame; ¶101) and the simulated cervix, while suspended, is allowed to move in response to user interaction (simulated uterus will hang and swing in response to being manipulated with surgical instruments; ¶101). But Black does not disclose this suspension and movement through a plurality of cords and instead it uses fasteners.
However, Miyazaki focuses devices, systems, and methods for practicing, teaching, and/or simulating various surgical procedures such as vaginal hysterectomy, which relates to Black because they both models focus on hysterectomy. Miyazaki teaches the internal space of a vagina having a first section comprising a plurality of ridges (vaginal wall 820 can have one or more ridges to simulate a human vagina; ¶187).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Miyazaki for the benefit of simulating the real internal space of a first section of a vagina properly because there are vaginal rugea formed in the shape of ridges.
Robbins focuses on phantoms simulating tissue, which relates to Black because they are both trying to simulate tissue with their models. Robbins teaches the use of nylon threads to suspend simulated tissue (col 2 lines 3-20). Thus, one of ordinary skill in the art would make a simple substitution of the use of fasteners in Black with the nylon threads from Robbins.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Robbins since it has been held that simple substitution of one known element for another yields predictable results. Here nylon threads are used to replace fasteners to suspend the simulated uterus and allow it to move in a realistic fashion with user interaction allow the support structure (simulated uterus) to have the same suspension and movement mechanism that the support structure would have with a plurality of fasteners. See MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 3, Black discloses wherein the support structure has an elongate tubular shape (the simulated uterus 216 has a tubular shape; Fig 14), the support structure having a proximal most end (proximal end 260 of simulated uterus 216; Fig 15 and ¶107) and a distal most end (distal end 262; Fig 15 and ¶107), the support structure being entirely elongate and tubular extending from the proximal most end of the support structure to the distal most end of the support structure (an example of a simulated uterus 32 has a tubular portion 44 in ¶95 and it extends to the bulbous portion 40 that is also tubular as shown in Fig 2 and Fig 4E shows a better angle of how the bulbous portion is tubular as well), the proximal most end of the support structure being connected to the distal end of the simulated cervix (proximal end 260 of the simulated uterus 216 in Fig 15 is connected to a distal end of the simulated cervix 318 because the simulated cervix is inserted into the proximal end 260).
Regarding claim 5, Black does not explicitly disclose wherein the plurality of cords comprise nylon.
However, Robbins focuses on phantoms simulating tissue, which relates to Black because they are both trying to simulate tissue with their models. Robbins teaches the use of nylon threads to suspend simulated tissue (col 2 lines 5-9).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Robbins because nylon is resistant to tearing, durable, and can withstand repeated cleaning or sterilization, making it a cost-effective and reliable material for training.
Regarding claim 11, Black discloses wherein the support structure further comprises a reinforcement matrix or sleeve to further reinforce or provide tear resistance (tubular portion 44 of simulated uterus is made of TPE to hold the suture without tearing in ¶101 and the mesh layer 230 prevents propagation of tear and makes the artificial uterus pliable and strong in ¶121).
Regarding claim 13, Black discloses wherein the frame comprises nonconductive material (frame can be made of nonconductive materials mentioned in ¶128). Black discloses the fasteners can be made of nonconductive material in ¶128 but does not explicitly disclose a plurality of cords comprising nonconductive material.
However, Robbins focuses on phantoms simulating tissue, which relates to Black because they are both trying to simulate tissue with their models. Robbins teaches a plurality of cords comprising nonconductive material (nylon is a nonconductive material; col 2 lines 5-9). Here we make a simple substitution of the use of fasteners in Black with the nylon threads from Robbins.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Robbins since it has been held that simple substitution of one known element for another yields predictable results. Here nylon threads are used to replace fasteners to suspend the simulated uterus and allow it to move in a realistic fashion with user interaction allow the support structure (simulated uterus) to have the same suspension and movement mechanism that the support structure would have with a plurality of fasteners. See MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 17, Black discloses further comprising a simulated peritoneum layer positioned at a distal end of the frame and attached to one or more of the support structure or the simulated cervix (both sheets 222 and 224 represent the peritoneum; ¶107), wherein the simulated peritoneum layer is dissectable (sheets 222 and 224 must allow for dissection because of their connection with dissecting layer 226; see Fig 14) thereby allowing a user to access a simulated peritoneal cavity past the simulated peritoneum layer (peritoneal cavity; ¶61-63).
Regarding claim 24, Black discloses further comprising a delineation between the first section and the second smooth section of the simulated vaginal canal (the first section is inside the vaginal canal and the second smooth section, as indicated in the specification of the present invention, is located near a circumferential area of the simulated vaginal canal where the simulated vaginal canal is connected to the simulated cervix, Black shows in ¶110 and Fig 14-15 that the vaginal canal is joined together with the uterus through proximal end of simulated uterus 260 and distal end of the simulated vaginal canal 258, and a simulated cervix is provided made of silicone and located inside the simulated uterus 216 at the proximal end 260; these pieces connecting to each other will create a clear delineation; furthermore, the simulated vaginal canal may contain an embedded mesh layer 230 in ¶107 and Fig 15, once the vaginal canal ends at the distal end 258, it will create a clear delineation between the first section and the smooth section).
In regards to “wherein the delineation serves as a visual indicator of where to make an incision,” this limitation belongs to intended use and thus since Black discloses the delineation, it would result in the same visual indicator applicant is claiming here.
Regarding claim 25, Black discloses wherein the second smooth section of the simulated vaginal canal is adjacent to a circumferential area of the simulated vaginal canal where the simulated vaginal canal is connected to the simulated cervix (the first section is inside the vaginal canal and the second smooth section, as indicated in the specification of the present invention, is located near a circumferential area of the simulated vaginal canal where the simulated vaginal canal is connected to the simulated cervix, Black shows in ¶110 and Fig 14-15 that the vaginal canal is joined together with the uterus through proximal end of simulated uterus 260 and distal end of the simulated vaginal canal 258, and a simulated cervix is provided made of silicone and located inside the simulated uterus 216 at the proximal end 260; Fig 14 clearly shows the smooth section is adjacent to the section where the simulated vaginal canal is connected to the simulated cervix).
Regarding claim 27, Black does not explicitly disclose wherein the plurality of cords are attached directly to the support structure. However, Black does mention the use of fasteners looped around frames and simulated organ structures (¶110 and ¶127).
However, Robbins discloses wherein the plurality of cords are attached directly to the support structure (nylon threads to suspend simulated tissue in col 2 lines 3-20, while we have previously stated the support structure to be equivalent to the simulated uterus, which is made up of simulated tissue).
Thus, one of ordinary skill in the art would make a simple substitution of the use of fasteners in Black with the nylon threads from Robbins.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Robbins since it has been held that simple substitution of one known element for another yields predictable results. Here nylon threads are used to replace fasteners to suspend the simulated uterus and allow it to move in a realistic fashion with user interaction allow the support structure (simulated uterus) to have the same suspension and movement mechanism that the support structure would have with a plurality of fasteners. See MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claims 1, 3-4, 11, 13, 17, 21, 24, 25, 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Miyazaki in view of Marelyn Medina (US 5368487 A; hereinafter Medina).
Regarding claim 1, Black discloses a simulated tissue structure (simulated organ structure 202; Fig 14) comprising: a frame having a top portion, a base and two sidewalls (frame 204 has a top portion, base, and two sidewalls as shown in Fig 9), wherein the frame has an opening at a proximal end of the frame (frame has opening at the proximal end as shown Fig 9); a simulated vaginal canal that defines an internal space within the frame (simulated vaginal canal 218; Fig 14), the internal space having a first section near a proximal end of the simulated vaginal canal (the first section is inside the simulated vaginal canal 218; Fig 14, an opening at the proximal end of the simulated vaginal canal corresponding to the opening at the proximal end of the frame (Opening of simulated vaginal canal in Fig 14 corresponding to the opening of the frame), and a second smooth section near a distal end of the simulated vaginal canal (near the distal end of the simulated vaginal canal we have the beginning of the simulated uterus 216 and inside the uterus we have the simulated cervix made of silicone, which is a smooth surface; ¶110); a simulated cervix located at and is connected to the distal end of the simulated vaginal canal such that a proximal end of the simulated cervix extends inside the simulated vaginal canal and a distal end of the simulated cervix extends past the internal space defined by the simulated vaginal canal (simulated cervix located between simulated uterus 216 and vaginal canal 214 at the proximal end 260 and the simulated cervix extends past the internal space defined by the simulated vaginal canal; ¶110 and Fig 14); and a support structure that is connected to the distal end of the simulated cervix (the simulated uterus acts as the support structure for the simulated cervix because the cervix is located inside the simulated uterus; ¶110), wherein the support structure is suspended within the frame (simulated uterus is suspended within the pelvic frame; ¶101), and wherein the simulated cervix is allowed to move in response to user interaction (simulated uterus will hang and swing in response to being manipulated with surgical instruments; ¶101). Black does not explicitly disclose the internal space having a first section comprising a plurality of ridges. Furthermore, Black discloses the support structure is suspended within the frame (this is already disclosed by a simulated uterus is suspended within the pelvic frame; ¶101) and the simulated cervix, while suspended, is allowed to move in response to user interaction (simulated uterus will hang and swing in response to being manipulated with surgical instruments; ¶101), But Black does not disclose this suspension and movement through a plurality of cords and instead it uses fasteners.
However, Miyazaki focuses devices, systems, and methods for practicing, teaching, and/or simulating various surgical procedures such as vaginal hysterectomy, which relates to Black because they both models focus on hysterectomy. Miyazaki teaches the internal space of a vagina having a first section comprising a plurality of ridges (vaginal wall 820 can have one or more ridges to simulate a human vagina; ¶187).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Miyazaki for the benefit of simulating the real internal space of a first section of a vagina properly because there are vaginal rugea formed in the shape of ridges.
However, Medina focuses on a device for assisting in training of laparoscopic surgical techniques, which relates to Black because they are both used in the medical field related to laparoscopic surgical training. Medina teaches the use of wires or threads to suspend a surface (wires or threads are looped around apertures to suspend a movable surface; col 4 lines 40-44 and Fig 3). Here we make a simple substitution of the use of fasteners in Black with the threads from Medina.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Medina since it has been held that simple substitution of one known element for another yields predictable results. Here threads or wires are used to replace fasteners to loop around apertures to suspend the simulated uterus to have the same suspension and movement mechanism that the simulated uterus would have with a plurality of fasteners. See MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
With regards to claims 3, 11, 17, 24, and 25, Black discloses the elements of the claims as noted in the above rejection.
Regarding claim 4, Black discloses wherein the frame further comprises a plurality of apertures (frame can also have multiple apertures; Fig 10), the plurality of apertures positioned on the two sidewalls (apertures on walls; Fig 9). Black discloses the apertures configured to receive one or more of the plurality of fasteners whereby the one or more of the plurality of fasteners are looped with the apertures (¶125) to connect the one or more of the plurality of fasteners with the two sidewalls (fasteners 210; Fig 9), but does not explicitly disclose using cords instead of fasteners for this suspension mechanism.
However, Medina focuses on a device for assisting in training of laparoscopic surgical techniques, which relates to Black because they are both used in the medical field related to laparoscopic surgical training. Medina teaches how a plurality of cords can be looped around apertures to suspend a surface (wires or threads are looped around apertures to suspend a movable surface; col 4 lines 40-44 and Fig 3).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Medina because cords/wires/threads going through holes/apertures suspend the simulated uterus, which provides the benefit of simulating how a real uterus is suspended by a complex web of ligaments and the tension from the simulated organ allows the organ to move and “rebound” just like it would in a real patient.
Regarding claim 21, Black discloses a simulated tissue structure (simulated organ structure 202; Fig 14) comprising: a simulated pelvic frame having a top portion, a base and two sidewalls (pelvic frame 204 has a top portion, base, and two sidewalls as shown in Fig 9), the simulated pelvic frame having an opening at a proximal end of the simulated pelvic frame (pelvic frame 204 shows 2 different openings at both ends; Fig 7); a simulated vaginal opening comprising simulated tissue covering the proximal end of the simulated pelvic frame (another example shows an opening of simulated vaginal canal 46 in Fig 4B covering over the proximal end of the simulated pelvic frame), the simulated tissue being attached to the top portion of the simulated pelvic frame and extending down an entire height of the simulated pelvic frame to the base of the simulated pelvic frame (simulated tissue extending through the whole pelvic frame as shown in Fig. 4B); a simulated vaginal canal defining an internal space within the simulated pelvic frame (simulated vaginal canal 218 defines a space inside as shown in Fig 14), the internal space having a first section near a proximal end of the simulated vaginal canal (the first section is inside the simulated vaginal canal 218; Fig 14) and a second smooth section near a distal end of the simulated vaginal canal (near the distal end of the simulated vaginal canal we have the beginning of the simulated uterus 216 and inside the uterus we have the simulated cervix made of silicone, which is a smooth surface; ¶110), an opening of the simulated vaginal opening leads to an opening of the simulated vaginal canal at the proximal end of the simulated vaginal canal (simulated vaginal canal 218 has an opening which is the opening leading to the simulated vaginal canal as shown in Fig 14); a simulated cervix connected to the distal end of the simulated vaginal canal (simulated cervix located between simulated uterus 216 and vaginal canal 214 at the proximal end 260 and the simulated cervix extends past the internal space defined by the simulated vaginal canal; ¶110 and Fig 14); fasteners looped to connect the support structure to the simulated pelvic frame to allow the simulated cervix to move in response to user interaction (simulated uterus is suspended within the pelvic frame and will hang and swing in response to being manipulated with surgical instruments; ¶101).
Black does not explicitly disclose the internal space of a vagina having a first section comprising a plurality of ridges. However, Miyazaki focuses on devices, systems, and methods for practicing, teaching, and/or simulating various surgical procedures such as vaginal hysterectomy, which relates to Black because they both models focus on hysterectomy. Miyazaki teaches the internal space of a vagina having a first section comprising a plurality of ridges (vaginal wall 820 can have one or more ridges to simulate a human vagina; ¶187).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Miyazaki for the benefit of simulating the real internal space of a first section of a vagina properly because there are vaginal rugea formed in the shape of ridges.
Black does not explicitly disclose the simulated cervix having a height being smaller than a height of the simulated vaginal opening and a width greater than a width of the simulated vaginal opening; a support structure connected to the distal end of the simulated cervix, the support structure having a height smaller than a height of the simulated vaginal canal and the height of the simulated cervix and the support structure having a width greater than the width of the simulated cervix and a width of the simulated vaginal canal. However, the choice to have certain heights or widths in the simulated components to be greater or smaller is merely a design choice, which fails to patentably distinguish over the prior art. The invention is intended to teach or practice how to perform a colpotomy procedure (¶20 of the present invention) and realistic differences in heights and widths between the simulated components will allow for improved teaching/practice.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement realistic dimensions in simulated gynecological components because they are essential for high-fidelity training, enabling accurate, hands-on practice that improves surgical proficiency, enhances spatial understanding, and reduces risks in real patient care.
Black does not disclose a cord threaded and looped through the support structure. However, Medina focuses on a device for assisting in training of laparoscopic surgical techniques, which relates to Black because they are both used in the medical field related to laparoscopic surgical training. Medina teaches how a plurality of cords can be threaded looped around apertures to suspend a surface (wires or threads are looped around apertures to suspend a movable surface; col 4 lines 40-44 and Fig 3).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Medina because cords/wires/threads going through holes/apertures suspend the simulated uterus, which provides the benefit of simulating how a real uterus is suspended by a complex web of ligaments and the tension from the simulated organ allows the organ to move and “rebound” just like it would in a real patient.
Regarding claim 27, Black does not explicitly disclose wherein the plurality of cords are attached directly to the support structure. However, Black does mention the use of fasteners looped around frames and simulated organ structures (¶110 and ¶127).
However, Medina discloses wherein the plurality of cords are attached directly to the support structure (wires or threads are looped around apertures to suspend a movable surface in col 4 lines 40-44 and Fig 3, and the movable surface is made to simulate skin in col 4 lines 7-19; while we have previously stated the support structure to be equivalent to the simulated uterus, which is made up of simulated tissue).
Thus, one of ordinary skill in the art would make a simple substitution of the use of fasteners in Black with the threads from Medina.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Medina since it has been held that simple substitution of one known element for another yields predictable results. Here threads or wires are used to replace fasteners to loop around apertures to suspend the simulated uterus to have the same suspension and movement mechanism that the simulated uterus would have with a plurality of fasteners. See MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 28, Black does not explicitly disclose wherein the plurality of cords are threaded through the support structure.
However, Medina teaches wherein the plurality of cords are threaded through the support structure (wires or threads are looped around apertures to suspend a movable surface in col 4 lines 40-44 and Fig 3, and the movable surface is made to simulate skin in col 4 lines 7-19; while we have previously stated the support structure to be equivalent to the simulated uterus, which is made up of simulated tissue).
Regarding claim 29, Black does not explicitly disclose wherein the plurality of cords are threaded through the support structure.
However, Medina teaches wherein the plurality of cords are threaded through the support structure (wires or threads are looped around apertures to suspend a movable surface in col 4 lines 40-44 and Fig 3, and the movable surface is made to simulate skin in col 4 lines 7-19; embedded means “firmly fixed, enclosed, or incorporated within a surrounding structure” and here the cords are embedded in the structure because they are routed through the movable surface and the frame holding it).
Claims 1, 3-4, 11, 13, 17, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Miyazaki in view of Karen S. Bush (US 20160379522 A1; hereinafter Bush).
Regarding claim 1, Black discloses a simulated tissue structure (simulated organ structure 202; Fig 14) comprising: a frame having a top portion, a base and two sidewalls (frame 204 has a top portion, base, and two sidewalls as shown in Fig 9), wherein the frame has an opening at a proximal end of the frame (frame has opening at the proximal end as shown Fig 9); a simulated vaginal canal that defines an internal space within the frame (simulated vaginal canal 218; Fig 14), the internal space having a first section near a proximal end of the simulated vaginal canal (the first section is inside the simulated vaginal canal 218; Fig 14, an opening at the proximal end of the simulated vaginal canal corresponding to the opening at the proximal end of the frame (Opening of simulated vaginal canal in Fig 14 corresponding to the opening of the frame), and a second smooth section near a distal end of the simulated vaginal canal (near the distal end of the simulated vaginal canal we have the beginning of the simulated uterus 216 and inside the uterus we have the simulated cervix made of silicone, which is a smooth surface; ¶110); a simulated cervix located at and is connected to the distal end of the simulated vaginal canal such that a proximal end of the simulated cervix extends inside the simulated vaginal canal and a distal end of the simulated cervix extends past the internal space defined by the simulated vaginal canal (simulated cervix located between simulated uterus 216 and vaginal canal 214 at the proximal end 260 and the simulated cervix extends past the internal space defined by the simulated vaginal canal; ¶110 and Fig 14); and a support structure that is connected to the distal end of the simulated cervix (the simulated uterus acts as the support structure for the simulated cervix because the cervix is located inside the simulated uterus; ¶110), wherein the support structure is suspended within the frame (simulated uterus is suspended within the pelvic frame; ¶101), and wherein the simulated cervix is allowed to move in response to user interaction (simulated uterus will hang and swing in response to being manipulated with surgical instruments; ¶101). Black does not explicitly disclose the internal space having a first section comprising a plurality of ridges. Furthermore, Black discloses the support structure is suspended within the frame (this is already disclosed by a simulated uterus is suspended within the pelvic frame; ¶101) and the simulated cervix, while suspended, is allowed to move in response to user interaction (simulated uterus will hang and swing in response to being manipulated with surgical instruments; ¶101), But Black does not disclose this suspension and movement through a plurality of cords and instead it uses fasteners.
However, Miyazaki focuses devices, systems, and methods for practicing, teaching, and/or simulating various surgical procedures such as vaginal hysterectomy, which relates to Black because they both models focus on hysterectomy. Miyazaki teaches the internal space of a vagina having a first section comprising a plurality of ridges (vaginal wall 820 can have one or more ridges to simulate a human vagina; ¶187).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Miyazaki for the benefit of simulating the real the internal space of a first section of a vagina properly because there are vaginal rugea formed in the shape of ridges.
Bush focuses on a system for regulating human intake of fluid, which relates to Black because this is another instance of how cords/threads are used to suspend an object in the medical field. Bush teaches the use of nylon threads to suspend a medical object, such as members 12 (¶23). Here we make a simple substitution of the use of fasteners in Black with the yarn cords from Bush.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Bush since it has been held that simple substitution of one known element for another yields predictable results. Here yarn cords are used to replace fasteners to suspend the simulated uterus and allow it to move in a realistic fashion with user interaction allow the support structure (simulated uterus) to have the same suspension and movement mechanism that the support structure would have with a plurality of fasteners. See MPEP 2143, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
With regards to claims 3, 11, 17, 24, and 25, Black discloses the elements of the claims as noted in the above rejection.
Regarding claim 4, Black discloses wherein the frame further comprises a plurality of apertures (frame can also have multiple apertures; Fig 10), the plurality of apertures positioned on the two sidewalls (apertures on walls; Fig 9). Black discloses the apertures configured to receive one or more of the plurality of fasteners whereby the one or more of the plurality of fasteners are looped with the apertures (¶125) to connect the one or more of the plurality of fasteners with the two sidewalls (fasteners 210; Fig 9), but does not explicitly disclose using cords instead of fasteners for this suspension mechanism.
However, Bush focuses on a system for regulating human intake of fluid, which relates to Black because this is another instance of how cords/threads are used to suspend an object in the medical field. Bush teaches how a plurality of cords can be looped around apertures to suspend an object (plurality of members 12 strung together along a cord, such as yarn; ¶23 and Fig 1).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Bush because cords/wires/threads going through holes/apertures suspend the simulated uterus, which provides the benefit of simulating how a real uterus is suspended by a complex web of ligaments and the tension from the simulated organ allows the organ to move and “rebound” just like it would in a real patient.
Regarding claim 6, Black does not explicitly disclose wherein the plurality of cords comprise yarn.
However, Bush focuses on a system for regulating human intake of fluid, which relates to Black because this is another instance of how cords/threads are used to suspend an object in the medical field. Bush teaches wherein the plurality of cords comprise yarn (plurality of members 12 strung together along a cord, such as yarn; ¶23).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Bush because yarn models are typically inexpensive and durable, which allows users to train over long periods of time with a reliable material.
Regarding claim 13, Black discloses wherein the frame comprises nonconductive material (frame can be made of nonconductive materials mentioned in ¶128).
Bush teaches a plurality of cords comprising nonconductive material (yarn is nonconductive; ¶23).
Regarding claim 21, Black discloses a simulated tissue structure (simulated organ structure 202; Fig 14) comprising: a simulated pelvic frame having a top portion, a base and two sidewalls (pelvic frame 204 has a top portion, base, and two sidewalls as shown in Fig 9), the simulated pelvic frame having an opening at a proximal end of the simulated pelvic frame (pelvic frame 204 shows 2 different openings at both ends; Fig 7); a simulated vaginal opening comprising simulated tissue covering the proximal end of the simulated pelvic frame (another example shows an opening of simulated vaginal canal 46 in Fig 4B covering over the proximal end of the simulated pelvic frame), the simulated tissue being attached to the top portion of the simulated pelvic frame and extending down an entire height of the simulated pelvic frame to the base of the simulated pelvic frame (simulated tissue extending through the whole pelvic frame as shown in Fig. 4B); a simulated vaginal canal defining an internal space within the simulated pelvic frame (simulated vaginal canal 218 defines a space inside as shown in Fig 14), the internal space having a first section near a proximal end of the simulated vaginal canal (the first section is inside the simulated vaginal canal 218; Fig 14) and a second smooth section near a distal end of the simulated vaginal canal (near the distal end of the simulated vaginal canal we have the beginning of the simulated uterus 216 and inside the uterus we have the simulated cervix made of silicone, which is a smooth surface; ¶110), an opening of the simulated vaginal opening leads to an opening of the simulated vaginal canal at the proximal end of the simulated vaginal canal (simulated vaginal canal 218 has an opening which is the opening leading to the simulated vaginal canal as shown in Fig 14); a simulated cervix connected to the distal end of the simulated vaginal canal (simulated cervix located between simulated uterus 216 and vaginal canal 214 at the proximal end 260 and the simulated cervix extends past the internal space defined by the simulated vaginal canal; ¶110 and Fig 14); fasteners looped to connect the support structure to the simulated pelvic frame to allow the simulated cervix to move in response to user interaction (simulated uterus is suspended within the pelvic frame and will hang and swing in response to being manipulated with surgical instruments; ¶101).
Black does not explicitly disclose the internal space of a vagina having a first section comprising a plurality of ridges. However, Miyazaki focuses on devices, systems, and methods for practicing, teaching, and/or simulating various surgical procedures such as vaginal hysterectomy, which relates to Black because they both models focus on hysterectomy. Miyazaki teaches the internal space of a vagina having a first section comprising a plurality of ridges (vaginal wall 820 can have one or more ridges to simulate a human vagina; ¶187).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Miyazaki for the benefit of simulating the real internal space of a first section of a vagina properly because there are vaginal rugea formed in the shape of ridges.
Black does not explicitly disclose the simulated cervix having a height being smaller than a height of the simulated vaginal opening and a width greater than a width of the simulated vaginal opening; a support structure connected to the distal end of the simulated cervix, the support structure having a height smaller than a height of the simulated vaginal canal and the height of the simulated cervix and the support structure having a width greater than the width of the simulated cervix and a width of the simulated vaginal canal. However, the choice to have certain heights or widths in the simulated components to be greater or smaller is merely a design choice, which fails to patentably distinguish over the prior art. The invention is intended to teach or practice how to perform a colpotomy procedure (¶20 of the present invention) and realistic differences in heights and widths between the simulated components will allow for improved teaching/practice.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement realistic dimensions in simulated gynecological components because they are essential for high-fidelity training, enabling accurate, hands-on practice that improves surgical proficiency, enhances spatial understanding, and reduces risks in real patient care.
Black does not disclose a cord threaded and looped through the support structure. However, Bush focuses on a system for regulating human intake of fluid, which relates to Black because this is another instance of how cords/threads are used to suspend an object in the medical field. Bush teaches how a plurality of cords can be threaded and looped around apertures to suspend an object (plurality of members 12 strung together along a cord, such as yarn; ¶23 and Fig 1).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Bush because cords/wires/threads going through holes/apertures suspend the simulated uterus, which provides the benefit of simulating how a real uterus is suspended by a complex web of ligaments and the tension from the simulated organ allows the organ to move and “rebound” just like it would in a real patient.
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Miyazaki in view of Robbins in view of Hofstetter et al. (US 20170018206 A1; hereinafter Hofstetter).
Regarding claim 7, Black discloses further comprising a simulated vesicocervical space (Fiber layer 229 with silicone layer 228 together comprise the vesicocervical space; Fig 14), the simulated vesicocervical space being positioned outside the distal end of the simulated vaginal canal (outside distal end of simulated vaginal canal as seen in Fig 14) and comprising at least two layers (silicone layer 228 and fiber layer 229; Fig 14), wherein a first set of pre- determined locations are connected with an interface material which allows the at least two layers to be severable (interface material would be the dissecting layer 226 in the top part; Fig 14 and ¶109), and wherein a second set of predetermined locations are molded together (interface material would be the dissecting layer 226 in the bottom part ; Fig 14 and ¶109). Black does not explicitly disclose these tissue layers to be severable using blunt dissection or sharp dissection.
However, Hofstetter focuses on simulated tissue for surgical training, which relates to Black because they both use simulated tissue for surgical training. Hofstetter teaches tissue layers to be severable using blunt dissection or sharp dissection (using sharp using scalpel or blunt dissection; ¶39).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Hofstetter for the benefit of using both sharp and blunt dissection on the severable layer because it allows simulated dissections to be performed with a wider range of techniques. Different surgical scenarios require different dissection techniques to be used.
Regarding claim 16, Black discloses wherein the simulated vaginal canal, the simulated cervix, the support structure, and the simulated vesicocervical space are formed as a monolithic piece or structure (simulated vaginal canal 218, simulated cervix 318 is inside the simulated uterus 216 in ¶125, the simulated uterus 216 acts as the support structure, and the vesicocervical space is formed by above layers 229 and 228, all these pieces are connected to form a monolithic piece; Fig 14).
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Miyazaki in view of Robbins in view of Souter et al. (US 20170301263 A1; hereinafter Souter).
Regarding claim 8, Black discloses wherein the support structure is assembled onto a three-dimensional mandrel and cast within a mold (the simulated uterus acts as the support structure as previously stated and the simulated uterus is made with a uterine mold comprising two halves 310a and 310b as shown in Fig 32 and a mandrel is placed onto half 310b; ¶120). Black does not explicitly disclose the support structure formed via yarn.
However, Souter focuses on a uterine simulation device that mimics the texture and shape of a uterus, which relates to Black because they both are trying to simulate the uterus. Souter teaches the support structure formed via yarn (as stated before, the simulated uterus acts as a support structure and Souter shows the simulated uterus is formed via fabric mesh made of yarn; ¶65).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Hofstetter because the use of yarn here provides the benefit of allowing the fabric mesh made of yarn to be capable of bonding to the silicone rubber material of which the simulated uterus is made. There is also full encapsulation of the fabric by the silicone material, which helps to avoid delamination of the mesh from the silicone material and such encapsulation further minimizes a coarse surface texture or ragged incision margins that can be produced with larger openings (such as rectangular openings) in the net.
Regarding claim 10, Black discloses wherein a color of the yarn is different from a color of a material used to cast the support structure (the artificial uterus acting as a support structure permits the color to be changed by using different colored silicone, which would allow the color to be different from the color of the yarn; ¶90).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Miyazaki in view of Robbins in view of Alexander et al. (US 20210043114 A1; hereinafter Alexander).
Regarding claim 19, Black does not explicitly disclose wherein the support structure further comprises a removable grounding cable adapted to be used during a simulated electrosurgical procedure.
However, Alexander focuses on a surgeon training apparatus that includes simulated tissue, which relates to Black because they are both using simulated tissue for surgical training. Alexander teaches wherein the support structure further comprises a removable grounding cable adapted to be used during a simulated electrosurgical procedure (as stated before, the support is structure is the simulated uterus which is made up of simulated tissue, Alexander shows the simulated tissue used with a grounding wire; ¶106).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Alexander because the use of a grounding wire provides accurate modeling of thermal effects on real tissue, allowing learners to understand the impact of grounding on incision and coagulation quality. Furthermore, it allows trainees to practice preventing high-density, unintended burns caused by poor pad contact or improper grounding.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Miyazaki in view of Robbins in view of Felsinger et al. (US 20160355676 A1; hereinafter Felsinger).
Regarding claim 20, Black does not explicitly disclose wherein the support structure further comprises a removable grounding pad.
However, Felsinger focuses on a surgical simulator for electrosurgical training and simulation, which relates to Black because they are both used for Laparoscopic surgical training. Felsinger teaches wherein the support structure further comprises a removable grounding pad (a simulated uterus is considered a simulated tissue structure as previously stated, and Felsinger shows simulate tissue is used with a grounding pad in ¶37).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Black to implement the teachings of Felsinger because the use of a grounding pad provides accurate modeling of thermal effects on real tissue, allowing learners to understand the impact of grounding on incision and coagulation quality. Furthermore, it allows trainees to practice preventing high-density, unintended burns caused by poor pad contact or improper grounding.
Allowable Subject Matter
Claims 9, 14, 15, 22, 23, and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE ANGELES whose telephone number is (703)756-5338. The examiner can normally be reached Mon-Thu 8am-5pm.
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, Dmitry Suhol can be reached at (571) 272-4430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSE ANGELES/Examiner, Art Unit 3715
/Jay Trent Liddle/ Primary Examiner, Art Unit 3715
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