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 02/20/2026. Presently, claims 1, 3-11, 13-17, and 19-23 are now pending.
Response to Arguments
Applicant's arguments filed on 02/20/2026 have been fully considered but are moot in view of the new rejection under 35 U.S.C. 103 presented below.
Applicant’s representative alleges the following:
In regards to Claim Rejections under 35 USC §103, Black does not describe a "first section being inside the vaginal canal 218" has an inner interface 308 or an outer interface 304 providing a soft and realistic tissue appearance and feel (Page 9 of Remarks).
In regards to Claim Rejections under 35 USC §103, Hart in ¶54 does not describe or suggest a simulated uterus (being equated in the action to our claimed "support structure") but rather a simulated tissue construct 20 shown in FIG. 6A-B above (Page 11 of Remarks).
In regards to Claim Rejections under 35 USC §103, the action fails to clearly articulate what simple substitution is being made (Page 12 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 amended claim 3 (Page 13 of Remarks).
In regards to Claim 4, Black does not explicitly disclose apertures configured to receive one or more of the plurality of cords whereby the one or more of the plurality of cords are looped with the apertures to connect the one or more of the plurality of cords with the two sidewalls (Page 14 of Remarks).
In regards to Claim 5, no part of Black's model can describe or suggest a plurality of cords, suspending its simulated uterus (being equated by the action to our claimed support structure) within its frame via a plurality of cords, or a plurality of cords are configured to allow the simulated cervix to move in response to user interaction. (Page 17 of Remarks).
In regards to Claim 6, Black, Hart, and any combination thereof do not describe or suggest each and every limitation as provided in claim 6 (Page 18 of Remarks).
In regards to Claim 8, Black cannot describe or suggest a support structure formed via yarn that is assembled onto a three- dimensional mandrel and cast within a mold. (Page 19 of Remarks).
In regards to Claim 9, Black does not imply, describe or suggest a "mandrel can have multiple components depending on what is needed for the specific shape" as indicated in the action absent hindsight reasoning. Furthermore, the action and Black fail to describe "what is needed for the specific shape" and thus any implication or suggestion as having a mandrel having multiple components (Page 20 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 21 of Remarks).
In regards to Claim 11, Black, Hart, and any combination thereof do not describe or suggest each and every limitation as provided in claim 11 and no reasoning with some rational underpinning can support a prima facie case of obviousness (Page 22 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 22 of Remarks).
In regards to Claim Rejections under 35 USC §103, 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 of pre-determined locations are connected with an interface material as required by claim 7. (Page 23 of Remarks).
In regards to Claim Rejections under 35 USC §103, Black fails to describe or suggest "all pieces connected together" are formed as a monolithic piece or structure (Page 24 of Remarks).
In regards to Claim Rejections under 35 USC §103, nowhere does Felsinger mention a grounding cable as required by claim 19 (Page 25 of Remarks).
In regards to Claim Rejections under 35 USC §103, Black, Hart, Felsinger and any combination thereof do not describe or suggest each and every limitation as provided in claim 20 and thus, a prima facie case of obviousness is not established (Page 26 of Remarks).
In regards to Claim Rejections under 35 USC §103, Black, Hart, Hofstetter, Ghez, and any combination thereof do not describe or suggest each and every limitation as provided in claim 14 and no reasoning with some rational underpinning can support a prima facie case of obviousness (Page 28 of Remarks).
In regards to Claim Rejections under 35 USC §103, 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 29 of Remarks).
In regards to Claim Rejections under 35 USC §103, Ghez cannot support the action's statement of its bladder can go in an upward and downward direction. Likewise, Ghez also fails to describe or suggest providing a simulated resistance to the expansion of the simulated bladder in an upward direction when the simulated bladder is made to expand via the pump (Page 30 of Remarks).
In regards to Claim Rejections under 35 USC §103, Black, Hart, Hofstetter, Ghez, and any combination thereof do not describe or suggest each and every limitation as provided in claim 15 and no reasoning with some rational underpinning can support a prima facie case of obviousness (Page 30 of Remarks).
Regarding point (1), the examiner notes that Black is not relied upon to teach or disclose this limitation in the instant rejection.
Applicant’s representative argues that Black's description of an inner interface 308 and an outer interface 304 of a transvaginal adapter providing a soft and realistic tissue appearance and feel does not and cannot support any implication providing a plurality of ridges or use of ridges to provide a more realistic appearance and feel of the vaginal canal, especially since the cited portion of Black as well as the inner interface 308 and outer interface 304 do not describe a vaginal canal or a section inside the vaginal canal.
In regards to the arguments above, the arguments have been considered but are moot in view of the new rejection presented below.
Regarding point (2), the examiner notes that Hart is not relied upon to teach or disclose this limitation in the instant rejection.
Applicant’s representative argues that contrary to the action, Hart does not teach the support structure, i.e., a supposed simulated uterus, suspended within the frame via a plurality of cords. Furthermore, Hart teaches its simulated tissue construct 20 fashioned with wires for suspension of its simulated tissue construct 20 to a training device and not within a frame and in particular a frame as recited in claim 1.
In regards to the arguments above, the arguments have been considered but are moot in view of the new rejection presented below (Please see 103 rejection below).
Regarding point (3), the examiner has made corrections to improve the articulation of the simple substitution.
Applicant’s representative argues that Black provides a simulated uterus, which incidentally is being equated to our claimed support structure by the action, is "suspended by a folded first sheet of silicone material on the anterior side of the simulated uterus 32 and a folded second sheet of silicone material on the posterior side of the simulated uterus 32.".
In regards to the arguments above, the office action has made corrections to clearly articulate what simple substitution is being made.
Regarding point (4), 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 amended claim 3.
In regards to the arguments above, Black does disclose these limitations because the simulated uterus as a support structure is entirely elongate and tubular as seen in Fig 4E (Please see 103 rejection below).
Regarding point (5), the examiner notes that Black alone is not relied upon to teach or disclose this limitation in the instant rejection.
Applicant’s representative argues that Black does not explicitly disclose apertures configured to receive one or more of the plurality of cords whereby the one or more of the plurality of cords are looped with the apertures to connect the one or more of the plurality of cords with the two sidewalls.
In regards to the arguments above, the arguments have been considered but are moot in view of the new rejection presented below (Please see 103 rejection below).
Regarding point (6), the examiner notes that Black alone is not relied upon to teach or disclose this limitation in the instant rejection.
Applicant’s representative argues that no part of Black's model can describe or suggest a plurality of cords, suspending its simulated uterus (being equated by the action to our claimed support structure) within its frame via a plurality of cords, or a plurality of cords are configured to allow the simulated cervix to move in response to user interaction.
In regards to the arguments above, the arguments have been considered but are moot in view of the new rejection presented below (Please see 103 rejection below).
Regarding point (7), the examiner notes that these references are not relied upon to teach or disclose this limitation in the instant rejection.
Applicant’s representative argues that "cotton and silk" do not denote any structure readable on the claimed limitation of yarn or any broadest reasonable interpretation of the claimed limitation.
In regards to the arguments above, the arguments have been considered but are moot in view of the new rejection presented below (Please see 103 rejection below).
Regarding point (8), the examiner notes that these references are not relied upon to teach or disclose this limitation in the instant rejection.
Applicant’s representative argues that Black cannot describe or suggest a support structure formed via yarn that is assembled onto a three- dimensional mandrel and cast within a mold.
In regards to the arguments above, the arguments have been considered but are moot in view of the new rejection presented below (Please see 103 rejection below).
Regarding point (9), the examiner notes that the arguments are valid.
Applicant’s representative argues that Black does not imply, describe or suggest a "mandrel can have multiple components depending on what is needed for the specific shape" as indicated in the action absent hindsight reasoning. Furthermore, the action and Black fail to describe "what is needed for the specific shape" and thus any implication or suggestion as having a mandrel having multiple components.
In regards to the arguments above, please see allowable subject matter below.
Regarding point (10), 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.
In regards to the arguments above, the artificial uterus permit the color to be changed by using different colored silicone, which allows the color to be different from the color of other parts (Please see 103 rejection below).
Regarding point (11), the examiner respectfully disagrees.
Applicant’s representative argues that Black, Hart, and any combination thereof do not describe or suggest each and every limitation as provided in claim 11 and no reasoning with some rational underpinning can support a prima facie case of obviousness.
In regards to the arguments above, the 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 (Please see 103 rejection below).
Regarding point (12), the examiner notes that these references are not relied upon to teach or disclose this limitation in the instant rejection.
Applicant’s representative argues that Black does not describe or suggest that the frame and the plurality of cords comprises nonconductive material.
In regards to the arguments above, the arguments have been considered but are moot in view of the new rejection presented below (Please see 103 rejection below).
Regarding point (13), 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 of pre-determined locations are connected with an interface material as required by claim 7.
In regards to the arguments above, Black discloses a simulated vesicocervical space with layers and a set of pre-determined locations connected with an interface material in Fig 14 (Please see 103 rejection below).
Regarding point (14), 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.
In regards to the arguments above, Black discloses all pieces connected together in Fig 14 (Please see 103 rejection below).
Regarding point (15), the examiner notes that these references are not relied upon to teach or disclose this limitation in the instant rejection.
Applicant’s representative argues that nowhere does Felsinger mention a grounding cable as required by claim 19.
In regards to the arguments above, the arguments have been considered but are moot in view of the new rejection presented below (Please see 103 rejection below).
Regarding point (16), the examiner respectfully disagrees.
Applicant’s representative argues that Black, Hart, Felsinger and any combination thereof do not describe or suggest each and every limitation as provided in claim 20 and thus, a prima facie case of obviousness is not established.
In regards to the arguments above, Felsinger does disclose the use of a grounding pad (Please see 103 rejection below).
Regarding point (17), the examiner notes that these references are not relied upon to teach or disclose this limitation in the instant rejection.
Applicant’s representative argues that Black, Hart, Hofstetter, Ghez, and any combination thereof do not describe or suggest each and every limitation as provided in claim 14 and no reasoning with some rational underpinning can support a prima facie case of obviousness
In regards to the arguments above, the arguments have been considered but are moot in view of the new rejection presented below (Please see 103 rejection below).
Regarding point (18), the examiner respectfully disagrees.
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.
In regards to the arguments above, Black does disclose this limitation because the thickening is the result of having another material at the top portion of the simulated bladder (Please see 103 rejection below).
Regarding point (19), the examiner notes that these references are not relied upon to teach or disclose this limitation in the instant rejection.
Applicant’s representative argues that Ghez cannot support the action's statement of its bladder can go in an upward and downward direction. Likewise, Ghez also fails to describe or suggest providing a simulated resistance to the expansion of the simulated bladder in an upward direction when the simulated bladder is made to expand via the pump.
In regards to the arguments above, the arguments have been considered but are moot in view of the new rejection presented below (Please see 103 rejection below).
Regarding point (20), the examiner notes that these references are not relied upon to teach or disclose this limitation in the instant rejection.
Applicant’s representative argues that Black, Hart, Hofstetter, Ghez, and any combination thereof do not describe or suggest each and every limitation as provided in claim 15 and no reasoning with some rational underpinning can support a prima facie case of obviousness.
In regards to the arguments above, the arguments have been considered but are moot in view of the new rejection presented below (Please see 103 rejection below).
Applicant’s representative argues that since the prior art does not disclose or suggest the suggested features of independent claims 1 or 21 and so, dependent claims, and new claims 21-23 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 Objections
Claim 4 objected to because of the following informalities:
Claim 4, line 4, “the apertures” should read “the plurality of apertures”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21-23 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites the following limitation: “the support structure having a width greater than the width of the simulated cervix and a width of the simulated vaginal canal, the simulated cervix having a width greater than a width of the simulated vaginal opening” This limitation is not adequately described in the specification as originally filed and forms the basis of the rejection. As such, the limitations are reasonably rejected under a theory of new matter. Therefore, claim 35 is rejected under 35 U.S.C. § 112(a), as failing to comply with the written description requirement.
Claim 23 recites the following limitation: “wherein the simulated vaginal canal has a height greater than a height of the support structure and the simulated vaginal canal has a width smaller than a width of the support structure” This limitation is not adequately described in the specification as originally filed and forms the basis of the rejection. As such, the limitations are reasonably rejected under a theory of new matter. Therefore, claim 35 is rejected under 35 U.S.C. § 112(a), as failing to comply with the written description requirement.
Claim 22 objected to as being dependent upon a rejected base claim.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 21-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation “the three-dimensional mandrel is a "plus-sign”” in line 3. What is the meaning of “plus-sign” and why is it inside quotations? It is unclear if applicant is referring to the three-dimensional mandrel being in a shape of a plus-sign or if the mandrel is an actual plus sign or something else. For purposes of examination, it is assumed that “the three-dimensional mandrel” is in the shape of a plus-sign.
Claim 21 recites the limitation “an opening of the simulated vaginal canal” in line 11. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “an opening of the simulated vaginal canal” of claim 21 line 11 or a second opening of the simulated vaginal canal. For purposes of examination, it is assumed that “an opening of the simulated vaginal canal” refers to the first instance of “an opening of the simulated vaginal canal” found in claim 21 line 11.
Claim 21 recites multiple limitations of the height and width of simulated parts in the simulated tissue structure. For example, applicant recites “the support structure having a width greater than the width of the simulated cervix and a width of the simulated vaginal canal” but there is clear description as to how much area is considered the width simulated cervix and how much area is considered the width of the support structure. There are 3 different dimensions in this model: the width, the height, and the depth. Applicant must clearly define which one is being described in the figures or the specification.
Claim 22 objected to as being dependent upon a rejected base claim.
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, and 17 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).
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 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, and 17, 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.
Claims 1, 3-4, 11, 13, 17, and 21are 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, and 17, 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).
Claims 14 and 15 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 in view of Kim et al. (A study on the fluid mechanical urinary bladder simulator and reproduction of human urodynamics; hereinafter Kim).
Regarding claim 14, Black discloses further comprising a simulated bladder (simulated bladder 214; ¶14), wherein the simulated bladder is positioned above the simulated vesicocervical space (above layers 229 and 228 that form the vesicocervical space; Fig 14). Black does not explicitly disclose wherein the simulated bladder is connected to a filling tube and a pump, and wherein the simulated bladder is configured to expand via the pump.
However, Kim focuses on a fluid mechanical bladder to reproduce human urinary tract bladder urodynamics movement, which relates to Black because they are both trying to simulate a human bladder for medical purposes. Kim teaches wherein the simulated bladder is connected to a filling tube (hoses; Page 680 Section 2.2 Device Configuration) and a pump (pump; Page 680 Section 2.2 Device Configuration), and wherein the simulated bladder is configured to expand via the pump (bladder can expand or shrink by water being pumped; Page 684 Section 5 Conclusions).
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 Kim because using a pump with a filling tube allows the realistic simulation of a how a bladder works.
Regarding claim 15, Black discloses wherein 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 (First sheet 222 attached to the top of the bladder; ¶108 and Fig 14) to provide a simulated resistance to an expansion of the simulated bladder in an upward direction (there is an inherent resistance, even if it is minuscule, when you are inflating an object and there is another object or layer on top of it. This resistance is due to several physical factors, primarily the added force required to displace or lift the top layer. Furthermore, there is an inherent resistance when inflating a flexible device because atmospheric pressure acts in all directions and to inflate the device, you must introduce enough internal pressure to overcome this external atmospheric pressure, plus any structural tension of the material). Black does not explicitly disclose an expansion of the simulated bladder in an upward direction when the simulated bladder is made to expand via the pump.
However, Kim focuses on a fluid mechanical bladder to reproduce human urinary tract bladder urodynamics movement, which relates to Black because they are both trying to simulate a human bladder for medical purposes. Kim teaches an expansion of the simulated bladder in an upward direction when the simulated bladder is made to expand via the pump (bladder can expand or shrink by water being pumped; Page 684 Section 5 Conclusions).
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 Kim because using a pump with a filling tube allows the realistic simulation of a how a bladder works.
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.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Miyazaki in view of Medina in view of Kim.
Regarding claim 22, Black discloses wherein the simulated pelvic frame is configured to be placed within a cavity defined by a top cover and a base of a surgical training device (in another embodiment, a pelvic frame 34 is inside a cavity of a surgical training device 10 with base 18 and top cover 16; Fig 4A), the base of the surgical training device connected to and spaced from the top cover of the surgical training device (top cover 16 and base 16 are spaced but connected as shown in Fig 1).
Black does not explicitly disclose wherein the simulated vaginal opening further includes a dedicated hole where a filling tube is inserted with one end of the filling tube connected to a pump outside the simulated pelvic frame and an opposite end of the filling tube connected to a simulated bladder. However, Kim focuses on a fluid mechanical bladder to reproduce human urinary tract bladder urodynamics movement, which relates to Black because they are both trying to simulate a human bladder for medical purposes. Kim teaches wherein the simulated vaginal opening further includes a dedicated hole (Kim is designed to resemble the urinary track system including the bladder, ureter, and urethra, and a real urethra is the dedicated hole or opening that connects to the bladder, which is a hole right above the vaginal canal; Page 680 Section 2.2 Device Configuration) where a filling tube is inserted (hoses; Page 680 Section 2.2 Device Configuration) with one end of the filling tube connected to a pump outside the simulated pelvic frame (pump shown outside in Fig 2; Page 680 Section 2.2 Device Configuration) and an opposite end of the filling tube connected to a simulated bladder (hose connected to bladder c; Fig 2).
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 Kim because using a pump with a filling tube allows the realistic simulation of a how a bladder works.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Black in view of Miyazaki in view of Bush in view of Kim.
Regarding claim 22, Black discloses wherein the simulated pelvic frame is configured to be placed within a cavity defined by a top cover and a base of a surgical training device (in another embodiment, a pelvic frame 34 is inside a cavity of a surgical training device 10 with base 18 and top cover 16; Fig 4A), the base of the surgical training device connected to and spaced from the top cover of the surgical training device (top cover 16 and base 16 are spaced but connected as shown in Fig 1).
Black does not explicitly disclose wherein the simulated vaginal opening further includes a dedicated hole where a filling tube is inserted with one end of the filling tube connected to a pump outside the simulated pelvic frame and an opposite end of the filling tube connected to a simulated bladder. However, Kim focuses on a fluid mechanical bladder to reproduce human urinary tract bladder urodynamics movement, which relates to Black because they are both trying to simulate a human bladder for medical purposes. Kim teaches wherein the simulated vaginal opening further includes a dedicated hole (Kim is designed to resemble the urinary track system including the bladder, ureter, and urethra, and a real urethra is the dedicated hole or opening that connects to the bladder, which is a hole right above the vaginal canal; Page 680 Section 2.2 Device Configuration) where a filling tube is inserted (hoses; Page 680 Section 2.2 Device Configuration) with one end of the filling tube connected to a pump outside the simulated pelvic frame (pump shown outside in Fig 2; Page 680 Section 2.2 Device Configuration) and an opposite end of the filling tube connected to a simulated bladder (hose connected to bladder c; Fig 2).
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 Kim because using a pump with a filling tube allows the realistic simulation of a how a bladder works.
Conclusion
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/JOSE ANGELES/Examiner, Art Unit 3715
/Jay Trent Liddle/Primary Examiner, Art Unit 3715