DETAILED ACTION
This is the first Office Action on the merits and is responsive to the papers filed on 01/09/2023. Claims 1-19 are currently pending and are examined below.
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 .
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0051] recites “roughnesses.” Examiner suggests amending to use clear and concise language.
Appropriate correction is required.
Claim Objections
Claims 1-9 are objected to because of the following informalities:
Claim 1 recites “a force perception mechanism has a first state and a second state” in lines 2-3 of the claim. Examiner suggests amending to recite “a force perception mechanism comprising a first state and a second state” as recited in independent claim 10 for clarity.
Claims 1-6, 9-10, and 14 recites “the model” throughout the claims. Examiner suggests amending to recite “the surgical training model” instead for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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 1-9 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 1 recites the limitation “at least partially attached to the model” in lines 3-4 of the claim. It is unclear how to measure “at least partially attached” in respect to the states and the force perception mechanism. Examiner suggests amending the claim to use claim language that can be measured and understood by a person having ordinary skill in the art. Claims 2-9 depend from claim 1, and are therefore rejected to on the same grounds.
Claim 3 recites the limitation "the body" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 4 depends from claim 3 and is therefore rejected to on the same grounds.
Claim 4 recites the limitation "the body" in 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “the post” in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 8 depends from claim 3 and is therefore rejected to on the same grounds.
Claim 8 recites the limitation “the post” in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andrea Fiaccavento (WO 2021234133 A1; hereinafter Fiaccavento).
Regarding independent claim 1, Fiaccavento discloses a surgical training model for developing and practicing skills associated with laparoscopic surgical procedures (see at least: Fiaccavento [Abstract]), the model comprising a force perception mechanism has a first state (Fiaccavento shows in FIG 6A below that the force perception mechanism is able to control the body to move between states a first state being connected) and a second state (Fiaccavento shows in 6B that the body has been manipulated to a second state), wherein in the first state, the force perception mechanism is at least partially attached to the model, wherein in the second state, the force perception mechanism is detached from the model (Fiaccavento shows between FIG6A and 6B that the body is detaching from the bottom as well as the elements 14/16 by pulling through the mechanism), and wherein a transition from the first state to the second state notifies a user when an amount of force being applied to the model exceeds a pre-determined amount the Specification of the instant application states in paragraph [0147]: “…the user would be visually informed that excessive force was detected” the notification that a user gets when the switch happens from the first state to the second state is a visual notification and as shown in FIG. 6A and 6B the body in the middle has been visually shown to be detached from the bottom and away from elements 14 and 16.
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Regarding independent claim 14, Fiaccavento discloses a surgical training model for identifying when an amount of force exceeding a pre- determined amount is being applied during a simulated surgical procedure (see at least: Fiaccavento [Abstract]), the model comprising: a base (see at least: Fiaccavento FIG. 6A-B, side photo showing the base of the enclosure) and a body (see at least: Fiaccavento FIG. 7D element in middle with limbs), wherein a portion of the body is configured to be removably attached to the base at a pre-determined location (see at least: Fiaccavento FIG. 7D elements 13 and 14); wherein the model has two states: a first state in which the portion of the body is attached to a portion of the base at the pre-determined location (as shown in Fiaccavento FIG. 6A the body is attached to the base at a predetermined location), and a second state in which the portion of the body is detached from the portion of the base at the pre-determined location (as shown in Fiaccavento FIG. 6B the body has been detached from the center), and wherein a transition between the first state and the second state informs a user that the force being applied to the model exceeds the pre-determined amount the Specification of the instant application states in paragraph [0147]: “…the user would be visually informed that excessive force was detected” the transition that “informs” a user would be informed of when the switch happens from the first state to the second state is a visual notification and as shown in FIG. 6A and 6B the body in the middle has been visually shown to be detached from the bottom and away from elements 14 and 16.
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 2, 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fiaccavento in view of Christopher C. Toly (US 20050064378 A1; hereinafter Toly).
Regarding claim 2, Fiaccavento discloses the claimed matter as stated above, and further discloses a wherein the model comprises a body (see at least: element inside housing of 6A-B). However, Fiaccavento doesn’t explicitly disclose a post.
Toly teaches a post (see at least: Element 50 in FIG. 4 shown inside the model (shown in FIG. 3) having two ends, and the proximal end is attached to the body of the model in FIG. 4 through element 48).
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It would have been obvious to one having ordinary skill in the art before the effective filing date to have included a post as taught by Toly to a surgical simulation training model as taught by Fiaccavento for the added benefit of having a tool that a user can use to manipulate the body and practice attaching and detaching the body with the post.
Regarding claim 7, Fiaccavento discloses the claimed matter as stated above; however, doesn’t explicitly disclose wherein the post comprises an indicator or protrusion.
Toly teaches wherein the post comprises an indicator or protrusion (see at least: the end of the post).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included an indicator or protrusion on the post for the added benefit of knowing when to stop using the post for the added benefit of students knowing where they need to focus on while practicing with the surgical simulator.
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Regarding claim 8, Fiaccavento in view of Toly discloses the claimed matter as stated above; Toly further teaches wherein the indicator is a visible marking made on the post (see at least: FIG. 7C above) it is visible to the user.
Regarding claim 9, Fiaccavento discloses the claimed matter as stated above; however, Fiaccavento doesn’t explicitly teach wherein the model is configured to be housed within an enclosure of a surgical trainer, the surgical trainer comprising a top, a bottom, and a plurality of legs which define the enclosure of the surgical trainer, the surgical trainer being configured to obstruct direct vision into the enclosure.
Toly teaches wherein the model is configured to be housed within an enclosure of a surgical trainer, the surgical trainer comprising a top, a bottom, and a plurality of legs which define the enclosure of the surgical trainer, the surgical trainer being configured to obstruct direct vision into the enclosure (A simulated anatomical structure 14 is contained within housing 32. One or more surgical instruments 16 pass through openings in cover 36 to access the practice volume defined by housing 32. In one embodiment, cover 36 is a plastic sheet that is placed over opening 34. When a trainee desires to introduce instruments 16 into the practice volume, holes can readily be formed into cover 36 using a scalpel or other object to pierce the cover (see at least: Toly paragraph [0040]; and FIG. 2 and 5 below)).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a surgical trainer as taught by Toly for the added benefit of simulating a “body” housing the simulated surgery to prepare students or user.
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Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Fiaccavento in view of Paul Yarin (US 20070166682 A1; hereinafter Yarin).
Regarding claim 3, Fiaccavento discloses the claimed matter as stated above, however, Fiaccavento does not explicitly disclose wherein the force perception mechanism comprises a peg that is inserted through a hole in the body of the model.
Yarin teaches wherein the force perception mechanism comprises a peg that is inserted through a hole in the body (see at least: element inside housing of 6A-B of Fiaccavento) of the model Yarin shows various medical training manipulations that can be used to simulate surgery training. (Referring also to FIG. 6, the peg module 84 is illustrated in greater detail. The peg module comprises a base plate 92 which may comprise the carousel cover 76. The base plate 92 includes nine through openings 94 through which pegs 96 can be inserted (see at least: Yarin paragraph [0059]; and FIG. 4 below)).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used pegs to that can be inserted in the simulated body of a laparoscopic surgery training model to train users how to manipulate the body of the surgery simulator to insert the peg or to use the pegs to hold down the body for further practicing.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fiaccavento in view of Yarin in further view of Toly.
Regarding claim 4, Fiaccavento in view of Yarin teach the claimed matter as stated above; however, they do not explicitly teach wherein the peg has an interference-type fit with the hole in the body of the model.
Toly teaches an interference-type fit with the hole in the body of the model (Preferably, an interference fit exists between shaft 64 and opening 62, such that when no force is applied to elongate member 50 (or simulated laparoscope handle 42), the elongate shaft remains fixed in its then current position (see at least: Toly paragraph [0049])).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used an interference-type fit as taught by Toly for the added benefit of keeping structures in place while a user is practicing a simulated surgery.
Claims 5-6, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Fiaccavento in view Charles Hart (US 20140248596 A1; hereinafter Hart).
Regarding claim 5, Fiaccavento teaches the claimed matter as stated above; however, they do not explicitly teach wherein the force perception mechanism comprises a tether that is attached between the model and a base, wherein the model sits on top of the base.
Hart teaches wherein the force perception mechanism comprises a tether that is attached between the model and a base, wherein the model sits on top of the base (The model organ 20 shown in FIG. 1 is a partial colon or intestine that is shown suspended from the top cover 14 by tethers 22 and connected to at least one leg 24 (see at least: Hart paragraph [0047])).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a tether as taught by Hart into the surgical training model of Fiaccavento for the added benefit of simulating how organs are attached in the body so that a user doesn’t tug or move the body of the simulated body with a strong force.
Regarding claim 6, Fiaccavento in view of Hart teaches the claimed matter as stated above; and Hart further teaches wherein the tether is removably attached with the model and/or the base. Hart teaches the tethers and the base can be removed to attach further bodies and other simulations for practice (see at least: Hart paragraph [0047]; and [0048]).
Regarding claim 15, Fiaccavento teaches the claimed matter as stated above; however, Fiaccavento does not explicitly teach wherein the body is removably attached to the base via a tether, wherein the pre-determined location on the base corresponds to a location of a slot, and wherein the tether is attached at one end to the portion of the body and on an opposite end of the tether is passed through the slot and attached beneath the base.
Hart teaches wherein the body is removably attached to the base via a tether, wherein the pre-determined location on the base corresponds to a location of a slot, and wherein the tether is attached at one end to the portion of the body and on an opposite end of the tether is passed through the slot and attached beneath the base (FIG. 1 is a partial colon or intestine that is shown suspended from the top cover 14 by tethers 22 and connected to at least one leg 24. The at least one leg 24 has an aperture (not shown) facing the internal body cavity 18. The model colon 20 includes a tube 26 having a proximal end and a distal end. The proximal end of the tube 26 is interconnected with the aperture of the leg 24 such that the aperture provides an access port to the lumen of the tube 26. The access port and aperture is shown to be closed off in FIG (see at least: Hart paragraph 0047])).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a tether as taught by Hart into the surgical training model of Fiaccavento for the added benefit of simulating how organs are attached in the body so that a user doesn’t tug or move the body of the simulated body with a strong force.
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Fiaccavento in view Yarin in further view of Toly.
Regarding independent claim 10, Fiaccavento further discloses a surgical training model for developing and practicing skills associated with laparoscopic surgical procedures, the model comprising (see at least: Fiaccavento [Abstract]): and a force perception mechanism comprising and a body, the force perception mechanism comprising a first state and a second state, wherein in the first state is connected to the body, wherein in the second state is detached from the body, and wherein a transition from the first state to the second state notifies a user when an amount of force being applied to the model via the post and/or the body exceeds a pre-determined amount (Fiaccavento shows in the FIG below that the first state where the “force perception mechanism” (elements on the base of the housing where the body goes through). The body is getting manipulated by the user to be detached and moved around in the housing displaying the first and second state of the surgical training model (see at least: Fiaccavento FIG. 6A-b, and 7D below). However, Fiaccavento does not explicitly teach a post and a peg.
Toly teaches a post (see at least: Toly Element 50 in FIG. 4 shown inside the model (shown in FIG. 3) having two ends, and the proximal end is attached to the body of the model in FIG. 4 through element 48).
It would have been obvious to one having ordinary skill in the art before the effective filing date to have included a post as taught by Toly to a surgical simulation training model as taught by Fiaccavento for the added benefit of having a tool that a user can use to manipulate the body and practice attaching and detaching the body with the post.
Yarin teaches a peg (a peg module 84 used to detect insertion of pegs into a grid of nine holes (see at least: Yarin paragraph [0058])).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used pegs to that can be inserted in the simulated body of a laparoscopic surgery training model to train users how to manipulate the body of the surgery simulator to insert the peg or to use the pegs to hold down the body for further practicing.
Regarding claim 11, Fiaccavento in view of Toly in further view of Yarin teach the claimed matter as stated above, and Yarin further teaches wherein the body comprises one or more limbs, and wherein the peg is connected to at least one of the one or more limbs via a hole positioned at a pre-determined location on the one or more limbs (FIG. 28 illustrates a peg manipulation task using the module 230. This task measures the ability to dexterously manipulate and position small objects. Rigid pegs 400 must be picked up from a storage tray 402 and placed into target holes 404. The user operates two laparoscopic forceps instruments 406 with both hands concurrently. The pegs 400 are detected by the peg task sensors 230S, see FIG. 26, which may comprise photo interrupter sensors located beneath the carousel 204. Prior to peg insertion, an infrared beam strikes a photo detector located across an air gap (see at least: Yarin paragraph [0090])).
Regarding claim 12, Fiaccavento in view of Yarin and teach the claimed matter as stated above, and Toly further teaches wherein the peg is removably connected to the hole having an interference-type connection which provides friction that prevents from disengaging with the body up to a pre-determined amount of force (Preferably, an interference fit exists between shaft 64 and opening 62, such that when no force is applied to elongate member 50 (or simulated laparoscope handle 42), the elongate shaft remains fixed in its then current position (see at least: Toly paragraph [0049])).
Regarding claim 13, Fiaccavento in view of Yarin teach the claimed matter as stated above; and Fiaccavento and Yarin further teach wherein at least one of the one or more limbs has a plurality of holes located along the length of that limb, wherein the model comprises of holes, and wherein the second state corresponds to at least one becoming detached from the body (a modular component comprising a modular body including various portions and integrable in the exercise space in any desired way, connecting it with the base element and with the covering element. For example, it may comprise the above-mentioned 15 work portion (for example having an oval shape), one or more ends projecting from the work portion for associating it to the system (e.g., to the base element, said ends being also possibly deformable), and one or more elastic thread connected to the ends (for example by magnets) for fastening to the covering element (see at least: Fiaccavento WIPO attached pg. 6; FIG. 7D below main element).
Fiaccavento doesn’t explicitly teach two or more pegs.
Yarin teaches two or more pegs (a peg module 84 used to detect insertion of pegs into a grid of nine holes (see at least: Yarin paragraph [0058])).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Fiaccavento in view Yarin.
Regarding claim 17, Fiaccavento teaches the claimed matter as stated above; however, Fiaccavento does not explicitly teach wherein the base further comprises a peg and the pre-determined location on the base also corresponds to a location of the peg, and wherein the portion of the body comprises a hole that is configured to receive the peg.
Yarin teaches wherein the base further comprises a peg and the pre-determined location on the base also corresponds to a location of the peg, and wherein the portion of the body comprises a hole that is configured to receive the peg (Yarin shows various medical training manipulations that can be used to simulate surgery training. (Referring also to FIG. 6, the peg module 84 is illustrated in greater detail. The peg module comprises a base plate 92 which may comprise the carousel cover 76. The base plate 92 includes nine through openings 94 through which pegs 96 can be inserted (see at least: Yarin paragraph [0059]; and FIGs 2-4 below)).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used pegs as taught in Yarin to the apparatus of Fiaccavento for the added benefit of holding down a simulated body or to further provide medical training simulations for students to use and practice.
Regarding claim 18, Fiaccavento teaches the claimed matter as stated above; however, Fiaccavento does not explicitly teach wherein the body is removably attached to the base via a flap, wherein the base comprises a slot and the pre-determined location on the base corresponds to a location of the slot, and wherein the flap that is attached to the body is configured to be inserted into the slot in the base.
Yarin teaches wherein the body is removably attached to the base via a flap, wherein the base comprises a slot and the pre-determined location on the base corresponds to a location of the slot, and wherein the flap that is attached to the body is configured to be inserted into the slot in the base (A laparoscopic needle holder 446 and curved suturing needle 448 are used. Two suture ends are tied together with an intracorporeal knot connecting fabric flaps 450 and 452. After the tying of the knot, the flaps 450 and 452 are drawn apart with a known force to test the knot's integrity. The knot integrity task sensor 238S senses whether the knot has held or has come loose (see at least: Yarin paragraph [0102])).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Fiaccavento in view of Hart in further view of Patrick Minnelli (US 8517931 B2; hereinafter Minnelli).
Regarding claim 16, Fiaccavento in view of Hart teach the claimed matter as stated above; however, they do not explicitly teach wherein the tether further comprises an indicator positioned on a portion beneath the base that is configured to be pulled to a visible position through the slot when the amount of force exceeds the pre-determined amount.
Minnelli teaches wherein the tether further comprises an indicator positioned on a portion beneath the base that is configured to be pulled to a visible position through the slot when the amount of force exceeds the pre-determined amount (pull string 104 can be coupled to the fabric 102 using various techniques. For example, as indicated above, the pull string 104 can be inlaid along a length of the fabric 102, possibly overhanging a portion of the fabric 102 as one or more tethers. In other embodiments, the pull string 104 can be integrally formed with the fabric 102, included as part of the fabric 102 (i.e., tethers of fabric extending from one or more places along the fabric's perimeter), or otherwise coupled to the fabric 102 (see at least: Minnelli [column 6, lines 20-34])).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the use of tethers as taught in Minnelli to the surgical simulator as taught by Fiaccavento in view of Hart for the added benefit of adding friction or more areas to pull onto in the surgical simulator.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Fiaccavento in view of Michael Gertner (US 20060189889 A1; hereinafter Gertner).
Regarding claim 19, Fiaccavento teaches the claimed matter as stated above; however, Fiaccavento does not explicitly teach wherein the pre-determined amount of force is customizable based on an amount of friction associated with a removable attachment between the portion of the body and the base at the pre-determined location
Gertner teaches in application wherein the pre-determined amount of force is customizable based on an amount of friction associated with a removable attachment between the portion of the body and the base at the pre-determined location (the support structure in some embodiments constructed to apply force which tends to constrict stomach 302. In some embodiments, the support structure is a constricting band placed around the stomach and the mesh aids in attachment of the constricting structure to the stomach 302. For example, the constricting structure can be any of the transgastric or extragastric structures described above and/or below. In one such embodiment, the constricting structure is removable and the mesh is permanent; therefore, attachment of the constricting structure relies on attachment of the constricting structure to a healed or healing mesh rather than the constricting structure being attached with surgical suturing (see at least: Gertner paragraph [0175])).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included a customizable amount of force as taught by Gertner when simulating a surgery because students practicing surgery simulations need to practice different techniques since each surgery is case-by-case and may require different techniques to get the results that make the most sense per individualized situation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to the applicant’s disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELWA A ALSOMAIRY whose telephone number is (703)756-5323. The examiner can normally be reached M-F 7:30AM to 5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Vasat can be reached at (571) 270-7625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SELWA A ALSOMAIRY/Examiner, Art Unit 3715
/PETER S VASAT/Supervisory Patent Examiner, Art Unit 3715