DETAILED ACTION
This is the first Office Action on the merits and is responsive to the papers filed on 3/29/2023. Claims 1-20 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 [0004] recites “The model is made so that a user manipulate, using one hand, a portion of the body with a first surgical instrument while manipulating the post using the other hand via a second surgical instrument.” Examiner suggests that the underlined part of the paragraph should read “so that a user can manipulate” or “so that a user manipulates” for clarity.
Appropriate correction is required.
Claim Objections
Claim 7, 10 are objected to because of the following informalities:
Claim 7 recites “that a force that is more than a pre-determined amount is been detected during the manipulation of the body and/or the post” in lines 2-3 of the claim. Examiner suggests amending the underlined part to recite: “amount has been detected” for clarity in the claim.
Claim 10 recites “the body is configured to be manipulated positioning the two or more holes to form a consolidated opening” in lines 2-3 of the claim. Examiner suggests amending the underlined part to recite “manipulated by positioning” or amending to use clear claim language that is easy to read.
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 1-20 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 “the body is configured to be manipulated” in line 5 of the claim. The Specification recites in paragraph [0008]: each of the limbs of the body is configured to be manipulated so that one of the connectors associated with a limb can be connected to the connector at the center of the body. It does not further explain how the manipulation is happening to the body and how it is configured to be manipulated. For the purpose of examination, examiner will interpret that the body is anything that is able to be moved/bent/flexed (further definition from paragraph [0077] that explains the post cannot be manipulated) and is made of anything. Claims 2-10 depend from claim 1 and are therefore rejected to on the same grounds.
Claim 4 recites the limitation “wherein the post is flexible” in line 1 of the claim. Claim 2 recites that the post is rigid. The Specification recites about the various embodiments in paragraph [0040]: the post 120 of the multiskill exercise model100 may have varying different degrees of stretchability or rigidness based on any combination of flexible and rigid materials which may be used to make the post 120. For the purpose of examination, any material used that can be flexible will be considered for the post under BRI.
Claim 6 recites the limitation “a plurality of limbs” in line 1 of the claim. The Specification recites in paragraph [0008]: The surgical training model has a body made of a plurality of limbs each having a proximal end and a distal end that extends away from a center of the body. For the purpose of examination, the body and “limbs” will be defined by this paragraph and can be considered any simulation that has ends that extend away from the center, for example simulated organs like a heart or stomach have “limbs” that extend away from the center.
Claim 7 recites the limitation “informs a user that a force is more than a pre-determined amount is been detected” in lines 2-3 of the claim. The Specification recites in paragraph [0037]: A visual cue (e.g., detachment of the body 110 from the peg 130) is provided in order to notify the user when excessive force has been detected. For the purpose of examination, any visual queue that can represent “excessive force” like for example, detachment of the body or breaking/messing up the body that be seen visually is enough to inform a user that too much force was used. Claim 8 depends from claim 7 and is therefore rejected to on the same grounds.
Claim 10 recites the limitation “wherein the body has two or more holes and wherein the body is configured to be manipulated positioning the two or more holes to form a consolidated opening” in lines 2-3 of the claim. It is unclear if the two or more holes are the same holes in the body as the one recited in independent claim 1 in line 2 of the claim. For the purpose of examination, it is the same claim element as the one recited in claim 1. The limitation “manipulated positioning” is unclear as it is currently written. For the purpose of examination, Examiner will interpret this to mean that the two or more holes on the body are lined up/aligned prior to the post being threaded.
Claim 11 recites the limitation “wherein each of the plurality of limbs configured to be manipulated” in line 8 of the claim. The Specification recites in paragraph [0008]: each of the limbs of the body is configured to be manipulated so that one of the connectors associated with a limb can be connected to the connector at the center of the body. It does not further explain how the manipulation is happening to the body and how it is configured to be manipulated. For the purpose of examination, examiner will interpret that the body is anything that is able to be moved/bent/flexed (further definition from paragraph [0077] that explains the post cannot be manipulated) and is made of anything. Claims 12-20 depend from claim 11 and are therefore rejected to on the same grounds.
Regarding claim 19, the limitation "wave-like" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "-like"), thereby rendering the scope of the claim unascertainable.
Examiner suggests amending the claim(s) to include claim language that is clear and concise regarding the scope of the application and to avoid indefinite language (“-like”).
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 1-4, 6-7, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Tamotsu Katayama (US 20150371558 A1; hereinafter Katayama) in view of Christopher C. Toly (US 20050064378 A1; hereinafter Toly).
Regarding claim 1, Katayama discloses a surgical training model (see at least: Katayama [Abstract]) comprising: a body having one or more holes at pre-determined locations (in the state that an esophagus of the simulated stomach WS is inserted in the hole that is formed in the middle of the simulated diaphragm WD (see at least: Katayama paragraph [0074]); wherein the body is configured to be manipulated to thread through one of the one or more holes (n all layer suture evaluation part adapted to evaluate whether or not a suture thread penetrates through all layers (see at least: Katayama paragraph [0017]).
However, Katayama does not explicitly show a post having a proximal end and a distal end, wherein the proximal end is attached to the body, and wherein the post extends away from the body, wherein the body is configured to be manipulated to thread the distal end of the post through one of the one or more holes.
Toly teaches a post having a proximal end and a distal end, wherein the proximal end is attached to the body (see at least: Element 50 in FIG. 4 shown inside the model (also shown in FIG. 2) having two ends, and the proximal end is attached to the body of the model in FIG. 4 through element 48), and wherein the post extends away from the body (see at least: element 50 extending away from the body in FIG. 3 below), wherein the body is configured to be manipulated to thread the distal end of the post through one of the one or more holes (see at least: FIG. 2-3 below the post is able to go inside of the model to perform the threading of the body through the posts).
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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 added the tools used in Toly to the apparatus of Katayama for the added benefit of having the tools needed to manipulate the body to perform the training.
Regarding claim 2, Katayama in view of Toly teach the claimed matter as stated above and Toly further teaches wherein the post is rigid Toly teaches that the posts used is a surgical instrument and the surgical instrument will be rigid to not move as the user is performing the training (see at least: FIGs above).
Regarding claim 3, Katayama in view of Toly teach the claimed matter as stated above and Toly further teaches wherein a cross-section of the post is non-circular, and wherein the one or more holes has a shape corresponding to the cross-section of the post shows that the post is non-circular in the FIGs above the body has holes that are in the corresponding shapes (see at least: FIGs above).
Regarding claim 4, Katayama in view of Toly teach the claimed matter as stated above and Toly further teaches wherein the post is flexible and is configured to be manipulated alongside the body to thread the distal end of the post through one of the one or more holes the post/surgical instruments can be moved/manipulated alongside the body to perform the surgical training (When adjustment knob 46a is loosened, the elongate member 50 can be freely moved relative to mounting brackets 46 so that a trainee can adjust the position of elongate member 50 within the practice volume, relative to housing 32 (see at least: Toly paragraph [0047]).
Regarding claim 6, Katayama in view of Toly teach the claimed matter as stated above and Katayama further teaches wherein the body comprises a plurality of limbs (the simulated body may simulate a diaphragm and a stomach (see at least: Katayama paragraph [0019]).
Regarding claim 7, Katayama in view of Toly teach the claimed matter as stated above and Katayama further teaches wherein the body is removably attached to a base at one or more pre-determined locations, and wherein detachment of the body from the base at the one or more pre-determined locations informs a user that a force that is more than a pre- determined amount is been detected during the manipulation of the body and/or the post (The simulated body W that has been performed nissen fundoplication is removed from the suture simulator 101, and the simulated body W is used for the suture evaluation by a suture evaluation apparatus 100 that is provided another place from the suture simulator 101 as illustrated in FIG. 13 (see at least: Katayama paragraph [0076])). The instant applications Specification states that “informs a user” can be a visual cue as explained above. Katayama shows that the simulated body is removable, therefore if a user applies enough force the body can be dislodged and removed off the base.
Regarding claim 9, Katayama in view of Toly teach the claimed matter as stated above and Katayama teaches further comprising a surgical trainer, wherein the surgical trainer is configured to house the surgical training model within an internal cavity (the surgical training is configured to house the model (see at least: Katayama FIG. 1 below))
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Regarding claim 10, Katayama in view of Toly teach the claimed matter as stated above and Katayama teaches wherein the body has two or more holes and wherein the body is configured to be manipulated positioning the two or more holes to form a consolidated opening prior to the post being threaded through the consolidated opening (This simulated body W includes a simulated diaphragm WD that simulates the diaphragm and a simulated stomach WS that simulates the stomach: the simulated diaphragm WD and the simulated stomach WS are made of elastic resin. The simulated body W is provided in the simulated torso 11 in the state that an esophagus of the simulated stomach WS is inserted in the hole that is formed in the middle of the simulated diaphragm WD (see at least: Katayama paragraph [0074])). Katayama teaches a suturing system and 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 known that if the training system needs to be manipulated and positioned before threading/suturing to try to position them into the correct position.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Katayama in view of Toly in further view of Andrea Fiaccavento (WO 2021234133 A1; hereinafter Fiaccavento).
Regarding claim 5, Katayama in view of Toly teach the claimed matter as stated above; however, they do not explicitly teach wherein the post further comprises a protrusion near the proximal end, and wherein the body is configured to be maneuvered down a length of the post past the protrusion Fiaccavento teaches wherein the post further comprises a protrusion near the proximal end (elements 16 and 14 and where the post will enter), and wherein the body is configured to be maneuvered down a length of the post past the protrusion (the main element is configured to be maneuvered down a length past the protrusion (element 18e shows this)).
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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 combined the protrusions and maneuvering the body in different ways as taught by Fiaccavento to the apparatus as taught by Katayama and Toly for the added benefit of testing medical students on their hand-eye-coordination with stability to see if they can move the body in different angles.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Katayama in view of Toly in further view of Paul Yarin (US 20070166682 A1; hereinafter Yarin).
Regarding claim 8, Katayama in view of Toly teach the claimed matter as stated above; however, they do not explicitly teach wherein the body has holes that are configured to removably attach the base to the body at the one or more pre-determined locations via pegs associated with the base.
Yarin teaches wherein the body has holes that are configured to removably attach the base to the body at the one or more pre-determined locations via pegs associated with the base 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 Katayama in view of Toly for the added benefit of holding down a simulated body or to further provide medical training simulations for students to use and practice hand-eye-coordination.
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Claims 11-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fiaccavento in view of Toly.
Regarding claim 11, Fiaccavento discloses A surgical training model (see at least: Fiaccavento [Abstract]) comprising a plurality of limbs having a proximal end and a distal end, wherein each of the plurality of limbs are layered on top of one another at their proximal ends, and wherein each of the plurality of limbs have one or more holes (The exercise element may be 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). However, Fiaccavento does not explicitly teach a post having a proximal end and a distal end, wherein the proximal end is attached to the proximal ends of the plurality of limbs, wherein the post extends away from the plurality of limbs, wherein each of the plurality of limbs is configured to be manipulated to thread the distal end of the post through their respective holes.
Toly teaches a post having a proximal end and a distal end, wherein the proximal end is attached to the proximal ends of the plurality of limbs, wherein the post extends away from the plurality of limbs (see at least: Element 50 in FIG. 4 shown inside the model (also shown in FIG. 2 above) having two ends, and the proximal end is attached to the body of the model in FIG. 4 through element 48), wherein each of the plurality of limbs is configured to be manipulated to thread the distal end of the post through their respective holes (see at least: FIG. 2-3 below the post is able to go inside of the model to perform the threading of the body through the posts).
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 the tools used in Toly to the apparatus of Fiaccavento for the added benefit of having the tools needed to manipulate the body to perform the training.
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Regarding claim 12, Fiaccavento in view of Toly teach the claimed matter as stated above and Fiaccavento further teaches wherein each of the one or more holes of the plurality of limbs has a pre-determined shape and size (see at least: the one hole on the body being manipulated in FIG. 7D above).
Regarding claim 13, Fiaccavento in view of Toly teach the claimed matter as stated above and Fiaccavento and Toly further teach wherein a diameter of the post decreases from its proximal end to its distal end Toly teaches that the posts can be used within the apparatus and that they are made to be small as practical, however the user can hold them as shown in the figure (diameters of the surgical instruments and the probe for the videoendoscopic camera are made as small as practical, to minimize the size of the incisions that are required. The endoscope is used to enable the surgeon to view, in real-time, the surgical field and the manipulation of the endoscopic instruments within that field (see at least: Toly paragraph [0002])).
Regarding claim 14, Fiaccavento in view of Toly teach the claimed matter as stated above and Toly further teaches wherein the post comprises a pre-determined number of sub-sections each having a different cross-sectional shape and size (see at least: Toly FIG. 3 and 4 above).
Regarding claim 15, Fiaccavento in view of Toly teach the claimed matter as stated above and Fiaccavento further teaches wherein at least one of the one or more holes of the plurality of limbs corresponds to the cross-sectional shape and size of one of the sub-sections of the post (see at least: the main element in FIG. 7D above and FIG 6A below).
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Regarding claim 16, Fiaccavento in view of Toly teach the claimed matter as stated above and Fiaccavento further teaches wherein the post has a plurality of protrusions having different cross-sectional shapes along a length of the post (see at least: FIG 6A showing the protrusions on the housing having different cross-sectional shapes).
Regarding claim 17, Fiaccavento in view of Toly teach the claimed matter as stated above and Fiaccavento further teaches wherein the one or more holes has a pre-determined shape and size corresponding to the cross-sectional shapes formed by the plurality of protrusions on the post, and wherein the plurality of limbs are rotatable with respect to the post to align the one or more holes with the cross-sectional shapes formed by the plurality of protrusions as limb is maneuvered along the length of the post (In some cases, the exercise element 18 can be kept hanging inside the space S, for example by insertion of all its ends 18e into the holes 14, as illustrated by way of example in figure 6B. This allows an even more realistic simulation to be obtained, encompassing also the most lateral 20 cases which can be encountered in laparoscopy; it also possible to force these exercise elements 18 to assume a twisted conformation, thanks to the soft and elastic body thereof (see at least: Fiaccavento WIPO attached page 26; and FIG 6G above).
Regarding claim 20, Fiaccavento in view of Toly teach the claimed matter as stated above and Fiaccavento further teaches wherein the plurality of limbs are rotatable with the post or proximal end of each of the plurality of limbs being at a center axis (see at least: Fiaccavento FIG 6A where the plurality of limbs are rotatable with the post inside the housing and they have a center axis).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Fiaccavento in view of Toly in further view of Yarin.
Regarding claim 18, Fiaccavento in view of Toly teach the claimed matter as stated above; however, they do not explicitly teach wherein the post has a non-linear profile along a length of the post.
Yarin teaches wherein the post has a non-linear profile along a length of the post (FIG. 21 illustrates a screen display on the video monitor 48 during the knot tying task. The monitor shows the image being recorded by the camera 46. In this instance, the camera is recording the tying of a knot about the horizontal tubular element 124, using an instrument, for example the instrument A (see at least: Yarin paragraph [0074])).
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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 posts like the one taught in Yarin into the apparatus of Fiaccavento in view of Toly for the added benefit of giving students different surgical tools that are used in practice that have different tips or functions.
Regarding claim 19, Fiaccavento in view of Toly teach the claimed matter as stated above; however, they do not explicitly teach wherein the post has a wave-like profile (FIG. 21 illustrates a screen display on the video monitor 48 during the knot tying task. The monitor shows the image being recorded by the camera 46. In this instance, the camera is recording the tying of a knot about the horizontal tubular element 124, using an instrument, for example the instrument A (see at least: Yarin paragraph [0074])). The tip of the instrument A has a “wave” like curve.
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 posts like the one taught in Yarin into the apparatus of Fiaccavento in view of Toly for the added benefit of giving students different surgical tools that are used in practice that have different tips or functions.
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