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 .
Response to Amendments
Applicant’s submission of a response was received on 04/15/2026. Presently, claims 1-20 are pending.
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10 recites “body comprise two or more holes” in line 2 of the claim. The Examiner suggests amending to recite clear and concise claim language.
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 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.
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 (recited in 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” (recited in at least: Katayama paragraph [0074]); wherein the body is configured to be manipulated to thread through one of the one or more holes (“all layer suture evaluation part adapted to evaluate whether or not a suture thread penetrates through all layers” (recited in 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 (shown in at least: Element 50 in FIG. 4 shown inside the model (also shown in at least 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 (shown in at least: element 50 extending away from the body in FIG. 3), wherein the body is configured to be manipulated to thread the distal end of the post through one of the one or more holes (shown in at least: FIG. 2-3 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 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 (shown in at least: FIGs 2-4).
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 (shown in at least: FIGs 2-4).
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” (recited in at least: Toly paragraph [0047]).
Regarding claim 6, Katayama in view of Toly teach the claimed matter as stated above and Katayama further discloses wherein the body comprises a plurality of limbs (“the simulated body may simulate a diaphragm and a stomach” (shown in at least: Katayama paragraph [0019]).
Regarding claim 7, Katayama in view of Toly teach the claimed matter as stated above and Katayama further discloses 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” (recited in at least: Katayama paragraph [0076])). The specification of the instant application states that “informs a user” can be a visual cue as explained above. Katayama shows that the simulated body is removable (recited in at least: Katayama paragraph [0076]), 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 discloses 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 (shown in at least: Katayama FIG. 1))
Regarding claim 10, Katayama in view of Toly teach the claimed matter as stated above and Katayama discloses wherein the one or more holes in the body comprise two or more holes and wherein the body is configured to be manipulated to position 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” (recited in 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 as applied to claim 1 above, and further in 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 show in at least FIG. 6B)).
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 as applied to claim 1 above, and further in 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 (recited in at least: Yarin paragraph [0059]; and shown in at least: FIGs 3-4)).
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.
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 (recited in 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” (recited at least: Fiaccavento pg. 6; FIG. 7D main element 18). However, Fiaccavento does not explicitly disclose 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 (shown in 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), wherein each of the plurality of limbs is configured to be manipulated to thread the distal end of the post through their respective holes (shown in at least: FIG. 2-3 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.
Regarding claim 12, Fiaccavento in view of Toly teach the claimed matter as stated above and Fiaccavento further discloses wherein each of the one or more holes of the plurality of limbs has a pre-determined shape and size (shown in at least: the one hole on the body being manipulated in FIG. 7D).
Regarding claim 13, Fiaccavento in view of Toly teach the claimed matter as stated above and Toly further teaches wherein a diameter of the post decreases from its proximal end to its distal end (“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” (recited in 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 (shown in at least: Toly FIGs 3- 4).
Regarding claim 15, Fiaccavento in view of Toly teach the claimed matter as stated above and Fiaccavento further discloses 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 (shown in at least: the main element (shown as element 18 below) in FIG. 7D and FIG 6A).
Regarding claim 16, Fiaccavento in view of Toly teach the claimed matter as stated above and Fiaccavento further discloses wherein the post has a plurality of protrusions having different cross-sectional shapes along a length of the post (shown in 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 discloses 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 (“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” (recited in at least: Fiaccavento page 26; and FIG 6G).
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 (shown in 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 as applied to claim 11 above, and further in 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” (recited in at least: Yarin paragraph [0074])).
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-shaped profile. Yarin teaches wherein the post has a wave-shaped 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” (recited in at least: Yarin paragraph [0074])). The tip of the instrument A has a “wave” shaped 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.
Response to Arguments
Claim Objections:
The objections made to claims 7 and 10 have been withdrawn.
35 U.S.C. § 112(b):
Applicant states that the Examiner failed to explain which ways the claims are ambiguous. The Examiner respectfully disagrees. Regarding claim 1, it is clear that there are no additional claim limitations that describe the body and the reason/how it can be manipulated. The Applicant states that it can be manipulated when threading the distal end of the post through the one of the one or more holes. The body’s material is not claimed and a person having ordinary skill in the art would not know the metes and bounds for what defines a “body” as to avoid infringement. The rejection set forth under 35 U.S.C. § 112 (b) is maintained for claim 1. Regarding claim 4, applicant states that a person having ordinary skill in the art would understand the meaning of the claim. The examiner stated that they will be taking the definition from the Specification for the purpose of prosecution, since there were no amendments made to the claim, the Examiners interpretation will be considered correct. The rejection set forth under 35 U.S.C. § 112 (b) for claim 4 has been withdrawn. Regarding claim 6, the same response for claim 4 will be applied here. The rejection set forth under 35 U.S.C. § 112 (b) for claim 6 has been withdrawn. Regarding claim 7, the same response for claim 4 will be applied here. The rejection set forth under 35 U.S.C. § 112 (b) for claim 7 has been withdrawn. Regarding claim 11, the same response for claim 1 applies here as well. The body’s material is not claimed and a person having ordinary skill in the art would not know the metes and bounds for what defines a “body” as to avoid infringement. The rejection set forth under 35 U.S.C. § 112 (b) is maintained for claim 11.
35 U.S.C. § 103:
Applicant states on page 5-12 of the remarks that the prior art does not teach the instant applications subject matter. The Examiner respectfully disagrees. The Applicant states on page 5 “The surgical instruments 16 of the Toly device are used to manipulate an anatomical structure 14. To the extent that Toly can properly be construed as describing that the surgical instruments 16 have proximal ends that are attached to the anatomical structure 14 (which the Office Action does not allege and which the Applicant does not concede), Toly does not teach or suggest that the anatomical structure 14 is configured to be manipulated to thread the opposite (distal) end of the surgical instrument 16 through a hole in the anatomical structure 14. The applied combination of Katayama and Toly fails to disclose or suggest a post having a proximal end attached to a body.” The Examiner respectfully disagrees. The claim language is very broad and when each claim limitation is looked at separately and then together as a whole, Katayama in view of Toly teach the claimed matter as stated in the rejection above. The Examiner suggests including more structural elements from the instant application’s specification as to further describe the instant application’s differences or key elements that differ from Toly and Katayama. As stated, Toly teaches a post extending away from the body and the post is able to go into the body through the one or more holes in the body in the attached FIG. 3 above. Applicant states on page 6 of the remarks that the examiner did not explain the reason for combination. The Examiner respectfully disagrees. The rejection was explained above and the reason for combination was because the tools needed to simulate a laparoscopic surgery are known to people having ordinary skill in the art and therefore Toly taught those into Katayama a person having ordinary skill in the art would understand the combination when simulating laparoscopic surgery for training. Applicant states on page 7 of the remarks that the tools are not flexible. However, since it was not amended, flexibility from the Specification (recited in ¶40) can mean any different degree. For the purpose of examination, any material used that can be flexible will be considered for the post under BRI. Applicant further states again on page 8 that the prior art does not teach the claimed matter and that Fiaccavento has been mischaracterized. The Examiner respectfully disagrees. Fiaccavento discloses a post where the body is configured to move a length past the protrusion. The Applicant further states on pages 9-11 that the elements claimed are not taught by the prior art, and they do not suggest or teach the plurality of limbs that are configured to be manipulated. However, The Examiner respectfully disagrees as Fiaccavento teaches a body that has a plurality of limbs that are configured to be manipulated and because the body has no defined material, Fiaccavento reads on the claimed language. Fiaccavento shows in at least FIG 6A shows a body that has a plurality of limbs that is being manipulated in a surgery simulator. Furthermore, the body is also shown in FIG 5, 6A-B, and 7C of Fiaccavento being manipulated and moved around.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELWA A ALSOMAIRY whose telephone number is (703)756-5323. The examiner can normally be reached M-F 7:30AM to 5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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
/Jay Trent Liddle/Primary Examiner, Art Unit 3715
Prosecution Insights