DETAILED ACTION
This action is in response to the initial filing filed on March 27, 2024 Claims 1-20 havebeen examined in this application.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-8, 10-11, 13, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hasson (US 5,947,743).
Regarding Claim 1, Hasson discloses a training aid assembly comprising (Col. 3 Lines 50-51 Referring initially to FIGS. 1-3, 5 and 6, a training apparatus, according to the present invention, is shown at 10):
- a base having an outer perimeter and a top surface (Fig. 2, Col. 4 Lines 21-22 In this particular embodiment, the model 22 has a base 64 which is guided along the frame 12, Col. 8 Line 35 The frame 302 has a top wall 322 (top surface));
- a wall structure comprising a front wall, a back wall opposite the front wall, with a first side wall joining the front wall and the back wall on a first side, and a second side wall joining the front wall and the back wall on a second side, the base and the wall structure defining a cavity (Figs. 1 and 2 Wall structure with a cavity, Col. 3 Lines 52-54 The training apparatus 10 consists of a frame 12 bounding a working Space 14 which simulates a body cavity, Col. 4 Lines 25-27 The base 64 is a unitary Subassembly consisting of three peripheral wall panels 70, 72, 74 connected to a bottom wall 76 which defines the guide legs 52, 62); and
- a display stand having a body positioned on the base and within the cavity, the display stand structurally configured to retain a model of a body part, - wherein the wall structure includes at least one opening port providing fluid communication with the cavity (Fig. 2 Wall structure has an opening which provides fluid communication with the cavity, Col. 3 Lines 62-67 According to the invention, various models 20, 22, 24, 26 (FIG. 11), 28 (FIG. 10) and 30 (FIG. 13) are introduced to the working Space 14 and are Selectively positioned on the frame 12 relative to the access opening 16 to permit procedures to be carried out with medical instrument assemblies 32, which procedures either Simulate a medical procedure or , Col. 4 Lines 1-5 are used to practice a movement that may be encountered in the performance of a medical procedure. The models 20-30 are introduced to the working space 14 through a Side wall opening 34 which is Selectively exposed and covered by a hinged closure 36, Col. 4 Lines 21-24 In this particular embodiment, the model 22 has a base 64 which is guided along the frame 12, a platform 66 on top of the base 64, and a practice system at 68 on top of the platform 66).
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Regarding Claim 3, Hasson discloses wherein the at least one opening port further comprises a first opening port and a second opening port spaced apart from the first opening port (Fig. 1 Element(s) 290 (cord(s) is/are coming through two ports spaced apart from each other)).
Regarding Claim 4, Hasson discloses wherein at least one of the first opening port and the second opening port are spaced apart from the top surface of the base (Fig. 1 Element(s) 290 Cords (are coming through two ports spaced apart from each other) and 12 Frame (cords can be seen spaced apart from the top surface of the base)).
Regarding Claim 5, Hasson discloses wherein each of the first opening port and the second opening port are spaced apart from the top surface of the base, and positioned on the same one of the front wall, the back wall, the first side wall and the second side wall (Fig. 1 Element(s) 290 Cords (are coming through two ports spaced apart from each other on the back wall (front, side, back are all a matter of point of reference)) and 12 Frame (cords can be seen spaced apart from the top surface of the base)).
Regarding Claim 6, Hasson discloses wherein each of the first opening port and the second opening port are positioned on the back wall (Fig. 1 Element(s) 290 Cords (are coming through two ports spaced apart from each other on the back wall (front, side, back are all a matter of point of reference)) and 12 Frame (cords can be seen spaced apart from the top surface of the base)).
Regarding Claim 7, Hasson discloses wherein the first opening port is positioned proximate the first side wall and the second opening port is positioned proximate the second side wall (Fig. 1 Element(s) 290 Cords (are coming through two ports spaced apart from each other on the back wall (front, side, back are all a matter of point of reference) proximate both side walls) and 12 Frame (cords can be seen spaced apart from the top surface of the base)).
Regarding Claim 8, Hasson discloses wherein the wall structure further defines an upper edge, with the upper edge having a flange defining a surface (Col. 4 Lines 28-30 The wall parts 70, 72, 74 define an upwardly facing ledge 78 (upper edge) to support the platform 66 (flange defining surface)).
Regarding Claim 10, Hasson discloses wherein the training aid further includes a top cover that extends over the upper edge, resting upon the flange (Col. 8 Lines 41-44 A membrane 332 is stretched across a frame 334 (flange) to define a membrane module which is removably held in place by buckles 336 on the top wall 322 to cover the access opening 324 and simulate human tissue).
Regarding Claim 11, Hasson discloses wherein the top cover is structurally configured to mimic skin (Col. 8 Lines 41-44 A membrane 332 is stretched across a frame 334 to define a membrane module which is removably held in place by buckles 336 on the top wall 322 to cover the access opening 324 and simulate human tissue).
Regarding Claim 13, Hasson discloses wherein the flange further includes a fastening member which attaches a lower surface of the top cover to the flange (Col. 5 Lines 20-24 To simulate human tissue, a membrane module 126 is placed over the access opening 16. The module 126 consists of a rectangular frame 128 which is supported upon an upwardly facing ledge 130 (flange) defined around the periphery of the access opening 16, Col. 8 Lines 41-44 A membrane 332 is stretched across a frame 334 to define a membrane module which is removably held in place by buckles 336 (fastening member) on the top wall 322 to cover the access opening 324 and simulate human tissue).
Regarding Claim 16, Hasson discloses the training aid assembly of claim 1 wherein the display stand further comprises a body defining a bed, with a plurality of fingers extending upwardly away from the top surface of the base on either side of the bed (Figs. 2, 3, and 8 Elements 64 (base), 66 (platform or bed), 68 (surgical practice/training system), and 170 (clamps/fingers) - Clamps (fingers) can be seen extending upwardly away from the top surface of the platform (bed) on either side of the pl, Col. 6 Lines 10-12 The practice system 68, as seen in FIGS. 2, 3 and 8, consists of four clamps 170 (plurality of fingers) situated at the corners of the platform 66 (body defining bed), Col. 8 Lines 7-8 The clamps 288 are carried on cords 290 which project through the frame).
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, 12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hasson (5,947,743) in view of Velasco (US 2018/0233067 A1).
Regarding Claim 2, Hasson discloses the training aid assembly of claim 1.
However, Hasson is not relied upon disclosing wherein the at least one opening port includes a coupling for attachment to an outside structure.
Velasco teaches wherein the at least one opening port includes a coupling for attachment to an outside structure ([0076] The adapter 30 includes an aperture 32 that is cylindrical in shape and is sized and configured for connecting with a simulated organ).
Hasson and Velasco are both considered to be analogous to the claimed invention, because they are in the same field of surgical training systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the applicant’s invention to modify the training aid assembly, as disclosed by Hasson, further including wherein the at least one opening port includes a coupling for attachment to an outside structure as taught by Velasco for the purpose of connecting with a simulated organ such as a simulated vagina or colon and particularly useful for practicing lateral access procedures including but not limited to vaginal hysterectomies and transanal procedures (Velasco, [0076]).
Regarding Claim 12, Hasson discloses the training aid assembly of claim 11.
However, Hasson is not relied upon disclosing wherein the top cover comprises a silicone sheet material.
Velasco teaches wherein the top cover comprises a silicone sheet material ([0083] A skin layer comprised of silicone mechanically bonded to an underlying foam layer has been created and integrated into the simulated abdominal wall).
Regarding Claim 14, Hasson discloses the training aid assembly of claim 13.
However, Hasson is not relied upon disclosing wherein the fastening member releasably attaches the lower surface of the top cover to the flange.
Velasco teaches wherein the fastening member releasably attaches the lower surface of the top cover to the flange ([0075] A latch (fastening member) 24 is provided and configured to release the tissue simulation region 14 from the top cover 16).
Regarding Claim 15, Hasson discloses the training aid assembly of claim 1.
However, Hasson is not relied upon disclosing wherein the base further includes an inner display slot, with the display stand positionable within the display slot.
Velasco teaches wherein the base further includes an inner display slot, with the display stand positionable within the display slot ([0076] The second platform (display stand) is adjust-able (positionable) by interchanging trays placing the artificial organs therein and sliding the tray onto the rails 26).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hasson (US 5,947,743) in view of Tracy (US 2014/0087347 A1).
Regarding Claim 9, Hasson discloses the training aid assembly of claim 8.
However, Hasson is not relied upon disclosing wherein the flange extends inwardly from the wall structure.
Tracy teaches wherein the flange extends inwardly from the wall structure (Fig. 2 Element 34 Flange post can be seen going inwardly into the training device from the wall structure, [0021] Each post 34 is provided with a flange and each aperture is keyed for allowing the flanged post 34 to pass into the aperture).
Hasson and Tracy are both considered to be analogous to the claimed invention, because they are in the same field of surgical training systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the applicant’s invention to modify the training aid assembly, as disclosed by Hasson, further including wherein the flange extends inwardly from the wall structure as taught by Tracy for the purpose of locking the post into position relative to the base (Tracy, [0021]).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hasson (US 5,947,743) in view of Schmidt (WO 2022/037748 A1).
Regarding Claim 17, Hasson discloses the training aid assembly of claim 16.
However, Hasson is not relied upon disclosing wherein the body part model comprises a portion of a spine, wherein a vertebral body of the body part is received on the bed, and wherein each of the plurality of fingers receives a transverse processes of the body part.
Schmidt teaches wherein the body part model comprises a portion of a spine, wherein a vertebral body of the body part is received on the bed, and wherein each of the plurality of fingers receives a transverse processes of the body part (Fig. 1 Elements 1, 2, and 7 Bed can be seen receiving transverse processes of the model spine, [0030] The surgical training simulator consists of a transparent or colored spinal anatomy pathology model 1 (model of a portion of a spine) embedded in a transparent or colored transparent matrix 2 (bed) mimicking human tissue).
Hasson and Schmidt are both considered to be analogous to the claimed invention, because they are in the same field of surgical training systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the applicant’s invention to modify the training aid assembly, as disclosed by Hasson, further including wherein the body part model comprises a portion of a spine, wherein a vertebral body of the body part is received on the bed, and wherein each of the plurality of fingers receives a transverse processes of the body part as taught by Schmidt for the purpose of simulating, training, teaching and/or evaluating surgical techniques, in particular for spinal surgery (Schmidt, [0017]).
Regarding Claim 18, Hasson discloses wherein the plurality of fingers comprises four fingers (Col. 6 Lines 10-12 The practice system 68, as seen in FIGS. 2, 3 and 8, consists of four clamps 170 (plurality of fingers) situated at the corners of the platform 66 (body defining bed)).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hasson (US 5,947,743) in view of Jabbour et al. (US 2016/0140876 A1).
Regarding Claim 19, Hasson discloses the training aid assembly of claim 1.
However, Hasson is not relied upon disclosing wherein the base includes an outer wall slot extending thereabout, with a lower end of the wall structure positionable within the outer wall slot.
Jabbour teaches wherein the base includes an outer wall slot extending thereabout, with a lower end of the wall structure positionable within the outer wall slot ([0038] Insertion of the plurality of rods 35 (lower end of wall structure) respectively into the plurality of sleeves 34 (outer wall slot) creates the expanded condition of the laparoscopic surgery training kit whereby the base surface 20 and top surface 10 are linearly separated).
Hasson and Jabbour are both considered to be analogous to the claimed invention, because they are in the same field of surgical training systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the applicant’s invention to modify the training aid assembly, as disclosed by Hasson, further including wherein the base includes an outer wall slot extending thereabout, with a lower end of the wall structure positionable within the outer wall slot as taught by Jabbour for the purpose of aiding in portability and storability of the laparoscopic training kit (Jabbour, [0038]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hasson (US 5,947,743) in view of Jabbour et al. (US 2016/0140876 A1), and in further view of Okayama et al. (US 2018/0018904 A1).
Regarding Claim 20, Hasson discloses the training aid of claim 19.
However, Hasson and Jabbour are not relied upon disclosing wherein the wall structure is transparent.
Okayama teaches wherein the wall structure is transparent ([0044] It is also preferable that the material for the side walls 11 to 14 and the bottom face 15 has is transparent).
Hasson and Okayama are both considered to be analogous to the claimed invention, because they are in the same field of surgical training systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the applicant’s invention to modify the training aid assembly, as disclosed by Hasson, further including wherein the wall structure is transparent as taught by Okayama for the purpose of making it possible to observe the behavior of the model installed inside the container (Okayama, [0044]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hoke et al. (US 2016/0071437 A1) teaches a simulated tissue structure for surgical training.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMID TARIQ HAFIZ whose telephone number is (571) 272-4629. The examiner can normally be reached 7:30 AM - 5:00 PM, Monday through Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kang Hu can be reached at 571-270-1344. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMID TARIQ HAFIZ/
Examiner, Art Unit 3715
/KANG HU/Supervisory Patent Examiner, Art Unit 3715
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