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 .
Status of Claims
This office action is in response to the patent application 18/134,500 originally filed on April 13, 2023. Claims 1-20 are presented for examination. Claims 1, 7, and 14 are independent.
Information Disclosure Statement
The Information Disclosure Statement filed on October 31, 2023 has been considered. An initialed copy of the Form 1449 is enclosed herewith.
Priority
This application is a continuation-in-part of US Application 17/846,824 (filed 6/22/2022), which is a continuation-in-part of US Application 17/489,151 (filed 9/29/2021) and US Application 17/151,140 (filed 1/16/2021), which is a continuation-in-part of US Application 14/989,165 (filed 1/6/2016) and US Application 16/449,179 (filed 6/21/2019), which is a continuation of US Application 15/919,024 (filed 3/12/2018), which is a continuation-in-part of US Application 14/943,099 (filed 11/17/2015), which is a divisional of US Application 14/494,490 (filed 9/23/2014), which is a divisional of US Application 12/803,609 (filed 6/30/2010).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 7, 10, and 14-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 7-9 of U.S. Patent No. 11,688,303. Although the claims at issue are not identical, they are not patentably distinct, as shown in the following comparison chart:
Instant Application
US Patent 11,688,303
1. An articulating rib cage for a simulated torso of a human, the articulating rib cage comprising:
at least one support rib section configured to removably mount onto to the simulated torso;
a sternum base affixed to the at least one support rib section;
a flex joint affixed to the sternum base, the flex joint configured to provide for elastic displacement from the sternum base; and
a flex rib section including at least one rib sized and dimension as a human rib, the flex rib section flexibly coupled to the sternum base at a first end via the flex joint, the flex rib section configured to remain decoupled from the simulated torso at a second end opposite the first end when the least one support rib section is mounted onto to the simulated torso, as a cantilever, and such that the flex rib section can be forced to non- destructively deviate from a normal anatomic range to a deflected position and return.
1. A simulated torso for an open surgery simulator, the simulated torso comprising:
a torso back shell having a concave front, and having a back shaped as at least a portion of a human torso back side;
a muscle backing nested within the torso back shell and configured as a flexible filling to the torso back shell, the muscle backing having a forward facing surface configured to appear as human muscle;
a rib cage module coupled to the torso back shell substantially in front of the muscle backing, the rib cage module including
a sternum base sized and dimension as a human sternum,
at least one support rib section configured to removably couple the rib cage module to the simulated torso, the at least one support rib section affixed to the sternum base,
a flex rib section including at least one rib sized and dimension as a human rib, and
a flex joint affixed to the sternum base and to the flex rib section, the flex joint configured to provide for elastic displacement of the at least one rib of the flex rib section,
an onboard fluid delivery system configured to deliver at least one of a liquid and a gas into and through the simulated torso, the onboard fluid delivery system including a fluid supply system interface configured to fluidly couple with an offboard fluid supply and a fluid channel configured to plumb a fluid into and through the simulated torso; and
a plumbed spine configured to route and conceal portions of the onboard fluid delivery system within the simulated torso, the plumbed spine having an external shell configured to appear as a human spine anatomically, and formed as a conduit having a central lumen, and a plurality of ports configured to provide access to the central lumen from the outside of the plumbed spine.
7. A simulated torso for an open surgery simulator, the simulated torso comprising:
a torso back shell having a concave front, and having a back shaped as at least a portion of a human torso back side, the torso back shell including at least one rib cage anchor and at least one a rib cage pad;
a muscle backing removably nested within the torso back shell, and configured as a flexible filling to the concave front of torso back shell, the muscle backing having a forward facing surface configured to appear as human muscle; and
an articulating rib cage module removably coupled to the torso back shell substantially in front of the muscle backing, the articulating rib cage module including
at least one support rib section configured to removably mount onto to the rib cage anchor of the simulated torso,
a sternum base affixed to the at least one support rib section,
a flex joint affixed to the sternum base, the flex joint configured to provide for elastic displacement from the sternum base, and
a flex rib section including at least one rib sized and dimension as a human rib, the flex rib section flexibly coupled to the sternum base at a first end via the flex joint, the flex rib section configured to remain decoupled from the simulated torso at a second end opposite the first end when the least one support rib section is mounted onto to the simulated torso, as a cantilever, and such that the flex rib section can be forced to non-destructively deviate from a normal anatomic range to a deflected position and return.
10. The simulated torso of claim 7, wherein the at least one rib cage anchor of the torso back shell includes a left side rib cage anchor and a right side rib cage anchor; and wherein the articulating rib cage module further includes a collar bone fixed to the at least one support rib section, the collar bone configured to removably couple the articulating rib cage module to the left side rib cage anchor and the right side rib cage anchor of the torso back shell.
3. A simulated torso for an open surgery simulator, the simulated torso comprising:
a torso back shell having a concave front, and having a back shaped as at least a portion of a human torso back side;
a muscle backing nested within the torso back shell and configured as a flexible filling to the torso back shell, the muscle backing having a forward facing surface configured to appear as human muscle; and
a rib cage module coupled to the torso back shell substantially in front of the muscle backing, the rib cage module including
a sternum base sized and dimension as a human sternum, and
at least one support rib section configured to removably couple the rib cage module to the simulated torso, the at least one support rib section affixed to the sternum base, a flex rib section including at least one rib sized and dimension as a human rib, and a flex joint affixed to the sternum base and to the flex rib section, the flex joint configured to provide for elastic displacement of the at least one rib of the flex rib section; and
wherein the rib cage module further includes a collar bone fixed to the articulating rib cage, the collar bone configured to removably couple the rib cage module to a left rib cage anchor and a right rib cage anchor of the torso back shell.
14. An open surgery simulator comprising:
a simulated torso including
a torso back shell having a concave front, and having a back shaped as at least a portion of a human torso back side, the torso back shell including at least one rib cage anchor and at least one a rib cage pad;
a muscle backing removably nested within the torso back shell, and configured as a flexible filling to the concave front of torso back shell, the muscle backing having a forward facing surface configured to appear as human muscle;
an articulating rib cage module removably coupled to the torso back shell substantially in front of the muscle backing, the articulating rib cage module including
at least one support rib section configured to removably mount onto to the rib cage anchor of the simulated torso,
a sternum base affixed to the at least one support rib section,
a flex joint affixed to the sternum base, the flex joint configured to provide for elastic displacement from the sternum base, and
a flex rib section including at least one rib sized and dimension as a human rib, the flex rib section flexibly coupled to the sternum base at a first end via the flex joint, the flex rib section configured to remain decoupled from the simulated torso at a second end opposite the first end when the least one support rib section is mounted onto to the simulated torso, as a cantilever, and such that the flex rib section can be forced to non-destructively deviate from a normal anatomic range to a deflected position and return; and,
a first prosthetic internal organ module positioned in the simulated torso in front of the muscle backing of the simulated torso, the prosthetic internal organ module including a plurality of simulated human organs.
15. The open surgery simulator of claim 14, wherein the simulated torso further includes a simulated diaphragm including a sheet of material removably coupled to and extending backward from the articulating rib cage module to the muscle backing;
wherein the simulated torso has a chest cavity defined as being between the muscle backing and the articulating rib cage module and above the simulated diaphragm, and an abdominal cavity defined as being in front of the muscle backing and below the simulated diaphragm; and
wherein the first prosthetic internal organ module is positioned in the abdominal cavity, and the plurality of simulated human organs are abdominal organs.
16. The open surgery simulator of claim 16, further comprising a second prosthetic internal organ module positioned in the chest cavity, the prosthetic internal organ module including a plurality of simulated human chest organs.
17. The open surgery simulator of claim 14, wherein the simulated torso further includes an onboard fluid delivery system configured to deliver at least one of a liquid and a gas into and through the simulated torso, the onboard fluid delivery system including a fluid supply system interface configured to fluidly couple with an offboard fluid supply and a fluid channel configured to plumb a fluid into and through the simulated torso.
7. An open surgery simulator comprising:
a simulated torso including
a torso back shell having a concave front, and having a back shaped as at least a portion of a human torso back side,
a muscle backing nested within the torso back shell and configured as a flexible filling to the torso back shell, the muscle backing having a forward facing surface configured to appear as human muscle, and
a rib cage module coupled to the torso back shell substantially in front of the muscle backing, the rib cage module including
a sternum base sized and dimension as a human sternum, and
at least one support rib section configured to removably couple the rib cage module to the simulated torso, the at least one support rib section affixed to the sternum base,
a flex rib section including at least one rib sized and dimension as a human rib,
a flex joint affixed to the sternum base and to the flex rib section, the flex joint configured to provide for elastic displacement of the at least one rib of the flex rib section,
a muscle covering configured visually and tactilely as chest muscles, said muscle affixed to and covering the support rib section and the flex rib section, the muscle covering including
a first access passageway through the muscle covering and between ribs, and
a second access passageway through the muscle covering and between ribs, the second access passageway locate on an opposite side of the articulating rib cage than the first access passageway;
a first prosthetic internal organ module positioned in the torso back shell in front of the muscle backing of the simulated torso, the first prosthetic internal organ module including a plurality of simulated human organs,
the first prosthetic internal organ module positioned in a chest cavity between the muscle backing and the rib cage module, and the plurality of simulated human organs of the first prosthetic internal organ module includes at least one of a simulated heart and a simulated lung;
a simulated diaphragm extending between the rib cage module and the muscle backing, below the chest cavity;
a second prosthetic internal organ module positioned in an abdominal cavity in front of the muscle backing and at least partially below simulated diaphragm, the second prosthetic internal organ module including a plurality of simulated human abdominal organs; and
an onboard fluid delivery system configured to deliver at least one of a liquid and a gas into and through the simulated torso, the onboard fluid delivery system including a fluid supply system interface configured to fluidly couple with an offboard fluid supply and a fluid channel configured to plumb a fluid into and through the simulated torso; and
a plumbed spine configured to route and conceal portions of the onboard fluid delivery system within the simulated torso, the plumbed spine having an external shell configured to appear as a human spine anatomically, and formed as a conduit having a central lumen, and a plurality of ports configured to provide access to the central lumen from the outside of the plumbed spine.
19. The open surgery simulator of claim 18, further comprising an outer covering including a simulated skin portion made of a first material, an accessibility portion made of a second material and having an access fastener, and a plumbing interface configured to pass the fluid supply system interface of the onboard fluid delivery system out of the outer covering, the outer covering configured to fittingly be worn by the simulated torso when placed over the simulated torso and the access fastener is secured.
8. The open surgery simulator of claim 7, further comprising an outer covering including a simulated skin portion made of a first material, and an accessibility portion made of a second material and having an access fastener, the outer covering configured to fittingly be worn by the simulated torso when placed over the simulated torso and the access fastener is secured.
18. The open surgery simulator of claim 17, further comprising the offboard fluid supply system, said offboard fluid supply system including a flow harness and at least one of a liquid system and a gas system, said flow harness having a simulator interface fluidly coupled to the fluid supply system interface of the onboard fluid delivery system, and said flow harness configured to communicate the fluid from the at least one of the liquid system and the gas system to the onboard fluid delivery system.
9. The open surgery simulator of claim 8, wherein the outer covering further includes a plumbing interface configured to provide access to the onboard fluid delivery system when worn by the simulated torso, the open surgery simulator further comprising an offboard fluid supply system including a flow harness and at least one of a liquid system and a gas system, said flow harness passing through the plumbing interface, said flow harness having a simulator interface fluidly coupled to the onboard fluid delivery system, and said flow harness configured to communicate a fluid from the at least one of the liquid system and the gas system to the onboard fluid delivery system.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Toly (US 2004/0126746) in view of Wen et al. (hereinafter “Wen,” US 2017/0169734).
Regarding claim 1, Toly discloses an articulating rib cage for a simulated torso of a human (see Toly Fig. 7, showing rib cover 156 and trainer 100), the articulating rib cage comprising:
…
a sternum base affixed to the at least one support rib section (Toly Fig. 8, showing sternum affixed to rib sections);
…
a flex rib section including at least one rib sized and dimension as a human rib (see Toly Fig. 7).
Toly does not explicitly teach every limitation of at least one support rib section configured to removably mount onto to the simulated torso… a flex joint affixed to the sternum base, the flex joint configured to provide for elastic displacement from the sternum base; and… the flex rib section flexibly coupled to the sternum base at a first end via the flex joint, the flex rib section configured to remain decoupled from the simulated torso at a second end opposite the first end when the least one support rib section is mounted onto to the simulated torso, as a cantilever, and such that the flex rib section can be forced to non-destructively deviate from a normal anatomic range to a deflected position and return.
However, Wen discloses at least one support rib section configured to removably mount onto to the simulated torso… a flex joint affixed to the sternum base, the flex joint configured to provide for elastic displacement from the sternum base; and… the flex rib section flexibly coupled to the sternum base at a first end via the flex joint, the flex rib section configured to remain decoupled from the simulated torso at a second end opposite the first end when the least one support rib section is mounted onto to the simulated torso, as a cantilever, and such that the flex rib section can be forced to non-destructively deviate from a normal anatomic range to a deflected position and return (Wen Figs. 14 and 15; also Wen [0088], “The breastbone 226 connects the right ribs 222 to the left ribs 224. The breastbone 226 loosely mimics the sternum and breastbone in the human body, and is shaped similar to a breastbone of a human. The left ribs 222 and the right ribs 224 loosely mimic the ribs in the human body, and are shaped similar to the ribs of a human. The breastbone 226 is flexibly connected to the right ribs 222 and the left ribs 224. The left ribs 222 and the right ribs 224 are connected to the back 216 of the phantom 200, specifically at a spine 217. The left ribs 222 and the right ribs 224 are attached to the spine 217 so that they can rotate relative to the spine 217. The flexible connection between the breastbone 226 and the right ribs 222 and the left ribs 224 is achieved by a connector, such as an elastomeric hinge 228. The ribs 222, 224 and the breastbone 226 have nodules 229 that connect to recesses 228a in the elastometic hinge 228. The breastbone 226 is hingedly connected to the spine 217 by two rib members 226a at the top of the breastbone 226,” where the breastbone includes the sternum, and the “elastomeric hinge” is a flex joint).
Wen is analogous to Toly, as both are drawn to the art of medical training simulators. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Toly, to include at least one support rib section configured to removably mount onto to the simulated torso… a flex joint affixed to the sternum base, the flex joint configured to provide for elastic displacement from the sternum base; and… the flex rib section flexibly coupled to the sternum base at a first end via the flex joint, the flex rib section configured to remain decoupled from the simulated torso at a second end opposite the first end when the least one support rib section is mounted onto to the simulated torso, as a cantilever, and such that the flex rib section can be forced to non-destructively deviate from a normal anatomic range to a deflected position and return, as taught by Wen, in order to represent the movement of the chest when it expands and contracts during respiration (Wen [0086]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 2, Toly does not explicitly teach wherein the flex rib section is made of a material that simulates a hardness and flexibility of human bone; and wherein the flex joint includes an elastomeric material, and is further configured to provide the elastic displacement of the flex rib section from the sternum base with a resistance against said elastic displacement in simulation of a natural resistance of a human rib to deflection.
However, Wen discloses wherein the flex rib section is made of a material that simulates a hardness and flexibility of human bone; and wherein the flex joint includes an elastomeric material, and is further configured to provide the elastic displacement of the flex rib section from the sternum base with a resistance against said elastic displacement in simulation of a natural resistance of a human rib to deflection (Wen Figs. 14 and 15; also Wen [0088], “The breastbone 226 connects the right ribs 222 to the left ribs 224. The breastbone 226 loosely mimics the sternum and breastbone in the human body, and is shaped similar to a breastbone of a human. The left ribs 222 and the right ribs 224 loosely mimic the ribs in the human body, and are shaped similar to the ribs of a human. The breastbone 226 is flexibly connected to the right ribs 222 and the left ribs 224… The flexible connection between the breastbone 226 and the right ribs 222 and the left ribs 224 is achieved by a connector, such as an elastomeric hinge 228”).
Wen is analogous to Toly, as both are drawn to the art of medical training simulators. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Toly, to include wherein the flex rib section is made of a material that simulates a hardness and flexibility of human bone; and wherein the flex joint includes an elastomeric material, and is further configured to provide the elastic displacement of the flex rib section from the sternum base with a resistance against said elastic displacement in simulation of a natural resistance of a human rib to deflection, as taught by Wen, in order to represent the movement of the chest when it expands and contracts during respiration (Wen [0086]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 4, Toly in view of Wen discloses a muscle covering configured as chest muscles affixed to and covering the support rib section and the flex rib section, the muscle covering including a first access passageway through the muscle covering, the first access passageway positioned between ribs of the support rib section and the flex rib section that are adjacent to each other; and a first muscle patch configured as a first section of simulated muscle, sized and dimensioned to cover the first access passageway of the muscle covering, the first muscle patch having an adhesive backing configured to removably adhere to an area of the muscle covering that surrounds the first access passageway (Toly [0094-0095], “The rib cage is covered by a rib cover 156, which is formed of one or several layers, bonded or non-bonded to one another. Rib cover 156 simulates several of the muscles surrounding the ribs, such as the serratus anterior muscle, the latissimus dorsi muscle, and the external abdominal oblique muscle… Spaces are preferably provided between ribs, since procedures may be called for that include inserting medical devices between the ribs.”).
Regarding claim 5, Toly in view of Wen discloses wherein the muscle covering further includes a second access passageway through the muscle covering, the second access passageway positioned between two ribs of the support rib section that are adjacent to each other, the second access passageway located on an opposite side of the articulating rib cage than the first access passageway, relative to the sternum base, the articulating rib cage further comprising a second muscle patch configured as a second section of simulated muscle, sized and dimensioned to cover the second access passageway of the muscle covering, the second muscle patch having an adhesive backing configured to removably adhere to an area of the muscle covering that surrounds the second access passageway; and wherein at least one of the first muscle patch and the second muscle patch is further configured to release a simulated blood when cut (Toly [0094-0095], “Spaces are preferably provided between ribs, since procedures may be called for that include inserting medical devices between the ribs,” the other side of the rib cage has similar spaces for inserting medical devices; also Toly [0087], “Channels 302 that define veins and arteries can be provided in every layer of the tissue structure, or in only one layer, or no layer. When a simulated vein is severed while there is simulated blood in the system, a trainee sees simulated blood filling the operative site, just as would occur if the trainee were operating on an actual live patient,” providing simulated bleeding).
Claims 7, 13, 14, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Toly in view of Gomo (US 2007/0087314), and in further view of Wen.
Regarding claim 7, Toly discloses a simulated torso for an open surgery simulator (Toly Fig. 1 and [0035], “a perspective view of a human torso surgical trainer”), the simulated torso comprising:
…
a sternum base affixed to the at least one support rib section (Toly Fig. 8, showing sternum affixed to rib sections),
…
a flex rib section including at least one rib sized and dimension as a human rib (see Toly Fig. 7).
Toly does not teach every limitation of a torso back shell having a concave front, and having a back shaped as at least a portion of a human torso back side, the torso back shell including at least one rib cage anchor and at least one a rib cage pad; a muscle backing removably nested within the torso back shell, and configured as a flexible filling to the concave front of torso back shell, the muscle backing having a forward facing surface configured to appear as human muscle; and an articulating rib cage module removably coupled to the torso back shell substantially in front of the muscle backing.
However, Gomo discloses a torso back shell having a concave front, and having a back shaped as at least a portion of a human torso back side, the torso back shell including at least one rib cage anchor and at least one a rib cage pad (see Gomo Fig. 3 and [0059], “FIG. 3 is a cross section through the torso 2 of a patient simulator, illustrating a back shell 20. The back shell serves to reinforce the torso. On the outside of the back shell 20 are two recesses 21 and 22, on the left and right sides of the torso, respectively. In each recess 21, 22 is an air cushion 23 and 24, respectively”); a muscle backing removably nested within the torso back shell, and configured as a flexible filling to the concave front of torso back shell, the muscle backing having a forward facing surface configured to appear as human muscle (Gomo [0062-0064], “The air cushions 23, 24 can be used in the following modes: … Simulation of normal muscle movements: Alternate and regular filling and emptying of air on the left and right sides… Simulation of muscle spasms”); an articulating rib cage module removably coupled to the torso back shell substantially in front of the muscle backing (see Gomo Fig. 1 and [0050], “Under the chest skin is a shell 4 to represent ribs and sternum… Under the plate 5 is one or preferably two lungs 6, one on the right side and one on the left side of the rib cage”).
Gomo is analogous to Toly, as both are drawn to the art of medical training simulators. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Toly, to include a torso back shell having a concave front, and having a back shaped as at least a portion of a human torso back side, the torso back shell including at least one rib cage anchor and at least one a rib cage pad; a muscle backing removably nested within the torso back shell, and configured as a flexible filling to the concave front of torso back shell, the muscle backing having a forward facing surface configured to appear as human muscle; and an articulating rib cage module removably coupled to the torso back shell substantially in front of the muscle backing, as taught by Gomo, in order to simulate muscular activity (Gomo Abstract). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Toly in view of Gomo does not explicitly teach at least one support rib section configured to removably mount onto to the rib cage anchor of the simulated torso… a flex joint affixed to the sternum base, the flex joint configured to provide for elastic displacement from the sternum base, and … the flex rib section flexibly coupled to the sternum base at a first end via the flex joint, the flex rib section configured to remain decoupled from the simulated torso at a second end opposite the first end when the least one support rib section is mounted onto to the simulated torso, as a cantilever, and such that the flex rib section can be forced to non-destructively deviate from a normal anatomic range to a deflected position and return.
However, Wen discloses at least one support rib section configured to removably mount onto to the rib cage anchor of the simulated torso… a flex joint affixed to the sternum base, the flex joint configured to provide for elastic displacement from the sternum base, and … the flex rib section flexibly coupled to the sternum base at a first end via the flex joint, the flex rib section configured to remain decoupled from the simulated torso at a second end opposite the first end when the least one support rib section is mounted onto to the simulated torso, as a cantilever, and such that the flex rib section can be forced to non-destructively deviate from a normal anatomic range to a deflected position and return (Wen Figs. 14 and 15; also Wen [0088], “The breastbone 226 connects the right ribs 222 to the left ribs 224. The breastbone 226 loosely mimics the sternum and breastbone in the human body, and is shaped similar to a breastbone of a human. The left ribs 222 and the right ribs 224 loosely mimic the ribs in the human body, and are shaped similar to the ribs of a human. The breastbone 226 is flexibly connected to the right ribs 222 and the left ribs 224. The left ribs 222 and the right ribs 224 are connected to the back 216 of the phantom 200, specifically at a spine 217. The left ribs 222 and the right ribs 224 are attached to the spine 217 so that they can rotate relative to the spine 217. The flexible connection between the breastbone 226 and the right ribs 222 and the left ribs 224 is achieved by a connector, such as an elastomeric hinge 228. The ribs 222, 224 and the breastbone 226 have nodules 229 that connect to recesses 228a in the elastometic hinge 228. The breastbone 226 is hingedly connected to the spine 217 by two rib members 226a at the top of the breastbone 226,” where the breastbone includes the sternum, and the “elastomeric hinge” is a flex joint).
Wen is analogous to Toly in view of Gomo, as both are drawn to the art of medical training simulators. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Toly in view of Gomo, to include at least one support rib section configured to removably mount onto to the rib cage anchor of the simulated torso… a flex joint affixed to the sternum base, the flex joint configured to provide for elastic displacement from the sternum base, and … the flex rib section flexibly coupled to the sternum base at a first end via the flex joint, the flex rib section configured to remain decoupled from the simulated torso at a second end opposite the first end when the least one support rib section is mounted onto to the simulated torso, as a cantilever, and such that the flex rib section can be forced to non-destructively deviate from a normal anatomic range to a deflected position and return, as taught by Wen, in order to represent the movement of the chest when it expands and contracts during respiration (Wen [0086]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 13, Toly in view of Gomo and Wen discloses an onboard fluid delivery system configured to deliver at least one of a liquid and a gas into and through the simulated torso, the onboard fluid delivery system including a fluid supply system interface configured to fluidly couple with an offboard fluid supply and a fluid channel configured to plumb a fluid into and through the simulated torso (Toly [0087], “Flexible hoses or tubing 308, 310 can be connected to junctures 304, 306 respectively, where a number of smaller channels converge. In this manner, simulated human tissue 300 can have a simulated circulatory system modeled therein. Tubing 308 is connected to the discharge of a pump (not shown). Simulated blood resides in a reservoir (not shown). Preferably, a manually operated pump, such as a syringe with a plunger, is used. Tubing 308, 310 connected at junctures 304, 306 thus form a path from reservoir to pump to tissue”).
Regarding claim 14, Toly discloses an open surgery simulator (Toly Fig. 1 and [0035], “a perspective view of a human torso surgical trainer”) comprising:
a simulated torso (Toly [0035], “a perspective view of a human torso surgical trainer”)
…
a sternum base affixed to the at least one support rib section (Toly Fig. 8, showing sternum affixed to rib sections),
…
a flex rib section including at least one rib sized and dimension as a human rib (see Toly Fig. 7)
…
a first prosthetic internal organ module positioned in the simulated torso in front of the muscle backing of the simulated torso, the prosthetic internal organ module including a plurality of simulated human organs (see Toly Fig. 5 and [0089], “FIG. 5 shows an operative site 118 relating to the abdominal region, for practicing diagnostic peritoneal lavage. The site includes simulated human organs enclosed within abdominal cavity 120. The simulated abdominal cavity is defined by a structural member shaped to correspond to the contours of the hip bones and surrounding muscles”).
Toly does not teach every limitation of a torso back shell having a concave front, and having a back shaped as at least a portion of a human torso back side, the torso back shell including at least one rib cage anchor and at least one a rib cage pad; a muscle backing removably nested within the torso back shell, and configured as a flexible filling to the concave front of torso back shell, the muscle backing having a forward facing surface configured to appear as human muscle; an articulating rib cage module removably coupled to the torso back shell substantially in front of the muscle backing.
However, Gomo discloses a torso back shell having a concave front, and having a back shaped as at least a portion of a human torso back side, the torso back shell including at least one rib cage anchor and at least one a rib cage pad (see Gomo Fig. 3 and [0059], “FIG. 3 is a cross section through the torso 2 of a patient simulator, illustrating a back shell 20. The back shell serves to reinforce the torso. On the outside of the back shell 20 are two recesses 21 and 22, on the left and right sides of the torso, respectively. In each recess 21, 22 is an air cushion 23 and 24, respectively”); a muscle backing removably nested within the torso back shell, and configured as a flexible filling to the concave front of torso back shell, the muscle backing having a forward facing surface configured to appear as human muscle (Gomo [0062-0064], “The air cushions 23, 24 can be used in the following modes: … Simulation of normal muscle movements: Alternate and regular filling and emptying of air on the left and right sides… Simulation of muscle spasms”); an articulating rib cage module removably coupled to the torso back shell substantially in front of the muscle backing (see Gomo Fig. 1 and [0050], “Under the chest skin is a shell 4 to represent ribs and sternum… Under the plate 5 is one or preferably two lungs 6, one on the right side and one on the left side of the rib cage”).
Gomo is analogous to Toly, as both are drawn to the art of medical training simulators. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Toly, to include a torso back shell having a concave front, and having a back shaped as at least a portion of a human torso back side, the torso back shell including at least one rib cage anchor and at least one a rib cage pad; a muscle backing removably nested within the torso back shell, and configured as a flexible filling to the concave front of torso back shell, the muscle backing having a forward facing surface configured to appear as human muscle; an articulating rib cage module removably coupled to the torso back shell substantially in front of the muscle backing, as taught by Gomo, in order to simulate muscular activity (Gomo Abstract). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Toly in view of Gomo does not explicitly teach at least one support rib section configured to removably mount onto to the rib cage anchor of the simulated torso… a flex joint affixed to the sternum base, the flex joint configured to provide for elastic displacement from the sternum base, and … the flex rib section flexibly coupled to the sternum base at a first end via the flex joint, the flex rib section configured to remain decoupled from the simulated torso at a second end opposite the first end when the least one support rib section is mounted onto to the simulated torso, as a cantilever, and such that the flex rib section can be forced to non-destructively deviate from a normal anatomic range to a deflected position and return.
However, Wen discloses at least one support rib section configured to removably mount onto to the rib cage anchor of the simulated torso… a flex joint affixed to the sternum base, the flex joint configured to provide for elastic displacement from the sternum base, and … the flex rib section flexibly coupled to the sternum base at a first end via the flex joint, the flex rib section configured to remain decoupled from the simulated torso at a second end opposite the first end when the least one support rib section is mounted onto to the simulated torso, as a cantilever, and such that the flex rib section can be forced to non-destructively deviate from a normal anatomic range to a deflected position and return (Wen Figs. 14 and 15; also Wen [0088], “The breastbone 226 connects the right ribs 222 to the left ribs 224. The breastbone 226 loosely mimics the sternum and breastbone in the human body, and is shaped similar to a breastbone of a human. The left ribs 222 and the right ribs 224 loosely mimic the ribs in the human body, and are shaped similar to the ribs of a human. The breastbone 226 is flexibly connected to the right ribs 222 and the left ribs 224. The left ribs 222 and the right ribs 224 are connected to the back 216 of the phantom 200, specifically at a spine 217. The left ribs 222 and the right ribs 224 are attached to the spine 217 so that they can rotate relative to the spine 217. The flexible connection between the breastbone 226 and the right ribs 222 and the left ribs 224 is achieved by a connector, such as an elastomeric hinge 228. The ribs 222, 224 and the breastbone 226 have nodules 229 that connect to recesses 228a in the elastometic hinge 228. The breastbone 226 is hingedly connected to the spine 217 by two rib members 226a at the top of the breastbone 226,” where the breastbone includes the sternum, and the “elastomeric hinge” is a flex joint).
Wen is analogous to Toly in view of Gomo, as both are drawn to the art of medical training simulators. It would be obvious to try by one of ordinary skill in the art at the time of filing to have modified the method as taught by Toly in view of Gomo, to include at least one support rib section configured to removably mount onto to the rib cage anchor of the simulated torso… a flex joint affixed to the sternum base, the flex joint configured to provide for elastic displacement from the sternum base, and … the flex rib section flexibly coupled to the sternum base at a first end via the flex joint, the flex rib section configured to remain decoupled from the simulated torso at a second end opposite the first end when the least one support rib section is mounted onto to the simulated torso, as a cantilever, and such that the flex rib section can be forced to non-destructively deviate from a normal anatomic range to a deflected position and return, as taught by Wen, in order to represent the movement of the chest when it expands and contracts during respiration (Wen [0086]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 17, Toly in view of Gomo and Wen discloses wherein the simulated torso further includes an onboard fluid delivery system configured to deliver at least one of a liquid and a gas into and through the simulated torso, the onboard fluid delivery system including a fluid supply system interface configured to fluidly couple with an offboard fluid supply and a fluid channel configured to plumb a fluid into and through the simulated torso (Toly [0087], “Flexible hoses or tubing 308, 310 can be connected to junctures 304, 306 respectively, where a number of smaller channels converge. In this manner, simulated human tissue 300 can have a simulated circulatory system modeled therein. Tubing 308 is connected to the discharge of a pump (not shown). Simulated blood resides in a reservoir (not shown). Preferably, a manually operated pump, such as a syringe with a plunger, is used. Tubing 308, 310 connected at junctures 304, 306 thus form a path from reservoir to pump to tissue”).
Regarding claim 18, Toly in view of Gomo and Wen discloses the offboard fluid supply system, said offboard fluid supply system including a flow harness and at least one of a liquid system and a gas system, said flow harness having a simulator interface fluidly coupled to the fluid supply system interface of the onboard fluid delivery system, and said flow harness configured to communicate the fluid from the at least one of the liquid system and the gas system to the onboard fluid delivery system (Toly [0087], “Flexible hoses or tubing 308, 310 can be connected to junctures 304, 306 respectively, where a number of smaller channels converge. In this manner, simulated human tissue 300 can have a simulated circulatory system modeled therein. Tubing 308 is connected to the discharge of a pump (not shown). Simulated blood resides in a reservoir (not shown). Preferably, a manually operated pump, such as a syringe with a plunger, is used. Tubing 308, 310 connected at junctures 304, 306 thus form a path from reservoir to pump to tissue,” the offboard fluid supply system comprises the pump and reservoir).
Claims 11, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Toly in view of Gomo and Wen, and in further view of Saracen (US 2007/0140413).
Regarding claim 11, Toly in view of Gomo and Wen does not teach every limitation of wherein the simulated torso has a chest cavity defined as being between the muscle backing and the articulating rib cage module, and an abdominal cavity defined as being in front of the muscle backing and below the articulating rib cage module, the simulated torso further comprising a simulated diaphragm configured to separate the chest cavity from the abdominal cavity, the simulated diaphragm including a sheet of material extending backward from a lower edge of the articulating rib cage module to the muscle backing, the simulated diaphragm forming at least a partial physical barrier between the chest cavity and the abdominal cavity.
However, Saracen discloses wherein the simulated torso has a chest cavity defined as being between the muscle backing and the articulating rib cage module, and an abdominal cavity defined as being in front of the muscle backing and below the articulating rib cage module, the simulated torso further comprising a simulated diaphragm configured to separate the chest cavity from the abdominal cavity, the simulated diaphragm including a sheet of material extending backward from a lower edge of the articulating rib cage module to the muscle backing, the simulated diaphragm forming at least a partial physical b