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 Amendment
In response to the amendment filed 10/20/2025; claims 2-21 are pending; claim 1 has been cancelled.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 2 – 3, 5 – 8 and 10 - 21 are rejected under 35 U.S.C. 103 as being unpatentable over Younker (US 5,620,326) in view of Cooper et al. (US 6,336,812 B1).
Re claim 2:
Younker teaches 2. A first entry system for practicing first entry surgical procedures (Younker, Abstract), the first entry system comprising:
an organ receptacle connected to a penetrable anatomical portion such that an interior of the organ receptacle is sealed from an exterior of the organ receptacle by at least a portion of said penetrable anatomical portion (Younker, col. 1, lines 27 – 43; col. 4, line 59 – col. 5, line 7, “The torso 12 is contoured to match the general contour of a human torso when the peritoneum has been inflated with air or other gas during endoscopic surgery. The peritoneum wall 16 has a thickness that is a predetermined thickness to simulate the rigidity of a chest cavity and inflated peritoneum”; col. 2, lines 54 – 68, “The elastomeric mounts have a predetermined diameter and thickness such that the force required to tilt each trocar is equivalent to the force required to deflect a trocar inserted within an actual patient's inflated peritoneal cavity”; col. 3, lines 7 – 17, “The elastomeric composition includes a liquid elastomer base such as water based latex that is curable to form a desired elastomer”; fig. 2, a receptacle (a simulated organ) is located inside of the simulated torso; fig. 1; col. 2, lines 30 – 39; col. 2, lines 54 – 67; fig. 2 shows a penetrable simulated torso),
wherein the organ receptacle is expandable in size upon penetration of one or more of the
penetrable anatomical portion and the organ receptacle to simulate surgical insufflation of an
abdominal cavity (Younker, figs. 1 – 2; the receptacle (i.e., torso) include expandable parts (such as chest and wall) and inlet and outlet port to cause movement of the abdominal wall to inflate or deflate; col. 4, line 59 – col. 5, line 7, “a human torso when the peritoneum has been inflated with air or other gas during endoscopic surgery. The peritoneum wall 16 has a thickness that is a predetermined thickness to simulate the rigidity of a chest cavity and inflated peritoneum”; col. 2, lines 54 – 68, “The elastomeric mounts have a predetermined diameter and thickness such that the force required to tilt each trocar is equivalent to the force required to deflect a trocar inserted within an actual patient's inflated peritoneal cavity”).
Younker does not explicitly suggest that an organ receptacle connected sealingly to a penetrable anatomical.
Cooper et al. (US 6,336,812 B1) teaches a training apparatus comprises a housing providing a simulation of at least part of a body and a plurality of simulations of internal body structures for reception in the housing, these simulations being a set of simulations of a particular part of the anatomy and being of increasing anatomical complexity and/or presenting increasing clinical or surgical difficulty. Cooper teaches an organ receptacle connected sealingly to a penetrable anatomical (Cooper, col. 3, lines 43 – 59; fig. 11). Therefore, in view of Cooper, it would have been obvious to one of ordinary skill in the art, at the time of invention was made, to modify the system described in Younker, by providing the sealingly enclosed simulated abdominal cavity as taught by Cooper, so that the training system capable of being expanded or inflated with carbon dioxide (or air) in the case of a simulated abdominal wall to simulate insufflation of the abdomen (Cooper, col. 3, lines 43 – 59).
Re claim 3:
3. The first entry system of claim 2 wherein penetration of one or more of the penetrable anatomical portion and the organ receptacle results in equalizing pressure differential between the interior and exterior of the organ receptacle, increasing a volume of the interior of the organ receptacle by transferring fluid into the receptacle, or inflating the organ receptacle by mechanical or electro-mechanical driving means (Younker, figs. 1 – 2; the receptacle (i.e., torso) include expandable parts (such as chest and wall) and inlet and outlet port to cause movement of the abdominal wall to inflate or deflate; col. 4, line 59 – col. 5, line 7, “a human torso when the peritoneum has been inflated with air or other gas during endoscopic surgery. The peritoneum wall 16 has a thickness that is a predetermined thickness to simulate the rigidity of a chest cavity and inflated peritoneum”; col. 2, lines 54 – 68, “The elastomeric mounts have a predetermined diameter and thickness such that the force required to tilt each trocar is equivalent to the force required to deflect a trocar inserted within an actual patient's inflated peritoneal cavity”).
Re claim 5:
5. The first entry system of claim 2 wherein the organ receptacle is made of elastic material configured to expand away from the penetrable anatomical portion by stretching the elastic material of the organ receptacle (Younker, figs. 1 – 2; the receptacle (i.e., torso) include expandable parts (such as chest and wall) and inlet and outlet port to cause movement of the abdominal wall to inflate or deflate; col. 4, line 59 – col. 5, line 7, “a human torso when the peritoneum has been inflated with air or other gas during endoscopic surgery. The peritoneum wall 16 has a thickness that is a predetermined thickness to simulate the rigidity of a chest cavity and inflated peritoneum”; col. 2, lines 54 – 68, “The elastomeric mounts have a predetermined diameter and thickness such that the force required to tilt each trocar is equivalent to the force required to deflect a trocar inserted within an actual patient's inflated peritoneal cavity”).
Re claims 6 – 8:
6. The first entry system of claim 2 further comprising at least one tissue simulation located inside the organ receptacle; the at least one tissue simulation is made of a material selected from the group consisting of silicone, Kraton ™, elastomer, polymer, plastic, rubber, hyrdrogel and mesh material (Younker, col. 4, lines 57 - 67).
7. The first entry system of claim 6 wherein the at least one tissue simulation comprises a solid or hollow structure; the hollow structure having a filling of liquid, water, or conductive material filaments (Younker, figs. 1 – 2; Abstract).
8. The first entry system of claim 6 wherein the at least one tissue simulation comprises simulated vasculatures, fats, organs, tumors, muscles, partial organs, or intestines (Younker, col. 3, lines 18 – 42; col. 10, lines 37 - 58).
Re claim 10:
10. The first entry system of claim 2 further comprising at least one tissue simulation, wherein the at least one tissue simulation comprises a two-dimensional image of interior organs of a patient attached to an inner surface of the receptacle which is smooth or contoured or a three-dimensional underlay to provide a realistic appearance of the patient's abdomen (Younker, col. 2, lines 7 – 13; col. 7, lines 14 – 40, “A suitable pigment is also added to provide a realistic color to the urethane formulation to mimic human tissue”; col. 10, lines 38 – 58, “add a suitable coloring agent to better simulate the visual appearance of the organs”; col. 13, lines 6 – 11, “proper visual appearance of the tissue”).
Re claims 11 – 15:
11. The first entry system of claim 2 wherein the organ receptacle comprises a base interconnected to one or more sidewalls having a top opening; the base being substantially planar and connected to the one or more sidewalls (Younker, figs. 1 – 2 shows top ports and a base 14).
12. The first entry system of claim 11 wherein the base is rigid and suitable for supporting at least one tissue simulation, and wherein the one or more sidewalls are flexible (Younker, figs 1 – 2, a base 14 is rigid enough to support the synthetic torso 12).
13. The first entry system of claim 11 wherein the organ receptacle is connected to the penetrable anatomical portion such that a perimeter of the top opening is sealed against a lower surface of the penetrable anatomical portion (Younker, figs. 1 - 2).
14. The first entry system of claim 11 wherein the top opening is connected to or captured between two opposed top and bottom frame elements of a support; the two opposed top and bottom frame elements are configured to snap together capturing the top opening and the penetrable anatomical portion (Younker, col. 4, lines 44 - 51).
15. The first entry system of claim 11 wherein the organ receptacle further comprises a radially outwardly extending flange around the top opening; the radially outwardly extending flange being captured within the two opposed top and bottom frame elements of the support (Younker, col. 4, lines 44 – 51, “The pump 44 is mounted on the base 14 within a recess 48 formed in the forward wall 50 of the torso 12”; col. 5, lines 8 – 30).
Re claim 16:
16. The first entry system of claim 2 wherein the organ receptacle comprises an amorphous bladder-like container with no distinguishable sides; the amorphous bladder-like container defining an interior having an open top or mouth, and wherein the open top or mouth is sealingly connected to a distal lower surface of the penetrable anatomical portion (Younker, figs. 1 - 2).
Re claims 17 - 18:
17. The first entry system of claim 2 wherein the organ receptacle comprises an enclosed container with no open top, wherein at least one side surface of the organ receptacle is adjacent and connected to a lower surface of the penetrable anatomical portion (Younker, figs. 1 - 2). 18. The first entry system of claim 2 wherein the organ receptacle comprises an enclosed container with no open top, wherein at least one side surface of the organ receptacle is part of the penetrable anatomical portion (Younker, figs. 1 – 2; the receptacle (i.e., torso) include expandable parts (such as chest and wall) and inlet and outlet port to cause movement of the abdominal wall to inflate or deflate; col. 4, line 59 – col. 5, line 7; col. 2, lines 54 – 68).
Re claim 19:
19. The first entry system of claim 2 wherein the penetrable anatomical portion comprises a plurality of substantially planar layers simulating an abdominal wall (Younker, fig. 1; col. 2, lines 30 – 39; col. 2, lines 54 – 67; fig. 2 shows a penetrable simulated torso).
Re claim 20:
20. The first entry system of claim 2 wherein the organ receptacle and the penetrable anatomical portion are contained inside a frame exposing a proximal upper surface of the anatomical portion and a distal outer surface of the organ receptacle (Younker, figs. 6 - 7, simulated layers – 90, 92, 94, 96; col. 7, lines 41 – 52; Cooper, col. 3, lines 32 – 42, “The walls and roof of the container are designed in size, shape and other characteristics such as fat, connective tissue, muscle, peritoneum and vessels in normal positions or abnormal positions, to simulate the abdominal wall or other structure of a patient.”).
Re claim 21:
21. The first entry system of claim 2 wherein the first entry system is adapted for insertion into a laparoscopic trainer such that the organ receptacle is suspended above a floor of an internal cavity of the laparoscopic trainer (Younker, fig. 1 show a synthetic torso 12 is raise from a base 14).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Younker (US 5,620,326) in view of Cooper et al. (US 6336812 B1) as applied to claim 2 above, and further in view of Pravong et al. (US 2012/0082970 A1).
Re claim 4:
Younker does not explicitly disclose penetrable simulated tissue structure by an unfoldment, unfurling or unwrinkling of the receptacle wall in one or more locations. Instead, Younker teaches a flexible phantom. (Younker, col. 2, lines 54 – 68, “The elastomeric mounts have a predetermined diameter and thickness such that the force required to tilt each trocar is equivalent to the force required to deflect a trocar inserted within an actual patient's inflated peritoneal cavity”; col. 3, lines 7 – 17, “The elastomeric composition includes a liquid elastomer base such as water based latex that is curable to form a desired elastomer”; two configurations). Pravong teaches the missing limitation: 4. The first entry system of claim 2 wherein the organ receptacle expands away from the penetrable anatomical portion by an unfoldment, unfurling or unwrinkling of the organ receptacle in one or more locations(Pravong, fig. 1; [0036], “FIG. 1 shows one embodiment of the disclosed portable pelvic/laparoscopic trainer, comprising a torso-shaped top cover 1, which is connected to a bottom plate or base 2 through collapsible hinges 3. A monitor 4 is attached to the top cover 1 and can be folded against the top cover 1 for portability or storage in a low-profile orientation”). Therefore, in view of Pravong, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device described in Younker, by collapsible hinge as taught by Pravong, for portability or storage in when it’s in the low-profile orientation (Pravong, [0036]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Younker (US 5,620,326) in view of Cooper et al. (US 6336812 B1) as applied to claim 1 above, and further in view of Pedersen et al. (US 2010/0179428 A1).
Re claim 9:
Younker teaches 9. The first entry system of claim 2 further comprising at least one tissue simulation formed integrally with the organ receptacle, wherein the organ receptacle is formed from a plurality of layers; each of the plurality of layers having a desired size, shape to simulate tissues and organs encountered within abdomen of a human being (Younker, figs. 6 - 7, simulated layers – 90, 92, 94, 96; col. 7, lines 41 – 52; Cooper, col. 3, lines 32 – 42, “The walls and roof of the container are designed in size, shape and other characteristics such as fat, connective tissue, muscle, peritoneum and vessels in normal positions or abnormal positions, to simulate the abdominal wall or other structure of a patient”).
Younker does not explicitly disclose each of the plurality of layers having a transparency to simulate tissues and organs encountered within abdomen of a human being. Pedersen teaches 18. The surgical training device of claim 1 wherein the wall of the receptacle is transparent (Pedersen, [0045], “phantom could be made of transparent "skin" and actually contain organs”). Therefore, in view of Pedersen, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device described in Younker, by providing a transparent phantom as taught by Pedersen, so that the trainee can see the internal organ of the phantom while performing the simulated surgery.
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.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 43 of U.S. Patent No. 11450236 (‘236). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed in the more specific claim 43 of ‘236.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. US 12288476 (‘476). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed in the more specific claims 1 and 5 of ‘476.
Conclusion
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/JACK YIP/Primary Examiner, Art Unit 3715
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