DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
This office action is in response to the patent application 18/457,245 originally filed on August 28, 2023. Claims 1-20 were originally presented for examination.
In the preliminary amendment filed January 31, 2024, claims 1-20 were canceled, and claims 21-40 were introduced as new claims. Claims 21-40 remain pending.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 11/8/2023, 12/11/2023, 3/21/2024, and 5/16/2024 have been considered. Initialed copies of the Form 1449 are enclosed herewith.
Priority
This application is a continuation of US Application 17/236,947 (filed 4/21/2021), which is a continuation of US Application 15/927,968 (filed 3/21/2018), which is a continuation of US Application 14/195,327 (filed 3/3/2014), which has a US Provisional application 61/771,316 (filed 3/1/2013).
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 21-25 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 8 of U.S. Patent No. 10,991,270. Although the claims at issue are not identical, they are not patentably distinct as shown in the comparison chart below:
Instant Application
US 10,991,270
21. A surgical simulation system for practicing electrosurgery, the system comprising:
a covering layer comprising:
a conductive layer that is operably severable under application of an electrical current, and
a non-conductive layer that is not operably severable under application of the electrical current,
wherein an arrangement of the conductive layer and the non-conductive layer is configured to simulate pathways encountered in real surgical procedures; and
a simulated tissue structure comprising:
an inner layer that is adjacent to and in contact with the covering layer, wherein the inner layer defines an interior cavity, and wherein a portion of the simulated tissue structure corresponds to a portion of a simulated uterus; and
a combination of a conductive material and a non-conductive material, the combination of the conductive material and the non-conductive material defining a pre- determined pathway that simulates pathways encountered in real surgical procedures to perform electrosurgery with respect to the simulated tissue structure.
1. A surgical simulation system for the practice of electrosurgical activity, comprising:
at least one outer layer;
wherein, the at least one outer layer is placed over the simulated tissue structure, wherein the at least one outer layer comprises an elastomeric hydrogel, the elastomeric hydrogel being electro-conductive such that the at least one outer layer is operably severable under application of the electrical current to simulate electrosurgery, and wherein the elastomeric hydrogel defines a predetermined pathway between non-conductive regions to simulate pathways encountered in real surgery for practicing electrosurgical activity.
a simulated tissue structure comprising
an inner layer that is adjacent to and in contact with the at least one outer layer, wherein the inner layer comprises a foam material, wherein the inner layer defines an interior cavity, and wherein both the inner layer and the at least one outer layer define a shape of at least a portion of a uterus; and
a simulated pathology located adjacent to or embedded in the simulated tissue structure, wherein the simulated pathology is removable from the simulated tissue structure via use of an electrical current,
22. The surgical simulation system of claim 21, wherein the conductive layer and the non-conductive layer are attached to at least a portion of the simulated tissue structure.
1. … wherein, the at least one outer layer is placed over the simulated tissue structure …
23. The surgical simulation system of claim 21, wherein the conductive layer includes hydrogels.
1. … wherein the at least one outer layer comprises an elastomeric hydrogel, the elastomeric hydrogel being electro-conductive …
24. The surgical simulation system of claim 21, wherein the non-conductive layer includes silicone elastomer and the inner layer comprises foam.
1. … wherein the inner layer comprises a foam material, wherein the inner layer defines an interior cavity, and wherein both the inner layer and the at least one outer layer define a shape of at least a portion of a uterus; and a simulated pathology located adjacent to or embedded in the simulated tissue structure …
3. The surgical simulation system of claim 1 wherein the simulated pathology is made of silicone and untreated fumed silicon dioxide.
25. The surgical simulation system of claim 21, wherein the simulated tissue structure further comprises a tube having a first end and a second end, wherein the tube is attached to the simulated tissue structure at one end and extends outwards, wherein the tube is configured to simulate a fallopian tube comprising silicone including electro-conductive material.
2. A surgical simulation system for the practice of electrosurgical activity, comprising: a simulated tissue structure comprising: an inner layer adjacent to and in contact with an outer layer, wherein the inner layer comprises a foam material, wherein the outer layer comprises an elastomeric hydrogel wherein the inner layer defines an interior cavity, and wherein both the inner layer and the outer layer define a shape of at least a portion of a uterus; a simulated pathology located adjacent to or embedded in the simulated tissue structure, wherein the simulated pathology is removable from the simulated tissue structure via use of an electrical current; and at least one tube having a first end and a second end; the tube extending outwardly from the outer layer and configured to mimic the shape of a fallopian tube; the tube comprising silicone containing electro-conductive material, wherein the elastomeric hydrogel is electro-conductive such that the elastomeric hydrogel is operably severable under application of the electrical current to simulate electrosurgery in a training environment.
35. A surgical simulation system for practicing electrosurgery, the system comprising:
a covering layer comprising:
a conductive layer that is operably severable under application of an electrical current, and a non-conductive layer that is not operably severable under application of the electrical current, wherein an arrangement of the conductive layer and the non- conductive layer is configured to simulate pathways encountered in real surgical procedures; and
a simulated tissue structure comprising:
an inner layer that is adjacent to and in contact with the covering layer, wherein the inner layer defines an interior cavity; and
wherein the simulated tissue structure is configured for transanal minimally invasive surgery for a local excision of a tumor, wherein portions of the simulated tissue structure comprises non-conductive material except for an area surrounding the tumor comprises conductive materials.
1. A surgical simulation system for the practice of electrosurgical activity, comprising:
at least one outer layer;
wherein, the at least one outer layer is placed over the simulated tissue structure, wherein the at least one outer layer comprises an elastomeric hydrogel, the elastomeric hydrogel being electro-conductive such that the at least one outer layer is operably severable under application of the electrical current to simulate electrosurgery, and wherein the elastomeric hydrogel defines a predetermined pathway between non-conductive regions to simulate pathways encountered in real surgery for practicing electrosurgical activity.
a simulated tissue structure comprising
an inner layer that is adjacent to and in contact with the at least one outer layer, wherein the inner layer comprises a foam material, wherein the inner layer defines an interior cavity, and wherein both the inner layer and the at least one outer layer define a shape of at least a portion of a uterus; and
a simulated pathology located adjacent to or embedded in the simulated tissue structure, wherein the simulated pathology is removable from the simulated tissue structure via use of an electrical current,
8. The surgical simulation system of claim 1, wherein the simulated pathology comprises one or more of tumors or cysts.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 21-26, 28, and 29 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sakezles (US 2007/0148633) in view of Lowe (US 2014/0011172).
Regarding claim 21, Sakezles discloses a surgical simulation system for practicing electrosurgery (Sakezles Abstract, “dielectric properties models that are designed to enable simulated use testing by medical device companies, medical device designers, individual inventors, or any other entity interested in the performance of medical devices”), the system comprising:
a covering layer (see Sakezles Fig. 2, showing covering layers 131, 133, and 132) comprising:
a conductive layer that is operably severable under application of an electrical current (Sakezles [0093], “Tissue analog materials comprised of hydrogels are typically employed to construct tissues in which dielectric properties are simulated. Provided below are examples of hydrogel formulations that may be used. It is noted that such hydrogel materials are typically doped with metal (aluminum, tin, or iron) and nonmetal (silicon or carbon) powders and/or salts, as appropriate, to achieve or alter the dielectric properties of a material depending on the tissue intended to be simulated,” doped with metal powders), and
a non-conductive layer that is not operably severable under application of the electrical current (Sakezles [0093], “Tissue analog materials comprised of hydrogels are typically employed to construct tissues in which dielectric properties are simulated. Provided below are examples of hydrogel formulations that may be used. It is noted that such hydrogel materials are typically doped with metal (aluminum, tin, or iron) and nonmetal (silicon or carbon) powders and/or salts, as appropriate, to achieve or alter the dielectric properties of a material depending on the tissue intended to be simulated,” doped with non-metal powders),
wherein an arrangement of the conductive layer and the non-conductive layer is configured to simulate pathways encountered in real surgical procedures; and
a simulated tissue structure (Sakezles [0084], “The artificial brain component 110 is contained within an artificial cranial encasing 130.”) comprising:
an inner layer that is adjacent to and in contact with the covering layer, wherein the inner layer defines an interior cavity (see Sakezles Fig. 2, showing artificial brain component 110 as the inner layer defining the interior cavity) …
a combination of a conductive material and a non-conductive material, the combination of the conductive material and the non-conductive material defining a pre-determined pathway that simulates pathways encountered in real surgical procedures to perform electrosurgery with respect to the simulated tissue structure (Sakezles [0093], “Tissue analog materials comprised of hydrogels are typically employed to construct tissues in which dielectric properties are simulated. Provided below are examples of hydrogel formulations that may be used. It is noted that such hydrogel materials are typically doped with metal (aluminum, tin, or iron) and nonmetal (silicon or carbon) powders and/or salts, as appropriate, to achieve or alter the dielectric properties of a material depending on the tissue intended to be simulated,” the hydrogel materials doped with metal and non-metal powders).
Sakezles does not explicitly teach wherein a portion of the simulated tissue structure corresponds to a portion of a simulated uterus.
However, Lowe discloses wherein a portion of the simulated tissue structure corresponds to a portion of a simulated uterus (Lowe Abstract, “The uterine assembly simulates the appearance and feel of natural tissue and includes a plurality of materials arranged and dimensioned to simulate anatomic structures”).
Lowe is analogous to Sakezles, as both are drawn to the art of surgical simulation. 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 Sakezles, to include wherein a portion of the simulated tissue structure corresponds to a portion of a simulated uterus, as taught by Lowe, in order to provide patient care training sessions that is more realistic and includes additional simulated features (Lowe [0004]). 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 22, Sakezles in view of Lowe discloses wherein the conductive layer and the non-conductive layer are attached to at least a portion of the simulated tissue structure (see Sakezles Fig. 2, showing outer layers 131-133 attached to inner tissue structure 110).
Regarding claim 23, Sakezles in view of Lowe discloses wherein the conductive layer includes hydrogels (Sakezles [0093], “Tissue analog materials comprised of hydrogels are typically employed to construct tissues in which dielectric properties are simulated.”).
Regarding claim 24, Sakezles in view of Lowe discloses wherein the non-conductive layer includes silicone elastomer and the inner layer comprises foam (Sakezles [0024], “Analog materials used to design tissue analog materials may include, but are not limited to, hydrogel, interpenetrating polymer networks, fibers, silicone rubber, natural rubber, other thermosetting elastomers, other thermoplastic elastomers, acrylic polymers, other plastics, ceramics, cements, wood, styrofoam, metals, actual human tissues, actual animal tissues, and any combination thereof”).
Regarding claim 25, Sakezles does not teach wherein the simulated tissue structure further comprises a tube having a first end and a second end, wherein the tube is attached to the simulated tissue structure at one end and extends outwards, wherein the tube is configured to simulate a fallopian tube comprising silicone including electro-conductive material.
However, Lowe discloses wherein the simulated tissue structure further comprises a tube having a first end and a second end, wherein the tube is attached to the simulated tissue structure at one end and extends outwards, wherein the tube is configured to simulate a fallopian tube comprising silicone including electro-conductive material (see Lowe Figs. 5 and 6; also Lowe [0055], “The fallopian tubes 202, 204 include fimbriae 205 at their free ends (i.e., ends not connected to the uterus 210). As a general matter, the anatomical inserts, including the uterine assembly 200, simulates the appearance and feel of realistic tissue, and the relative arrangement and dimensions of the simulated anatomic structures accurately reflect true anatomical relationships.”).
Lowe is analogous to Sakezles, as both are drawn to the art of surgical simulation. 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 Sakezles, to include wherein the simulated tissue structure further comprises a tube having a first end and a second end, wherein the tube is attached to the simulated tissue structure at one end and extends outwards, wherein the tube is configured to simulate a fallopian tube comprising silicone including electro-conductive material, as taught by Lowe, in order to provide patient care training sessions that is more realistic and includes additional simulated features (Lowe [0004]). 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 26, Sakezles does not teach wherein the tube defines a lumen extending between the first end and the second end and further comprising soft fibrous fiberfill material located inside a portion of the lumen of the tube, the tube having a bulbous portion near the second end transitioning to a funnel having a plurality of axial cuts therein.
However, Lowe discloses wherein the tube defines a lumen extending between the first end and the second end and further comprising soft fibrous fiberfill material located inside a portion of the lumen of the tube, the tube having a bulbous portion near the second end transitioning to a funnel having a plurality of axial cuts therein (Lowe [0140], “the fallopian tubes 202, 204 are molded in one piece from a platinum-cured silicone thermoset or a platinum cured silicone thermoset blend with a shore hardness as low as 00-20 but no higher than 30 A. Silicone pigments may be added to replicate the natural pigments of average human fallopian tubes. In some embodiments, two or more different platinum-cured silicones are blended to optimize hardness, tissue dissection, and suture retention. In some instances, silicone tubing (e.g., Dow Corning Silastic silicone tubing, 0.132'' ID.times.0.183'' OD, catalog #508-11) is embedded within the mold prior to injection to create patent fallopian tubes that can be used during procedures, such as chromopertubation… In some instances, the fallopian tubes 202, 204 are molded from a platinum-cured silicone thermoset with a shore hardness of 10 A (e.g., Dragon Skin® 10 Medium, Smooth-On, Inc., Easton, Pa.) as it is highly effective for dissection and suture retention.”).
Lowe is analogous to Sakezles, as both are drawn to the art of surgical simulation. 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 Sakezles, to include wherein the tube defines a lumen extending between the first end and the second end and further comprising soft fibrous fiberfill material located inside a portion of the lumen of the tube, the tube having a bulbous portion near the second end transitioning to a funnel having a plurality of axial cuts therein, as taught by Lowe, in order to provide patient care training sessions that is more realistic and includes additional simulated features (Lowe [0004]). 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 28, Sakezles in view of Lowe discloses wherein the covering layer is transparent or translucent (Sakezles [0049], “The term "hydrogel(s)" as used herein refers to a unique class of materials that contain a large amount of water and generally exhibit a high degree of elasticity and lubricity. These materials are ideal for simulating the physical properties of many living soft tissues. Hydrogels are materials that are wetable and swell in the presence of moisture and retain water without dissolving. These materials are generally constructed of one or more hydrophilic polymer molecules, although copolymerization with hydrophobic monomers may also lead to the formation of a hydrogel. These materials are generally elastic, and exhibit a three-dimensional network that is either crosslinked directly by chemical bonds or indirectly through cohesive forces such as ionic or hydrogen bonding,” hydrogels are often transparent or translucent).
Regarding claim 29, Sakezles in view of Lowe does not explicitly teach wherein the covering layer is calendared. However, the Applicant’s use of a calendaring process for creating the covering layer is an obvious design choice. Applicant has not disclosed that preparing the covering layer by calendaring solves any stated problem or is for any particular purpose. Moreover, it appears that forming the covering layer with the process used by Sakezles in view of Lowe or the Applicant would perform equally well. Therefore, it would have been prima facie obvious to modify Sakezles in view of Lowe to manufacture the covering layer as specified in claim 29, because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Sakezles in view of Lowe.
Claim 27 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sakezles in view of Lowe, and in further view of Park et al. (hereinafter “Park,” US 2010/0209899).
Regarding claim 27, Sakezles in view of Lowe does not explicitly teach wherein the covering layer has a plurality of strong and weak regions configured for separation by mechanical dissection instruments and scissors.
However, Park discloses wherein the covering layer has a plurality of strong and weak regions configured for separation by mechanical dissection instruments and scissors (Park Abstract, “A physical model representing an anatomic model of the abdominal wall that provides for the option of: tactile feedback, the option for photo realism, the inclusion of various pathologies (including, but not limited to, abdominal wall defects such as hernia), and the customizability to mount the model to various training boxes or frames. This medical/anatomic simulation model is composed of various material layers including, but not limited to, non-elastomeric and elastomeric materials such as papers, fabrics, metallic sheets, metallic meshes, rubber-like foams, and other materials. This is a physical/mechanical model that simulates skin, tissue, and organs associated with abdominal wall morphology and pathology.”).
Park is analogous to Sakezles in view of Lowe, as both are drawn to the art of surgical simulations. 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 Sakezles in view of Lowe, to include wherein the covering layer has a plurality of strong and weak regions configured for separation by mechanical dissection instruments and scissors, as taught by Park, in order to provide realistic, simulated skin, tissue and organ (Park [0017]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Claims 30 and 31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sakezles in view of Lowe, and in further view of Arnal et al. (hereinafter “Arnal,” US 7,553,159).
Regarding claim 30, Sakezles in view of Lowe does not teach wherein the conductive layer of the covering layer further comprises a fabric reinforcement configured to prevent tearing of the covering layer.
However, Arnal discloses wherein the conductive layer of the covering layer further comprises a fabric reinforcement configured to prevent tearing of the covering layer (Arnal col. 9 lines 21-38, “the skin 12 of the female training model 10 may comprise layers of fabric reinforced polymers or polymer sheets of differing density to mimic characteristics of human skin”).
Arnal is analogous to Sakezles in view of Lowe, as both are drawn to the art of surgical 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 Sakezles in view of Lowe, to include wherein the conductive layer of the covering layer further comprises a fabric reinforcement configured to prevent tearing of the covering layer, as taught by Arnal, in order to provide a realistic training model to facilitate training (Arnal col. 4 lines 41-44). 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 31, Sakezles in view of Arnal does not teach wherein the simulated tissue structure is configured for simulating ovarian procedures, the simulated tissue structure comprising: one or more simulated fallopian tubes, simulated round ligaments, simulated ovarian ligaments, simulated IP ligament, simulated broad ligaments, simulated bladder flap, simulated uterine arteries and veins, simulated cardinal ligament, or simulated uterosacral ligaments comprising conductive materials; and one or more simulated ovaries, simulated rectum, simulated urinary bladder, simulated ureter, and simulated kidneys comprising non-conductive materials.
However, Lowe discloses wherein the simulated tissue structure is configured for simulating ovarian procedures, the simulated tissue structure comprising: one or more simulated fallopian tubes, simulated round ligaments, simulated ovarian ligaments, simulated IP ligament, simulated broad ligaments, simulated bladder flap, simulated uterine arteries and veins, simulated cardinal ligament, or simulated uterosacral ligaments comprising conductive materials; and one or more simulated ovaries, simulated rectum, simulated urinary bladder, simulated ureter, and simulated kidneys comprising non-conductive materials (Lowe [0055], “the uterine assembly 200 includes a right fallopian tube 202, a left fallopian tube 204, a right ovary 206, a left ovary 208, a uterus 210 including a cervix 212 (not visible in FIG. 5), a bladder 214, ureters 216, a peritoneum 218, uterine vessels 220 (arteries and veins), ligaments 222 (i.e., round, uterosacral, infundibulopelvic, and cardinal ligaments), ovarian vessels 223 (arteries and veins) (not clearly visible in FIG. 6), and a perineum 224 with an integrated vagina 226 (not visible in FIG. 6). The fallopian tubes 202, 204 include fimbriae 205 at their free ends (i.e., ends not connected to the uterus 210). As a general matter, the anatomical inserts, including the uterine assembly 200, simulates the appearance and feel of realistic tissue, and the relative arrangement and dimensions of the simulated anatomic structures accurately reflect true anatomical relationships.”; also Lowe [0052], “The patient simulator 110 is shaped and configured to interface and interact with a wide variety of anatomical inserts 115, including by way of non-limiting example uterine assemblies, bowel inserts, and kidney inserts.”).
Lowe is analogous to Sakezles in view of Arnal, as both are drawn to the art of surgical simulation. 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 Sakezles in view of Arnal, to include wherein the simulated tissue structure is configured for simulating ovarian procedures, the simulated tissue structure comprising: one or more simulated fallopian tubes, simulated round ligaments, simulated ovarian ligaments, simulated IP ligament, simulated broad ligaments, simulated bladder flap, simulated uterine arteries and veins, simulated cardinal ligament, or simulated uterosacral ligaments comprising conductive materials; and one or more simulated ovaries, simulated rectum, simulated urinary bladder, simulated ureter, and simulated kidneys comprising non-conductive materials, as taught by Lowe, in order to provide patient care training sessions that is more realistic and includes additional simulated features (Lowe [0004]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Claim 32 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sakezles in view of Lowe and Arnal, and in further view of Park.
Regarding claim 32, Sakezles in view of Lowe and Arnal does not teach a surgical trainer having a top cover spaced apart from a base thereby defining an internal cavity, wherein the internal cavity is configured to receive the simulated tissue structure, and wherein the surgical trainer is configured to partially obstruct vision of the user of the internal cavity.
However, Park discloses a surgical trainer having a top cover spaced apart from a base thereby defining an internal cavity, wherein the internal cavity is configured to receive the simulated tissue structure, and wherein the surgical trainer is configured to partially obstruct vision of the user of the internal cavity (Park [0035], “The model 10 incorporates several layers that may be included in a simulated abdominal wall 13. Variable and various layers of foam and fabric, which each have various physical properties, including variable elasticity and hardness, thereby allowing for the recreation of abdominal wall feel, thickness, pathology, and variability. The "wall" 13 is stretched and affixed to and/or over any type of trainer box, frame or skeleton, such as shown generally as 14 in FIG. 2, that is adapted to allow an interface The outer "skin" 17 has components incorporated into it that affix it to a frame 14. Additionally, the skin 17 can be used to encase much of the remaining layers. Preferably, each layer has components incorporated into it to affix the layer to frame 14.”).
Park is analogous to Sakezles in view of Lowe, as both are drawn to the art of surgical simulations. 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 Sakezles in view of Lowe, to include a surgical trainer having a top cover spaced apart from a base thereby defining an internal cavity, wherein the internal cavity is configured to receive the simulated tissue structure, and wherein the surgical trainer is configured to partially obstruct vision of the user of the internal cavity, as taught by Park, in order to provide realistic, simulated skin, tissue and organ (Park [0017]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Claim 35 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sakezles in view of Humphries et al. (hereinafter “Humphries,” US 2006/0257836).
Regarding claim 35, Sakezles discloses a surgical simulation system for practicing electrosurgery (Sakezles Abstract, “dielectric properties models that are designed to enable simulated use testing by medical device companies, medical device designers, individual inventors, or any other entity interested in the performance of medical devices”), the system comprising:
a covering layer (see Sakezles Fig. 2, showing covering layers 131, 133, and 132) comprising:
a conductive layer that is operably severable under application of an electrical current (Sakezles [0093], “Tissue analog materials comprised of hydrogels are typically employed to construct tissues in which dielectric properties are simulated. Provided below are examples of hydrogel formulations that may be used. It is noted that such hydrogel materials are typically doped with metal (aluminum, tin, or iron) and nonmetal (silicon or carbon) powders and/or salts, as appropriate, to achieve or alter the dielectric properties of a material depending on the tissue intended to be simulated,” doped with metal powders), and
a non-conductive layer that is not operably severable under application of the electrical current, wherein an arrangement of the conductive layer and the non- conductive layer is configured to simulate pathways encountered in real surgical procedures (Sakezles [0093], “Tissue analog materials comprised of hydrogels are typically employed to construct tissues in which dielectric properties are simulated. Provided below are examples of hydrogel formulations that may be used. It is noted that such hydrogel materials are typically doped with metal (aluminum, tin, or iron) and nonmetal (silicon or carbon) powders and/or salts, as appropriate, to achieve or alter the dielectric properties of a material depending on the tissue intended to be simulated,” doped with non-metal powders); and
a simulated tissue structure (Sakezles [0084], “The artificial brain component 110 is contained within an artificial cranial encasing 130.”) comprising:
an inner layer that is adjacent to and in contact with the covering layer, wherein the inner layer defines an interior cavity (see Sakezles Fig. 2, showing artificial brain component 110 as the inner layer defining the interior cavity).
Sakezles does not teach wherein the simulated tissue structure is configured for transanal minimally invasive surgery for a local excision of a tumor, wherein portions of the simulated tissue structure comprises non-conductive material except for an area surrounding the tumor comprises conductive materials.
However, Humphries discloses wherein the simulated tissue structure is configured for transanal minimally invasive surgery for a local excision of a tumor, wherein portions of the simulated tissue structure comprises non-conductive material except for an area surrounding the tumor comprises conductive materials (Humphries [0005], “Electrosurgery procedures involve the application of RF electric fields to produce local heating. The goal is to destroy or to alter selected tissues. Applications include blood-vessel cauterization, incision sealing and minimally-invasive procedures for tumor destruction”; also Humphries [0080], “FIG. 8 shows a two dimensional slice plot of the electrical solution. Here, the probe 32 with length 3.0 cm is inserted in a 2.0 cm diameter tumor 54 within a liver 56. The calculation was performed in single octant with symmetry boundaries at x=0.0, y=0.0 and z=0.0 using a mesh of 74,000 elements. In the calculation, both the liver 56 and tumor 54 have the conductivity variation shown in FIG. 4. Electrical conductivity rises 2% per degree up to around 100.degree. C. where a sharp drop represents tissue vaporization.”).
Humphries is analogous to Sakezles, as both are drawn to the art of surgical 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 Sakezles, to include wherein the simulated tissue structure is configured for transanal minimally invasive surgery for a local excision of a tumor, wherein portions of the simulated tissue structure comprises non-conductive material except for an area surrounding the tumor comprises conductive materials, as taught by Humphries, in order to reduce the cost and time associated with certain experiments (Humphries [0006]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Allowable Subject Matter
Claims 33, 34, and 36-40 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest cited prior art of record to the claims is Sakezles. Sakezles teaches dielectric properties models designed to enable simulated use testing. However, Sakezles does not teach at least the limitations of providing electrosurgical uterus simulation, electrosurgical tumor excision simulation, reinforcing simulated skin with fabric, having a base with top cover, providing a try to receive the simulated tissue structure, and providing a simulated stomach with simulated gastric vessels and simulated mesentery/omentum comprising conductive materials for electrosurgery. None of the cited prior art references of record, alone or in combination, anticipate or render obvious at least these features of the claims.
Conclusion
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/STEPHEN ALVESTEFFER/ Examiner, Art Unit 3715