DETAILED ACTION
Remarks
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The Amendment filed 5/11/26 has been entered. Claim(s) 1-11 and 17-20 are pending in the application and are under examination.
Claim Rejections - 35 USC § 103 (AIA )
Claims 1 and 3-9 are rejected under 35 U.S.C. 103 as being obvious over US 2009/0298034 to PARRY in view of US 2020/0126449 A1 to HORST.
Regarding claim 1, PARRY teaches a vein simulator (FIG. 11a and 11b; Abstract: wearable wound simulant including a skin replica; par. 0019: wearable wound simulant could include one or more tubes, replicating the resiliency of vascular elements; par. 0072: a supply tube 25, replicating the functionality of a vein, artery, or other vascular structure, could be embedded within a skin replica 1) comprising: simulated skin, wherein the simulated skin forms an outermost surface of the vein simulator (FIG. 1 and 2, ref. 2-3 of skin replica 1; FIG. 11a and 11b, showing an outermost upper layer representing skin; par. 0052: skin replica 1 replicates or approximates the visual characteristics of human skin via the layered arrangement of polymer layers; par. 0053: highlight layers 2, 3 are the outermost or exterior layers of the skin replica 1); simulated tissue into which the simulated skin is integrated…forming an innermost surface of the vein simulator and contacting the simulated skin (FIG. 1 and 2, ref. 4-8 layers of skin replica 1; FIG. 11a and 11b, showing multi-layer simulated tissue below the upper most skin layer and comprising an innermost layer of the simulator, comprising a simulated vein 25 integrated into the multi-layer simulated tissue; par. 0062: Fabrication of a skin replica 1 includes the layered application of one or more silicone polymers and fabric sheets…The bond between two polymer layers is preferred to be a chemical or adhesive bond at least as strong as the weakest polymer); and one or more simulated veins that are embedded into the simulated tissue (FIG. 11a and 11b, ref. 25; par. 0072: a supply tube 25, replicating the functionality of a vein…could be embedded within a skin replica 1). To the extent PARRY does not disclose wherein the simulated tissue comprises a gel, HORST teaches making a simulated tissue with tissue-mimicking gelatin configured to imitate the ultrasound properties of human tissue, the stiffness and feel of human tissue, and the penetration forces and characteristics of human tissue during venipuncture (par. 0087). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of gelatin as a material for simulated tissue, as taught by HORST, into the invention of PARRY, in order to more accurately mimic human-tissue using a known technique, thereby providing a more realistic training experience.
Regarding claim 3, PARRY further teaches the elements above, but does not disclose wherein the simulated tissue is a ballistic gel. However, HORST further teaches the gel used for the simulated tissue includes a ballistic gel, which HORST describes as maintaining the desired transparency while also simulating human subcutaneous fat and connective tissue (par. 0087). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of ballistics gel as a material for simulated tissue, as taught by HORST, into the invention of PARRY, in order to more accurately mimic human-tissue, including maintains the desired transparency while also simulating human subcutaneous fat and connective tissue, using a known technique, thereby providing a more realistic training experience.
Regarding claim 4, PARRY further teaches wherein the one or more simulated veins are a tubular elastomeric material (FIG. 11a and 11b, ref. 25; par. 0072: a supply tube 25, replicating the functionality of a vein…could be embedded within a skin replica 1… supply tube 25 is a compressible, translucent tube disposed between a base layer 4 and a backup layer 6 so as to allow deflection thereof when a force 17 is applied by a tourniquet or the like, as represented in FIG. 11b; claim 13: tube approximating the resiliency of a vascular element).
Regarding claim 5, PARRY further teaches wherein the simulated skin is integrated into the simulated tissue by causing the simulated tissue to solidify while in contact with the simulated skin (par. 0062: Fabrication of a skin replica 1 includes the layered application of one or more silicone polymers and fabric sheets…The bond between two polymer layers is preferred to be a chemical or adhesive bond at least as strong as the weakest polymer; par. 0063: a pigmented silicone polymer is applied onto the second highlight layer 3 forming a base layer 4 and thereafter a fabric layer 5 is applied to the base layer 4 before the base layer 4 cures. Thereafter, the base layer 4 is cured at room temperature. Next, a pigmented silicone polymer is applied onto the fabric layer 5 so as to fully impregnate the fabric with polymer. Thereafter, the polymer is cured at room temperature).
Regarding claim 6, PARRY further teaches wherein the simulated skin includes a protruding vein channel (FIG. 11a and 11b, showing skin replica 1 includes a protruding channel in the outer layers to accommodate supply tube 25 replicating a vein).
Regarding claim 7, PARRY further teaches wherein a first simulated vein of the one or more simulated veins extends along the protruding vein channel (FIG. 11a and 11b, showing supply tube 25 replicating a vein extending along the protruding channel).
Regarding claim 8, PARRY further teaches wherein an inner section of the simulated skin is integrated into the simulated tissue (par. 0062: Fabrication of a skin replica 1 includes the layered application of one or more silicone polymers and fabric sheets…The bond between two polymer layers is preferred to be a chemical or adhesive bond at least as strong as the weakest polymer) and end portions of the simulated skin are not integrated into the simulated tissue (par. 0070: flaps 45 extend from the leg simulant 19 so as to encircle the body part onto which the simulant is applied; par. 0071: a closable fastener system 23, one example being a zipper, could be provided along the length of an arm simulant 22 to secure it onto an actor).
Regarding claim 9, PARRY further teaches wherein the end portions of the simulated skin include one or more fasteners for interconnecting the end portions (FIG. 9a and 9b; par. 0070: flaps comprise hook-and-loop, i.e., VELCRO; FIG. 10a and 10b; par. 0071: closable fastener system comprises zipper).
Claim 2 is rejected under 35 U.S.C. 103 as being obvious over PARRY in view of HORST, as applied to claim 1, in further view of US 2021/0129393 A1 to EHERENFELDT.
Regarding claim 2, PARRY further teaches the elements above, but does not disclose wherein the simulated skin is leather or artificial leather. However, EHERENFELDT teaches a surgical simulation system comprising anatomical components such as simulated skin tissue made of leather which simulate the mechanical properties of human skin (par. 0068; 0088). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of leather for a simulated skin tissue, as taught by EHERENFELDT, into the invention of PARRY, in order to use a known material that simulates human skin properties, thereby providing a more realistic training experience.
Claim 10 is rejected under 35 U.S.C. 103 as being obvious over PARRY in view of HORST, as applied to claim 1, in further view of US 5,945,056 to DAY.
Regarding claim 10, PARRY teaches the elements above, but fails to expressly disclose one or more cameras disposed within the one or more simulated veins for capturing images or video of the one or more simulated veins.
However, DAY teaches a surgical simulator (Abstract) comprising a simulated vein (col. 1, lines 30-40) and a video camera (angioscope) wherein to facilitate the simulated surgical operation, an angioscope, a miniaturized video camera is used to relay the internal images of the vein to a television camera (col. 4, lines 10-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the angioscope (i.e., miniaturized video camera) placed inside a simulated vein, as taught by DAY, into the modified simulator of PARRY, in order to facilitate the simulated surgical operation including relaying an internal image of the vein to a television camera, thereby allowing the simulator user to see inside during the simulation.
Claim 11 is rejected under 35 U.S.C. 103 as being obvious over PARRY in view of HORST, as applied to claim 1, in further view of CA 3000164 to FLAMAND.
Regarding claim 11, PARRY teaches the elements above and further discloses the invention facilitates visual, tactile, and functional aspects of a battlefield wound facilitating the diagnosis of injuries and implementation of treatments, and further facilitates treatment of a wound including the insertion of a needle (par. 0020). However, PARRY does not expressly disclose one or more sensors extending along a length of the one or more simulated veins for providing feedback indicative of a location of a needle relative to the one or more simulated veins. However, FLAMAND teaches a method and system for simulating an insertion of an elongated instrument into a subject that may occur during a surgery procedure (pg. 6, lines 23-24) comprising a medical or body simulating apparatus, an elongated medical instrument insertable at least partially into the medical apparatus, a sensing unit, a simulation computer machine provided at least with a processing unit configured for generating medical images, and a display unit for displaying the generated medical images thereon (pg. 7, lines 8-13). FLAMAND discloses the medical apparatus may be an artery or vein in which the elongated instrument is to be inserted (pg. 16, lines 3-13) and the sensing unit may comprise a linear position tracking device, such as a capacitive displacement sensor (pg. 18, lines 23-27). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the linear position tracking device comprising a capacitive sensor for measuring position of a medical instrument into a simulated vein, as taught by FLAMAND, into the modified invention of PARRY, in order to generate a medical image corresponding to the position of the inserted needle relative to the simulated vein using a known technique for tracking the position of a medical instrument in a simulated body, thereby providing an accurate representation simulating the insertion of an elongated instrument into a subject.
Claims 17-19 are rejected under 35 U.S.C. 103 as being obvious over PARRY in view of HORST and FLAMAND.
Regarding claim 17, PARRY teaches a vein simulator (FIG. 11a and 11b; Abstract: wearable wound simulant including a skin replica; par. 0019: wearable wound simulant could include one or more tubes, replicating the resiliency of vascular elements; par. 0072: a supply tube 25, replicating the functionality of a vein, artery, or other vascular structure, could be embedded within a skin replica 1) comprising: simulated skin that is formed of leather, artificial leather or another human skin analogue (FIG. 1 and 2, ref. 2-3 of skin replica 1; FIG. 11a and 11b, ref. par. 0052: skin replica 1 replicates or approximates the visual characteristics of human skin via the layered arrangement of polymer layers; par. 0053: highlight layers 2, 3 are the outermost or exterior layers of the skin replica 1); simulated tissue (FIG. 1 and 2, ref. 4-8 layers of skin replica 1; FIG. 11a and 11b, ref. 5)…the simulated skin being integrated into the simulated tissue (par. 0062: Fabrication of a skin replica 1 includes the layered application of one or more silicone polymers and fabric sheets…The bond between two polymer layers is preferred to be a chemical or adhesive bond at least as strong as the weakest polymer); and a simulated vein that is embedded in the simulated tissue (FIG. 11a and 11b, ref. 25; par. 0072: a supply tube 25, replicating the functionality of a vein…could be embedded within a skin replica 1). To the extent PARRY does not disclose the simulated tissue formed of a ballistic material, medical gel or another gel, HORST teaches making a simulated tissue with tissue-mimicking gelatin configured to imitate the ultrasound properties of human tissue, the stiffness and feel of human tissue, and the penetration forces and characteristics of human tissue during venipuncture (par. 0087). Additionally, HORST teaches the gel used for the simulated tissue includes a ballistic gel, which HORST describes as maintaining the desired transparency while also simulating human subcutaneous fat and connective tissue (par. 0087). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of gelatin as a material for simulated tissue, as taught by HORST, into the invention of PARRY, in order to more accurately mimic human-tissue using a known technique, thereby providing a more realistic training experience. To the extent PARRY does not disclose a capacitive sensor lining a sidewall of the simulated vein, wherein the capacitive sensor is configured to generate a signal that represents a proximity of a needle, FLAMAND teaches a method and system for simulating an insertion of an elongated instrument into a subject that may occur during a surgery procedure (pg. 6, lines 23-24) comprising a medical or body simulating apparatus, an elongated medical instrument insertable at least partially into the medical apparatus, a sensing unit, a simulation computer machine provided at least with a processing unit configured for generating medical images, and a display unit for displaying the generated medical images thereon (pg. 7, lines 8-13). FLAMAND discloses the medical apparatus may be an artery or vein in which the elongated instrument is to be inserted (pg. 16, lines 3-13) and the sensing unit may comprise a linear position tracking device, such as a capacitive displacement sensor (pg. 18, lines 23-27). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the linear position tracking device comprising a capacitive sensor for measuring position of a medical instrument into a simulated vein, as taught by FLAMAND, into the modified invention of PARRY, in order to generate a medical image corresponding to the position of the inserted needle relative to the simulated vein using a known technique for tracking the position of a medical instrument in a simulated body, thereby providing an accurate representation simulating the insertion of an elongated instrument into a subject.
Regarding claim 18, PARRY further teaches wherein the simulated skin and the simulated tissue form a protruding vein channel and the simulated vein extends along the protruding vein channel (FIG. 11a and 11b, showing skin replica 1 includes a protruding channel in the outer layers to accommodate supply tube 25 replicating a vein, and showing the supply tube 25 extending along the protruding channel).
Regarding claim 19, PARRY further teaches wherein the simulated skin is configured to secure the vein simulator to a manikin (par. 0070: flaps 45 extend from the leg simulant 19 so as to encircle the body part onto which the simulant is applied; par. 0071: a closable fastener system 23, one example being a zipper, could be provided along the length of an arm simulant 22 to secure it onto an actor; FIG. 9a and 9b; par. 0070: flaps comprise hook-and-loop, i.e., VELCRO; FIG. 10a and 10b; par. 0071: closable fastener system comprises zipper).
Claim 20 is rejected under 35 U.S.C. 103 as being obvious over PARRY in view of HORST and FLAMAND, as applied to claim 17, in further view of DAY.
Regarding claim 20, PARRY teaches the elements above and further discloses a wearable wound simulant capable of replicating such properties so as to facilitate a realistic medical training tool (par. 0013). To the extent PARRY does not disclose one or more cameras disposed within the simulated tissue for capturing images or videos inside the vein simulator, DAY teaches a surgical simulator (Abstract) comprising a simulated vein (col. 1, lines 30-40) and a video camera (angioscope) wherein to facilitate the simulated surgical operation, an angioscope, a miniaturized video camera is used to relay the internal images of the vein to a television camera (col. 4, lines 10-17). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the angioscope (i.e., miniaturized video camera) placed inside a simulated vein, as taught by DAY, into the modified simulator of PARRY, in order to facilitate the simulated surgical operation including relaying an internal image of the vein to a television camera, thereby allowing the simulator user to see inside during the simulation.
RESPONSE TO ARGUMENTS
35 USC § 102 and 103 – Rejections
Applicant's arguments filed 5/11/26 have been fully considered but they are not persuasive. The previous rejections are withdrawn in view of the amendment filed 5/11/26, but new grounds of rejection are set forth in this Office Action as necessitated by claim amendment. Further, Applicant argues that the previously applied prior art references, i.e., PARRY and HORST, do not teach or suggest the newly added limitations of claim 1 or 17. Although PARRY does not disclose using gel as recited in claim 1, PARRY in view of HORST render this limitation obvious under 35 USC 103 (see rejection). Additionally, although PARRY and HORST do not teach using a capacitive sensor as recited in claim 17, a new ground of rejection is set forth in this Office Action rendering this limitation obvious under 35 USC 103 (see rejection). Therefore, Applicant’s arguments are moot.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Hull whose telephone number is 571-272-0996. The examiner can normally be reached on Monday-Friday from 8:00am to 5:00pm MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached at telephone number 571-272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES B HULL/Primary Examiner, Art Unit 3715
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