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 .
Election/Restrictions
Applicant’s election without traverse of invention I (claims 1-11 and 17-20) in the reply filed on 10/8/25 is acknowledged. Claims 12-16 are withdrawn, and claims 1-11 and 17-20 are under examination.
Claim Rejections – 35 USC 102 (AIA )
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9 and 17-19 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2009/0298034 to PARRY.
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 (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 into which the simulated skin is integrated (FIG. 1 and 2, ref. 4-8 layers of skin replica 1; FIG. 11a and 11b, ref. 5; 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).
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) that is formed of a ballistic material, medical gel or another gel (par. 0061: Upon removal of the needle 10, the elastic properties of the polymers and fabric cause the cavity 11 to collapse or close, much like human tissues, to nearly at least the original condition of the skin replica 1), 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).
Regarding claim 2, PARRY further teaches wherein the simulated skin is 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).
Regarding claim 3, PARRY further teaches wherein the simulated tissue is a ballistic material, medical gel, or another gel (par. 0061: Upon removal of the needle 10, the elastic properties of the polymers and fabric cause the cavity 11 to collapse or close, much like human tissues, to nearly at least the original condition of the skin replica 1).
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).
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 Rejections - 35 USC § 103 (AIA )
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 10, 11, and 20 are rejected under 35 U.S.C. 103 as being obvious over PARRY, as applied to claims 1 and 17, in view of US 2020/0126449 A1 to HORST.
Regarding claim 10, PARRY teaches the elements above, but fails to expressly disclose one or more cameras for capturing images or video of the simulated tissue or the one or more simulated veins.
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 for providing feedback indicative of a location of a needle relative to the one or more simulated veins.
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). However, PARRY does not expressly disclose one or more cameras for capturing images or videos inside the vein simulator.
However, HORST teaches a vascular access training simulator system (Abstract) for pre-treatment planning and/or for training clinicians how to perform an ultrasound guided needle insertion and allows clinicians to complete the insertion procedure with subsequent guidewire or catheter device components in order to practice the procedure and build further competency by visualizing the insertion in an anatomical training model (par. 0072). HORST discloses that such training is advantageous in order to understand what went wrong during the insertion procedure before trying it on a human patient (par. 0072). HORST further discloses the system is configured to capture and record multiple views of the insertion procedure on video, including inside the anatomical model, and to display each video recording in real-time on a single display screen or monitor 200, such as a computer screen, thus allowing the clinician or onlookers to easily view the procedure live in real-time from various different viewpoints (par. 0075; 0092). Additionally, HORST discloses using an imaging device 170, such as an ultrasound machine, configured to capture and record a video showing an ultrasound guidance view of the simulated blood vessel 124 during the insertion procedure, the ultrasound machine 170 may further comprise an ultrasound display screen 174 configured to display the ultrasound guidance view during needle insertion into the puncture insert 115 and the associated simulated body tissue 122 and simulated blood vessel 124 (par. 0076). 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 imaging devices, i.e., sensors, including cameras configured to capture a view inside the anatomical model and a display device for providing visual feedback , as taught by HORST, into the invention of PARRY, in order to provide real-time visual feedback showing needle advancement to a vessel, i.e., vein, thereby improving pre-treatment planning and/or needle insertion training.
Conclusion
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