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 .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over David Warren Lee (US 20030176906 A1; hereinafter Lee) in view of John S. Eggert (US 6503087 B1; hereinafter Eggert).
Regarding claim 1, Lee discloses an electrical connector system for body portion, the electrical connector system comprising: a base (element 600 as shown in at least FIG. 1A, known as the “physician programmer”) configured to be fixedly secured to a portion of the body portion (examples shown to be connected to a body portion are found in FIG. 1A-B), the base including a magnetic component (“FIG. 2A is a front side view of a male connector interface of the present invention mounted to a magnet housing used in programming an implanted medical pump” (recited in at least: Lee paragraph [0012])); a first electrical interface component configured to be removably coupled to the base based, at least in part, on an interaction with the magnetic component; and a second electrical interface component configured to be removably coupled to the base based, at least in part, on an interaction with the magnetic component, wherein the second electrical interface component is structurally different than the first electrical interface component (“FIGS. 2A-C illustrate male connector interface 100, including at least one interface flange 110A and 110B. Male connector interface 100 further includes bearing surface 115. Male interface 100 is shown on magnet housing 120. Although FIGS. 2A-C show male interface 100 in relation to magnet housing 120, interface 100 can be used in relation to any other device of the programming system so long as the two devices to be connected carry different, interlocking interfaces, i.e., one male, one female. FIG. 2D illustrates the reverse side of magnet housing 120” (recited in at least: Lee paragraph [0030])). Lee does not disclose that the electrical connector system is used on a simulated body portion. Eggert teaches an interactive education system for teaching patient care that has systems in the simulated manikin, including having a base that has the ability to be connected to a simulated body portion as well as electrical systems that give biometric data to the user on an interface (see at least: FIGs 2, and 4-5 and the detailed descriptions).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have used the system of Lee in a simulated environment/manikin as taught in Eggert for the added benefit of allowing medical students to learn and train before treating real patients.
Regarding claim 2, Lee in view of Eggert teaches the claimed subject matter as stated above, and Eggert further teaches wherein the base is configured to be in electrical communication with EKG circuitry of the simulated body portion (“EKG monitor 12c comprises a 3, 5, or 12 lead system, including a real-time trace monitor and R-wave sonic markers, and a plurality of color-coded patches for attachment to a torso of the simulator 14” (recited in at least: Eggert [column 3, lines 57-60])).
Regarding claim 3, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further discloses wherein the base is configured to be in electrical communication with defibrillation circuitry of the simulated body portion (“Those skilled in the art will appreciate, however, that the present invention can be used in conjunction with any implanted medical devices, including, for example without limitation, neurostimulators, drug delivery devices, pacemakers, defibrillators, and cochlear implants, and that FIGS. 1A and 1B serve merely as examples of how the present invention can be used” (recited in at least: Lee paragraph [0030])).
Regarding claim 4, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further discloses wherein the base is configured to be fixedly secured to a skin layer of the simulated body portion (“which is brought into contact with a patient's skin” (recited in at least: Lee paragraph [0030])).
Regarding claim 5, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further suggests wherein magnetic component is annular (as shown in FIGs 2A-D, and 4A-B, there is a circular opening for the magnetic component and a person having ordinary skill in the art would use an annular magnet for the connection since it would fit into the geometry of the device).
Regarding claim 6, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further discloses wherein the first electrical interface component is configured to interface with a defibrillator connector (“Those skilled in the art will appreciate, however, that the present invention can be used in conjunction with any implanted medical devices, including, for example without limitation… defibrillators” (recited in at least: Lee paragraph [0030])).
Regarding claim 7, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further discloses wherein the first electrical interface component and base are configured to provide an electrical pathway between the defibrillator connector and defibrillation circuitry of the simulated body portion (“These devices provide treatment therapy by delivering electrical stimulation or drugs to various portions of the body and include, for example without limitation, neurostimulators, drug delivery devices, pacemakers, defibrillators, and cochlear implants. In the case of providing electrical stimulation, one or more electrodes are implanted within the body” (recited in at least: Lee paragraph [0004]).
Regarding claim 8, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further suggests wherein a non-conducting element separates the magnetic component from the electrical pathway between the defibrillator connector and the defibrillation circuitry of the simulated body portion. It would be obvious to a person having ordinary skill in the art before the effective filing date to use any well-known non-conducting element (such as plastic) separating the base that connects with the magnetic connection to the portion that collects biometric data to prevent the magnets from interfering with the reading.
Regarding claim 9, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further suggests wherein the first electrical interface component is further configured to be removably coupled to the base by a physical connection (“for example, a magnet housing having a male interface connector can be connected to a telemetry module for programming an implanted pump, and the magnet can be removed when the same telemetry module is used to program an INS. Likewise, the same telemetry module can be directly connected to a patient programmer or to an ENS” (recited in at least: Lee paragraph [0007])).
Regarding claim 10, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further suggests wherein the physical connection also provides an electrical connection (“Once a therapy is established, ENS 500 is disconnected, and INS 20 is connected to leads 25 and implanted within the body. As one skilled in the art will recognize, it would be advantageous to be able to uniformly connect telemetry head 330 to ENS 500 to facilitate programming and communications between the devices. Likewise, it would be advantageous to be able to communicate with INS 20 using the same telemetry module used to program an implanted pump like pump 10 shown in FIG. 1A, without a magnet attachment connected to the telemetry module” (recited in at least: Lee paragraph [0029])).
Regarding claim 11, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further suggests wherein the magnetic component is annular (as shown in FIGs 2A-D, and 4A-B, there is a circular opening for the magnetic component and a person having ordinary skill in the art would use an annular magnet for the connection since it would fit into the geometry of the device).
Regarding claim 12, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further discloses wherein a portion of the first electrical interface component extends through a central opening of the magnetic component when the first electrical interface is removably coupled to the base (“FIGS. 5A and 5B illustrate a magnet housing 120 connected to telemetry module 330 via the uniform connector interface of the present invention. In this configuration, telemetry module 330 can be used to program an implanted pump. Alternatively, magnet housing 120 can be removed, and telemetry module 330 can be used to program an INS” (recited in at least: Lee paragraph [0035])).
Regarding claim 13, Lee in view of Eggert teaches the claimed subject matter as stated above, and Eggert further teaches wherein the second electrical interface component is configured to interface with an EKG patch (“EKG monitor 12c comprises a 3, 5, or 12 lead system, including a real-time trace monitor and R-wave sonic markers, and a plurality of color-coded patches for attachment to a torso of the simulator 14” (recited in at least: Eggert [column 57-60])).
Regarding claim 14, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further suggests wherein the second electrical interface component includes a planar surface (the surface as shown in at least FIGs 2A-D are planar).
Regarding claim 15, Lee in view of Eggert teaches the claimed subject matter as stated above, and Eggert further suggests wherein the second electrical interface component and the base are configured to provide an electrical pathway between the EKG patch and the EKG circuitry of the simulated body portion. It would be obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to know that a pathway needs to be between the EKG patch and the circuitry for the user of the electrical connector system to be able to collect biometric data that is relevant to the simulated learning lesson.
Regarding claim 16, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further suggests wherein the second electrical interface component is further configured to be removably coupled to the base by a physical connection (“for example, a magnet housing having a male interface connector can be connected to a telemetry module for programming an implanted pump, and the magnet can be removed when the same telemetry module is used to program an INS. Likewise, the same telemetry module can be directly connected to a patient programmer or to an ENS” (recited in at least: Lee paragraph [0007])).
Regarding claim 17, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further suggests wherein the physical connection also provides an electrical connection to the base (“Once a therapy is established, ENS 500 is disconnected, and INS 20 is connected to leads 25 and implanted within the body. As one skilled in the art will recognize, it would be advantageous to be able to uniformly connect telemetry head 330 to ENS 500 to facilitate programming and communications between the devices. Likewise, it would be advantageous to be able to communicate with INS 20 using the same telemetry module used to program an implanted pump like pump 10 shown in FIG. 1A, without a magnet attachment connected to the telemetry module” (recited in at least: Lee paragraph [0029])).
Regarding claim 18, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further suggests wherein the magnetic component is annular (as shown in FIGs 2A-D, and 4A-B, there is a circular opening for the magnetic component and a person having ordinary skill in the art would use an annular magnet for the connection since it would fit into the geometry of the device).
Regarding claim 19, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further suggests wherein a portion of the second electrical interface component extends through a central opening of the magnetic component when the second electrical interface is removably coupled to the base (“for example, a magnet housing having a male interface connector can be connected to a telemetry module for programming an implanted pump, and the magnet can be removed when the same telemetry module is used to program an INS. Likewise, the same telemetry module can be directly connected to a patient programmer or to an ENS” (recited in at least: Lee paragraph [0007])).
Regarding claim 20, Lee in view of Eggert teaches the claimed subject matter as stated above, and Lee further suggests a plurality of the bases; a plurality of the first electrical interface components; and a plurality of the second electrical interface components (in a classroom setting, it would be obvious to a person having ordinary skill in the art to have a plurality of the devices so that all the students can practice).
Response to Arguments
35 U.S.C. § 103:
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/SELWA A ALSOMAIRY/Examiner, Art Unit 3715 /Jay Trent Liddle/Primary Examiner, Art Unit 3715