DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to claims in application 19/030,688 filed on 1/17/2025.
The instant application claims benefit to provisional application #63/623,203 with a priority date of 1/19/2024.
The Pre-Grant publication #2025/0239185 is published on 7/4/2025.
Claims 1-20 are pending.
Claim Rejections - 35 USC § 102
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 1-4,11-14 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by US 20210225203 A1 to Rodriguez et al. (Rodriguez).
Claim 1. Rodriguez teaches a patient simulator, comprising:
a simulated torso ( Fig.1 element 100 torso included); and
a plurality of overlays configured to be coupled to the simulated torso, wherein each of the plurality of overlays includes a simulated skin layer and one or more engagement features (Fig.4,5 element 265 Para 0057; 3 overlays and simulated skin 265 into which one or more optical fibers 270 are embedded to provide dynamic skin color control) , wherein:
the simulated skin layer is sized and shaped to match an exterior surface of the simulated torso (Para 0057 one or more optical fibers can each be shaped into a single strand or layered to cover a larger area, size and shaped accordingly as alternatively be embedded into simulated skin elsewhere on the patient simulator e.g., as an overlay on the simulated neck, the simulated torso, the simulated right arm the simulated left arm, the simulated right leg , the simulated left leg, or any combination thereof)
the one or more engagement features are configured to engage with one or more corresponding engagement features of the simulated torso ( Para 0063 engagement features and coupling of mating engagements); and
each of the plurality of overlays is configured to represent a different medical scenario ( Para 0049 processing module to simulate different medical and/or surgical scenarios during operation of the patient simulator)
Claim 2. Rodriguez teaches the patient simulator of claim 1, wherein the different medical scenarios comprise different levels and/or types of trauma (Para 0055 simulated respiratory features for medical scenario of different levels of trauma adapted from coupled compressor and other operating equipment such as compressor adapted to supply pneumatic pressure to the one or more simulated respiratory features for natural respiratory processes e.g., breathing of a human patient).
Claim 3. Rodriguez teaches the patient simulator of claim 1, wherein the one or more engagement features comprise one or more projections and the one or more corresponding engagement features comprise one or more recesses or openings (Para 0064 alignment and mating engagement between the upper electronic multi-connector port and the lower electronic multi-connector port, power and/or communication can be passed from the power source and/or the control unit 215 contained in the simulated torso 115 to various features/components contained in the simulated neck 110 and/or the simulated head 105 (e.g., sensors, actuators, etc.).
Claim 4. Rodriguez teaches the patient simulator of claim 1, wherein the one or more engagement features comprise one or more recesses or openings and the one or more corresponding engagement features comprise one or more projections (Para 0084 alignment and mating engagement e.g. latch extending within the recess adjacent the pin hole in the simulated torso with one or more projections for various features/components e.g. for sensors, actuators, etc.).
Claim 11. . Rodriguez teaches a plurality of overlays for use with a patient simulator, the plurality of overlays comprising: a plurality of overlays configured to be coupled to a simulated torso, wherein each of the plurality of overlays includes a simulated skin layer and one or more engagement features, wherein: the simulated skin layer is sized and shaped to match an exterior surface of the simulated torso; the one or more engagement features are configured to engage with one or more corresponding engagement features of the simulated torso; and each of the plurality of overlays is configured to represent a different medical scenario. (Para 0057 one or more optical fibers can each be shaped into a single strand or layered to cover a larger area, size and shaped accordingly as alternatively be embedded into simulated skin elsewhere on the patient simulator e.g., as an overlay on the simulated neck, the simulated torso, the simulated right arm the simulated left arm, the simulated right leg , the simulated left leg, or any combination thereof; engagement features are configured to engage with one or more corresponding engagement features of the simulated torso; Para 0063 engagement features and coupling of mating engagements; Para 0049 processing module to simulate different medical and/or surgical scenarios during operation of the patient simulator)
Claim 12. Rodriguez teaches the plurality of overlays of claim 11, wherein the different medical scenarios comprise different levels and/or types of trauma (Para 0055 simulated respiratory features for medical scenario of different levels of trauma adapted from coupled compressor and other operating equipment such as compressor adapted to supply pneumatic pressure to the one or more simulated respiratory features for natural respiratory processes e.g., breathing of a human patient.
Claim 13. Rodriguez teaches the plurality of overlays of claim 11, wherein the one or more engagement features comprise one or more projections and the one or more corresponding engagement features comprise one or more recesses or openings (Para 0064 alignment and mating engagement between the upper electronic multi-connector port and the lower electronic multi-connector port, power and/or communication can be passed from the power source and/or the control unit contained in the simulated torso to various features/components contained in the simulated neck and/or the simulated head (e.g., sensors, actuators, etc.).
Claim 14. Rodriguez teaches the plurality of overlays of claim 11, wherein the one or more engagement features comprise one or more recesses or openings and the one or more corresponding engagement features comprise one or more projections (Para 0084 alignment and mating engagement e.g. latch extending within the recess adjacent the pin hole in the simulated torso with one or more projections for various features/components e.g. for sensors, actuators, etc.) .
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.
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.
Claims 5-10, 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Patent Application Publication Number US 20210225203 A1 to Rodriguez et al. (Rodriguez) in view of Patent Application Publication Number US 20140272876 A1 (US Patent 9437117 B2 ) to Carvajal l et al. ( Carvajal).
Claim 5. Rodriguez teaches the patient simulator of claim 1 wherein simulated skin layer is not identified as an exact offset of the exterior surface of a lower region of the simulated torso. Carvajal, however, teaches a simulated skin layer that could be identified as an exact offset of the exterior surface of a region of the simulated torso (Carvajal: Para 0093 ensure skin boundaries of the tummy cover so to offset exterior surface and the lower torso are concealed). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to incorporate wherein the simulated skin layer is an exact offset of the exterior surface of a lower region of the simulated torso, as taught by Carvajal, into the patient simulator of Rodriguez, in order to facilitate secure coupling of the tummy cover to the torso of a patient simulator in an aligned manner)
Claim 6. Rodriguez in combination with Carvajal teaches the patient simulator of claim 5, wherein each of the plurality of overlays includes a portion configured to extend into an interior portion of a vaginal canal of the simulated torso (Carvajal: Fig.13 para 0093 tummy overlay cover include locking mechanism securing the overlay to the torso of the maternal patient simulator to include vaginal canal) .
Claim 7. Rodriguez in combination teaches the patient simulator of claim 1, wherein each of the plurality of overlays is configured to be coupled to the simulated torso without an adhesive.
Claim 8. Rodriguez in combination teaches the patient simulator of claim 7, wherein each of the plurality of overlays is formed of a blend of silicone materials (Rodriguez: Para 0081 blend of silicone tube).
Claim 9. Rodriguez in combination with teaches the patient simulator of claim 8, wherein each of the plurality of overlays is painted to represent the different medical scenarios (Rodriguez: Para 0057 color control for paints) .
Claim 10. Rodriguez in combination teaches the patient simulator of claim 9, wherein the different medical scenarios include one or more of a bruise, a wound, or a lesion (Carvajal: Para 0104 control system defines the amount of dilation of the cervix for a particular medical scenario independent of the descent of the fetal simulator along the birth canal such that a possible a bruise, a wound, or a lesion medical scenario could be adjusted).
Claim 15. Rodriguez in combination teaches the plurality of overlays of claim 11, 1 wherein simulated skin layer is not identified as an exact offset of the exterior surface of a lower region of the simulated torso. Carvajal, however, teaches a simulated skin layer that could be identified as an exact offset of the exterior surface of a region of the simulated torso (Carvajal: Para 0093 ensure skin boundaries of the tummy cover so to offset exterior surface and the lower torso are concealed). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to incorporate wherein the simulated skin layer is an exact offset of the exterior surface of a lower region of the simulated torso, as taught by Carvajal, into the patient simulator of Rodriguez, in order to facilitate secure coupling of the tummy cover to the torso of a patient simulator in an aligned manner).
Claim 16 Rodriguez in combination teaches the plurality of overlays of claim 15, wherein each of the plurality of overlays includes a portion configured to extend into an interior portion of a vaginal canal of the simulated torso (Fig.13 para 0093 tummy overlay cover include locking mechanism securing the overlay to the torso of the maternal patient simulator to include vaginal canal ).
Claim 17. Rodriguez in combination teaches the plurality of overlays of claim 11, wherein each of the plurality of overlays is configured to be coupled to the simulated torso without an adhesive (Para 0094 insert is held in place securely using snaps i.e. without adhesive).
Claim 18. Rodriguez in combination teaches the plurality of overlays of claim 17, wherein each of the plurality of overlays is formed of a blend of silicone materials (Rodriguez: Para 0081 blend of silicone tube).
Claim 19. Rodriguez in combination teaches the plurality of overlays of claim 18, wherein each of the plurality of overlays is painted to represent the different medical scenarios (Rodriguez: Para 0057 color control for paints) .
Claim 20. Rodriguez in combination teaches the plurality of overlays of claim 19, wherein the different medical scenarios include one or more of a bruise, a wound, or a lesion (Carvajal: Para 0104 control system defines the amount of dilation of the cervix for a particular medical scenario independent of the descent of the fetal simulator along the birth canal such that a possible a bruise, a wound, or a lesion medical scenarios could also be adjusted).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 9437117 B2 Carvajal; Miguel et al.
Birthing Simulation Devices, Systems, and Methods
US 8500452 B2 Trotta; Thomas Neil et al.
Interactive education system for teaching patient care
US 8696362 B2 Eggert; John S. et al.
Interactive education system for teaching patient care.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SADARUZ ZAMAN whose telephone number is (571)270-3137. The examiner can normally be reached M-F 9am to 5pm CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai can be reached at (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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/S.Z/Examiner, Art Unit 3715 July 23, 2026
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715
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