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 .
Application Status
Present office action is in response to application filed 01/17/2025. Claims 1-19 are currently pending in the application.
Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, 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 negatived by the manner in which the invention was made.
Claims 1-6, 9-10 and 13-17 are rejected under 35 U.S.C. 103 as obvious over Rodriguez et al. (US 20210225203 A1) (Rodriguez) in view of Kehoe (US 20060183964 A1) (Parry).
Re claims 1-6, 9-10 and 13-17:
[Claims 1-5] Rodriguez teaches or at least suggests a patient simulator, comprising: a simulated head; a simulated neck coupled to the simulated head (at least ¶ 5: FIG. 1 is a perspective view of a patient simulator including a simulated torso, a simulated head, a simulated neck ); a simulated left vocal cord assembly positioned within at least one of the simulated head or the simulated neck; and a simulated right vocal cord assembly configured to be selectively engage with the simulated healthy vocal assembly (at least ¶ 65: … a left vocal cord assembly 480, and a right vocal cord assembly 485).
Rodriguez appears to be silent on the simulated left vocal cord assembly and the simulated right vocal cord assembly being respectively a simulated healthy vocal cord assembly and a simulated abnormal vocal cord assembly, ([Claim 2]) wherein the simulated abnormal vocal cord assembly includes a body having a simulated vocal cord portion simulating natural vocal cords that have been subject to trauma, ([Claim 3]) wherein the vocal cord portion includes a central opening narrower than a central opening of the simulated healthy vocal cord assembly, ([Claim 4]) wherein the simulated vocal cord portion further includes a color and/or a texture simulating the natural vocal cords that have been subject to trauma, ([Claim 5]) wherein the color and/or the texture of the simulated vocal cord portion is different than a corresponding color and/or texture of the simulated healthy vocal cord assembly. However, it is common knowledge that, like any organ in the human body, vocal cords may be healthy or unhealthy, as evident in Kehoe (¶ 2) “Certain individuals develop vocal nodules as a result of excessive vocal intensity. These nodules on the individual's vocal folds (also known as vocal cords) begin as a reddening, then thicken, swell, turn gray and, in the last stage, become fibrotic and callous-like”. Hence, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, when faced with the issue of providing “a patient simulator that expands the functionality of the simulators by increasing the realism of the look, feel, and functionality of the simulators that can be used to train medical personnel in a variety of clinical situations” (Rodriguez, ¶ 48), one would have looked to incorporate the known multi-stage visual symptoms of vocal cord disorders like vocal nodules, as taught by Kehoe and modify Rodriguez as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
[Claim 6] Rodriguez in view of Kehoe teaches or at least suggests wherein the simulated abnormal vocal cord assembly includes a body and a support structure within the body (at least Rodriguez: ¶ 65: … The laryngospasm assembly 470 includes a mounting bracket 475, a left vocal cord assembly 480, and a right vocal cord assembly 485. The mounting bracket 475 includes a base plate 490, a left support plate 495, and a right support plate 500. The left support plate 495 extends transversely from the base plate 490. The right support plate 500 extends transversely from the base plate 490, opposite the left support plate 495. As a result, the base plate 490, the left support plate 495, and the right support plate 500, in combination, are generally “U”-shaped. In several embodiments, as in FIGS. 13-15, the left support plate 495 and the right support plate 500 are spaced in a parallel relation).
[Claims 13-17] Rodriguez teaches or at least suggests a plurality of vocal cord assemblies for use with a patient simulator, the plurality of vocal cord assemblies comprising: a first simulated vocal cord assembly; and a second simulated vocal cord assembly (at least ¶ 5: FIG. 1 is a perspective view of a patient simulator including a simulated torso, a simulated head, a simulated neck; ¶ 65: … a left vocal cord assembly 480, and a right vocal cord assembly 485).
Rodriguez appears to be silent on the first simulated vocal cord assembly being a first simulated abnormal vocal cord assembly configured to selectively engage with a simulated healthy vocal assembly of the patient simulator, the first simulated abnormal vocal cord assembly simulating a first vocal cord trauma configured to selectively engage with the simulated healthy vocal assembly of the patient simulator, and the second simulated vocal cord assembly being a second simulated abnormal vocal cord assembly simulating a second vocal cord trauma different than the first vocal cord trauma, ([Claim 14]) wherein each of the first and second simulated abnormal vocal cord assemblies includes a simulated vocal cord portion having a central opening narrower than a central opening of the simulated healthy vocal cord assembly, ([Claim 15]) wherein: the simulated vocal cord portion of the first simulated abnormal vocal cord assembly further includes a color and/or a texture simulating the first vocal cord trauma; and the simulated vocal cord portion of the second simulated abnormal vocal cord assembly further includes a color and/or a texture simulating the second vocal cord trauma, ([Claim 16]) wherein: the color and/or the texture of the simulated vocal cord portion of the first simulated abnormal vocal cord assembly is different than a corresponding color and/or texture of the simulated healthy vocal cord assembly; and the color and/or the texture of the simulated vocal cord portion of the second simulated abnormal vocal cord assembly is different than a corresponding color and/or texture of the simulated healthy vocal cord assembly, ([Claim 17]) wherein the first vocal cord trauma is a Grade II vocal cord trauma and the second vocal cord trauma is a Grade IV vocal cord trauma However, it is common knowledge that, like any organ in the human body, vocal cords may be healthy or unhealthy, as evident in Kehoe (¶ 2) “Certain individuals develop vocal nodules as a result of excessive vocal intensity. These nodules on the individual's vocal folds (also known as vocal cords) begin as a reddening, then thicken, swell, turn gray and, in the last stage, become fibrotic and callous-like”. Hence, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, when faced with the issue of providing “a patient simulator that expands the functionality of the simulators by increasing the realism of the look, feel, and functionality of the simulators that can be used to train medical personnel in a variety of clinical situations” (Rodriguez, ¶ 48), one would have looked to incorporate the known multi-stage visual symptoms of vocal cord disorders like vocal nodules, as taught by Kehoe and modify Rodriguez as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
Re claims 9-10:
[Claims 9-10] Rodriguez in view of Kehoe teaches or at least suggests wherein the simulated abnormal vocal cord assembly simulates a Grade II vocal cord trauma, wherein the simulated abnormal vocal cord assembly simulates a Grade IV vocal cord trauma (at least Kehoe: ¶ 2: … nodules on the individual's vocal folds (also known as vocal cords) begin as a reddening, then thicken, swell, turn gray and, in the last stage, become fibrotic and callous-like).
Claims 7-8 and 18-19 are rejected under 35 U.S.C. 103 as obvious over Rodriguez in view of Kehoe, as applied to claims 6 and 16, and further in view of Erol et al. (US 20230154354 A1) (Erol).
Re claims 7-8 and 18-19:
[Claim 7] Rodriguez in view of Kehoe appears to be silent on but Erol teaches or at least suggests wherein the body is formed of a more flexible material than the support structure (at least ¶ 47: … The more rigid material 516 (e.g. carbon fiber) is intended to provide support and/or a mounting structure for the components of the simulator 100). Hence, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have utilized the more rigid material to provide support and/or a mounting structure feature of Erol and to have modified Rodriguez in view of Kehoe as claimed because this would amount to no more than applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
[Claim 8] Rodriguez in view of Kehoe and Erol appears to be silent on wherein the body and the simulated vocal cord portion are formed of silicone and the support structure is formed of a plastic. However, it is common knowledge that silicon boasts a greater flexibility than most plastics1. Hence, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified Rodriguez in view of Kehoe and Erol as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
[Claim 18] Rodriguez in view of Kehoe teaches or at least suggests wherein each of the first and second simulated abnormal vocal cord assemblies includes a body and a support structure within the body (at least Rodriguez: ¶ 65: … The laryngospasm assembly 470 includes a mounting bracket 475, a left vocal cord assembly 480, and a right vocal cord assembly 485. The mounting bracket 475 includes a base plate 490, a left support plate 495, and a right support plate 500. The left support plate 495 extends transversely from the base plate 490. The right support plate 500 extends transversely from the base plate 490, opposite the left support plate 495. As a result, the base plate 490, the left support plate 495, and the right support plate 500, in combination, are generally “U”-shaped. In several embodiments, as in FIGS. 13-15, the left support plate 495 and the right support plate 500 are spaced in a parallel relation). Rodriguez in view of Kehoe appears to be silent on but Erol teaches or at least suggests wherein the body is formed of a more flexible material than the support structure (at least ¶ 47: … The more rigid material 516 (e.g. carbon fiber) is intended to provide support and/or a mounting structure for the components of the simulator 100). Hence, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have utilized the more rigid material to provide support and/or a mounting structure feature of Erol and to have modified Rodriguez in view of Kehoe as claimed because this would amount to no more than applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
[Claim 19] Rodriguez in view of Kehoe and Erol appears to be silent on wherein the body is formed of silicone and the support structure is formed of a plastic. However, it is common knowledge that silicon boasts a greater flexibility than most plastics2. Hence, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified Rodriguez in view of Kehoe and Erol as claimed because this would amount to no more than applying known techniques to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
Claim 11 is rejected under 35 U.S.C. 103 as obvious over Rodriguez in view of Kehoe, as applied to claim 6, and further in view of Hoffman et al. (US 20120150293 A1) (Hoffman).
Re claim 11:
[Claim 11] Rodriguez in view of Kehoe appears to be silent on but Hoffman teaches or at least suggests wherein the simulated healthy vocal cord assembly is fixedly integrated into at least one of the simulated head or the simulated neck (at least ¶ 33: After it has been determined that the adjacent vocal fold (e.g., the paralyzed vocal fold PVF) is correctly positioned, in one example the displacement member 12 may be configured to inhibit further adjustment, thereby substantially permanently retaining the paralyze vocal fold in the desired medial position). Hence, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have utilized the permanently retaining the paralyze vocal fold in the desired medial position feature of Hoffman and to have modified Rodriguez in view of Kehoe as claimed because this would amount to no more than applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
Claim 12 is rejected under 35 U.S.C. 103 as obvious over Rodriguez in view of Kehoe, as applied to claim 6, and further in view of Johns et al. (US 20080241807 A1) (Johns).
Re claim 12:
[Claim 12] Rodriguez in view of Kehoe appears to be silent on but Johns teaches or at least suggests wherein the simulated healthy vocal cord assembly is removably coupled to at least one of the simulated head or the simulated neck (at least ¶ 35: The surgeon can then cut through the top layer 96 of the vocal fold model 82 representing the skin, excise the nodule 98 representing the polyp, and replace the top layer over the middle layer 94. The vocal fold model 82 can then be removed from the larynx model 14 and replaced by a new vocal fold model to enable the surgeon to re-practice the procedure, if desired). Hence, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have utilized the removable vocal fold model feature of Johns and to have modified Rodriguez in view of Kehoe as claimed because this would amount to no more than applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).
Conclusion
The prior art made of record and not relied upon is listed in the attached PTO Form 892 and is considered pertinent to applicant's disclosure.
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/EDDY SAINT-VIL/Primary Examiner, Art Unit 3715
1 https://www.zerowaste.com/blog/silicone-vs-plastic-whats-best/
2 https://www.zerowaste.com/blog/silicone-vs-plastic-whats-best/
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