DETAILED ACTION
Applicant's Submission of a Response (RCE)
Applicant’s submission of a response on 9/16/2026 has been received and fully considered. No amendments were made. A declaration of Michael G. Silver under 37 CFR 1.132 was submitted. Claims 1, 2, and 4-24 are pending.
Information Disclosure Statement
Applicant’s submission of an Information Disclosure Statement on 9/16/2026 has been received and considered.
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.
Claims 1, 2, 5-12, and 15-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2017/0358248 to Podolsky.
Regarding claim 1, Podolsky discloses a surgical simulation device (e.g., see at least paragraph 6 that states “embodiments of the disclosure related to surgical simulators”), comprising:
a base (e.g., see Figs 27A and 27B that show a base 700; see also paragraph 100 that discusses base 700), wherein the base includes one or more simulated anatomical structures (e.g., see at least Fig. 28 that shows cranial base 600 with simulated anatomical structures; see also paragraph 100 that discusses cranial base 600);
a surgical model including a simulated anatomical malformation (e.g., see at least paragraph 81 that discloses a simulated cleft 150 in at least one of simulated hard palate 200 and simulated soft palate 400, wherein a cleft palate is an anatomical malformation); and
a model support including an internal volume sized and shaped to receive at least a portion of the surgical model such that an operating surface of the surgical model is exposed, the model support configured to be releasably engaged with the base (e.g., see at least paragraph 23 that discloses the “simulator may form a cartridge that replaceably fits within a complete or partial simulated face”; see additional cartridge detail in paragraphs 102-104 and Figs. 30-36);
[claim 2] wherein the base (e.g., see Fig. 35A to 35C that shows a base 700) includes a cavity configured to releasably receive the model support (e.g., see paragraphs 102 that notes that “replaceable cartridge 1310 that replaceably fits within a complete or partial simulated face 1308 to attached to base 700”);
[claim 5] wherein the device is configured to present an operative face of the surgical model at an angle relative to an underlying surface on which the base is disposed that simulates a position of a patient during a surgical procedure (e.g. see at least paragraph 100 that discloses that the base may be adjusted from zero to ninety degrees);
[claim 6] wherein the device is configured to form an angle between a sagittal axis of a simulated patient and the underlying surface that is greater than or equal to 200 and less than or equal to 60° (e.g. see at least paragraph 100 that discloses that the base may be adjusted from zero to ninety degrees);
[claim 7] wherein the surgical model comprises one or more simulated tissue (e.g., see paragraph 102 that discloses “simulated soft tissue fatty layer 1200”);
[claim 8] wherein the one or more simulated tissues includes at least one selected from a simulated skin layer, a simulated muscle, a simulated fat layer (e.g., see paragraph 102 that discloses “simulated soft tissue fatty layer 1200”), a simulated organ;
[claim 9] wherein at least one of the one or more simulated tissues comprises a silicone material and a reinforcing material (e.g., see at least paragraphs 78 and 79 that disclose the use of a silicone to simulate soft material and also includes a simulated mucosal layer 300 that includes a flexible high transparency wire mesh sheet that serves a reinforcing material);
[claim 10] wherein the reinforcing material is disposed in an area to be sutured during a simulated surgical procedure (e.g., see at least paragraph 110 and 111 that disclose “suturing the simulated soft palate musculature 400; and suturing the simulated mucosal layer 300, wherein layer 300 is closed in paragraph 79 to include a wire mesh sheet, that will provide reinforcing);
[claim 11] wherein the reinforcing material comprises a first portion of reinforcing material and a second portion of reinforcing material, each of the first and second portions of reinforcing material being included in a single simulated tissue (e.g., see at least paragraphs 78 and 79 that disclose the use of a silicone to simulate soft material and also includes a simulated mucosal layer 300 that includes a flexible high transparency wire mesh sheet that serves a reinforcing material, wherein different areas of the mesh sheet could reasonably considered first and second portions of reinforcing material);
[claim 12] wherein the reinforcing material is disposed around a perimeter of an anatomical structure of the surgical model e.g., see at least paragraphs 78 and 79 that disclose the use of a silicone to simulate soft material and also includes a simulated mucosal layer 300 that includes a flexible high transparency wire mesh sheet that serves a reinforcing material, wherein the outer portion of the mesh sheet could reasonably considered disposed around a perimeter of the anatomical structure of the surgical model);
Regarding claim 15, Podolsky discloses a method of surgical simulation (e.g., see at least paragraph 6 that states “embodiments of the disclosure related to surgical simulators”), the method comprising:
inserting a first surgical model of a surgical simulation device into a base of the surgical simulation device, wherein the base includes one or more simulated anatomical structures (e.g., see at least paragraph 102 that discloses replaceable cartridges 1310);
performing a first simulated surgical procedure on the first surgical model (e.g., see at least paragraph 102 that discloses the model being used to simulate surgery);
removing the first surgical model from the base (e.g., see at least paragraph 102 that discloses replaceable cartridges 1310);
inserting a second surgical model into the base of the surgical simulation device; and performing a second simulated surgical procedure on the second surgical model (e.g., see at least paragraph 102 that discloses replaceable cartridges 1310), wherein at least one of the first and second surgical models includes a simulated anatomical malformation (e.g., see at least paragraph 81 that discloses a simulated cleft 150 in at least one of simulated hard palate 200 and simulated soft palate 400, wherein a cleft palate is an anatomical malformation);
[claim 16] wherein: inserting the first surgical model into the base comprises inserting a first model support into the base, at least a portion of the first surgical model being disposed on and supported by the first model support (e.g., see paragraphs 102 that notes that “replaceable cartridge 1310 that replaceably fits within a complete or partial simulated face 1308 to attached to base 700”);
removing the first surgical model from the base comprises removing the first model support from the base (e.g., see at least paragraph 102 that discloses replaceable cartridges 1310);
inserting the second surgical model into the base comprises inserting a second model support into the base, at least a portion of the second surgical model being disposed on and supported by the second model support (e.g., see paragraphs 102 that notes that “replaceable cartridge 1310 that replaceably fits within a complete or partial simulated face 1308 to attached to base 700”);
removing the second surgical model from the base comprises removing the second model support from the base (e.g., see at least paragraph 102 that discloses replaceable cartridges 1310); and the base includes a cavity configured to releasably receive one of the first and second model support (e.g., see paragraph 102 that states the cartridge 1310 “fits within” a model attached to the base);
[claim 17] further comprising positioning the surgical model at an angle relative to an underlying surface on which the base is disposed that simulates a position of a patient during a surgical procedure (e.g. see at least paragraph 100 that discloses that the base may be adjusted from zero to ninety degrees);
[claim 18] wherein performing the first or second simulated surgical procedures comprises performing one or more simulated procedure steps on one or more simulated tissues of the first or second surgical model (e.g., see at least paragraph 110 and 111 that disclose “suturing the simulated soft palate musculature 400; and suturing the simulated mucosal layer 300, wherein layer 300 is closed in paragraph 79 to include a wire mesh sheet, that will provide reinforcing, wherein suturing is a simulated procedure);
[claim 19] wherein performing the one or more simulated procedure steps on the one or more simulated tissues of the first or second surgical model includes performing the one or more simulated procedure steps on at least one selected from a simulated skin layer, a simulated muscle, a simulated fat layer (e.g., see paragraph 102 that discloses “simulated soft tissue fatty layer 1200”), and a simulated organ;
[claim 20] wherein at least one of the one or more simulated tissues comprises a silicone material and a reinforcing material e.g., see at least paragraphs 78 and 79 that disclose the use of a silicone to simulate soft material and also includes a simulated mucosal layer 300 that includes a flexible high transparency wire mesh sheet that serves a reinforcing material); and
[claim 21] wherein performing the one or more simulated procedure steps includes suturing one or more of the simulated tissues in an area that includes the reinforcing material model (e.g., see at least paragraph 110 and 111 that disclose “suturing the simulated soft palate musculature 400; and suturing the simulated mucosal layer 300, wherein layer 300 is closed in paragraph 79 to include a wire mesh sheet, that will provide reinforcing, wherein suturing is a simulated procedure);
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 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Podolsky in view of U.S. Patent Application Publication No. 2016/0104394 to Miyazaki.
Regarding claims 4 and 14, Podolsky discloses all of the recited features but is silent regarding the surgical model being a pelvic region and including a simulated bladder cavity. Podolsky discloses a surgical model being a cranial region (e.g., see at least paragraph 10).
In the same field of endeavor, Miyazaki teaches a surgical model being a pelvic region (e.g.,. see at least Fig. 2 and paragraph bridging columns 1 and 2 that disclose a “pelvic model”) and including a simulated bladder cavity (e.g., see at least column 22, line 66 to column 24, line 7 that disclose a bladder module 600; see also Fig. 12 that shows bladder module 600).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the current invention to modify Podolsky with a pelvic region having a simulated bladder as taught by Miyazaki in order to use a known technique to improve similar devices (methods, or products) in the same way. In this case, providing a pelvic module with a simulated bladder allows simulated surgery for pelvic region procedures.
Claims 13 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Podolsky in view of U.S. Patent Application Publication No. 2021/0161941 to Ben Tre.
Regarding claims 13 and 22, Podolsky discloses all of the recited features but is silent regarding the simulated anatomical malformation is selected from a list consisting of imperforate anus, rectal atresia, rectal stenosis, rectoperitoneal fistula, cloacal fistula, rectovestibular fistula, rectobulbar urethral fistula, rectoprostatic urethral fistula, and rectobladder neck fistula. As discussed above, Podolsky discloses an anatomical malformation (i.e., a cleft lip).
In the same field of endeavor, Ben Tre teaches a simulated anatomical malformation is selected from a list consisting of imperforate anus, rectal atresia (e.g., see at least paragraph 71 and 74 that noted that cleft lip and rectal atresia are malformations), rectal stenosis, rectoperitoneal fistula, cloacal fistula, rectovestibular fistula, rectobulbar urethral fistula, rectoprostatic urethral fistula, and rectobladder neck fistula.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the current invention to modify Podolsky with a rectal atresia as taught by Ben Tre in order to use a known technique to improve similar devices (methods, or products) in the same way. In this case, providing the surgical model with a simulated rectal atresia allows simulated surgery for rectal atresia. While only one of the listed malformations was addressed (since claims 13 and 22 only require a single listed malformation), it would obvious to simulate any of the listed malformations because patients will benefit from a surgeon simulating each procedure.
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Podolsky in view of U.S. Patent Application Publication No. 2016/0256605 to Hadamitzky.
Regarding claims 23 and 24, Podolsky discloses all of the recited features but is silent regarding the anatomical malformation being an anorectal malformation. As discussed above, Podolsky discloses an anatomical malformation (i.e., a cleft lip).
In the same field of endeavor, Hadamitzky teaches an anatomical malformation being both cleft lip and anorectal malformation (e.g., see at least paragraphs 23 and 63 that state “reconstructive surgery corrects a congenital defect selected from the group consisting of birthmark, cleft palate, cleft lip, syndactyly, urogenital and anorectal malformations”) (emphasis added by the Examiner).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the current invention to modify Podolsky with an anorectal malformation as taught by Hadamitzky in order to use a known technique to improve similar devices (methods, or products) in the same way. In this case, providing the surgical model with a simulated anorectal malformation allows simulated surgery for anorectal malformations.
Response to Arguments
Applicant’s arguments with respect to claims 1, 2, and 4-24 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES S MCCLELLAN whose telephone number is (571)272-7167. The examiner can normally be reached Monday-Friday (8:30AM-5:00PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kang Hu can be reached at 571-270-1344. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James S. McClellan/Primary Examiner, Art Unit 3715
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