DETAILED ACTION
Applicant's Submission of a Response
Applicant’s submission of a response on 3/6/2026 has been received and fully considered. In the response, claims 1, 4, 9, 13, 15, 16, 20-22 have been amended; claim 3 has been canceled; and new claims 23 and 24 have been added. Therefore, claims 1, 2 and 4-24 are pending.
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, 2, 4, 5, 7, 8, 13, 14, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2022/0148460 to Hall (Fig. 3 shown below for convenience, but the entire reference is relevant) in view of U.S. Patent No. 7,544,062 to Hauschild.
PNG
media_image1.png
729
719
media_image1.png
Greyscale
With regard to claim 1, Hall discloses surgical simulation device (e.g., see at least Fig. 3, the wound incision model 100), comprising: a base (e.g., see Fig. 3, support piece 128; see at least paragraph 44 for discussion of support piece 128); a surgical model a simulated malformation (e.g., see Fig. 3, simulated tissue 102; see at paragraph 40, see at least paragraph 41 for discussion of simulated tissue 102); and a model support (e.g., see Fig. 3, outer frame 104; see at least paragraph 40 for discussion of outer frame 104) 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 (e.g., see Fig. 1 for assembled device with exposed simulated tissue/wound), the model support configured to be releasably engaged with the base (e.g., see at least paragraph 44 for discussion of support piece 128 configured to stabilize the model);
[claim 2] wherein the base includes a cavity configured to releasably receive the model support (e.g., see at least Fig. 3 that shows support piece including a channel/cavity for receiving the outer frame 104);
[claim 5] 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 44 that discusses the orientation of the surgical model, in this case perpendicular to the underlying surface);
[claim 7] wherein the surgical model comprises one or more simulated tissues (e.g., see at least paragraph 40 for discussion of simulated tissue 104);
[claim 8] wherein the one or more simulated tissues includes at least one selected from a simulated skin layer (e.g., see at least paragraph 41 that discusses “the simulated tissue 102 includes a skin slayer 122; see also Fig. 5), a simulated muscle, a simulated fat layer, a simulated organ;
[claim 13] wherein the simulated malformation is selected from the 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 (the term “anorectal malformation” is initially recited as functional language as it relates to a surgical model, therefore simulated tissue 102 could be configured to represent any of above listed malformations that require sutures); and
[claim 24] wherein the simulated malformation comprises an anorectal malformation (the term “anorectal malformation” is initially recited as functional language as it relates to a surgical model, therefore simulated tissue 102 could be configured to represent any of above listed malformations that require sutures).
With regard to claims 1, 4, and 14, Hall discloses all of the recited features but is silent regarding the base includes one or more simulated anatomical structures, wherein the base includes a simulated pelvic region and the surgical model includes a simulated bladder cavity.
In the same field of endeavor, Hauschild teaches a surgical simulation device including a base that includes one or more simulated anatomical structures/pelvic region (e.g., see pelvic model in Fig. 3) and the surgical model includes a simulated bladder cavity (e.g., see at least column 4, lines 19-26 for discussion of bladder module).
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 Hall with a pelvic region base with space for a simulated bladder as taught by Hauschild in order to provide a simulation for specific medical issue for more precise medical simulation than the generic simulation of Hall.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Hauschild and in further view of U.S. Patent Application Publication No. 2022/0093099 to Lebovic.
With regard to claim 6, Hall in combination with Hauschild make obvious all of the recited features but is silent regarding 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 20 degrees and less than or equal to 60 degrees.
In the same field of endeavor, Lebovic teaches a surgical simulation device including a base that 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 20 degrees and less than or equal to 60 degrees (e.g., see 60-degree angle shown in Fig. 6D)
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 Hall with an angle adjustment of 60 degrees as taught by Lebovic in order to provide a simulation with a preferred viewing angle (e.g., see paragraph 58).
Claims 9-12, 15, 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Hall in view of Hauschild and in further view of U.S. Patent No. 11,158,212 to Hoke.
With regard to claims 9-12, Hall in combination with Hauschild make obvious all of the recited features as forth above but is silent regarding the simulated tissue including a reinforcing material disposed in an area to be sutured, including first and second reinforcing members and reinforcing members around a perimeter of the surgical model. Hall discloses simulated tissue being silicone in paragraph 51.
In the same field of endeavor, Hoke teaches a surgical simulation device including a reinforcing material disposed in an area to be sutured, including first and second reinforcing members and reinforcing members around a perimeter of the surgical model (e.g., see column 5, lines 49-54 for discussion of reinforcing members including one or more layers of material including mesh, fabric, etc. to reduce tearing during suturing as shown in Fig. 4).
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 Hall with reinforced simulated tissue for suturing as taught by Hoke in order to provide reduce the likelihood of tearing when suturing (e.g., see Hoke, column 5, lines 49-54)
With regard to claims 15 and 17-23, Hall in combination with Hauschild make obvious all of the recited features but is silent regarding a first and second surgical procedure on a first and second surgical model. As set forth above, Hoke teaches a reinforcing material.
In the same field of endeavor, Hoke teaches a surgical simulation device for performing first/second surgical procedures on first/second surgical models (e.g., see column 8, lines 23-30 for discussion of discarding a first surgical model and replacing with a second surgical model)
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 Hall with multiple surgical models for different procedures as taught by Hoke in order to allow the device to be reusable, which will decrease training costs.
Allowable Subject Matter
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed on March 6, 2026 have been fully considered but they are not persuasive.
On page 6, under “Objections to the Claims”, Applicant acknowledges amending claim 16 to correct the claim dependency. The previous objection of claim 16 is withdrawn.
On page 6, final paragraph, Applicant argues that “Hoke does not teach at least the above-noted limitations of amended claim 1.” Applicant appears to be referencing Hoke instead of referencing the secondary reference (Hauschild) that was relied upon for the features previously recited in claim 3. As set forth above, Hauschild teaches a simulated anatomical structure (e.g., see at least Fig. 3 of Hauschild).
On page 7, final paragraph (continued on page 8), Applicant again appears to be referencing Hoke instead of referencing the secondary reference (Hauschild) that was relied upon for the features related to a simulated anatomical model. Hauschild, not Hoke, is relied upon in the previous Office Action for teaching a simulated anatomical structure (e.g., see at least Fig. 3 of Hauschild).
For at least these reasons claims 1, 2, and 4-24 are rejected as set forth above in detail.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James S. McClellan/Primary Examiner, Art Unit 3715
Prosecution Insights