Detailed Action
Response to Amendment
This action is responsive to Applicant’s communication filed on 01/09/2026.
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.
In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. If this application names joint inventors, Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 8, 14-21 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hart et al (US 2014/0248596 A1) in view of Podolsky et al (US 2025/0209942 A1)
Regarding claim 1, Hart discloses a surgical simulation device comprising a base (Fig. 1), a first surgical model configured to simulate a first condition (Fig. 1: 38), a second surgical model configured to simulate a second condition (Fig. 1: 38), and a model support configured to be releasably engaged with the base (¶ [0054]: simulated tissue holder and training device are connected using clips, fasteners, wires, hooks, etc.), the first surgical model disposed on a first surface of the model support and the second surgical model disposed on a second surface of the model support (Figs. 6A – 6B and ¶ [0057]: tissue modules are connectable to top and/or bottom of module support), the base including an internal volume sized and shaped to receive one of the first surgical model and the second surgical model (Fig. 1), wherein the other of the first surgical model and the second surgical model is at least partially exposed when the model support is engaged with the base (Fig. 1). Podolsky suggests—where Hart does not disclose—wherein the first and second conditions are cleft lip conditions (Abstract). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the invention to combine the disclosures of Hart and Podolsky in order to allow the trainee to practice both external and internal aspects of a procedure.
Regarding claim 2, Hart discloses wherein the first and second conditions are the same (¶ [0057]: tumor and non-tumor modules may be used interchangeably). Podolsky suggests—where Hart does not disclose—wherein the first and second conditions are cleft lip conditions (Abstract). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the invention to combine the disclosures of Hart and Podolsky in order to permit the trainee to repeat the procedure.
Regarding claim 3, Hart discloses wherein the first surface is disposed on a first side of the model support, and the second surface is disposed on a second side of the model support opposite the first side (Figs. 6A – 6B and ¶ [0057]: tissue modules are connectable to top and/or bottom of module support).
Regarding claim 4, Hart discloses wherein the internal volume is sized and shaped to receive at least a portion of the model support (Fig. 1).
Regarding claim 8, Hart discloses wherein the device is configured to present the first surgical model at an angle relative to an underlying surface the base is disposed during use, the angle being configured to simulate a position of a patient during a surgical procedure (Fig. 1).
Regarding claim 14, Hart discloses wherein the first surgical model comprises one or more simulated tissues (¶ [0011]).
Regarding claim 15, Hart discloses wherein the one or more simulated tissues includes at least one selected from a simulated skin layer, a simulated muscle, and a simulated fat layer (¶ [0063]).
Regarding claim 16, Hart discloses wherein at least one of the simulated tissues comprises a silicone material (¶ [0011]).
Regarding claim 17, Hart discloses wherein at least one of the simulated tissues further comprises at least one reinforcement material (¶ [0051]).
Regarding claim 18, Hart discloses wherein the at least one reinforcement material is selected from an elastic woven fabric, a porous non-woven fabric, a porous non-woven fabric impregnated with a flexible matrix material, a mesh, or a web (¶ [0051]).
Regarding claim 19, Hart discloses a method of surgical simulation comprising exposing a first surgical model of a surgical simulation device (Fig. 1), performing a first simulated surgical procedure on the first surgical model (Fig. 1: 38), exposing a second surgical model of the surgical simulation device (Fig.1), and performing a second simulated surgical procedure on the second surgical model (Fig. 1: 38). Podolsky suggests—where Hart does not disclose— wherein at least one of the first and second surgical models is configured to simulate a cleft lip condition (Abstract). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the invention to combine the disclosures of Hart and Podolsky in order to allow the trainee to practice both external and internal aspects of a procedure.
Regarding claim 20, Hart discloses wherein exposing the first surgical model comprises providing a model support of the surgical simulation device releasably engaged with a base of the device (¶ [0054]: simulated tissue holder and training device are connected using clips, fasteners, wires, hooks, etc.), the first and second surgical models being at least partially disposed on the model support (Fig. 1), and wherein exposing the second surgical model comprises releasing the model support from the base and releasably re-engaging the model support with the base (¶ [0054]: simulated tissue holder and training device are connected using clips, fasteners, wires, hooks, etc.).
Regarding claim 21, Hart discloses wherein providing the model support releasably engaged with the base comprises providing the model support with the first surgical model disposed on a first side of the model support and the second surgical model disposed on a second side of the model support opposite the first side (Figs. 6A – 6B and ¶ [0057]: tissue modules are connectable to top and/or bottom of module support), the second surgical model being provided at least partially disposed within an internal volume of the base (Fig. 1), and wherein releasably re-engaging the model support with the base includes turning the model support over to: expose the second surgical model, and at least partially dispose the first surgical model within the internal volume of the base (Fig. 1: module support can be positioned with either side facing forward).
Regarding claim 24, Hart discloses 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 (¶ [0011]).
Regarding claim 25, Hart discloses 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, and a simulated fat layer (¶ [0063]).
Regarding claim 26, Hart discloses wherein at least one of the simulated tissues comprises a silicone material and a reinforcement material (¶ [0051]).
Allowable Subject Matter
Claims 5-7, 9-13, 22 and 23 are 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 01/09/2026 have been fully considered but they are not persuasive.
Applicant argues:
As seen in FIG. 1 of Hart reproduced below, Hart discusses a surgical simulation device 10 that simulates an internal body cavity 18. Simulated tumors 38 are positioned on the internal organ 20 within the internal body cavity 18. (See art at I [0046]). On the other hand, Podolsky teaches a device simulating a cleft lip condition. As would be appreciated by those of skill in the art, a human's lips are external organs located on a person's face rather than within their body cavity. Therefore, a person of skill would not have found it obvious to include Podolsky's cleft lip model within Hart's simulated body cavity as doing so would result in an anatomically inaccurate surgical simulation device rendering it unfit for its intended purpose..
Examiner respectfully disagrees. Claim 1 recites a “surgical simulation device.” Hart discloses a surgical simulation system which is capable of accommodating a variety of insertable surgical models. There is no limitation in the claim regarding the specific positioning of the model on or within the structure. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, since the combination of Hart and Podolsky discloses or suggests a surgical model which can accommodate insertable modules, Examiner respectfully suggests it meets the claim.
Applicant argues:
The combination of Hart and Podolsky fails to teach or render obvious the above- noted elements of claim 1. Instead, Hart teaches that the module 50 supporting the tumor 38 can be positioned "between or at one of the openings at either surface 51, 53." (See Hart at I [0054] and FIGs. 6A-6B reproduced below). In other words, there is no teaching that a tumor 38 is placed in the openings at each surface 51, 53 or that a tumor can be supported on both sides of the module 50. Accordingly, even if a person of skill were to modify Hart's device with Podolsky despite the anatomical inaccuracy as described above, the modification would position Podolsky's device on only one surface of module 50 / the module support 52, instead of on both the first and second surfaces 51, 53. Therefore, the proposed combination fails to teach or suggest at least at the above- noted limitation of claim 1 directed to first and second surgical models disposed on separate first and second surfaces.
Examiner respectfully disagrees. As noted supra, Figure 6A and ¶ [0057] of Hart disclose multiple tumor models 50 and multiple receiving positions 54 – 58. The modules are positionable facing either of surfaces 51 or 52 (¶ [0057]). Therefore, Examiner respectfully submits that Hart fairly discloses the feature “the first surgical model disposed on a first surface of the model support and the second surgical model disposed on a second surface of the model support.”
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 STEVE ROWLAND whose telephone number is (469) 295-9129. The examiner can normally be reached on M-Th 10-8. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Dmitry Suhol can be reached at (571)-272-4430. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/STEVE ROWLAND/Primary Examiner, Art Unit 3715