DETAILED ACTION
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 .
Claim 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 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 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 1-2,5,7-11 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Clifton, III et al. (US 2023/0136935 A1) in view of Wendt (US 2,707,102).
Re claims 1, 11, 18:
Clifton teaches 1. A method for fabricating a training model (Clifton, Abstract) comprising:
fabricating at least one inverse anatomical feature representative of an anatomical feature in an animal(Clifton, [0007]; [0096], “negative mold”; Abstract, “animal”);
forming a mold of the animal (Clifton, [0095] – [0096]);
connecting the at least one inverse anatomical feature in the mold of the animal (Clifton, figs. 6 – 15; [0095] – [0096]; [0104]);
filling the mold of the animal with a filling material, thereby forming a cast (Clifton, figs. 5 - 15); and
removing the cast from the mold (Clifton, [0106], “When first cast, silicone rubber molds exhibit natural release characteristics. Depending on what is being cast into the mold, mold lubricity may be depleted over time and parts will begin to stick”; fig. 2; [0078], “allowed to set for the complete cure time of 2 hours before use”; [0114]; [0122], “the mixture becomes slightly stiff”).
Clifton teaches 11. A method for fabricating a training system (Clifton, Abstract) comprising:
fabricating a mold comprising a shell of an animal (Clifton, [0007]; [0096], “negative mold”; Abstract, “animal”);
inserting foam in the mold (Clifton, [0053], “an injected foam 44 filling in the space of the spinal vertebral model 42”; [0054]);
forming at least one anatomical feature in the foam (Clifton, [0095] – [0096]);
applying at least one coat of material over the foam (Clifton, [0008], “a first layer”; [0044], “a second layer”; [0045]); and
affixing the mold to a display system (Clifton, [0101], “one or more coatings of a clear acrylic lacquer are applied to the model surface”; [0098]).
Clifton teaches 18. A model (Clifton, Abstract) comprising:
a cast silicone structure in a shape of an animal (Clifton, [0007]; [0096], “negative mold”; Abstract, “animal”);
at least one anatomical feature formed in the case silicone structure (Clifton, figs. 6 – 15; [0095] – [0096]; [0104]); and
at least one view port configured to provide visual and/or physical access to the at least one anatomical feature formed in the base silicone structure (Clifton, [0128] – [0132]; [0101], “one or more coatings of a clear acrylic lacquer are applied to the model surface”; [0098]).
Clifton teaches an animal model; however, Clifton does not explicitly disclose an animal’s head (i.e., horse or horse head). Wendt (US 2,707,102) teaches an invention related to a toy riding horse. Wendt further teaches a plastic molded horse model with head, neck and ears (Wendt, col. 4, lines 11 – 16). The substitution of one known element (different organs / anatomical features as shown in Clifton) for another (horse head as shown in Wendt) would have been obvious to one of ordinary skill in the art, before the effective filing date the invention since the substitution of the shown Wendt would have yielded predictable results, namely, to provide a surgical training of a horse head.
Re claim 2:
2. The method for fabricating a training model of claim 1 further comprising: acquiring a digital model of the animal's head (Clifton, [0081]).
Re claims 5, 7, 15, 19:
5. The method for fabricating a training model of claim 1 wherein the at least one inverse anatomical feature comprises at least one of: a nare; a nasopharynx; a laryngopharynx; an oropharynx; an esophagus; a trachea; and a guttural pouch. 7. The method for fabricating a training model of claim 5 further comprising adhering the at least one anatomical features to one another. 15. The method for fabricating a training system of claim 11 wherein the at least one anatomical feature comprises at least one of: a mouth; a nose; a nasal cavity; a laryngopharynx; an oropharynx; an epiglottis; an esophagus; and a trachea. 19. The head model of claim 18 wherein the at least one anatomical feature comprises at least one of: a nare; a nostril; a nasopharynx; a laryngopharynx; an oropharynx; an esophagus; a trachea; a guttural pouch; a nasal cavity; and an epiglottis (Clifton, [0128] – [0130]).
Re claims 8 – 9, 13 - 14:
8. The method for fabricating a training model of claim 1 wherein the filling material comprises silicone. 9. The method for fabricating a training model of claim 8 further comprising: curing the silicone. 13. The method for fabricating a training system of claim 11 wherein the coat of material comprises silicone. 14. The method for fabricating a training system of claim 13 further comprises: curing the silicone (Clifton, [0102]; [0083]).
Re claim 16:
16. The method for fabricating a training system of claim 11 wherein the display system comprises: a transparent sheet (Clifton, [0101], “one or more coatings of a clear acrylic lacquer are applied to the model surface”; [0098]).
Re claims 10, 17, 20:
10. The method for fabricating a training model of claim 1 wherein the animal's head comprises a horse's head. 17. The method for fabricating a training system of claim 11 wherein the animal's head comprises a horse's head. 20. The head model of claim 18 wherein the animal's head comprises a horse's head (Wendt, col. 4, lines 11 – 16).
Claims 3 – 4 are rejected under 35 U.S.C. 103 as being unpatentable over Clifton, III et al. (US 2023/0136935 A1) and Wendt (US 2,707,102) as applied to claim 1 above, and further in view of Qiu et al. (US 2019/0130791 A1).
Re claims 3 – 4:
Clifton teaches 3D printed parts; however, Clifton does not explicitly disclose 3D printing the inverse anatomical features. Qiu teaches a method of assessing the performance of a human or robot carrying out a medical procedure by using a phantom resembling a human or animal organ or tissue and to an assessment tool comprising such a phantom (Qiu, Abstract). Qiu further teaches 3. The method for fabricating a training model of claim 1 wherein fabricating inverse anatomical features representative of anatomical features in an animal's head further comprises: 3D printing the inverse anatomical features (Qiu, [0149], “3D printed negative mold”). Therefore, in view of Qiu, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method described in Clifton, by providing the 3D printed negative mold as taught by Qiu, since it was known in the art to use 3D printer to create a cast so that multiple anatomical features can be replicated precisely, fast and cost-effectively (Qiu, [0166]).
4. The method for fabricating a training model of claim 3 further comprising: coating the inverse anatomical features with an applique to smooth the inverse anatomical features (Clifton, [0101]; [0107]).
Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Clifton, III et al. (US 2023/0136935 A1) and Wendt (US 2,707,102) as applied to claims 5 and 11 above, and further in view of Felsinger et al. (US 2016/0027344 A1).
Re claims 6:
Clifton does not explicitly disclose a viewing window; nor disclose cutting away. Felsinger teaches a simulated dissectible tissue for surgical training (Felsinger, Abstract). Felsinger teaches 6. The method for fabricating a training model of claim 5 further comprising: fabricating a viewing window in the mold of the animal's head. 12. The method for fabricating a training system of claim 11 wherein forming the at least one anatomical feature in the foam comprises: cutting away foam in anatomically accurate shapes (Felsinger, figs. 10A – 10H; [0004]; [0054]; [0042]). Therefore, in view of Felsinger, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method described in Clifton, by providing the viewing window and cutting away foam as taught by Felsinger, in order to provide a demonstrate model of the anatomical features of one or more organs.
Conclusion
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/JACK YIP/Primary Examiner, Art Unit 3715
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