DETAILED ACTION
Remarks
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The Amendment filed 5/17/26 has been entered. Claim(s) 1-7 and 17 are pending in the application and are under examination.
Applicant’s amendments have overcome all claim objections from the previous Office Action mailed on 1/30/26.
Applicant’s amendments have overcome all rejections from the previous Office Action mailed on 1/30/26.
Claim Rejections - 35 USC § 103 (AIA )
Claims 1, 2, 5, and 17 are rejected under 35 U.S.C. 103 as being obvious over US 2014/0154656 A1 to SEGALL in view of US 10,580,327 B1 to SHRIVASTAVA.
Regarding claim 1, SEGALL teaches a head and neck anatomical simulator apparatus for training medical professionals in procedures involving the head and neck (FIG. 2 and 9, ref. 100; Abstract: The Tactical Combat Casualty Care Trainer … for the purpose of providing an emergency medical services provider hands-on training … having specific anatomical features which provide the trainee or provider with appropriate tactile response analogous to a real human patient, thereby increasing the fidelity of training and improving the skills necessary to conduct procedures such as cricothyrotomy), the apparatus comprising a head and neck model substantially shaped like that of the human head and neck (par. 0050: head 106 and neck 151), having a base (FIG. 9; par. 0035: torso 108), one or more cylindrical cut outs (FIG. 6; par. 0051: nasal passage 156, as shown comprising a pair of substantially cylindrical openings), a rectangular cut out (FIG. 9; par. 0050: trachea module insertion area 150, as shown comprising rectangular-shaped opening), a mouth cut out (FIG. 9; par. 0051: open mouth 154), and a throat opening (par. 0054: continuous path from the nasal passage or mouth . . . allows insertion of a breathing tube . . . as would be accomplished during an intubation procedure through the nasal passage, mouth, or via cricothyrotomy), but does not disclose wherein the base includes means for securing the head and neck anatomical simulator apparatus to an underlying surface.
Regarding claim 17, SEGALL teaches the elements above, but does not disclose wherein the base includes suction cups for securing the head and neck anatomical simulator apparatus to the underlying surface.
However, regarding claims 1 and 17, SHRIVASTAVA teaches a related system for anatomical training (Abstract) including a base unit for supporting an anatomical model to an underlying surface by suction cups on its lower surface to allow temporary fixation to a table top or other smooth surface for added stability (col. 3, lines 46-50; col. 4, lines 42-46). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate suction cups on the lower surface an anatomical model supporting base, as taught by SHRIVASTAVA, into anatomical trainer of SEGALL, in order to allow temporary fixation of the trainer to a table top or other smooth surface for added stability.
Regarding claim 2, SEGALL further teaches a cricothyroid model (FIG. 10, ref. 152; par. 0056-57: Trachea module) substantially shaped like that of the human cricothyroid cartilage (par. 0056-57: cartilage), thyroid cartilage (par. 0056-57: thyroid cartilage 172), and trachea (par. 0056-57: trachea) having a cricothyroid top end, a cricothyroid bottom end, an airway (a central lumen 160 that is continuous through the center of the trachea module 152 from the top 162 at the [simulated] hyoid bone, to the bottom 164 where the [simulated] cricoid cartilage meets the rest of the trachea as it progresses toward the lungs (not shown)), a thyroid protrusion (thyroid 172), and a procedure site (simulated cricothyroid membrane 170), wherein the cricothyroid model is removably attached to the rectangular cut out of the head and neck model (par. 0052: user-replaceable, user-repairable trachea module 152).
Regarding claim 5, SEGALL further teaches wherein the head and neck simulator apparatus is made of a nonmetallic material (par. 0045: flexible resin; par. 0051: trachea module 152 is also constructed from silicone, rubber, plastics, and other materials, providing a realistic, tactile experience for the user).
Claim 3 is rejected under 35 U.S.C. 103 as being obvious over SEGALL in view of SHRIVASTAVA, as applied to claim 1, in view of US 7,291,016 B2 to OTTO.
Regarding claim 3, SEGALL teaches the elements above, including the model comprising two eye sockets (claim 1), but does not expressly disclose one or more eye models substantially shaped like that of the human eye and surrounding structures having an eyeball, an eye inset, and an eye base, wherein the one or more eye models are removably attached to one or more cylindrical cut outs of the head and neck model. However, OTTO teaches a related surgery simulation device comprising a prosthetic head with eye socket including an eye for practicing surgical techniques (Abstract) comprising one or more eye models (FIG. 6, ref. 100; col. 4, lines 20-28; col. 5, line 64-col. 6, line 9) substantially shaped like that of the human eye (as illustrated in Fig. 6) and surrounding structures having an eyeball (100, Fig. 6; col. 5, line 64-col. 6, line 9), an eye inset (35, Fig. 6; col. 4, lines 43-61), and an eye base (which includes 20 and 25, as illustrated in Fig. 1; col. 4, lines 20-28), wherein the one or more eye models are removably attached to one or more cylindrical cut outs of the head and neck model (27, Fig. 1; col. 4, lines 29-42) of a head and neck model (10, Fig. 3; col. 3, line 65-col. 4, line 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the eye model, as taught by OTTO, into the invention of SEGALL, in order to provide additional anatomical features, thereby allowing additional practice procedures to be performed on the anatomical model, and in particular the anatomy of the human eyes.
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being obvious over SEGALL in view of SHRIVASTAVA, as applied to claim 3, in view of US 5,951,301 to YOUNKER.
Regarding claim 4, SEGALL further teaches wherein the apparatus has an esophagus model substantially shaped like that of the human esophagus (par. 0065: internal construction within the skull provides further Hyper-Realistic training, allowing the nasal airway 178 or oral airway 180 in use to follow a correct anatomical path from either the nose 157 or mouth 154 into the trachea module 152. In such an embodiment, the interior of the skull 112 is formed with specific pathways, replicating the human oral cavity, palate, nasal passageways, epiglottis, and esophagus (not shown), allowing either a nasal intubation or oral intubation), but does not expressly disclose the particulars of said esophagus including having a mouth opening, an esophagus, an esophagus extension top end, an esophagus extension bottom end, an esophagus extension base, an esophagus extension attachment, and an esophagus extension passage, wherein the esophagus model is removably attached to the mouth cut out of the head and neck model such that the esophagus model forms an integral part of the head and neck model. However, YOUNKER also teaches an esophagus model (FIG. 1, ref. 10; col. 4, lines 23-38) to assist in training medical professionals in procedures involving the human esophagus (as illustrated in FIG. 1; "esophagus", col. 4, lines 38-47) comprising: an esophagus (FIG. 2, ref. 38; col. 4, lines 38-47); an esophagus extension top end (the top of 30, from the perspective of the simulated human body, as illustrated in FIG. 2; col. 4, lines 38- 47); an esophagus extension bottom end (the bottom of 30, from the perspective of the simulated human body, as illustrated in Fig. 2; col. 4, lines 38-47); an esophagus extension base (FIG. 2, ref. 32; col. 4, lines 38-47); an esophagus extension attachment (which includes 34 and 36, as illustrated in FIG. 2; col. 4, lines 38-47); and a passage (the bore/lumen of 38, 34, and 36, as illustrated in FIG. 2; "into the esophagus", col. 4, lines 38-47). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the esophagus model, as taught by YOUNKER, into the internal construction of the airway of SEGALL such that the esophagus is connected to the mouth opening, in order to provide correct anatomical path from either the nose or mouth into the trachea module, as doing so would provide a more realistic training experience for practicing oral intubation.
Regarding claim 6, SEGALL teaches the elements above, including wherein the head and neck model, the cricothyroid model, and the esophagus model made of one continuous structure (as shown in FIG. 6, for example the continuous structure includes a head 106, neck 151, and trachea module comprising a cricothyroid 152; see also par. 0065, defining the model as comprising additional internal construction including an esophagus (not shown)), but does not expressly disclose the eye model. However, OTTO teaches a related surgery simulation device comprising a prosthetic head with eye socket including an eye for practicing surgical techniques (Abstract) comprising one or more eye models (FIG. 6, ref. 100; col. 4, lines 20-28; col. 5, line 64-col. 6, line 9) substantially shaped like that of the human eye (as illustrated in Fig. 6) and surrounding structures having an eyeball (100, Fig. 6; col. 5, line 64-col. 6, line 9), an eye inset (35, Fig. 6; col. 4, lines 43-61), and an eye base (which includes 20 and 25, as illustrated in Fig. 1; col. 4, lines 20-28), wherein the one or more eye models are removably attached to one or more cylindrical cut outs of the head and neck model (27, Fig. 1; col. 4, lines 29-42) of a head and neck model (10, Fig. 3; col. 3, line 65-col. 4, line 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the eye model, as taught by OTTO, into the assembly of SEGALL, in order to provide additional anatomical features, thereby allowing additional practice procedures to be performed on the anatomical model, and in particular the anatomy of the human eyes.
Claim 7 is rejected under 35 U.S.C. 103 as being obvious over SEGALL in view of SHRIVASTAVA, as applied to claim 4, in view of OTTO and US 4,209,919 to KIRIKAE.
Regarding claim 7, SEGALL teaches the elements above including a cricothyroid model (as shown in FIG. 6, for example the structure includes a trachea module comprising a cricothyroid 152); see also par. 0065, defining the model as comprising additional internal construction including an esophagus (not shown)), an esophagus model (par. 0065, defining the model as comprising additional internal construction including an esophagus (not shown), but does not expressly disclose wherein each of the cricothyroid model, the eye model, and the esophagus model includes a plurality of pegs wherein the pegs are configured to be removably engaged with peg holes of the head and neck model.
To the extent SEGALL does not expressly disclose an eye model, OTTO teaches a related surgery simulation device comprising a prosthetic head with eye socket including an eye for practicing surgical techniques (Abstract) comprising one or more eye models (FIG. 6, ref. 100; col. 4, lines 20-28; col. 5, line 64-col. 6, line 9) substantially shaped like that of the human eye (as illustrated in Fig. 6) and surrounding structures having an eyeball (100, Fig. 6; col. 5, line 64-col. 6, line 9), an eye inset (35, Fig. 6; col. 4, lines 43-61), and an eye base (which includes 20 and 25, as illustrated in Fig. 1; col. 4, lines 20-28), wherein the one or more eye models are removably attached to one or more cylindrical cut outs of the head and neck model (27, Fig. 1; col. 4, lines 29-42) of a head and neck model (10, Fig. 3; col. 3, line 65-col. 4, line 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the eye model, as taught by OTTO, into the assembly of SEGALL, in order to provide additional anatomical features, thereby allowing additional practice procedures to be performed on the anatomical model, and in particular the anatomy of the human eyes.
Additionally, to the extent the modified device of SEGALL does not expressly disclose the cricothyroid model, the eye model, and the esophagus model includes a plurality of pegs wherein the pegs are configured to be removably engaged with peg holes of the head and neck model, KIRIKAE teaches a model used to practice surgical operations, wherein anatomical features are removably attachable to the head model by a peg-hole connection (col. 3, lines 33-41, describing the holding member 31 is demounted from the ear holding portion 8B, after the surgical operation, and the incised condition of the eardrum can be observed in detail outside of the model). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the peg-hole connection style of KIRIKAE into the invention of SEGALL, in order to allow for desired anatomical features to be removed from the head, in order to allow a better visual inspection of the condition of that component after practicing a surgical operation.
RESPONSE TO ARGUMENTS
Claim Objections
Applicant’s amendments have overcome all claim objections from the previous Office Action mailed on 1/30/26.
35 USC § 112 – Rejections
Applicant’s amendments have overcome all rejections under 35 USC 112 from the previous Office Action mailed on 1/30/26.
35 USC § 102/103 – Rejections
Applicant’s amendments have overcome all rejections under 35 USC 102 and 103 from the previous Office Action mailed on 1/30/26. However, an updated search has revealed new relevant prior art, and accordingly a new grounds of rejection under 35 USC 103 is provided in this Office Action.
Applicant argues that “the Segall reference fails to disclose the inclusion of a means for securing the simulator to an underlying surface.” Although Examiner concedes that SEGALL does not teach this limitation, Applicant is directed to the new grounds of rejection which addresses this limitation. Therefore, Applicant’s argument is not persuasive.
Applicant further argues that “[t]he Segall apparatus would be difficult to provide on a widespread basis due to its likely prohibitive cost.” The fact that a "combination would not be made by businessmen for economic reasons" does not mean that a person of ordinary skill in the art would not make the combination because of some technological incompatibility. In re Farrenkopf, 713 F.2d 714, 718, 219 USPQ 1, 4 (Fed. Cir. 1983) (Prior art reference taught that addition of inhibitors to radioimmunoassay is the most convenient, but costliest solution to stability problem. The court held that the additional expense associated with the addition of inhibitors would not discourage one of ordinary skill in the art from seeking the convenience expected therefrom.). To the extent Applicant is arguing an unclaimed intended use, it does not patentably distinguish the claimed invention over the prior art. 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. Applicant is arguing a feature that is neither claimed, nor further defining the structure of the claimed apparatus. Therefore, the Applicant’s argument is not persuasive.
Applicant further argues that “one of skill in the art would not combine Younker with Segall” because Applicant argues “[t]he Younker apparatus is a unitary structure with no indication that it could be incorporated into a head and torso model such as that of Segall” and that “there is no indication that the complex structure of the Segall model could incorporate therein an esophagus model such as the one described by Younker.” However, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, SEGALL teaches a head and neck anatomical simulator comprising, inter alia, an esophagus model (see rejection). While SEGALL does not teach the particular details of the esophagus model in claim 4, YOUNKER is also directed to an anatomical simulator with comprising an esophagus model with the structure recited in claim 4 (see rejection). Thus, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the specific details of an esophagus as taught by YOUNKER, in the anatomical simulator of SEGALL, in order to provide a known technique for accurately simulating an esophagus in an anatomical simulator, thereby achieving the predictable result of a more realistic training experience. Therefore, Applicant’s argument is not persuasive.
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 James Hull whose telephone number is 571-272-0996. The examiner can normally be reached on Monday-Friday from 8:00am to 5:00pm MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached at telephone number 571-272-7147. 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.
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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
/JAMES B HULL/Primary Examiner, Art Unit 3715
Prosecution Insights