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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-7) in the reply filed on 11/25/25 is acknowledged. Accordingly, claims 8-16 are withdrawn from examination. Claims 1-7 are under examination.
Claim Objections
Claims 2-7 are objected to because of the following informalities: In claim 2-7, the preamble refers to either “The simulator apparatus of claim 1” or “The apparatus of claim 1”. However, claim 1, from which claims 2-7 depend, use the phrase “head and neck anatomical simulator apparatus” to describe the invention. In order to avoid inconsistent claim language, and thus improve clarity of the claimed invention, claim 2-7 should be amended to read “The head and neck anatomical simulator apparatus of claim 1”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 6 and 7 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 6 and 7 recite the limitation "the cricothyroid model”, “the eye model”, and “the esophagus model ". These limitations lack sufficient antecedent basis in the claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, and 5 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2014/0154656 A1 to SEGALL.
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).
Regarding claim 2, SEGALL further teaches wherein the apparatus has 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 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 Rejections - 35 USC § 103 (AIA )
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 of this title, 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.
Claim 3 is rejected under 35 U.S.C. 103 as being obvious over SEGALL, 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 wherein the apparatus has 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, as applied to claim 1, 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 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. 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 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, as applied to claim 1, 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.
Conclusion
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