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 .
Response to Amendment
In response to the amendment filed 1/26/2026; claims 1-13 and 15-21 are pending; claim 14 has been cancelled.
Claim Objections
Claim 12 is objected to because of the following informalities: claim 12 amended to includes two periods or “.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "said second opening" on page 7 of 17. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 – 13 and 15 – 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 12 recite “said inner chamber having a first orifice, said inner chamber having a second orifice separate from said first orifice”. It’s unclear which indicia in Applicant’s figure 6 are first orifice and second orifice. For examination purpose, the Office interprets “O” (in Applicant’s figure 6) as the first orifice and the tubular end of the MITS device as the second orifice.
Claims 11 and 21 recite “wherein said first and second passages and said platform inner chamber and second orifice collectively form a second training cavity”. Applicant’s specification has not clearly described a “second training cavity”.
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 1-6,9-13,15-16 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over of Sakezles (US 2014/0302475 A1) in view of Chia (US 2022/0246062 A1).
Re claims 1 and 12:
Sakezles teaches 1. A modular Cricothyrotomy training adjunct for a medical training platform, said platform having a body with an inner chamber (Sakezles, fig. 4, 24; fig. 5, 24; [0038], “one ring clip 34 may be used to affix the cricoid membrane 30 to the tracheal structure 24”; tracheal structure has an inner chamber), said inner chamber having a first orifice (Sakezles, fig. 4, 24; [0038], “one disposed on either side of a tracheal opening 32 … the tracheal opening 32 to occur”), said inner chamber having a second orifice separate from said first orifice (Sakezles, see fig. 5 below), said adjunct comprising:
a. a base, said base releasably attaching to said medical training platform proximate said first orifice, said base having a first passage there through, said first passage communicating at least in part with said first orifice when said base attaches to said medical training device (Sakezles, figs. 4 – 5, 28, 30; [0037], “the hyoid cartilage component 28 … a cricoid membrane 30”; [0040], “through the hyoid opening 29”; the hyoid cartilage component 28 and a cricoid membrane 30 can be cut open to form a first passage to the first orifice or tracheal opening 32); and
a simulated larynx having a front face, said simulated larynx having a second passage, said second passage extending from said front face through said simulated larynx, said simulated larynx being attached to said base, said second passage communicating at least in part with said first passage in said base (Sakezles, figs 3 – 7; [0029], “a hyoid cartilage component affixed at least at one end to the tracheal structure and disposed ventral to the removable cricoid membrane”; [0030], “cricoid membrane may be secured to the tracheal structure with one or more ring clips”);
wherein said first and second passages and said platform inner chamber collectively form a first training cavity, said first training cavity being configured to receive the insertion of at least a portion of a one of a cricothyroid airway device and an intubation device through said first and second passages and into said inner chamber (Sakezles, [0033], “an airway incision is made through the replaceable skin component and the replaceable cricoid membrane in the tracheal structure … Following the incision, an air tube can be inserted into the airway incision”).
12. A modular Cricothyrotomy training system (Sakezles, Abstract), said system comprising:
a. a medical training platform, said platform having a body with an inner chamber (Sakezles, fig. 4, 24; fig. 5, 24; [0038], “one ring clip 34 may be used to affix the cricoid membrane 30 to the tracheal structure 24”; tracheal structure has an inner chamber), said inner chamber having a first orifice (Sakezles, fig. 4, 24; [0038], “one disposed on either side of a tracheal opening 32 … the tracheal opening 32 to occur”), said inner chamber having a second orifice separate from said first orifice (Sakezles, see fig. 5 below);
b. a simulated larynx, with a simulated anterior larynx oriented on one side of said base (Sakezles, figs. 4 – 5, 28, 30; [0037], “the hyoid cartilage component 28 … a cricoid membrane 30”; [0040], “through the hyoid opening 29”; the hyoid cartilage component 28 and a cricoid membrane 30 can be cut open to form a first passage to the first orifice or tracheal opening 32), said simulated anterior larynx having a passage traversing through said simulated anterior larynx and said base (Sakezles, figs 3 – 7; [0029], “a hyoid cartilage component affixed at least at one end to the tracheal structure and disposed ventral to the removable cricoid membrane”; [0030], “cricoid membrane may be secured to the tracheal structure with one or more ring clips”), said passage being shaped and sized to enable the insertion at least in part of a Cricothyrotomy training device there through (Sakezles, [0033], “an airway incision is made through the replaceable skin component and the replaceable cricoid membrane in the tracheal structure … Following the incision, an air tube can be inserted into the airway incision”); and
c. a fastener, said fastener releasably attaching said adjunct to said medical training platform such that said passage communicates with said medical training platform first orifice when said adjunct is attached to said medical training platform (Sakezles, [0038], “The cricoid membrane 30 is attached to the tracheal structure 24 by ring clips 34 … one ring clip 34 may be used to affix the cricoid membrane 30 to the tracheal structure 24”).
wherein said passage and said platform inner chamber collectively form a first training cavity, said first training cavity being configured to receive the insertion of at least a portion of a one of a cricothyroid airway device and an intubation device through said passage and into said inner chamber (Sakezles, [0033], “an airway incision is made through the replaceable skin component and the replaceable cricoid membrane in the tracheal structure … Following the incision, an air tube can be inserted into the airway incision”).
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Sakezles does not explicitly disclose an adjunct comprising a simulated larynx having a front face; nor disclose b. a simulated larynx adjunct, said adjunct having a base. Instead Sakezles teaches an integrated simulated larynx having a front face (Sakezles, fig. 3 and fig. 7).
Chia (US 2022/0246062 A1) teaches an artificial anatomical model for simulating a cricothyroidotomy procedure. Chia teaches Claim 1. said adjunct comprising: a simulated larynx having a front face, said simulated larynx having a second passage, said second passage extending from said front face through said simulated larynx, said simulated larynx being attached to said base, said second passage communicating at least in part with said first passage in said base. Claim 12. b. a simulated larynx adjunct, said adjunct having a base (Chia, figs. 2A – 2E; i.e., fig. 2E, 52 is adjunct to the component 54; [0064], “The first component 52 is the relatively hard structure representing or mimicking the anatomy of a real human patient in the trachea larynx structure 30”; [0065], “The second component 54 is the resilient and incisable material which forms the cricothyroid membrane- the membrane spanning the cricothyroid space 40, together with the thyohyoid membrane 34, tracheal rings 42 cricoid cartilage 38”; [0067], “the second component 54 defines an air tight chamber, until an incision is made in the portion of the second component spanning the cricothyroid space 40 defined by the (relatively harder) first component 52”). Therefore, in view of Chia, 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 system described in Sakezles, by providing the removable simulated larynx instead of the integrated larynx as taught by Chia, so that the parts of the model can be removed to view the anatomical features (Chia, [0073]).
Re claim 2:
2. The modular Cricothyrotomy training adjunct of Claim 1, further comprising a simulated skin patch, said simulated skin patch being positioned at least in part over said simulated larynx front face (Sakezles, [0015]; [0026]).
Re claim 3:
3. The modular Cricothyrotomy training adjunct of claim 2, wherein said simulated skin patch releasably attaches to one of said medical training platform, said base, and said simulated larynx (Sakezles, [0015]; [0026]).
Re claim 4:
4. The modular Cricothyrotomy training adjunct of claim 1, wherein said simulated larynx front face has an upper structure and a lower structure, said second opening being positioned between said upper and lower structures, one of said upper structure and said lower structure corresponding in shape to one of: (a) the anterior of the cricoid cartilage and lower end of the thyroid cartilage of a human body; and (b) the upper anterior portion of the trachea cartilage of a human body (Sakezles, [0012]; [0038]).
Re claim 5:
5. The modular Cricothyrotomy training adjunct of Claim 1, further comprising a fastener, said fastener releasably attaching said adjunct to said medical training platform (Sakezles, [0038]).
Re claim 6:
6. The modular Cricothyrotomy training adjunct of claim 5, wherein said fastener comprises one of a grip, a clip, a clamp, a ratchet, a belt, a latch, a screw, a bolt, an elastic band, a hook, and a pin (Sakezles, [0038]).
Re claim 9:
9. The modular Cricothyrotomy training adjunct of claim 1, further comprising an alignment structure, said alignment structure aligning said base with said medical training platform in a desired orientation when said base is attached to said platform (Sakezles, figs. 4 – 6; Chia, figs. 2A - 2E; fig. 2C in Chia shows orientation of the based and platform).
Re claim 10:
10. The modular Cricothyrotomy training adjunct of claim 1, further comprising simulated cricoid process membrane positioned at least in part over across second passage (Sakezles, fig. 5, 30).
Re claim 11:
11. The modular Cricothyrotomy training adjunct of Claim 1, wherein said first and second passages and said platform inner chamber and second orifice collectively form a second training cavity said second training cavity being configured to receive the insertion of at least a portion of an intubation device through said first and second passages, into said body inner chamber and through said second orifice (Sakezles, [0033], “an airway incision is made through the replaceable skin component and the replaceable cricoid membrane in the tracheal structure … Following the incision, an air tube can be inserted into the airway incision”).
Re claim 13:
13. The modular Cricothyrotomy training system of Claim 12, further comprising a simulated skin patch, said simulated skin patch being positioned at least in part over said simulated anterior larynx adjunct, said simulated skin patch releasably attaching to one of said simulated anterior larynx adjunct and said medical training platform (Sakezles, [0015]; [0026]).
Re claim 15:
The modular Cricothyrotomy training system of Claim 12, wherein said simulated anterior larynx adjunct comprises a front face oriented opposite said base, said front face having an upper structure and a lower structure, said passage being positioned between said upper and lower structures, one of said upper structure and said lower structure corresponding in shape to one of: (a) the anterior of the cricoid cartilage and lower end of the thyroid cartilage of a human body; and (b) the upper anterior portion of the trachea cartilage of a human body (Sakezles, [0012]; [0038]).
Re claim 16:
16. The modular Cricothyrotomy training system of claim 12, wherein said fastener comprises one of a clip, a clamp, a ratchet, a belt, a latch, a screw, a bolt, an elastic band, a hook, and a pin (Sakezles, [0038]).
Re claim 19:
19. The modular Cricothyrotomy training adjunct of claim 12, further comprising an alignment structure, said alignment structure aligning said base to said medical training platform in a desired orientation when said base is attached to said medical training platform (Sakezles, figs. 4 – 6; Chia, figs. 2A - 2E; fig. 2C in Chia shows orientation of the based and platform).
Re claim 20:
20. The modular Cricothyrotomy training adjunct of claim 12, further comprising simulated cricoid process membrane positioned at least in part across said passage (Sakezles, fig. 5, 30).
Re claim 21:
21. The modular Cricothyrotomy training adjunct of Claim 12, wherein said passage and said platform inner chamber and second orifice collectively form a second training cavity, said second training cavity being configured to receive the insertion of at least a portion of an intubation device through said first and second passages, into said body inner chamber and through said second orifice (Sakezles, [0033], “an airway incision is made through the replaceable skin component and the replaceable cricoid membrane in the tracheal structure … Following the incision, an air tube can be inserted into the airway incision”).
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sakezles (US 2014/0302475 A1) in view of Chia (US 2022/0246062 A1) as applied to claim 1 above, and further in view of Hung (US 2018/0071556 A1).
Re claims 7, 17:
The combination of Sakezles and Chia does not explicitly disclose an elastic flange. Hung teaches elastic flange for securing between two devices. Hung teaches a fixing device is applied to fix a breathing tube (Hung, Abstract). Hung teaches 7. The modular Cricothyrotomy training adjunct of claim 1, wherein said base comprises an elastic flange, said elastic flange being positioned and oriented to apply pressure to said medical training platform when said base is attached to said medical training platform (Hung, fig. 3 and fig. 7; [0027], “The fixer 13”). 17. The modular Cricothyrotomy training adjunct of claim 12, wherein said fastener extends from said base and comprises an elastic flange, said elastic flange being positioned and oriented to apply pressure to said medical training platform when said base is attached to said medical training platform (Hung, fig. 3 and fig. 7; [0027], “The fixer 13”). Therefore, in view of Hung, 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 training device described in Sakezles, by providing the elastic flange as taught by Hung, since the two arms (flanges) arcuate, flexibly, rotatably clamp the breathing tube (tracheal opening) at a desired angle (Hung, [0027]).
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sakezles (US 2014/0302475 A1) in view of Chia (US 2022/0246062 A1) as applied to claim 1 above, and further in view of Felsinger et al. (US 2018/0240366 A1).
Re claims 8, 18:
Sakezles teaches 8. The modular Cricothyrotomy training adjunct of claim 1, wherein said medical training platform body is generally tubular and has a sidewall and a first end, said first orifice being positioned on said sidewall and comprising at least in part a medical training region, said second orifice being positioned proximate said first end. 18. The modular Cricothyrotomy training adjunct of Claim 12, wherein said medical training platform body is generally tubular and has a sidewall and a first end, said first orifice being positioned on said sidewall and comprising at least in part a medical training region, said second orifice being positioned proximate said first end (Sakezles, fig. 4, 24; fig. 5, 24; [0038], “one ring clip 34 may be used to affix the cricoid membrane 30 to the tracheal structure 24”; tracheal structure has an inner chamber), said inner chamber having a first orifice (Sakezles, fig. 4, 24; [0038], “one disposed on either side of a tracheal opening 32 … the tracheal opening 32 to occur”).
Sakezles does not explicitly disclose said adjunct further comprising a cap, said cap releasably attaching to said body and covering at least in part said second orifice when so attached. Felsinger et al. (US 2018/0240366 A1) teaches a simulated rectum model for training transanal minimally invasive surgery. Felsinger teaches said adjunct further comprising a cap, said cap releasably attaching to said body and covering at least in part said second orifice when so attached (Felsinger, [0022], “two end caps”; fig. 9; [0058], “cylindrical canister having one or more end cap 250”). 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 device described in Sakezles, by providing the end caps as taught by Felsinger in order to seal the simulated organ (Felsinger, [0072], “The model of the present invention also allows the trainee to learn how to handle a billowing situation that occurs due an imbalance of the insufflation gas going in and out of the sealed rectum”).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 – 13 and 15 - 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/JACK YIP/Primary Examiner, Art Unit 3715