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 . This action is in response to the Request for Continued Examination received on March 24, 2026. Claims 52, 55-59, 69, and 70 are currently pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 24, 2026 has been entered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, a proximal end of an endotracheal tube (claim 52), an ETT opening (claims 52, 69 and 70), a first opening (claims 52 and 70), second opening (claims 52 and 70), front end of the housing (claims 52, 69 and 70), an opening in a front end of the housing (claim 69), a straight configuration from the second opening to the ETT opening (claim 52), and a straight configuration along an entirety of a distance between the opening in the front end and the ETT opening (claims 69 and 70).
Examiner Note: Include in the response , reference numerals and citations in the specification for each feature described above. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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 52, 55-59, 69, and 70 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.
In claim 52, line 4, recites “a proximal end of an endotracheal tube, the endotracheal tube coupler defining an ETT opening”. It is unclear where the proximal end of an endotracheal tube is located or support for the endotracheal tube defining an ETT opening.
In claims 52, 69, and 70 recite “a first opening in a front end”. It is unclear where the first opening and front end surface are defined in the specification and shown in the drawings. It appears 1755 or 1756 may represent a front opening in the housing through which the introducer is located. It further appears 19J represents a front end view of the assembly not an actual front end of the housing.
In claim 52, 69, and 70 recite “a second opening in the front end surface”. It is unclear where the second opening and front end surface are defined in the specification and shown in the drawings. It appears 1755 or 1756 may represent a front opening in the housing through which the introducer is located. It further appears 19J represents a front end view of the assembly not an actual front end of the housing.
In claim 52, 69, and 70 recite “a straight configuration from the second opening to the ETT opening”. It is unclear where the straight configuration extends from, since the second opening and ETT opening are unknown.
In claims 52, 69 and 70 recite “a front end of the housing”. It further appears 19J represents a view of a front end of the housing [paragraph 294] rather than an actual front end surface.
Claims 52, 55-59, 69, and 70 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.
In the claims recite “ETT”, it is unclear what ETT is an abbreviated term for. It is not spelled out or described in the specification in a manner that one would know what ETT stands for and is therefore indefinite.
Claim Rejections - 35 USC § 102
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 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)(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 52, 54-59, 69, and 70 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Genova et al. (US Patent 10,398,287), hereinafter “Genova”
Regarding claim 52, Genova discloses an introducer assembly (108, Figure 1) capable of introducing a medical tool during an airway management procedure (i.e., instruments can be inserted into a body cavity of a patient (Col. 7, lines 25-28), comprising: an introducer housing (222, Figure 2A); including an endotracheal tube coupler (214, Figure 2A) capable of being releasably coupled to a proximal end of an endotracheal tube (i.e. the channel 214 is capable of receiving and guiding one or more instruments, such as an endotracheal tube (Col. 8, lines 28-33);
an elongate medical tool introducer (224, Figure 2A) having a first end (224B, Figure 2A) that is fixed relative to the introducer housing (i.e. 224A can be non-removably attached (Col. 8, lines 49-51)), extends out of a first opening in a front end surface (see the diagram) of the introducer housing in a loop configuration (Col. 8, lines 59-60), and then extends back into the introducer housing (Col. 8, lines 60-65 and Figures 2A-2B) through a second opening in the front end surface (see the diagram below), and between first and second rotatable mechanical interfaces (232A and 232B, Figure 2A) that are positioned to interface with the introducer to facilitate axial movement of the introducer within and relative to the introducer housing (Col.8, lines 59-65), the second opening and the ETT opening positioned such that the introducer is maintained in a straight configuration from the second opening to the ETT opening.
Examiner note: The ETT opening and its particulars are not positively recited within the claim. Therefore, the prior art does not have to teach said limitation in order to reject the claim.
Regarding claim 55, Genova discloses wherein the introducer extends through the endotracheal tube coupler (i.e., channels 214 can also permit insertion of 224, Col. 8, lines 37-40)
Regarding claim 56, Genova discloses wherein the introducer housing is sized and capable of being detachably coupled to a handheld controller (i.e. the introducer is capable of being attached to another device within the system 100, see Figure 1) housing attaches to drive unit 106, Col. 12, lines 16-19), and wherein the first and second rotatable mechanical interfaces (i.e. drivers, Col. 8, lines 54-59) are capable of being adapted and arranged to be actuated by the handheld controller to cause the axial movement of the introducer.
Examiner Note: The handheld controller and its particulars are not positively recited within the claim. Therefore, the prior art does not have to teach said limitation in order to reject the claim.
Regarding claim 57, Genova discloses wherein the introducer housing further comprises one or more introducer deflection elements (232A and 232B, Col.15, lines 20-52) that are arranged relative to the introducer to cause deflection of the introducer.
Regarding claim 58, Genova discloses wherein the introducer housing is sized and capable of being detachably coupled to a handheld controller (i.e. the introducer is capable of being attached to another device within the system 100, see Figure 1) housing attaches to drive unit 106, Col. 12, lines 16-19) and wherein the one or more introducer deflection elements (232A and 232B, Col.15, lines 20-52) are capable and arranged to be actuated by the handheld controller to cause deflection of the introducer.
Examiner Note: The handheld controller and its particulars are not positively recited within the claim. Therefore, the prior art does not have to teach said limitation in order to reject the claim.
Regarding claim 59, Genova discloses wherein the introducer includes a camera (i.e. 224 is a camera tube) at an introducer distal end (224B, Col. 8, lines 42-44).
Regarding claim 69, Genova discloses an introducer assembly (108, Figure 1) capable of introducing a medical tool during an airway management procedure (i.e., instruments can be inserted into a body cavity of a patient (Col. 7, lines 25-28), comprising: an introducer housing (222, Figure 2A) that includes an endotracheal tube coupler (214, Figure 2A), the endotracheal tube coupler having an ETT opening (see the diagram below, opening through which 224 extends from) therethrough; an elongate medical tool introducer (224, Figure 2A) having a first end (224B, Figure 2A) that is fixed relative to the introducer housing, extends out of the introducer housing in a loop configuration (see Figure 2A), then extends back into the introducer housing through an opening in a front end of the housing (see the diagram below) and between first and second rotatable mechanical interfaces (232A and 232B, Figure 2A) that are positioned to interface with the introducer to facilitate axial movement of the introducer within and relative to the introducer housing, and then extends through the ETT opening (see Figure 2A), the opening and ETT opening positioned relative to each other such that the introducer is maintained a straight configuration along an entirety of a distance between the opening in the front end and the ETT opening (see Figure 2A the straight portion that extends from 214).
Regarding claim 70, Genova discloses an introducer assembly (108, Figure 1) capable of introducing a medical tool during an airway management procedure(i.e., instruments can be inserted into a body cavity of a patient (Col. 7, lines 25-28), comprising: an introducer housing (222, Figure 2A) with a front end, the front end including first and second openings (see the diagram below), an endotracheal coupler defining an ETT opening, an elongate introducer having a first end (224B, Figure 2A)that is fixed relative to the introducer housing, extends out of a first opening in the front end, forms a loop configuration (see Figure 2A), extends back into the introducer housing through a second opening in the front end, extends between first and second rotatable mechanical interfaces (232A and 232B, Figure 2A)that are positioned within the housing to interface with the introducer to facilitate axial movement of the introducer within and relative to the introducer housing, and then extends through the ETT, the second opening and the ETT opening positioned relative to each other such that the introducer is maintained in a straight configuration along an entirety of a distance between the second opening in the front end and the ETT opening (see Figure 2A the straight portion that extends from 214).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA S JONES whose telephone number is (571)270-5963. The examiner can normally be reached Monday to Friday (8am to 4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Diana Jones/Examiner, Art Unit 3775
/KEVIN T TRUONG/Supervisory Patent Examiner, Art Unit 3775
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