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 Status
Claims 1-20 filed 3/22/2024 are pending and subject to examination on the merits in this office action.
Drawings
The drawings are objected to because figure 3 appears to be a photograph.
Photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention. See: MPEP 608.01(f).
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.
Specification
The disclosure is objected to because of the following informalities: The specification is objected to because it utilizes acronyms prior to defining the acronyms. For example, ENT and ICU have been used in paragraph [003] without properly identifying these acronyms.
Appropriate correction is required.
Claim Objections
Claims 14 and 15 are objected to because of the following informalities:
Claim 14 is objected because it lacks a space between “(TDK)” and “of” (i.e. (TDK)of).
Claim 15 is objected to because it lacks “is” between “tip” and “located” in line 11.
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.
Claims 1-19 are 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.
Claims 1, 15-16 and 19 are rejected because it is confusing what constitutes a “standard tracheal dilator” and a “standard tracheal dilator kit”. Moreover, standards change over time and therefore what may be a standard dilator today would be considered something different throughout time. Moreover, a standard tracheal dilator is typically referred to as a surgical instrument used to gently widen and hold open an incision on the trachea during a tracheostomy that allows for safe insertion or replacement of a tracheostomy tube, which typically includes the Trusseau Dilator and/or the Laborde Dilator. Thus, applicant’s claims to a “standard tracheal dilator” do not appear consistent with what one having ordinary skill in the art would be apprised of as a standard tracheal dilator. Moreover, if applicant is claiming a tracheal dilator that is a “standard tracheal dilator” then, the “standard tracheal dilator” would be considered admitted prior art, as it is a “standard tracheal dilator”. Finally, as standards change over time, the metes and bounds of what is encompassed by the claimed “standard tracheal dilator” are subject to change over time and applicant has not provided an adequate description for future standards.
Moreover, applicant has claimed “the quadritube tracheal dilator (TD-Q) is a four-lumen tube with a first end and second end, wherein the dilator tip located on the first end, wherein the ETT cuff is located on the first end, and wherein the dilation balloon is located on the first end” and simultaneously claimed “the standard tracheal dilator (TD-S) is a triple-lumen tube with a first end and second end, wherein the rigid dilator tip located on the first end, wherein the ETT cuff is located on the first end, and wherein the dilation balloon is located on the first end”. It is unclear if:
“the rigid dilator tip located on the first end” of the standard tracheal dilator is the same “the dilator tip located on the first end” of the quadritube tracheal dilator;
“the ETT cuff” of the standard tracheal dilator is the same is the same “the ETT cuff” of the quadritube tracheal dilator; and
“the dilation balloon” of the standard tracheal dilator is the same is the same “the dilation balloon” of the quadritube tracheal dilator.
Based on the specification and the drawings, it appears the quadritube tracheal dilator (TD-Q) is a four-lumen tube with a first end and second end having its own, separate dilator tip, ETT cuff, and dilation balloon; and, the standard tracheal dilator is a triple-lumen tube with a first end and second end and its own separate dilator tip, ETT cuff and dilation balloon.
Claim 2 is confusing because it is unclear if “the dilator tip” is the “dilator tip” of the quadritube tracheal dilator, the standard tracheal dilator, or a shared “dilator tip”.
Claim 3 is confusing because it is unclear if “the ETT cuff” is the “the ETT cuff” of the quadritube tracheal dilator, the standard tracheal dilator, or a shared “the ETT cuff”.
Claim 4 is confusing because it is unclear if “dilation balloon” is the “dilation balloon” of the quadritube tracheal dilator, the standard tracheal dilator, or a shared “dilation balloon”.
Claim 5 is confusing because it depends from claims 1-4 wherein the distance is unascertainable due to it being unclear where the objects are located that are being used as reference points.
Claims 6-13 are rejected as depending from a rejected base claim.
Claims 14 and 18 are confusing because it is unclear what is meant by “wherein the pressure measurement tube directs the pressure sensors to the first end to measure pressure in the first end”. It is unclear how the pressure measurement tube “directs the pressure sensors to the first end to measure pressure in the first end”. Does the pressure measurement tube “connect the pressure sensors to the first end to measure pressure in the first end”?
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)(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.
Claim(s) 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tagliavini (20100024827).
Regarding claim 20, Tagliavini discloses a quadritube (figure1) configured for use in a tracheal dilator kit (TDK), wherein the quadritube is a four-lumen tube (2, 6, 9, & 14) with a first end (distal end) and second end (proximal end), wherein the first end (distal end) includes a dilator tip (distal tip of 2), and wherein each of the four lumens at the second end (proximal end) is configured to receive and couple to one of an ETT cuff inflator tube (tube 14 connecting 13), a pressure measurement tube (via 9), a balloon inflator tube (tube 6 connecting 4), and a ventilation lumen (tube connecting 2).
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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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9 and 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tagliavini (20100024827) and further in view of Chapiro (10179219) and Zou et al, Scientific Reports, A randomized comparison of the prone ventilation endotracheal tube versus the traditional endotracheal tube in adult patients undergoing prone position surgery (Herein referred to as Zou).
Regarding claims 1 and 15, Tagliavini discloses a quadritube wherein the quadritube tracheal dilator (TD-Q) is a four-lumen tube (2, 6, 9, & 14) with a first end (distal end) and second end (proximal end), wherein the dilator tip (distal tip of 2) located on the first end (distal end), wherein the ETT cuff (13) is located on the first end, and wherein the dilation balloon (4) is located on the first end.
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However, Tagliavini lacks the teaching of a standard tracheal dilator (TD-S), a dilator tip, an endotracheal tube (ETT) cuff, and a dilation balloon, wherein the standard tracheal dilator (TD-S) is a triple-lumen tube with a first end and second end, wherein the rigid dilator tip located on the first end, wherein the ETT cuff is located on the first end, and wherein the dilation balloon is located on the first end.
First, it appears applicant is referring to the standard tracheal dilator as something that is known in the art (i.e. “standard”). Thus, such an admission can be considered Applicant Admitted Prior Art. However, assuming arguendo that applicants did not intend for this to be an admission of prior art, the examiner has provided Chapiro as a teaching of a triple-lumen tube.
Chapiro teaches (Figure 1) an intubation tube with three lumens. Chapiro has a dilator tip (tip of distal end), an endotracheal tube (ETT) cuff (128), and a dilation balloon (126), wherein the standard tracheal dilator (TD-S) is a triple-lumen tube (111, 112, 119) with a first end (distal end) and second end (proximal end), wherein the rigid dilator tip located on the first end (distal end), wherein the ETT cuff (128) is located on the first end (distal end), and wherein the dilation balloon (126) is located on the first end (the first end is considered the portion of the tube below the two inflation cuffs).
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Although the combined references individually disclose a quadritube (Tagliavini) and a triple tube (standard tracheal dilator), neither reference discloses the combination of both tubes as a kit.
Zou discloses a tracheal dilator kit (combination of prone ventilation endotracheal tube and the traditional endotracheal tube) comprising: an experimental endotracheal tube (prone ventilation endotracheal tube) and a standard tracheal dilator (TD-S) (the traditional endotracheal tube). Zou discloses comparing a standard tube to an experimental tube and discusses the results of the comparison.
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It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have formed a kit (as taught by Zou) comprising an experimental quadritube, as taught by Tagliavini, and a three lumen standard tracheal tube, as taught by Chapiro, in order to have a control (standard tracheal tube) to compare the results of the experimental tracheal tube (quadritube). Moreover, it is noted that Chapiro also teaches a four-lumen tube (figure 3) which would further provide a reason for comparing the three-lumen tube to a four-lumen tube.
Regarding claim 2, the tracheal dilator kit (TDK) of the combined references has the dilator tip located at the end of the first end.
Regarding claim 3, the tracheal dilator kit (TDK) of the combined references has the ETT cuff located a first distance away from the dilator tip.
Regarding claim 4, the tracheal dilator kit (TDK) of the combined references has the dilation balloon located a second distance away from the dilator tip.
Regarding claim 5, the tracheal dilator kit (TDK) of the combined references has the first distance (distal cuff to distal tip) is shorter than the second distance (proximal cuff to distal tip).
Regarding claims 6 and 16, the tracheal dilator kit (TDK) of the combined references has an ETT cuff inflator tube (tube inflating distal cuff), a pressure measurement tube, a balloon inflator tube, and a ventilation lumen, wherein the ETT cuff inflator tube, pressure measurement tube, balloon inflator tube, and ventilation lumen each separately couple to the quadritube tracheal dilator (TD-Q) at the second end (See figure 1 of Tagliavini).
Regarding claims 7 and 17, the tracheal dilator kit (TDK) of the combined references has each of the ETT cuff inflator tube, pressure measurement tube, balloon inflator tube, and ventilation lumen each couple to one of the four lumens in the four-lumen quadritube tracheal dilator (TD-Q) (See figure 1 of Tagliavini wherein the tubes are capable of performing the claimed functions).
Regarding claim 8, the tracheal dilator kit (TDK) of the combined references comprises an ETT cuff inflation syringe, wherein the ETT cuff inflation syringe couples to the ETT cuff inflator tube (at 7, 10 or 15 of Tagliavini), and wherein the ETT cuff inflator tube directs air from the ETT cuff inflation syringe to the ETT cuff to fill the ETT cuff. See: Paragraph [0056] of Tagliavini.
Regarding claim 9, the tracheal dilator kit (TDK) of the combined references has a dilation balloon syringe, wherein the dilation balloon inflation syringe couples to the balloon inflator tube, and wherein the balloon inflator tube directs air from the dilation balloon inflation syringe to the dilation balloon to fill the dilation balloon. See: Paragraph [0056] of Tagliavini.
Regarding claim 14 and 18, the tracheal dilator kit (TDK) of the combined references has a pressure-measuring component with pressure sensors, wherein the pressure-measuring component couples to the pressure measurement tube, and wherein the pressure measurement tube directs the pressure sensors to the first end to measure pressure in the first end (the tubes at the proximal end).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tagliavini (20100024827) and further in view of Chapiro (10179219) and Zou et al, Scientific Reports, A randomized comparison of the prone ventilation endotracheal tube versus the traditional endotracheal tube in adult patients undergoing prone position surgery (Herein referred to as Zou) and further in view of Fry (5520175).
Regarding claim 10, the combined references disclose a tracheal dilator kit (TDK) but lack the specific teaching of having a guide wire, wherein the guide wire couples to the balloon inflator tube, and wherein the guide wire moves from the balloon inflator tube to the first end.
Guide wires are commonly used in the placement of endotracheal tubes. Fry specifically discloses using a guide wire that couples to the balloon inflator tube to the first end. See figures 2A and 2B and col. 4, line 49 - col 5, line 12.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have used a guide wire, which is a well-known mechanism for introducing an endotracheal tube in order to provide a guide for insertion of an endotracheal tube into a patient.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tagliavini (20100024827) and further in view of Chapiro (10179219) and Zou et al, Scientific Reports, A randomized comparison of the prone ventilation endotracheal tube versus the traditional endotracheal tube in adult patients undergoing prone position surgery (Herein referred to as Zou) and further in view of Anderson (4244362).
Regarding claim 11, the combined references disclose a tracheal dilator kit (TDK) but lack the specific teaching of having an ETT stylet, wherein the ETT stylet is configured to be introduced into the ventilation lumen, wherein the ETT stylet is selectively deformable, and wherein the quadritube tracheal dilator (TD-Q) is configured to selectively deform to conform to the shape of the ETT stylet.
Stylets are well known in the art for introducing an endotracheal tube, as taught by Anderson. See: Figures 1-9 and abstract.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have used a stylet, which is a well-known mechanism for introducing an endotracheal tube in order to provide a guide for insertion of an endotracheal tube into a patient.
Regarding claim 12 the tracheal dilator kit (TDK) of the combined references has the ventilation lumen is configured to selectively couple with a ventilator.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tagliavini (20100024827) and further in view of Chapiro (10179219) and Zou et al, Scientific Reports, A randomized comparison of the prone ventilation endotracheal tube versus the traditional endotracheal tube in adult patients undergoing prone position surgery (Herein referred to as Zou) and further in view of Fischer et al (20130204082).
Regarding claim 13, the combined references disclose a tracheal dilator kit (TDK) but lack the specific teaching of the kit further comprising a connector with at least two connection ports, wherein the connector couples to the balloon inflator tube.
Multiport connections are well known in the art for use with endotracheal tubes and Fischer discloses multiport connections with rotatable ports. See: Figures 1-10.
It would have been obvious to one having ordinary skill in the art at the time the invention was flied to have modified the connector of the combined references to use a multiport connector, as taught by Fischer in order to provide a connector that could be easily accessed and provide multiple connections with the additional benefit that the connector could rotate to provide easier access to the ports during use.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tagliavini (20100024827) and further in view of Chapiro (10179219) and Zou et al, Scientific Reports, A randomized comparison of the prone ventilation endotracheal tube versus the traditional endotracheal tube in adult patients undergoing prone position surgery (Herein referred to as Zou) and further in view of Fry (5520175) and further in view of Anderson (4244362).
Regarding claim 19, the combined references teach the tracheal dilating system but lack the specific teaching of having a guide wire and an ETT stylet, wherein the dilation balloon inflation syringe couples to the balloon inflator tube; wherein the guide wire couples to the balloon inflator tube, and wherein the guide wire moves from the balloon inflator tube to the first end, wherein the ETT stylet is configured to be introduced into the ventilation lumen, wherein the ETT stylet is selectively deformable, and wherein the quadritube tracheal dilator (TD-Q) is configured to selectively deform to conform to the shape of the ETT stylet.
Guide wires are commonly used in the placement of endotracheal tubes. Fry specifically discloses using a guide wire that couples to the balloon inflator tube to the first end. See figures 2A and 2B and col. 4, line 49 - col 5, line 12.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have used a guide wire, which is a well-known mechanism for introducing an endotracheal tube in order to provide a guide for insertion of an endotracheal tube into a patient.
Stylets are well known in the art for introducing an endotracheal tube, as taught by Anderson. See: Figures 1-9 and abstract.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have used a stylet, which is a well-known mechanism for introducing an endotracheal tube to provide a guide for insertion of an endotracheal tube into a patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, as it discloses additional multitube endotracheal tubes with multiple cuffs.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLINTON T OSTRUP whose telephone number is (571)272-5559. The examiner can normally be reached M-F 8:30 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Teixeira Moffat can be reached at 571-272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CLINTON T OSTRUP/Supervisory Patent Examiner, Art Unit 3732
