Prosecution Insights
Last updated: April 19, 2026
Application No. 16/330,810

ENDOTRACHEAL TUBE STYLET

Final Rejection §103§112
Filed
Mar 06, 2019
Examiner
DITMER, KATHRYN ELIZABETH
Art Unit
3785
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
H. Lee Moffitt Cancer Center and Research Institute, Inc.
OA Round
10 (Final)
58%
Grant Probability
Moderate
11-12
OA Rounds
3y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allow Rate
428 granted / 742 resolved
-12.3% vs TC avg
Strong +50% interview lift
Without
With
+49.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
63 currently pending
Career history
805
Total Applications
across all art units

Statute-Specific Performance

§101
1.9%
-38.1% vs TC avg
§103
39.4%
-0.6% vs TC avg
§102
18.8%
-21.2% vs TC avg
§112
29.5%
-10.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 742 resolved cases

Office Action

§103 §112
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 This office action is in response to the amendment filed 7/14/2025. As directed by the amendment, claims 9, 13 and 17 have been amended, and claims 1-6, 15, 16 and 18 have been cancelled. As such, claims 9-14 and 17 are pending in the instant application. Applicant has amended the claims to address the previous claim objection, which is hereby withdrawn. Applicant has amended the specification in response to the previous drawing objection, but the amendments do not address all of the instances of “stylet 20”; the previous drawing objection is updated below. Applicant has cancelled claims 16 and 18, rendering the duplicate claim issue moot. Applicant has amended the claims and cancelled claims 15-16 to address the previous rejections under 35 USC 112(a)/first paragraph, which are hereby withdrawn. Applicant has amended the claims to remove the language regarding “one and only one aperture” and “a bottom”; the previous rejection of the claims under 35 USC 12(b)/second paragraph is hereby withdrawn. Applicant has amended the body of claim 13 to be further limiting, but the preamble of claim 13 is now not further limiting because of the amendments to claim 9. The previous rejection of claim 13 under 35 112(d)/fourth paragraph is updated below. Response to Arguments Applicant's arguments filed 7/14/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive. Applicant asserts on page 12 of Remarks that “[c]urrent endotracheal tube systems require insertion of multiple tubes to allow for multiple flow paths,” arguing that “[t]his is different than the present invention, which allows for multiple flow paths within the same tube…reducing the need to insert multiple tubes.” The Examiner disagrees with Applicant’s assertion that current systems “require” multiple tubes to provide multiple flow paths. Endotracheal tube systems that allow for multiple flow paths within the same tube were so well known before the effective filing date of the claimed invention that they have their own subclass in the CPC classification system: A61M16/0486 Multi-lumen tracheal tubes. Indeed, previously-applied Galel, Adair and Boretos all disclose multi-lumen tubes for providing multiple flow pathways through the same tube. Applicant’s asserted benefits would have been readily predictable to an artisan before the effective filing date of the claimed invention; Applicant’s argument is unconvincing. Applicant asserts on page 12 of Remarks that “Gao does not teach or suggest…the elongated flexible conduit defining a first, a second, a third, or a fourth flow path….Galel, Levin and Hete do not remedy the deficiencies of Gao.” While Gao is no longer applied in the updated rejection in light of the amendments to the claims, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the elongated flexible conduit defining a first, a second, a third, or a fourth flow path) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The amended claims only require “at least two” fluid flow paths, i.e. they require a second but not necessarily a third and/or fourth. However, it is noted that previously-cited Galel, Adair and Boretos all teach that it would have been obvious to an artisan before the effective filing date of the claimed invention to include two or more than two fluid flow paths to provide increased control over steering, i.e. third and/or fourth fluid paths would not be a point of non-obviousness even if they were included in the claims. On pages 13-15 of Remarks, Applicant does not argue the application of art to the dependent claims separately from the limitations of claim 9. Claim 9 remains obvious in view of the prior art as discussed in the updated rejection below, and the teachings of Kolobow, Levin, Boretos and Klima remain applicable; therefore, the rejections of the dependent claims are maintained/updated below. Drawings The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “20” has been used to designate both stylet (paras [0025] and para [0026] of the PGPub of the instant application, i.e. two instances) and conduit (remainder of the specification) within the description of the specification. The drawings are objected to because the lead line for “stylet 10” in Figs. 1 and 2 appears to point to the system in general (which includes both the stylet and an endotracheal tube 60) and not the stylet in particular, i.e. as an element separate from the endotracheal tube 60, which is how the stylet is presented throughout the written specification. 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, the conduit with at least two pathways, single valve in communication with the at least two pathways, and nozzle with an inlet port directing the at least two pathways downward to move the conduit (claim 9), particularly in combination with a mechanical hinge or a pivot (claim 17) must be shown or the feature(s) canceled from the claim(s). 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 9-14 and 17 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. Applicant states on page 5 of Remarks that at least paras [0020] and [0027] of the PGPub of the instant application support the amendments to claim 1. However, para [0020] of the PGPub only describes an embodiment (see e.g. instant Fig. 3) with a single flow path that extends to a single aperture 36 via a single inlet port (understood to be to the left in Fig. 3, i.e. at the location of the label 34). While para [0027] indicates that multiple, independently-controlled air flow paths could extend through the flexible conduit, para [0027] also indicates that each of these pathways would flow from the valve to their own associated aperture in the nozzle, such that an inlet port in the nozzle for each path is inferred, and that any additional apertures would be placed so as to direct air flow to move the distal end of the flexible conduit in a different direction (“air flow through the second, third or fourth aperture can redirect the distal end…in a second direction, e.g. lateral or posterior directions,” para [0027] of the instant PGPub). The specification as originally filed makes no mention of/does not support a single inlet port in a nozzle as claimed directing at least two fluid flow paths, it does not support an inlet port itself directing movement (it is the radially-positioned aperture(s) that provide(s) this functionality), and it does not support two fluid flow paths both directed in the same (downward) direction to move the distal end of the flexible conduit. As such, claim 9 (and thus its dependent claims) contain new matter. 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 9-14 and 17 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. Regarding claim 9 (and thus its dependent claims), the amended claims recite an endotracheal tube, a stylet, and an elongated flexible conduit, each on their own line, which appears to indicate that these are three different elements, in light of 37 C.F.R. 1.75(i). However, it is understood from the previous claim sets as well as the specification as originally filed that the flexible conduit is the stylet, such that the claims are now indefinite because it is unclear how many different elements are being recited/required. As best understood, for purposes of examination, claim 9, line 6 will be considered to read “the stylet comprising an elongated flexible conduit…”. Further regarding claim 9 (and thus its dependent claims), “downward relative to an orientation of the endotracheal tube and the stylet” is indefinite, because it is unclear in the claim how the “orientation” is positioned in space/what direction relative to the elements of the tube/stylet is “down”, e.g. is the orientation vertical, such that “down” is a longitudinal end of the conduit, or is the orientation horizontal, such that “down” corresponds to a sidewall portion that is arbitrarily positioned facing the ground, or is the orientation angled, or twisted, or curved or combinations thereof? As best understood from e.g. instant Figs. 3 and 7 and para [0027] of the PGPub of the instant application, the pathway(s) are positioned such that fluid flows longitudinally toward the distal end and then exits radially from opening(s) thereof that are located in the sidewall of the nozzle, such that holding the flexible conduit with the distal end down means that flow along the longitudinal axis is downward OR holding the flexible conduit with one of said openings facing toward the ground means fluid radially exiting from said aperture will be directed downward. Therefore, for purposes of examination, as best understood, “downward relative to an orientation of the endotracheal tube and the stylet” will be considered to mean either “toward the distal end” OR “radially outward relative to a longitudinal axis of the flexible conduit.” Regarding claim 13, line 2 recites “an aperture” that is unassociated with any claimed structure and is attributed no claimed functionality. Where/what is this aperture? Is it on one of the claimed elements, or is it part of e.g. a connected device for providing fluid to the flow paths? As best understood, for purposes of examination, the aperture is on the nozzle/is for directing fluid radially outward relative to a/the longitudinal axis of the flexible conduit, such that Applicant could include either this location or this functionality or both in claim 13 to clarify the claim language and address this rejection. Claim 17 recites the limitation "the aperture" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the claim will be considered to read “an aperture”. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 10-14 and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The preambles of the dependent claims only recite/purport to further limit the “endotracheal tube stylet” (emphasis added) and not the entire system of claim 9; therefore, they fail to include all of the limitations of the claim upon which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Applicant could address this rejection by amending the preambles of claims 10-14 and 17 to recite “The endotracheal tube system”. 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. Claim(s) 9, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Galel et al. (US 5,498,239; hereinafter “Galel”) in view of Pagan (US 6,463,927 B1; hereinafter “Pagan”) and Adair (US 5,643,175; hereinafter “Adair”). Regarding claim 9, Galel discloses a medical tube system (Figs. 1-7 and 17) comprising: a medical tube (catheter 11); a stylet (tubular member 12); as best understood, the stylet comprising an elongated flexible conduit (Figs. 1-3) defining a proximal end (off to the right in Figs. 1-3), a distal end (distal end 14), and at least two fluid flow paths (e.g. within two lumens 34, 35 OR lumens 44, 45) between the proximal end and the distal end (e.g. Figs. 6-7; col. 3, lines 48-51; col. 6, lines 36-59), the elongated flexible conduit extending through the endotracheal tube (Figs. 1-3; col. 5, lines 5-7); a valve (Fig. 17; variable speed pump 85, 86…valves…single-lever…rather than two individual valves…may be substituted for the variable speed pumps, col. 8, lines 8-36) affixed to the proximal end of the elongated flexible conduit and fluidly-connectable to a source of pressurized oxygen (Fig. 17; i.e. in the same manner as the conduit is taught to be fluidly connected to common reservoir 87), wherein the valve is in fluid communication with the at least two fluid flow paths (Fig. 17; col. 8, lines 8-36); and directing the at least two fluid flow paths downward relative to an orientation of the endotracheal tube and the stylet to move the distal end of the elongated flexible conduit (Fig. 6, when “downward” is considered towards the distal end of the conduit/into the plane of the drawing, i.e. the fluid must flow first downward/distally before being directed radially outward, OR Fig. 7, because the conduit is fully capable of being positioned such that the direction of the arrows is oriented “downward”) (col. 3, lines 20-34 and lines 48-67; col. 5, lines 35-45; col. 6, line 60-col. 7, line 8), and, in the alternative, see also Adair Fig. 13, which teaches that it was known in the fluid-steerable medical tubing art before the effective filing date of the claimed invention to include two flow paths (one of each of the tubes 180, 182) that are directed downward/in the same direction, i.e. fluid is directed longitudinally then radially outward from aligned, downward-facing openings 176, 168, such that it would have been obvious to an artisan before the effective filing date of the claimed invention to additionally or alternatively include the aligned-openings-on-each-side construction taught by Adair in the conduit of Galel, in order to predictably provide for independent propulsion and steering on each side of the flexible conduit and/or to avoid high pressures at the jets (Galel col. 3, lines 48-67 and col. 7, lines 4-10). While Galel teaches that the catheter thereof is intended to provide access to internal bodily passages (Galel col. 1, lines 11-12), and Adair demonstrates that it was well known in the fluid-steerable medical tube art before the effective filing date of the claimed invention to utilize such tubes for intubation (Adair col. 1, lines 63-65), Galel (or modified Galel) is silent regarding the tube being specifically an endotracheal tube with a balloon coupled to the endotracheal tube, and an inflation line fluidly coupled to the balloon and extending along the endotracheal tube. However, Pagan demonstrates that it was well known in the guided medical tube art before the effective filing date of the claimed invention for a stylet (guide 2) to be utilized with an endotracheal tube (endotracheal tube 8/40) (Figs. 1 and 8) with a balloon (inflatable cuff 42) coupled to the endotracheal tube (Figs. 1/8; col. 3, lines 28-29 and 52-58), and an inflation line (inflation lumen 44) fluidly coupled to the balloon and extending along the endotracheal tube (Fig. 8; col. 3, lines 28-29 and 52-58). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for Galel (or modified Galel) to include the tube being specifically an endotracheal tube with a balloon coupled to the endotracheal tube, and an inflation line fluidly coupled to the balloon and extending along the endotracheal tube as taught by Pagan, in order to provide the predictable result of a tube/stylet arrangement tailored for intubation using a standard endotracheal tube with balloon for sealing against the trachea and a steerable stylet for increased control during the insertion. Modified Galel is silent regarding a nozzle coupled to the distal end of the elongated flexible conduit, wherein the nozzle comprises an inlet port for the directing discussed above. However, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art, see MPEP 2144.04.V.C, and Pagan further educates modified Galel to include a nozzle (plug 23) coupled to the distal end of the elongated flexible conduit, wherein the nozzle comprises an inlet port (Pagan Fig. 2), which would obviously be divided in modified Galel in order to direct fluid to the individual lateral apertures of modified Galel, in order to provide the end of the flexible conduit with an atraumatic end (Pagan col. 2, lines 45-47) while retaining the steerability of modified Galel, and which would predictably allow for separate machining of the distal outlets apart from the rest of the flexible conduit for ease of manufacturing and/or component sourcing due to the side-apertures-containing portion being a separate piece that can be added onto standard divided tubing and/or to allow the side-apertures-containing portion to be swapped out if the apertures become blocked and/or if different sized apertures are desired. Regarding claim 12, Galel in view of Pagan and Adair teaches the endotracheal tube [system] of claim 9, wherein Galel further discloses wherein the elongated flexible conduit comprises an elastomeric material that is not gas-permeable (tubular member will be of an elastic material…silicone rubbers, col. 8, lines 40-48). Regarding claim 13, Galel in view of Pagan and Adair teaches the endotracheal tube [system] of claim 9, wherein Galel further discloses wherein the inlet port is fluidly connected to an aperture (port 37, 38, 46 or 47 of Galel Figs. 6-7 or one of the aligned sidewall openings taught by Adair as discussed above regarding claim 9) (Galel col. 3, lines 20-34 and lines 48-67; col. 5, lines 35-45; col. 6, line 60-col. 7, line 8). Claim(s) 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Galel in view of Pagan and Adair as applied to claim 9 above, and further in view of Kolobow et al. (US 5,687,714; hereinafter “Kolobow”). Regarding claims 10 and 11, Galel in view of Pagan and Adair teaches the endotracheal tube [system] of claim 9, wherein Galel further discloses wherein the elongated flexible conduit has an inner diameter and an outer diameter (Figs. 1 and 6-7), but modified Galel is silent regarding the outer diameter of the elongated flexible conduit being from 3 to 8 mm and the inner diameter of the elongated flexible conduit being from 2 to 7 mm. However, optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05, Adair teaches an outer diameter of 7 mm (col. 6, lines 3-5), and Kolobow demonstrates that it was well known in the respiratory therapy art before the effective filing date of the claimed invention for an elongated flexible conduit (tubular catheter 14) (Fig. 1; catheter 14…preferably formed of a flexible plastic, col. 2, lines 59-60) positioned within an endotracheal tube (endotracheal tube 12) to have an outer diameter of from 3 to 8 mm and an inner diameter from 2 to 7 mm ([f]or an adult human…catheter 14 of 3.4 mm outside diameter and 2.64 mm inside diameter has been found to be suitable to sustain the desire air flow rates, col. 2, lines 62-65). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the elongated flexible conduit of modified Galel to have an outer diameter of from 3 to 8 mm and an inner diameter from 2 to 7 mm as taught by Adair and Kolobow, in order to provide the expected result of a conduit sized to be inserted into small bodily passageways (Adair col. 6, line 6) and thus into a standard endotracheal tube and able to deliver sufficient airflow to a patient of a given size, e.g. an adult human (Kolobow, col. 2, lines 62-67), to provide ventilation during the intubation procedure. Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Galel in view of Pagan and Adair as applied to claim 9 above, and further in view of Levin (US 5,676,635; hereinafter “Levin”). Regarding claim 14, Galel in view of Pagan and Adair teaches the endotracheal tube [system] of claim 9, but modified Galel is silent regarding an illumination device coupled to the distal end of the elongated flexible conduit. However, Adair demonstrates that it was well known in the fluid-steerable medical tube art before the effective filing date of the claimed invention to include means for illuminating the distal end of a stylet (e.g. col. 6, lines 15-18), and Levin teaches that it was well known in the stylet art before the effective filing date of the claimed invention for a stylet (instrument 10) (Figs. 2 and 4) have an illumination device (light source 68) coupled to a distal end (distal end 24) (col. 4, lines 61-64). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Galel to include an illumination device coupled to the distal end of the elongated flexible conduit as taught by Levin, in order to provide the predictable result of a standard means by which to aid the user in visualizing the entrance to the bodily passage, e.g. the larynx and/or the location of the stylet within the trachea (Levin col. 1, lines 46-50 and col. 2, lines 7-18). Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Galel in view of Pagan and Adair as applied to claim 9 above, and further in view of Boretos (US 4,403,985; hereinafter “Boretos”) and Klima et al. (US 2013/0297013 A1; hereinafter “Klima”). Regarding claim 17, Galel in view of Pagan and Adair teaches the endotracheal tube [system] of claim 9, wherein Galel further discloses wherein the elongated flexible conduit includes a portion of the distal end configured to actuate (e.g. Figs. 1-3) when a flow of fluid exits [an] aperture (port 37, 38, 46 or 47 of Galel Figs. 6-7 or the aligned sidewall openings taught by Adair as discussed above regarding claim 9) (Galel col. 3, lines 20-34 and lines 48-67; col. 5, lines 35-45; col. 6, line 60-col. 7, line 8), but modified Galel is silent regarding wherein the elongated flexible conduit includes a mechanical hinge or a pivot configured to actuate when a flow of fluid exits [an] aperture. However, Boretos teaches that it was known in the art of hydraulically-steerable medical tubes before the effective filing date of the claimed invention for a hydraulically-steerable elongated flexible conduit (elongated tube 11) to include a hinge or pivoting region proximate to the nozzle (pleated section 31) configured to actuate when a flow of fluid exits one of a plurality of radially-directing apertures (port 23) (Fig. 3), and Klima teaches that it was known in the art of steerable medical tubes before the effective filing date of the claimed invention for a hinged portion proximate to a nozzle to either be achieved via a flexible material section (flexible portion 330) (Fig. 8; para [0040]) similar to that of Boretos, or by including a mechanical hinge or a pivot (comprising pins 140) comprised by the nozzle (pivot arm 150) and the associated conduit (shaft 110) (Fig. 4B). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Galel to include wherein the elongated flexible conduit includes a mechanical hinge or a pivot that is configured to actuate when a flow of fluid exits an aperture as taught by Boretos and Klima, in order to utilize standard hinging means to provide the predictable result of controlling the flexion caused by the hydraulic steering taught by modified Galel such that it causes the distal end of the stylet of modified Galel to readily flex off-axis at a known/predetermined location (Boretos col. 2, lines 57-64 and col. 3, lines 26-34) while rotating only within a single plane relative to the conduit (Klima para [0033]), in order to provide predictable/prescribed movement, e.g. up-and-down, for simplified/constrained steering. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M-Th 7:30a-4:30p, F 7:30a-11:30a ET. 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) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. 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. /KATHRYN E DITMER/ Primary Examiner, Art Unit 3785
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Prosecution Timeline

Mar 06, 2019
Application Filed
Feb 26, 2021
Non-Final Rejection — §103, §112
Jun 30, 2021
Response Filed
Sep 24, 2021
Final Rejection — §103, §112
Jan 28, 2022
Request for Continued Examination
Jan 31, 2022
Response after Non-Final Action
Feb 24, 2022
Non-Final Rejection — §103, §112
Aug 22, 2022
Response Filed
Nov 07, 2022
Final Rejection — §103, §112
Feb 16, 2023
Request for Continued Examination
Feb 22, 2023
Response after Non-Final Action
Apr 07, 2023
Non-Final Rejection — §103, §112
Jul 12, 2023
Response Filed
Jul 26, 2023
Final Rejection — §103, §112
Oct 24, 2023
Response after Non-Final Action
Nov 01, 2023
Response after Non-Final Action
Jan 18, 2024
Request for Continued Examination
Jan 23, 2024
Response after Non-Final Action
Jan 31, 2024
Non-Final Rejection — §103, §112
Aug 01, 2024
Response Filed
Aug 27, 2024
Final Rejection — §103, §112
Feb 26, 2025
Request for Continued Examination
Feb 27, 2025
Response after Non-Final Action
Mar 12, 2025
Non-Final Rejection — §103, §112
Jul 14, 2025
Response Filed
Sep 15, 2025
Final Rejection — §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12582786
Compliance Monitor for Loosely Coupling to an Inhaler
2y 5m to grant Granted Mar 24, 2026
Patent 12569401
ELONGATE FORM MEDICAMENT CARRIER AND MEDICAMENT DISPENSER
2y 5m to grant Granted Mar 10, 2026
Patent 12569633
OSCILLATORY RESPIRATORY CARE APPARATUS
2y 5m to grant Granted Mar 10, 2026
Patent 12558511
PORTABLE OXYGEN CONCENTRATOR
2y 5m to grant Granted Feb 24, 2026
Patent 12551647
RESTING BLOCK AND ADJUSTABLE LOCKING MECHANISM FOR SAME
2y 5m to grant Granted Feb 17, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

11-12
Expected OA Rounds
58%
Grant Probability
99%
With Interview (+49.8%)
3y 6m
Median Time to Grant
High
PTA Risk
Based on 742 resolved cases by this examiner. Grant probability derived from career allow rate.

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