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 .
Status of Claims
The present Office action is responsive to the Remarks and Amendments filed on 06-16-2026. As directed, claims 11-17 and 22-23 have been withdrawn from consideration, and claims 19-21 have been canceled. Thus, claims 1-10 and 18 are currently pending examination.
Election/Restrictions
Claims 11-17 and 22-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06-16-2026.
Applicant's election with traverse of claims 1-10 and 18 in the reply filed on 06-16-2026 is acknowledged. The traversal is on the ground(s) that Totz (US 2009/0125002) does not relate to the shared technical feature of the claims. This is not found persuasive because in each of Totz’s Figures 24 and 26, the tubing that is contained before the clip 906 and more proximal to the proximal opening 100 is oriented in a substantially straight line, whereas the tubing within and following the clip 906 proximal to balloon cuff 130 is shown as being angled downwardly at and following the area of attachment at the clip 906. Each of Figures 24 and 26 were previously cited in the restriction requirement of record. To the extent that the clip 906 creates a path for the endotracheal tube 101 that diverges from its path at an area to the left of clip 906 in the recited figures, the apparatus can reasonably be regarded as a structure/apparatus that creates a bend in the endotracheal tube 101. Note also that the clip is recited as being flexible (paragraph 213, lines 1-5), and is thus regarded as structurally capable of bending the tube contained within it as the clip 906 were to flex by virtue of its attachment to the exterior of endotracheal tube 101.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 5 and 9-10 are objected to because of the following informalities:
At claim 5, line 2, it is suggested that “adjacent extension portions” be replaced with “adjacent curved extension portions of the plurality of curved extension portions” for consistency in the claims.
At claim 9, it is suggested that “configured” be added following “hole” for clarity and to more explicitly avoid claiming the human patient.
At claim 10, line 3, it is suggested that a comma be added before “fixing” to clarify the claim.
Appropriate correction is required.
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.
Claims 1, 5-9, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chaturvedi (US 2018/0236195) (Figure 23A-B embodiment).
Regarding claim 1, Chaturvedi discloses an endotracheal tube bending apparatus (2370) (paragraph 173, lines 1-15; Figs. 23A-B), comprising:
a backbone portion (2373) comprising at least a partially curved surface creating an angle between a proximate end of the apparatus (2370) and a distal end of the apparatus (2370) (paragraph 173, lines 1-15; see Fig. 23B, and note than an axis at each extreme end that runs width-wise produce an angle between the ends when the axes are extended towards the top of the figure due to the curvature of the device along its length); and
a plurality of curved extension portions (2383) structured to capture an endotracheal tube against the backbone portion (2373) (paragraph 173, lines 1-15; Figs. 23A-B).
Regarding claim 5, Chaturvedi discloses the endotracheal tube bending apparatus of claim 1, as discussed above.
Chaturvedi further discloses an opening between adjacent curved extension portions (2383) (see annotated Fig. 23B below).
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Regarding claim 6, Chaturvedi discloses the endotracheal tube bending apparatus of claim 1, as discussed above.
Chaturvedi further discloses a rounded tab structure (see tab forming opening 2386) proximate to a first end of the apparatus (2370) oriented longitudinally along the apparatus (2370) (paragraph 173, lines 9-15; Fig. 23A).
Regarding claim 7, Chaturvedi discloses the endotracheal tube bending apparatus of claim 6, as discussed above.
Chaturvedi further discloses wherein the rounded tab structure (see tab forming opening 2386) has a rotational position opposite the one of the plurality of curved extension portions (2383) when viewed in cross-section at the first end of the apparatus (2370) (see paragraph 79 for an explanation of the view of Fig. 23A; see Fig. 23A, and note that the tab forming opening 2386 is oriented on an opposite side of the longitudinal axis of the device as extension portion 2383; paragraph 173, lines 5-10; note that a “rotational position” is interpreted as offset from a longitudinal axis of the overall device, such that the two sections fall on opposite sides of the device circumference, and are therefore rotationally offset relative to the longitudinal axis).
Regarding claim 8, Chaturvedi discloses the endotracheal tube bending apparatus of claim 6, as discussed above.
Chaturvedi further discloses wherein the rounded tab structure (see tab forming opening 2386) has a rotational position between an edge of one of the plurality of curved extension portions (2383) and opposite the one of the plurality of curved extensions (2383) when viewed in cross-section at the first end of the apparatus (2370) (see annotated Fig. 23A below; see paragraph 79 for an explanation of the view of Fig. 23A; paragraph 173, lines 5-10; note that a “rotational position” is interpreted as offset from a longitudinal axis of the overall device, such that the two sections fall on opposite sides of the device circumference, and are therefore rotationally offset relative to the longitudinal axis).
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Regarding claim 9, Chaturvedi discloses the endotracheal tube bending apparatus of claim 6, as discussed above.
Chaturvedi further discloses wherein the rounded tab structure (see tab forming opening 2386) has a hole for a safety string to pass therethrough to enable removal of the apparatus (2370) from a patient (paragraph 173, lines 1-15, note that the channel 2386 formed within the tab is structurally capable of receiving a safety string for removing the device from the patient; see MPEP 2112 IV, in re Schreiber).
Regarding claim 18, Chaturvedi discloses the endotracheal tube bending apparatus of claim 1, as discussed above.
Chaturvedi further discloses wherein the apparatus comprises polyethylene, silicone, or other plastic or rubber material (paragraph 164, lines 1-8; note “respiratory insertion device” 2370 in paragraph 173).
Claims 1, 5, 10, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chaturvedi (US 2018/0236195) (Figure 24A-B embodiment).
Regarding claim 1, Chaturvedi discloses an endotracheal tube bending apparatus (2470) (paragraph 174, lines 1-17; Figs. 24A-B), comprising:
a backbone portion comprising at least a partially curved surface creating an angle between a proximate end of the apparatus (2470) and a distal end of the apparatus (2470) (see annotated Fig. 24B below, and note than an axis at each extreme end that runs width-wise produce an angle between the ends when the axes are extended towards the top of the figure due to the curvature of the device along its length); and
a plurality of curved extension portions (2487) structured to capture an endotracheal tube against the backbone portion (paragraph 174, lines 1-17; Figs. 24A-B, see annotated Fig. 24B below).
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Regarding claim 5, Chaturvedi discloses the endotracheal tube bending apparatus of claim 1, as discussed above.
Chaturvedi further discloses an opening between adjacent curved extension portions (2487) (see annotated Fig. 24B below).
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Regarding claim 10, Chaturvedi discloses the endotracheal tube bending apparatus of claim 1, as discussed above.
Chaturvedi further discloses an extended notch (2486) in the backbone portion (see annotated Fig. 24B above for the backbone portion; see Fig. 24A, where the backbone contains extended channel 2486 comprised of a notch in the backbone), the extended notch (2486) structured to engage a pilot balloon tube of the endotracheal tube fixing a position of the apparatus relative to the endotracheal tube (paragraph 174, lines 10-17; Fig. 23A; note that the notch is structurally capable of receiving and engaging a pilot balloon tube and fixing the position of the apparatus relative to the endotracheal tube given the channel formed; see MPEP 2112 IV, in re Schreiber; Examiner further notes that the instant specification at paragraph 37 and Fig. 3C shows and describes the claimed extended notch 354, which appears to be positioned in a manner similar to Chaturvedi’s channel 2486, and thus Chaturvedi’s structure is further interpreted as capable of the functional limitations listed in the claim).
Regarding claim 18, Chaturvedi discloses the endotracheal tube bending apparatus of claim 1, as discussed above.
Chaturvedi further discloses wherein the apparatus comprises polyethylene, silicone, or other plastic or rubber material (paragraph 164, lines 1-8; note “respiratory insertion device” 2370/2470 in paragraphs 173 and 174).
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 non-obviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Chaturvedi (US 2018/0236195) (Figure 23A-B embodiment), as applied to claim 1 above, in view of Freed (US 5,398,679).
Regarding claim 2, Chaturvedi discloses the endotracheal tube bending apparatus of claim 1, as discussed above.
Chaturvedi fails to disclose wherein each of the plurality of curved extension portions comprises a series of ridges structured to grip the endotracheal tube in place against the backbone portion.
However, Freed teaches an endotracheal tube holder (10) (Col. 4, lines 18-23; Fig. 1) that includes a series of ridges (18) structured to grip the endotracheal tube in place against the sleeve (14) (Col. 4, lines 29-37; Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner surface of the plurality of curved extensions of the endotracheal bending apparatus of Chaturvedi to include a series of ridges, as taught by Freed, in order to grip the endotracheal tube in place against the backbone portion to ensure the tube isn’t allowed to slip.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Chaturvedi (US 2018/0236195) (Figure 23A-B embodiment), as applied to claim 1 above, in view of Melilli (US 2019/0247602).
Regarding claim 3, Chaturvedi discloses the endotracheal tube bending apparatus of claim 1, as discussed above.
Chaturvedi fails to explicitly disclose wherein the backbone portion and the plurality of curved extension portions are structured to bend the endotracheal tube by the angle which is between 60 degrees and 90 degrees.
However, Melilli teaches a curve stabilizer (20) for an endotracheal tube (paragraph 35, lines 1-3; Fig. 8) wherein the curvature of the device is structured to bend the endotracheal tube by the angle which is between 45 degrees and 90 degrees (paragraph 36, lines 1-8; Fig. 8) to enable conversion of straight tubing into a desired curved configuration (paragraph 30, lines 1-7).
In the case where the range disclosed/taught by the prior art overlaps the claimed range with sufficient specificity, a prima facie case of obviousness exists (see MPEP 2144.05 I). In this case, the range of 45-90 degrees is considered to overlap the claimed range of 60-90 degrees with sufficient specificity, particularly because the entirety of the claimed range is contained within the prior art range.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endotracheal tube bending apparatus of Chaturvedi such that the backbone portion and the plurality of curved extension portions are structured to bend the endotracheal tube by the angle which is between 45 degrees and 90 degrees, as taught by Melilli, to enable conversion of straight tubing into a desired curved configuration. The range is further rendered obvious due to its overlap with the claimed range (MPEP 2144.05 I).
Regarding claim 4, Chaturvedi discloses the endotracheal tube bending apparatus of claim 1, as discussed above.
Chaturvedi fails to explicitly disclose wherein the backbone portion and the plurality of curved extension portions are structured to bend the endotracheal tube by the angle which is less than 60 degrees.
However, Melilli teaches a curve stabilizer (20) for an endotracheal tube (paragraph 35, lines 1-3; Fig. 8) wherein the curvature of the device is structured to bend the endotracheal tube by the angle which is less than 60 degrees (paragraph 36, lines 1-8, see the range of 45-59 degrees; Fig. 8) to enable conversion of straight tubing into a desired curved configuration (paragraph 30, lines 1-7).
In the case where particular examples established in the prior art lie within the claimed range, a prima facie case of obviousness exists (see MPEP 2144.05 I). In this case, the range of exemplary angles from 45-59 degrees each lie within the claimed range of less than 60 degrees, rendering the range obvious.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endotracheal tube bending apparatus of Chaturvedi such that the backbone portion and the plurality of curved extension portions are structured to bend the endotracheal tube by the angle which is less than 60 degrees, as taught by Melilli, to enable conversion of straight tubing into a desired curved configuration. The range is further rendered obvious due to the exemplary angles provided within the claimed range (MPEP 2144.05 I).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Chaturvedi (US 2018/0236195) (Figure 24A-B embodiment), as applied to claim 1 above, in view of Freed (US 5,398,679).
Regarding claim 2, Chaturvedi discloses the endotracheal tube bending apparatus of claim 1, as discussed above.
Chaturvedi fails to disclose wherein each of the plurality of curved extension portions comprises a series of ridges structured to grip the endotracheal tube in place against the backbone portion.
However, Freed teaches an endotracheal tube holder (10) (Col. 4, lines 18-23; Fig. 1) that includes a series of ridges (18) structured to grip the endotracheal tube in place against the sleeve (14) (Col. 4, lines 29-37; Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner surface of the plurality of curved extensions of the endotracheal bending apparatus of Chaturvedi to include a series of ridges, as taught by Freed, in order to grip the endotracheal tube in place against the backbone portion to ensure the tube isn’t allowed to slip.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Chaturvedi (US 2018/0236195) (Figure 24A-B embodiment), as applied to claim 1 above, in view of Melilli (US 2019/0247602).
Regarding claim 3, Chaturvedi discloses the endotracheal tube bending apparatus of claim 1, as discussed above.
Chaturvedi fails to explicitly disclose wherein the backbone portion and the plurality of curved extension portions are structured to bend the endotracheal tube by the angle which is between 60 degrees and 90 degrees.
However, Melilli teaches a curve stabilizer (20) for an endotracheal tube (paragraph 35, lines 1-3; Fig. 8) wherein the curvature of the device is structured to bend the endotracheal tube by the angle which is between 45 degrees and 90 degrees (paragraph 36, lines 1-8; Fig. 8) to enable conversion of straight tubing into a desired curved configuration (paragraph 30, lines 1-7).
In the case where the range disclosed/taught by the prior art overlaps the claimed range with sufficient specificity, a prima facie case of obviousness exists (see MPEP 2144.05 I). In this case, the range of 45-90 degrees is considered to overlap the claimed range of 60-90 degrees with sufficient specificity, particularly because the entirety of the claimed range is contained within the prior art range.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endotracheal tube bending apparatus of Chaturvedi such that the backbone portion and the plurality of curved extension portions are structured to bend the endotracheal tube by the angle which is between 45 degrees and 90 degrees, as taught by Melilli, to enable conversion of straight tubing into a desired curved configuration. The range is further rendered obvious due to its overlap with the claimed range (MPEP 2144.05 I).
Regarding claim 4, Chaturvedi discloses the endotracheal tube bending apparatus of claim 1, as discussed above.
Chaturvedi fails to explicitly disclose wherein the backbone portion and the plurality of curved extension portions are structured to bend the endotracheal tube by the angle which is less than 60 degrees.
However, Melilli teaches a curve stabilizer (20) for an endotracheal tube (paragraph 35, lines 1-3; Fig. 8) wherein the curvature of the device is structured to bend the endotracheal tube by the angle which is less than 60 degrees (paragraph 36, lines 1-8, see the range of 45-59 degrees; Fig. 8) to enable conversion of straight tubing into a desired curved configuration (paragraph 30, lines 1-7).
In the case where particular examples established in the prior art lie within the claimed range, a prima facie case of obviousness exists (see MPEP 2144.05 I). In this case, the range of exemplary angles from 45-59 degrees each lie within the claimed range of less than 60 degrees, rendering the range obvious.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endotracheal tube bending apparatus of Chaturvedi such that the backbone portion and the plurality of curved extension portions are structured to bend the endotracheal tube by the angle which is less than 60 degrees, as taught by Melilli, to enable conversion of straight tubing into a desired curved configuration. The range is further rendered obvious due to the exemplary angles provided within the claimed range (MPEP 2144.05 I).
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Chaturvedi (US 2018/0236195) (Figure 23A-B embodiment), as applied to claim 1 above, in view of Sudge (US 6,408,850).
Regarding claim 6, Chaturvedi discloses the endotracheal tube bending apparatus of claim 1, as discussed above.
Under an alternate interpretation, Chaturvedi fails to disclose a rounded tab structure proximate to a first end of the apparatus oriented longitudinally along the apparatus.
However, Sudge teaches an endotracheal tube holder (Col. 4, lines 37-41; Fig. 1) which includes a rounded tab (6) structure proximate to a first end of the apparatus oriented longitudinally along the apparatus for placement of auxiliary medical equipment as desired (Col. 4, lines 44-47; Figs. 1 and 4, note that the tab extends along the longitudinal aspect of the device and originates at the proximal end).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endotracheal tube bending apparatus of Chaturvedi to include a rounded tab structure proximate to a first end of the apparatus oriented longitudinally along the apparatus, as taught by Sudge, in order to allow for placement of auxiliary medical equipment as desired.
Regarding claim 10, Chaturvedi discloses the endotracheal tube bending apparatus of claim 1, as discussed above.
Chaturvedi fails to disclose an extended notch in the backbone portion, the extended notch structured to engage a pilot balloon tube of the endotracheal tube fixing a position of the apparatus relative to the endotracheal tube.
However, Sudge teaches an endotracheal tube holder (Col. 4, lines 37-41; Fig. 1) which includes an extended notch (see material forming 6), the extended notch (see material forming 6) structured to engage a pilot balloon tube of the endotracheal tube, fixing a position of the apparatus relative to the endotracheal tube for placement of the tracheal cuff inflation line (7) as desired (Col. 4, lines 44-47; Figs. 1 and 4; Examiner notes that retaining the line 7 within notch 6 produces at least a width-wise fixation of the endotracheal tube relative to the tube holder given the attachment of line 7, retained in notch 6, to the endotracheal tube).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endotracheal tube bending apparatus of Chaturvedi to include an extended notch in the backbone portion, the extended notch structured to engage a pilot balloon tube of the endotracheal tube fixing a position of the apparatus relative to the endotracheal tube, as taught by Sudge, in order to allow for placement of the pilot balloon tube as desired.
Claim 9 is are rejected under 35 U.S.C. 103 as being unpatentable over Chaturvedi (US 2018/0236195) (Figure 23A-B embodiment) in view of Sudge (US 6,408,850), as applied to claim 6 above, in further view of Osborn (US 5,009,595).
Regarding claim 9, Chaturvedi in view of Sudge disclose the endotracheal tube bending apparatus of claim 1, as discussed above.
The device of modified Chaturvedi includes wherein the rounded tab (see material forming 6) structure has a hole (see Figs. 1 and 4 and Col. 4, lines 44-47 of Sudge).
Modified Chaturvedi fails to explicitly disclose that the hole is used for a safety string to pass therethrough to enable removal of the apparatus from a patient.
However, Osborn teaches a dental appliance (10) wherein a hole (36) is provided for the explicit purpose of feeding a safety string in the form of floss or a cord therethrough in order to enable removal of the apparatus from a patient in the event that the device is inadvertently swallowed and lodged in the throat (Col. 3, lines 15-19; Figs. 1 and 6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the opening/hole provided in the rounded tab of the device of modified Chaturvedi could reasonably be used for a safety string to pass therethrough to enable removal of the apparatus from a patient, as taught by Osborn, as a safety measure in the event that the device is inadvertently swallowed/lodged in the throat.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Augustine (US 4,832,020) is cited for its rounded tab (38) placed at an end of the intubation guide (10) to facilitate proper hand placement by the physician (see Figs. 1-2).
Oren (CN 100407981) is cited for its extended notch (26) on the inner surface of tube 20 for placement of various medical tools therein (see Fig. 1 and the abstract).
Setty (US 2011/0196204) is cited for its tube bending apparatus as shown in Figure 3.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAIGE BUGG whose telephone number is (571)272-8053. The examiner can normally be reached Monday-Friday 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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