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 6/1/2026. As directed by the amendment, claims 14-20 have been cancelled, and claims 21-27 have been added. As such, claims 1-13 and 21-27 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a stylet, in the reply filed on 6/1/2026 is acknowledged. As Applicant has elected claims directed to the apparatus, if the apparatus claims are subsequently found allowable, withdrawn method claims that depend from or otherwise require all the limitations of an allowable apparatus claim will be considered for rejoinder. All claims directed to a nonelected method must require all the limitations of an allowable apparatus claim for that method to be rejoined; it is advised that the method claims be amended along with the apparatus claims during prosecution to ensure that the method claims contain all of the limitations of an allowable apparatus claim in the event that allowable subject matter is determined.
Applicant has cancelled claims 14-20, drawn to a non-elected method/invention.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 63/258,169 and 17/698,978, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior applications only describe the tip as “pliable.” They do not disclose it as “configured to elastically deform” (instant claims 1, 6 and 21, and thus their dependent claims), nor do they disclose specific hardness ranges (instant claims 3, 10, 11 and 25) or relative Young’s moduli (instant claims 4, 12 and 26). Therefore, the priority date of the instant claims is the filing date of the instant application, that is, 10/20/23.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: RIGID ENDOTRACHEAL INTUBATION STYLET
WITH ELASTICALLY DEFORMABLE TIP.
Claim Objections
Claims 1, 6 and 21 are objected to because of the following informalities:
Regarding claims 1, 6 and 21, in light of the preambles and the conditional-use language, the endotracheal tube is understood not to be a positively-recited component, such that the independent claims should be amended to read “wherein, when the stylet is fully inserted into the endotracheal tube, the tip of the stylet is configured to extend
Appropriate correction is required.
Claim Interpretation
The relative term “rigid” is understood in contrast to the term “elastically deform,” see e.g. instant paras [0045] and [0053], and understood to include stylets formed from metal, see instant para [0039], including copper per instant para [0053].
A handle that is “configured to facilitate removal of the stylet” is understood to be any graspable arrangement that aids in gripability of a stylet.
The term “fixedly coupled” is understood in view of e.g. instant paras [0043] and [0054-55] to encompass integral formation as well as subsequent (permanent) attachment of separate components.
An oblique cone is one where the axis of the cone is not perpendicular to the base/the apex is not centered over the base, see e.g. para [0046].
The Examiner notes that because the endotracheal tube (ET) is not positively recited (see Claim Objection section above), the tip extending beyond the end of the ET in the independent claims is only intended use and is dependent on the relative length of the unclaimed ET to the claimed stylet. Since ETs come in all different lengths, any stylet that is taught for use with an ET will be considered fully capable of the intended use, because any stylet is fully capable of being used with an ET that has a shorter length than the stylet. If Applicant wishes to positively recite the ET, they could amend the preambles to read e.g. “stylet
The relative rigidity of the body is understood to render the stylet “configured to provide structure” to an ET, and any ET stylet that is a thin, elongated stylet is understood to be “configured to…enable use of a laryngoscope” as claimed.
Regarding claim 21, the tip extending away from the second end “at a fixed oblique angle” is understood in view of e.g. instant para [0047] to mean that the tip is positioned/maintained at a predetermined, non-parallel/perpendicular angle, aside from the (elastic) flexing that occurs in the tip when a force is applied.
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) 1, 4, 6-8, 12, 21-23 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelson (US 2006/0081253 A1; hereinafter “Nelson”).
Regarding claim 1, Nelson discloses a stylet (stylet 124) (Figs. 2, 3 and 8) configured to be inserted into an endotracheal tube (endotracheal tube 102) for an endotracheal intubation procedure (Figs. 1, 5 and 6; para [0043]), comprising:
a solid elongated body (metal rod) (Fig. 3; paras [0010] and [0042]) having a first section (near fitting 118 in Fig. 2; para [0042]) adjacent a first end of the body (to the left in Fig. 2) and a second section (comprising first curvature C1) adjacent a second end of the body distal to the first end (to the right in Fig. 2), wherein the body is formed of a rigid material (co[p]per wire…rigid enough to support and help maintain the endotracheal tube 102 in a desired contour, para [0042]), the first section extends straight in a first direction (to the right in Fig. 2), and the second section is curved such that the second end is oriented in a second direction that is substantially perpendicular to the first direction (downward in Fig. 2; para [0045]);
a handle fixedly coupled to the first end of the body and configured to facilitate removal of the stylet from the endotracheal tube (Fig. 2; the rearward end of the stylet 124 can be curved or looped, as shown, or have a larger cross section, or can include a collar or grip to provide a better gripping surface, para [0042]); and
a tip (guide portion 128) fixedly coupled to the second end of the body and configured to elastically deform (Figs. 2 and 8; a rubber composition…extends longitudinally outwardly from the forward end to the stylet 124 to form a soft, flexible and malleable guide portion 128, para [0042]), the tip having a truncated cone shape (taper portion 134 as shown in Fig. 8) (para [0047]), wherein the tip is angled (at the angle of curvature C2) toward the handle with respect to the second end of the body (Fig. 2; para [0045]);
wherein when the stylet is fully inserted into the endotracheal tube, the tip of the stylet extends beyond an end of the endotracheal tube (Fig. 2; para [0043]); and
wherein the stylet is configured to provide structure to the endotracheal tube and enable use of a laryngoscope during the endotracheal intubation procedure (stylet 124…co[p]per wire…rigid enough to support and help maintain the endotracheal tube 102 in a desired contour, para [0042], and see Fig. 2, where stylet 124 is thin and elongated, and see also para [0005]).
Regarding claim 4, Nelson discloses the stylet of claim 1, wherein the body comprises a first material (copper) and the tip comprises a second material (rubber) and wherein the first material has a Young's Modulus higher than a Young's Modulus of the second material (the Young’s Modulus (YM) of copper is 110-130 GPa and the YM of rubber is about 0.05 GPa).
Regarding claim 6, Nelson discloses a stylet (stylet 124) (Figs. 2, 3 and 8) configured to be inserted into an endotracheal tube (endotracheal tube 102) for an endotracheal intubation procedure (Figs. 1, 5 and 6; para [0043]), comprising:
an elongated body (metal rod) formed of a rigid material (co[p]per wire…rigid enough to support and help maintain the endotracheal tube 102 in a desired contour, para [0042]) and having a solid core (Fig. 3; paras [0010] and [0042]);
a handle fixedly coupled to a first end of the body (to the left in Fig. 2) and configured to facilitate removal of the stylet from the endotracheal tube (Fig. 2; the rearward end of the stylet 124 can be curved or looped, as shown, or have a larger cross section, or can include a collar or grip to provide a better gripping surface, para [0042]); and
a tip (guide portion 128) fixedly coupled to a second end of the body (to the right in Fig. 2) and configured to elastically deform (Figs. 2 and 8; a rubber composition…extends longitudinally outwardly from the forward end to the stylet 124 to form a soft, flexible and malleable guide portion 128, para [0042]), wherein the tip is angled (at the angle of curvature C2) with respect to the second end of the body (Fig. 2; para [0045]);
wherein when the stylet is fully inserted into the endotracheal tube, the tip of the stylet extends beyond an end of the endotracheal tube (Fig. 2; para [0043]).
Regarding claim 7, Nelson discloses the stylet of claim 6, wherein the stylet is configured to provide structure to the endotracheal tube and enable use of a laryngoscope during the endotracheal intubation procedure (stylet 124…co[p]per wire…rigid enough to support and help maintain the endotracheal tube 102 in a desired contour, para [0042], and see Fig. 2, where stylet 124 is thin and elongated, and see also para [0005]).
Regarding claim 8, Nelson discloses the stylet of claim 6, wherein the tip has a truncated cone shape (taper portion 134 as shown in Fig. 8) (para [0047]).
Regarding claim 12, Nelson discloses the stylet of claim 6, wherein the body comprises a first material (copper) and the tip comprises a second material (rubber) and wherein the first material has a Young's Modulus higher than a Young's Modulus of the second material (the Young’s Modulus (YM) of copper is 110-130 GPa and the YM of rubber is about 0.05 GPa).
Regarding claim 21, Nelson discloses a stylet (stylet 124) (Figs. 2, 3 and 8) configured to be inserted into an endotracheal tube (endotracheal tube 102) for an endotracheal intubation procedure (Figs. 1, 5 and 6; para [0043]), comprising:
an elongated body (metal rod) formed of a rigid material (co[p]per wire…rigid enough to support and help maintain the endotracheal tube 102 in a desired contour, para [0042]) and having a solid core (Fig. 3; paras [0010] and [0042]);
a handle fixedly coupled to a first end of the body (to the left in Fig. 2) and configured to facilitate removal of the stylet from the endotracheal tube (Fig. 2; the rearward end of the stylet 124 can be curved or looped, as shown, or have a larger cross section, or can include a collar or grip to provide a better gripping surface, para [0042]); and
a tip (guide portion 128) fixedly coupled to a second end of the body (to the right in Fig. 2) and configured to elastically deform (Figs. 2 and 8; a rubber composition…extends longitudinally outwardly from the forward end to the stylet 124 to form a soft, flexible and malleable guide portion 128, para [0042]), wherein the tip extends away from the second end at a fixed oblique angle (a predetermined curvature…C2, para [0045]) with respect to the second end and with respect to the first end (Fig. 2; see also para [0005]);
wherein when the stylet is fully inserted into the endotracheal tube, the tip of the stylet extends beyond an end of the endotracheal tube (Fig. 2; para [0043]); and
wherein the stylet is configured to provide structure to the endotracheal tube and enable use of a laryngoscope during the endotracheal intubation procedure (stylet 124…co[p]per wire…rigid enough to support and help maintain the endotracheal tube 102 in a desired contour, para [0042], and see Fig. 2, where stylet 124 is thin and elongated, and see also para [0005]).
Regarding claim 22, Nelson discloses the stylet of claim 21, wherein a first section of the body (near fitting 118 in Fig. 2; para [0042]) adjacent the first end extends straight in a first direction (to the right in Fig. 2) and a second section of the body (comprising first curvature C1) adjacent the second end is curved such that the second end is oriented in a second direction that is substantially perpendicular to the first direction (downward in Fig. 2).
Regarding claim 23, Nelson discloses the stylet of claim 21, wherein the tip has a truncated cone shape (taper portion 134 as shown in Fig. 8) (para [0047]).
Regarding claim 26, Nelson discloses the stylet of claim 21, wherein the body comprises a first material (copper) and the tip comprises a second material (rubber) and wherein the first material has a Young's Modulus higher than a Young's Modulus of the second material (the Young’s Modulus (YM) of copper is 110-130 GPa and the YM of rubber is about 0.05 GPa).
Claim Rejections - 35 USC § 103
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) 2, 5, 9, 13, 24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Keller et al. (US 7,650,886 B1; hereinafter “Keller”).
Regarding claims 2, 9 and 24, Nelson discloses the stylet of claims 1, 8 and 23, but since Nelson does not explicitly depict where the angle forming second curvature C2 in Fig. 2 is located relative to the base of the cone of Fig. 8, Nelson is considered silent regarding wherein the truncated cone shape is an oblique truncated cone. However, a change in shape is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04.IV.B, and Keller teaches that it was known in the ET stylet art before the effective filing date of the claimed invention for the base (rear portion 10) of an elastically-deformable tip (proximal section 2) at the distal end of a rigid stylet body (intermediate section 4) (col. 2, lines 52-62) to be offset from the apex (front portion 8) of the tip (Fig. 1). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Nelson to include wherein the truncated cone shape is an oblique truncated cone as taught by Keller in view of the truncated cone of Nelson, in order to provide the predictable result of a suitably tapered and angled tip for aiding in guiding the stylet into the trachea (Nelson Figs. 1, 2, 5 and 6 and para [0045]; Keller Figs. 7-8 and col. 3, lines 46-67).
Regarding claims 5, 13 and 27, Nelson discloses the stylet of claims 1, 6 and 21, wherein Fig. 2 of Nelson further suggests an angle between the tip and the closest end of the body of about 45 degrees (Fig. 2), but Nelson does not explicitly recite wherein an angle between the tip and the body is between 15 degrees and 45 degrees. 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, and Keller teaches that it was known in the ET stylet art before the effective filing date of the claimed invention to include wherein an angle between the tip (comprised by proximal section 2) and the body (intermediate section 4) is between 15 degrees and 45 degrees (Fig. 7; proximal section 2 is bent upwardly at an angle from about 25˚ to about 45˚ and preferably about 35˚ for insertion into the trachea, col. 3, lines 14-16). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Nelson to include wherein an angle between the tip and the body is between 15 degrees and 45 degrees though routine experimentation and in view of the angle taught by Nelson Fig. 2 and the angles taught by Keller, in order to provide the predictable result of a suitably angled tip for aiding in guiding the stylet into the trachea (Nelson Figs. 1, 2, 5 and 6 and para [0045]; Keller Figs. 7-8 and col. 3, lines 46-67).
Claim(s) 3, 10, 11 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Keller and Field (US 5,919,183; hereinafter “Field”) (and as evidenced by Shore A to Shore D Converter, available at https://www.steelsolver.com/p/rubber-durometer-hardness-converter.html, hereinafter “Shore Converter”).
Regarding claims 3, 10, 11 and 25, Nelson discloses the stylet of claims 1, 6 and 21, wherein Nelson teaches that the tip is a softer material than the body (para [0042]), but Nelson does not explicitly recite wherein the tip has a hardness between 90 and 100 on the Shore A scale, and wherein the body has a hardness between 60 and 80 on the Shore D scale. 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, Keller teaches that it was known in the ET stylet art before the effective filing date of the claimed invention to include wherein the tip (proximal section 2) has a hardness that is 20-30% less than the hardness of the body (intermediate section 4), and wherein the body has a hardness between 50 on the Shore A scale and 90 on the Shore D scale (col. 3, lines 36-42), and Field teaches that about 60 on the Shore D scale is specifically desirable for the body of a stylet (abstract), such that it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Nelson to include wherein the tip has a hardness between 90 and 100 on the Shore A scale, and wherein the body has a hardness between 60 and 80 on the Shore D scale, though routine experimentation and in view of the relative hardnesses taught by Nelson and the ranges and suitable values for hardnesses taught by Keller and Field [where 20-30% of 60 Shore D, i.e. 42-48 Shore D, is ~91-95 Shore A as evidenced by the Shore Converter, see screenshots below], in order to provide the predictable results of a sufficiently rigid body for inserting and advancing the stylet and a more malleable tip for avoiding trauma of the tissue of the patient’s airway during insertion that resumes its shape after deflection in order to retain its directive/navigational abilities (Nelson paras [0005-7] and [0042]; Keller col. 3, lines 50-63; Field abstract).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references that could be applied under 35 USC 102 to reject at least claim 6: Cook (GB 2357437 A); Gardner (US 2020/0139081 A1); Sun (US 10,974,005 B1). Additional references teaching ET stylets with rigid bodies and softer/elastic, tapered/conical and/or angled tips: Augustine (US 5,235,970); Annis (US 10,434,272 B1); Bottom et al. (US 2019/0038861 A1); Boedecker (US 2013/0211263 A1); Cant et al. (GB 2504581 A); De Freitas Valeiro Garcia (US 2024/0252774 A1); Herskovic (US 2019/0014980 A1; note: Fig. 7 teaches a handle with a structure substantially similar to the disclosed handle); Kloka et al. (WO 2022/101059 A1); Levitan (US 2012/0204867 A1); Mizus (US 4,960,122); Sovndal (US 2015/0034078 A1).
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 7:30a-3:30p, T/Th 8:30a-2:30p, W 11:30a-4:30p, F 1-4p ET.
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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.
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/KATHRYN E DITMER/ Primary Examiner, Art Unit 3785
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