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 12/9/2025. As directed by the amendment, claims 1, 2, 6 and 7 have been amended, claims 3-5 and 8-10 have been cancelled, and claims 11-14 have been added. As such, claims 1, 2, 6, 7, and 11-14 are pending in the instant application.
Applicant has amended the title to be more descriptive and the specification to address minor informalities; the objections to the specification are withdrawn.
Applicant has cancelled claim 5 and 10, rendering the drawing objection moot.
Applicant has amended claim 6 to address a minor informality; the previous objection of claim 6 is withdrawn.
Applicant has amended the claims to remove indefinite relative language and to provide antecedent basis and points of reference for directions; the previous rejections of the claims under 35 USC 112(b)/second paragraph are withdrawn.
Applicant has cancelled claims 3, 4, 8 and 9, rendering the rejections under 35 USC 112(d)/fourth paragraph moot.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Claim 1, line 7 should recite “the patient” because it is clearly referring to that of line 6
Claim 6, line 9 should recite “the patient” because it is clearly referring to that of line 8
Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 12/9/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Applicant argues on page 14 of Remarks that “rather than teaching that any known means could be employed, Runnels actually [teaches] that a “tip 1420” should be remotely actuated by a “trigger 1440”…a pull trigger…or any other type of trigger is fundamentally different structurally, conceptually, and functionally than the particularly claimed shape memory alloy.”
The Examiner respectfully notes that it was the actuation mechanism/means of Runnels, not the trigger, with which the rejection was (and is) concerned, and 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., that a trigger is excluded) 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 instant claims do not exclude a trigger (indeed, the previously-claimed heat source of cancelled claims 5/10 presumably had some means of triggering/activating said heat source), and using the trigger of Runnels to actuate a heat-actuatable shape-memory alloy is what is taught by the combination of references as discussed in the 103 rejections maintained/updated below.
Applicant argues on page 15 of Remarks that “Runnels teaches that manual actuation through a “trigger 1440” should be employed…thus relying on the action and dexterity of the operator, the…claimed distal portion automatically deflects at the predetermined temperature.”
The Examiner respectfully notes there is nothing in the instant claims that excludes the claimed deflection temperature from being achieved by a manually actuated/triggerable source; indeed, an external heat source for heating the stylet to the predetermined temperature (inferred to be controllable/triggerable) was elected by original presentation in cancelled claims 5/10. Furthermore, in as far as the stylet of modified Runnels comprises a heat-actuatable shape-memory alloy that deflects from a first shape to a second shape as discussed in the 103 rejections maintained/updated below, its distal portion will “automatically” deflect at the predetermined temperature-- regardless of what causes the stylet to arrive at said temperature--as an inherent material property of a heat-actuatable shape-memory alloy that is configured to deflect from a first shape to a second shape at said temperature.
On page 16 of Remarks, Applicant argues that Gage teaches “one or more bending elements…[f]or example, one or more shape memory alloy wires may be provided along the stylet,” which Applicant argues “instructs away” from the claimed device because “a wire disposed along a stylet is fundamentally different in structure than a stylet comprising a shape-memory alloy as claimed.” The Examiner respectfully notes that the term “comprising” is synonymous with “including” and “containing,” see MPEP 2111.03.I, and the Examiner notes that the claims do not specify how the shape memory alloy is to be incorporated into the distal end of stylet. Gage is not a teaching away from the claimed invention; if the distal end of a stylet includes e.g. one or more shape memory alloy wires therealong, then the distal end of the stylet comprises a shape memory alloy by virtue of comprising said wires. Moreover, Chikama and Stice teach elongated elements/rods/stylets made of shape-memory alloy, such that even if the distal end of the claimed stylet were amended to be e.g. “made from/composed of” shape-memory alloy (see MPEP 2111.03.IV), the prior art would still render the instant claims obvious.
Applicant argues on pages 16-17 of Remarks that Chikama “teaches away” from the claimed invention because the memorized/first shape of the stylet of Chikama is straight and not curved as claimed, and the stylet of Chikama is not disclosed as being used in intubation.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The base reference of Runnels already discloses a first curved resting position and deflection into a second, opposite curved position for aiding in intubation, as discussed in the 103 rejections maintained/updated below. Chikama need not teach this curvature/use; the teachings of Chikama (and newly applied Stice) merely demonstrate standard shape-memory alloy operation/materials that were well-known before the effective filing date of the claimed invention to be used for the steering of medical stylets, which render the claimed temperature-activated operation/materials obvious in view of the steering of the intubation stylet of Runnels.
On page 18 of Remarks, Applicant asserts that the “only teaching for an intubation stylet [as claimed]…comes from the Applicant,” again arguing that Runnels teaches a remotely actuated trigger, Gage teaches shape-memory alloy “provided along the stylet” and Chikama teaches a stylet that starts off straight.
The Examiner disagrees. As discussed above, the instant claims do not exclude a remotely actuated trigger, they do not exclude the shape-memory alloy from being wires comprised by the distal end of the stylet (and even if they did, making the stylet as a whole from shape-memory alloy is also taught by the prior art), and the teachings of Chikama are independent from its starting position. The Examiner maintains that teaching of an intubation stylet as claimed is found within the references themselves and the general knowledge of the artisan to produce predictable results (i.e. heat-activated intubation stylet steering) as discussed in the 103 rejections maintained/updated below.
Applicant argues on page 19 of Remarks that “the claimed structural differences…enable functional differences that are neither contemplated nor possible according to the cited art even when combined as proposed…[s]uch a practice is neither discloses nor possible according to the teachings of the cited art.”
Applicant has provided no objective evidence to demonstrate that modified Runnels cannot function as asserted by Applicant. Modified Runnels teaches heat-activated steering (as taught by Gage and Chikama, and see also Stice) of an intubation stylet, with an initial distal end curvature pointing toward the anterior of the patient and a subsequent curvature in an opposite direction to point the stylet directly into the glottis opening for railroading a tube thereon (see Runnels Figs. 7-10 and 14-15B) as discussed in the 103 rejections maintained/updated below. Therefore, it is presumed to have the same functionality as asserted by Applicant.
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, 2, 6, 7 and 11-14 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 claims 1 and 6 (and thus their dependent claims), it is unclear what is meant by a direction that “represents an anterior/posterior direction in a patient.” As best understood, for purposes of examination, claims 1 and 6 will be considered to read “direction that is configured to correspond to an anterior/posterior direction in a/the patient,” although it is noted that the directions with regards to the patient are only intended use in the apparatus claims.
Claims 1 and 6 (and thus their dependent claims) recite the limitation "the thermal mass of the distal portion" in lines 13 and 18, respectively. There is insufficient antecedent basis for this limitation in the claims, because the recited thermal mass is not that of the distal portion as a whole, but of the shape-memory alloy. To address this rejection, Applicant could amend the claims to read “the thermal mass of the shape-memory alloy of the distal portion”.
Claims 2, 7, 11 and 12 recite the limitation "the at least a portion" in lines 3, 2-3, 1-2 and 1-2, respectively. There is insufficient antecedent basis for this limitation in the claims. To address this rejection, Applicant could amend the claims to read “the curved portion”.
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 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, 2, 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Runnels et al. (US 2021/0093817 A1; hereinafter “Runnels”) in view of Gage et al. (US 2024/0252775 A1; hereinafter “Gage”) and Chikama (US 4,601,283; hereinafter “Chikama”).
Regarding claims 1 and 2, Runnels discloses an intubation stylet (introducer 1405) (Figs. 14-15B) comprising:
a proximate portion (shaft 1405) configured to be moldable (para [0131] in view of para [0063] and e.g. Fig. 7, where the proximate portion is disclosed as flexible/moldable to the shape of the upper airways of a patient, and see also Chikama discussed below, which teaches the proximate portion to comprise a moldable, shape-memory alloy material);
a distal portion (comprising tip 1420) fixed to the proximate portion (Figs. 14-15B), wherein the distal portion is manufactured with a curved portion (see the curved portion in the first position/resting position 1425 in Fig. 15A) with a direction of curvature in a first direction (upward in Figs. 14/15) that, as best understood, represents an anterior direction in a patient (upward in Fig. 7) and a shape (the opposite curvature seen in Fig. 15B) in a second direction (downward in Figs. 14/15B) that, as best understood, represents a posterior direction in a patient (downward in Fig. 7), and wherein the second direction is opposite the first direction (Figs. 14-15B; paras [0132-134]);
wherein the curved portion of the distal portion is configured to deflect from the first direction to the second direction to at least partially reverse the direction of curvature (Figs. 14-15B);
a tube (endotracheal tube 106) slidably attached over the intubation stylet (Figs. 9-10 in view of paras [0092] and [0131]);
wherein the intubation stylet is configured also to deflect the tube from the first direction to the second direction for a direct approach to a glottis opening of a patient with a positioning of the distal portion at the glottis opening of the patient (Figs. 9-10 and 15B; para [0092]).
While Runnels teaches that the deflection from the first direction to the second direction can be actuated by any known means (para [0135]), Runnels does not explicitly disclose the distal portion comprising a shape-memory alloy with a thermal mass and a shape memory in the second direction, such that, at a predetermined temperature based in part on the thermal mass [of the shape-memory alloy] of the distal portion, the portion of the distal portion is configured to deflect from the first direction to the second direction at the predetermined temperature and wherein the distal portion is configured to be moldable prior to the predetermined temperature at which the [curved] portion of the distal portion is configured to deflect from the first direction to the second direction. However, Gage demonstrates that it was well known in the intubation art before the effective filing date of the claimed invention to utilize a stylet with a distal portion (bendable sections 22) (Fig. 4) comprising a shape-memory alloy (para [0266]), and Chikama teaches that it was known in the insertable medical tubing art before the effective filing date of the claimed invention for both the proximal (e.g. Block C) and distal portions (e.g. Block A) of an elongated, deflectable, tube-steering member to comprise a shape-memory alloy with a thermal mass (shape memory alloy 26) (e.g. Fig. 4; see also Fig. 6 and col. 4, lines 42-60; where all materials necessarily have a thermal mass) having a shape memory (memorized shape) in a second direction (col. 2, lines 20-31; col. 5, lines 4-7), such that, at a predetermined temperature based in part on the thermal mass [of the shape-memory alloy] of the distal portion (transformation point), a portion of the distal portion (e.g. block A) is configured to deflect from a first direction (changed shape) to the second direction (memorized shape) (col. 2, lines 20-31; col. 2, lines 39-44; col. 3, lines 36-59) at the predetermined temperature at which the portion of the distal portion is configured to deflect from the first direction to the second direction and configured to be moldable prior to its deflection at the predetermined temperature ([a]t temperatures other than the transformation point, the shape memory alloy is very soft and it resembles lead in that if it is bent, the bent shape is retained, col. 2, lines 39-44). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Runnels to include the distal portion comprising a shape-memory alloy with a thermal mass and a shape memory in the second direction, such that, at a predetermined temperature based in part on the thermal mass [of the shape-memory alloy] of the distal portion, the curved portion of the distal portion is configured to deflect from the first direction to the second direction to at least partially reverse the direction of curvature at the predetermined temperature, and wherein the distal portion is configured to be moldable prior to its deflection at the predetermined temperature at which the [curved] portion of the distal portion is configured to deflect from the first direction to the second direction, and for the proximal portion to be made of/comprise the same alloy and thus also be firm and easily moldable, as taught by Gage and Chikama, in order to utilize a well-known means (i.e. heat-activated shape-memory alloy) to predictably actuate the deflection from the first direction to the second direction, and in order to provide the proximal and distal portions as a single material to avoid seams (Runnels para [0064]) as well as to allow the proximal end curve taught by Runnels Figs. 7-10 to be easily formed and/or memory formed and/or controllably formed as well.
Regarding claims 6 and 7, Runnels in view of Gage and Chikama teaches a method of intubating a patient, the method comprising the following steps:
providing an intubation stylet as claimed, see claims 1-2 discussion above,
manipulating the proximate portion so that the distal portion points in the anterior direction of the patient (see Runnels Figs. 6-7);
deflecting the distal portion to a position that facilitates positioning the distal portion at a glottic opening of the patient by heating the distal portion to the predetermined temperature whereby the distal portion deflects from the first direction to the second direction for a direct approach to the glottis opening of the patient (see Runnels Figs. 7-8 and Fig. 15B, paras [0130-135], in view of the heat-actuated deflection discussed above regarding claim 1), in order to predictably guide the stylet and tube cleanly and directly into the trachea; and
sliding the tube over the intubation stylet and through the patient's vocal cords (Runnels Figs. 9-10; paras [0092-97]).
Claim(s) 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Runnels in view of Gage and Chikama as applied to claims 1 and 6 above, and further in view of Stice (US 4,984,581; hereinafter “Stice”).
Regarding claims 11 and 12, Runnels in view of Gage and Chikama teaches the intubation stylet of claim 1 and method of claim 6, but modified Runnels is silent regarding wherein the predetermined temperature at which the at least a portion of the distal portion is configured to deflect from the first direction to the second direction is 98.6°F +/-10°F. 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 Stice teaches that it was known in the art of heated shape-memory alloys for steering a medical stylet before the effective filing date of the claimed invention to include wherein the predetermined temperature at which the deflectable portion of the distal portion is configured to deflect from the first direction to the second direction is 98.6°F +/-10°F [37 ˚C ± 5.6] (e.g. Fig. 2; repeatable memory effect which constitutes a reversal of the original direction…upon the change in temperature of the alloy…[t]he guide is preferably operated at temperatures between 36 ˚C and 45 ˚C, col. 6, lines 43-47). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Runnels to include wherein the predetermined temperature at which the at least a portion of the distal portion is configured to deflect from the first direction to the second direction is 98.6°F +/-10°F through routine experimentation and as taught by Stice, in order to provide the predictable result of a heated shape-memory alloy actuation temperature that operates with low energy costs (i.e. some of the energy required to actuate the deflection comes from body temp so that not much more additional energy, if any, is required to actuate the deflection) and that also avoids temperatures that could be destructive to body tissues (Stice col. 6, lines 47-50).
Regarding claims 13 and 14, Runnels in view of Gage and Chikama teaches the intubation stylet of claim 1 and method of claim 6, but modified Runnels is silent regarding wherein the distal portion of the intubation stylet comprises nitinol. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Stice teaches that it was known in the art of heated shape-memory alloys for steering a medical stylet before the effective filing date of the claimed invention to include wherein the distal portion of the stylet comprises nitinol (e.g. Fig. 2; core wire 12…is fabricated of a shape memory allow…particularly preferred alloy is nitinol, col. 3, lines 42-56). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Runnels to include wherein the distal portion of the intubation stylet comprises nitinol as taught by Stice, in order to utilize a standard shape-memory alloy, particularly one with biocompatibility (nitinol), to provide the predictable result of a shape-memory alloy that is well suited for human applications (Stice col. 3, lines 51-53).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references teaching the use of heated nitinol to steer/change the shape of medical tubing: previously-cited Lowery and Pile-Spellman; Hakkens (US 10,485,400 B2); Griffin et al. (US 7,850,623 B2).
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 7:30a-3:30p, T/Th 8:30a-2:30p, W 11:30a-4:30p, F 1-4p ET.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785