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 .
Election/Restrictions
Applicant’s election without traverse of Species A, corresponding to claims 1-15, in the reply filed on 10/2/2025 is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/2/2025.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Claim 1, line 8 should read “a first position and a second position”
Claim 1, lines 9-11 should read “and configured to cause at least a portion of the support segment to move to resulting” for clarity
Claim 11, line 6 should read “a first position and a second position”
Appropriate correction is required.
Claim Interpretation
Per para [0126] of the instant specification, “the first curve…may be having no curve,” i.e. “a curve” according to claim 15 is understood to encompass a straight extension.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: release mechanism in claim 6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Per the instant specification at para [0139] and in view of instant Fig. 14, the disclosed “release mechanism” is a hinged handle housing.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 1-5, 11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lo (US 2014/0378766 A1; hereinafter “Lo”).
Regarding claims 1 and 11, Lo discloses a tracheal intubation system (Figs. 2-4 and 7; abstract), comprising:
a stylet (stylet 2) configured to mount an endotracheal tube (endotracheal tube 1) (Figs. 2-3 and 7), the stylet including:
an articulating segment (leading section 21) extending between a distal tip of the stylet and a joint of the stylet (weakened area 223) (Fig. 3), the articulating segment configured to move relative to the joint (Figs. 3 and 11; paras [0041], [0046] and [0048-49]);
a support segment (comprising body section 22 and tail section 23) extending between the joint of the stylet and a proximal tip of the stylet (Figs. 3-4), the support segment configured to cause the articulating segment to move between a first position a second position (Figs. 3 and 11; paras [0041], [0046] and [0048-49]); and
a handle (graspable controller 3) configured to couple with the support segment of the stylet and cause at least a portion of the support segment to move that results in the articulating segment of the stylet to move (Figs. 3-4 and 11; paras [0041], [0046] and [0048-49]).
Regarding claim 2, Lo discloses the tracheal intubation system of claim 1, wherein the support segment comprises a longitudinal split (comprising slits 24) (Figs. 3 and 13) that divides the support segment into a first portion (first driven sheet 231) configured to be secured in a fixed position relative to the handle (the first gear 3211 may be omitted from the first connecting unit 321…the first rack 3213 [and by extension, the first driven sheet 231] is secured to the shell, para [0049]) and a second portion (second driven sheet 232) configured to be moveable relative to the first portion and to the handle (Figs. 3-4 and 7; paras [0046] and [0049]).
Regarding claim 3, Lo discloses the tracheal intubation system of claim 2, wherein the handle further includes an actuator (driving mechanism 32 with operating member 33) configured to cause the second portion of the support segment to move relative to the first portion in response to movement of the actuator (Figs. 3-4, 7 and 11; paras [0046] and [0048-49]).
Regarding claim 4, Lo discloses the tracheal intubation system of claim 3, wherein the actuator further comprises: a trigger (operating member 33) configured to cause rotational movement in a disk (primary gear 323 and/or second connecting unit 322) in response to the trigger moving from a third position to a fourth position, wherein the disk is configured to cause linear movement of the second portion of the support segment in response to the rotational movement of the disk, wherein the linear movement of the second portion of the support segment is configured to cause the articulating segment to move between the first position and the second position (Figs. 3-4, 7 and 11; paras [0041], [0043], [0046] and [0048-49]).
Regarding claim 5, Lo discloses the tracheal intubation system of claim 4, wherein the disk is configured to couple with a grooved track (rack 3222) of the second portion of the support segment (Fig. 6-7, where rack 3222 is considered as part of the sheet 232 because it is an extension thereof).
Regarding claim 15, Lo discloses the stylet of claim 11, wherein:
the first position of the articulating segment comprises a first curve; and
the second position of the articulating segment comprises a second curve (Fig. 11; paras [0041], [0046] and [0048-49]).
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.
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) 6-8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lo in view of Runnels et al. (US 2018/0110950 A1; hereinafter “Runnels”).
Regarding claim 6, Lo discloses the tracheal intubation system of claim 1, Lo is silent regarding wherein the handle further includes: a release mechanism configured to selectively couple the handle with the stylet, because the portions of the handle of Lo are connected via tongue-and-groove rather than a hinge (para [0040]). However, Runnels teaches that it was known in the tracheal stylet art before the effective filing date of the claimed invention for a handle to include a release mechanism that is a hinge configured to selectively couple the handle with the stylet (Figs. 48-49; para [0239]).Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the handle of Lo to include a release mechanism that is a hinge configured to selectively couple the handle with the stylet as taught by Runnels, in order to provide the predictable result of a handle housing where the portions of the housing are retained together after opening in order to avoid unintentional separation or loss of a housing portion when inserting/removing the stylet from the handle.
Regarding claims 7, 8 and 12, Lo discloses the tracheal intubation system of claim 1 and stylet of claim 11, but Lo is silent regarding wherein the stylet further comprises: a plurality of depth assessment bands located on the articulating segment, each depth assessment band visually distinct from an adjacent depth assessment band, a first depth assessment band located near the distal tip and having a first visual representation configured to whether an insertion depth of the distal tip is appropriate when positioned adjacent to an anatomical structure of a patient. However, Runnels teaches that it was known in the tracheal stylet art before the effective filing date of the claimed invention for a handle to include a plurality of depth assessment bands (depth assessment bands 142) located on an articulating segment, each depth assessment band visually distinct from an adjacent depth assessment band (see the key in Fig. 5), a first depth assessment band located near the distal tip and having a first visual representation configured to whether an insertion depth of the distal tip is appropriate when positioned adjacent to an anatomical structure of a patient, wherein the anatomical structure of the patient is a vocal cord (vocal cords V) of the patient (Figs. 3-5 and 10-13; paras [0134] and [0137-143]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the stylet of Lo to include a plurality of depth assessment bands located on the articulating segment, each depth assessment band visually distinct from an adjacent depth assessment band, a first depth assessment band located near the distal tip and having a first visual representation configured to whether an insertion depth of the distal tip is appropriate when positioned adjacent to an anatomical structure of a patient as taught by Runnels, in order to provide the predictable result of a known means by which to inform a user as to the relative depth and positioning of the articulating segment (Runnels paras [0134] and [0137-143]).
Allowable Subject Matter
Claims 9, 10, 13 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Esnouf (US 2016/0279365; Fig. 21), Berman (US 3,930,507; Figs. 1 and 4-5), Frankel (US 4,672,960) and Salem et al. (US 3802440; Fig. 6) teach that tongue-and-groove connection means between slidable members were known in the tracheal stylet/introducer art before the effective filing date of the claimed invention, but there is no motivation to include such a connection means, e.g. as seen in instant Fig. 13, in Lo because there is an intentional space/channel between the split portions of Lo to accommodate a camera/light via body 41, see Lo Fig. 13, which would be eliminated if Lo were modified to have a tongue-and-groove connection means as claimed/disclosed/taught by the prior art, thus rendering the device of Lo unable to function as intended, i.e. as a means for guiding a camera/light.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references regarding hinged handle portions and/or depth assessment bands: Runnels et al. (US 2021/0093817 A1); Horrisberger et al. (US 2024/0307644 A1; Figs. 9-11); Hipolito et al. (US 6,668,832). Additional references regarding a stylet with articulating segment that is moved relative to a joint as a result of movement of a portion of a support segment: Chen (US 2009/0065000 A1); McIntyre et al. (US 2009/0069632 A1); Venticinque et al. (US 2021/0213224 A1, e.g. Figs. 11A-B); Mccormick et al. (US 2014/0123976 A1); Karlsson et al. (US 2020/0023151 A1); Smith, Jr. (US 3,314,431); Caine (US 2,541,402); Nobis et al. (US 7,959,642 B2; Fig. 8). Additional references regarding a split tracheal stylet/introducer segment: Schroeder (US 5,259,377).
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.
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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