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 on 10/27/2025. As directed by the amendment, claims 2-3, 7-9, 11-15, 18, 21-24, and 28-45 were canceled, claims 1, 4-6, 10, 16-17, 19-20, and 25-27 were amended, and no claims were newly added. Thus, claims 1, 4-6, 10, 16-17, 19-20, and 25-27 are presently pending in this application.
Claim Interpretation
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:
“a tube movement mechanism” of claim 1 line 10
Corresponding structure is thumb interface 131 or [0052] “the tube movement mechanism includes clips for engaging the endotracheal tube, the clips being configured to disengage the endotracheal tube in response to activation of the second digit interface”
“an auxiliary movement mechanism” of claim 10 line 8
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.
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 § 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 5, 10, and 27 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 5 line 2, the term “an object” is unclear as to if the term is the same or different than “an object” claim 1 line 18.
Regarding claim 10 line 6, the term “auxiliary conduit” is unclear if this is the same or different than the “an auxiliary conduit” of claim 1 line 13.
Regarding claim 27 line 3, the term “the auxiliary control” is indefinite because it lacks proper antecedent basis.
Any remaining claims are rejected as being dependent upon a rejected base claim.
Claim limitation “an auxiliary movement mechanism” of claim 10 line 8” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Specification paragraph [0230] “the intubation device 800 may include an auxiliary movement mechanism (not shown) for moving the bronchoscope 890 through the auxiliary conduit 880 and endotracheal tube 210.” However, it is unclear what corresponding structure performs the claimed function of moving the auxiliary conduit, in the form of a bronchoscope in the paragraph above. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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, 4-5, 10, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGrath et al. (US 2012/0059223).
Regarding claim 1, McGrath discloses an intubation device for use in an endotracheal intubation procedure (see McGrath Fig. 12 laryngoscope 100; [0063] “FIG. 12 is an isometric view of the laryngoscope of FIG. 11 with an insertion section of FIG. 1 attached thereto”), the intubation device including:
a) a laryngoscope blade having a tip and a base (see McGrath laryngoscope insertion section 1);
b) a handle attached to the base of the laryngoscope blade for allowing the intubation device to be held in a single hand of a user (see McGrath handle 102);
c) a channel for receiving an endotracheal tube (see McGrath endotracheal tube 12A, 12B sitting in channel formed by proximal superior tube guiding member 62, distal superior tube guiding member 54, and inferior tube guiding member 56 [0076]), the channel extending along the laryngoscope blade and partially along the handle (see McGrath Fig. 12 member 62 rests against handle 102), and the channel including an outlet proximate to the tip for allowing a distal end of the endotracheal tube to be advanced from the outlet (see McGrath Fig. 12 distal end 14 of channel is the distal end of guiding member 54);
d) a tube movement mechanism in the handle for moving the endotracheal tube through the channel to thereby advance the endotracheal tube (see McGrath [0027] “a manually operable control to enable a user to move the moveable tube guiding member relative to the elongate support member”; [0090] tube guiding member can be moved by manually operable control (such as a button) on laryngoscope handle), the tube movement mechanism being configured to allow the user to hold the intubation device and advance the endotracheal tube in the endotracheal intubation procedure using the single hand of the user (see McGrath [0090] manual operation above); and
e) an auxiliary conduit that extends at least partially along the laryngoscope blade (see McGrath elongate cavity 16; [0074] “an elongate cavity 16 which extends along a part of the length of the insertion section from an aperture 18”), wherein the auxiliary conduit includes an auxiliary outlet proximate to the tip (see McGrath [0074] “The elongate cavity is closed off at its distal end by a window 20”), and wherein the auxiliary conduit is configured for allowing one of i) an object (see McGrath [0074] the elongate cavity retains support member 104 comprising camera 106 on the distal end).
Regarding claim 4, McGrath discloses the auxiliary conduit further extends at least partially along the handle (see McGrath Fig. 11 support member 104 runs past the handle 102)
Regarding claim 5, McGrath discloses the auxiliary conduit is configured to allow delivery of an object that is one of: a) an endoscope (see McGrath [0074] the elongate cavity retains support member 104 comprising camera 106 on the distal end).
Regarding claim 10, McGrath discloses the auxiliary conduit includes an auxiliary inlet at a proximal end of the auxiliary conduit (see McGrath aperture 18 [0074]) for allowing the object to be introduced into the auxiliary conduit via the auxiliary inlet (see McGrath support member 104 arranged within elongate cavity 16 enters through aperture 18).
Regarding claim 27, McGrath discloses the intubation device is configured to allow the user to hold the intubation device, advance the endotracheal tube, and operate the auxiliary control using the single hand of the user (see McGrath the tube is released with the one hand already used on the handle: [0081] “As the endotracheal tube is already retained within the tube guide, the user will not be required to carry out the additional step of introducing an endotracheal tube into a patient's oral cavity, freeing up one of their hands”. To advance the tube, [0028] “The manually operable control is preferably located to be operable with a user's fingers”. The auxiliary function is controlled by slight movements of the fingers as well, as the camera is at the distal end of the tube assembly [0083]).
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.
Claims 1, 6, 16-17, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Stone (US 5,184,603) in view of Buras (US 4,693,243).
Regarding claim 1, Stone discloses an intubation device for use in an endotracheal intubation procedure (see Stone Abstract “An intubating instrument… for endotracheal intubation), the intubation device including:
a) a laryngoscope blade (see Stone laryngoscopic blade 31) having a tip (see Stone distal end 32) and a base (see Stone end of blade 31 mounted to handle 60 through plate 33);
b) a handle attached to the base of the blade for allowing the intubation device to be held in a hand of a user (see Stone power handle 60);
c) a channel for receiving an endotracheal tube (see Stone channel 45 for endotracheal tube 40), the channel extending along the blade and partially along the handle (see Stone Fig. 3 channel 45 extends length of blade 31, and along plate 33 which extends partially along handle 60), and the channel including an outlet proximate to the tip for allowing a distal end of the endotracheal tube to be advanced from the outlet (see Stone Col. 4 lines 51-54 endotracheal tube 40 advances forwardly through the channel 45 to project the distal end 41 of the endotracheal tube into the trachea);
d) a tube movement mechanism in the handle for moving the endotracheal tube through the channel to thereby advance the endotracheal tube (see Stone pushbutton switch 78 energizes cog wheel 50 to rotate, advancing endotracheal tube 40), the tube movement mechanism being configured to allow the user to hold the intubation device and advance the endotracheal tube in an endotracheal intubation procedure using a single hand (see Stone Col. 5 lines 36-38 “depression of the pushbutton 78 by the same hand of the operator which is holding and manipulating the instrument”); and
Stone is silent as to an auxiliary conduit that extends at least partially along the laryngoscope blade, wherein the auxiliary conduit includes an auxiliary outlet proximate to the tip, and wherein the auxiliary conduit is configured for allowing one ii) a fluid including at least one bioactive agent, to be delivered via the auxiliary conduit and through the auxiliary outlet.
However, Buras teaches an auxiliary conduit that extends at least partially along the tube (see Buras Fig. 2 irrigating system 60, comprising tubing 20 and irrigation passage 24. Tubing passage 24 runs alongside endotracheal tube 80. In Stone, tubing is located within blade 31, wherein further modifications of irrigating system 60 onto the blade of Stone would extend the auxiliary conduit along the laryngoscope blade.), wherein the auxiliary conduit includes an auxiliary outlet proximate to the tip (see Buras distal end 32 near distal end of tube 80), and wherein the auxiliary conduit is configured for allowing one ii) a fluid including at least one bioactive agent, to be delivered via the auxiliary conduit and through the auxiliary outlet (see Buras Fig. 1-2; Col. 4 lines 49-62 surrounding balloon cuff 14 is the structure of conduit bands 40 with rings 34, 42, each of which comprise openings 38 through which topical anesthetic leaks). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon seal 42 of Stone with the addition of the irrigation passage 24 alongside the blade 31 of Stone and overall irrigating system 60 on the balloon seal 42 of Stone as taught by Buras so as “to allow for infusion of topically applied medicinal substance(s), such as anesthetic or anti-inflammatory substances, directly onto those tissues so affected by the cuff and tube” (see Buras Abstract lines 13-16).
Regarding claim 6, modified Stone discloses a blade conduit portion of the auxiliary conduit that extends along the laryngoscope blade is at least one of located laterally relative to the channel (see modification of Stone in view of Buras above in claim 1, regarding the irrigation passage 24 of Buras passing alongside blade 31 of Stone. The would be located on the side of the blade 31, wherein all of the side of blade 31 are lateral to the channel 45).
Regarding claim 16, modified Stone discloses the at least one bioactive agent includes at least one of anesthetic agent (see Buras anesthetic agent above in claim 1 rejection).
Regarding claim 17, modified Stone discloses the auxiliary conduit includes one or more auxiliary outlets located on the blade for allowing the fluid to be delivered via the one or more auxiliary outlets (see Buras openings 38 for delivering anesthetic, wrapped around balloon 42 of Stone, which is located along blade 45).
Regarding claim 27, modified Stone discloses the intubation device is configured to allow the user to hold the intubation device, advance the endotracheal tube, and activate the auxiliary function using a single hand (see Stone Col. 2 lines 38-39 “the laryngoscope-intubation instrument is configured so that only one hand is needed to operate it”. Modification by Buras can be simply leaking the already loaded anesthetic from the openings 38, involving no additional hands.).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Stone in view of Buras as applied to claim 1 above, and further in view of Parker et al. (US 5,389,074; hereinafter “Parker”).
Regarding claim 19, modified Stone is silent as to a reservoir for storing fluid. However, Parker teaches a reservoir for storing the fluid (see Parker syringe 58 or other source of anesthetic fluid that can be engaged with anesthetic line 56). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the end of the auxiliary conduit of modified Stone with the connection to a fluid reservoir in the form of a syringe as taught by Parker so as to provide fresh anesthetic when needed and control the amount of anesthetic reaching the patient.
Regarding claim 20, modified Stone discloses the reservoir is provided separate from the device (see Parker syringe 58 or other source of anesthetic fluid is separable from the line 56).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over McGrath as applied to claim 1 above, and further in view of Ouyang et al. (US 2018/0256009; hereinafter “Ouyang”).
Regarding claim 25, McGrath is silent as to the intubation device includes an auxiliary control for controlling delivery of the object via the auxiliary conduit. However, Ouyang teaches the intubation device includes an auxiliary control for controlling delivery of the object via the auxiliary conduit (see Ouyang endoscope 100 where [0079] “camera module in tip assembly 110 pass through a separate channel in cannula 120”. Within handle portion 140 contains image capture button 160 for operating camera module). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection between the camera, handle, and display of McGrath with the addition of an image capture button on the handle as taught by Ouyang so as to control what image is sent to the display when necessary.
Regarding claim 26, modified McGrath discloses the intubation device includes:
a) a first digit interface for allowing the user to operate the tube movement mechanism using a digit of the hand that is holding the intubation device (see McGrath [0046] manually operable control may be located on the handle; [0028] “The manually operable control is preferably located to be operable with a user's fingers”); and
b) a second digit interface for allowing the user to activate operate the auxiliary function control using a digit of the hand that is holding the intubation device (see McGrath modified by Ouyang to include image capture button 160 on handle).
Response to Arguments
Applicant's arguments filed 10/27/2025 have been fully considered but they are not persuasive.
Applicant argues, on page 8 of the remarks, that regarding the 112(b) “Claim 10 already consistently refers to the "the auxiliary conduit" and it is submitted that it would be clear to a skilled person reading the claim that this is the same as "an auxiliary conduit" in initially defined in claim 1”. Examiner disagrees and maintains the rejection. Claim 10 lines 3 and 4 comprise “the auxiliary conduit”, referring to the structure from claim 1. The language should be continued into line 6 of claim 10 as such for clarity. Thus, the rejection still stands.
Applicant’s arguments, see page 9-10 of the remarks, with respect to the rejection(s) of claim 1 under 35 USC 102(a)(1) in view of Stone have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 USC 103 in view of Stone in view of Buras. See new rejection in view of the amended language above.
Applicant’s arguments with respect to claims 2-5 in view of Stone in view of Christopher on pages 10-11 of the remarks have been considered but are moot because the new ground of rejection does not rely on the Christopher reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues, on page 11 of the remarks, with regards to the rejection of Stone in view of Buras that “A skilled person seeking to combine the teachings of Stone and Buras would only contemplate adding an anesthetic irrigation passage (24) as taught by Buras to the endotracheal tube alongside the conduit (43) for inflating the balloon seal (42) that is taught by Stone.” Due to the amended language, the Examiner has modified the rejection of Stone in view of Buras above to clarify the position of combining Stone and Buras. See rejection to claim 1 under 35 USC 103 above. Therefore, the rejection still stands.
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 GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
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, Tim Stanis can be reached at (571) 272-5139. 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.
/GWYNNETH L HOWELL/Examiner, Art Unit 3785 /RACHEL T SIPPEL/Primary Examiner, Art Unit 3785