DETAILED ACTION
This action is pursuant to the claims filed on August 5, 2025. Claims 1, 5-16 and 18-20 are pending. Claims 2-3 and 17 is/are canceled. Claims 10-16, 18 and 20 is/are withdrawn. A first action on the merits of claims 1, 5-9 and 19 is as follows.
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 . 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 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.
Claim Objections
Claims 1, 5-9 and 19 are objected to because of the following informalities:
Claims 1, 5-9 and 19 referring each of the claimed elements with a numerical value which should be omitted in the next submission.
Claims 1 & 19, ln. 1: “Endotracheal tube” should be changed to –An endotracheal tube--;
Claims 5-9, ln. 1: “Endotracheal tube” should be changed to –The endotracheal tube--;
Claim 6, ln. 2: “the lining” should be changed to –the at least one lining”;
Claim 7, ln. 7: “the tube exterior” should be changed to –the exterior surface of the tube-; and
Claim 7, ln. 9: “the tube outer side” should be changed to –the exterior surface of the tube--;
Appropriate corrections are required.
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, 5-9, and 19 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 pre-AIA the applicant regards as the invention.
Claim 1 recites “at least two electrodes… arranged in the at least one electrode array” and “the endotracheal tube comprises: either at least two stimulation electrodes (4a) and at least two conduction electrodes (4b); or at least two combination electrodes (4c). However, it is unclear if there is/are one or two different set(s) of “at least two stimulation electrodes and at least two conduction electrodes or at least two combination electrodes”. For the purpose of applying prior art, it is understood that the two sets are the same.
Accordingly, claims 5-9 are rejected by virtue of its dependency on independent claim 1.
Claim 7 recites “at least one of the electrodes”. However, it is unclear which limitations, e.g. “the at least two electrodes, “at least two stimulation electrodes”, “at least two conduction electrodes”, “at least two combination electrodes”, etc. the “at least one of the electrodes” it is referring to.
Claim 7 recites “at least one of the paddings”. However, there is insufficient antecedent basis for said limitation.
Claim 19 recite “optionally wherein at least two further ones of the electrodes are the at least two measuring elements’. The phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 & 19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by McFarlin et al. (hereinafter ‘McFarlin’, WO 2019/040602).
In regards to independent claims 1 & 19, McFarlin discloses endotracheal tube for intra-operative neuromonitoring (EMG endotracheal tube apparatus 602 in Fig. 10, [35]), comprising:
a tube of substantially circular cross-section configured to be inserted into a trachea of a patient (the endotracheal tube 602 shows a circular cross-section configured for positioning in a region of a trachea and for stimulating vocal folds of a patient, [74]);
a fixation element (the ET tube includes a balloon cuff 902 which is an inflatable balloon located near the end of the tube to create a seal against the tracheal wall, [34]) configured, when the tube is inserted into the trachea of the patient, to fix the tube in the trachea ([74]);
at least two electrodes configured as stimulating electrodes for electrically stimulating tissue or as deriving electrodes for deriving stimulus responses from tissue, or configured as combination electrodes for electrically stimulating tissue and deriving stimulus responses from tissue (electrodes 904 in Fig. 10; [35]: the electrodes 904 is connected to the module 604 which configures two electrodes for EMG recording and two electrodes for stimulation), and forming at least one electrode array which is arranged at a predefined array distance from a distal end of the tube on the tube outer side and completely surrounds the tube outer side (Fig. 10 shows that the electrodes 904 are arranged circumferentially around the surface of the tube 602 distal to the distal end of the tube 602 and each of the electrodes 904 are spaced apart from each other),
wherein the at least two electrodes are arranged in the at least one electrode array such that they are at a predefined electrode spacing from their respective adjacent electrode and are substantially parallel to each other and are circular over 360 around the tube; wherein the at least two electrodes extend axially or circularly in a predefined range along the tube; and wherein the endotracheal tube (four electrodes are 90 degrees apart from each other and are arranged along a longitudinal axis of the tube, which meets the parallel configuration) comprises:
either at least two stimulation electrodes/inducing electrodes and at least two conduction electrodes; or at least two combination electrodes (electrodes 904 in Fig. 10; [35]: the electrodes 904 is connected to the module 604 which configures two electrodes for EMG recording and two electrodes for stimulation); wherein the electrode array is divided into at least two sub-arrays; and wherein the sub-arrays are arranged such that each has a predefined sub-array spacing to its adjacent sub-array (four electrodes are divided into two sub-arrays: stimulation electrodes 904 connected to STIM+/- and EMG electrodes 904 connected to EMG CH+/-).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over McFarlin as applied to claim 1 above, and further in view of Kartush (U.S. PGPub. No. 2010/0317956).
In regards to claims 5-7, McFarlin discloses the invention substantially as claimed in claim 1 above.
However, McFarlin does not disclose at least one lining associated with at least one of the at least two electrodes and having elasticity in radial direction, wherein the at least one lining/at least one of paddings is attached to an underside of the at least one electrode and supports the at least one electrode on the tube exterior such that, under the influence of force in the radial direction, the at least one lining is elastically deformed, and wherein the at least one electrode can be displaced in the radial direction and, when the force is removed, the at least one lining can deform back and the at least one electrode can be displaced back, wherein the lining comprises a foam structure, spring element, an elastic balloon filled with a gas or gas mixture.
Kartush teaches an endotracheal tube for intra-operative neuromonitoring ([0017], [0029], [0067]: endotracheal tube 10 in exemplary Fig. 1; attention is directed to an embodiment as shown in Figs. 18-20) similar to McFarlin. Specifically, Kartush teaches providing a lining/a padding (support element 540 constructed from a sponge-like material, [0114] which reads on a foam structure, thus meeting claim 6), supporting a plurality of sensors/electrodes (514) via adhesive such that the support element is adapted to expand or contract depending upon different environmental conditions, i.e. contracts when dry condition and expands when subjected to liquids. This allows for the lining (support element 540) to elastically deform in a radial direction and displace the sensors/electrodes (514) in the radial direction when subjected to liquids so that the sensors/electrodes are adapted to enhance contact to a target muscle for monitoring nerves associated with those muscles ([0089], [0114]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the portion of the endotracheal tube supporting the electrodes of McFarlin and incorporate the lining/padding and electrode arrangement as taught by Kartush, as doing so allows for expansion of the lining in the presence of liquid or within a patient to enhance contact to a target muscle for monitoring and/or stimulating the nerves associated with those muscles ([0114]).
In regard to claims 8-9, in view of the combination as set forth in claim 7 above, Kartush further teaches providing an alignment indicator (16), an optical member, along various locations including above electrodes (14) which can illuminate or otherwise provide output through the tissue of the neck to provide the appropriate location of the electrodes/sensors to a health care provider, for example, if the ET tube tip is far enough in the trachea or rotate relative to the preferred location within the laryngeal space ([0092]-[0093]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the electrode adhered to the lining/padding of the McFarlin/Kartush combination and further provide alignment indicator/optics as doing so provide an appropriate location of the electrode/sensor to a healthcare provider ([0093]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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, JOSEPH STOKLOSA can be reached at (571) 272-1213. 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.
/EUN HWA KIM/Primary Examiner, Art Unit 3794 8/16/2025