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 01/09/2026. Claims 1, 7 and 8 have been amended. Claims 2, 5 and 6 have been cancelled. Currently, claims 1, 3, 4, 7 and 8 are under examination.
Applicant has cancelled the claims previously objected to and incorporated into the amended claim 1. Per the amendments to claim 1, the claim objections in response to the previous rejection have been withdrawn.
Per the amendment to claim 7, the 112(b) rejection has been withdrawn.
Claim Objections
Claims 1, 3, 4, 7 and 8 are objected to because of the following informalities:
Claims 1, 3, 4, 7 and 8: the recitation of “endotracheal intubation”, should read ---endotracheal tube---, to avoid the use of a verb as the intended invention, where a noun is proper for an apparatus claim.
Claims 1 and 7: the recitation of “wherein the hollow intubation body further comprises a bifurcated tube having an end connected between the front end of a part of the hollow intubation body excluding the bifurcated tube and the tail end of the part”, lacks clarity. It is unclear whether the hollow intubation body ‘10’ is intended to encompass the bifurcated tube ‘15’, or if the bifurcated tube ‘15’ is distinct from the hollow intubation body ‘10’.
Claims 1 and 7: the recitation of “the expanded state” in line 16, should read ---an expanded state---, to avoid any antecedent basis issues.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1, 3, 4, 7 and 8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1,3, 4, 7 and 8, there is no support for the Murphy eye ‘111’ being arranged on the bifurcated tube ‘15’ as claimed, instead it is depicted in Figure 6 as being arranged on the hollow intubation body ‘10’.
Figure 6 shows that the Murphy eye ‘111’ is provided on ‘10’ the hollow intubation body only, and that ‘15’ is the bifurcated tube section (bifurcated tube), that does not include the Murphy eye ‘111’, the bifurcated tube ‘15’ only is provided with the one-way valve ‘151’. Additionally, the specification only provides sufficient detail that the hollow intubation body ‘10’ is provided with a Murphy eye ‘111’ that is located adjacent to the front end ‘11’ and that the Murphy eye ‘111’ serves as an alternative vent when the front end ‘11’ is blocked (see pg. 8 lines 5-7 – Murphy eye description). Therefore, there is no support for the Murphy eye ‘111’ being on the bifurcated tube ‘15’.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being obvious over Xiao (CN 207722204 U) in view of Cohen (WO 2005070489 A1).
Regarding claim 1, Xiao discloses an endotracheal intubation for preventing injury to throat, vocal cords, and trachea (Figure 1 below; where there is an endotracheal tube (hollow intubation body) and helps to prevent injury to the throat – Xiao Abstract lines 9-11) comprising:
a hollow intubation body with a variable outer diameter dimension, comprising a front end, a tail end, an inner wall and an outer wall, the front end and the tail end located at two opposite ends of the hollow intubation body, and the inner wall and the outer wall located at two opposite inner and outer sides of the hollow intubation body (Figure 1 below; inner wall, outer wall at opposite ends, tail end and front end at opposite ends and Figure 2 below; where the hollow intubation body has a variable outer dimension);
wherein and the hollow intubation body having has a retracted state with a smaller outer diameter and an expanded state with a larger outer diameter (Figure 2 below; retracted state and expanded state);
and the hollow intubation body in the retracted state being able to be changed to the expanded state (Figure 2 below; where the hollow intubation body can be changed between retracted / expanded state as shown);
and the hollow intubation body in the retracted state is able to penetrate into another hollow intubation body in the expanded state through a tube (Figure 1 below; penetration tip allowable to penetrate another hollow intubation body (capable of going through the branch of another tube), can be in retracted or expanded state with varying diameters)
wherein the hollow intubation body is a longitudinally sectioned intubation piece which is curved (Figure 2 below; where the hollow intubation body is a longitudinally sectioned intubation piece that is curved);
the longitudinally sectioned intubation piece comprises two abutment surfaces respectively on both sides of the longitudinally sectioned intubation piece and are configured to be correspondingly engaged (Figure 2 below; where there is two abutment pieces on both sides of the longitudinally sectioned intubation piece, in the expanded state they are configured to be engaged with each other);
and wherein the hollow intubation body is in the retracted state when the two abutment surfaces are not correspondingly engaged (Figure 2 below; where there is no corresponding engagement with the retracted state of the abutment pieces);
and the hollow intubation body is in the expanded state when the abutment surfaces are correspondingly engaged (Figure 2 below; where there is corresponding engagement when in the expanded state of the abutment pieces);
wherein the two abutment surfaces are each provided with a snap-fit structure, and the snap-fit structure is made of a convex part and a concave part (Figure 2 below; where the abutment pieces have a snap fit structure to be correspondingly engaged and the snap fit pieces are rounded in a way that there is a convex and a concave portion to them).
Xiao fails to disclose a bifurcated tube.
Cohen discloses an endobronchial device,
wherein the hollow intubation body further comprises a bifurcated tube having an end connected between the front end of a part of the hollow intubation body excluding the bifurcated tube and the tail end of the part (Figure 3 below; where there is a hollow intubation body that has a bifurcated tube that has an end connected between the front end and the tail end);
and the bifurcated tube is tilted toward the tail end and provided with a one-way valve configured to provide fluid to flow toward the hollow intubation body (Figure 3 below; where ‘40’ is a one-way valve on the branch of the hollow intubation body – the bifurcated portion of the tube (that is tilted toward the tail end), that is configured to provide fluid to flow toward the hollow intubation body)
wherein the Murphy eye is arranged on the bifurcated tube (Figure 3 below; where there is a Murphy eye arranged on the front end of the hollow intubation body).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the expandable endotracheal tube of Xiao to include a bifurcated tube with a one-way valve and a murphy eye at the front end of the tube as taught by Cohen, since, the arrangement is less traumatic to the bronchus, and therefore the trachea, helps to better maintain positioning of the tube, and because a single tube design can obstruct gas and/ or irrigation fluids from being properly aspirated from or added to the branched tube (bifurcation section) (Cohen [0007], [0038]).
PNG
media_image1.png
746
486
media_image1.png
Greyscale
Figure 1: Annotated Figure 2 of Xiao; cross-sectional view of hollow intubation body with various features.
PNG
media_image2.png
484
674
media_image2.png
Greyscale
Figure 2: Annotated Figure 4 of Xiao; retracted and expanded state of inside of the hollow intubation body.
PNG
media_image3.png
659
543
media_image3.png
Greyscale
Figure 3: Annotated Figure 1 of Cohen.
Regarding claim 3, Modified Xiao further discloses the endotracheal intubation as claimed in claim 1, wherein the endotracheal intubation comprises a flexible intubation sleeve covering the hollow intubation body and extending to the front end and the tail end (Xiao: Contents of this utility model [03]; drum shaped elastic pipe body outer wall bonded together with portion of the sleeve inner wall – flexible intubation sleeve).
Claim 4 is rejected under 35 U.S.C. 103 as being obvious over Xiao (CN 207722204 U) in view of Cohen (WO 2005070489 A1), and further in view of Shikani (US 5762638 A).
Regarding claim 4, Modified Xiao further discloses the endotracheal intubation as claimed in claim 1.
Modified Xiao is silent to wherein the endotracheal intubation comprises an inner membrane disposed on the inner wall and extending to the front end and the tail end.
Shikani discloses the endotracheal tube wherein,
the endotracheal intubation comprises an inner membrane disposed on the inner wall and extending to the front end and the tail end (Shikani col. 8 lines 22-25; “layer contains either anti-inflammatory agent or anti-infective agents” …”coating can be a monolayer or a multilayer” and lines 18-22; “the coating is applied to the surface by dipping or spraying solutions”...” can be anti-infectives or anti-inflammatories or both”; wherein the inner membrane’s purpose is to be a layer in the endotracheal tube for anti-infectious reasons).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Xiao with inner membrane layer in Shikani, since the layer will help to control or prevent the issue of inflammation and infection that may occur with prolonged endotracheal use (Shikani col.1 lines 17-21).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being obvious over Xiao (CN 207722204 U) in view of Cohen (WO 2005070489 A1), further in view of Eversull (US 7637902 B2), and even further in view of Lauryssen (US 9,211,140).
Regarding claim 7, Xiao discloses an endotracheal intubation for preventing injury to throat, vocal cords, and trachea (Figure 1 above; where there is an endotracheal tube (hollow intubation body) and helps to prevent injury to the throat – Xiao Abstract lines 9-11) comprising:
a hollow intubation body with a variable outer diameter dimension, comprising a front end, a tail end, an inner wall and an outer wall, the front end and the tail end located at two opposite ends of the hollow intubation body, and the inner wall and the outer wall located at two opposite inner and outer sides of the hollow intubation body (Figure 1 above; inner wall, outer wall at opposite ends, tail end and front end at opposite ends and Figure 2 above; where the hollow intubation body has a variable outer dimension);
wherein and the hollow intubation body having has a retracted state with a smaller outer diameter and an expanded state with a larger outer diameter (Figure 2 above; retracted state and expanded state);
and the hollow intubation body in the retracted state being able to be changed to the expanded state (Figure 2 above; where the hollow intubation body can be changed between retracted / expanded state as shown);
and the hollow intubation body in the retracted state is able to penetrate into another hollow intubation body in the expanded state through a tube (Figure 1 above; penetration tip allowable to penetrate another hollow intubation body (capable of going through the branch of another tube), can be in retracted or expanded state with varying diameters)
wherein the hollow intubation body is a longitudinally sectioned intubation piece which is curved (Figure 2 above; where the hollow intubation body is a longitudinally sectioned intubation piece that is curved);
the longitudinally sectioned intubation piece comprises two abutment surfaces respectively on both sides of the longitudinally sectioned intubation piece and are configured to be correspondingly engaged (Figure 2 above; where there is two abutment pieces on both sides of the longitudinally sectioned intubation piece, in the expanded state they are configured to be engaged with each other);
and wherein the hollow intubation body is in the retracted state when the two abutment surfaces are not correspondingly engaged (Figure 2 above; where there is no corresponding engagement with the retracted state of the abutment pieces);
and the hollow intubation body is in the expanded state when the abutment surfaces are correspondingly engaged (Figure 2 above; where there is corresponding engagement when in the expanded state of the abutment pieces);
wherein the two abutment surfaces are each provided with a snap-fit structure, and the snap-fit structure is made of a convex part and a concave part (Figure 2 above; where the abutment pieces have a snap fit structure to be correspondingly engaged and the snap fit pieces are rounded in a way that there is a convex and a concave portion to them).
Xiao fails to disclose a bifurcated tube.
Cohen discloses an endobronchial device,
wherein the hollow intubation body further comprises a bifurcated tube having an end connected between the front end of a part of the hollow intubation body excluding the bifurcated tube and the tail end of the part (Figure 3 above; where there is a hollow intubation body that has a bifurcated tube that has an end connected between the front end and the tail end);
and the bifurcated tube is tilted toward the tail end and provided with a one-way valve configured to provide fluid to flow toward the hollow intubation body (Figure 3 above; where ‘40’ is a one-way valve on the branch of the hollow intubation body – the bifurcated portion of the tube (that is tilted toward the tail end), that is configured to provide fluid to flow toward the hollow intubation body)
wherein the Murphy eye is arranged on the bifurcated tube (Figure 3 above; where there is a Murphy eye arranged on the front end of the hollow intubation body).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the expandable endotracheal tube of Xiao to include a bifurcated tube with a one-way valve and a murphy eye at the front end of the tube as taught by Cohen, since, the arrangement is less traumatic to the bronchus, and therefore the trachea, helps to better maintain positioning of the tube, and because a single tube design can obstruct gas and/ or irrigation fluids from being properly aspirated from or added to the branched tube (bifurcation section) (Cohen [0007], [0038]).
Modified Xiao fails to disclose wherein the hollow intubation body is composed of two half-tube bodies with an abutment surface therein.
Eversull discloses an endotracheal tube,
wherein the hollow intubation body is composed of two half-tube bodies and the two half-tube bodies are configured to be arranged crosswise (Eversull col. 8 lines 25-26; longitudinal channels may be cut, lines 39-40; width of longitudinal channel can be controlled, lines 54-63; there can be a cut at multiple locations of the channel for circumferential interruptions with two semi-circular in cross-section (crosswise) to be attached to the tube);
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to cut the endotracheal tube of Xiao to form two half-tube bodies, as taught by Eversull, because the two inner half-tube bodies allow for the endotracheal tube to be more easily removed from the outer tube without peeling or cutting the device for removal (Eversull col. 8 lines 64-67). In this embodiment,
Modified Xiao in view of Eversull fails to disclose each of the two half-tube bodies including an abutment surface thereon.
Lauryssen discloses an endotracheal tube comprising:
two half-tube bodies, wherein each of the two half-tube bodies includes an abutment surface thereon configured to be engaged with each other (Lauryssen Figure 4B; 31, 32, 33 and 34).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide each of the two half-tube bodies with an abutment surface thereon in order to maintain alignment of elongate members (Column 9, lines 24-26).
Regarding claim 8, Modified Xiao in view of Eversull and further in view of Lauryssen further discloses the endotracheal intubation as claimed in claim 7, wherein a snap-fit structure at the end of the two half-tube bodies (Lauryssen, 31-34, Figure 4B and Column 9, lines 24-26).
Conclusion
The following prior art were considered but not used on a 35 U.S.C. § 102 or 103 rejection:
Wang (CN 112263762 A): bifurcated tube with a murphy eye.
Han (CN 108310573 B): a multi-functional tracheal tube with a one-way valve on the branch of the tube.
Li (CN 111529869 A): a loop type anesthesia ventilation system with a one-way valve, bifurcated tube, and an artificial airway like a tracheal tube.
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 AISLINN MOIRA JONES whose telephone number is 571-272-3835. The examiner can normally be reached Monday-Friday 8am-5pm, EO Friday 8am-4pm EST.
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, 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.
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.
/AISLINN M JONES/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785