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 7/16/2026. As directed by the amendment, claims 4 and 12 have been amended, and claims 1-3 and 9-11 have been cancelled. As such, claims 4 and 12-14 are pending in the instant application.
Applicant has cancelled claim 9, rendering the rejection under 35 USC 101 moot.
Applicant has amended claims 4 and 12 to provide antecedent basis; the rejections under 35 USC 112(b)/second paragraph are withdrawn.
Response to Arguments
Applicant's arguments filed 7/16/2026 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
Applicant argues on page 4 of Remarks that “Walters teaches using an adhesive tag 519 but this is different than the operation as claimed…all of the applied references taken individually or in combination fail to suggest [wrapping the tape around the endotracheal tube in the manner claimed].”
The Examiner disagrees that the combination of Walters in view of Bayron would not have led an artisan to wrapping the tape around the endotracheal tube as claimed. Walters Fig. 10A discloses attaching a tape (519) located at the end of a sleeve to an endotracheal tube (106), and Bayron Figs. 5-6 teach wrapping a tape (72) located at the end of a sleeve around a tube (70). Therefore, when modifying Walters to include a wrapped/wrappable tape as taught by Bayron as discussed on pages 12-13 of the Office Action mailed 1/16/2026, it would have been obvious to an artisan before the effective filing date of the claimed invention for the deployment of said tape to include securing the tape to and around the endotracheal tube by wrapping the tape around the endotracheal tube as taught by Walters Fig. 10A in view of Bayron Figs. 5-6, e.g. by wrapping the tape around the top of the sleeve (and thus around the underlying endotracheal tube) as shown by Bayron as well as up onto (and around, as taught by Bayron) the endotracheal tube directly as taught by Walters, in order to predictably provide a leak-free connection between the top of the sleeve and the tube for sterile extubation. Therefore, the rejection in view of Walters and Bayron is maintained/updated below.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12, line 2 should read “the airtight seal” because it is understood to be referring to that of claim 4, line 11
Appropriate correction is required.
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.
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) 4, 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Walters (US 2014/0041673 A1; hereinafter “Walters”) in view of Kumar et al. (US 2003/0047189 A1; hereinafter “Kumar”), Bayron et al. (US 5,746,199; hereinafter “Bayron”) and Hirsch (US 4,008,851; hereinafter “Hirsch”).
Regarding claims 4 and 12, Walters discloses a method, comprising:
placing an endotracheal tube (breathing tube 106) in a mouth belonging to a patient (breathing tube 106, such as of a ETT or an LM device, para [0084]; intubation, para [0085], i.e. similar to Fig. 2A or 11E);
placing a sanitary extubation cover over the endotracheal tube (Fig. 8B; see also para [0085], i.e. similar to Fig. 11E), the sanitary extubation cover (bodily fluids guard, e.g. BFG 500) (e.g. Figs. 8A-B) comprising a mask (annulus 518) (where the annulus comprehends a mask because it covers at least part of a person’s face in use, i.e. similar to Fig. 2A or 11E) and an expandable hollow sleeve (flexible sleeve wall 516) (during extubation, the sleeve wall 516 will automatically be caused to unfold and extend around the tube 106 upon extubation, para [0085]; see expansion from Fig. 8A to 8B) connected to the mask (Figs. 8A-B; para [0085]), and tape (adhesive tag 519) attached to the expandable hollow sleeve at an end thereof (upper end in Fig. 8B), wherein a first end of the tape (the free upper end) is configured to be off the sleeve and a second end of the tape (lower end) opposite the first end is connected to the sleeve (Fig. 8B), the hollow sleeve configured to expand when pulled thereby providing an extended cover for the endotracheal tube (Fig. 8B; para [0085]);
placing the mask against a face belonging to the patient covering the patient’s mouth (518…pushed against the patient’s face, para [0085], i.e. similar to Fig. 11E);
attaching the tape to the endotracheal tube (Fig. 10A; tags 519…used to fix the sleeve wall 516 to a breathing tube 106 after intubation, para [0085]);
removing the endotracheal tube from the mouth while the mask remains on the face, wherein, as the endotracheal tube is removed, the hollow sleeve expands and covers a withdrawn portion of the endotracheal tube (during extubation, the sleeve wall 516 will automatically be caused to unfold and extend around the tube 106 upon extubation, para [0085]; see expansion from Fig. 8A to 8B in view of e.g. Fig. 11F);
removing the mask from the face (Fig. 8B; bodily fluids guard of Fig. 8A with an extubated breathing tube retracted and sealed therein for disposal, para [0044], where the BFG must be removed from the face in order to be thrown away as inferred by Walters); and
disposing of the sanitary extubation cover (bodily fluids guard of Fig. 8A with an extubated breathing tube retracted and sealed therein for disposal, para [0044]).
While Walters acknowledges that breathing tubes can be inserted through the mouth or the nose (para [0076]), Walters is silent regarding the mask covering the mouth and nose, and wherein the mask comprises an air cushion forming an airtight seal between the person’s face and the mask. However, Kumar teaches that it was known in the respiratory therapy art before the effective filing date of the claimed invention to provide a mask (mask 20) (Figs. 1-3) covering the person’s mouth and nose and comprising an air cushion (soft seal 32) forming an airtight seal between the person’s face and the mask (Figs. 2 and 4; abstract, para [0027]), to enable both oral and nasal access (e.g. paras [0013-14]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the method of Walters to include the mask covering the person’s mouth and nose and comprising an air cushion forming an airtight seal between the person’s face and the mask as taught by Kumar, in order to provide the predictable result of a single annulus/mask configured to allow for sanitary removal of both oral and/or nasal tubes (for versatility and/or ease of ordering/inventory) and a comfortable patient-interfacing/sealing side for said annulus/mask that provides for sterile/leak-free extubation using common components (i.e. an air cushion).
Walters is silent regarding wherein the tape is wrapped around the expandable hollow sleeve at the end thereof, wherein the first end of the tape is configured to be peeled off the sleeve, wherein the second end of the tape is integrally connected to the sleeve, and peeling the first end of the tape from the sleeve and wrapping the tape around the endotracheal tube. However, Bayron teaches/suggests that it was known in the respiratory therapy art before the effective filing date of the claimed invention to utilize tape (seal forming adhesive tape 72) (Figs. 5-6) wrapped around an upper longitudinal end of an expandable hollow sleeve (bag-like attachment 60) for attaching the sleeve to a tubular medical component (fixture 70) (para [0067]), wherein the first end of the tape is configured to be peeled off the sleeve (see the free end of 72 in Fig. 5) and peeling the first end of the tape from the sleeve and wrapping the tape around the tubular medical component (Fig. 6), because it would have been obvious to an artisan before the effective filing date of the claimed invention for said free end in Bayron Fig. 5 to have been peeled off the sleeve, so as to have delivered the sleeve/tape in an initial, wrapped storage position around the sleeve, and wherein Bayron further suggests that the second end of the tape (see the attached end of 72 in Bayron Fig. 5) is integrally connected to the sleeve, because it would have been obvious to an artisan before the effective filing date of the claimed invention for the second end to be integrally connected to the sleeve in order to maintain it in position/prevent detachment/loss of the tape, because this was a well-established configuration for peelable, deployable tape before the effective filing date of the claimed invention, as demonstrated by Hirsch (Figs. 1-6; adhesive tape is relatively permanently attached at one end to a bag near the open end thereof and is strippably attached to the bag in the remaining portions, abstract; closure tap 16 is relatively permanently attached at one end 18 to bag 10, col. 2, lines 16-20). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Walters such that the tape at the end of the expandable portion of the sleeve is (initially) wrapped around the sleeve in said location, wherein the first end of the tape is configured to be peeled off the sleeve, wherein the second end of the tape is integrally connected to the sleeve, and peeling the first end of the tape from the sleeve and wrapping the tape around the endotracheal tube as taught/suggested by Bayron in view of Walters (which teaches securing the deployed tape directly to the tube) and reinforced by Hirsch, in order to provide the predictable results of an easily deployed, pre-stored tape means for allowing the mask/sleeve of Walters to be used in a sterile fashion (Bayron col. 7, lines 25-63) by securing the tape to and around the endotracheal tube (e.g. by wrapping the tape around the top of the sleeve/around the endotracheal tube as well as up onto and around the endotracheal tube directly), with the second end integrally connected to the sleeve so as to predictably maintain the tape in position/prevent detachment/loss of the tape during transport and/or tape deployment while providing for enhanced sanitary extubation by reducing or eliminating any opening(s) between the top of the sleeve and the upper portion of the endotracheal tube that could otherwise allow contaminants from the patient to exit the sleeve during extubation.
Regarding claim 14, Walters in view of Kumar, Bayron and Hirsch teaches the method as recited in claim 4, wherein Kumar further educates modified Walters to include wherein the mask further comprises at least one porthole (inflation valve, para [0027] and/or aperture 34) (Kumar Figs. 2-3; para [0028]), in order to provide the predictable result(s) of a standard means for providing for adjustable inflation of an air cushion (see claim 12 limitations discussed above) and/or to allow discharge of exhaled gases, gas sampling and/or gas or oxygen delivery (Kumar para [0028]) during the extubation process.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Walters in view of Kumar, Bayron and Hirsch as applied to claim 12 above, and further in view of Jacobelli (US 5,660,174; hereinafter “Jacobelli”).
Regarding claim 13, Walters in view of Kumar, Bayron and Hirsch teaches the method as recited in claim 12, but modified Walters is silent regarding wherein the air cushion is comprised of silicone. 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 Jacobelli teaches that it was known before the effective filing date of the claimed invention for an air cushion (inflated cushion 8) (Fig. 5) to be comprised of silicone (col. 2, lines 53-64). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the air cushion of modified Walters to be comprised of silicone as taught by Jacobelli, in order to provide the predictable result of a soft/pliable, hypoallergenic patient-interfacing/sealing cushion.
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 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
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