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 .
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.
Claim(s) 1 – 4 and 8 - 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vomastek (US 20130167839) in view of Brillant (US 20120184921).
Regarding claim 1, Vomastek discloses a combination stylet device for use in guiding an endotracheal tube during an intubation procedure [0002], the device comprising: an elongated sleeve having a hollow interior (68); a fitting disposed at a proximal end of the sleeve (66), the fitting having a connector opening configured for mating with a syringe (48, which provides assistance in injecting medicine within and through the sleeve 68, see [0041], and is fully capable of mating with a syringe, e.g. similar to syringe 124 discussed in Denton US 6112743 below); apertures disposed at a distal end of the sleeve, the apertures configured to generating a fine spray of a liquid (apertures 76, see [0037]); and an elongated bendable guiding stylet (78) disposed coaxially within the sleeve between the fitting and the distal tip (see Figs. 12 - 14, [0041], [0039]), wherein a channel is defined between an outer surface of the guiding stylet and an inner surface of the sleeve (see Fig. 13, [0041]), wherein liquid introduced under pressure through the fitting is communicated by the channel to the apertures [0041]; wherein the sleeve is configured for insertion into the endotracheal tube during intubation, the sleeve having a length configured to position the apertures and distal tip near a distal end of the endotracheal tube (see Fig. 14, [0008]; the distal tip would hold the nozzle, as explained below).
Vomastek discloses anesthetizing the orotracheal region both before and during the endotracheal insertion procedure, see [0007], and furthermore discloses that the distal end of the sleeve may be configured in any desired arrangement for delivery of the anesthetic spray, see [0029], [0037]. However, Vomastek does not disclose a nozzle disposed at a distal end of the sleeve, the nozzle having a concentric bore with an outlet at a distal tip, the outlet configured to project a fine spray of a liquid axially forward beyond the distal tip, wherein liquid introduced under pressure through the fitting is communicated by the channel to the bore of the nozzle. Nonetheless, Brillant discloses a sleeve for anesthetizing the orotracheal region before an endotracheal insertion procedure, see [0009], the sleeve including a nozzle (9) disposed at a distal end of the sleeve (15), the nozzle having a concentric bore (channel within nozzle, see Fig. 3, Fig. 4a, illustrating the concentricity similar to applicant’s illustration of concentricity) with an outlet at a distal tip (31/32), the outlet configured to project a fine spray of a liquid axially forward beyond the distal tip (see [0012, 0017]), wherein liquid introduced under pressure through the fitting is communicated by the channel to the bore of the nozzle (see Fig. 1, Fig. 2, [0013, 0017]). Therefore, according to the teachings of Brillant, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the distal end of Vomastek with a nozzle for the benefit of sending anesthetic further inside the trachea, see [0017], while maintaining a flexible sleeve with soft tip, see [0016]. An endotracheal tube combined with a sleeve having a nozzle is known in the art, see the previously applied reference to Herskovic in the non-final dated 07/01/2025.
2. The device of claim 1, wherein the fitting is configured for releasable attachment to the syringe (fitting connector opening 48 is fully capable of releasable attachment to a syringe, such as syringe 124 discussed in Denton US 6112743 below), and wherein the syringe generates sufficient pressure to force liquid in the syringe out of the nozzle (connector 48 assists in injecting medicine within and through the cannula 68, see [0041]).
3. The device of claim 1, wherein the liquid is a topical anesthetic [0008].
4. The device of claim 1, wherein the fitting further comprises an insertion stop configured to limit an insertion length within the endotracheal tube (80, [0041]).
Regarding claim 8, Vomastek in view of Brillant discloses a stylet device for guiding an endotracheal tube during intubation, the device comprising: an elongated cylindrical sleeve having a hollow interior (68), the sleeve formed from a flexible medical grade plastic material (see [0036] and general teaching in [0030]); an elongated bendable guiding stylet disposed coaxially within the sleeve (78), the guiding stylet having an outer diameter smaller than an inner diameter of the sleeve so that a channel is defined between the guiding stylet and the sleeve (see Fig. 13); a fitting disposed at a proximal end of the sleeve to define a liquid-tight seal (68; per Fig. 12, the fitting fits tightly around the sleeve 68 without any spaces so that liquid may pass through the nozzles, see [0041]; this is akin to applicant’s liquid-tight seal, see p. 7: 10 – 14; examiner additionally notes that an o-ring is illustrated in Fig. 12 for sealing passage of the stylet, allowing for proper administration of liquid through the nozzles) the fitting having a connector opening configured for mating with a syringe (48); and a nozzle disposed at a distal end of the sleeve (see Brillant nozzle 9 as disclosed above), the nozzle having a concentric bore with an outlet at a distal tip, the outlet configured to project a fine spray of a liquid axially forward beyond the distal tip when a pressure is applied at the proximal end of the sleeve (see Brillant nozzle 9, per rejection in claim 1 above); wherein the sleeve is configured for coaxial insertion into the endotracheal tube during intubation, the sleeve having a length configured to position the nozzle near a distal end of the endotracheal tube (see claim 1 above).
9. The device of claim 8, wherein the fitting is configured for releasable attachment to the syringe, and wherein the syringe is configured to generate the pressure (see arguments in claim 2 above).
10. The device of claim 8, wherein the liquid is a topical anesthetic (see arguments in claim 3 above).
11. The device of claim 8, wherein the fitting further comprises an insertion stop configured to limit an insertion length within the endotracheal tube (see arguments in claim 4 above).
Claim(s) 5 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vomastek (US 20130167839) in view of Brillant (US 20170182265) in view of Denton (6112743).
Regarding claim 5, Vomastek in view of Herskovic discloses the device of claim 1, but does not explicitly disclose wherein the fitting comprises a Luer-style fitting configured for releasably mating with a Luer-style syringe. Nonetheless, Denton discloses a medical device for creating therapeutic mists (c. 1: 7), wherein the device comprises a hollow sleeve of any applicable length (108, see Fig. 4, c. 5: 13 – 24), the sleeve communicating with a nozzle (123), a proximal end of the sleeve connected to a fitting (121), wherein the fitting comprises a Luer-style fitting configured for releasably mating with a Luer-style syringe (Denton, c. 4: 6 – 22). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the fitting of Vomastek with the Luer-lock of Denton for the benefit of easily and reliably connecting/disconnecting a fluid/pressure source for passage of medicament through to the device.
12. The device of claim 8, wherein the fitting comprises a Luer-style fitting configured for releasably mating with a Luer-style syringe (see above).
Claim(s) 6 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vomastek (US 20130167839) in view of Brillant (US 20170182265) in view of Lorenzen (US 5730123)
Regarding claim 6, Vomastek in view of Herkovic discloses the device of claim 1, Lorenzen discloses a fitting for endotracheal access further comprising a connector (180) disposed at an end of an elongated tubing (190), the connector configured for releasably mating with the fitting (c. 8: 47) and the elongated tubing having a length configured to allow administration of additional liquids at a non-interfering distance from the intubation procedure (c. 8: 48 – 49, c. 9: 28 – 32). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the fitting of Vomastek with the connector/tubing of Lorenzen for the benefit of administering medication for any desired length of tubing so as to clear access around the surgical site in a position more comfortable to the surgeon.
13. The device of claim 8, further comprising a connector disposed at an end of an elongated tubing, the connector configured for releasably mating with the fitting and the elongated tubing having a length configured for administration of additional liquids at a non-interfering distance from the intubation procedure (see above).
Claim(s) 7 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vomastek (US 20130167839) in view of Brillant (US 20170182265) in view of Caine (US 2541402)
Regarding claim 7, Vomastek in view of Herskovic discloses the device of claim 1. Caine discloses an endotracheal insertion device comprising an outer sleeve and inner stylet, the device further comprising a removable stop configured for attachment to the fitting or the sleeve to limit insertion of the device to a predetermined insertion depth within the endotracheal tube (c. 2: 35 – 41, wherein adjustment along the longitudinal length of the uniform sleeve would allow for removal of the stop). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the sleeve of Vomastek with the stop of Caine for the benefit of adjustably limiting insertion of the device according to the length of the endotracheal tube, see c. 1: 30 – 34.
14. The device of claim 8, further comprising a removable stop configured for attachment to the fitting or the sleeve to limit insertion of the device to a predetermined insertion depth within the endotracheal tube (see above).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 8, and dependents therein 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.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 4402684- atomizing sleeve with coaxial stylet
US 5257620 – outside connections on endotracheal tube
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 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, Brian Casler can be reached at (571) 272-4956. 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.
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799