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 .
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) 1-3 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Persson (2004/0226564) in view of Flagler et al. (2015/0174353).
Regarding claim 1, Persson teaches a trachea cannula for laryngectomized and/or tracheotomized persons (fig. 2) comprising a cannula tube part (10) a connector part (17, 18) and at least two supporting wings (12) for fastening a strap (19), wherein the supporting wings (12) are disposed on the connector part (17), wherein the connector part (17, 18) comprises a first conical part (fig. 4 shows an internal conical part adjacent tube 10) and a second conical part (18), wherein the first conical part (interior conical part) is disposed on the cannula tube (10) and widens away from the cannula tube part (as shown in fig. 4, the conical part widens upward) and wherein the second conical part (18) is disposed on the first conical part and widens towards the first conical part (as shown in fig. 2, the external conical part 18 is located on and widens towards the interior conical part).
Persson substantially teaches the claimed invention except for the connector part and tube part are formed as one piece. However, Flagler teaches the tube (12) and connector part (20, 24) are formed as one piece ([0028] lines 1-10, [0026] lines 1-15, [0034] lines 1-20 disclose over molding and injection molding to form the cannula connected as one piece). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have manufactured the cannula of Persson to be formed as one piece as taught by Flagler to provide the advantage of enhanced ease in cleaning since there would be less crevices at connection points.
Regarding claim 2, Persson discloses the first conical part (interior) and the second conical part (exterior part) are adjacent to each other via a transition region (as shown in fig. 4, there is created a transition region around flange 17).
Regarding claim 3, Persson discloses the supporting wings (12) are disposed substantially in the transition region (as shown in fig. 4, the wings 12 are in the transition region).
Regarding claim 10, the modified Persson discloses the connector and tube part are formed by injection molding together in one production step ([0034] lines 1-20 of Flagler disclose that the parts are formed together as one piece via injection molding without requiring an additional fusing step).
Claim(s) 4-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Persson in view of Flagler, as applied to claim 1 above, and further in view of Ramdohr et al. (2019/0184120).
Regarding claim 4, Persson substantially teaches the claimed invention except for the supporting wings are curved. However, Ramdohr discloses curved wings (8). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wings of Persson to be curved as taught by Ramdohr to provide the advantage of enhanced accommodation of a user’s anatomy less likely to interfere with clothing since the wings stick out less.
Regarding claim 5, the modified Persson teaches (see fig. 1 of Ramdohr) wherein a radius of a curve of each of the supporting wings (8) can be disposed substantially in a transverse plane (as shown, the radius is substantially in a transverse plane).
Regarding claim 6, the modified Persson teaches (see fig. 1 of Ramdohr) the supporting wings (8) extend distally and laterally from a connection point on the connector part (as shown, the wings extend backward and laterally from the center connection point).
Regarding claim 7, the modified Persson teaches (see fig. 1 of Ramdohr ) an end of the supporting wings (8) facing away from the connection point (center) comprises a distance to a frontal plane (xy plane) on which a transition point arranged in the transition region is arranged (as shown a point is arranged in the transition region at a distance from the frontal plane).
Regarding claim 8, the modified Persson teaches (see fig. 1 of Ramdohr) wherein the distance (from the frontal plane) corresponds approximately to a width of at least one strap recess (as shown in fig. 2 of Ramdohr the strap recess extends approximately the distance) arranged in the supporting wings.
Regarding claim 9, Persson substantially teaches the claimed invention except for in that at least the cannula tube part comprises a hardness of about 60 Shore-A to about 80 Shore-A according to DIN ISO 7619-1 (2012-02). However, Ramdohr teaches a hardness of about 60 Shore-A to about 80 Shore-A ([0023] discloses 60-70 shore A which is within the claimed range). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have manufactured the tube of Persson to have hardness with in the claimed range as taught by Ramdohr to provide the advantage of softness and flexibility for enhanced patient comfort and safety.
Response to Arguments
Applicant's arguments filed 12/26/2025 have been fully considered but they are not persuasive.
Applicant argues on page 6 2nd paragraph that figs. 2 nd 4 of Persson are different embodiments. Examiner respectfully disagrees. [0013]-[0016] of Perssons disclose that figs .4 is a plan view of the same embodiment. Thus Persson teaches the limitation as claimed.
Applicant argues on page 6 last paragraph through page 7 3rd paragraph that Persson does not teach the newly added limitations. However, Examiner notes that Flagler is now relied on. Thus the combination of Persson and Flagler teach the limitations as claimed.
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 LATOYA M LOUIS whose telephone number is (571)270-5337. The examiner can normally be reached M-F 1 pm - 6:30 pm ET.
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, Kendra Carter can be reached at 571-272-9034. 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.
/LaToya M Louis/Primary Examiner, Art Unit 3785
Prosecution Insights